OT-A201

This first-in-man trial conducted by Onward Therapeutics, under the license and co-development agreement, is a Phase 1 clinical trial for the evaluation of a bispecific antibody generated from Biomunex' proprietary BiXAb® platform. The Phase 1 study is evaluating the safety, tolerability, pharmacokinetics, immunogenicity and preliminary anti-tumoral activity of a “first-in-class” bispecific antibody targeting two immune checkpoints (OT-A201), given as monotherapy or in combination in patients with either solid tumors or hematological malignancies. The enrollment of the first patient in this clinical trial demonstrates the potential of the BiXAb platform to generate clinical candidates. It also triggered the first clinical milestone payment by Onward Therapeutics to Biomunex. PARIS & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Biomunex Pharmaceuticals (Biomunex), a French biopharmaceutical company that develops cutting-edge immunotherapies through the discovery and development of bi- and multi-specific antibodies, generated from the BiXAb platform, for the treatment of cancer, announced today the enrollment in 2023 of the first patient in a Phase 1 clinical trial conducted by Onward Therapeutics SA (Onward Therapeutics). In preclinical studies, this antibody generated from Biomunex' proprietary, best-in-class, bi- and multi-specific antibody platform, BiXAb, has demonstrated not only good pairing, low aggregation, high stability, excellent manufacturability but also excellent specificity and safety, and displayed important in vivo anti-tumoral activities at different doses. The clinical trial takes place within the framework of the license and co-development agreement signed in 2021 by Biomunex with Onward Therapeutics, a global biotechnology company focused on development for cancer treatment, and thus triggered a milestone payment tied to the start of a Phase 1 clinical trial. Under the terms of the agreement, Biomunex has already received an upfront payment and is also eligible for further clinical, regulatory and commercial milestone payments, as well as tiered royalties on global net sales and other potential payments. "We are delighted to announce this clinical trial for the evaluation of one of the antibodies generated thanks to our unique BiXAb platform, with Onward Therapeutics," said Dr. Pierre-Emmanuel Gerard, founder, President and CEO of Biomunex. "The achievement of this key milestone supports the scientific and technological relevance of our BiXAb platform to identify, generate and develop rapidly and efficiently novel bispecific antibodies. With this clinical trial, we hope to demonstrate the potential major impact of our antibodies in cancer patients, particularly in those with significant unmet medical needs.” This Phase 1 clinical trial is a European multicenter and open-label study that is divided in two parts. The first part is a dose escalation stage of the BiXAb candidate as single agent in patients with selected advanced/metastatic solid tumors or relapsed/refractory hematological malignancies, that will mainly evaluate safety and tolerability and will determine the maximum tolerated and recommended Phase 2 doses. The second part is an expansion stage that will further evaluate the safety and preliminary anti-tumoral activity of the candidate as monotherapy or in combination in selected solid tumors and hematological malignancies. "We are convinced of the potential of this “first-in-class” bispecific antibody, capable of simultaneously targeting two immune checkpoints, based on our proprietary BiXAb platform, to provide better anti-tumor effects with a favorable therapeutic window and potentially become a true novel immunotherapeutic option for various cancers, both solid and liquid”, added Dr. Simon Plyte, Chief Scientific Officer of Biomunex. “This clinical evaluation of our BiXAb format paves the way for the successive development of our first-in-class BiXAb-MAIT engager approach that we will rapidly advance to the clinic”. About Biomunex Pharmaceuticals : Biomunex Pharmaceuticals is a biopharmaceutical company based in Paris (France) and Cambridge, MA, USA, led by an international and experienced team. Biomunex is focused on the discovery and development of breakthrough immunotherapeutic approaches, based on solid data and proven biological and clinical evidence, to address unmet medical needs in oncology. Biomunex has created and developed BiXAb, a robust, 'Plug and Play', next-generation bi- and multi-specific antibody technology platform, using a proprietary computational modeling approach, with a very robust IP and patent portfolio. The BiXAb platform, which allows the generation of bispecific antibodies from any pair of monoclonal antibodies in a simple, fast and cost-effective manner, has been validated through licensing agreements and collaborations with the pharmaceutical and biotech industry, with Sanofi then Onward Therapeutics. Biomunex is also the leading company worldwide developing an immuno-oncology approach that allows, through bispecific antibodies from its BiXAb platform, to specifically target, engage and redirect MAIT cells, a subpopulation of T cells naturally present throughout the body, most specifically in mucosal and barrier tissues, to kill cancer cells, for the treatment of solid tumors.

EPALINGES, Switzerland and MONTPELLIER, France, June 20, 2022 /PRNewswire/ -- Onward Therapeutics SA (Onward Therapeutics) and Emercell SAS (Emercell) announced today the recent exercise of Onward Therapeutics' second of three instalments of equity investment in Emercell. With this investment, Onward Therapeutics has become Emercell's majority shareholder. Emercell has developed a platform technology to produce off-the-shelf natural killer (NK) cells. NK cells are highly potent immune effectors, used alone as a monotherapy, or in combination with therapeutic antibodies, or are genetically engineered to produce Chimeric Antigen Receptor (CAR)-NK cells for the treatment of hematological malignancies and solid tumors. NK-001 is an optimized cell therapy product consisting of highly activated and alloreactive allogeneic NK cells. Its patented manufacturing process allows full industrialization using the same batch of NK cells for multiple patients. "This second equity investment in Emercell confirms that the NK-001 project has been advancing well since our first equity investment in February 2021, and we will be able to scale up and industrialize the production of activated NK cells rapidly, to offer new treatments for cancer patients," said Dr. C. Grace Yeh, Chairman and CEO of Onward Therapeutics. "We are pleased that the collaboration with Onward Therapeutics has reached another critical milestone. Their investment allows us to pursue the NK-001 project and focus on the production of clinical batches," declared Dr. Patrick Henno, Founder and CEO of Emercell. "We can also start looking at further optimizing our production process for NK cells and exploring other potential new cell therapies," commented Dr. Alain Herrera, Chairman of the board of Emercell. About Onward Therapeutics Onward Therapeutics is an oncology company focusing on the identification and development of innovative medicines for the treatment of cancer. The Company, led by an experienced team in translational science and drug development, acquires licenses for potential development candidates and invests in partners with transformative technology platforms. Onward Therapeutics licensed a preclinical stage bispecific antibody (OT-A201) targeting two immune checkpoints from Biomunex Pharmaceuticals SAS, Paris, France; has an exclusive option to a worldwide license agreement for an onco-metabolism program with Institut du Cancer de Montpellier (ICM); and collaborates with Emercell SAS, Montpellier, France, in the development of NK-001, allogenic natural killer cells. In addition, the Company invested in Biomunex Pharmaceuticals SAS for their multi-specific antibody platform, and in Emercell SAS for their NK cell technology. The company is headquartered at Biopôle (a life sciences campus in Epalinges), near Lausanne, Switzerland, has an affiliate in Paris, France, and an office in Taipei, Taiwan. About Emercell Emercell is an oncology company developing a platform technology to produce off-the-shelf allogenic natural killer (NK) cells. The company's R&D activities are located at the IRMB (Institute of Regenerative Medicine and Biotherapies) at the Saint-Éloi University Hospital Center, Montpellier, France. Emercell's lead drug candidate, NK-001, is intended, among others, for the treatment of lymphoma patients who are refractory to conventional therapies. It is a patented process for pre-activating and amplifying allogeneic NK (Natural Killer) cells. Emercell collaborates with numerous industrial and academic partners. The company has received the support of the Occitanie Region (ADI) and Bpifrance and has obtained a FUI (financing). Emercell is a member of Eurobiomed. SOURCE Onward Therapeutics SA; Emercell SAS