On September 22, 2020 IMMUNOPRECISE ANTIBODIES LTD. (the "Company" or "IPA") (TSX VENTURE: IPA) (OTCQB: IPATF) (FSE:TQB2), a leader in full-service, therapeutic antibody discovery and development, reported that its subsidiary, IPA Europe, has made a substantial investment in its B-Cell Select platform at its research division in Oss, The Netherlands, enabled by investments in additional equipment to automate and significantly innovate their multi-species, target-interaction-based single B-cell selection technology and subsequent single cell cloning, thereby significantly accelerating the identification of comprehensive panels of diverse lead therapeutic antibodies (Press release, ImmunoPrecise Antibodies, SEP 22, 2020, View Source [SID1234565480]). The advanced B Cell Select platform seamlessly integrates into IPA’s optimization and antibody developability profiling workflow.

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"Our dedicated and motivated team members are driving the success our B Cell Select platform expansion. This powerful, multi-species platform is combined with direct, single B cell cloning and antibody binding profiling to rapidly identify highly diverse, clinically relevant antibodies to treat various diseases involving a broad variety of complex target antigens." stated Debby Kruijsen, General Manager of IPA Europe.

"Next to its suitability for a broad range of antibody sources, our advanced B Cell Select platform is also compatible with various target tools, including target-expressing cells, enabling us to select clones at an early stage of antibody discovery based on a functional read-out as well." says Ilse Roodink, Scientific Director of IPA-EU.

Interested in learning more? Our second-generation B Cell Select platform will be one of IPA’s showcased technologies presented at our webinar "High-Throughput Identification of Genetically Distinct, Target-Specific Antibodies", airing September 23rd at 11:00 EDT. Click here to register online.

About B Cell Select

ImmunoPrecise Antibodies’ B Cell Select platform enables the interrogation of a greater diversity of an antibody repertoire than otherwise possible. By interrogating isolated B-cells, IPA can analyze full organism repertoires with very little manipulation. This proprietary platform is species independent allowing for the generation of antibodies from samples not possible using other methods. B Cell Select can develop antibodies from any species (including humans) as well as from any tissue. As the platform explores the entire antibody repertoire, it can develop antibodies for anything that is possible in an animal’s immune repertoire including any protein class, complex therapeutic targets, post-translational modifications, and small molecules.

The B Cell Select platform enables the interrogation of 10 million blood cells to generate native monoclonal antibodies from immunized animals that specifically target an antigen. The B cell selection process takes place early in the antibody development process allowing for the rapid selection of top candidates, drastically increasing the success rate of antibody discovery. The platform also harnesses the power of the immune system to generate natural pairing of the antibodies produced by selected B cells. These deliverables in our discovery programs have less liabilities within the antibody sequences compared to unnatural pairs from in vitro screening that could potentially affect manufacturability of the antibodies.

On September 22, 2020 Genmab A/S (Nasdaq: GMAB) reported that it has commenced binding arbitration of two matters arising under its license agreement with Janssen Biotech, Inc. (Janssen) relating to daratumumab (Press release, Genmab, SEP 22, 2020, View Source [SID1234565478]). Under the license agreement, Genmab is, among other things, entitled to royalties from Janssen on sales of daratumumab (marketed as DARZALEX for intravenous administration and, in the United States, as DARZALEX FASPRO for subcutaneous administration).

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The arbitration first is to settle whether Genmab is required to share in Janssen’s royalty payments to Halozyme Therapeutics, Inc. for the Halozyme enzyme technology used in the subcutaneous formulation of daratumumab. The royalties Janssen pays to Halozyme represent a mid-single digit percentage rate of subcutaneous daratumumab sales. Janssen has started reducing its royalty payments to Genmab by what it claims to be Genmab’s share of Janssen’s royalty payments to Halozyme for the second quarter of 2020.

The arbitration is also to settle whether Janssen’s obligation to pay royalties on sales of licensed product extends, in each applicable country, until the expiration or invalidation of the last-to-expire relevant Genmab-owned patent or the last-to-expire relevant Janssen-owned patent covering the product, as further defined and described in the license agreement. The relevant Genmab-owned issued U.S., European and Japanese patents will expire in the late 2020s and early 2030s. The relevant Janssen-owned issued patents and patent applications (if granted) covering the subcutaneous formulation of daratumumab would expire in the mid-2030s.

Under the agreement, the arbitration will be conducted in New York pursuant to the rules of the CPR Institute for Dispute Resolution for Non-Administered Arbitration before a panel of three arbitrators. While Genmab intends to vigorously protect its rights under the agreement, the outcome of any arbitration proceeding, as well as its duration, is inherently uncertain. The arbitration will be confidential, subject to the parties’ disclosure obligations under applicable law. Other than pursuant to these obligations, Genmab does not intend to comment or provide additional information regarding the arbitration until an order on the merits or other material order is issued in the arbitration or the arbitration is otherwise concluded. While the arbitration is pending, Genmab’s collaborations with Janssen on daratumumab and HexaBody-CD38 will continue.

Based on currently available information, Genmab does not expect these matters to materially affect its 2020 financial guidance.

On September 22, 2020 GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with metabolic and liver diseases, reported that it will announce its first half-year 2020 financial results and new corporate strategy following market close on Wednesday, September 30, 2020 (Press release, Genfit, SEP 22, 2020, https://ir.genfit.com/news-releases/news-release-details/genfit-announce-first-half-year-2020-financial-results-and-new [SID1234565477]). The press release will be followed by two conference calls hosted by GENFIT management to discuss the results and new strategy:

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Conference Call in English on September 30, 2020 at 4:30pm EDT / 22:30 CEST, and in French on October 1, 2020 at 1:30am EDT / 07:30am CEST

Both the English and French conference calls will be accessible on the investor page of our website, under the events section at https://ir.genfit.com/ or by calling 877-407-9167 (toll-free U.S. and Canada), 201-493-6754 (international) or 0 800 912 848 (France) five minutes prior to the start time (no passcode needed). A replay will be available shortly after the call.

On September 22, 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 George Buchman, Ph.D., Vice President, Preclinical & Process Development, Catalent Cell & Gene Therapy, will present at the World Vaccine Congress, which will take place virtually on Sept. 28 – October 1, 2020 (Press release, Catalent, SEP 22, 2020, https://www.catalent.com/catalent-news/advantages-of-oncolytic-viruses-as-immunotherapies-to-be-discussed-by-catalent-gene-therapy-expert/ [SID1234565476]).

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On Sept. 30 at 4:05 p.m. EST, Dr. Buchman will present "Next-Generation Vaccines and Oncolytic Viruses: Current Challenges and Future Promise", giving an overview of the benefits and limitations of oncolytic viruses as immunotherapies. His presentation will discuss the manufacturing and analytical considerations, as well as a collaborative study that evaluates a new technology to assess transfection efficiency.

Dr. Buchman joined Catalent through its acquisition of Paragon Gene Therapy in 2019. He has more than 30 years of experience in the biotech industry, and has held roles at companies including Life Technologies (now Thermo Fisher), Celera Genomics and Gene Logic. Dr. Buchman obtained a bachelor’s degree in biochemistry from Albright College, Reading, Pennsylvania, and a doctorate in biochemistry from University of Maryland.

On September 22, 2020 ALX Oncology (NASDAQ:ALXO), a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, reported it has entered into a clinical trial collaboration with Merck, known as MSD outside the United States and Canada, to evaluate the combination of ALX148, an investigational next generation CD47 blocker, and KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, for the treatment of patients with Head & Neck Squamous Cell Carcinoma (HNSCC) (Press release, ALX Oncology, SEP 22, 2020, View Source [SID1234565475]).

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Under the terms of the agreement, ALX Oncology will conduct a Phase 2 program comprising two separate Phase 2 studies. The first study will evaluate the efficacy of ALX148 in combination with KEYTRUDA for the first line treatment of patients with PD-L1 expressing metastatic or unresectable, recurrent HNSCC. The second study will evaluate ALX148 in combination with KEYTRUDA and standard chemotherapy for the first line treatment of patients with metastatic or unresectable, recurrent HNSCC.

These new studies will be initiated based on promising data from ALX148 in combination with pembrolizumab generated by ALX Oncology in a Phase 1b trial evaluating patients with HNSCC that was the basis for ALX148’s Fast Track Approval granted by the U.S. Food and Drug Administration. Phase 1b trial results presented at ASCO (Free ASCO Whitepaper) 2020 showed that patients with HNSCC who had progressed on prior platinum therapy and who had never received a checkpoint inhibitor treated with ALX148 in combination with pembrolizumab demonstrated a 40% objective response rate (ORR), a median progression-free survival (PFS) of 4.6 months with a median overall survival (OS) that was not reached.

"ALX148 was designed for use in combination to maximize clinical activity with a range of anti-cancer agents. We believe that blocking the CD47 myeloid checkpoint pathway bridges the innate and adaptive immune response against cancer to enhance efficacy. This collaboration builds upon the compelling combination activity observed in patients with ALX148 and KEYTRUDA," said Jaume Pons, Ph.D., Founder, President and Chief Executive Officer of ALX Oncology. "Our goal is to transform treatment options for patients with cancer by developing ALX148 as a foundational checkpoint immunotherapy."

ALX Oncology owns worldwide commercial rights to ALX148.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.