On April 15, 2021 Prestige BioPharma and Pharmapark LLC reported that the two companies have entered into a binding agreement for the exclusive partnership and supply for the commercialization of Prestige BioPharma’s Bevacizumab biosimilar in the Russian Federation (Press release, Prestige BioPharma, APR 15, 2021, View Source [SID1234578099]).

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Prestige’s Bevacizumab (HD204) is a mAb biosimilar to Roche’s Avastin, an inhibitor of vascular endothelial growth factor (VEGF), which is used in combination with other therapies to treat patients with multiple forms of cancer including metastatic colorectal cancer, advanced non-small-cell lung cancer, advanced kidney cancer, certain types of epithelial cancers and cancers of the cervix. HD204 is currently in Phase III clinical development with active recruitment ongoing within the pivotal efficacy and safety trial SAMSON-II. Positive results were previously reported from the Phase I clinical trial (SAMSON-I) which evaluated the pharmacokinetics, safety and immunogenicity of HD204 to Avastin.

The partnership arrangement includes the exclusive rights for Pharmapark to commercialize the Bevacizumab biosimilar in the Russian Federation, leveraging the company’s strong sales and marketing capabilities and experience in successfully bringing new biosimilars to market. Whilst the terms of the deal are not being disclosed, Prestige BioPharma will assume responsibility for product commercial supply out of its manufacturing facilities in Osong, Korea, while Pharmapark will be responsible for local registration, sales and marketing in the Russian Federation with the option to manufacture the product in Russian Federation in line with the Russian import substitution strategy.

This agreement expands upon the existing collaboration between Prestige BioPharma and Pharmapark LLC with the companies signing a license agreement in July 2019 for Prestige BioPharma’s Herceptin biosimilar.

On April 15, 2021 NKGen Biotech, a biotechnology company harnessing the power of the body’s immune system through the development of Natural Killer (NK) cell therapies, reported that it has appointed Steven Cha, M.D. as its Chief Medical Officer (Press release, NKGEN Biotech, APR 15, 2021, View Source [SID1234578709]). Dr. Cha will oversee the clinical development of NKGen Biotech’s lead product SNK01 as well as its pipeline of other novel NK cell therapies.

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"We are extremely pleased to have Steven join the NKGen Biotech team during this rapid growth phase for the Company," said Stephen Chen, Chief Operating Officer. "His broad expertise and leadership in oncology, early and late-stage drug development, and proficiency with business development transactions make him an ideal fit for NKGen Biotech," he concluded.

Dr. Cha has 15 years of R&D industry experience encompassing both large and small pharmaceutical companies. Since 2018 he has served as Vice President of Oncology at Samumed LLC, a privately held clinical-stage biotechnology company. Prior to that Dr. Cha was Senior Director, Global Clinical Lead at Pfizer focused on early oncology development. In his earlier roles Dr. Cha was Head of the metastatic breast cancer franchise at Puma Biotechnology, Senior Medical Director, Clinical Development at MEI Pharma, Medical Director at Allergan where he worked on Botox in urologic disorders, and Medical Director at Amgen where he was primarily focused on Nplate and blinatumomab.

Dr. Cha joins NKGen Biotech during an exciting period as the Company advances its allogeneic program towards IND filing while continuing work on SNK01 in refractory solid tumors in both monotherapy and combination therapy partnered programs.

"NK cell therapy represents a highly promising novel treatment paradigm in oncology," said Dr. Cha. "I am extremely enthusiastic about joining the NKGen Biotech team to work on SNK01 and the follow-on allogeneic and CAR-NK programs, which I believe have the potential to become best-in-class NK cell therapies for oncology patients."

Dr. Cha completed a BS in Biochemistry and Cell Biology from the University of California, San Diego and obtained his M.D. from the Tufts University School of Medicine. He has also completed fellowships in Hematology and Blood and Marrow Transplant at Stanford University.

On April 14, 2021 Samsung Biologics reported on the 17th that it has signed a consignment development (CDO) contract with Panolos Biosciences for ‘PB101’, a new anti-cancer drug candidate (Press release, Panolos Bioscience, APR 14, 2021, View Source [SID1234633685]).

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Through this contract, Samsung Biologics plans to provide services throughout the CDO process, from cell line development of Panolos ‘PB101’ to process development, clinical sample production and clinical trial plan (IND) submission support, and non-clinical and global clinical material production.

‘PB101′, Panolos’ next-generation anti-cancer drug candidate, targets all families (VEGF-A, VEGF-B, Placental Growth Factor) of VEGF (Vascular Endothelial Growth Factor) that is overexpressed around cancer cells. It acts to inhibit the growth of cancer cells. ‘PB101’ is a substance with high difficulty in research due to its complex protein structure.

Samsung Biologics established a customized development strategy for the success of ‘PB101’ and was once again recognized for its complex protein-based high-level development capability and differentiated expertise.

Lim Hye-seong, CEO of Panolos, said, "’PB101′ is expected to have excellent efficacy as an anticancer and VEGF-related disease treatment by itself, and moreover, the material itself has already proven its value as a platform technology." He continued, "In the future, in the development of multiple target candidates including ‘PB101’, we expect to be able to demonstrate high synergy through close mutual cooperation with Samsung Biologics, which has development capabilities."

Taehan Kim, CEO of Samsung Biologics, said, "We are very pleased to have entered into a partnership with Panolos, which has outstanding potential in the field of protein new drug development. We will do our best to accelerate the development of our client’s materials with the world’s best CDO service provided by our company"

On April 14, 2021 aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of innovative medicines based on novel biological pathways, and Lonza reported that the companies have entered into an agreement for the manufacture of ATYR2810, aTyr’s monoclonal antibody targeting Neuropilin-2 (NRP2) that is currently in preclinical development for cancer (Press release, aTyr Pharma, APR 14, 2021, View Source [SID1234578046]).

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Under the terms of the agreement, Lonza will utilize its Ibex Design, a fully integrated end-to-end program, to manufacture cGMP material for ATYR2810. The agreement will cover the early stages from gene to Investigational New Drug (IND) and will provide both drug substance (DS) and drug product (DP) to support toxicological studies in animals and early clinical development in humans.

The scope will include process support, including cell line development, process development, and supply chain simplification, to DS and DP manufacturing at Lonza’s Visp and Stein (CH) sites.

"As we prepare to advance ATYR2810 to clinical stage development, we are pleased to work with Lonza, a partner with extensive and proven capability in antibody manufacturing, for the production of our first anti-NRP2 antibody," said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. "Having recently initiated IND-enabling activities for ATYR2810 following some compelling preclinical data in triple-negative breast cancer, strengthened by additional data in lung cancer, this agreement with Lonza reflects our commitment to this program and will support our efforts to eventually advance ATYR2810 to in-patient trials in cancer, including certain aggressive tumors where NRP2 is implicated."

"We look forward to supporting aTyr as they advance their novel therapeutic antibody from preclinical stages into the clinic. This collaboration signifies our commitment and flexibility in accommodating the specific and unique needs of small biotech companies," said Jennifer Cannon, Senior Vice President, Global Head of Mammalian Biologics, Lonza.

About ATYR2810

aTyr is developing ATYR2810 as a potential therapeutic for certain aggressive tumors where Neuropilin-2 (NRP2) is implicated. ATYR2810 is a fully humanized monoclonal antibody that is designed to specifically and functionally block the interaction between NRP2 and one of its primary ligands, VEGF. ATYR2810 is the first Investigational New Drug (IND) candidate to arise from aTyr’s in-house research program designing monoclonal antibodies to selectively target the NRP2 receptor and its associated signaling pathways. NRP2 is a cell surface receptor that is highly expressed in certain tumors, in the lymphatic system and on key immune cells implicated in cancer progression. Increased NRP2 expression is associated with worse outcomes in many cancers. Preclinical data suggest that ATYR2810 could be effective against certain types of solid tumors. ATYR2810 is currently undergoing IND-enabling studies.

On April 14, 2021 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of checkpoint antibodies, cell therapies, adjuvants, and vaccines designed to activate immune response to cancers and infections, reported the dosing of the first cancer patient with agenT-797, an allogeneic iNKT cell therapy, in a Phase 1 clinical trial through its subsidiary, AgenTus Therapeutics (Press release, Agenus, APR 14, 2021, View Source [SID1234578047]).

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"Our proprietary iNKT cell therapy has been advancing in the clinic in patients with acute respiratory distress syndrome (ARDS) secondary to COVID-19; we are now expanding our iNKT cell therapy to treat patients with cancer," said Jennifer Buell, PhD, President and COO of Agenus. "iNKT cells penetrate tissues, demonstrate potent tumor killing, and show compelling curative potential in solid tumor models with activating iNKT cell therapies and checkpoint antibodies. We are thrilled to advance this cell therapy for broader benefit in patients with solid tumors and in combination with antibodies."

The Phase 1 trial has been initiated in hematologic cancers, with expansion into solid tumors expected to begin shortly. Led by Clifton Mo, MD, Director of Autologous Stem Cell Transplantation for Multiple Myeloma at the Dana-Farber Cancer Institute, the Phase I dose-escalation trial will explore the safety, tolerability, and preliminary clinical activity of agenT-797 in patients with relapsed/refractory multiple myeloma. Agenus anticipates initial data readouts for the Phase 1 study in the fourth quarter of 2021.

A Phase 1 trial of agenT-797 for intubated patients with moderate to severe symptoms of COVID-19 was initiated in late 2020. Preliminary data show no adverse events attributable to agenT-797 and suggest early signals of activity. Dose escalation is expected to be completed in the first half of 2021 with expansion into a Phase 2 trial with data readouts expected this year.

iNKT cell therapy is expected to eliminate graft-versus-host disease, may not require genetic manipulation, and can be manufactured to treat large numbers of patients from a single dose. These attributes support the possibility of a safer and more affordable and accessible therapy than currently approved cell therapies.

As a subsidiary of Agenus, AgenTus currently has unique access to Agenus’ portfolio of checkpoint antibodies and cancer vaccines which allows for optimal combinations with its cell therapies. This gives the company enormous flexibility to develop effective combinations with curative potential for patients with cancer and infectious disease.