2022 – Biotheryx

Biotheryx to Present Preclinical Findings on Protein Degrader Programs at 5th Annual Targeted Protein Degradation Summit

Data from degrader program targeting SOS1 for KRAS mutant cancers to be presented in keynote plenary session

Latest preclinical data for BTX-1188, a degrader of GSPT1 and IKZF1/3, to be presented

SAN DIEGO, CA. October 24, 2022 — Biotheryx, Inc., a clinical stage company discovering and developing a portfolio of innovative small molecule targeted protein degraders (TPDs) in areas of high unmet medical need, today announced that it will present preclinical data from its targeted protein degrader programs at the 5^th Annual Targeted Protein Degradation Summit, being held October 25-28, 2022, in Boston, Massachusetts.

Leah Fung, Ph.D., Chief Scientific Officer of Biotheryx, will present as a Keynote Plenary Speaker in a session, “Highlighting Key Discoveries of Bifunctional Degraders to New Targets,” to highlight novel small molecule bifunctional degraders of son of sevenless homolog 1 (SOS1), potent inhibitors of Kirsten rat sarcoma (KRAS) mutant cancers. Aparajita Chourasia, Ph.D., Vice President of Biology of Biotheryx will also present the latest preclinical data in support of the Company’s BTX-1188 molecular glue program targeting GSPT1 and IKZF1/3.

“We are looking forward to sharing findings at the TPD Summit that highlight the potential of our innovative PRODEGY platform to develop new and exciting cancer therapies,” said Dr. Fung. “The data Biotheryx are presenting are evidence of our team’s commitment to the discovery and design of first-in-class protein degraders.”

Details for Biotheryx’s presentations at the 5^th Annual TPD Summit are as follows:

Keynote Plenary Session: Highlighting Key Discoveries of Bifunctional Degraders to New Targets
Presentation: Novel Small Molecule Bifunctional Degraders of SOS1 For Inhibition of Pan-KRAS Mutant Cancers
Presenter: Leah Fung, Ph.D., CSO
Date and Time: Thursday, October 27, 2022, at 8:30 a.m. EST

Presentation: BTX-1188, a First-in-Class Dual Degrader of GSPT1 and IKZF1/3, for Treatment of Acute Myeloid Leukemia (AML) and Solid Tumors
Presenter: Aparajita Hoskote Chourasia, Ph.D.
Session: Late Breaking Update of Clinical Monovalent Degraders
Date and Time: Wednesday, October 26, 2022, at 2:30 p.m. EST

About Biotheryx, Inc.

Biotheryx is a clinical stage biopharmaceutical company discovering and developing a portfolio of innovative small molecule targeted protein degraders (TPDs) in areas of high unmet medical need, with an initial focus on cancer and inflammatory disorders. Members of our founding and scientific teams previously developed the first U.S. Food and Drug Administration (FDA) approved modulators of Cereblon, the most widely validated E3 ligase involved in protein degradation, and have applied their expertise in Cereblon binding to build our proprietary PRODEGY platform. Our lead product candidate, BTX-1188, is a rationally designed dual-targeting molecular glue degrader of GSPT1 and IKZF1/3, which we are currently developing in a Phase 1/2 clinical trial in acute myeloid leukemia and solid tumor patients. Our pipeline of first-in-class degrader programs includes degraders of SOS1 for KRAS mutant cancers, CDK2/4/6 for solid tumors and PDE4 for auto-immune and inflammatory diseases. For more information, please visit www.biotheryx.com and engage with us on LinkedIn.

Contacts:

Investors/Media
Argot Partners
212.600.1902
[email protected]

Biotheryx Announces Appointment of Tracy Lawhon as Chief Development Officer

Ms. Lawhon has nearly 20 years of oncology drug development, partner engagement and corporate strategy leadership experience

SAN DIEGO, CA. August 24, 2022 — Biotheryx, Inc., a clinical stage company discovering and developing a portfolio of innovative small molecule targeted protein degraders (TPDs) in areas of high unmet medical need, today announced the appointment of Tracy Lawhon, J.D., as Chief Development Officer (CDO).

“We are thrilled to welcome Tracy to Biotheryx as our Chief Development Officer,” said Philippe Drouet, President and Chief Executive Officer (CEO) of Biotheryx. “She brings a tremendous depth of expertise, having led drug development and other strategic initiatives at clinical and commercial stage biopharmaceutical companies, and she shares our commitment to advancing new medicines for people with cancer and other diseases. I am confident that Tracy’s entrepreneurial approach and knowledge will enhance our development strategy and capabilities as we progress our pipeline of TPDs.”

“I am honored to join the protein degradation pioneers at Biotheryx and help build it into a leading next-generation TPD company to better support patients with cancers and other serious diseases,” said Ms. Lawhon. “The Company’s pipeline and proprietary PRODEGY platform show great potential, and I am excited to collaborate with the talented Biotheryx team to bring innovative new therapies to patients.”

Ms. Lawhon previously served as Vice President of Strategic Development and Clinical Operations at Valo Health Inc., where she co-led clinical development and led pharmaceutical sciences using real world data and modeling to advance two cardiovascular/metabolism assets into Phase 2 development and led pharmaceutical sciences through acquisition and IND-enabling development of a biologic for oncology. Prior, Ms. Lawhon was a founding executive at Adastra Pharmaceuticals, Inc. (formerly Tragara), where she held roles including Chief Operating Officer, Interim CEO and CDO. During her tenure, she drove the strategic and operational development of drug candidates and designed and executed regulatory strategies and submissions for multiple IND applications. Ms. Lawhon also held leadership roles at Cabrellis Pharmaceuticals, Novartis and Schering-Plough Research Institute. She earned her J.D. from Indiana University School of Law and B.S. in Microbiology from Indiana University.

About Biotheryx, Inc.

Biotheryx is a clinical stage biopharmaceutical company discovering and developing a portfolio of innovative small molecule targeted protein degraders (TPDs) in areas of high unmet medical need, with an initial focus on cancer. Members of our founding and scientific teams previously developed the first Food and Drug Administration (FDA) approved modulators of Cereblon, the most widely validated E3 ligase involved in protein degradation, and have applied their expertise in Cereblon binding to build our proprietary PRODEGY platform. Our lead product candidate, BTX-1188, is a rationally designed dual-targeting molecular glue degrader of GSPT1 and IKZF1/3, which we are currently developing in a Phase 1/2 clinical trial in acute myeloid leukemia and solid tumor patients. Our broad and growing pipeline includes degraders of SOS1 for KRAS mutant cancers and CDK2/4/6 for solid tumors, with a goal of submitting three additional investigational new drug (IND) applications to the FDA over the next three years. For more information, please visit www.biotheryx.com and engage with us on LinkedIn.

Contacts:

Investors/Media
Argot Partners
212.600.1902
[email protected]

Biotheryx to Present Preclinical Data for Its Dual Protein Degrader BTX-1188 at the 2022 American Society of Clinical Oncology Annual Meeting

BTX-1188 Showed Deep and Durable Dual Degradation of GSPT1 and IKZF1/3 In Vitro Along with Beneficial Immunomodulatory Properties

Data Support Ongoing Phase 1 Development for the Treatment of Hematologic and Solid Tumor Malignancies

SAN DIEGO, CA. May 26, 2022 — Biotheryx, Inc., a clinical stage company discovering and developing a portfolio of innovative small molecule targeted protein degraders (TPDs) in areas of high unmet medical need, today announced that its abstract highlighting supportive preclinical data for its lead asset BTX-1188, a potentially first-in-class, dual protein degrader of GSPT1 and IKZF1/3, will be presented in a poster at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting taking place June 3-7, 2022, in Chicago, Illinois and virtually.

“Our distinctive PRODEGY platform is designed to enable the discovery and development of a broad range of targeted protein degrader molecules and BTX-1188 is the first of our pipeline to enter the clinic,” said Leah Fung, Ph.D., Chief Scientific Officer of Biotheryx. “BTX-1188 is a molecular glue that was rationally designed to degrade GSPT1 and IKZF1/3. The data being presented at ASCO 2022 support the ongoing Phase 1 clinical trial evaluating BTX-1188 in patients with hematologic and solid tumor cancers and demonstrate what we believe to be our ability to design first-in-class molecular glues with the potential to improve clinical outcomes for patients with cancer and other serious diseases.”

“We are leveraging our deep expertise with the modulation of Cereblon, the only clinically and commercially validated E3 ligase, to design innovative targeted protein degraders with the potential to address significant unmet medical need,” said Philippe Drouet, President and Chief Executive Officer of Biotheryx. “We look forward to presenting these pre-clinical data from our lead program, BTX-1188, at ASCO 2022.”

Key Highlights from BTX-1188 Preclinical Results

BTX-1188 has shown deep and durable degradation of GSPT1 and IKZF1/3 and inhibition of MYC in several types of hematologic and solid tumor cell lines, including lymphoma, diffuse large B-cell lymphoma, non-small cell lung cancer and glioma.
BTX-1188 has shown inhibition of pro-inflammatory cytokines and enhancement of immune stimulatory cytokines, owing to IKZF1/3 degradation, which may prevent the known systemic inflammatory dose-limiting toxicities associated with pure GSPT1 degradation (Uy 2019)¹.
BTX-1188 potently inhibits tumor cell proliferation and tumor growth in ex vivo and in vivo models of acute myeloid leukemia (AML) and in in vitro and in vivo models of lung, breast and ovarian cancer.
These preclinical results support the ongoing Phase 1 clinical evaluation of BTX-1188 in patients with AML and certain solid tumors, especially in MYC-dependent cancers.

Details for the BTX-1188 ASCO 2022 poster presentation are as follows:

Title: BTX-1188, a first-in-class dual degrader of GSPT1 and IKZF1/3, for treatment of acute myeloid leukemia (AML) and solid tumors
Presenter: Aparajita Hoskote Chourasia, Ph.D.
Abstract Number: 7025
Poster Number: 256
Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Date and Time: Saturday, June 4, 2022 at 9:00 a.m. CT (10:00 a.m. ET)

This poster presentation will be available on the ASCO Meeting website. Following the presentation at the meeting, a PDF copy of the poster will be available in the “Publications and Presentations” section of Biotheryx’s website.

About BTX-1188

Biotheryx’s lead molecular glue drug candidate BTX-1188 is a dual protein degrader which was designed to degrade GSPT1, a promising cancer target, and IKZF1/3 (also known as Ikaros/Aiolos), both clinically validated anti-inflammatory and immunomodulatory targets. Prior literature has demonstrated that degradation of GSPT1 can result in antitumor activity in difficult-to-treat tumors such as acute myeloid leukemia (AML) and in solid tumors, including those that overexpress oncogenic transcription factors, such as MYC, however, prior clinical research by others has shown that administration of a GSPT1-only degrader was associated with dose-limiting toxicities related to the release of pro-inflammatory cytokines. BTX-1188 was specifically designed as a potent degrader of GSPT1 that can also directly block inflammation by degrading IKZF1/3. In preclinical studies conducted by Biotheryx, administration of BTX-1188 led to complete eradication of tumors and extended survival in xenograft models of AML. BTX-1188 also led to potent cell killing in a number of cell lines derived from solid tumors. BTX-1188 is currently being evaluated in a Phase 1 dose-escalation trial in patients with hematologic and solid tumor malignancies.

About Biotheryx, Inc.

Biotheryx is a clinical stage biopharmaceutical company discovering and developing a portfolio of innovative small molecule targeted protein degraders (TPDs) in areas of high unmet medical need, with an initial focus on cancer. Members of our founding and scientific teams previously developed the first U.S. Food and Drug Administration (FDA) approved modulators of Cereblon, the most widely validated E3 ligase involved in protein degradation, and have applied their expertise in Cereblon binding to build our proprietary PRODEGY platform. Our lead product candidate, BTX-1188, is a rationally designed dual-targeting molecular glue degrader of GSPT1 and IKZF1/3, which we are currently developing in a Phase 1/2 clinical trial in acute myeloid leukemia and solid tumor patients. Our broad and growing pipeline includes degraders of SOS1 for KRAS mutant cancers and CDK2/4/6 for solid tumors, with a goal of submitting three additional investigational new drug (IND) applications to the FDA over the next three years. For more information, please visit www.biotheryx.com and engage with us on LinkedIn.

Contacts:

Investors/Media
Argot Partners
212.600.1902
[email protected]

¹ Uy, G.L., et al. Blood 134 (Supplement_1): 232 (2019)

Biotheryx Announces Appointment of Jeff Caravella as Chief Financial Officer

Mr. Caravella has more than 20 years of healthcare finance experience, including at Tango Therapeutics and Johnson & Johnson

SAN DIEGO, April 25, 2022 /PRNewswire/ — Biotheryx, Inc., a clinical stage company discovering and developing a portfolio of innovative small molecule targeted protein degraders (TPDs) in areas of high unmet medical need, today announced the appointment of Jeff Caravella as Chief Financial Officer.

“Throughout Jeff’s healthcare industry tenure, he has led finance organizations impacting corporate, business development, commercial and operational strategies that supported these companies’ greater missions to create innovative healthcare solutions and medicines for patients,” said Philippe Drouet, President and Chief Executive Officer of Biotheryx. “We are glad to welcome Jeff to our leadership team as we advance the clinical development of our lead protein degrader product candidate BTX-1188 and the rest of our product candidate pipeline to create better medicines for patients.”

“I’m honored to join Biotheryx at an important time for the Company and the protein degradation field. I look forward to playing a key role in Biotheryx’s future in leveraging PRODEGY, the Company’s proprietary platform for the discovery and development of potentially first-in-class TPDs,” said Mr. Caravella. “I look forward to partnering with this team to execute on its strategy and help realize the potential of their platform, innovative product candidate pipeline and commitment to finding solutions for patients.”

Mr. Caravella previously served as Vice President of Finance at Tango Therapeutics, a public biotechnology company where he built and led the finance and accounting organization. Prior, he held finance roles across commercial, business development and operations functions at other publicly-held companies, including Editas Medicine, Charles River Laboratories and Johnson & Johnson. During his 10-year tenure at Johnson & Johnson, he spent two years as the Head of Finance for the Johnson & Johnson Boston Innovation Center, where he led the assessment and strategy for multiple business development and licensing deals. Mr. Caravella earned his M.B.A. and B.S. from Syracuse University.

About Biotheryx, Inc.

Biotheryx is a clinical stage biopharmaceutical company discovering and developing a portfolio of innovative small molecule targeted protein degraders (TPDs) in areas of high unmet medical need, with an initial focus on cancer. Members of our founding and scientific teams previously developed the first Food and Drug Administration (FDA) approved modulators of Cereblon, the most widely validated E3 ligase involved in protein degradation, and have applied their expertise in Cereblon binding to build our proprietary PRODEGY platform. Our lead product candidate, BTX-1188, is a rationally designed dual-targeting molecular glue degrader of GSPT1 and IKZF1/3, which we are currently developing in a Phase 1/2 clinical trial in acute myeloid leukemia and solid tumor patients. Our broad and growing pipeline includes degraders of SOS1 for KRAS mutant cancers and CDK2/4/6 for solid tumors, with a goal of submitting three additional investigational new drug (IND) applications to the FDA over the next three years. For more information, please visit www.biotheryx.com and engage with us on LinkedIn.

BioTheryX Appoints Nancy Miller-Rich as Chair of Its Board of Directors

Ms. Miller-Rich brings over 35 years of biopharma leadership experience, including senior roles at Merck & Co. and Schering-Plough

David Stirling, Ph.D., co-founder of BioTheryX, to remain on Board of Directors

SAN DIEGO, Feb. 23, 2022 — BioTheryX, Inc., a clinical-stage company focused on developing targeted protein degraders to create life-saving medicines, today announced that Nancy Miller-Rich has assumed the role of Chair of the BioTheryX Board of Directors. Ms. Miller-Rich, who has been serving as an active Independent Board Director, succeeds David Stirling, Ph.D., a co-founder of BioTheryX and previous Chief Scientific Officer of Celgene, who will remain as a member of the Board.

“Nancy has honed her commercial and business strategy expertise over 35 years in the biopharmaceutical industry. Her energetic and savvy brand of leadership has become instrumental as BioTheryX evolves into a clinical-stage company, with our first development candidate BTX-1188 entering the clinic earlier this year. Her vision and passion as Chair of the Board will be invaluable as we continue to build BioTheryX into a leader in next generation protein degradation,” said Philippe Drouet, President and Chief Executive Officer of BioTheryX. “We thank David for his pivotal role as co-founder of BioTheryX and for his many years of dedicated involvement. We look forward to our continued collaboration with David on the Board.”

Ms. Miller-Rich previously served as Senior Vice President, Global Business Development and Licensing, Strategy and Commercial Support for Human Health at Merck & Co., where her responsibilities included global business development, alliance management, strategy, commercial assessment, forecasting, market research, promotion, social media and commercial digital transformation. Prior, Ms. Miller-Rich held several leadership positions at Schering-Plough, including Group Vice President, Consumer Care Global New Ventures and Strategic Commercial Development, and she also worked for Sandoz and Sterling Drug. Ms. Miller-Rich serves on the Boards of Directors of Intercept Pharmaceuticals, Aldeyra Therapeutics, 4D Molecular Therapeutics and Attralus.

“I am honored to assume the role of Chair of the Board at such a pivotal time for BioTheryX. This incredible team continues to build upon their industry-leading expertise in protein degradation to advance a broad and growing pipeline of targeted protein degradation therapies that have the potential to transform the treatment of patients with a range of serious cancer, inflammatory and immunological diseases,” said Ms. Miller-Rich. “It has been a privilege to serve on the Board alongside David, an industry pioneer, and I look forward to partnering with him, the Board and management team.”

About BioTheryX, Inc.

BioTheryX is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients suffering from cancer, inflammatory and immunological diseases through the discovery, development and commercialization of targeted protein degradation therapies. We leverage our proprietary PRODEGY technology platform and differentiated targeted protein degradation approach to design small molecules that regulate protein homeostasis. We believe our approach is applicable to a broad range of diseases and has the potential to target proteins that have historically been considered undruggable. Our initial programs are focused on oncology indications with high unmet medical need. For more information, please visit www.biotheryx.com and engage with us on LinkedIn.

Contacts:

Investors/Media
Argot Partners
212.600.1902
[email protected]

BioTheryX Doses First Patient in Phase 1 Study Investigating Lead Protein Degrader Candidate BTX-1188

Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of BTX-1188 in Patients with Advanced Hematologic and Solid Tumor Malignancies

SAN DIEGO, Jan. 26, 2022 — BioTheryX, Inc., a clinical-stage company focused on developing targeted protein degraders to create life-saving medicines, today announced dosing of the first patient in a new, first-in human Phase 1 study investigating its lead candidate BTX-1188, an oral, dual target protein degrader specifically engineered to degrade GSPT1 and IKZF1/3, in patients with advanced hematologic and solid tumor malignancies.

“BTX-1188 has demonstrated rapid, deep and durable degradation of both GSPT1 and IKZF1/3 at low nanomolar concentrations in preclinical models, and we are delighted to make this exciting advancement into the clinic,” said Zung Thai, M.D., Ph.D., Chief Medical Officer of BioTheryX. “We are grateful to our clinical trial site partners for initiating this study in these challenging times and thank them for their commitment to investigating potential new therapeutic options for people facing difficult-to-treat cancers.”

The Phase 1 clinical trial is a multicenter, open label, non-randomized, sequential dose escalation study to assess the safety, pharmacokinetics and preliminary efficacy of BTX-1188 in patients with acute myeloid leukemia, advanced lymphoid and solid tumors who have failed standard therapy. The primary objective of the Phase 1 study is to determine a recommended Phase 2 dose, which will then be carried forward into expansion cohorts where the safety and efficacy of BTX-1188 will be evaluated in both hematologic and solid tumor malignancies. More information can be found on clinicaltrials.gov (NCT05144334).

“BTX-1188 is one of many potential best-in-class protein degrader candidates our team has designed and developed leveraging our distinctive PRODEGY targeted protein degradation platform to provide new treatment approaches for people living with cancer and other diseases,” said Philippe Drouet, President and Chief Executive Officer of BioTheryX. “With our clinical trial site partners, we are working as expeditiously as possible to study BTX-1188 and validate the potential of our platform.”

About BTX-1188

BTX-1188 is the first orally bioavailable, rationally designed dual target protein degrader, engineered to specifically degrade validated oncology targets GSPT1 and IKZF1/3. By degrading GSPT1 and IKZF1/3, BTX-1188’s profile is expected to be differentiated from protein degraders that exclusively target GSPT1. Preclinical data for BTX-1188 has shown rapid, deep and durable degradation of these targets at low nanomolar concentrations. Acute myeloid leukemia (AML) xenograft experiments have also shown significant decreases in tumor volume and increased survival compared to controls and other degraders of GSPT1. BioTheryX believes BTX-1188 has broad potential applicability in both hematologic and solid tumor malignancies and is currently studying the molecule in both settings as part of a Phase 1 clinical study.

About BioTheryX, Inc.

Contacts:

Investors/Media
212.600.1902
[email protected]

BioTheryX Announces Appointment of Sahm Nasseri as Chief Business Officer

SAN DIEGO, Jan. 20, 2022 — BioTheryX, Inc., a clinical-stage company focused on targeted protein degradation to create life-saving medicines, today announced the appointment of Sahm Nasseri as Chief Business Officer.

“Sahm is an accomplished biopharma leader with impressive experience in business development, corporate strategy, commercialization and program management. His expertise and leadership, most recently growing the U.S operations of an international biotech company and previously leading global commercial franchises for Merck, will help advance our pipeline of best-in-class protein degraders,” said Philippe Drouet, President and Chief Executive Officer of BioTheryX. “As the company’s first Chief Business Officer, Sahm will play an important role in establishing relationships with potential collaborators as we continue to expand our research and development programs.”

Mr. Nasseri previously served as Chief Executive Officer of PYC Therapeutics, an RNA therapeutics company based in the United States and Australia, where he built out the Company’s U.S. presence and preclinical, clinical and corporate development teams. Prior to this, Mr. Nasseri served at Merck & Co for seven years as a leader across business development, investor relations and corporate strategy functions where he gained extensive commercial drug development experience. He led global strategy for Merck’s growing oncology organization and served as interim Vice President and Global Product Leader for Merck’s HPV Vaccines, a family of vaccines with over $4 billion in annual revenue. Before Merck, Mr. Nasseri worked as a strategy consultant for McKinsey & Company. Mr. Nasseri holds a Bachelor of Chemical Engineering from the University of New South Wales in Sydney and an MBA from Columbia Business School in New York City.

“The outstanding team at BioTheryX has spent years building the leading targeted protein degradation platform in the industry. This PRODEGY platform is now poised to make a significant impact on patients with cancer with the lead protein degrader program entering Phase 1 clinical trials,” said Mr. Nasseri. “I am passionate about bridging great science towards the efficient development of medicines that can address important unmet patient needs and as such, I am excited to join BioTheryX and support the ongoing growth of the company and the continued development of its pipeline of first-in-class and best-in-class protein degradation therapies.”

About BioTheryX, Inc.

BioTheryX is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients suffering from cancer, inflammatory and immunological diseases through the discovery, development and commercialization of targeted protein degradation therapies. We leverage our proprietary PRODEGY technology platform and differentiated targeted protein degradation approach to design small molecules that regulate protein homeostasis. We believe our approach is applicable to a broad range of diseases and has the ability to address protein targets that have historically been considered undruggable. Our initial programs are focused on oncology indications with high unmet medical need. For more information, please visit www.biotheryx.com and engage with us on LinkedIn.

Contacts:

Investors/Media
[email protected]