Shots:
China’s NMPA has received 2 IND applications for HF158K1 (K1) & HFK2 (K2) to initiate P-I dose escalation trial in China to evaluate safety & PK of K1 alone & its preliminary efficacy with K2 to treat pts with solid tumors refractory to prior therapies
Preclinical studies of K1, K2, & their combination showed…
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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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Lexicon has granted Novo Nordisk exclusive global rights to develop, manufacture & commercialize LX9851 (oral ACSL5 inhibitor) in all indications
As per the deal, Lexicon will receive $45M upfront, ~$485M in regulatory & launch milestones, ~$475M in sales milestones, & tiered royalties from single to low-double-digit % of annual net sales. Lexicon will complete…
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The EC has approved Breyanzi for r/r follicular lymphoma adults treated with ≥2 previous lines of systemic therapy in 30 EEA states
Approval was based on global P-II (TRANSCEND FL) study, assessing Breyanzi’s safety & efficacy to treat r/r indolent B-cell NHL incl. FL
In pts treated in 3L+ setting, study met…
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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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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 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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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…
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:…

