ONTX - Onconova Therapeutics Inc. and Trawsfynydd Therapeutics Inc. Announce Business Combination to Form Traws Pharma Inc a Best-in-Class Virology and Oncology Company | Benzinga
- Closing cash balance of approximately $28 million expected from concurrent private placement led by OrbiMed and Torrey Pines
- Funding expected to advance development of three potential best-in-class/class leading assets: viroksavir, a cap-dependent endonuclease inhibitor for influenza; travaltrelvir, a protease inhibitor for COVID19; and narazaciclib, a next generation CDK4/6 inhibitor for low grade endometriod endometrial cancer (LGEEC)
- Multiple near-term catalysts, for viroksavir and travaltrevir in 2024, with first top-line read-outs expected in H2 2024
- Traws Pharma to be led by incoming CEO, Werner Cautreels, Ph.D.
- Combined board to be led by Executive Chairman Iain Dukes DPhil (OrbiMed) along with Nikolay Savchuk, Ph.D. (Torrey Pines)
- Companies to host joint webcast, April 2, 2024 at 8:30 a.m. ET
NEWTOWN, Pa. and ROCKVILLE, Md., April 02, 2024 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (NASDAQ:ONTX) ("Onconova"), and Trawsfynydd Therapeutics, Inc. ("Trawsfynydd"), a privately-held biotechnology company developing next-generation, best-in-class antivirals for influenza, COVID and other infectious diseases, today announced that the companies have entered into a definitive merger agreement to combine in an all-stock transaction (the "Merger"). Under the terms of the agreement, Onconova acquired 100% of Trawsfynydd's outstanding equity interests. In connection with the transaction and concurrent with the Merger, the combined company which has been renamed "Traws Pharma, Inc." ("Traws") will trade on NASDAQ under the new ticker symbol "TRAW", commencing prior to the opening of trading Wednesday, April 3, 2024.
In connection with the Merger, Traws announced that it will raise $14 million in a committed private placement financing by OrbiMed and Torrey Pines, expected to close on April 3, 2024. Upon closing of the private placement, Traws expects to have in excess of $28 million of cash and cash equivalents from the proceeds of the private placement and cash from both companies. These proceeds will be used to advance the Traws' programs through multiple clinical data catalysts and complete the dose ranging study for narazaciclib.
"I am pleased to announce the combination of Onconova and Trawsfynydd at this important time, as Trawsfynydd readies to initiate Phase 2 studies in H2 2024 for its lead antiviral programs for influenza and COVID19, supported by advisors with unparalleled expertise in viral disease, and Onconova is preparing to finalize the recommended Phase 2 dose (RP2D) for narazaciclib," said Dr. Cautreels incoming Chief Executive Officer of the combined company.
Commented Steven Fruchtman, M.D., President and Chief Executive Officer of Onconova and President and CSO, Oncology of the combined company, "Trawsfynydd has a differentiated pipeline and an accomplished leadership team poised to advance their lead programs. With a shared focus on developing best-in-class medicines for patients with unmet needs, we look forward to Traws' continued progress with its anti-viral programs and narazaciclib."
Traws Proprietary Portfolio:
TRX100 (viroksavir): a cap-dependent endonuclease inhibitor for influenza: Phase 1
- Targets the cap-dependent endonuclease of influenza and is a potent inhibitor of influenza virus replication including A and B strains
- Preclinical data showed that TRX100 inhibits viral replication of pandemic-potential influenza viruses circulating in nature during 2022, and importantly, also in oseltamivir and baloxavir-resistant viruses
- Completed a first Phase 1 study that demonstrated safety and tolerability in healthy volunteers. The study also provided pharmacokinetics and pharmacodynamics (PK/PD) data to support the potential use of a single oral dose administration for either treatment or prophylaxis
Next milestones: H2 2024
- Phase 1 dose extension will evaluate two additional, higher doses prior to the initiation of Phase 2 studies in H2 2024. Topline data from the Phase 2 study are expected in H1 2025
TRX01 (travaltrevir): Mpro protease inhibitor for COVID19: Phase 1
- Potent oral inhibitor of SARS-CoV-2 Mpro (3CL protease), effective against the original, delta, and omicron variants of SARS-CoV-2, with potentially superior properties to nirmatrelvir (Pfizer's Mpro inhibitor, PAXLOVID™)
- Does not require co-administration with a human cytochrome P450 (CYP) inhibitor such as ritonavir, avoiding potential significant drug:drug interactions, with the opportunity to expand the number of eligible patients
- Safe in GLP toxicology studies with no adverse events (AEs) in the expected human dose range. The drug candidate's pharmacokinetic (PK) profile may enable ...