Avacta and Daewoong Pharmaceutical Form Immunotherapy Focused Joint Venture

On January 8, 2020 Avacta Group plc (AIM: AVCT), the developer of Affimer biotherapeutics and reagents, and Daewoong Pharmaceutical Co. Ltd., (KSX: 069620), a leading Korean pharmaceutical company, reported that they have agreed to establish a joint venture in South Korea, and to enter a collaboration and license agreement for the joint venture to develop the next generation of cell and gene therapies incorporating Affimer proteins to enhance the immune-modulatory effects (Press release, Avacta, JAN 8, 2020, View Source [SID1234612389]).

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Mesenchymal stem cells (MSCs) are promising agents for the treatment of autoimmune and inflammatory diseases. The joint venture will develop a new class of MSCs that are primed to produce Affimer proteins, which are designed to enhance the immune-modulatory effect when administered to patients, by reducing inflammatory or autoimmune responses.

Daewoong will provide the joint venture with access to its proprietary technology for generating allogeneic MSCs from a single donor to treat a large number of patients. This proprietary technology facilitates developing cell therapies as "off-the-shelf" products.

Avacta will develop Affimer proteins against several undisclosed targets which will be transferred to the joint venture to be incorporated into MSCs. The resulting engineered MSCs will have broad ranging therapeutic utility, depending on the Affimer proteins’ intended therapeutic purposes.

Avacta’s research and development costs will be fully covered by the joint venture and Avacta retains the rights to commercialise the Affimer proteins outside of the field of cell therapies. Avacta’s shareholding in the joint venture is 45% with Daewoong holding 55%, and the joint venture will be operationally managed by Seng-ho Jeon, CEO of Daewoong, with a Board composed of representatives of both Avacta (Alastair Smith, CEO and Matthew Vincent, VP Business Development and Strategy) and Daewoong.

"Our partnership reinforces the shared vision of both companies to design the next level of treatment paradigm, and to open up a new horizon in immunotherapeutic strategies", said Seng-ho Jeon. "This innovative collaboration will deliver invaluable synergy and lead to new solutions with the potential to transform patients’ lives."

"We are very excited to establish the joint venture with Daewoong, a world-class partner, combining our powerful Affimer platform with MSCs to develop breakthrough medicines targeting immune-mediated diseases", said Dr Alastair Smith, CEO of Avacta. "Affimer proteins have the potential to selectively modulate signalling pathways in inflammatory diseases in order to reduce the aberrant immune response occurring in those tissues, as well as positively impacting tissue regenerative pathways meant to repair and restore normal function to the affected tissues. We look forward to working closely with the Daewoong team to advance these promising therapeutics, and get them to the patients who need them."

Veracyte Announces Biopharmaceutical Collaboration with Acerta Pharma

On January 8, 2020 Veracyte (Nasdaq: VCYT) reported a multi-year partnership with Acerta Pharma, the hematology research and development arm of AstraZeneca (LSE/STO/NYSE: AZN), to provide genomic information that will support the biopharmaceutical company’s development of oncology therapeutics (Press release, Veracyte, JAN 8, 2020, View Source [SID1234552842]). Financial and other terms of the collaboration were not disclosed.

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The agreement marks Veracyte’s first biopharmaceutical partnership since the company announced its acquisition of the exclusive diagnostics rights to the NanoString nCounter platform and genomic tests in breast cancer and lymphoma on December 3, 2019. That transaction positions Veracyte to expand globally using a distributed platform and comprehensive menu of advanced genomic tests.

"We are excited to partner with Acerta Pharma and AstraZeneca, global leaders whose innovative medicines are benefitting millions of patients worldwide," said Bonnie H. Anderson, Veracyte’s chairman and chief executive officer. "This collaboration reflects the significant value we can bring to biopharmaceutical companies through our expanding global footprint, as well as our ability to potentially inform diagnosis and treatment decisions in new oncology indications."

BioLineRx to Present at the 2020 Biotech Showcase

On January 8, 2020 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology, reported that management will provide a corporate update at the 2020 Biotech Showcase in San Francisco, California (Press release, BioLineRx, JAN 8, 2020, View Source [SID1234552859]).

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2020 Biotech Showcase Presentation Details:

Date: Tuesday, January 14, 2020
Time: 9:30 a.m. Pacific Time
Location: Hilton Union Square Hotel, San Francisco
Track: Yosemite A (Ballroom Level)
Webcast: Link to webcast information

The Company will also host institutional investor and partnering meetings at the 9th Annual LifeSci Advisors Corporate Access Event taking place in San Francisco, January 13-15, 2020.

To schedule a meeting with BioLineRx, investors can register on the online system managed by the Company’s US investor relations firm, LifeSci Advisors, LLC, or make a request via e-mail at [email protected].

Cellect Biotechnology Ltd. Prices $3m Registered Direct Offering of American Depositary Shares

On January 8, 2020 Cellect Biotechnology Ltd. (Nasdaq: APOP) ("Cellect" or the "Company"), a developer of innovative technology which enables the functional selection of stem cells, reported it has entered into a securities purchase agreement with institutional investors for the purchase and sale of 1,000,000 American Depositary Shares ("ADSs"), each representing 100 of the Company’s ordinary shares, at an offering price of $3.00 per ADS, pursuant to a registered direct offering (Press release, Cellect Biotechnology, JAN 8, 2020, View Source [SID1234552876]). The gross proceeds of the offering will be approximately $3,000,000 before deducting fees and other estimated offering expenses. The closing of the registered direct offering is expected to take place on or about January 10, 2020, subject to the satisfaction of customary closing conditions.

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A.G.P./Alliance Global Partners is acting as sole placement agent for the offering.

This offering was made pursuant to an effective shelf registration statement on Form F-3 (File No. 333-219614) previously filed with the U.S. Securities and Exchange Commission (the "SEC"). This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. A prospectus supplement relating to the shares of common stock will be filed by Cellect with the SEC. When available, copies of the prospectus supplement, together with the accompanying prospectus, can be obtained at the SEC’s website at www.sec.gov or from A.G.P./Alliance Global Partners, 590 Madison Avenue, 36th Floor, New York, New York 10022 or by email at [email protected].

Study shows protein inhibitor as potential treatment approach for common mutations found in non-Hodgkin lymphomas

On January 8, 2020 A study at The University of Texas MD Anderson Cancer Center reported a potential new approach to treating two of the most common subtypes of lymphoma through manipulation of molecular programs controlled by the cAMP-response element binding protein (CREBBP) (Press release, MD Anderson, JAN 8, 2020, View Source [SID1234553265]). Mutations of CREBBP are frequently found in follicular lymphoma and diffuse large B-cell lymphomas (DLBCL), and allow malignant cells to hide from the immune system.

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Study results were published in the Jan. 8 online issue of Cancer Discovery. Co-lead investigators, Michael Green, Ph.D., assistant professor of Lymphoma & Myeloma at MD Anderson and Ari Melnick, M.D., of Weill Cornell Medical School, reported on how inhibition of a protein called histone deacetylase 3 (HDAC3) restores immune programs lost as a result of CREBBP mutations, paving the way for potential immunotherapy approaches for common forms of non-Hodgkin lymphoma.

CREBBP is the second most frequently mutated chromatin-modifying gene in both follicular lymphoma and DLBCL. It encodes a protein that alters the activity of genes by modifying the histone proteins around which DNA is wrapped.

"CREBBP mutations are highly recurrent in B-cell lymphomas and either inactivate its histone acetyltransferase (HAT) domain or truncate the protein," said Green." We showed that these two classes of mutations yield different degrees of disruption of the epigenome, with HAT mutations being more severe and associated with inferior clinical outcome."

Through CRISPR/Cas9 gene editing of cell lines and using mouse models, the research team also showed that HDAC3 selective inhibitors reverse aberrant epigenetic programming caused by CREBBP resulting in growth inhibition of lymphoma cells and restoration of immune surveillance.

"Our study characterized the molecular consequences of CREBBP mutations and identified key cellular pathways silenced as a result of unopposed HDAC3 activity," said Green. "We demonstrated how inhibition of HDAC3 restores these pathways, suppressing growth and most critically enabling T cells to recognize and kill lymphoma cells."

HDAC3 inhibitors appear to affect expression of major histocompatibility molecular class II (MHC class II), molecules, which are antigen presentation proteins crucial for initiating adaptive immune responses.

"The frequency of MHC class II loss in DLBCL exceeds the frequency of CREBBP mutations in this disease through unknown mechanisms," said Green. "The ability of HDAC3 inhibition to induce MHC class II expression may have potentially broad implications for immunotherapy. We believe that inhibition of HDAC3 represents a novel mechanism-based immune-epigenetic therapy for CREBBP- mutant lymphomas."

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The study was funded by the National Institutes of Health (R01 CA201380, R01 CA055349, U54 OD020335 01, P50 CA192937, P30 CA016672, and P30 CA008748); the Chemotherapy Foundation; the Star Cancer Consortium; the Jaime Erin Follicular Lymphoma Research Consortium; the Schweitzer Family Fund; and the Futcher Foundation. The study was also supported with funding from the B-Cell Lymphoma Moon Shot, part of MD Anderson’s Moon Shots Program, a collaborative effort to accelerate the development of scientific discoveries into clinical advances that save patients’ lives. Green previously served on the Scientific Advisory Board of KDAc Therapeutics, and he owns stock equity in the company.

MD Anderson study participants included Saber Tadros, Ph.D.; Neeraj Jain, Ph.D.; Haopeng Yang, Ph.D.; Man Chun John Ma, Ph.D.; Sreejoyee Ghosh, Ph.D.; Loretta Nastoupil, M.D.; and Sattva Neelapu, M.D., all of the Department of Lymphoma & Myeloma; and Cassian Yee, M.D., of the Department of Melanoma Medical Oncology.