1. DotBio announced the establishment of a next-generation immuno-oncology drug based on domain antibody
DotBio, a new company focused on the development of new anti-tumor drugs for humanized antibodies, has officially announced the successful launch of a $2.3 million seed round financing led by HeungKong Group through Futec Biomedical Investments Limited. DotBio is a company independent from Singapore’s Nanyang Technological University (NTU). The founders include Professor Pär Nordlund, the world’s leading structural biologist at the NTU and Karolinska Institute and Dr. Ignacio Asial, who design and conceptualize the DotBody technology based on protein and antibody engineering at the NTU School of Biological Sciences.
DotBodies are multispecific, humanized and highly stable domain therapeutic antibodies. Due to their small size, domain antibodies are expected to have excellent tumor penetrating ability and can be used as building blocks for multispecific antibodies. DotBodies increase antibody stability, reduce aggregation and reduce the risk of immunogenicity, thereby increasing the likelihood of success in clinical trials.
2. Alteogen gastric cancer ADC drug obtained FDA orphan drug qualification
ALT-P7 being developed by Alteogen obtained FDA-approved orphan drug qualification for gastric cancer treatment. ALT-P7 is an antibody drug conjugate (ADC) with the isomerized antibody of trastuzumab. This qualification is expected to give Alteogen an exclusive market for seven years after FDA approves ALT-P7 for gastric cancer treatment.
ALT-P7 is an ADC candidate for the treatment of gastric and breast cancer, developed by the NexMabTM platform technology. ALT-P7 obtained the IND approval from the Korea Food and Drug Safety (MFDS) last year and its phase 1 human clinical trials is being conducted for breast cancer patients in Korea (NCT03281824). Alteogen plans to begin phase 2 clinical trials of breast cancer patients in 2019. In addition to breast cancer trials, Alteogen has completed preclinical and in vivo studies and will expand the clinical development of ALT-P7 in gastric cancer.
3. Sutro Biopharma receives $85.4 million in Series E financing for ADC drug development
Sutro Biopharma received $85.4 million in Series E funding, which will drive some early projects and their cancer pipeline, including a pair of antibody drug conjugates (ADCs). In the Sutro’s ADC assets, STRO-001 is a phase 1 study of lymphoma and multiple myeloma, and STR-002 will enter ovarian and endometrial cancer clinical trials in early 2019. Sutro is also working with other pharmaceutical companies to develop bispecific antibodies, other ADCs and cytokine derivatives. The company’s internal R&D pipeline is based on its cell-free protein synthesis and site-specific binding platform, enabling Sutro to quickly evaluate a variety of protein structures and create “highly optimized single molecule antibodies.”
4. Harbor Biomed obtained exclusive rights to Glenmark’s bispecific antibodies in Greater China
Harbor Biomed and Glenmark Pharmaceuticals of India announced that they have made an agreement on the development, production and marketing of GBR 13021302 (a bispecific antibody targeting HER2 and CD3 developed by Glenmark for the treatment of HER2-positive cancer). GBR 1302 is generated using Glenmark’s BEATTM (Bispecific Engagement by Antibodies based on the T cell receptor) technology platform and is currently undergoing first human studies to confirm the maximum tolerated dose (MTD) in various HER2-positive cancer patients. Clinical studies of GBR 1302 are currently being enrolled in the United States and Germany.