IRICoR and Université de Montréal Enter into Research Collaboration with AbbVie to Discover Tumor-Specific Neoantigens

On June 5, 2018 The Institute for Research in Immunology and Cancer – Commercialization of Research (IRICoR) and its host institution, the Université de Montréal (UdeM) reported that they have entered into a research collaboration with AbbVie, a global research and development-driven biopharmaceutical company, in order to identify Tumor-Specific Neoantigens (TSNA) based on a novel proprietary platform developed by Drs. Claude Perreault and Pierre Thibault, both of whom are Principal Investigators at the Institute for Research in Immunology and Cancer (IRIC) of the Université de Montréal (Press release, IRICoR, JUN 5, 2018, View Source [SID1234626500]).

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Under the terms of the agreement, AbbVie will fund certain research activities at the IRIC to identify TSNA in a specific cancer indication. AbbVie will obtain an option to secure an exclusive worldwide license on the intellectual property arising from the collaboration.

"We are very pleased to have been able to successfully conclude an agreement with AbbVie around the identification of TSNA that are of mutual interest to both AbbVie and to IRICoR," stated Dr. Steven Klein, Vice-President, Business Development of IRICoR. "Having a partner such as AbbVie validates the novel approach that Drs. Perreault and Thibault have developed to identify TSNA across multiple tumor types, and demonstrates the value of IRICoR in initially funding this unique platform. This is the second platform technology supported by IRICoR and developed by Drs. Perreault and Thibault that has been advanced towards commercialization. The first one is based on the identification of Minor Histocompatibility Antigens which has been licensed to SpecificiT, a Montreal-based immunotherapy-focused company."

"AbbVie is truly excited about this partnership because it provides a real opportunity to identify new antigens that are produced in cancer cells, which the immune system can recognize. Drs. Perreault’s and Thibault’s work consists of developing technologies to identify these specific proteins at the surface of cancer cells and their approach is quite novel. It’s an area of immuno-oncology we are eager to investigate in order to accelerate and discover new therapies," explains Dr. Thomas Hudson, VP, Head of Oncology Discovery and Early Development, AbbVie.

"Drs. Perreault’s and Thibault’s research will undoubtedly have a remarkable impact on how we treat cancer. Ultimately, AbbVie looks for innovative partnerships and partners who are pushing the boundaries of science in order to tackle the toughest challenges in oncology," says Stéphane Lassignardie, General Manager, AbbVie Canada.

(CORRECTION) Immune Therapeutics Acquires 10% Stake in Cytocom; Obtains Exclusive Rights to Lodonal™ for Pets in United States

On June 5, 2018 Immune Therapeutics, Inc. (OTCQB:IMUN) ("Immune," "IMUN" or the "Company"), a clinical late stage biopharmaceutical company focused on the development of two immunomodulating therapies for the treatment of autoimmune diseases, inflammatory diseases, cancer and HIV/AIDS reported a modification of the Company’s 2014 exclusive licensing agreement with Cytocom, Inc., a late stage biotechnology company that specializes in T-Cell activation immunotherapies (Press release, Immune Therapeutics, JUN 5, 2018, https://www.immunetherapeutics.com/2022/08/correction-immune-therapeutics-acquires-10-stake-in-cytocom-obtains-exclusive-rights-to-lodonal-for-pets-in-united-states/ [SID1234618215]).

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In addition to the rights granted in the 2014 agreement to make products containing Lodonal and Met-Enkelphline in Africa, Central America, South American and the Caribbean and to market and distribute the same for human use in certain emerging markets, the newly amended and restated license agreement also grants the Company the exclusive marketing and distribution rights for products containing Lodonal and Met-Enkelphline for treatment of animals in the United States.

According to Global Industry Analysts, Inc., the global market for animal medication is projected to reach US $44.4 billion by 2022, driven by increasing investments in animal drug development in response to unmet animal health needs and developments in veterinary diagnostics and services. The Company is developing its strategy to capture a portion of this market.

The Company’s CEO, Noreen Griffin, stated that: "We are confident in our ability to fast track our development program for companion animals in several qualified OMUMS (The Office of Minor Use and Minor Species) indications. Once approved, the company will receive seven years of exclusive marketing rights, which means we should face no competition from another sponsor marketing the same drug in the same dosage form for the same intended use for that time frame."

The amended and restated license agreement was entered in conjunction with a stock purchase agreement where the Company agreed to acquire 10% of Cytocom’s issued and outstanding common stock in exchange for cancelation of approximately $4,100,000 of debt owed by Cytocom to the Company. Under the original spin-out of Cytocom from the Company, IMUN was required to return all Cytocom shares to Treasury upon the funding of Cytocom, leaving them with no ownership in Cytocom. The Company’s Board, after due discussions and review of Cytocom’s potential, decided to make the investment. The acquisition solidifies the new direction of the strategic alliance between the Company and Cytocom.

Corporate Update

The Company has retained the services of a Ruderfer & Associates, Inc. Verona, NJ 07044 to assist with the search for a new CEO so that Noreen Griffin can be released to serve Cytocom and help grow the value of the Company’s investment in Cytocom.

The Company has filed two new patents in the last 30 days. At this time, the Company has now filed six patents pending applications in the last 18 months. The newest two patents include the use of Lodonal as a combination therapy for inflammation, autoimmune disease and cancer in both humans and animals, as well as use of Met-Enkelphline as a combination immunotherapy in the treatment of cancer.

The Company continues to work with the Pharmacy and Poison Board in Kenya and will update shareholders as soon as the Company receives additional information.

The Company is moving forward in Nigeria with implementing the launch of a marketing program with its partner Fidson Healthcare Plc and is hopeful that the initiative will result in sales in the coming months following the initiative.

Foundation Medicine to Present at Upcoming Investor Conferences

On June 5, 2018 Foundation Medicine, Inc. (NASDAQ:FMI) reported that members of the company’s management team will present at the following upcoming investor conferences (Press release, Foundation Medicine, JUN 5, 2018, View Source [SID1234527172]):

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Goldman Sachs Annual Healthcare Conference on Tuesday, June 12, 2018 at 1:20 p.m. P.T. in Rancho Palos Verdes, California.

William Blair Growth Stock Conference on Thursday, June 14, 2018 at 8:40 a.m. C.T. in Chicago.

A live, listen-only webcast of the presentation may be accessed by visiting the investors section of the company’s website at investors.foundationmedicine.com. A replay of the webcast will be available shortly after the conclusion of each presentation and will be archived on the company’s website for 90 days.

Aptus Clinical enters into a global partnership agreement with Artelo Biosciences

On June 5, 2018 Artelo Biosciences, Inc. (OTCQB: ARTL), a biopharmaceutical company focused on the development of therapeutic treatments that modulate the endocannabinoid system, reported that it has entered into a global research and development partnership with Syngene International Ltd (Press release, Aptus Clinical, JUN 5, 2018, View Source [SID1234527281]). (Syngene), an India-based integrated discovery-development service provider, through its wholly-owned subsidiary, Trinity Research and Development Limited, and Aptus Clinical Ltd. (Aptus), a specialist UK-based Clinical Contract Research Organization with particular expertise in oncology, rare diseases and advanced therapies. The partnership will focus on supporting the drug discovery and clinical development of ART27.13, Artelo’s Phase 2 ready, high-potency dual cannabinoid agonist, in oncology.

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"ART27.13 represents an important new therapeutic class of anti-cancer medicine. While a lot is already known about the drug’s pre-clinical and clinical profile, we believe working alongside proven global talent will ensure that our new insights into ART27.13 are rapidly transitioned into the clinic," said Andrew Yates, PhD, ART27.13 Program Leader. "This partnership is a premier example of how global partners with a common interest can be harnessed inside the exciting R&D environment in the United Kingdom."

As part of the agreement, Syngene will be the discovery and development partner providing a pre-clinical data package to support the advancement of ART27.13 for anti-cancer indications. Aptus Clinical will develop and design an anti-cancer clinical study that is scientifically credible, ethically acceptable and operationally deliverable. It will also provide clinical development and regulatory expertise to the partnership. Previously, Artelo established a UK subsidiary at the Alderley Park BioHub in Cheshire, where Dr. Yates directs the ART27.13 program.

"It is an honor to be a part of such an innovative delivery model that globally integrates the best in drug discovery and clinical development expertise to support Artelo in its efforts to develop future novel oncology drugs for the benefit of patients," stated Steve McConchie, CEO of Aptus Clinical.

Dr. Manoj Nerurkar, Chief Operating Officer, Syngene International added, "We are happy to partner with Artelo in developing ART27.13 for anti-cancer indications. Oncology is one of the focus areas for Syngene and this global partnership will help us harness our individual expertise to develop a better product for the benefit of cancer patients worldwide."

About ART27.13

ART27.13 is a clinic-ready, potent, peripherally restricted CB1/CB2 synthetic agonist. Existing clinical data with ART27.13 suggests meaningful potential for the treatment of cancer-related anorexia and weight loss (cachexia). In five Phase I clinical studies including over 200 subjects, ART27.13 demonstrated a statistically significant and dose-proportional increase in body weight. In ongoing consultation with regulatory authorities, Artelo plans to advance ART27.13 as a multi-modal supportive care therapy for cancer patients suffering from anorexia or weight loss. In addition to its potential for cancer related anorexia, ART27.13 may also have direct anti-tumor activity. Numerous non-peripherally restricted CB1 and CB2 agonists have shown promising results as anti-tumor drugs, yet their profile made them unsuitable for further development. Because ART27.13 is peripherally restricted, Artelo is investigating the dual agonist for its anti-cancer potential. ART27.13 is under a global option and license agreement from the NEOMED Institute (Montreal, Canada) and with whom Artelo is also collaborating on the clinical development of ART27.13.

Polaris Group Announces Results of a Phase 1 Clinical Study with its Lead Therapeutic Candidate ADI?PEG 20 in Metastatic Uveal Melanomas

On June 5, 2018 Polaris Group, a biopharmaceutical company focused on developing novel drugs for cancer, reported results from a phase 1 clinical study that features Polaris lead therapeutic candidate ADI‑PEG 20 in combination with pemetrexed and cisplatin (ADIPEMCIS) in first-line treatment for argininosuccinate synthetase (ASS1) deficient metastatic uveal melanomas (Press release, Polaris Pharmaceuticals, JUN 5, 2018, View Source [SID1234527207]). The results were presented by Dr. Peter Szlosarek from Barts Cancer Center in the UK (abstract No.2589) at the American Society Clinical Oncology’s 2018 annual meeting.

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ADIPEMCIS was well tolerated in a cohort of 10 patients. The best response was stable disease; which was observed in 7 of 10 patients and hence a disease control rate of 70%. The 12-month survival rate was 50% and the median overall survival is 11.5 months, with 1 patient still alive at 27.1 months.

Metastatic uveal melanoma has been resistant to systemic therapies, with low response rates and low overall survival. There is clearly an unmet medical need that requires the development of an effective and safe treatment for these patients. It has been observed previously that ADI‑PEG 20 had efficacy as a monotherapy in several earlier melanoma studies and now the combination with PEM/CIS has further enhanced the activity.

"ADIPEMCIS showed activity in these metastatic uveal melanoma patients," said John Bomalaski, M.D., Executive Vice President, Medical Affairs, of Polaris. "We believe that ADI‑PEG 20 would benefit these patients, for whom there is no established treatment regimen. Based on this encouraging data as well as for ADI‑PEG 20 monotherapy in uveal melanoma, a trial of ADI‑PEG 20 in combination with checkpoint inhibitors, including programmed death and CTLA-4 antibodies is planned for uveal melanoma patients."

About ADI-PEG 20

ADI‑PEG 20 is a biologic being developed by Polaris Group to treat cancers carrying a major metabolic defect that renders them unable to internally synthesize arginine. Because arginine is essential for protein synthesis and survival of cells, these cancer cells become dependent upon the external supply of arginine to survive and grow. ADI‑PEG 20 is designed to deplete the external supply of arginine, causing arginine-dependent cancer cells to die while leaving the patient’s normal cells unharmed. Multiple cancers have been reported to have a high degree of arginine-dependency and can potentially be treated with ADI‑PEG 20.