CD47 x DLL3

Phanes’ PT217 is a delta-like ligand 3 (DLL3) and a cluster of differentiation 47 (CD47- targeting bispecific antibody. Image Credit: Huen Structure Bio / Shutterstock. The US Food and Drug Administration (FDA) has granted an orphan drug designation to Phanes Therapeutics’ PT217 in neuroendocrine carcinoma (NEC) indication. This is the second orphan drug designation the therapy has received from the FDA. In 2022, PT217 received the designation for the treatment of small cell lung cancer (SCLC). The orphan drug status gives sponsors tax credits from clinical trials, exemption from user fees, and a potential seven years of market exclusivity for the therapy after approval, compared to the usual five years. PT217 is a delta-like ligand 3 (DLL3) and a cluster of differentiation 47 (CD47)-targeting bispecific antibody. Phanes is investigating the therapy in patients with advanced or refractory cancers expressing DLL3, including SCLC, extrapulmonary NECs, and large cell neuroendocrine carcinoma of the lung (LCNEC). The Phase I SKYBRIDGE trial (NCT05652686) is evaluating the safety, tolerability and pharmacokinetics of PT217 in combination with Roche’s PD-L1 therapy Tecentriq (atezolizumab). Multiple pharmaceutical companies have invested in the development of bispecific antibody therapies . Earlier this month, Merck & Co (MSD) unveiled plans to acquire a CD3 and CD19-targeting T cell engager bispecific antibody, CN201, from Curon Biopharmaceutical. The deal is worth approximately $1.3bn in upfront and milestone-based payments. It is expected to close in Q3 this year. In May, Johnson & Johnson (J&J) paid $1.25bn to acquire global rights for Numab Therapeutics’ IL-4R and IL-31-targeting bispecific antibody. The therapy is being evaluated as a treatment for atopic dermatitis in a Phase I trial (NCT05859724). See Also: AstraZeneca wins approval for Imfinzi in NSCLC perioperative setting Hoth and Aronnax partner for HT-KIT cancer therapy development Other therapies in Phanes’s pipeline are a CD73-targeting monoclonal antibody PT199, a Claudin 18.2 (CLDN18.2), and the CD47-targeting bispecific antibody PT886. The company is evaluating PT199 as a combination treatment with BeiGene’s Tivimbra (tislelizumab) for solid tumours in a Phase I MORNINGSTAR trial (NCT05431270). The bispecific antibody PT886 is being trailed in combination with MSD’s Keytruda (pembrolizumab) in a Phase I/II TWINPEAK study (NCT05482893). The trial is expected to enrol approximately 114 participants with either unresectable or metastatic gastric adenocarcinoma, gastroesophageal junction (GEJ) adenocarcinoma, and pancreatic ductal adenocarcinoma (PDAC).

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

SAN DIEGO, April 8, 2024 /PRNewswire/ -- Phanes Therapeutics, Inc. (Phanes), a clinical stage biotech company focused on innovative drug discovery and development in oncology, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PT217 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. PT217 was also granted orphan drug designation for the treatment of small cell lung cancer by the FDA in 2022. PT217, a first-in-class native IgG-like bispecific antibody (bsAb) targeting DLL3 and CD47, is being developed for the treatment of patients with small cell lung cancer (SCLC), large cell neuroendocrine carcinoma of the lung (LCNEC), and extrapulmonary neuroendocrine carcinomas (EP-NECs). SCLC is an aggressive form of cancer characterized by high mortality rates and significant morbidities. The average survival for patients who present with ES-SCLC without treatment is 2-4 months after diagnosis; the median survival for patients with treatment is 7-11 months. "PT217 has the potential to be a transformative treatment option for patients with SCLC, LCNEC and EP-NECs in various settings," said Ming Wang, Founder and CEO of Phanes Therapeutics. "Now we have two Fast Track designations in our pipeline. Last month, PT886 was granted Fast Track designation for the treatment of patients with metastatic claudin 18.2-positive pancreatic adenocarcinoma. Both assets are from our optimized anti-CD47 bispecific antibody franchise and currently in clinical studies. We believe the optimized anti-CD47 bispecific antibody approach can unlock the full potential of the innate immunity in targeting solid tumors." The multi-center Phase I clinical trial of PT217 (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. 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, please visit . For business development or media inquiries please contact [email protected] or [email protected], respectively. SOURCE Phanes Therapeutics