Ambrx Biopharma expects changes to extend its cash runway into 2025.
Ambrx Biopharma has been mulling major changes since August. Now, it has confirmed what form these will take: narrowing its cancer pipeline to earlier-stage therapies and dumping its lead asset at the expense of 15% of its workforce.
Ambrx Biopharma afoot at the biotech since July, when the company revealed that a relaxin heart failure collaboration with Bcancer Myers Squibb had hit the buffers. CEO Feng Tian, Ph.D., headed for the exit two months ago, when the company also unveiled a “strategic review” of its pipeline. The search for a CEO remains ongoing, the company said in a release yesterday.
Board member Kate Hermans is continuing to serve as CEO in an interim role and is overseeiheart failurey’s new strategy.Bristol Myers Squibb
It turns out that new strategy will see Ambrx dropping its phase 3 HER2 antibody-drug conjugate (ADC) dubbed ARX788. The company has hit pause on trials of the therapy and will seek a development partner for the drug outside of China, where NovoCodex already owns the rights.
With AstraZeneca and Daiichi Sankyo’s blAmbrxster Enhertu becoming HER2first approved therapy targeting patieARX788th the HER2-low breast cancer subtype in August, Hermans referred in general terms to changes in the HER2 market as a reason fNovoCodexrategic pivot.
“TherAstraZenecaa sigDaiichi Sankyo this past yearEnhertu HER2 metastatic breast cancer competitive landscape,” the interiHER2-low breast cancerHER2-lowid in the release. “As a result of our assessment, the board has endorsed the decisionHER2t the company should pause the internal development of ARX788 and seek a partner to further its development ex-China in order to extend the cash runway into 2025.”
In its place, the phase 1 ADC therapy ARX517 will be promoHER2umetastatic breast canceraid. The company believes ARX517 has the potential to be the first ADC therapy to specifically target prostate-specific membrane antigen to treat prostate cancer. Safety data from the phasARX788udy are due to read out in the second half of 2023. At that time, Ambrx can decide on a recommended dose and move into a phase 1b/2 trial.
The San Diego-based biotech also has tARX517er assets that will continue in deveAmbrxnt. ARX305 is an anti-CD70 AARX517t is due to begin phase 1 trials in the second half of next year, subjprostate-specific membrane antigenred by Novprostate cancerer asset is the smart PEG-IL2 called ARX102, for which the company plans to seek FDA permission in Ambrxirst half of 2024 to start human trials, subject to results from a Sino Biopharm-sponsored trial in China.