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.

On June 5, 2018 bluebird bio, Inc. (Nasdaq: BLUE) reported that members of the management team will present at the following upcoming investor conferences in June (Press release, bluebird bio, JUN 5, 2018, View Source [SID1234527175]):

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Jefferies Global Healthcare Conference, Thursday, June 7, at 10:00 a.m. ET at the Grand Hyatt, New York City.

Goldman Sachs Global Healthcare Conference, Tuesday, June 12, at 11:20 a.m. PT at the Terranea Resort, Rancho Palos Verdes, California.

As previously announced, the Company will also host a conference call to review data being presented at the Annual Congress of the European Hematology Association (EHA) (Free EHA Whitepaper):

EHA Data Review Conference Call, Friday, June 15, 8:00 a.m. EST. Investors may listen to the call by dialing (844) 825-4408 from locations in the United States or +1 (315) 625-3227 from outside the United States. Please refer to conference ID number 4678706.
To access the live webcasts of bluebird bio’s presentations and conference calls, please visit the "Events & Presentations" page within the Investors and Media section of the bluebird bio website at View Source Replays of the webcasts will be available on the bluebird bio website for 90 days following the events.

On June 5, 2018 Dr. Reddy’s Laboratories Ltd (BSE: 500124, NSE: DRREDDY, NYSE: RDY) reported that the Company will be presenting at the Jefferies 2018 Healthcare Conference on Wednesday, June 6th, 2018, in New York City (Press release, Dr Reddy’s, JUN 5, 2018, View Source [SID1234527176]). The presentation is scheduled to begin at 3:00 p.m. EST [12:30 a.m. IST on June 7th, 2017].

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On June 5, 2018 Endocyte, Inc. (Nasdaq:ECYT), a biopharmaceutical company developing targeted therapeutics for personalized cancer treatment, reported the enrollment of the first patient in its global phase 3 VISION trial of 177Lu-PSMA-617 in prostate cancer by Dr. Luke Nordquist at Urology Cancer Center in Omaha, NE, a member of Precision Cancer Research (Press release, Endocyte, JUN 5, 2018, View Source [SID1234527177]). The international, prospective, open-label, multicenter, randomized phase 3 study is evaluating patients with progressive prostate specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC), who have received at least one novel androgen axis drug (abiraterone or enzalutamide) and at least one taxane regimen.

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"We are pleased to announce the initiation of this important clinical trial so quickly following our end-of-phase 2 meeting with the FDA. This speed of execution is a result of the enthusiasm of participating physicians and the focus and urgency of our clinical operations team," said Mike Sherman, president and CEO of Endocyte. "Having collaborated with several of the key opinion leaders in prostate cancer around the world, we are confident in the robustness of the VISION trial design and eager to complete enrollment."

"In spite of the introduction of new drugs in the last several years, there continues to be a significant need for therapeutic alternatives with new mechanisms of action for men suffering from metastatic castration-resistant prostate cancer," said Oliver Sartor, M.D., Medical Director of the Tulane Cancer Center. "The data generated with 177Lu-PSMA-617 in early clinical trials have yielded a high level of enthusiasm among physicians. There is a real need to advance this investigational therapy as quickly as possible for these heavily pre-treated patients and begin the work to evaluate it in earlier lines of therapy, particularly in advance of chemotherapy."

Phase 2 Clinical Data Presented at ASCO (Free ASCO Whitepaper)

Incremental data from an expansion cohort of 20 patients recently presented at ASCO (Free ASCO Whitepaper) confirmed and improved upon PSA response to 177Lu-PSMA-617 previously reported in a cohort of 30 patients enrolled in a phase 2 trial at the Peter MacCallum Cancer Centre in Melbourne, Australia.

"Twenty-six of the 50 patients (52%) enrolled in this trial are more heavily pre-treated than the minimum eligibility criteria for the VISION trial, so it is particularly compelling to see a PSA decline of 50% or more in 62% of these advanced patients and a median PSA progression-free survival (PFS) of 7.0 months," said Alison Armour, chief medical officer of Endocyte. "While the overall survival data are not yet mature for the second cohort of 20 patients, we were pleased to see six-month survival rates similar to the first cohort of 30 patients. Consistent response rates across patient groups with variations in prior therapy is likely a result of a potential differentiated mechanism of action for 177Lu-PSA-617 compared to currently approved therapies."

177Lu-PSMA-617 was generally well tolerated, with no significant dose-limiting toxicities observed. The most common treatment-related toxicity was Grade 1-2 xerostomia (dry mouth) seen in 68% of patients, but infrequently required any intervention. The occurrence of treatment-related Grade 3-4 hematologic toxicity was low and comparable to the largest retrospective published cohort.

VISION Phase 3 Trial Design

VISION will enroll up to 750 patients worldwide with PSMA-positive scans, randomized in a 2:1 ratio to receive either 177Lu-PSMA-617 plus best supportive/best standard of care versus best supportive/best standard of care alone. Best supportive/best standard of care is palliative in nature and, at the discretion of the investigator, may include enzalutamide or abiraterone. Patients treated with 177Lu-PSMA-617 will receive 7.4 gigabecquerel (GBq) intravenously every six weeks for a maximum of six cycles.

The primary endpoint of the study agreed to by the FDA is overall survival (OS). Secondary endpoints include radiographic progression-free survival (rPFS), response evaluation criteria in solid tumors (RECIST) response, and time to first symptomatic skeletal event. Two interim efficacy analyses of OS will be conducted at 50% and 70% of the first 489 targeted events. Endocyte plans to discuss modifying the first interim analysis endpoint to rPFS to expedite a potential accelerated approval in the U.S. Further information on the global Phase 3 VISION study can be found at www.VISIONClinicalTrial.com.

Website Information

Endocyte routinely posts important information for investors on its website, www.endocyte.com, in the "Investors & News" section. Endocyte uses this website as a means of disclosing material information in compliance with its disclosure obligations under Regulation FD. Accordingly, investors should monitor the "Investors & News" section of Endocyte’s website, in addition to following the company’s press releases, SEC filings, public conference calls, presentations and webcasts. The information contained on, or that may be accessed through, Endocyte’s website is not incorporated by reference into, and is not a part of, this document.

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.