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.

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 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."

On October 15, 2018 Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company developing highly selective medicines for patients with genomically defined cancers, reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to LOXO-292, a selective RET inhibitor, for the treatment of patients with advanced RET fusion-positive thyroid cancer who require systemic therapy, have progressed following prior treatment and have no acceptable alternative treatment options (Press release, Loxo Oncology, OCT 15, 2018, View Source [SID1234529908]). This designation supplements the two LOXO-292 Breakthrough Therapy Designations granted in September 2018. The Breakthrough Therapy Designation announced today was also based on data from the ongoing global Phase 1/2 LIBRETTO-001 clinical trial.

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The FDA’s Breakthrough Therapy Designation is intended to expedite the development and review of a drug candidate that is planned for use to treat a serious or life-threatening disease or condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.

About LOXO-292
LOXO-292 is an oral and selective investigational new drug in clinical development for the treatment of patients with cancers that harbor abnormalities in the rearranged during transfection (RET) kinase. RET fusions and mutations occur across multiple tumor types with varying frequency. LOXO-292 was designed to inhibit native RET signaling as well as anticipated acquired resistance mechanisms that could otherwise limit the activity of this therapeutic approach. LOXO-292 has been granted Breakthrough Therapy Designation by the U.S. FDA.

LOXO-292 is currently being studied in the global LIBRETTO-001 Phase 1/2 trial. For additional information about the LOXO-292 clinical trial, please refer to www.clinicaltrials.gov. Interested patients and physicians can contact the Loxo Oncology Physician and Patient RET Clinical Trial Hotline at 1-855-RET-4-292 or email [email protected].

About RET-Altered Cancers
Genomic alterations in RET kinase, which include fusions and activating point mutations, lead to overactive RET signaling and uncontrolled cell growth. RET fusions have been identified in approximately 2% of non-small cell lung cancer, 10-20% of papillary and other thyroid cancers, and a subset of other cancers. Activating RET point mutations account for approximately 60% of medullary thyroid cancer (MTC). Both RET fusion cancers and RET-mutant MTC are primarily dependent on this single activated kinase for their proliferation and survival. This dependency, often referred to as "oncogene addiction," renders such tumors highly susceptible to small molecule inhibitors targeting RET.

On October 15, 2018 Neurocrine Biosciences, Inc. (NASDAQ: NBIX) reported that it will report third quarter financial results after the Nasdaq market closes on Monday, Nov. 5, 2018 (Press release, Neurocrine Biosciences, OCT 15, 2018, View Source;p=RssLanding&cat=news&id=2371705 [SID1234530025]). Neurocrine will then host a conference call and webcast to discuss its financial results and provide a Company update that day at 1:30 p.m. Pacific Time (4:30 p.m. Eastern Time).

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Participants can access the live conference call by dialing 877-876-9176 (US) or 785-424-1667 (International) using the conference ID: NBIX. The webcast can also be accessed on Neurocrine’s website under Investors at www.neurocrine.com. A replay of the webcast will be available on the website approximately one hour after the conclusion of the event and will be archived for one month.