Another PROTAC entered clinical study

December 24, 2021—Accutar Biotechnology, a biotechnology company focused on AI drug development, announced that the FDA has approved its IND for AC0176 for the treatment of patients with metastatic decompensated refractory prostate cancer (mCRPC).

AC0176 is an orally administered chimeric degradant molecule designed to target and degrade the androgen receptor (AR) with high potency, selectivity, and broad mutant coverage. The AR is a hormone-regulated transcription factor whose activation plays a key role in the development and progression of prostate cancer. Accutar Biotechnology expects to begin enrolling subjects in a Phase I clinical trial of AC0176 in the first quarter of 2022.

"The IND approval of AC0176 is another important validation following the recent clinical entry of our AC0682 and demonstrates that our artificial intelligence platform can support and drive the rapid discovery of potentially differentiated clinical candidates, particularly for complex compounds such as chimeric degraders," said Dr. Jie Fan, CEO of Accutar Biotechnology. "AC0176's approval is particularly crucial in terms of giving a potential novel treatment for prostate cancer, which works differently than second-generation NSAID AR antagonists that are now the standard of care for this patient population. We're excited to see what clinical benefits AC0176 treatment can offer prostate cancer patients."

The Phase I study will evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of AC0176 treatment in patients with mCRPC.

About AC0176

AC0176 is an oral biologic agent that is a chimeric degradation agent of the androgen receptor (AR) for the possible treatment of prostate cancer. In preclinical studies, AC0176 has demonstrated effective and selective AR protein degradation, broad coverage of AR mutants, good pharmacological properties, and good antitumor activity in animal models.

PROTAC boom

Protein degradation technologies like PROTAC would undoubtedly be one of the buzzwords for the biopharmaceutical industry in 2021 if we had to choose.

• In July, Arvinas, the star company in PROTAC therapeutics, announced a more than $2 billion agreement with Pfizer to advance the development of a potential "first-in-class" therapy, ARV-471.
• In August, Bayer announced a $2 billion acquisition of protein degradation therapy startup Vividion Therapeutics, and Eli Lilly entered into a $1.6 billion partnership with Lycia Therapeutics, which is developing an innovative protein degradation technology.
• In November, Novartis and Dunad Therapeutics entered a more than $1.3 billion R&D collaboration.

As an emerging technology, PROTAC greatly expands the possibilities of target selection for future human drug development.

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