News

BioAtla® Appoints James Allison PhD and Padmanee Sharma MD PhD as Scientific Advisors

Leading researchers in immuno-oncology will advise BioAtla on company’s proprietary CAB programs and design of combination therapies

SAN DIEGO, CA – November 16, 2017 - BioAtla, LLC, a global biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics, today announced the appointments of James Allison, Ph.D. and Padmanee Sharma, M.D., Ph.D. as scientific advisors.  Drs. Allison and Sharma are leading researchers in the field of immuno-oncology.  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.  Dr. Sharma has participated in numerous impactful research studies since 1996, focusing primarily on immunotherapy in collaboration with Dr. Allison.  In their collaborative work, Dr. Sharma is exploring combinations of immunological therapies and targeted drugs in preclinical studies to more effectively treat a variety of cancers.

“The knowledge, experience and insights of Drs. Allison and Sharma will provide valuable contributions to the direction and prioritization of our CAB development programs.  In particular, their advice will enhance our decisions and design of combination CAB immunotherapies and CAB bispecifics,” said Jay M. Short, Ph.D., chairman, president and chief financial officer of BioAtla.

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 and received the Lasker-Debakey Clinical Medical Research Award in 2015.

About Dr. Sharma

Padmanee Sharma, M.D., Ph.D., is Professor of Genitourinary Medical Oncology and Immunology in the Division of Cancer Medicine at MD Anderson. Dr. Sharma is also Scientific Director, Immunotherapy Platform, and Co-Director, Parker Institute for Cancer Immunotherapy at M. D. Anderson Cancer Center.  She has tested novel cancer immunotherapy strategies in clinical trials that permitted access to surgical samples or longitudinal biopsy samples, which allowed her to identify mechanisms of response and resistance to therapy. She has won numerous awards during her career including the Doris Duke Clinical Scientist Development Award, the Prostate Cancer Foundation Challenge Award, the MD Anderson Cancer Center Faculty Scholar Award and the Emil Frei Award for Translational Research. 

BioAtla® and Sinobioway Expand Collaboration Agreement and Enter Into Services Agreement

Five new CAB antibody candidates to be selected

New services agreement provides for discounted development and manufacturing costs

SAN DIEGO, CA – May 16, 2017 – BioAtla® LLC, a global biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics, today announced that BioAtla and Beijing Sinobioway Group Company, Limited (Sinobioway) expanded their CAB development and commercialization collaboration agreement with the addition of five new CAB antibody targets, and entered into a new services agreement for Sinobioway to provide specified development and manufacturing services to BioAtla.

In March 2015, BioAtla and Sinobioway entered into a strategic collaboration for the development and commercialization of select CAB antibodies for specific indications in China, Hong Kong, Macau and Taiwan (the Territory). As a result of the selection of the initial four CAB candidates and the specific indications for development under this agreement for 2016, BioAtla received collaboration funding payments from Sinobioway in 2015 and 2016 totaling $40 million. Under the expanded agreement, Sinobioway is obligated to select five additional new CAB antibody indications and to pay BioAtla a total of $50 million, comprised of $30 million in cash and $20 million in the form of credits for future manufacturing and development services to be performed at discounted rates by Sinobioway pursuant to the services agreement.

Of the $30 million cash payment, BioAtla is entitled to receive $5 million in May 2017 and $25 million following the first approval of an Investigational New Drug application (IND) filed by BioAtla with the U.S. Food and Drug Administration (FDA) to commence a Phase 1 clinical trial of a CAB antibody candidate. In addition, pursuant to the expanded agreement, upon the later of BioAtla's first IND approval and March 31, 2018, Sinobioway will be obligated to pay BioAtla upfront payments totaling $40 million in cash for four more antibody candidate indications. BioAtla is currently completing pre-IND development of its CAB Axl-ADC and CAB Ror2-ADC antibody product candidates. CAB Axl-ADC for the treatment of pancreatic cancer and CAB Ror2-ADC for the treatment of triple negative breast cancer are two of the four initial CAB antibody indications previously selected by Sinobioway for the Territory. Under the collaboration agreement, Sinobioway or certain affiliated entities are obligated to fund the development, manufacturing, clinical trials and commercialization costs in the Territory for each of the Sinobioway selected CAB antibody candidate indications.

The new master services agreement allows for BioAtla to have Sinobioway perform development and manufacturing services pursuant to mutually-agreed upon work plans. These services are available for development and manufacturing of BioAtla's own CAB product candidates as well as for CAB product candidates BioAtla may license to partners other than Sinobioway for development and commercialization primarily in the rest of the world outside of Sinobioway's Territory. Such services may include manufacturing product for clinical trials and for commercialization. Because BioAtla expects that most of the CAB candidates it would seek to develop or manufacture through Sinobioway's services would also be licensed to Sinobioway under the collaboration agreement, Sinobioway would also benefit from performing the services for such CAB products.

Pursuant to the services agreement, Sinobioway is obligated to provide BioAtla pricing at a discount of at least 85% to prevailing market prices for services relating to CAB product candidates through Phase 2 development until BioAtla has received an aggregate of $20 million worth of services at the discounted rate. Thereafter, BioAtla is entitled to a discount of 75% to prevailing market prices for services relating to CAB product candidates through Phase 2 development. In addition, BioAtla is entitled to pricing at Sinobioway's "most preferred rate" for services relating to CAB product candidates in Phase 3 development and for commercial supplies of any approved CAB product. Sinobioway is also required to prioritize work under the work plans for each CAB program over all other projects, including use of equipment for manufacturing projects and animals in animal testing.

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 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 Beijing Sinobioway Group Company, Limited

Sinobioway was founded in 1992 and is one of the three main industrial groups affiliated with Peking University. Sinobioway is mainly engaged in bioeconomy system establishment and bio-industry development. It primarily invests in biomedicine, bioagriculture, bioenergy, bioenvironment, bioservices, biomanufacturing and biointelligence. Biologic therapeutics is a particular focus of Sinobioway in its plans to develop and commercialize new medicines. Sinobioway is constructing a large biologics production facility, with a long-term capability goal of 100 production lines, in the planned Bio-Economic zone under construction in Hefei.

BioAtla® Appoints Yong Ben, M.D. as Chief Medical Officer

Leader of several oncology drug approvals to head BioAtla’s CABs clinical development programs focused on immuno-oncology

SAN DIEGO, CA – May 9, 2017 – BioAtla, LLC, a global biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics, today announced the appointment of Yong Ben, M.D., as chief medical officer.  Dr. Ben, an experienced biotechnology drug developer in oncology, joins the Company from AstraZeneca, where he was most recently Global Clinical Lead, Immuno-Oncology. His clinical leadership in pharmaceutical and biotechnology companies led to several oncology drug approvals including, for AstraZeneca, the most recent approval of a PD-L1 antibody, durvalumab (Imfinzi), for the treatment of urothelial cancer, ixazomib (Ninlaro) in multiple myeloma for Millennium/Takeda, axitinib (Inlyta) in renal cancer for Pfizer, and oncolytic virus H101 in head and neck cancer for SunwayBio. 

"Dr. Ben's experience and proven capabilities in leading the clinical development of innovative oncology products over a range of indications greatly enhances BioAtla's ability to design, implement, and execute clinical programs evolving from our CAB platform" said Jay M. Short, Ph.D., chairman, president and chief executive officer of BioAtla.

 

About Dr. Ben

Dr. Ben joins BioAtla with over 20 years of industry and academic experience in oncology. During his 13 years of increasing responsibility in biotechnology and pharmaceutical companies, he has led wide-spectrum clinical development efforts from start to finish covering from phase 1 to phase 3 clinical trials, from strategy planning to study execution and BLA/NDA submissions. Prior to his career at AstraZeneca, Dr. Ben was Medical Director, Oncology Clinical Research at Millennium Pharmaceuticals where, in addition to leading the pivotal global phase 3 study for ixazomib in refractory/relapsed multiple myeloma, he was clinical lead in the orteronel and alisertib programs. Prior to then, Dr. Ben was Lead Clinician/Global Medical Monitor, Clinical Development for the Pfizer Oncology Business Unit and earlier was Project Manager, Asia Research & Development for Pfizer Global Research & Development. Dr. Ben began his career in industry with Shanghai Sunway Biotech Co., the world leader in the field of oncolytic virus. Dr. Ben started his career as a surgical oncologist at Peking Union Medical College Hospital and completed a postdoctoral fellowship at California Pacific Medical Center Research Institute.  Dr. Ben received his medical degree from Norman Bethune Medical University and his MBA from University of California, San Diego.

BioAtla® and F1 Oncology Announce Collaboration to Develop CAB-CAR-T’s for Solid Tumors

Sinobioway affiliates and US entities invest $37M in F1 Oncology, Inc. First clinical trial with CAB CAR-T in solid tumors planned for China in 2017

SAN DIEGO, CA and WEST PALM BEACH, FL – January 6, 2017 – BioAtla® LLC, a global biotechnology company focused on the development of Conditionally Active Biologic (CAB) protein therapeutics, and F1 Oncology, Inc., a biotechnology company discovering and developing a new class of adoptive cellular therapies (ACTs), today announced a global license agreement to combine BioAtla’s CAB technology with F1 Oncology’s proprietary technologies to develop and commercialize chimeric antigen receptor T-cell (CAR-T) therapies and other ACTs for the treatment of cancer.

F1 Oncology recently completed a $37M Series A financing led by F1 BioVentures LLC, Sinobioway Group, and SunTerra Capital. Through its international affiliates, F1 Oncology also entered into a development and commercialization agreement with Shanghai SunTerra Biotechnology Ltd. and its network of academic investigators to enable clinical investigation of CAB CAR-T candidates in China. F1 Oncology’s partners intend to begin clinical trials in China in 2017 targeting a solid tumor indication using F1’s first CAB CAR-T therapy candidate. The financial terms of this agreement include technical and regulatory milestone-based equity investments of up to $50 million through 2018, as well as supply-related payments by target and indication. F1 Oncology retains rights to all products outside China, Hong Kong, Macau and Taiwan.

BioAtla has granted F1 Oncology an exclusive worldwide license under patents and know-how controlled by BioAtla to discover, develop, manufacture and commercialize ACT preparations and treatments for cancer. The financial terms of this license to F1 Oncology include a mid-single digit royalty outside of China, Hong Kong, Macau and Taiwan (the Territory). Within the Territory, the license is royalty-free and fully paid, and BioAtla shares in the product revenue. In exchange for the license rights, as well as BioAtla’s agreement not to compete in ACTs, BioAtla received a majority, non-controlling interest of the outstanding capital stock of F1 Oncology and has no funding or financial obligation. BioAtla also has a conditional and time-limited option to acquire at a fixed valuation all of the outstanding equity securities of F1 Oncology held by all other investors.

BioAtla and F1 Oncology have identified CAR-T and other ACT therapies as potential opportunities for the application of CAB technology. BioAtla has demonstrated in preclinical studies that CAB antibodies can be constructed in the same single chain format used by CAR-Ts and can retain their selectivity for binding under conditions representative of the tumor microenvironment (TME) and with minimal to no detectable binding in normal cell conditions. CARs are constructs that contain an antigen–binding domain of an antibody fused to a strong T-cell activator domain. T-cells modified with the CAR construct can bind to the antigen and be stimulated to attack the bound cells. On-target, off-tumor toxicity has largely limited current CAR-T therapies to target blood cancers such as leukemia and some lymphomas. While CAR-T related toxicities are multifactorial and complex, CAR-T cells containing CAB CAR domains targeting solid tumor antigens would be intended to reduce on-target, off-tumor toxicity and potentially increase patient safety.

“We are pleased and excited to collaborate with Dr. Frost and his experienced team at F1 Oncology to combine our CAB technology with F1 Oncology’s proprietary technology and manufacturing expertise to develop new CAR-T therapies. Through our combined efforts, F1 Oncology will focus on developing effective and safer therapy to patients and especially to those afflicted with solid tumor cancers representing the great majority of cancer cases,” stated Jay M. Short, Ph.D., Chairman, President and Chief Executive Officer of BioAtla. “The structure of our agreements provides for the advancement of CAB opportunities in the important field of ACTs while allowing BioAtla to focus its research, development and management capabilities and financial resources on its primary objectives of creating and commercializing CAB antibodies for cancer therapy and for treatment of other diseases.”

“Dr. Short and I have a successful history of early research collaborations in protein evolution that we look forward to applying to this key challenge of adoptive cellular therapy for solid tumors” noted Gregory I. Frost, Ph.D., Chairman and CEO of F1 Oncology, Inc. “While patient safety, CAR-T cell engraftment, and definitive radiologic response are the key milestones from which these first programs must be judged, we are encouraged by the successful generation and pre-clinical testing by F1 Oncology of conditionally active CAR-T cells in primary human lymphocytes with a number of BioAtla’s CAB domains in F1 Oncology’s CAR-T platform.”

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-designed mAbs can be programmed to deliver their therapeutic payload and/or recruit the immune response in specific and selected locations and conditions within the body. CABs have the potential to increase safety because they are designed to be active only in the presence of a particular cellular microenvironment thereby preferentially binding to their intended target protein in the area of disease. In addition, the activation is reversible and can repeatedly switch ‘on and off’ should the CAB move from a diseased to a normal cellular microenvironment and vice versa, thereby further reducing chances the CAB would bind to the same protein located in healthy tissue or in other parts of the body and cause undesirable toxicity.

About F1 Oncology, Inc.

F1 Oncology, Inc. is a private Delaware C corporation formed in November 2015 with operations in West Palm Beach, Florida, San Diego, California and international affiliates in George Town, Cayman Islands, Hong Kong, and Shanghai, China. F1 Oncology was founded by Gregory Frost, Ph.D., co-founder and former CEO of Halozyme Therapeutics Inc., Health Sector Chief at Intrexon Corporation, and current managing director of F1 BioVentures, LLC, a biotechnology-focused investment vehicle. F1 Oncology leverages its globally integrated science, development and informatics teams located across multiple time zones to accelerate the design, high-throughput screening, discovery and development of adoptive cellular therapy candidates. The company is developing two CAB-based ACT platforms to develop TME restricted CAR-T therapies for solid tumors, as well as developing highly scalable systems for global deployment, beginning in Asia. Learn more at www.f1oncology.com.

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. By utilizing its proprietary technologies in product design and development, from target discovery to manufacturing and preclinical studies, BioAtla seeks to develop differentiated, patentable therapeutic proteins for its partners, including Pfizer, Inc., Sinobioway and F1 Oncology, and for its internal programs. BioAtla has over 170 patents issued and pending that cover its platform technologies representing a full complement of therapeutic protein development capabilities.

About Beijing Sinobioway Group Company, Limited 

Sinobioway was founded in 1992 and is one of the three main industrial groups affiliated with Peking University. Sinobioway is mainly engaged in bioeconomy system establishment and bio-industry development. It primarily invests in biomedicine, bioagriculture, bioenergy, bioenvironment, bioservices, biomanufacturing and biointelligence. Biologic therapeutics is a particular focus of Sinobioway in its plans to develop and commercialize new medicines. Sinobioway is constructing a large biologics production facility, with a long-term capability goal of 100 production lines, in the planned 20 billion RMB bio-economic zone under construction in Hefei.

BioAtla® and Sinobioway Complete Selection of First Four Programs for Strategic Collaboration in China Market

BioAtla® receives $36 million as balance of 2016 CAB program selection payments

SAN DIEGO, CA – December 6, 2016 – BioAtla® LLC, a global biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics, today announced that BioAtla® and Beijing Sinobioway Group Company, Limited (Sinobioway) selected their first four CAB product programs for development. The specific program candidates and the targeted indications are not disclosed. In March 2015, BioAtla and Sinobioway entered into a strategic collaboration for the development and commercialization of select CAB antibodies for specific indications in China, Hong Kong, Macau and Taiwan (the Territory). Related to this agreement and as a result of the selection of all four of the 2016 CAB candidates for development, BioAtla received on November 1, 2016 a $36 million payment from Sinobioway representing the balance of the collaboration funding for the selection of the four 2016 CAB candidates and the specific indications. Including these funds, BioAtla has received more than $100 million in program payments and equity investments relating to its strategic collaboration agreement with Sinobioway.

BioAtla and Sinobioway are working collaboratively to develop several CAB candidates for specific indications for the Territory. Sinobioway pays BioAtla pre-determined collaboration fees for each indication it chooses to license and develop. As part of the agreement, Sinobioway has exclusive rights to develop and commercialize selected CAB antibodies for selected indications in the Territory and BioAtla retains the rest of world rights to these products candidates and indications. Sinobioway is obligated to fund the development, manufacturing, clinical trials and commercialization costs in the Territory. BioAtla is further eligible to receive certain milestone payments and double-digit royalties on sales. BioAtla’s agreement with Sinobioway is open-ended as there is no annual minimum number of CAB antibody indications that Sinobioway is obligated to select after the initial four and no maximum that BioAtla may nominate and that Sinobioway may select, and the indication nomination and selection process remains active through the term of the agreement. However, in order to maintain exclusivity in the Territory for the CAB antibodies in indications it has licensed, Sinobioway is obligated to select a minimum number of CAB antibodies for certain indications BioAtla nominates each year, which would result in BioAtla’s receipt of at least $40 million per year from collaboration fees on an ongoing basis.

This strategic collaboration is the keystone of BioAtla’s long-term plans to address the growing demand for innovative therapeutic products in the China pharmaceutical market. BioAtla’s patent protected Conditionally Active Biologics platform represents a potentially disruptive technology for the development of a new class of immunotherapeutics that are activated in selected microenvironments within the body, such as those indicative of cancerous tumors. CABs can be generated in several different formats including naked monoclonal antibodies (mAbs), antibody drug conjugates, immune checkpoint inhibitors, bispecific antibodies, and chimeric antigen receptor (CAR) T cells.

“BioAtla’s strategy is to broadly pursue novel therapeutic products based on our patented CAB and other proprietary technologies,” said Jay M. Short, Ph.D., president, chief executive officer and chairman of the board of BioAtla. “China is an immensely important opportunity for CABs and we are excited to be working with Sinobioway with its demonstrated commitment and strong capabilities to execute and to fulfill our mutual goals. We will continue to build upon our drug development experience to pursue the potential of the CAB platform for our collaboration with Sinobioway, as well as for our collaboration with Pfizer and for our portfolio of proprietary CAB product candidates.”

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-designed mAbs can be programmed to deliver their therapeutic payload and/or recruit the immune response in specific and selected locations and conditions within the body. CABs have the potential to increase safety because they are designed to be active only in the presence of a particular cellular microenvironment thereby preferentially binding to their intended target protein in the area of disease. In addition, the activation is reversible and can repeatedly switch ‘on and off’ should the CAB move from a diseased to a normal cellular microenvironment and vice versa, thereby further reducing chances the CAB would bind to the same protein located in healthy tissue or in other parts of the body and cause undesirable toxicity.

BioAtla believes CABs can facilitate higher dosing, the development of effective, non-immunogenic drugs, and the use of targets that are validated for cancer cells but traditionally considered too prevalent among normal cells to be used safely in current drug therapies. This could open a potentially rich range of targets for CABs that cannot be addressed using existing technologies.

About Beijing Sinobioway Group Company, Limited

Sinobioway was founded in 1992 and is one of the three main industrial groups affiliated with Peking University. Sinobioway is mainly engaged in bioeconomy system establishment and bio-industry development. It primarily invests in biomedicine, bioagriculture, bioenergy, bioenvironment, bioservices, biomanufacturing and biointelligence. Biologic therapeutics is a particular focus of Sinobioway in its plans to develop and commercialize new medicines. Sinobioway is constructing a large biologics production facility, with a long-term capability goal of 100 production lines, in the planned 20 billion RMB bio-economic zone under construction in Hefei.

BioAtla® and Sinobioway Select First Program for Strategic Collaboration in China Market

BioAtla® receives $19 million in first program payments plus equity

SAN DIEGO, CA – January 6, 2016 – BioAtla® LLC, a global biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics, today announced that BioAtla® and Beijing Sinobioway Group Company, Limited (Sinobioway) selected their first product programs for development. In May 2015, BioAtla® and Sinobioway entered into a strategic collaboration for the development and commercialization of select CAB antibodies and other CAB-based therapeutics in China, Hong Kong, Macau and Taiwan (the Territory). Related to and as a result of this agreement, BioAtla® received a previously reported $30 million equity investment from a China-based investor group. BioAtla® now receives $19 million in program payments plus equity investment from Sinobioway as a result of the selection of the first CAB candidates and achievement of other corporate objectives. Including these funds, BioAtla® will receive a total of more than $70 million in program payments and equity investment from Sinobioway over the course of the next twelve months.

BioAtla® and Sinobioway are working collaboratively to develop several CAB candidates for the Territory. As part of the agreement, Sinobioway has exclusive rights to develop and commercialize selected CAB antibodies in the Territory and BioAtla® retains the rest of world (ROW) rights to these products. Sinobioway will fund the development, manufacturing, clinical trials and commercialization costs in the Territory and is committed to making recurring product development payments to BioAtla® for additional CAB candidates. BioAtla® is further eligible to receive certain milestone payments and double-digit royalties on sales.

This strategic collaboration is the keystone of BioAtla®’s long-term plans to address the growing high demand for innovative therapeutic products in the China pharmaceutical market. BioAtla®’s patent protected Conditionally Active Biologics platform represents a disruptive technology for the development of a powerful new class of immunotherapeutics that are activated in selected microenvironments within the body, such as those indicative of cancerous tumors. CABs can be generated in several different formats including naked monoclonal antibodies (mAbs), antibody drug conjugates, immune checkpoint inhibitors, bispecific antibodies, and chimeric antigen receptor (CAR) T cells.

“BioAtla®’s strategy is to broadly and rapidly pursue novel therapeutic products based on our patented CAB and other proprietary technologies,” said Jay M. Short, Ph.D., president, chief executive officer and chairman of the board of BioAtla®. “China is an immensely important opportunity for CABs and we are excited to be working with Sinobioway with its demonstrated commitment and strong capabilities to execute and to fulfill our mutual goals. Since BioAtla®’s founding in 2007, we have utilized our San Diego and Beijing development and operations capabilities to successfully develop dozens of protein products under contract and shared development. We will continue to build upon our drug development experience to pursue the great prospects of the CAB platform for our collaboration with Sinobioway, as well as for our collaboration with Pfizer that we announced last month on December 8, and for our portfolio of proprietary CAB products.”

“Conditionally Active Biologics is an innovative and breakthrough technology to develop the new class of immuno-oncology therapeutics,” said Dr. Pan Aihua, chairman of Sinobioway. “The CAB technology and its prospects will be important elements in Sinobioway’s mission to advance science and industrial development, and improve health in China through creating and delivering safer and more effective medicines to patients.”

About Conditionally Active Biologics (CABs)

Conditionally Active Biologic proteins are generated using BioAtla®’s proprietary protein 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).

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, which was first described in the early 1900’s and is the basis of the widely-used PET scan cancer detection method today. CAB-designed mAbs can be programmed to deliver their therapeutic payload and/or recruit the immune response in specific and selected locations and conditions within the body. CABs increase safety because the drug’s activation depends on its presence in a particular cellular microenvironment thereby preferentially binding to its intended target protein in the area of disease. In addition, the activation is reversible and can repeatedly switch ‘on and off’ should the CAB product move from a diseased to a normal cellular microenvironment and vice versa thereby further reducing chances the CAB would bind to the same protein located in healthy tissue or in other parts of the body and cause undesirable toxicity.

CABs allow for higher dosing, the development of effective, non-immunogenic drugs, and the use of targets that are validated for cancer cells but traditionally considered too prevalent among normal cells to be used safely in current drug therapies. This opens a potentially rich range of targets for CABs that cannot be addressed using existing technologies. CABs may also be employed as diagnostic tools to reveal and pinpoint conditions indicative of cancerous activity.

About Beijing Sinobioway Group Company, Limited

Sinobioway was founded in 1992 and is one of the three main industrial groups affiliated with Peking University. Sinobioway is a leader in establishing a bioeconomy system in China and developing that country's bio-industry. It invests in biomedicine, bioagriculture, bioenergy, bioenvironment, bioservices, biomanufacturing and biointelligence. Biologic therapeutics is a particular focus of Sinobioway in its plans to develop and commercialize new medicines. Sinobioway is constructing a large biologics production facility, with a long-term capability goal of 100 production lines, in the planned 20 billion RMB bio-economic zone under construction in Hefei.

BioAtla® Enters Into Strategic License And Option Agreement With Pfizer

Agreement combines BioAtla®’s Conditionally Active Biologic (CAB) antibodies with Pfizer’s Proprietary ADC Payloads

Pfizer gains rights to BioAtla® CAB immune checkpoint inhibitors targeting CTLA-4

SAN DIEGO, CA – December 8, 2015 – BioAtla® LLC, a biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics, today announced that it has entered into a license and option agreement with Pfizer Inc. (NYSE: PFE) to advance the development and commercialization of a new class of antibody therapeutics based on BioAtla®’s CAB platform and utilizing Pfizer’s proprietary antibody drug conjugate (ADC) payloads.

Under the agreement, BioAtla® and Pfizer will each have a license to the other’s respective technology to pursue the development and commercialization of several CAB-ADC antibodies. Pfizer also gains an exclusive option to develop and commercialize BioAtla® CAB antibodies that target CTLA4, a validated immuno-oncology target in humans. If successful, BioAtla®’s technology would allow the selective targeting of CTLA4 expressed on immune cells localized in the tumor microenvironment. BioAtla® and Pfizer are both eligible to receive milestone payments and royalties based on individual CAB-ADC antibody candidates developed and commercialized by the other party. Including the CTLA4 option and license, BioAtla® is eligible to receive a potential total of more than $1.0 billion in up-front, regulatory and sales milestone payments as well as tiered marginal royalties reaching double digits on potential future product sales.

CAB-ADC antibodies aim to address the inherent limitations of current ADC antibody technology by actively binding to antigens expressed on tumor tissue-resident cancer cells, but not to the same antigens expressed on normal cells in non-diseased tissues. If successful, this approach would allow the preferential targeting of tumor tissues by ADCs, thereby increasing the efficacy-safety ratios of CAB-ADCs relative to their conventional counterparts. The use of CAB antibodies as payload delivery vehicles could dramatically increase the number of tumor-associated antigens that are addressable with ADC technology.

“CAB-ADC antibodies and CAB immune checkpoint inhibitors such as those targeting CTLA-4 can potentially improve current therapies and enable combination immuno-oncology treatments for many cancers. This agreement combines the therapeutic effectiveness of Pfizer’s clinically validated ADC technology with the safety and expansive receptor applicability of BioAtla® CAB antibodies,” said Jay M. Short, Ph.D., co-founder, president, chief executive officer and chairman of the board of BioAtla®. “We are enthusiastic about working with Pfizer to develop these novel products with strategic importance in building BioAtla®’s portfolio of proprietary products.”

“This agreement between Pfizer and BioAtla® provides an exciting opportunity to further explore innovative and potentially breakthrough technologies in the treatment of human cancers,” said Bob Abraham, Senior Vice President and Head of Pfizer’s Oncology-Rinat Research & Development Group. “By leveraging the unique capabilities of the two companies, we hope to advance our mission to deliver safer and more effective medicines to our patients.”

About Conditionally Active Biologics (CABs)

BioAtla®’s patent protected CAB platform represents a disruptive technology for the development of a powerful new class of biologic therapeutics that are activated in selected microenvironments within the body, such as those associated with all cancerous tumors. CAB proteins can be generated in several different formats including naked monoclonal antibodies (mAbs), antibody drug conjugates, immune checkpoint inhibitors, bispecific antibodies, and chimeric antigen receptor (CAR) T cells. CAB proteins are generated using BioAtla®’s proprietary protein discovery, evolution, screening and expression technologies. These proteins can be mAbs, enzymes and other proteins designed with functions dependent on changes in microphysiological conditions.

Studies have shown that cancerous tumors create highly specific conditions at their site that are not present in normal tissue. These cancerous microenvironments are in part a result of the well-studied, unique glycolytic metabolism associated with cancer cells. CAB-designed mAbs can be engineered to deliver their therapeutic payload (CAB-ADCs) and/or recruit the immune response in specific and selected locations and conditions within the body. The CAB antibody’s selective activation results from amino acid substitutions of human-like sequences made to ensure compatibility. In addition to reducing risk of immunogenicity, this approach also improves the manufacturing yield of the drug. Reliably good expression and high manufacturing yields are also derived from BioAtla®’s patented Comprehensive Integrated Antibody Optimization™ (CIAO™) technology that allows every step of development and screening of antibody variants through final CAB lead selection to be conducted in the mammalian cell type to be used in manufacturing.

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