On December 1, 2020 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, reported that it has entered into a license agreement with Cleveland Clinic for exclusive, world-wide rights to an innovative ovarian cancer vaccine technology (Press release, Anixa Biosciences, DEC 1, 2020, View Source [SID1234572022]).

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Cleveland Clinic immunologist Dr. Vincent Tuohy has been working on a method to vaccinate women against ovarian cancer and other gynecological malignancies. This development-stage vaccine targets the extracellular domain of anti-mullerian hormone receptor 2 (AMHR2-ED), that appears in many types of ovarian cancer. AMHR2-ED is one of several proteins identified by Dr. Tuohy as "retired" proteins. While these proteins are necessary during the early stages of life, they are "retired" as a person ages, and are no longer expressed, or made at appreciable levels, in healthy adults. AMHR2-ED re-appears in cancerous cells and accordingly, it is an attractive target for vaccination.

Anixa and Cleveland Clinic are already collaborating on a preventative breast cancer vaccine also developed by Dr. Tuohy based on his research into "retired" proteins. The organizations plan to begin human trials with the breast cancer vaccine in early 2021.

"Through this collaboration we are expanding into additional preventive and therapeutic areas and we look forward to seeing the development of this ovarian cancer vaccine," said Dr. Tuohy. "Research into cancer therapies has typically focused on attacking the disease after a patient has been diagnosed, but if we could immunize people to prevent the cancer from ever forming, it could represent a paradigm shift for patients, their caregivers and the healthcare system."

"We are pleased to broaden our relationship and to expand our work with Dr. Tuohy," stated Amit Kumar, Ph.D., President and Chief Executive Officer of Anixa. "Though it is still early days for the experimental ovarian cancer vaccine, pre-clinical research suggests the potential of this technology as both a prophylactic that prevents the occurrence of cancer, and a therapeutic that treats women with ovarian cancer."

Dr. Kumar added, "Anixa’s goal is to present patients that have limited treatment options with meaningful new therapeutic and prophylactic alternatives. We see this vaccine as a complementary component to our growing immuno-oncology portfolio, which includes a CAR-T therapy targeting ovarian cancer, for which we anticipate filing an IND shortly."

Conference Call Information:
Anixa will host a conference call and live audio webcast Thursday, December 3, 2020, at 1:15 p.m. PST. Interested parties may access the conference call by dialing:

An audio webcast will be accessible via the Investors section of the Anixa website: View Source An archive of the webcast will remain available for 30 days after the call.

On December 1, 2020 MaaT Pharma reported that the company secured an additional €7.35 million ($8.7 million) in an extension of its Series B financing round, bringing the total raised in this round to €25.35 million (Press release, MaaT Pharma, DEC 1, 2020, View Source [SID1234572038]). The new capital from the PSIM Fund managed by Bpifrance on behalf of the French State, with participation from SkyViews Life Science and Celeste Management, underscores the potential of MaaT Pharma’s microbiome restoration biotherapeutics platform and the progress the company has made towards developing drugs that harness the rich diversity of the gut microbiome to improve overall survival in blood cancers and Graft-versus-Host Disease (GvHD). In February, the company announced the initial closing of an €18 Million Series B Financing Round, led by US investor SymBiosis, LLC, with support from Seventure Partners, Crédit Mutuel Innovation, and Biocodex.

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The final closing of the Series B financing round will primarily support the advancement of an innovative fermentation production platform for the development of next-generation, large-scale, fully controlled microbiome ecosystem therapeutics. By leveraging MaaT Pharma’s GutPrint computational data science platform, the new industrial fermentation platform will enable to develop and manufacture both "standard" high-richness, high-diversity fermented product MaaT034, and a pipeline of indication-specific candidates. In particular, the fermentation technology supports pipeline extension towards solid tumors indications, for combination with immunotherapy. The resulting new product candidates will complement the company’s donor-derived lead products MaaT013 (enema) and MaaT033 (oral formulation) for the treatment of GvHD and liquid tumors.

The funding will also support the production of MaaT013 to meet the demand from clinicians wanting to access the product for the treatment of their GvHD patients with no other therapeutic options; this compassionate use is permitted by the French regulator under an "ATUn" program.

"Raising additional capital through an extension of our Series B is a testament to the relevance of our innovative full-ecosystem microbiome therapy approach. We are now supported by a syndicate of seven highly respected investors, enabling us to further advance and expand our portfolio with confidence. Serving patients has always been the cornerstone of our purpose and we look forward to meeting their needs through our microbiome therapeutics development and in our early-access-program," commented Hervé Affagard, CEO and Co-founder of MaaT Pharma. "I would like to thank all of our investors for their trust and for sharing our company’s commitment to improving patients’ lives and treatment outcomes in a variety of cancer indications by restoring gut microbiome function and immune system homeostasis."

"MaaT Pharma has developed an innovative portfolio of microbiome-based biotherapeutics that we believe offers tremendous short-term and long-term potential, addressing the needs of advanced-stage cancer patients with limited options," commented Muriel Prudent, Senior Investment Manager at Bpifrance. "We look forward to working with MaaT Pharma’s team to expand its leadership position and contribute to advancing its innovative pipeline."

Dr Stefan Catsicas, Managing Partner at SkyViews Life Science said: "SkyViews Life Science is delighted to join a strong group of investors collectively committed to supporting MaaT Pharma, a leader in the field of microbiome functionality, as they address severe unmet needs of cancer patients."

"MaaT Pharma has brought together a strong team grounded in scientific and manufacturing excellence with a compelling vision for microbiome-based therapies, which convinced us to support this endeavor," added Dimitri Boulanger, Chief Executive Officer, Celeste Management.

On December 1, 2020 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing innovative medicines worldwide, reported the commencement of an underwritten public offering of 1,511,546 American Depositary Shares ("ADSs"), each representing 13 of its ordinary shares, par value $0.0001 per share, by fund partnerships affiliated with Baker Bros (Press release, BeiGene, DEC 1, 2020, View Source [SID1234572053]). Advisors LP (the "Selling Shareholders"). The Selling Shareholders also intend to grant the underwriter a 30-day option to purchase up to an additional 151,154 ADSs. BeiGene will not receive any of the proceeds from the sale of the shares being offered by the Selling Shareholders but will bear certain expenses incident to this offering (excluding underwriting discounts and commissions).

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Goldman Sachs & Co. LLC is acting as the underwriter for the offering. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed or as to the actual size or terms of the offering.

An automatically effective shelf registration statement on Form S-3 was filed with the Securities and Exchange Commission ("SEC") on May 11, 2020. The proposed offering will be made only by means of a prospectus and prospectus supplement. A copy of the preliminary prospectus supplement relating to this offering may be obtained, when available, by visiting the SEC’s website at www.sec.gov or by contacting the offices of Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, by telephone: 1-866-471-2526 or by emailing [email protected]. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any offer or sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

On December 1, 2020 Zai Lab Limited ("Zai Lab") (NASDAQ: ZLAB; HKEX: 9688), an innovative commercial-stage biopharmaceutical company, reported the appointment of Alan Sandler, M.D., to the newly created position of President, Head of Global Development, Oncology, where he will lead global oncology development and related enabling functions to support the Company’s development activities (Press release, Zai Laboratory, DEC 1, 2020, View Source [SID1234572071]). Dr. Sandler was most recently the Senior Vice President and Global Head of Product Development Oncology at Genentech, a member of the Roche Group. He will report to Dr. Samantha Du, Chief Executive Officer, and serve on the executive team.

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"We are delighted to welcome Alan to Zai Lab as we continue to expand globally and strengthen our R&D leadership," said Dr. Samantha Du, Founder, Chairwoman and CEO of Zai Lab. "Throughout his distinguished career, Alan has made significant contributions as a respected leader in the oncology community, both in industry and through his clinical practice and academic research. Alan has played a key role in the development of many innovative oncology therapies. We look forward to his leadership of our oncology franchise as we advance towards our goal of becoming a leading global biopharma company."

"I’m very excited to be joining Zai Lab, given its robust pipeline of innovative clinical compounds," said Dr. Sandler. "I look forward to accelerating the development of Zai’s extensive and differentiated pipeline of oncology compounds, guide them through regulatory review, and bring them as quickly as possible to patients in need in China and around the world. I am also excited about working to identify additional product candidates to further expand Zai’s oncology portfolio."

Dr. Sandler brings nearly 30 years of oncology and drug development experience across industry and academia. During his tenure at Genentech/Roche, he led the teams responsible for the global development and regulatory approval of several innovative medicines, most recently Tecentriq. Prior to joining Genentech/Roche, Dr. Sandler served as Professor and Chief of Hematology/Oncology at Oregon Health and Science University. Previously, he served on the faculties of the medical schools of Indiana University and Vanderbilt University. He holds a Doctor of Medicine degree from Rush Medical College. Dr. Sandler completed his training in internal medicine and a fellowship in medical oncology at Yale-New Haven Medical Center. He has published over 300 peer-reviewed publications, articles, abstracts and book chapters.

On December 1, 2020 Immunomic Therapeutics, Inc. (ITI) reported that it will be presenting at the 2nd Annual Glioblastoma Drug Development Virtual Summit (Press release, Immunomic Therapeutics, DEC 1, 2020, View Source [SID1234572023]). On Wednesday, December 9th, Chief Executive Officer at ITI, Dr. Bill Hearl, will be presenting a talk titled, "Adaptive T-cell Immunotherapy for Newly Diagnosed Glioblastoma: Using Targeted Antigen Presentation to Enhance Immune Responses." Dr. Hearl will discuss ITI’s investigational platform technology, the company’s lead program and its preliminary data in GBM, as well as the company’s future focus.

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Presentation details are as follows:

Title: Adaptive T-cell Immunotherapy for Newly Diagnosed Glioblastoma: Using Targeted Antigen Presentation to Enhance Immune Responses

Presentation Category: Vaccines

Date and Time: Wednesday, December 9, 2020 12:40 PM EST / 9:40 AM PDT

Location: Virtual Summit

About UNITE

ITI’s investigational UNITE platform, or UNiversal Intracellular Targeted Expression, works by fusing pathogenic antigens with the Lysosomal Associated Membrane Protein 1, an endogenous protein in humans, for immune processing. In this way, ITI’s vaccines (DNA or RNA) have the potential to utilize the body’s natural biochemistry to develop a broad immune response including antibody production, cytokine release and critical immunological memory. This approach puts UNITE technology at the crossroads of immunotherapies in a number of illnesses, including cancer, allergy and infectious diseases. UNITE is currently being employed in a Phase II clinical trial as a cancer immunotherapy. ITI is also collaborating with academic centers and biotechnology companies to study the use of UNITE in cancer types of high mortality, including cases where there are limited treatment options like glioblastoma and acute myeloid leukemia. ITI believes that these early clinical studies may provide a proof of concept for UNITE therapy in cancer, and if successful, set the stage for future studies, including combinations in these tumor types and others. Preclinical data is currently being developed to explore whether LAMP1 nucleic acid constructs may amplify and activate the immune response in highly immunogenic tumor types and be used to create immune responses to tumor types that otherwise do not provoke an immune response.