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.

Exelixis to Present at the William Blair & Co. 38th Annual Growth Stock Conference on June 12, 2018

On JUN 5, 2018 Exelixis, Inc. (NASDAQ: EXEL) reported that Michael M. Morrissey, Ph.D., the company’s President and Chief Executive Officer, reported it will provide an overview of the company at the William Blair 2018 Growth Stock Conference taking place June 12-14 in Chicago, IL (Press release, Exelixis, JUN 5, 2018, View Source;p=irol-newsArticle&ID=2353360 [SID1234527192]). The Exelixis presentation is scheduled for 11:50 AM ET / 10:50 AM local Chicago time / 8:50 AM PT on Tuesday, June 12, 2018.

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To access the webcast link, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the presentation to ensure adequate time for any software download that may be required to listen to the webcast. A replay will also be available at the same location for 14 days.

Sensei Biotherapeutics Reports New Data from Phase 1 Clinical Trial of SNS-301

On JUN 5, 2018 Sensei Biotherapeutics, Inc., a privately-held biopharmaceutical company developing immuno-oncology therapies that teach the immune system to recognize and attack cancer, reported the publication of data from the company’s multi-center Phase 1 clinical trial to assess safety and immunogenicity of SNS-301 (formerly PAN-301) in patients with biochemically recurrent prostate cancer (Press release, Sensei Biotherapeutics, JUN 5, 2018, View Source [SID1234527190]). Data were published in conjunction with the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, IL.

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Sensei announced publication of data from its phase 1 clinical trial of SNS-301 in patients with persistent prostate cancer in conjunction with #ASCO2018.

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SNS-301 is a first-in-class immunotherapy candidate utilizing a bacteriophage viral vector targeting a novel embryonic antigen called human aspartate β-hydroxylase (ASPH). In adults, ASPH is only expressed on the surface of cancer cells and has been detected in more than 20 different types of cancer. SNS-301 was created using Sensei’s SPIRIT platform to optimize for antigen presentation and vaccine immunogenicity.

In the Phase 1 trial, SNS-301 was administered every 21 days via intradermal injection to men with biochemically relapsed prostate cancer, using a fixed dose-escalation schema to establish the recommended Phase 2 dose. A minimum of three doses of SNS-301 were administered to each patient. Fifteen patients who met all other inclusion and exclusion criteria were screened for ASPH expression using a serum-based companion diagnostic test, and 12 of the 15 patients presented the minimum threshold for ASPH expression. These patients received as many as 18 doses of SNS-301 (mean = 10 doses per patient), including a minimum of 3 treatments at the high dose, over the 15-month duration of the study. Highlights of the safety and immunogenicity data published at ASCO (Free ASCO Whitepaper) include:

SNS-301 was well tolerated with a favorable safety profile across all dose levels in the Phase 1 study.
No dose-limiting toxicities were observed at the three dose levels evaluated in the trial.
All patients in the study experienced dose-dependent, ASPH-specific humoral and cellular immune responses, including ASPH-specific B-cell and T-cell responses.
75% (6/8) of evaluable patients achieved improvements in Prostate-Specific Antigen (PSA) doubling time and/or absolute PSA. Improvements in PSA doubling rate are an indicative measure of slowing disease progression.
"We are extremely encouraged by these clinical results from our Phase 1 study of SNS-301 which validate the potential of our proprietary SPIRIT drug development platform to generate novel immuno-oncology therapies," said John Celebi, President and Chief Executive Officer of Sensei Biotherapeutics. "SNS-301 exemplifies Sensei Biotherapeutics’ ability to engineer promising therapeutic candidates designed to teach the immune system to recognize and attack cancer."

This Phase 1 study of SNS-301 was initiated in January 2017 and enrollment of 12 patients was completed in February 2018. SNS-301 is the lead clinical candidate from Sensei Biotherapeutics’ proprietary SPIRIT drug development platform. Final results will be presented at a medical meeting in the second half of 2018 and initial enrollment in a Phase 2 efficacy trial is anticipated by the end of the year.

About SNS-301

SNS-301 is a first-in-class immunotherapy candidate utilizing a bacteriophage viral vector that targets human aspartate β-hydroxylase (ASPH), a cell surface enzyme that is normally expressed during fetal development. Following fetal development, the protein is no longer expressed. Expression of ASPH is uniquely upregulated in more than 20 different types of cancer and is related to cancer cell growth, cell motility and invasiveness. ASPH expression levels are inversely correlated with disease prognosis.

Though enhanced antigen presentation and other engineered immunotherapeutic features, SNS-301 is designed to overcome self-tolerance and induce robust and durable humoral and cellular immune responses that are specific to ASPH. SNS-301 is delivered through intradermal injection and avoids time-consuming and uncomfortable infusions, greatly facilitating ease of use.