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Makana Therapeutics & Tonix Pharmaceuticals

Makana Therapeutics Collaborates with Tonix Pharmaceuticals for TNX-1500

Shots: Makana Therapeutics has collaborated with Tonix Pharmaceuticals for TNX-1500 (anti-CD40L mAb) to reduce rejection of Makana’s genetically engineered (GE) pig organs in xenotransplantation Preclinical R&D collaboration may extend across Makana’s kidney, heart, & islet cell transplant programs, with an aim to support the US FDA’s IND submission for compassionate use in xenotransplantation pts Makana’s…

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Bioheng Therapeutics

Bioheng Therapeutics Secures the FDA Clearance of IND Application for CTD402 in T-ALL/LBL

Shots: The US FDA approved Bioheng’s IND application for CTD402 to treat pediatric and adult patients with relapsed/refractory T-cell acute lymphoblastic leukemia/lymphoma (R/R T-ALL/LBL) CTD402 will be evaluated in a P-Ib/II single-arm, open-label, dose-finding study to optimize dosing and accelerate clinical development CTD402 is a CD7-targeted universal CAR-T (UCAR-T) cell therapy that is genetically…

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Fapon Biopharma

Fapon Biopharma Reports the US FDA Approval of IND Application for FP008 to Treat Solid Tumors

Shots: The company received the US FDA’s approval on the IND application of FP008 to treat pts with solid tumors refractory to anti-PD-1 therapy FP008 exhibited safety, PK, and developability in cynomolgus monkey; currently seeking global strategic partnerships to co-develop FP008 through clinical trials & commercialization FP008 is an anti-PD-1×IL-10M fusion protein with a…

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The NMPA Clears Shanghai Henlius’ IND Application of HLX17 (Biosimilar, Keytuda) for Treating Solid Tumors

Shots:  The NMPA has cleared IND application of HLX17 to conduct its clinical study in comparison with Keytruda for treating melanoma, NSCLC, esophageal cancer, HNSCC, CRC, HCC, biliary tract cancer, TNBC, MSI-H/dMMR cancer & gastric cancer   HLX17 was assessed under pharmacologic comparative trial, preclinical pharmacology study as well as PK/PD & immunogenicity studies that showed similarity…

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PharmaShots Interview Purnanand Sarma, CEO of Immunome, Shares Insights on R&D Update IL-38 Targeting Antibody Treatment for Cancer

PharmaShots Interview: Purnanand Sarma, CEO of Immunome, Shares Insights on R&D Update IL-38 Targeting Antibody Treatment for Cancer

Shots:  Purnanand spoke about the preclinical results of lead candidate in oncology and how its identifies IL-38 as a target to treat cancer Purnanand also talked about Immunome’s collaboration with Fox Chase Cancer Center for the further development of its prime product The interview gives a understanding of Immunome’s goal of developing therapeutics to treat…

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PharmaShots Interview In Conversation with Cidara’s CEO, Dr.Jeff Stein, Where he Shares Insights on the IND acceptance by the FDA to Treat Influenza

PharmaShots Interview: In Conversation with Cidara’s CEO, Dr.Jeff Stein, Where he Shares Insights on the IND acceptance by the FDA to Treat Influenza

Shots: Jeff spoke about IND acceptance by the US FDA for its lead flu drug-Fc conjugate immunotherapy for the prevention and treatment of Influenza He also discussed Cidara’s collaboration with Janssen Pharmaceuticals to develop and commercialize Cidara’s DFCs The interview also emphasizes Cidara’s Cloudbreak platform to develop immunotherapeutic antivirals and treatment options for influenza Smriti:…

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