Adastra Pharmaceuticals, Inc.

Ms. Lawhon has nearly 20 years of oncology drug development, partner engagement and corporate strategy leadership experience SAN DIEGO, Aug. 24, 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 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 and engage with us on LinkedIn. SOURCE Biotheryx, Inc.

Adastra Pharmaceuticals welcomes CRO pitches for a Phase II trial of zotiraciclib in adults with recurrent high-grade gliomas and an isocitrate dehydrogenase (IDH) mutation, CEO Scott Megaffin said. In addition, the company has initiated a $45m Series B round to finance the study and other clinical trial development. The Princeton, New Jersey-based company aims to start the trial by 2Q21 with trial sites in both the US and Europe, Megaffin said. Adastra eyes a CRO with previous experience working with small molecules and conducting high-grade glioma trials, he added. The company would prefer a full-service CRO, with no specific preferences for CRO size or geographic location, he explained. Though the trial details will be based on upcoming regulatory conversations, the trial could enrol approximately 200–300 patients, Megaffin said. Adastra is considering overall survival and median progression-free survival (PFS) after 6 and 12 months as possible trial endpoints, as are consistent with industry standards, he noted. Previously, a Phase Ib trial measuring safety and efficacy of zotiraciclib with temozolomide in patients with recurrent high-grade gliomas found a stronger efficacy signal in the subset of patients with IDH-mutated tumours, Megaffin said. Currently, there are no trials focusing on this specific subpopulation, indicating a significant unmet need in the field, he added. The Phase Ib, which was conducted by the National Cancer Institute, met its PFS endpoint, according to topline results published in a 13 January company press release. Adastra plans to publish the full study results during ASCO in June, Megaffin said. To finance the upcoming Phase II trial, and to bring zotiraciclib to clinic in several other oncology indications with metastasis-initiating cells, Adastra is now initiating a Series B fundraising round, Megaffin said. The company hopes to close the round in 2Q21, shortly before it begins the Phase II, he explained. Currently, there is significant internal interest among a number of blue-chip venture capital firms and partners in China and Russia that have already invested in the company, Megaffin said. Adastra’s current investors include Domain Associates, Lee’s Pharma, Morgenthaler Private Equity, ProQuest, RusnanoMedInvest and Mitsubishi, according to the company website. Adastra will also open the round to outside private investors, though the company has not yet determined what specific types of investors it seeks, he added. An unspecified amount of current company funding will last up to the start of the Phase II trial, he explained. Zotiraciclib is a potent oral cyclin-dependent kinase 9 inhibitor that can cross the blood-brain barrier and deplete antiapoptotic oncogenes, according to the company website. William Newton is a Reporter for Clinical Trials Arena parent company GlobalData’s investigative journalism team. A version of this article originally appeared on the Insights module of GlobalData’s Pharmaceutical Intelligence Center. To access more articles like this, visit GlobalData. Thematic Reports Are you worried about the pace of innovation in your industry? GlobalData's TMT Themes 2021 Report tells you everything you need to know about disruptive tech themes and which companies are best placed to help you digitally transform your business. Find out more

PRINCETON, N.J., Jan. 14, 2021 /PRNewswire/ -- Adastra Pharmaceuticals Inc. (Adastra), a biopharmaceutical company focused on the development of first-in-class therapeutics for the treatment of cancer, today announced that Scott Megaffin, Chief Executive Officer, will present at the inaugural 2021 B. Riley Securities' Oncology Investor Conference, being held virtually January 20-21, 2021. Mr. Megaffin will present Adastra's corporate strategy and clinical plans for its lead candidate, Zotiraciclib, which is a potent, orally delivered, cyclin-dependent kinase 9 (CDK9) inhibitor that readily crosses the blood-brain barrier to treat cancers characterized by Myc overexpression. Adastra recently announced positive top-line results from a clinical trial of Zotiraciclib in the treatment of high-grade gliomas. The announcement can be accessed here. Presentation Details About Adastra Pharmaceuticals Adastra Pharmaceuticals Inc. is an innovative, private, clinical-stage biopharmaceutical company committed to providing responsible solutions to advance patient care in oncology. Our vision is to identify, develop and deliver to patients important new therapies for diseases with significant unmet need. This commitment is epitomized by our lead clinical candidate, zotiraciclib, which is initially being developed for the treatment of high-grade gliomas (HGG) and diffuse intrinsic pontine glioma (DIPG), two forms of brain cancer characterized by Myc overexpression. Adastra possesses a rich history of institutional and academic collaboration, including ongoing clinical research programs with the National Cancer Institute (NCI) and the European Organisation for Research and Treatment of Cancer (EORTC). We invite you to learn more about Adastra, our clinical and scientific partners and our journey to bring meaningful new therapies to patients, by visiting . Ignacio Guerrero-Ros, Ph.D. Russo Partners, LLC (646) 942-5604 Ignacio.Guerrero-Ros@russopartnersllc.com David Melamed, Ph.D. Russo Partners, LLC (212) 845-4225 David.Melamed@russopartnersllc.com