BioSpace Global Roundup, June 20

Global Connection

BioNTech SE – Germany-based BioNTech announced the initiation of its first-in-human Phase I/IIa study with DuoBody-PD-L1x4-1BB, a bispecific antibody in joint development with Genmab A/S, which is being studied in patients with metastatic or unresectable malignant solid tumors, who are not candidates for standard therapy. DuoBody-PD-L1x4-1BB is the first product candidate from the companies’ worldwide 50% cost-sharing 50% profit-sharing collaboration to enter the clinic. The objective of the collaboration, signed in 2015 and expanded in 2016 to include additional targets and technologies, is to develop and commercialize multiple novel bispecific antibodies with superior in vivo efficacy that specifically activate the immune system against cancer cells. DuoBody-PD-L1x4-1BB’s pan-cancer, dual-immuno-stimulatory mode of action contributes an additional layer of treatment options to our overall cancer pipeline, Ugur Sahin, chief executive officer of BioNTech said in a statement. He added that it also serves BioNTech’s strategy of exploiting novel targets and mechanisms to harness the full potential of the immune system for cancer immunotherapy.

Osteolabs GmbH – Another German company, Osteolabs GmbH closed its seed financing round with contributions by Seed und Start-Up Fonds II of MBG, Laboratory MVZ Dr. Krause und Kollegen and two life sciences-related business angels. The funds will be used for further expansion of osteolabs GmbH and for commercialization of its novel proprietary test for osteoporosis. Osteolabs GmbH was founded in 2018 as a spin-off from GEOMAR institute with a goal to successfully commercialize its proprietary test for osteoporosis. This novel test for osteoporosis is capable of providing early insights into osteoporosis development based on a simple urine or blood sample, the company said.

BeiGene – Based in China and with a significant presence in the United States, BeiGene and Celgene Corporation agreed to terminate the parties’ global collaboration for tislelizumab, which was established in 2017, BeiGene’s investigational anti-PD-1 antibody in advance of the pending acquisition of Celgene by Bristol-Myers Squibb. In connection with the termination, Celgene has agreed to pay $150 million to BeiGene. BeiGene CEO John V. Oyler said his company has been leading most of the ongoing Phase III efforts and will be well-positioned to continue the work alone. Tislelizumab has been dosed in over 2,950 patients globally. With two new drug applications under review in China, BeiGene expects tislelizumab to receive its first regulatory approval later this year. BeiGene noted that its acquisition of Celgene's commercial operations in China and an exclusive license to Celgene's cancer commercial portfolio in China, including Abraxane, Revlimid and Vidaza are not affected by the termination of the tislelizumab agreement.

Cytuvax B.V. – Netherlands-based CyTuVax released positive results of the HBAI20 Phase II “BE-Responder” trial in hepatitis B. The mid-stage trial showed the efficacy of the company’s adjuvant platform technology in this indication. The trial focused on non-responders to hepatitis B vaccination, persons who have been vaccinated with at least one complete vaccination course (three injections of a licensed hepatitis B vaccine) without achieving a protective immune response. In this study population, the HBAI20 vaccine reduced the percentage of non-responders to 8% compared to 21% in the HBVaxPro-10 group. Statistical evaluation using a generalized linear mixed model demonstrates that subjects who have received the HBAI20 vaccine are 3.5 times more likely to attain seroprotection at the end of the study compared with subjects who received the licensed HBVaxPro-10 vaccine, the company said. With the HBAI20 vaccine, seroprotection was achieved earlier than with the HBVAxPro-10 vaccine. The company said 83% of the non-responders attained seroprotection after only two vaccinations. In contrast, with the licensed HBVaxPro-10 vaccine only 79% of the non-responders achieved seroprotection.

Owlstone Medical – A leader in breath biopsy, U.K,-based Owlstone Medical announced the development of an innovative alternative approach to breath-based testing through the utilization of Exogenous Volatile Organic Compound (EVOC) Probes. The novel probes will enable Breath Biopsy to be deployed for a wider range of applications, the company said. Exhaled human breath contains over 1,000 volatile organic compounds (VOCs). To date, VOC-based breath research has focused on the identification of endogenous VOCs as disease biomarkers, however, few tests based on this approach have made it to the clinic. EVOCs can be used as metabolic pathway-specific probes, the company said and added that they have a wide range of applications. The company’s initial focus will be research into drug metabolism, liver function, and Nonalcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis.

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Bavarian Nordic – Based in Denmark, Bavarian Nordic A/S initiated a Phase III trial of its freeze-dried formulation of MVA-BN smallpox vaccine in more than 1,100 patients. The company said the trial will evaluate the immunogenicity and safety of three consecutive vaccine lots of the freeze-dried formulation of MVA-BN smallpox vaccine, similar to the completed Phase III study for the liquid-frozen MVA-BN formulation. A Biologics License Application for the liquid frozen formulation of MVA-BN is currently under review at the FDA, with anticipated completion and licensure in the second half of 2019. Upon completion of the current study, which is expected in 2021, the company intends to submit a supplement to the BLA to extend the approval for both formulations of MVA-BN. Based on the successful completion of the study and subsequent regulatory process, the company anticipates approval of the freeze-dried vaccine in 2022.

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