On June 5, 2018 PharmaMar (MSE:PHM) has reported how crossover has had an influence on the overall survival of the ADMYRE trial (Press release, PharmaMar, JUN 5, 2018, View Source [SID1234527173]). The impact on overall survival of those patients that relapsed after receiving dexamethasone as a single agent and who were subsequently treated with plitidepsin in combination with dexamethasone was analyzed. Of the 84 patients treated from the comparator arm –dexamethasone as a single agent– 44%, 37 patients were treated with the combination with plitidepsin thereafter. This data has been presented as a poster discussion session during the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) that is being held from the 1st to the 5th of June in Chicago (USA).

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The ADMYRE study is a pivotal, randomized, open label, international, multicenter, phase III study, which included 255 multiple myeloma patients who had relapsed after having previously received at least 3, but no more than 6 prior lines and that compared both the safety and efficacy of plitidepsin plus dexamethasone against
dexamethasone alone.

The primary endpoint of this study was Progression Free Survival -which resulted to be positive- was to demonstrate a statistically significant reduction in the risk of disease progression or death of 35% against the comparator.

During the presentation, the 2 statistical models used (RPSFT and the two stage method) to correct and measure the impact of crossover on overall survival were discussed, emphasizing the two stage model (Latimer et al.), that was considered the most adequate in the context of the Admyre study..

Accordingly, and taking into account the effect of crossover using the two stage method, a statistically significant increase in overall survival in the plitidepsin plus dexamethasone arm (11.6 months) against the comparator (6.4 months) was
observed.

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.

On June 5, 2018 Alexion Pharmaceuticals (Nasdaq: ALXN) reported that management will present at the Goldman Sachs 39th Annual Global Healthcare Conference in Rancho Palos Verdes, CA on Tuesday, June 12, 2018 at 11:20 a.m., PDT (Press release, Alexion, JUN 5, 2018, View Source [SID1234527174]).

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An audio webcast of the presentation will be available live. You can access the webcast at: View Source An archived version of the remarks will also be available through the Company’s website for a limited time following the conference.

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.

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.