On October 15, 2018 HiFiBiO Therapeutics, a world leader in the discovery of therapeutic antibodies through single-cell screening and analysis, reported the acquisition of H-Immune Therapeutics, an early-stage biotechnology company engaged in the discovery and development of novel immuno-oncology therapeutics (Press release, HiFiBiO Therapeutics, OCT 15, 2018, View Source [SID1234555288]). The acquisition strengthens HiFiBiO Therapeutics’ strategic focus on identifying first-in-class targets for multiple immune cell types, as well as applying industry-leading technologies to develop diverse antibody therapeutics. Specific financial terms of the transaction were not disclosed.

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Established in late 2016 as a spin-out of the French Atomic Energy Commission, H-Immune was founded by Luc Boblet, PhD, Former Co-founder and CEO of Institute Pasteur spin-out PathoQuest, and Michel Léonetti, PhD, Senior Immunologist. H-Immune has pioneered a unique in vitro immunization-based fully human antibody generation platform (IVI), which complements HiFiBiO’s world-leading single-cell platform, and has developed an early-stage novel pipeline through translational collaborations with leading cancer centers in Europe. Following the acquisition, Dr. Boblet has joined the HiFiBiO Therapeutics’ leadership team as Executive Vice President, Business Development.

"Over the past several months, we have made significant strides in our evolution as a biotherapeutics pioneer with this acquisition of H-Immune Therapeutics, collaborations with major pharmaceutical companies including Takeda and Kite, and fast progression of our own internal projects through our open innovation model," said Liang Schweizer, PhD, President and CEO of HiFiBiO Therapeutics. "This acquisition not only adds a pipeline of promising novel therapeutics, but also strengthens our team of world-class immunologists and immune assay scientists. Together, we will accelerate the development of a full repertoire of innovative antibody drugs that will soon transform patient care."

"HiFiBiO Therapeutics is well known for its expertise with immune modulation antibody therapies and unprecedented drug discovery engine," said Dr. Boblet. "My team and I are excited to join this group of experienced, enthusiastic drug hunters. Together, with our synergies, we will be able to bring innovative immuno-oncology drugs to patients in need, faster and more effectively than before."

Shanghai, China – Virogin Biotech Ltd. ("Virogin") has been named 2018 Ernst & Young Fudan China’s Most Promising Enterprise, recognized within the ‘Health Reimagined’ category (Press release, Virogin Biotech, OCT 15, 2018, View Source [SID1234532328]).

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Hosted by global professional services firm Ernst & Young and Fudan University’s School of Management, these 8th annual awards identified prominent companies and future industry leaders that exhibit a commitment to innovation, sustained high growth, and potential to strengthen the economic development of China. At the industry awards ceremony, Virogin was recognized for their leadership in bio-innovative drug research and development.

As stated by the Ernst & Young Fudan China Most Potential Enterprise Selection Jury, "the award-winning companies represent a creative, entrepreneurial, diversified and inclusive corporate paradigm in today’s highly disruptive business world".

Virogin’s CEO and co-founder, Chris Huang says: "For Virogin, this award is testament to the work of our core team, all whom possess extensive experience and deep background in technology development, clinical advancement and business operations. At present, the company has three independent R&D projects and ongoing cooperative research and development projects. Our clinical product VG161 will enter clinical phase in the first half of 2019. We look forward to continuing our R&D work, and strengthening relations with our strategic partners to advance our SynerlyticTM platform."

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.

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.

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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."

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]).

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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.