Phanes Therapeutics announces FDA IND clearance for PT217 for cancer patients

Phanes Therapeutics, Inc. (Phanes), a clinical stage biotech company focused on oncology, announced today that it has received clearance from the US Food and Drug Administration (FDA) to commence Phase I studies with PT217, its anti-Delta-like ligand 3 (DLL3)/anti-Cluster of differentiation 47 (CD47) bispecific antibody being developed for patients with small cell lung cancer (SCLC) and other neuroendocrine cancers. PT217 has recently been granted an orphan drug designation by the FDA for the treatment of SCLC.

“This is the third program in our pipeline that has received IND clearance by FDA this year, which is an important milestone for Phanes and a record for a biotech company of our size. The opportunity to bring this potential first-in-class bispecific antibody to cancer patients who have such a high unmet medical need is at the core of what drives us as a company,” said Dr. Ming Wang, Founder and CEO. “With a strong pipeline targeting both the adaptive and innate immunity and the bispecific antibody technology platforms we have built, Phanes is well positioned to make important impacts in delivering innovative cancer therapies.”

The Phase I study will evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of PT217 in subjects with advanced or refractory cancers. Patients with the following tumor types will be eligible for screening: unresectable SCLC, large cell neuroendocrine cancer (LCNEC), neuroendocrine prostate cancer (NEPC) and gastroenteropancreatic neuroendocrine tumors (GEP-NET). Subjects must have progressed after standard therapy (at least one line of platinum-based chemotherapy with or without immune checkpoint inhibitor for SCLC) or standard therapy has proven to be ineffective, intolerable or was considered inappropriate.

SCLC is an aggressive pulmonary carcinoma hallmarked by high early mortality rates and significant morbidities throughout the disease’s progression. The 1-year survival of patients with SCLC is only 32.9%, with survival steadily decreasing with only 10.7% of patients surviving 3 years.

Phanes current clinical programs include: PT199, a differentiated anti-CD73 monoclonal antibody, enrolling at 3 US study sites and PT886, an anti-Claudin 18.2/anti-CD47 bispecific antibody, which is in study startup at The University of Texas MD Anderson Cancer Center, Houston, TX.

About Phanes Therapeutics

Phanes Therapeutics, Inc. is a clinical stage biotech company focused on innovative drug discovery and development in oncology. Currently, it has three assets at clinical stage, including its best-in-class monoclonal antibody (mAb) program, PT199, and two first-in-class bispecific antibody programs, PT886 and PT217. Both PT886 and PT217 have been granted orphan drug designation by FDA. Its pipeline also includes humanized mAbs, biparatopics, and single-chain variable fragments (scFvs) against multiple tumor-associated antigens (TAAs) that are suitable for ADC and CAR-T applications, respectively.

The company has built a strong pipeline by leveraging its proprietary technology platforms: PACbody, ATACCbody, and SPECpair to develop novel biologics that address high unmet medical needs in cancer. PACbody, is a proprietary approach for constructing bispecific antibodies without using protein engineering so that the antibody molecules maintain native structures with superb CMC characteristics. SPECpair allows mAb-like manufacturability of bispecific antibodies with native IgG-like structures, and ATACCbody is a technology for targeting solid tumors using immuno-oncology molecules with modulated activities designed to minimize the risk of cytokine release syndrome.

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