mavrostobart (PT199) / Phanes Therap - LARVOL DELTA

Dose Escalation/Expansion Study of PT199 (an Anti-CD73 MAb) Administered Alone and in Combination with a PD-1 Inhibitor or Chemotherapy (the MORNINGSTAR Study) (clinicaltrials.gov) - P1/2 | N=40 | Recruiting | Sponsor: Phanes Therapeutics | Phase classification: P1 ➔ P1/2 | Trial completion date: Aug 2025 ➔ Aug 2028 | Trial primary completion date: Dec 2024 ➔ Dec 2027

Checkpoint inhibition • Phase classification • Trial completion date • Trial primary completion date • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • CD73

Dose Escalation/Expansion Study of PT199 (an Anti-CD73 mAb) Administered Alone and in Combination With a PD-1 Inhibitor (the MORNINGSTAR Study) (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: Phanes Therapeutics | Trial completion date: Jan 2024 ➔ Aug 2025 | Trial primary completion date: Nov 2023 ➔ Dec 2024

Combination therapy • Metastases • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CD73

Phanes Therapeutics Announces the Establishment of Oncology Clinical Advisory Board (PRNewswire) - "Phanes Therapeutics, Inc...today announced that it has formed a Clinical Advisory Board (CAB) to enhance the development of its three clinical stage programs: PT199 for solid tumors, PT886 for gastric, gastroesophageal junction and pancreatic adenocarcinomas, and PT217 for small cell lung cancer and other neuroendocrine cancers....Members of Phanes' Clinical Advisory Board: Tony Mok..."

Commercial • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Lung Cancer • Neuroendocrine Tumor • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Small Cell Lung Cancer • Solid Tumor

Phanes Therapeutics Announces the Establishment of Oncology Clinical Advisory Board (PRNewswire) - "Phanes Therapeutics, Inc...today announced that it has formed a Clinical Advisory Board (CAB) to enhance the development of its three clinical stage programs: PT199 for solid tumors, PT886 for gastric, gastroesophageal junction and pancreatic adenocarcinomas, and PT217 for small cell lung cancer and other neuroendocrine cancers."

Commercial • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Lung Cancer • Neuroendocrine Tumor • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Small Cell Lung Cancer • Solid Tumor

Phanes Therapeutics Announces Clinical Supply Agreement with BeiGene to Evaluate PT199 in combination with Tislelizumab (PRNewswire) - "Phanes Therapeutics, Inc...announced a clinical supply agreement with BeiGene, Ltd. (NASDAQ: BGNE) to evaluate the safety and efficacy of Phanes' PT199, a differentiated anti-CD73 monoclonal antibody in combination with BeiGene's tislelizumab, an anti-PD-1 monoclonal antibody in the Phase I clinical study (NCT05431270) for the treatment of multiple advanced solid tumors."

Licensing / partnership • Oncology • Solid Tumor

A Phase I, Dose Escalation and Expansion Study of PT199, a Next Generation CD73 Monoclonal Antibody, Administered Alone and in Combination with a PD-1 Inhibitor in Adult Patients with Advanced Solid Tumors (SITC 2022) - P1 | "Trial Registration NCT05431270 Ethics Approval The study obtained ethics approval through a central IRB (Advara IRB: Pro00063442). All participants have given informed consent before taking part in this trial."

Clinical • Combination therapy • IO biomarker • Oncology • Solid Tumor

Phanes Therapeutics Announces First Patient Dosed in Phase 1 Study of PT199 for Advanced Solid Tumors (PRNewswire) - "Phanes Therapeutics, Inc...announced today that the first patient has been dosed in the phase 1 clinical study (NCT05431270) of PT199, an anti-CD73 monoclonal antibody (mAb) for the treatment of multiple advanced solid tumors....The multi-center Phase I clinical trial of PT199 is evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of PT199, alone and in combination with a PD-1 inhibitor, in patients with locally advanced or metastatic solid tumors that have progressed after all available standard therapy or for which standard therapy has proven to be ineffective, intolerable, or is considered inappropriate."

Trial status • Oncology • Solid Tumor

Dose Escalation/Expansion Study of PT199 (an Anti-CD73 mAb) Administered Alone and in Combination With a PD-1 Inhibitor (clinicaltrials.gov) - P1 | N=38 | Recruiting | Sponsor: Phanes Therapeutics | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Oncology • Solid Tumor

Dose Escalation/Expansion Study of PT199 (an Anti-CD73 mAb) Administered Alone and in Combination With a PD-1 Inhibitor (clinicaltrials.gov) - P1 | N=38 | Not yet recruiting | Sponsor: Phanes Therapeutics

Combination therapy • New P1 trial • Oncology • Solid Tumor

Phanes Therapeutics revealed manufacturing validation of its bispecific technology platforms PACbody and SPECpair at AACR 2022 (PRNewswire) - "Phanes Therapeutics, Inc...revealed that the company has completed the manufacturing scale production of a bispecific antibody constructed with its PACbody™ and SPECpair™ technologies....The lead molecule is PT886...being studied for pancreatic and gastric cancers, with a target IND filing date in Q2 2022....In addition to the PT886 poster, Phanes presented two other posters at AACR 2022 on PT199, an anti-CD73 mAb with a differentiated mechanism of action, and PT217, an anti-DLL3/anti-CD47 bispecific antibody, respectively."

Commercial • IND • Preclinical • Gastric Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer

PT199, a next generation anti-CD73 mAb that inhibits both membrane-bound and soluble CD73 activity to completion without “hook effect” (AACR 2022) - "Taken together, our data confirms PT199 as a potential best-in-class anti-hCD73 mAb. Phase 1 clinical trial is planned to start in the first quarter of 2022."

Oncology

Phanes Therapeutics' anti-CD73 antibody patent granted in the US (PRNewswire) - "Phanes Therapeutics, Inc...announced today that the company has been granted a patent (Patent No. US 11,299,550 B2) on its anti-CD73 antibodies by the United States Patent and Trademark Office (USPTO). The patent includes the invention of PT199, for which the company just received clearance from the US Food and Drug Administration to commence Phase I studies...'We expect to file two additional INDs in 2022, both first-in-class bispecific antibody programs, and anticipate receiving more issued patents'."

IND • Patent • Oncology • Solid Tumor

Phanes Therapeutics announces FDA IND clearance for PT199, a next generation monoclonal antibody against human CD73 (PRNewswire) - "Phanes Therapeutics, Inc...announced today that it has received clearance from the US Food and Drug Administration to commence Phase I studies with PT199, its next generation monoclonal antibody (mAb) against CD73 in adult patients with advanced solid tumors....'We have built a strong pipeline in immuno-oncology by leveraging our proprietary technology platforms and expect to file two additional INDs in 2022, both first-in-class bispecific antibody programs."

IND • New P1 trial • Oncology • Solid Tumor

Phanes Therapeutics Announces Three Upcoming Presentations at the 2022 American Association for Cancer Research (AACR) Annual Meeting (PRNewswire) - "Phanes Therapeutics...announced today that three posters featuring its IND-enabling stage molecules will be presented at the upcoming 2022 American Association for Cancer Research (AACR 2022) Annual Meeting....'These are the first three lead molecules that are planned to enter Phase 1 clinical studies this year. More first-in-class bispecific antibody programs will follow from our pipeline after we file three INDs in 2022'....'The posters will showcase our deep science and how the preclinical data packages support our clinical development plans'."

IND • Preclinical • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor