CLINICAL AND REGULATORY
TCR2 gains on gavo-cel data in mesothelin-expressing solid tumors
TCR2 Therapeutics reported positive top-line results from the Phase 1 trial of gavocabtagene autoleucel (gavo-cel) for mesothelin-expressing solid tumors. Consistent tumor regression was seen in 28 of 30 (93%) evaluable patients with a disease control rate of 77%, as of the Sept. 9 data cutoff. The mesothelioma cohort showed progression-free survival of 5.6 months and overall survival of 11.2 months. Gavo-cel, which is an engineered T-cell therapy using all the parts of the TCR and works across all HLA types, is already in the trial’s Phase 2 portion, which will enroll 75 mesothelioma patients and a combined 20 patients with ovarian cancer, non-small cell lung cancer and cholangiocarcinoma.
Calibr team’s data bring switchable CAR Ts back into focus
With some of the first clinical evidence that a switchable CAR T cell may build on the safety and efficacy of traditional CAR T designs, a team from the Calibr drug discovery division of Scripps Research may be renewing interest in the therapeutic structure. The Calibr team, with support from partner AbbVie, reported at the CAR-TCR Summit 2022 that CD19-targeting CAR T cell therapy CLBR001 plus small molecule switch SWI019 led to objective responses in seven of nine B cell malignancy patients (78%), and complete responses in six (67%). Patients received a median of five prior lines of treatment, but the types of B cell malignancies were not reported. Switchable CAR T cell therapies, which involve engineering the cells to turn on or off in response to an external stimulus such as a small molecule, were one of the hottest technologies in the modality’s early days of development.
Rubius cuts 75% of workforce as it moves on to new platform
A little more than four years after going public at a $1.8 billion valuation, Rubius Therapeutics is discontinuing its original engineered red blood cell platform that expressed therapeutic proteins in favor of a red cell conjugation technology. The switch will see the biotech abandon two clinical-stage programs based on the original platform, RTX-240 and RTX-224, which were both in Phase I testing, and cut 75% of its workforce, primarily in clinical development and manufacturing.
DEALS AND FINANCING
Abpro and Celltrion partner to commercialize bispecific mAb
Celltrion will pay Abpro Bio up to $1.8 billion to develop ABP 102, a T cell engaging bispecific mAb to treat HER2+ breast, gastric, pancreatic cancer. The payment includes equity investment, development and commercial milestone payments and worldwide profit sharing. Financial details were not disclosed.
Cell therapy company Neukio Biotherapeutics raises $50 million Series A-1
Neukio Biotherapeutics will build its team and develop its iPSC-derived, off-the-shelf CAR NK cell therapy products with a $50 million series A-1 funding round. The financing was led by CD Capital, with the participation of new investors Alwin Capital and Surplus Capital and existing investors Lilly Asia Ventures, Sherpa Healthcare Partners and IDG Capital. The company is led by founder, chair and CEO Richard Wang, who founded Fosun Kite Biotechnology and commercialized Yescarta axicabtagene ciloleucel in China.
ImmunoScape raise earmarked $14 million to develop TCRs
A $14 million venture raise by ImmunoScape will enable the Singapore immunomics company to discover and characterize cancer-specific T cell receptors. Existing investor Anzu Partners led the financing with participation by new investor Amgen Ventures and existing investor EDBI, the investment arm of the Economic Development Board of Singapore. Founded in 2016, ImmunoScape has labs in Singapore and San Diego and roots in Singapore’s Agency for Science, Technology, and Research (A*Star).
Cell therapy company Arsenal raises $220 million in Series B
Arsenal Biosciences will take its cell therapy programs into clinical development with an oversubscribed, $220 million series B. New investors included Softbank Vision Fund 2, BMS, Byers Capital, Emerson Collective Investments, Green Sands, Hitachi Ventures, and Sixth Street. Also participating were existing investors Parker Institute for Cancer Immunotherapy, Westlake Village BioPartners, the University of California San Francisco Foundation Investment Company, Euclidean Capital, Waycross Ventures and Kleiner Perkins. Arsenal was founded by CEO Ken Drazan, former president of Grail, and is developing CAR T therapies to treat solid tumors.