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Fusion Pharma to Present at the EANM 2018 Congress and BIO Investor Forum 2018

On November 15, 2018 Fusion Pharmaceuticals, a biopharmaceutical company focused on radiotherapeutics (specifically, targeted alpha therapeutics), reported that it will present at two separate conferences this week (Press release, Fusion Pharmaceuticals, OCT 15, 2018, View Source [SID1234531595]).

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On Tuesday, October 16, 2018, Fusion will present scientific data on its lead program FPI-1434 at the European Association of Nuclear Medicine (EANM) 2018 Congress. The meeting is behind held in the CCD, Congress Center Dusseldorf, in Dusseldorf, Germany.

On Thursday, October 18, 2018, at 10:00am PT, Fusion will present at the BIO Investor Forum 2018. The event is being held at the Westin St. Francis Hotel in San Francisco, California.

Anixa Biosciences Files Pre-Submission and Requests Meeting with FDA Regarding Cchek™ Artificial Intelligence based Cancer Detection Technology

On October 15, 2018 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on using the body’s immune system to fight cancer, reported it has filed an IVD pre-submission with the US Food and Drug Administration (FDA) for use of its Cchek artificial intelligence based cancer detection technology, as a prostate cancer test (Press release, Anixa Biosciences, OCT 15, 2018, View Source [SID1234530496]). The FDA’s Pre-Submission Program (Pre-Sub) allows medical device and in vitro diagnostic (IVD) manufacturers to discuss specific aspects of the regulatory process and requirements with FDA. In the submission, Anixa requested a face-to-face meeting with the FDA to discuss the agency’s feedback on the proposed preclinical and clinical performance testing plan required to support a pre-market application, and to determine the appropriate regulatory path.

Dr. Amit Kumar, CEO of Anixa stated, "We are pleased to request a Pre-Sub meeting with the FDA. This meeting will be an important step in the commercialization path for Cchek as a prostate cancer test, which will be the first in a series of cancer detection and confirmation tests using our Cchek technology." Dr. Kumar continued, "This is a major milestone event for us as we begin the process of interfacing with the FDA on our diagnostic testing technology."

Dr. Kumar added, "This request for a meeting is in addition to a meeting already scheduled with the FDA regarding our CAR-T ovarian cancer therapy. I want to make clear that these are two separate and independent paths that address two different potential products. We are excited to have both of our programs ready for discussions with the FDA, and we plan on sharing the results of those meetings as appropriate."

ADVANCED PROTEOME THERAPEUTICS REPORTS PROGRESS ON COLLABORATION WITH NORIA PHARMACEUTICALS

On October 15, 2018 Advanced Proteome Therapeutics Corporation ("APC" or the "Company") (TSXV: APC) (FSE: 0E8), reported the successful completion of the first phase of the Collaboration of APC with Noria Pharmaceuticals Inc. in the rapidly growing and dynamic field of antibody radioisotope conjugates which is expected to have a major impact in the fight against cancer (Press release, Advanced Proteome Therapeutics, OCT 15, 2018, View Source [SID1234530347]).

APC has succeeded in creating a construct using its proprietary, site-selective, linker technology with Noria’s proprietary MacroPa radioisotope chelation technology in combination with a well-established, commercially successful antibody. The excellent bio-affinity/targeting capability of the parent antibody has been preserved in the novel antibody-MacroPa conjugate in measurements performed by an independent laboratory. This accomplishment sets the stage for studies of targeted alpha-particle therapy, which is intended to carry a uniquely powerful radiation source to specific treatment points to destroy tumor cells.

In light of this development, APC and Noria have agreed to move forward with the second phase of their announced collaboration (July 17, 2018 (GLOBE NEWSWIRE) which will involve radiolabeling and testing utilizing cell lines and animal studies.

Dr. Allen Krantz, CSO and Founder of APC commented "We look forward to demonstrating the superiority of our site-selective approach to creating antibody-radioisotope-conjugates with Noria’s novel chelation technology that have commercial potential and advance cancer therapies." This program evokes synergies with our independent efforts involving targeted beta therapy for cancers and will allow us to leverage our technology in both initiatives.

Bill Dickie, APC’s President and CEO, stated that "it is exciting to witness the speed with which we have successfully applied APC technology to the development of vehicles for the targeted delivery of radiopharmaceuticals. These programs provide an important dimension to our overall mission involving anti-cancer therapeutics, which include recently announced (Oct. 09, 2018 (GLOBE NEWSWIRE)) positive results with antibody-amanitin conjugates which will be more fully reported shortly.".

Dr. Allan Green, President and CEO of Noria commented "We are indeed excited to continue our collaboration with APC and look forward to working with them to create superior antibody-based therapies.

Mustang Bio Appoints Martina A. Sersch, M.D., Ph.D., as Chief Medical Officer

On October 15, 2018 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a company focused on the development of novel immunotherapies based on proprietary chimeric antigen receptor engineered T cell (CAR T) technology and gene therapies for rare diseases, reported the appointment of Martina A. Sersch, M.D., Ph.D., as Chief Medical Officer ("CMO") (Press release, Mustang Bio, OCT 15, 2018, View Source [SID1234530345]). Dr. Sersch will oversee the clinical development of Mustang’s pipeline in CAR T technology and gene therapies. Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, "We are delighted to welcome Martina to the Mustang leadership team. Her extensive global immuno-oncology drug
development expertise and vast array of experience in bringing innovative oncology products to market will help guide Mustang’s clinical development efforts and regulatory strategies in an exciting time of growth for the company."

Dr. Sersch is an experienced drug developer and physician with specialty training in oncology, infectious and tropical diseases. She has more than 17 years of experience in early- and late-stage clinical development in academia and industry. Prior to joining Mustang, Dr. Sersch served as executive director at Amgen, where she successfully led supplemental Biologics License Application filings in the area of hematology, as well as indication strategies for early- and late-stage compounds in hematology. Prior to Amgen, Dr. Sersch held positions of increasing responsibility on regional and global levels in oncology drug development, including novel immuno-oncology drugs at IRAD Oncology, Genentech, Roche and Pfizer. At Roche, Dr. Sersch was instrumental in the biologics strategy, where she led initiatives globally and regionally with a specific focus in Asia Pacific and China, including supporting the development of regional guidelines for drug development. Dr. Sersch obtained her medical and graduate degrees from Heidelberg University in Germany and subsequently trained in England, South Africa and the United States.

Dr. Sersch said, "I am thrilled to join Mustang to help advance the development of its CAR T and CRISPR/Cas9-enhanced CAR T therapies across multiple cancers, as well as its lentiviral gene therapy for XSCID. I look forward to working with the Mustang team as we strive to deliver promising new treatment options for patients and their families in areas of unmet medical need."

Allogene Therapeutics Announces Closing of Initial Public Offering and Full Exercise of Underwriters’ Option to Purchase Additional Shares

On October 15, 2018 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) therapies for cancer, reported the closing of its previously announced initial public offering of 20,700,000 shares of its common stock, which includes 2,700,000 shares sold pursuant to the exercise in full by the underwriters of their option to purchase additional shares, at a price to the public of $18.00 per share (Press release, Allogene, OCT 15, 2018, View Source [SID1234530319]). Including the option exercise, the gross proceeds to Allogene Therapeutics from the offering, before deducting the underwriting discounts and commissions and offering expenses, were $372.6 million.

Goldman Sachs & Co. LLC, J.P. Morgan Securities LLC, Cowen and Company, LLC and Jefferies LLC acted as the joint book-running managers for the offering.

The offering was made only by means of a prospectus. Copies of the final prospectus related to the offering may be obtained from:

Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, or via telephone: 1-866-471-2526, or via email: [email protected]; or

J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or via telephone: 1-866-803-9204; or

Cowen and Company, LLC, c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, or via email: [email protected]; or

Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or via telephone: 1-877-547-6340, or via email: [email protected].

Registration statements relating to these securities have been filed with the Securities and Exchange Commission and became effective on October 10, 2018. This press release shall not constitute an offer to sell or a 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.