Genome & Company acquires patent for flagship pipeline’GEN-001

On August 21, 2020 Genome & Company (CEO Bae Bae Soo, Park Han Soo) reported that a domestic patent application for its flagship pipeline’GEN-001′ has been patented (Press release, Genome & Company, AUG 21, 2020, View Source [SID1234563922]).

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With this patent decision, Genome & Company has secured exclusive rights for GEN-001, the main pipeline, not only for the strain itself, but also for GEN-001 alone and in combination with chemo/immuno-cancer drugs.

GEN-001 is a candidate substance for oral microbiome treatment and has immune activity, and is being developed as an anticancer agent as a combination therapy with an immune checkpoint inhibitor. GEN-001 is a single strain of bacteria isolated from healthy volunteers and has been found to activate dendritic cell, macrophage, and T cell responses. In the preclinical stage, GEN-001 has secured optimal safety, and in particular, when administered in combination with an immune checkpoint inhibitor (ICI), it has a synergistic effect that significantly inhibits cancer growth in models that respond to existing immune checkpoint inhibitors and models that do not respond. Showed.

Genome & Company is the first in Korea to conduct a combined clinical trial for cancer patients with Merck/Pfizer’s immune anticancer drug (Abelumab) after approval of the US Food and Drug Administration (FDA) clinical trial plan (IND) as an anticancer microbiome in April 2020. Is in progress.

Park Han-soo, CEO of R&D, said, "It is of great significance not only for the anticancer microbiome itself, but also for obtaining a patent decision for single or combined administration regardless of carcinoma. Through development, we will become a company that can give hope to cancer patients."

AbCellera Acquires OrthoMab Bispecific Platform to Propel the Development of Antibody Therapies for Pharma and Biotech Partners

On August 20, 2020 AbCellera reported the acquisition of the OrthoMab bispecific platform from Dualogics, LLC. (Dualogics) (Press release, AbCellera, AUG 20, 2020, View Source [SID1234622736]). OrthoMab is a clinically validated platform that uses the most advanced computational and experimental protein engineering methods to create IgG-like bispecific antibodies from any two antibody sequences . By integrating OrthoMab into its existing technology stack, AbCellera provides the industry with a rapid and complete solution for generating tailored, stable and developable bispecific antibodies that meet the needs of the growing $140B biologics market.

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Under the terms of the asset purchase agreement, AbCellera acquires full rights to the OrthoMab platform and Dualogics retains rights to develop existing internal assets and to complete existing partnership programs. Dr. Tim Jacobs, who led multiple bispecific antibody programs as CTO of Dualogics, joined AbCellera’s team in early August. Dr. Jacobs brings 10 years of protein engineering experience and has pioneered numerous computational and experimental strategies to design, modify, and enhance protein-based therapies.

"Bispecifics have opened new vistas for antibody therapeutics and are the fastest growing format in clinical development. Despite this early success, the technological barriers for successful development of bispecifics, including challenges in discovery, pair selection, protein engineering and manufacturing, are keeping many firms out," said Carl Hansen, Ph.D., CEO of AbCellera. "By welcoming Tim to our team and OrthoMab into our stack, we have consolidated the talent and technologies needed to address these challenges. Through our partnerships, we’ll democratize access to leading bispecific technology across the industry, connecting science with technology to bring new therapies to the clinic."

The addition of OrthoMab to AbCellera’s antibody discovery technology creates a unified bispecific platform that optimizes every step of the process, including:

Sourcing diverse antibodies from any animal, including fully human monoclonal antibodies from humanized mice;
Searching, decoding, and analyzing antibodies to identify the best combinations for achieving the desired functions;
Engineering IgG-like bispecific antibodies that are tailored to maximize therapeutic effect while retaining optimal stability and developability profiles; and
Assessing immunogenicity with in silico screening tools.
"AbCellera’s deep technical expertise and industry-leading discovery pipeline uniquely positions it to make the most of the OrthoMab platform," said Tim Jacobs, Ph.D., Senior Research Scientist at AbCellera. "I am extremely excited to be joining the AbCellera team and look forward to bringing best-in-class bispecific and protein-engineering capabilities to our partners."

Cannabics Pharmaceuticals to Establish a Division for its Antitumor Drug Candidate RCC-33

On August 20, 2020 Cannabics Pharmaceuticals Inc. (OTCQB: CNBX), a leader in personalized cannabinoid medicine focused on cancer and its side effects, reported that it is establishing a dedicated division for the development of its Antitumor Drug Candidate RCC-33 for the treatment of colorectal cancer (Press release, Cannabics Pharmaceuticals, AUG 20, 2020, View Source [SID1234570869]).

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The announcement comes as the company is gearing up to expand its clinical validation efforts for its RCC-33 formula, and is already preparing a plan for the next steps in its clinical validation path, including in-vivo experiments, collaborations with key medical centers, and the preparation of a product dossier with which the company plans to schedule a Pre IND Meeting with the FDA.

Eyal Barad, Cannabics’ CEO commented: "The development of our drug candidate for the treatment of colorectal cancer based on our novel and proprietary formulation RCC-33 has become a central strategic activity for the company. Up until now we have conducted various POC experiments in our in-house drug discovery facility, and at this time, the company has decided to establish a dedicated division to centralize, coordinate and lead all aspects of the development of its drug candidate going forward. Our Scientific Advisory Board Member Dr. Erez Scapa has accepted the position of Medical Director for the new RCC-33 division and assist the company in its forthcoming plans for clinical validation. This is indeed exciting news for the company."

Dr. Erez Scapa commented: "I thank the company for their trust and am looking forward for the opportunity to drive a comprehensive clinical validation plan for the company’s drug candidate RCC-33 for colorectal cancer. As a gastroenterologist, I am aware that currently over 65% of treated colorectal cancer patients survive for 5 years or more in the US. While we are still in the early stages of a long and challenging path, the mere possibility to demonstrate even a modest positive impact for these patients, gets me excited and motivates me to undertake the challenges ahead."

Cytocom, Inc. Announces Agreement to Reacquire Rights to Lead Drug Candidate CYTO-201 and CYTO-401 in Emerging Markets

On August 20, 2020 Cytocom, Inc. (Cytocom), a clinical-stage biopharmaceutical company developing novel immune modulating therapies based on proprietary platforms, reported the company and Immune Therapeutics, Inc. (OTC: IMUN; Immune) have entered into an agreement to reacquire the emerging market rights to distribute and market its late-stage investigational drug candidates CYTO-201 and CYTO-401 (Press release, Cytocom, AUG 20, 2020, https://www.prnewswire.com/news-releases/cytocom-inc-announces-agreement-to-reacquire-rights-to-lead-drug-candidate-cyto-201-and-cyto-401-in-emerging-markets-301115965.html [SID1234568903]). The agreement contemplates the execution of certain additional documents and consents in order to complete the assumption of various liabilities from noteholders and other creditors. The company does not anticipate any issues with the closing of this transaction, which is expected by the end of the third quarter 2020.

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As part of the 2014 spin off of Cytocom as a separate company, Immune licensed the rights to make and sell therapeutics containing CYTO-201 and CYTO-401 in over 80 countries, including Brazil and China. Cytocom is now reacquiring this license in exchange for the assumption of up to approximately $5 million of Immune liabilities.

"We are excited by this transaction and the opportunity to pursue the development of these products for indications such as cancer and HIV, not just in the U.S., but in other major markets such as Brazil and China," said Michael Handley, Cytocom CEO. "This agreement is consistent with our renewed strategic focus, and we look forward to advancing efforts to bring these potential new treatment options to patients as quickly as possible."

Cytocom’s lead investigational drug candidate, CYTO-201, an immune modulator, is now being studied in late-stage clinical trials for Crohn’s disease, fibromyalgia, multiple sclerosis and the human immunodeficiency virus (HIV), and is awaiting FDA clearance of an Investigational New Drug Application (IND) for a Phase 2 study in COVID-19. CYTO-401 is being developed as a cancer immunotherapy and antiviral therapy targeting HIV, as well as the H1N1 virus.

Admission to trading of Biofrontera’s 1.00% qualified subordinated mandatory convertible bond 2020/2021

On August 20, 2020 Biofrontera AG (shares of Biofrontera AG ISIN: DE 00 6046113) reported the successful placement of the 1.00% qualified subordinated mandatory convertible bond 2020/2021 with gross proceeds of EUR 7.9 million (Press release, Biofrontera, AUG 20, 2020, View Source [SID1234568551]). Within the scope of the issuance, 2,638,150 qualified subordinated mandatory convertible bearer bonds (the "Bond") were issued . The subscription price equaled 100% of the nominal value, corresponding to EUR 3.00 per Bond.

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The mandatory convertible bond 2020/2021, with the German Securities Identification Number A3E454 / ISIN DE000A3E4548, matures on December 20, 2021 and has been admitted for trading on the Open Market of the Frankfurt Stock Exchange as of today, August 20, 2020.

According to Section 8 (2) of the terms and conditions of the mandatory convertible bond 2020/2021, the issuer Biofrontera AG, has, for an unlimited period of time, the right of "mandatory conversion" any time after the stock price of Biofrontera’s shares (ISIN: DE0006046113) has exceeded EUR 4.50 at least once ("Mandatory Conversion Trigger Price"). The relevant stock price shall be the daily volume-weighted average quotation of the issuer’s shares determined on the XETRA trading platform of the Frankfurt Stock Exchange within a continuous period of fifteen trading days. The Mandatory Conversion Trigger Price has already been exceeded as of today according to the calculation described above, and the relevant average price stands at EUR 4.8350. The issuer reserves the right to decide at what point in time it will exercise its right of mandatory conversion and will select the most appropriate time to do so after taking into account all foreseeable circumstances. According to Section 16 of the terms and conditions of the mandatory convertible bond, the request for mandatory conversion will be published in the Federal Gazette as well as via a corporate news release.