First Conditionally Active Biologics licensing participation in Greater China territory

San Diego, CA - April 16, 2019 - BioAtla^©, LLC, a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) protein therapeutics for the oncology market, today announced that Himalaya Therapeutics SEZC, a Cayman Island corporation and majority owned subsidiary of BioAtla, has the exclusive license from BioAtla to develop and commercialize several specific, differentiated product candidates for the Greater China market of the PRC, Hong Kong, Macau and Taiwan. The Himalaya Therapeutics portfolio includes two CAB candidates, CAB-AXL-ADC and CAB-ROR2-ADC, each currently in Phase 1/2 clinical trials conducted by BioAtla at sites in the United States. In addition, Himalaya Therapeutics will participate in BioAtla's potential Greater China derived returns from the recently announced BioAtla and BeiGene, Ltd. global co-development and collaboration agreement for the development, manufacture and commercialization of CAB-CTLA-4 (BA3071).  Himalaya will also support Bioatla's global clinical trials effort in Greater China.  

"We believe that Himalaya's product development and business related activities directly addressing Greater China will maximize the strategic opportunities for both BioAtla and Himalaya in the world's second largest pharmaceutical market," stated Carolyn Short, General Manager of Himalaya Therapeutics. "The access to clinical development capabilities in China can accelerate the global development and potential commercialization of the BioAtla product portfolio and effectively address markets with strong growth potential and high unmet medical need," added Scott Smith, President of BioAtla.

Recent sweeping changes to the China regulatory processes for the development of pharmaceutical products now closely align them with those in the United States and broadens the use of clinical data for regulatory purposes between the two nations.  Consequently, close coordination of clinical development in the U.S. and China of a pharmaceutical candidate is highly desireable and more efficient.  Furthermore, the access to capital markets for early-stage biotechnology companies in China has recently been greatly enhanced especially with the revision to the stock listing requirements on the Hong Kong Stock Exchange. Himalaya Therapeutics is expected to fund its operations independent from BioAtla.  These were primary motivating factors for Beijing Sinobioway Group Company and its related investor groups to contribute all of their rights to certain and any future CAB candidates that were part of their 2015 collaboration agreement with BioAtla in exchange for a minority equity position in Himalaya Therapeutics.   

About Conditionally Active Biologics (CABs)

Conditionally Active Biologics are proteins generated using BioAtla's proprietary protein discovery, evolution and expression technologies. These proteins can be monoclonal antibodies, enzymes and other proteins designed with functions dependent on changes in micro physiological conditions (e.g., pH level, oxidation, temperature, pressure, presence of certain ions, hydrophobicity and combinations thereof) both outside and inside cells. Studies have shown that cancerous tumors create highly specific conditions at their site that are not present in normal tissue. These cancerous microenvironments are primarily a result of the well understood unique glycolytic metabolism associated with cancer cells, referred to as the Warburg Effect in aerobic cancer cells. CAB proteins are designed to deliver their therapeutic payload and/or recruit the immune response in specific and selected locations and conditions within the body and to be active only in the presence of a particular cellular microenvironment. In addition, the activation is designed to be reversible to repeatedly switch ‘on and off' should the CAB move from a diseased to a normal cellular microenvironment and vice versa. CABs can be developed in a variety of formats, including antibodies, antibody drug conjugates (ADCs), bispecifics, chimeric antigen receptor T-cells (CAR-Ts) and combination therapies.

About BioAtla, LLC

BioAtla is a global clinical-stage biotechnology company with operations in San Diego, California, and Beijing, China. BioAtla develops novel monoclonal antibody and other protein therapeutic product candidates designed to have more selective targeting, greater efficacy, and more cost-efficient and predictable manufacturing than traditional antibodies. BioAtla has two programs currently in Phase 1/2 clinical testing in the United States, BA3011, a novel conditionally active AXL-targeted antibody-drug conjugate (CAB-AXL-ADC), and BA3021, a novel conditionally active ROR2-targeted antibody-drug conjugate (CAB-ROR2-ADC).

 

Contact:

Richard Waldron

Chief Financial Officer BioAtla, LLC rwaldron@bioatla.com 858.356.8945

Plan to pursue development as a monotherapy and in combination with BeiGene's investigational anti-PD-1 antibody, tislelizumab

 

San Diego, CA; Beijing, China and Cambridge, MA,  - April 8, 2019 - BioAtla ^©, LLC, a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) protein therapeutics, and BeiGene, Ltd. (Nasdaq: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, today announced that the two companies have entered into a global co-development and collaboration agreement for the development, manufacturing and commercialization of BioAtla's investigational CAB CTLA-4 antibody (BA3071). BA3071 is a novel, CTLA-4 inhibitor that is designed to be conditionally activated in the tumor microenvironment in order to reduce systemic toxicity and potentially enable safer combinations with checkpoint inhibitors such as BeiGene's investigational anti-PD-1 antibody, tislelizumab, a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages.

 

Under the terms of the collaboration, BioAtla will co-develop the CAB-CTLA-4 antibody to defined early clinical objectives and BeiGene will then lead the parties' joint efforts to develop the product candidate and be responsible for global regulatory filings and commercialization. Subject to the terms of the agreement, BeiGene will hold a co-exclusive license with BioAtla to develop and manufacture the product candidate globally and an exclusive license to commercialize the product candidate globally. BeiGene will be responsible for all costs of development, manufacturing and commercialization in Asia (ex-Japan), Australia and New Zealand, and the parties will share development and manufacturing costs and commercial profits and losses upon specified terms in the rest of the world. BioAtla will receive an upfront payment of $20 million and a milestone payment upon reaching the defined early clinical objectives. BioAtla is also eligible to receive up to $249 million in subsequent development and regulatory milestones globally and commercial milestones in the BeiGene territory, together with tiered royalties on sales in the BeiGene territory. Additional terms of the agreement were not disclosed.

 

"BeiGene is a recognized leader in China-inclusive global clinical development, with broad oncology clinical programs, which include tislelizumab," said Scott Smith, President of BioAtla. "This collaboration complements our strategy of building our pipeline of innovative CAB oncology candidates, advancing combination product therapies, and effectively addressing markets with strong growth potential and high unmet medical need."

 

 

"BioAtla has developed an exciting proprietary protein discovery and expression platform to generate CABs, which in turn have been applied to BA3071, a novel, investigational CTLA-4 inhibitor that is designed to be conditionally activated in the tumor microenvironment," commented Dr. Lai Wang, Senior Vice President, Asia Pacific Clinical Development, Global Research, Clinical Operations and Biometrics, for BeiGene. "The unique nature of BA3071 provides an exciting opportunity to combine this CTLA-4 antibody with our anti-PD-1 antibody, tislelizumab. We look forward to working with BioAtla through proof-of-concept, followed by global development of this potentially unique cancer therapy as a single agent or in combination with other therapies."

 

"We believe that our collaboration with BeiGene will accelerate the global development and potential commercialization of BA3071 and advance the prospects and potential of safer and more effective combination therapies for the treatment of several cancer indications," stated Jay M. Short, Ph.D., Chairman, CEO and co-founder of BioAtla. "The application of BioAtla's CAB technology to CTLA-4 inhibition may offer greater potency and safety, thereby improving this important cancer therapy and expanding its potential applications."

 

About BA3071

 

BA3071 is a novel, investigational conditionally active CTLA-4 inhibitor. The first investigational new drug (IND) filing is currently planned for mid-2019. Subject to regulatory clearance of the IND, a Phase 1/2 multi-center, open-label study designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity and antitumor activity of BA3071 alone and in combination with BeiGene's tislelizumab, an investigational anti-PD-1 inhibitor, is anticipated to start in the second half of 2019.

 

The cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) is an inhibitory receptor expressed on T cells. The CTLA-4 pathway is a key immune checkpoint pathway that provides a downregulating signal to T cells. The blockade of CTLA-4 is intended to induce an antitumor immune response by promoting the activation and proliferation of tumor-specific T cells. Although inhibition of CTLA-4 has been shown to significantly improve antitumor response, it may also lead to immune attack of healthy cells. To minimize on-target off-tumor toxicity, BioAtla has applied its proprietary CAB technology with the intent to activate binding to the CTLA-4 receptor only on T cells in the tumor microenvironment.

 

Inhibition of immune checkpoints using anti-programmed cell death-1 (PD-1) or anti-CTLA-4 monoclonal antibodies has revolutionized the management of patients with advanced-stage melanoma and are among the most promising components of treatment approaches for many other cancers. Employing BioAtla's proprietary CAB technology, BA3071 is designed to improve the efficacy and safety of anti-CTLA-4 therapy, as a monotherapy and in combination with other therapies, by restricting its activation and that of tumor specific T cells to the tumor microenvironment.

 

About Conditionally Active Biologics (CABs)

 

Conditionally Active Biologics are proteins generated using BioAtla's proprietary protein discovery, evolution and expression technologies. These proteins can be monoclonal antibodies, enzymes and other proteins designed with functions dependent on changes in micro physiological conditions (e.g., pH level, oxidation, temperature, pressure, presence of certain ions, hydrophobicity and combinations thereof) both outside and inside cells.

 

Studies have shown that cancerous tumors create highly specific conditions at their site that are not present in normal tissue. These cancerous microenvironments are primarily a result of the well understood unique glycolytic metabolism associated with cancer cells, referred to as the Warburg Effect in aerobic cancer cells. CAB proteins are designed to deliver their therapeutic payload and/or recruit the immune response in specific and selected locations and conditions within the body and to be active only in the presence of a particular cellular microenvironment. In addition, the activation is designed to be reversible to repeatedly switch ‘on and off' should the CAB move from a diseased to a normal cellular microenvironment and vice versa. CABs can be developed in a variety of formats, including antibodies, antibody drug conjugates (ADCs), bispecifics, chimeric antigen receptor T-cells (CAR-Ts) and combination therapies.

 

About Tislelizumab

 

Tislelizumab (BGB-A317) is an investigational humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells. Tislelizumab is the first drug candidate produced from BeiGene's immuno-oncology biologic program, and is being developed as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers.

 

Clinical trials of tislelizumab include a global Phase 3 clinical trial in patients with second-line non-small cell lung cancer (NSCLC); a global Phase 3 clinical trial in first-line patients with hepatocellular carcinoma (HCC); a global Phase 3 clinical trial in second-line patients with esophageal squamous carcinoma (ESCC); a global Phase 3 clinical trial in first-line patients with gastric cancer (GC); a global Phase 3 clinical trial in first-line patients with ESCC; a global Phase 3 trial in patients with Stage III NSCLC; a global Phase 2 clinical trial in second- or third-line patients with HCC; a global Phase 1 clinical trial in patients with relapsed/refractory (R/R) NK/T-cell lymphomas; and a global Phase 1 clinical trial in patients with solid tumors. In China, BeiGene has completed a pivotal Phase 2 clinical trial in patients with R/R classical Hodgkin's lymphoma (cHL), and is conducting a Phase 3 clinical trial in first-line patients with non-squamous NSCLC; a Phase 3 clinical trial in first-line patients with squamous NSCLC; a Phase 2 clinical trial in second-line urothelial cancers (UC); and a Phase 2 clinical trial in patients with MSI-H or dMMR solid tumors.

 

The new drug application (NDA) in China for R/R cHL has been accepted by the China National Medical Products Administration (NMPA) and granted priority review.

BeiGene and Celgene Corporation have a global strategic collaboration for the development of tislelizumab in solid tumor cancers outside of Asia (except Japan).

 

About BioAtla, LLC

 

BioAtla is a global clinical-stage biotechnology company with operations in San Diego, California, and Beijing, China. BioAtla develops novel monoclonal antibody and other protein therapeutic product candidates designed to have more selective targeting, greater efficacy, and more cost-efficient and predictable manufacturing than traditional antibodies. BioAtla has two programs currently in Phase 1/2 clinical testing in the United States, BA3011, a novel conditionally active AXL-targeted antibody-drug conjugate (CAB-AXL-ADC), and BA3021, a novel conditionally active ROR2-targeted antibody-drug conjugate (CAB-ROR2-ADC).

 

About BeiGene

 

BeiGene is a global, commercial-stage, research-based biotechnology company focused on molecularly-targeted and immuno-oncology cancer therapeutics. With a team of over 2,200 employees in China, the United States, Australia and Europe, BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for cancer. BeiGene is also working to create combination solutions aimed to have both a meaningful and lasting impact on cancer patients. BeiGene markets ABRAXANE^© (nanoparticle albumin-bound paclitaxel), REVLIMID^© (lenalidomide), and VIDAZA (azacitidine) ^© in China under a license from Celgene Corporation.¹ 

 

BeiGene Cautionary Note Regarding BeiGene's Forward-Looking Statements

 

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding future research, development and potential commercialization activities under the agreement with BioAtla, potential payments payable to BioAtla, the speed and outcome of drug development plans, the advancement of and anticipated clinical development, regulatory milestones and commercialization of BA3071 and tislelizumab, potential advantages and differentiation of BA3071 and tislelizumab, BioAtla's and BeiGene's development and commercial plans, and other information that is not historical information.  Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeiGene's ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; BeiGene's ability to achieve commercial success for its marketed products and drug candidates, if approved; BeiGene's ability to obtain and maintain protection of intellectual property for its technology and drugs; BeiGene's reliance on third parties to conduct drug development, manufacturing and other services; BeiGene's limited operating history and BeiGene's ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates, as well as those risks more fully discussed in the section entitled "Risk Factors" in BeiGene's most recent annual report on Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in BeiGene's subsequent filings with the U.S. Securities and Exchange Commission.  All information in this press release is as of the date of this press release, and BeiGene undertakes no duty to update such information unless required by law.

 

BeiGene Investor Contact
Craig West
+1 857-302-5189
ir@beigene.com 

 

BeiGene Media Contact
Liza Heapes
+1 857-302-5663 
media@beigene.com

 

BioAtla Contact:

Richard Waldron

Chief Financial Officer

BioAtla, LLC

rwaldron@bioatla.com

858-356-8945

 

¹ ABRAXANE^©, REVLIMID^©, and VIDAZA^© are registered trademarks of Celgene Corporation.

 

Oral presentation highlights CAB-CTLA-4 pre-clinical data demonstrating expected efficacy and reduced immune side effects and toxicities as monotherapy or in combination with PD-1 inhibitors

 

Poster presentation of CAB-EpCAM-ADC demonstrating anti-tumor efficacy in vivo

 

San Diego, CA - February 27, 2019 - BioAtla ^©, LLC, a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) protein therapeutics, will present pre-clinical data on BA3071 and BA3181, the company's novel CAB-CTLA-4 and CAB-EpCAM-ADC programs, at the 2019 American Association For Cancer Research (AACR) annual meeting in Atlanta, Georgia on March 29-April 3, 2019.

"These new data showcase the capabilities of our proprietary CAB technology, which we believe will expand the number of druggable protein targets and maximize both potency and safety in combination therapies, antibody drug conjugate (ADC) medicines, bispecifics and other targeted therapy formats for cancer treatments," stated Jay M. Short, Ph.D., Chairman, CEO and co-founder of BioAtla.

"We are particularly excited by these new preclinical data for our novel CAB-CTLA-4 program as a single-agent or in combination with checkpoint inhibitors. This novel CAB has the potential for an improved safety margin and therapeutic index thereby improving this important cancer therapy," said Scott Smith, President of BioAtla.

"These preclinical data suggest that our CAB technology may effectively address the issue of on-target off-tumor toxicity and allow leveraging the widely expressed and promising EpCAM target for cancer therapy," added Scott Smith.

BA3071 is a novel conditionally active CTLA-4 inhibitor. The CTLA-4 pathway is a key immune checkpoint pathway that provides a downregulating signal to T cells. Although inhibition of CTLA-4 has been shown to significantly improve the antitumor response, it may also lead to immune attack of healthy cells. To minimize on-target off-tumor toxicity, BioAtla applies its proprietary CAB technology with the intent to activate binding to the CTLA-4 receptor preferentially on T cells in the tumor microenvironment. The data to be presented at AACR indicate that our CAB-CTLA-4 molecule may have a superior safety profile when used in combination with PD-1 inhibitors and allow increased dosing levels to achieve superior efficacy to current anti-CTLA-4 therapy as a single agent or in combination with other anti-cancer therapies including immuno-oncology agents. The BA3071 IND filing is planned for mid-2019. A Phase 1/2 multi-center, open-label study designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity and antitumor activity of BA3071 alone and in combination with a PD-1 inhibitor is anticipated to start in H2 2019.

BA3181 is a novel conditionally active EpCAM targeted antibody drug conjugate (CAB-EpCAM-ADC). EpCAM is expressed at high levels exclusively in epithelia and epithelial-derived neoplasms, making it a suitable target for many important solid tumor types and cancer stem cells. EpCAM expression on normal tissues limits its utility as a target for therapeutic antibodies and ADCs due to the potential effects on normal epithelial throughout the body. Using our CAB technology, BioAtla has developed CAB antibodies to EpCAM that reversibly bind to recombinant EpCAM and EpCAM expressing cells under select conditions that are present in the tumor microenvironment but not in normal tissues. In vitro and in vivo efficacy data for several anti-EpCAM antibodies and ADCs will be presented and suggest that conditionally active EpCAM ADCs generated using the CAB technology provided drug candidates, including BA3181, that have the potential to have an increased safety margin and therapeutic index in the clinic. 

Abstract Selected for Oral Presentation:

19-A-6330-AACR:  Potent CAB CTLA-4 antibody to reduce immune side effects and toxicities associated with single agent and combination cancer immuno therapies

Abstract Control Number: 6215

Session Title:  Rational Combinations of Immunotherapy

Session Date and Time: 4/1/2019 3:00PM - 5:00 PM

Presenter:  William Boyle, Ph.D., Chief of Translational Medicine, BioAtla LLC

Abstract Selected for Poster Presentation

Novel conditionally active biologic (CAB) antibody targeting EpCAM demonstrates anti-tumor efficacy in vivo

Session Title:  New Anticancer Agents

Session Date and Time:   Sunday Mar 31, 2019 1:00 PM - 5:00 PM

Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 14

Poster Board Number:  17

Permanent Abstract Number: 356 

Session information is available online via the Annual Meeting Itinerary Planner through the AACR website at www.aacr.org.

About Conditionally Active Biologics (CABs)

Conditionally Active Biologic proteins are generated using BioAtla's proprietary protein discovery, evolution and expression technologies. These proteins can be monoclonal antibodies, enzymes and other proteins designed with functions dependent on changes in micro physiological conditions (e.g., pH, oxidation, temperature, pressure, presence of certain ions, hydrophobicity and combinations thereof) both outside and inside cells.

Studies have shown that cancerous tumors create highly specific conditions at their site that are not present in normal tissue. These tumor microenvironments (TMEs) are primarily influenced by the characteristic glycolytic metabolism associated with cancer cells, including for those cells under aerobic conditions referred to as the Warburg Effect. CAB proteins are designed to deliver their therapeutic payload and/or recruit the immune response in specific and selected locations and conditions within the body and to be active only in the presence of a particular cellular microenvironment. In addition, the activation is designed to be reversible, to repeatedly switch ‘on and off' should the CAB move from a diseased to a normal cellular microenvironment and vice versa, thereby widening the therapeutic index. CABs can be developed in a variety of formats including antibodies, antibody drug conjugates (ADCs), bispecifics, chimeric antigen receptor T-cells (CAR-Ts) and combination therapies.

About BioAtla , LLC

BioAtla is a global clinical-stage biotechnology company headquartered in San Diego, California, and with operations in Beijing, China. BioAtla develops novel monoclonal antibody and other protein therapeutic product candidates designed to have more selective targeting, greater efficacy, and more cost-efficient and predictable manufacturing than traditional antibodies. BioAtla has two programs currently in Phase 1/2 clinical testing in the US, BA3011 a novel conditionally active AXL-targeted antibody-drug conjugate (CAB-AXL-ADC) and BA3021 a novel conditionally active ROR2-targeted antibody-drug conjugate (CAB-ROR2-ADC), in addition to two licensed, royalty-bearing clinical stage CAB programs.

 

Contact:

Richard Waldron

Chief Financial Officer

BioAtla, LLC

rwaldron@bioatla.com

858.356.8945

 

Drs. Allison and Sharma advising BioAtla on its CAB-CTLA4 antibody drug candidate and other proprietary CAB programs and the design of combination therapies

 

SAN DIEGO, CA - October 4, 2018 - BioAtla, LLC, a global biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics, congratulates James Allison, Ph.D., for receiving the 2018 Nobel Prize in Physiology or Medicine recognizing his leading role in launching an effective new way to attack cancer by treating the immune system. Dr. Allison and Padmanee Sharma, M.D., Ph.D., both at MD Anderson and leading researchers in the field of immuno-oncology, are scientific advisors to BioAtla. Dr. Allison's pioneering research in the regulation of T cell responses and strategies for cancer immunotherapy led to the development of the ipilimumab antibody to CTLA-4, the first immune checkpoint blockade therapy approved by the U.S. Food and Drug Administration. 

 

"We congratulate Jim for receiving the world's preeminent award for outstanding discoveries in the field of life sciences and medicine," said Jay M. Short, Ph.D., Chairman, Chief Executive Officer and co-founder of BioAtla. "As scientific advisors to BioAtla, he and Dr. Sharma provide valuable contributions to the direction and prioritization of our CAB development programs, including our CAB-CTLA4 antibody candidate, and to enhance our decisions and design of combination CAB immunotherapies and CAB bispecifics,"

 

About Dr. Allison

James Allison, Ph.D., is Chair of the Department of Immunology, the Vivian L. Smith Distinguished Chair in Immunology, Director of the Parker Institute for Cancer Research, and the Executive Director of the Immunotherapy Platform at The University of Texas MD Anderson Cancer Center (MD Anderson).

 

Among Dr. Allison's most notable discoveries in his distinguished career studying the regulation of T cell responses, are the determination of the T cell receptor structure and that CD28 is the costimulatory molecule that allows full activation of naïve T cells and prevents anergy in T cell clones.  His lab resolved a major controversy by demonstrating that CTLA-4 inhibits T cell activation by opposing CD28-mediated costimulation and that blockade of CTLA-4 could enhance T cell responses, leading to tumor rejection in animal models, and launched the emerging field of immune checkpoint blockade therapy for cancer. Dr. Allison is a member of the National Academies of Science and Medicine.  In addition to recently receiving the Nobel Prize, he received the Lasker-Debakey Clinical Medical Research Award in 2015.

 

About Conditionally Active Biologics (CABs)

Conditionally Active Biologic proteins are generated using BioAtla's proprietary protein discovery, evolution and expression technologies. These proteins can be antibodies, enzymes and other proteins designed with functions dependent on changes in microphysiological conditions (e.g., pH level, oxidation, temperature, pressure, presence of certain ions, hydrophobicity and combinations thereof) both outside and inside cells.

 

Studies have shown that cancerous tumors create highly specific conditions at their site that are not present in normal tissue. These cancerous microenvironments are primarily a result of the well understood unique glycolytic metabolism associated with cancer cells, referred to as the Warburg Effect. CAB proteins are designed to deliver their therapeutic payload and/or recruit the immune response in specific and selected locations and conditions within the body and to be active only in the presence of a particular cellular microenvironment. In addition, the activation is designed to be reversible to repeatedly switch ‘on and off' should the CAB move from a diseased to a normal cellular microenvironment and vice versa. CABs can be developed in a variety of formats including monoclonal antibodies (mAbs), antibody drug conjugates (ADCs), bi-specifics, chimeric antigen receptor T-cells (CAR-Ts) and combination therapies.

 

About BioAtla, LLC

BioAtla is a global biotechnology company with operations in San Diego, California, and Beijing, China. BioAtla develops novel monoclonal antibody and other protein therapeutic product candidates designed to have more selective targeting, greater efficacy, and more cost-efficient and predictable manufacturing than traditional antibodies. Two of the Company's conditionally active drug candidates, BA3011, an AXL-targeted antibody-drug conjugate (CAB-AXL-ADC), and BA3021, a ROR2-targeted antibody-drug conjugate (CAB-ROR2-ADC), currently are each the subject of a multi-center, open-label, Phase 1/2 study designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity and antitumor activity of the CAB candidate in patients with advanced solid tumors. In addition, two licensed CAB CAR-T antibodies are in clinical trials for solid tumors in China.

 

Learn more at www.bioatla.com.

 

 

Contact:
Richard Waldron

Chief Financial Officer

BioAtla, LLC

rwaldron@bioatla.com

858.356.8945

Experienced biopharmaceutical executive to drive expansion of operations, product strategy and corporate partnering efforts

 

SAN DIEGO, CA - September 10, 2018 - BioAtla, LLC, a global biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics, today announced the appointment of Scott Smith, as President. Mr. Smith, an experienced biotechnology and pharmaceutical executive, joins the Company from Celgene Corporation, where he was President and Chief Operating Officer.

 

"Scott's experience and proven capabilities in building and leading organizations for the development and commercialization of innovative products makes him ideally suited to help lead the expansion of BioAtla's operations, including business development and partnering activities, new product development and execution of our strategies to advance our CAB platform opportunities worldwide. I look forward to working with Scott to build on and accelerate BioAtla's progress," said Jay M. Short, Ph.D., Chairman, Chief Executive Officer and Co-founder of BioAtla.

 

About Scott Smith

Mr. Smith joins BioAtla with 30 years of biotechnology and pharmaceutical industry experience. In his ten years at Celgene from 2008-2018 his leadership role expanded from Vice President of Global Marketing for Inflammation & Immunology, to Global Head of that division, to President of the Inflammation & Immunology Franchise to his appointment in 2017 as Celgene's President and Chief Operating Officer. With a particular emphasis and interest in immunology, Mr. Smith drove the growth of Celgene's Inflammation and Immunology division from 13 to more than 1,300 people worldwide and oversaw the clinical development, global registration and commercial success of the blockbuster drug Otezla. Mr. Smith's prior experience at Pharmacia (acquired by Pfizer) and at Biovail included global responsibility for sales and marketing, creating and executing commercial and business development strategies and contributing to regulatory and clinical development strategies. Mr. Smith also serves on the board of directors of Titan Pharmaceuticals, Triumvira Immunologics and Springbank Pharmaceuticals. Mr. Smith received both his BSc degree in Chemistry and Biology and his HBSc degree in Pharmacology and Toxicology from the University of Western Ontario and his Masters of International Business Management from the American Graduate School of International Management (Thunderbird).

 

About Conditionally Active Biologics (CABs)

Conditionally Active Biologic proteins are generated using BioAtla's proprietary protein discovery, evolution and expression technologies. These proteins can be mAbs, enzymes and other proteins designed with functions dependent on changes in microphysiological conditions (e.g., pH level, oxidation, temperature, pressure, presence of certain ions, hydrophobicity and combinations thereof) both outside and inside cells.

 

Studies have shown that cancerous tumors create highly specific conditions at their site that are not present in normal tissue. These cancerous microenvironments are primarily a result of the well understood unique glycolytic metabolism associated with cancer cells, referred to as the Warburg Effect. CAB proteins are designed to deliver their therapeutic payload and/or recruit an immune response in specific and selected locations and conditions within the body and to be active only in the presence of a particular cellular microenvironment. In addition, the activation is designed to be reversible to repeatedly switch ‘on and off' should the CAB move from a diseased to a normal cellular microenvironment and vice versa. CABs can be developed in a variety of formats including antibodies, antibody drug conjugates (ADCs), bi-specifics, chimeric antigen receptor T-cells (CAR-Ts) and combination therapies.

 

 

About BioAtla, LLC

BioAtla is a global biotechnology company with operations in San Diego, California, and Beijing, China. BioAtla develops novel monoclonal antibody and other protein therapeutic product candidates designed to have more selective targeting, greater efficacy, and more cost-efficient and predictable manufacturing than traditional antibodies. Two of the Company's conditionally active drug candidates, BA3011, an AXL-targeted antibody-drug conjugate (CAB-AXL-ADC), and BA3021, a ROR2-targeted antibody-drug conjugate (CAB-ROR2-ADC), currently are the subject of multi-center, open-label, Phase 1/2 studies designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity and antitumor activity of the CAB candidate in patients with advanced solid tumors. In addition, two licensed CAB CAR-T antibodies are in clinical trials for solid tumors in China.

 

Learn more at www.bioatla.com.

 

Contact:

Richard Waldron

Chief Financial Officer

BioAtla, LLC

rwaldron@bioatla.com

858.356.8945

Leading clinical researcher in cancer immunotherapy will advise BioAtla on clinical trial designs of the company's proprietary CABs in combination therapies

 

SAN DIEGO, CA - July 24, 2018 - BioAtla, LLC, a global biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics, today announced the appointment of Lawrence Fong, M.D., as a scientific advisor. Dr. Fong is a leader in clinical research and has dedicated 20 years to the field of cancer immunotherapy.  Dr. Fong's research focuses on understanding the ways by which immunotherapies can lead to clinical responses as well as to treatment-induced side effects. This work includes tracking antigen-specific T cell responses both in pre-clinical models and in treated cancer patients and developing biomarkers that are associated with clinical outcomes.

 

"The knowledge, experience and insight of Dr. Fong will provide valuable contributions to the direction and prioritization of our CAB development programs.  In particular, his advice will enhance our decisions and design of clinical trials for combination CAB bispecific antibodies and CAB immunotherapies ," said Jay M. Short, Ph.D., Chairman, Chief Executive Officer and President of BioAtla.

 

About Dr. Fong

Lawrence Fong, M.D. is Efim Guzik Distinguished Professor in Cancer Biology and leads the Cancer Immunotherapy Program at the University of California, San Francisco (UCSF).  He is a physician-scientist in the Department of Medicine, Division of Hematology/Oncology directing both a translational research program and an NIH funded research lab. At UCSF he also co-directs the Parker Institute of Cancer Immunotherapy and co-leads the Cancer Immunology Program in the Helen Diller Family Comprehensive Cancer Center. He has served on multiple NIH study sections and committees including the NCI Investigational Drug Steering Committee (IDSC) and Genitourinary Cancers Steering Committee (GUSC). He has also served on multiple scientific advisory boards and journal editorial boards including the Journal of Clinical Oncology and Cancer Immunology Research.

 

About Conditionally Active Biologics (CABs)

Conditionally Active Biologic proteins are generated using BioAtla's proprietary protein discovery, evolution and expression technologies. These proteins can be monoclonal antibodies, enzymes and other proteins designed with functions dependent on changes in microphysiological conditions (e.g., pH level, oxidation, temperature, pressure, presence of certain ions, hydrophobicity and combinations thereof) both outside and inside cells.

 

Studies have shown that cancerous tumors create highly specific conditions at their site that are not present in normal tissue. These cancerous microenvironments are primarily a result of the well understood glycolytic metabolism associated with cancer cells, even in the presence of oxygen, referred to as the Warburg Effect. CAB proteins are designed to deliver their therapeutic payload and/or recruit the immune response in specific and selected locations and conditions within the body and to be active only in the presence of a particular cellular microenvironment. In addition, the activation is designed to be reversible to repeatedly switch ‘on and off' should the CAB move from a diseased to a normal cellular microenvironment and vice versa. CABs can be developed in a variety of formats including monoclonal antibodies, antibody drug conjugates (ADCs), bispecific antibodies, chimeric antigen receptor T-cells (CAR-Ts) and combination therapies.

About BioAtla, LLC

BioAtla is a global biotechnology company with operations in San Diego, California, and Beijing, China. BioAtla develops novel monoclonal antibody and other protein therapeutic product candidates designed to have more selective targeting, greater efficacy, and more cost-efficient and predictable manufacturing than traditional antibodies.

Learn more at www.bioatla.com.

Contact:
Richard Waldron
Chief Financial Officer
BioAtla, LLC
rwaldron@bioatla.com
858.356.8945

CAB-ROR2-ADC in clinical testing for treatment of several solid tumor types

SAN DIEGO, CA - June 28, 2018 - BioAtla, LLC, a global biotechnology company focused on the development of Conditionally Active Biologic (CAB) protein therapeutics, announced today the treatment of the first patient in its clinical trial BA3021-001 for BioAtla's BA3021, a novel conditionally active ROR2-targeted antibody-drug conjugate (CAB-ROR2-ADC). This is a multi-center, open-label, Phase 1/2 study designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity and antitumor activity of BA3021 in patients with advanced solid tumors including non-small cell lung cancer (NSCLC), triple negative breast cancer and soft tissue sarcoma. CAB-ROR2-ADC is BioAtla's second CAB investigational product to enter clinical trials following BA3011, CAB-AXL-ADC in February of this year.

 

The first patient in the BA3021 clinical study was enrolled and dosed at Sarah Cannon Research Institute at Tennessee Oncology in Nashville, TN under the direction of the principal investigator, Howard A. "Skip" Burris III, MD. Dr. Burris, a recognized leader in clinical oncology, serves as chief medical officer and president of clinical operations at Sarah Cannon. "Innovative advancements in the treatment of cancer include tumor specific activation of therapy and promoting appropriate immune response. Providing access to cutting-edge therapies in clinical trials, such as the BA3021 clinical study, further supports our mission to advance care for cancer patients," said Dr. Burris.

 

The ROR2 transmembrane protein tyrosine kinase is an onco-fetal protein that acts as a non-canonical Wnt 5A receptor.  ROR2 is found to be highly expressed during embryonic development and in several important cancer types, and the level of expression in tumors is tightly correlated with patient prognosis.  Recently, ROR2 and its ligand Wnt 5A have been shown to be induced in cancers that are resistant to treatment with immune checkpoint inhibitors such as anti-PD-1 antibody immune therapy suggesting a mechanistic role of this receptor-ligand axis in resistance to standard cancer treatments resulting in relapsing, minimal residual disease.  However, low to moderate levels of expression of ROR2 in multiple normal adult tissues are predicted based on RNA expression, histological analysis and functional studies. To minimize the risk of potential disruption of normal function of ROR2 receptors on normal cells, BioAtla applies its proprietary CAB technology to develop its CAB antibody-drug conjugate (ADC) targeting ROR2 with the intent to activate binding to the ROR2 receptor only in the tumor microenvironment and deliver the toxic payload to the cancerous cells.  The CAB-ROR2-ADC BA3021 is designed to maximize efficacy on ROR2 expressing tumors while minimizing toxicity, leading to better clinical outcomes.  

 

About Conditionally Active Biologics (CABs)

Conditionally Active Biologic proteins are generated using BioAtla's proprietary protein discovery, evolution and expression technologies. These proteins can be monoclonal antibodies, enzymes and other proteins designed with functions dependent on changes in microphysiological conditions (e.g., pH level, oxidation, temperature, pressure, presence of certain ions, hydrophobicity and combinations thereof) both outside and inside cells.

 

Studies have shown that cancerous tumors create highly specific conditions at their site that are not present in normal tissue. These cancerous microenvironments are primarily a result of the well understood unique glycolytic metabolism associated with cancer cells, referred to as the Warburg Effect. CAB proteins are designed to deliver their therapeutic payload and/or recruit the immune response in specific and selected locations and conditions within the body and to be active only in the presence of a particular cellular microenvironment. In addition, the activation is designed to be reversible to repeatedly switch ‘on and off' should the CAB move from a diseased to a normal cellular microenvironment and vice versa. CABs can be developed in a variety of formats including antibodies, antibody drug conjugates (ADCs), bi-specifics, chimeric antigen receptor T-cells (CAR-Ts) and combination therapies.

 

About BioAtla, LLC

BioAtla is a global biotechnology company with operations in San Diego, California, and Beijing, China. BioAtla develops novel monoclonal antibody and other protein therapeutic product candidates designed to have more selective targeting, greater efficacy, and more cost-efficient and predictable manufacturing than traditional antibodies.

 

 

Contact:

Richard Waldron

Chief Financial Officer

BioAtla, LLC

rwaldron@bioatla.com

858.356.8945

CAB-ROR2-ADC to be clinically tested for treatment of several solid tumor cancers

 SAN DIEGO, CA - April 16, 2018 - BioAtla, LLC, a global biotechnology company focused on the development of Conditionally Active Biologic (CAB) protein therapeutics, announced today the U.S. Food and Drug Administration (FDA) has cleared BioAtla's Investigational New Drug application (IND) for BA3021, a first-in-class conditionally active ROR2-targeted antibody-drug conjugate (CAB-ROR2-ADC), in patients with solid tumors. Under this IND, the company intends to initiate a first-in-human, open label, multicenter, dose escalation and dose expansion study of CAB-ROR2-ADC in patients with locally advanced or metastatic solid tumors. CAB-ROR2-ADC will be BioAtla's second CAB investigational product to enter clinical trials in the United States with BioAtla initiating patient dosing in February of this year with CAB-AXL-ADC for treatment of solid tumors.

 

ROR2 is a developmentally restricted receptor tyrosine kinase (RTK) that interacts with Wnt ligands.  Although essential for embryonic development, ROR2 expression is rare in normal adult tissues. Many of the activities associated with ROR2 in development have been implicated also in cancer including cell migration and invasiveness. ROR2 has been found to be overexpressed in multiple types of cancer including breast, renal, colorectal, melanoma, pancreatic, non-small cell lung cancer (NSCLC), and gastrointestinal stromal tumor (GIST). In general, ROR2 expression is associated with more aggressive disease states and poorer patient prognosis.  Furthermore, recent studies by others indicate that overexpression of either ROR2 or AXL receptor is associated with resistance to anti-PD-1 therapy thereby suggesting immuno-oncology roles for BioAtla's first two clinical stage CAB candidates that target these receptors.

 

ROR2 is a cell surface Wnt5a receptor that is overexpressed in cancer cells making it an attractive target for therapy. BioAtla applies its proprietary CAB technology to develop its CAB antibody-drug conjugate (ADC) targeting ROR2 with the intent to activate binding to the ROR2 receptor in the tumor microenvironment and deliver the toxic payload only to the cancerous cells.

 

About Conditionally Active Biologics (CABs)

Conditionally Active Biologic proteins are generated using BioAtla's proprietary protein discovery, evolution and expression technologies. These proteins can be monoclonal antibodies, enzymes and other proteins designed with functions dependent on changes in microphysiological conditions (e.g., pH level, oxidation, temperature, pressure, presence of certain ions, hydrophobicity and combinations thereof) both outside and inside cells.

 

Studies have shown that cancerous tumors create highly specific conditions at their site that are not present in normal tissue. These cancerous microenvironments are primarily a result of the well understood unique glycolytic metabolism associated with cancer cells, referred to as the Warburg Effect. CAB proteins are designed to deliver their therapeutic payload and/or recruit the immune response in specific and selected locations and conditions within the body and to be active only in the presence of a particular cellular microenvironment. In addition, the activation is designed to be reversible to repeatedly switch ‘on and off' should the CAB move from a diseased to a normal cellular microenvironment and vice versa. CABs can be developed in a variety of formats including antibodies, antibody drug conjugates (ADCs), bi-specifics, chimeric antigen receptor T-cells (CAR-Ts) and combination therapies.

CAB-AXL-ADC in clinical testing for treatment of several solid tumor cancers

SAN DIEGO, CA - February 28, 2018 - BioAtla^© LLC, a global biotechnology company focused on the development of Conditionally Active Biologic (CAB) protein therapeutics, announced today the treatment of the first patient in its clinical trial BA3011-001 for BioAtla's BA3011, a novel conditionally active AXL-targeted antibody-drug conjugate (CAB-AXL-ADC). This is a multi-center, open-label, Phase 1/2 study (NCT03425279) designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity and antitumor activity of BA3011 in patients with advanced solid tumors including non-small cell lung cancer (NSCLC), castration resistant prostate cancer and pancreatic cancer. CAB-AXL-ADC is BioAtla's first CAB investigational product to enter clinical trials.

The first patient in the BA3011 clinical study was enrolled and dosed at Sarah Cannon Research Institute at Tennessee Oncology in Nashville, TN under the direction of the trial's principal investigator, Howard A. "Skip" Burris III, MD. Dr. Burris, a recognized leader in clinical oncology, serves as chief medical officer and president of clinical operations at Sarah Cannon. "Innovative advancements in the treatment of cancer include tumor specific activation of therapy and promoting appropriate immune response. Providing access to cutting-edge therapies in clinical trials, such as the BA3011 clinical study, further supports our mission to advance care for people facing cancer in communities across the U.S. and UK," said Dr. Burris.

The AXL receptor tyrosine kinase is often highly expressed in several cancer types that can lead to poor prognosis. A principal role of AXL appears to be in sustaining a major mechanism of resistance to diverse anticancer therapies. In addition, AXL is a factor in the repression of the innate immune response which may also limit response to treatment including immuno-oncology (IO) therapy.  While this makes the AXL receptor an attractive target for tumor therapy, the AXL receptor is also prevalent in normal tissue of several organs in the body.  To minimize on-target off-tumor toxicity of binding to AXL receptors on normal cells, BioAtla applies its proprietary CAB technology to develop its CAB antibody-drug conjugate (ADC) targeting AXL with the intent to activate binding to the AXL receptor only in the tumor microenvironment and deliver the toxic payload to the cancerous cells.

About Conditionally Active Biologics (CABs)

Conditionally Active Biologic proteins are generated using BioAtla's proprietary protein discovery, evolution and expression technologies. These proteins can be monoclonal antibodies, enzymes and other proteins designed with functions dependent on changes in microphysiological conditions (e.g., pH level, oxidation, temperature, pressure, presence of certain ions, hydrophobicity and combinations thereof) both outside and inside cells.

Studies have shown that cancerous tumors create highly specific conditions at their site that are not present in normal tissue. These cancerous microenvironments are primarily a result of the well understood unique glycolytic metabolism associated with cancer cells, referred to as the Warburg Effect. CAB proteins are designed to deliver their therapeutic payload and/or recruit the immune response in specific and selected locations and conditions within the body and to be active only in the presence of a particular cellular microenvironment. In addition, the activation is designed to be reversible to repeatedly switch ‘on and off' should the CAB move from a diseased to a normal cellular microenvironment and vice versa. CABs can be developed in a variety of formats including antibodies, antibody drug conjugates (ADCs), bi-specifics, chimeric antigen receptor T-cells (CAR-Ts) and combination therapies.

CAB-AXL-ADC to be clinically tested for treatment of several solid tumor cancers

SAN DIEGO, CA - January 24, 2018 - BioAtla^© LLC, a global biotechnology company focused on the development of Conditionally Active Biologic (CAB) protein therapeutics, announced today the U.S. Food and Drug Administration (FDA) has cleared BioAtla's Investigational New Drug application (IND) for BA3011, a novel conditionally active AXL-targeted antibody-drug conjugate (CAB-AXL-ADC), in patients with solid tumors. Under this IND, the company intends to initiate a first-in-human, open label, multicenter, dose escalation and dose expansion study of CAB-AXL-ADC in patients with locally advanced or metastatic solid tumors. CAB-AXL-ADC will be BioAtla's first CAB investigational product to enter clinical trials in the United States.

The AXL receptor tyrosine kinase is often highly expressed in several cancer types that can lead to poor prognosis. A principal role of AXL appears to be in sustaining a major mechanism of resistance to diverse anticancer therapies. In addition, AXL is a factor in the repression of the innate immune response which may also limit response to treatment including immuno-oncology (IO) therapy.  While this makes the AXL receptor an attractive target for tumor therapy, the AXL receptor is also prevalent in normal tissue of several organs in the body.  To minimize on-target-off-tumor toxicity of binding to AXL receptors on normal cells, BioAtla applies its proprietary CAB technology to develop its CAB antibody-drug conjugate (ADC) targeting AXL with the intent to activate binding to the AXL receptor only in the tumor microenvironment and deliver the toxic payload to the cancerous cells.

About Conditionally Active Biologics (CABs)

Conditionally Active Biologic proteins are generated using BioAtla's proprietary protein discovery, evolution and expression technologies. These proteins can be monoclonal antibodies, enzymes and other proteins designed with functions dependent on changes in microphysiological conditions (e.g., pH level, oxidation, temperature, pressure, presence of certain ions, hydrophobicity and combinations thereof) both outside and inside cells.

Studies have shown that cancerous tumors create highly specific conditions at their site that are not present in normal tissue. These cancerous microenvironments are primarily a result of the well understood unique glycolytic metabolism associated with cancer cells, referred to as the Warburg Effect. CAB proteins are designed to deliver their therapeutic payload and/or recruit the immune response in specific and selected locations and conditions within the body and to be active only in the presence of a particular cellular microenvironment. In addition, the activation is designed to be reversible to repeatedly switch ‘on and off' should the CAB move from a diseased to a normal cellular microenvironment and vice versa. CABs can be developed in a variety of formats including antibodies, antibody drug conjugates (ADCs), bi-specifics, chimeric antigen receptor T-cells (CAR-Ts) and combination therapies.