News

BIOATLA APPOINTS LAWRENCE FONG, M.D. AS SCIENTIFIC ADVISOR

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

BIOATLA ANNOUNCES FIRST PATIENT TREATED IN PHASE1/2 BA3021-001 CLINICAL TRIAL FOR CAB-ROR2-ADC THERAPEUTIC

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

BioAtla Announces FDA Clearance of Investigational New Drug Application For CAB-ROR2-ADC Therapeutic

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.

BioAtla Announces First Patient Treated in CAB-AXL-ADC Phase 1/2 Clinical Trial BA3011-001

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.

BioAtla Announces FDA Clearance of IND Application for CAB-AXL-ADC Therapeutic

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.

Clinical Trial Utilizing BioAtla’s Conditionally Active Biologics in CAR-T Candidates for Solid Tumors to be Initiated in China

Axl and Ror2 targeted CAB-CAR-T cellular products to be tested in patients with refractory, metastatic kidney cancer

SAN DIEGO, CA – January 8, 2018 - BioAtla® LLC, a global biotechnology company focused on the development of Conditionally Active Biologic (CAB) protein therapeutics, announced today that Shanghai Sinobioway Sunterra Biotechnology, a partner of F1 Oncology, Inc., has received ethics committee approval of a clinical trial for two novel, conditionally active chimeric antigen receptor T cell (CAB-CAR-T) product candidates targeting Axl and Ror2 for the treatment of metastatic renal cell carcinoma. The precision medicine-driven clinical trial will enroll patients in China with multi-organ, recurrent/refractory metastatic renal cell carcinoma based on expression of the Axl or Ror2 targets in tumor biopsy. F1 Oncology, BioAtla’s partner in CAB technology applications for adoptive cellular therapies (ACTs), combines BioAtla’s CAB technology with F1 Oncology’s proprietary technologies with the goal of developing and commercializing CAB-CAR-T therapies for the treatment of solid tumor malignancies. CAB-CAR-T cell therapies are designed to be conditionally active only in the tumor microenvironment and may therefore help reduce potential adverse events associated with on-target, off-tumor effects of CAR-T therapies.

In 2016 BioAtla 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 amended financial terms of this license to F1 Oncology include a mid-single digit royalty outside of China, Hong Kong, Macau and Taiwan (the Territory) and a low single-digit royalty within the Territory. BioAtla has a majority, non-controlling interest in the outstanding capital stock of F1 Oncology and has no funding or financial obligation.

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.

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. 

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