On October 12, 2020 Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, reported that Jesse Trekker, Ph.D., Business Director, Strategic Partnerships, Catalent Cell & Gene Therapy, will present at the Allogeneic Cell Therapies Summit, which will take place virtually on 26 – 28 October, 2020 (Press release, Catalent, OCT 12, 2020, https://www.catalent.com/catalent-news/catalent-to-discuss-innovative-approaches-to-achieving-t-cell-commercial-readiness-at-upcoming-industry-conference/ [SID1234568331]).

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On Monday, 26 Oct., at 12:30 p.m. EST, Dr. Trekker will present "How to Commercially Scale T-cell Allogeneic Therapies", where he will consider ways to overcome scale up challenges to progress successful development programs. Dr. Trekker will also discuss Catalent’s custom manufacturing methodology, and approaches to accelerate T-cell therapies to commercial readiness, so that patients can benefit sooner from innovative new therapies.

Dr. Trekker joined Catalent through its acquisition of MaSTherCell in 2020. Prior to joining MaSTherCell, he worked as a valorization researcher at Imec. Dr. Trekker holds a master’s degree in biomedical sciences, and a doctorate in biomedical technology, both from the University of Leuven (KU Leuven), Belgium.

ABOUT CATALENT CELL & GENE THERAPY
With deep experience in viral vector scale-up and production, Catalent Cell & Gene Therapy is a full-service partner for adeno-associated virus (AAV) and lentiviral vectors, and CAR-T immunotherapies. When it acquired MaSTherCell, Catalent added expertise in autologous and allogeneic cell therapy development and manufacturing to position it as a premier technology, development and manufacturing partner for innovators across the entire field of advanced biotherapeutics. Catalent has a global cell and gene therapy network of dedicated, large-scale clinical and commercial manufacturing facilities, and fill-finish and packaging capabilities located in both the U.S. and Europe. An experienced partner, Catalent Cell & Gene Therapy has worked with industry leaders across 70+ clinical and commercial programs.

On October 12, 2020 Glycostem Therapeutics, a leading clinical-stage company focused on the development of therapeutic off-the-shelf Natural Killer (NK) cells, reported it has received the FDA’s Orphan Drug Designation (ODD) for treatment of Multiple Myeloma (MM) patients with its investigational product oNKord (Press release, Glycostem Therapeutics, OCT 12, 2020, View Source [SID1234568359]). The designation will provide Glycostem with certain incentives, like eligibility for 7 years of market exclusivity and clear FDA guidance on specific aspects of development for rare diseases. These pave an accelerated path towards market access and treatment of patients suffering from this relatively rare form of cancer.

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oNKord is Glycostem’s first-generation off-the-shelf Natural Killer (NK) cellular immunotherapy product. Over the coming months, AML patients will receive this form of treatment as part of a phase I-IIa (pivotal) trial in AML. A phase II trial for MM patients is expected to start in 2021. This makes Glycostem one of the frontrunners in this promising field of cellular immunotherapy.

"Since 2012 we have been pioneers in the field of developing and manufacturing off-the-shelf Natural Killer cell therapy products for cancer treatment. In 2020 we’re entering a new and exciting phase," says Troels Jordansen, CEO of Glycostem. "It is great to experience that after receiving FDA and EMA ODD designation for AML, the FDA has also granted us this designation for MM. This allows us to accelerate oNKord’s access to the US market and our ultimate ambition: curing cancer."

Multiple Myeloma (MM)

MM is the second most common blood cancer, accounting for 15% of blood cancers, and 2% of all cancers. In the US alone it affects more than 130,000 patients; approximately 32,000 Americans are diagnosed with MM each year. MM occurs in infection-fighting plasma cells (a type of white blood cell) found in the bone marrow. These cancerous cells multiply, produce an abnormal protein and push out other healthy blood cells from the bone marrow.

Orphan Drug Designation

The FDA grants orphan drug designation to drugs and biologics for the prevention, diagnosis, or treatment of diseases or conditions affecting fewer than 200,000 persons in the US. The designation allows manufacturers to qualify for various incentives, including exemption of FDA application fees), tax credits for qualified clinical trials and be eligible for 7 years of market exclusivity after regulatory approval.

On October 11, 2020 CStone Pharmaceuticals ("CStone", HKEX: 2616) reported the completion of the Share Subscription Agreement through which an affiliate of Pfizer Inc. ("Pfizer",NYSE: PFE) subscribed for newly issued CStone shares at approximately US$200 million (equivalent to approximately HK$1.55 billion), bringing into effect the multifaceted strategic collaboration that the companies announced on September 30, 2020 (Press release, CStone Pharmaceauticals, OCT 11, 2020, View Source [SID1234568284]).

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The Listing Committee of the Stock Exchange of Hong Kong approved the listing of 115,928,803 additional shares subscribed by Pfizer at a price of approximately HK$13.37 per share. The shares represent approximately 9.90 percent of the issued share capital of CStone as enlarged by the allotment and issue of the shares.

CStone entered into the share subscription as part of a strategic collaboration framework with Pfizer to advance its strategic, commercial and financial objectives as it transitions into a fully integrated biopharma company. Completion of the share subscription allows the companies to proceed with the initiatives envisioned as part of this framework:

CStone has agreed to grant Pfizer an exclusive license to commercialize sugemalimab, an anti-PD-L1 monoclonal antibody and one of CStone’s core late-stage assets, in mainland China
CStone and Pfizer will collaborate on the development and commercialization of additional oncology assets in the Greater China market
CStone and Pfizer may pursue on a selected basis joint in-licensing arrangements for additional oncology assets for the Greater China market

On October 10, 2020 Antengene Corporation, a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in-class therapeutics in hematology and oncology, and WuXi Biologics ("WuXi Bio") (2269.HK) reported that they have signed a strategic cooperation Memorandum of Understanding (MoU) to co-operate in the development and production of novel drugs, and jointly promote the R&D of innovative oncology therapies (Press release, Antengene, OCT 10, 2020, View Source [SID1234568285]).

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China’s cancer incidence and mortality have been increasing in recent years. Low rates of survival and access to innovative therapies are persistent obstacles to local cancer treatment. With the vision of "Treating patients beyond borders", Antengene is committed to bringing novel mechanisms of action and cutting-edge anti-tumor therapies to patients in China, the rest of Asia Pacific and around the world. By leveraging outstanding R&D capability and applying a differentiated discovery and development strategy, Antengene has built a pipeline with 12 innovative clinical and preclinical products characterized by their high target selectivity and synergistic activity within the pipeline. Foundations have been built in oncology with the breadth of diseases in which the pipeline has shown activity also extending to viral infections, autoimmunity and other disease fields. As a leading global open-access biologics technology platform, Wuxi Biologics offers end-to-end solutions based on its sophisticated R&D system and technological platform to advance the process of promoting drug R&D from concept to commercial manufacturing. Through the collaboration, Antengene and WuXi Biologics will make full use of their extensive resources and professional capabilities to accelerate the research and development of first-in-class or best-in-class innovative cancer therapies and provide patients with high-quality and affordable treatment plans as soon as possible .

"We are very glad to launch a strategic cooperation with WuXi Biologics. This cooperation is a timely decision. WuXi Biologics has first-class biopharmaceutical capabilities and could empower us with advanced technology," said Dr. Jay Mei, Founder, Chairman and CEO of Antengene, "At present, Antengene has carried out a comprehensive layout for the research and development of innovative cancer medicines, and continues to promote the science-oriented R&D of anti-tumor drugs such as small molecule drugs, monoclonal drugs and bispecific antibody drugs. We are looking forward to enhancing the quality of research and development and leveraging complementary strengths of both companies in order to ultimately benefit a wider range of cancer patients."

Dr. Chris Chen, CEO of WuXi Biologics, said: "We are pleased to establish a strategic cooperation with Antengene. Through our diversified and integrated biologics technology platform, WuXi Biologics will continue to empower Antengene to accelerate the R&D process of innovative oncology therapies. We look forward to working together to achieve a win-win situation based on our capabilities and advantages and make positive contribution to the health and wellness of patients in China and the world."

On October 9, 2020 Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, reported that leading science and technology company and existing shareholder Merck KGaA, Darmstadt, Germany, through its wholly owned subsidiary, Ares Trading S.A., has elected to voluntarily convert a convertible note with an outstanding principal balance of $25 million to increase its stake in Precigen from approximately 11.6% to 14.8% of outstanding shares, remaining as Precigen’s second largest shareholder (Press release, Precigen, OCT 9, 2020, View Source [SID1234568260]). As previously announced in December 2018, Merck KGaA, Darmstadt, Germany, reassigned to Precigen exclusive chimeric antigen receptor T-cell (CAR-T) development rights that were part of an earlier transaction between the companies. This reassignment allowed Precigen to regain full autonomous development of its proprietary CAR-T technology platform in exchange for $150 million in stock and a $25 million convertible note, allowing Merck KGaA, Darmstadt, Germany, to maintain an investment in the future potential of Precigen’s next-generation CAR-T development. The convertible note, which would have otherwise converted in December of 2020, is being exercised ahead of its designated maturity.

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"In line with Merck KGaA, Darmstadt, Germany’s mission to discover innovative therapies with transformative results, we are pleased to continue our relationship with Dr. Sabzevari and her team as they advance Precigen’s pipeline of next generation CAR-T therapies," said Belén Garijo, Vice Chair of the Executive Board and Deputy CEO of Merck KGaA, Darmstadt, Germany, and CEO of Healthcare. "We look forward to continuing a productive relationship with Precigen leading to better health outcomes for patients with a broad range of cancers."

The relationship between Precigen and Merck KGaA, Darmstadt, Germany is longstanding, dating back to 2015 when the two companies signed an agreement to develop and commercialize CAR-T cancer therapies utilizing Precigen’s proprietary Sleeping Beauty non-viral gene integration technology. This technology has evolved into Precigen’s UltraCAR-T next generation CAR-T therapies, which have demonstrated superior efficacy in preclinical studies and combine rapid manufacturing to improve time to treatment. Two UltraCAR-T therapies are currently being evaluated in Phase 1 clinical trials, including PRGN-3005 in ovarian cancer and PRGN-3006 in acute myeloid leukemia (AML).

"We welcome a strengthened relationship with Merck KGaA, Darmstadt, Germany, a recognized leader in oncology and patient care, as it increases its ownership position in Precigen," said Helen Sabzevari, PhD, President and CEO of Precigen. "We look forward to building value for all of our stakeholders through the clinical milestones we have planned over the next year and beyond."