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BioNTech reported positive results from a P-II study cohort of trastuzumab pamirtecan (BNT323/DB-1303) in HER2-expressing recurrent endometrial cancer, meeting its 1EP of ORR
The study cohort (n=145) demonstrated a confirmed ORR of 47.9% (n=96; central testing) and 49.3% in pts. (n=73) previously treated with checkpoint inhibitors, with a mPFS of 8.1mos., showing consistent efficacy…
Oxford BioTherapeutics Partners with BMS to Develop Next-Generation T-cell Engagers for Solid Tumors
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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,…
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China’s National Medical Products Administration has accepted the BLA for DualityBio’s trastuzumab pamirtecan (T-Pam; DB-1303/BNT323), an investigational ADC, for the second-line treatment of unresectable or metastatic HER2+ breast cancer
The application is supported by interim results from the pivotal P-III (DB-1303-O-3001) trial, which met its primary endpoint, demonstrating statistically significant improvement in PFS vs…
Imagene AI has entered into a collaboration with Daiichi Sankyo to advance biomarker discovery and response prediction across oncology drug development programs
Under the collaboration, Daiichi Sankyo will leverage Imagene’s OI Suite, powered by the CanvOI foundation model, to integrate H&E and IHC whole-slide images with molecular and clinical data to enhance biomarker identification and…
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Gilead has entered into a definitive agreement to acquire Tubulis, making it an ADC research organization within Gilead, with the Munich site serving as a hub for ADC innovation
As per the deal, Gilead will acquire Tubulis for $3.15B upfront & ~$1.85B in contingent milestone payments; closing is expected in Q2’26
Acquisition will expand…
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The Chinese NMPA has granted IND approval to HLX18, a biosimilar version of Opdivo (nivolumab) for the treatment of certain resected solid tumors following the US FDA IND clearance
Additionally, HLX17 (biosimilar, Keytruda) & HLX13 (biosimilar, Yervoy) are under P-I trials with first patient dosing completed, while the IND for HLX15-SC (biosimilar, Darzalex), was…
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Voro Therapeutics has entered into a research collaboration with Daiichi Sankyo via its Daiichi Sankyo Research Institute, San Diego to develop tumor-activated biologics using the PrimeBody platform
The collaboration will focus on generating masked ADCs designed for tumor-selective activation, using proprietary masking domains & protease-cleavable linkers to improve therapeutic index
Voro will design &…
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IDEAYA Biosciences has enrolled the first patient in its P-I dose escalation/expansion trial of IDE034, a B7H3/PTK7 bispecific TOP1 ADC, for solid tumors
The company is planning to assess the safety, tolerability, & PK of IDE034 as monotx. in a P-I trial & explore combinations with DDR-targeting agents, incl. its proprietary PARG inhibitor, IDE161…
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Daiichi Sankyo has dosed the first patient with DS3790 in the P-I/II trial for pts with r/r B-cell non-Hodgkin lymphoma
The trial will assess DS3790 in ~420 pts with r/r B-cell NHL, evaluating safety endpoints as well as efficacy endpoints incl. overall response, DCR, DoR, time to response, PFS, & OS
DS3790 is a…
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Mabwell has dosed the first patient with 7MW4911 in a P- I/II study in the US for the treatment of advanced colorectal cancer & other advanced GI tumors
Preclinical studies showed that 7MW4911 delivered potent antitumor activity across CDX/PDX GI tumor models & outperformed MMAE/DXd-based ADCs in multidrug-resistant settings. It also reversed tumor progression after…

