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Biotech Clinical Trials

AstraZeneca Reports Results of Imfinzi (durvalumab) and Imfinzi + Tremelimumab in P-III POSEIDON Study as 1L Treatment for Stage IV Non-Small Cell Lung Cancer

Shots: The P-III POSEIDON study involves assessing Imfinzi + platinum-based CT or Imfinzi + Tremelimumab + CT vs CT as monothx as a 1L treatment in patients with mNSCLC The study demonstrated improvement in OS

Pharma

Merck and Fusion Pharmaceuticals Enter into a Clinical Collaboration for FPI-1434 + Keytruda (pembrolizumab) to Treat Solid Tumors Expressing IGF-1R

Shots: The collaboration will evaluate Fusion’s FPI-1434 + Merck’s Keytruda in patients with solid tumors expressing IGF-1R. Fusion will sponsor the study and Merck will supply Keytruda The companies plan to initiate a P-I/II trial

MedTech

BMS Signs a Research Collaboration with DarwinHealth to Discover Novel Cancer Target Initiative

Shots: DarwinHealth will receive an upfront and eligible to receive as a commercial milestone, as part of the NCTI collaboration The focus of the collaboration is to identify NCTs across tumor subtypes for different cancer

Pharma

BeiGene and Asieris Enter into Clinical Collaboration for APL-1202 + Tislelizumab to Treat Muscle Invasive Bladder Cancer

Shots: BeiGene and Asieris collaborate to evaluate the safety and efficacy of APL-1202 + tislelizumab as neoadjuvant therapy in patients with MIBC. APL-1202 has been approved to treat patients with locally advanced or metastatic UC

Biotech

AbCellera Signs a Multi-Target Collaboration with Amgen to Develop Bispecific Antibodies for the Treatment of Diabetic Retinopathy

Shots: AbCellera will receive equity and research fees and is eligible to receive milestone along with royalties based on the development and commercialization of Abs Angios gets the rights to develop and commercialize therapeutic products

Regulatory

Merck and Eisai Receive the US FDA‘s Priority Review for Keytruda (pembrolizumab) + Lenvima (lenvatinib) to Treat Advanced Renal Cell Carcinoma and Endometrial Carcinoma

Shots: The 1st sNDA and sBLA is based on results from the P-III CLEAR Study evaluating Lenvima + Keytruda or in combination with everolimus vs sunitinib in a ratio (1:1:1) in 1,069 patients with advanced

Regulatory

Amgen Reports the US FDA’s Acceptance of sNDA for Review of Otezla (apremilast) to Treat Mild-To-Moderate Plaque Psoriasis

Shots: The acceptance is based on a P-III ADVANCE trial assessing the efficacy of Otezla (30 mg, bid) vs PBO in 595 patients in a ratio (1:1) with mild-to-moderate plaque psoriasis for the first 16wks.

COVID-19

Roche’s Ab Cocktail (Casirivimab and Imdevimab) Receives EUA to Treat COVID-19 in India

Shots: The CDSCO has granted a EUA for Roche’s casirivimab and imdevimab to treat COVID-19 in India. The approval of the Ab cocktail was based on the data that has been filed for the EUA

Biotech

Sanofi Signs a Three-Year Collaboration with Stanford Medicine to Accelerate Immunology Research

Shots: Sanofi and Stanford Medicine collaborated to initiate three “deep-dive” research projects focusing on autoimmune diseases and inflammatory conditions The partners will organize a joint committee to fund three programs in a year with an