Phanes Therapeutics, Inc. Announces Clinical Supply Agreement with Roche to Evaluate PT217 in Combination with an anti-PD-L1 Therapy

2024-05-08

·PRNewswire

临床1期孤儿药快速通道免疫疗法

PT217 is Phanes' first-in-class bispecific antibody targeting DLL3 and CD47;

atezolizumab (

TECENTRIQ®

)

is Roche's anti-PD-L1 monoclonal antibody

The clinical

supply agreement

will focus on evaluating PT217 in combination with

atezolizumab

for the treatment of small cell lung cancer (SCLC), large cell neuroendocrine carcinoma of the lung (LCNEC) and extrapulmonary neuroendocrine carcinomas (EP-NECs)

PT217 was recently granted Fast Track designation by the FDA for

the treatment of patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression following platinum chemotherapy with or without a checkpoint inhibitor

SAN DIEGO, May 8, 2024 /PRNewswire/ -- Phanes Therapeutics, Inc. (Phanes), a clinical stage biotech company focused on innovative drug discovery and development in oncology, announced today that it has entered into a clinical supply agreement with Roche to study PT217, its first-in-class bispecific antibody targeting DLL3 and CD47, in combination with Roche's anti-PD-L1 therapy, atezolizumab, in patients with small cell lung cancer (SCLC), large cell neuroendocrine carcinoma of the lung (LCNEC) and extrapulmonary neuroendocrine carcinomas (EP-NECs). PT217 was granted orphan drug designation (ODD) for the treatment of SCLC by the FDA in 2022, and recently granted Fast Track designation by the agency for the treatment of patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression following platinum chemotherapy with or without a checkpoint inhibitor.

Phanes is currently enrolling patients in a multi-center Phase I clinical trial of PT217. The Phase I clinical trial (NCT05652686), known as the SKYBRIDGE study, is currently evaluating the safety, tolerability, pharmacokinetics and preliminary efficacy of PT217 in patients with advanced or refractory cancers expressing DLL3. The next phase of Phanes' study is investigating the therapeutic potential of PT217 as a combination therapy in SCLC, LCNEC and EP-NECs. The clinical collaboration with Roche will evaluate PT217 in combination with atezolizumab in these patients.

"Phanes is very excited about partnering with Roche on this novel approach to treat patients with SCLC, LCNEC and EP-NECs," said Rita Laeufle, MD, PhD, Chief Medical Officer (CMO) of Phanes. "DLL3 is highly expressed in SCLC, LCNEC and EP-NECs and an important target for treating these cancers. We believe the mechanisms of PT217 and atezolizumab are complementary and the combination has the potential to improve outcomes for patients. This collaboration marks another milestone for Phanes in fulfilling our vision of developing innovative approaches to treat cancer."

TECENTRIQ

® is a registered trademark of Roche.

ABOUT PHANES THERAPEUTICS

Phanes Therapeutics, Inc. is a clinical stage biotech company focused on innovative drug discovery and development in oncology. Currently, it is conducting three Phase I clinical trials, including the MORNINGSTAR study with its best-in-class monoclonal antibody (mAb) program, PT199, the TWINPEAK study with PT886 and the SKYBRIDGE study with PT217. Both PT886 and PT217 are first-in-class bispecific antibodies and have been granted orphan drug designation as well as Fast Track designation by the FDA.

The company has built a strong pipeline by leveraging its proprietary technology platforms: PACbody®, SPECpair® and ATACCbody® to develop novel biologics that address high unmet medical needs in cancer.

For more information about Phanes Therapeutics, please visit www.phanesthera.com

For business development or media inquiries, please contact [email protected] or [email protected], respectively.

SOURCE Phanes Therapeutics

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