Shots:
Oxford BioTherapeutics has entered into a multi-year strategic collaboration with Bristol Myers Squibb (BMS) to discover and develop next-generation T-cell engager therapies targeting solid tumors
Under the agreement, OBT will leverage its OGAP-Verify platform to identify tumor-selective targets and design & delivery of developed candidates, while Bristol Myers Squibb will lead subsequent clinical research,…
Shots:
Regulatory momentum remained strong, with key biosimilar launches and approvals including Celltrion’s Remsima IV (EU) and Avtozma SC (US), Teva’s FDA-approved Ponlimsi, Japan’s approval of tocilizumab BS MA by Mochida Pharmaceutical and AYUMI Pharmaceutical, and IND clearance for HLX18 by National Medical Products Administration.
Strategic partnerships expanded access, led by Samsung Bioepis–Sandoz collaboration, Formycon’s aflibercept settlement deal with Regeneron Pharmaceuticals and Bayer, and Bio-Thera…
Shots:
ImmunityBio announced positive results from two clinical studies evaluating ANKTIVA (nogapendekin alfa inbakicept) in combination with checkpoint inhibitors (CPI) in non-small cell lung cancer (NSCLC), demonstrating statistically significant immune restoration across 151 pts
In 1L NSCLC, the randomized QUILT-2.023 study showed a significant and sustained increase in absolute lymphocyte count (ALC) with ANKTIVA +…
Shots:
The US FDA has granted Breakthrough Therapy Designation (BTD) to Ipsen’s investigational therapy IPN60340 (ICT01) in combination with venetoclax and azacitidine for the treatment of 1L unfit acute myeloid leukemia (AML)
The designation was supported by data from the P-I/II (EVICTION) study (n=57), where IPN60340 + Ven-Aza showed encouraging response rates, including a near…
Shots:
RemeGen has granted AbbVie exclusive rights to develop, manufacture, & commercialize RC148 outside of the Greater China
In return, RemeGen will receive $650M upfront, ~$4.95B in development, regulatory, & commercial milestones, with tiered, double-digit royalties on sales in AbbVie’s licensed areas
RC148 is a PD-1/VEGF-targeted bispecific antibody that is being developed as a monotx.…
Shots:
The company has filed a P-I/II IND with the FDA to begin clinical trials of CYPS317 for mod. to sev. Psoriasis
In animal studies, a single dose of CYPS317 matched or exceeded multiple anti-IL-23 mAb doses, showing durable effects and reduced disease recurrence
CYPS317 is an investigational allogeneic fibroblast spheroid therapy for mod. to…
Shots:
Citius Pharmaceuticals celebrates its first-ever FDA approval with Lymphir, a novel therapy for relapsed or refractory cutaneous T-cell lymphoma
In an exclusive conversation, Leonard Mazur, Co-Founder and CEO at Citius Pharmaceuticals, shares insights on Lymphir’s launch strategy and its potential impact on the oncology landscape
Leonard also highlights Mino-Lok, Citius’ innovative…
Shots:
PDS Biotech reported the final topline results from the P-II (VERSATILE-002) Study evaluating safety and efficacy of PDS0101 (Versamune HPV) + Keytruda in 1L R/M HPV16+ HNSCC (n=53)
In the Study PDS0101 (SC) with pembrolizumab (IV) for the first 4 cycles, then as a final single dose on cycle 12. Pembrolizumab monotx. was given…
Shots:
HanchorBio entered into an out-licensing agreement with Shanghai Henlius Biotech and granted exclusive rights to develop and commercialize HCB101 in Greater China, Southeast Asia, and MENA
Under the terms and agreement, HanchorBio will receive $10M upfront and up to $192M in development and regulatory milestones, plus tiered royalties
Henlius will also oversee development, production,…
Shots:
Vetigenics initiated dosing in a multisite CHECKMATE K9 pilot study evaluating the safety and preliminary efficacy of VGS 001 (anti‑cCTLA‑4 mAb) + VGS 002 (anti‑cPD‑1 mAb) in dogs with various solid tumors
Early data from single-agent use demonstrated strong safety and encouraging therapeutic responses in Dogs
VGS 001 is an anti‑cCTLA‑4 mAb and VGS…

