On October 5, 2018 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on using the body’s immune system to fight cancer, reported that it will present data from its ongoing studies utilizing Cchek, Anixa’s artificial intelligence (AI) driven early cancer detection technology, at the 30th Anniversary AACR (Free AACR Whitepaper) Special Conference – Convergence: Artificial Intelligence, Big Data and Prediction in Cancer (Press release, Anixa Biosciences, OCT 5, 2018, View Source [SID1234530495]). This AACR (Free AACR Whitepaper) special conference will cover the state of research in understanding cancer from incident to early diagnosis, prevention, and treatment using big data and machine learning. The meeting will be held October 14–17, 2018 in Newport, Rhode Island and will attended by global leaders in the intersection of cancer research and artificial intelligence. To receive a copy of the presentation, please email your request to AACR (Free AACR Whitepaper)[email protected] starting October 17, 2018 and include your name, title, and contact information.

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"We are pleased to be presenting our latest data on Cchek at this special Artificial Intelligence conference. This poster will discuss prostate cancer detection, which we have previously announced is our first commercial focus. The data will discuss Cchek’s ability to distinguish between tumor bearing and healthy individuals as well as between tumor bearing and those with benign prostate conditions, such as benign prostatic hyperplasia (BPH). It is well known that the majority of men (upwards of 85-90%) who get prostate biopsies do not have cancer. The current screening technique, which measures circulating levels of prostate specific antigen (PSA), causes many men to undergo unnecessary biopsies due to its poor accuracy. Our recent Cchek data demonstrates that many of these unneeded biopsies may be avoided. More details of the ongoing study will be available after the presentation," stated Dr. Amit Kumar, President and CEO of Anixa.

American Association of Cancer Research (AACR) (Free AACR Whitepaper)
The American Association of Cancer Research (AACR) (Free AACR Whitepaper) (www.aacr.org) is a 501(c)(3) public charity headquartered in Philadelphia, PA. The mission of the AACR (Free AACR Whitepaper) is to prevent and cure cancer through research, education, communication and collaboration. Through its programs and services, the AACR (Free AACR Whitepaper) fosters cancer research and related biomedical science; accelerates the dissemination of new research findings among scientists and others dedicated to the conquest of cancer; promotes science education and training; and advances the understanding of cancer causes, prevention, diagnosis and treatment throughout the world.

On October 5, 2018 Genoscience Pharma reported the extension to US of its Phase 1b/2a clinical study with GNS561 in advanced liver cancers (cholangiocarcinoma and hepatocellular carcinoma) (Press release, GenoScience, OCT 5, 2018, View Source [SID1234530226]). In October 2017, GNS561 received an IND for an international clinical trial involving up to 50 patients with liver cancer.

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Opened Clinical Centers

Memorial Sloan Kettering Cancer Center (MSKCC) – New York, USA – enrolled its first liver cancer patient in the ongoing Phase 1b/2a clinical trial to evaluate the safety and efficacy of GNS561. MSKCC is one of the five clinical centers participating to patients’ recruitment in our study, with Jules Bordet Institute (Brussels, Belgium), Saint-Joseph Hospital, AP-HP (Paris, France), Croix Rousse Hospital (Lyon, France), Hospitalo-Universitary Center of Grenoble (Grenoble, France).

MSKCC

Memorial Sloan Kettering Cancer Center — the world’s oldest and largest private cancer center — has devoted more than 130 years to exceptional patient care, innovative research, and outstanding educational programs.

On October 5, 2018 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) has accepted for filing with Priority Review its New Drug Application (NDA) seeking accelerated approval for selinexor, its first in class, oral SINE compound, as a new treatment for patients with penta-refractory multiple myeloma (Press release, Karyopharm, OCT 5, 2018, View Source [SID1234529861]). The FDA also granted Karyopharm’s request for Priority Review and assigned an action date of April 6, 2019 under the Prescription Drug User-Fee Act (PDUFA). In its acceptance letter, the FDA has stated that it is currently planning to hold an advisory committee meeting to discuss this application.

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"As a potential new therapy with a novel mechanism and compelling clinical profile, we believe oral selinexor, if approved, will provide a meaningful therapeutic option for patients battling highly resistant, penta-refractory myeloma," said Sharon Shacham, PhD, MBA, Founder, President and Chief Scientific Officer of Karyopharm. "The acceptance of this NDA for review and grant of Priority Review mark significant milestones for the selinexor program, and further underscores the high level of unmet need in this patient population. We look forward to working with the FDA during the review process."

Provided marketing approval is granted by the FDA, Karyopharm plans to commercialize selinexor in the U.S. as early as the first half of 2019. The Company also plans to submit a Marketing Authorization Application to the European Medicines Agency in early 2019 with a request for conditional approval.

Priority Review is granted by the FDA to drugs that, if approved, would provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of a serious condition when compared to standard applications. Selinexor has received both Orphan Drug and Fast Track designations from the FDA for the treatment for patients with penta-refractory multiple myeloma.

About Selinexor

Selinexor is a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound. Selinexor functions by binding with and inhibiting the nuclear export protein XPO1 (also called CRM1), leading to the accumulation of tumor suppressor proteins in the cell nucleus. This reinitiates and amplifies their tumor suppressor function and is believed to lead to the selective induction of apoptosis in cancer cells, while largely sparing normal cells. To date, over 2,600 patients have been treated with selinexor. In April and September 2018, Karyopharm reported positive top-line data from the Phase 2b STORM study evaluating selinexor in combination with low-dose dexamethasone in patients with penta-refractory multiple myeloma. Selinexor has been granted Orphan Drug Designation in multiple myeloma and Fast Track designation for the patient population evaluated in the STORM study. Karyopharm’s New Drug Application (NDA) has been accepted for filing and granted Priority Review by the FDA, and oral selinexor is currently under review by the FDA as a possible new treatment for patients with penta-refractory multiple myeloma. The Company also plans to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in early 2019 with a request for conditional approval. Selinexor is also being evaluated in several other mid- and later-phase clinical trials across multiple cancer indications, including in multiple myeloma in a pivotal, randomized Phase 3 study in combination with Velcade (bortezomib) and low-dose dexamethasone (BOSTON), as a potential backbone therapy in combination with approved therapies (STOMP), in diffuse large B-cell lymphoma (SADAL), liposarcoma (SEAL), and an investigator-sponsored study in endometrial cancer (SIENDO), among others. Additional Phase 1, Phase 2 and Phase 3 studies are ongoing or currently planned, including multiple studies in combination with approved therapies in a variety of tumor types to further inform Karyopharm’s clinical development priorities for selinexor. Additional clinical trial information for selinexor is available at www.clinicaltrials.gov.

Further Information About Potential Accelerated Approval for Selinexor in Multiple Myeloma

The FDA instituted its Accelerated Approval Program to allow for expedited approval of drugs that treat serious conditions and that fill an unmet medical need based on a surrogate endpoint or an intermediate clinical endpoint thought to predict clinical benefit, like overall response rate (ORR). Accelerated approval is available only for drugs that provide a meaningful therapeutic benefit over existing treatments at the time of consideration of the application for accelerated approval, which the FDA has reiterated in its feedback to the Company. Particularly in disease areas with multiple available and potential new therapies, such as multiple myeloma, accelerated approval carries a high regulatory threshold. Consistent with its general guidance, the FDA has noted to the Company its preference for randomized studies geared toward full approval, which the Company has undertaken with the ongoing pivotal, Phase 3 BOSTON study, and has reminded the Company that accelerated approval requires patients to have exhausted all available approved therapies. FDA’s Fast Track designation is available to therapeutics treating an unmet medical need in a serious condition; the Company has received Fast Track designation from the FDA specifically for the population treated in the STORM trial. In light of this recognition that the STORM patient population represents an unmet medical need and the positive top-line data reported in April and September 2018, the Company believes that the STORM study should support its request to the FDA for accelerated approval.

On October 5, 2018 BerGenBio ASA (OSE: BGBIO) reported that the first patient has been dosed in the second stage of the phase II trial (BGBC008) evaluating the Company’s selective AXL inhibitor bemcentinib in combination with MSD’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in patients with previously treated advanced adenocarcinoma of the lung (non-small cell lung cancer, NSCLC) whose disease is progressing (Press release, BerGenBio, OCT 5, 2018, View Source [SID1234529834]).

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The trial was advanced into the second stage on the basis that the first stage met its clinical efficacy endpoint (as announced on 26 June 2018). Updated results from the first stage (n=24) were presented at the 19th Annual World Conference on Lung Cancer (WCLC: 25 September 2018)*. The Company reported an overall response rate (ORR) of 40% in patients who tested positive for AXL expression (4 out of 10 pts). Efficacy was also seen in PD-L1 negative patients (ORR of 27%, 3 out of 11 pts) for whom KEYTRUDA monotherapy is currently not indicated. Treatment with the bemcentinib/KEYTRUDA combination was well tolerated.

The second stage will enrol a further 24 patients at sites in Norway, Spain, UK and the US, and aims to confirm the safety and clinical efficacy of the combination. Comprehensive exploratory studies will continue to evaluate biomarkers in tumour and blood indicative of AXL expression and immune modulation. Preliminary results from the trial are expected during 2019.

The BGBC008 trial (ClinicalTrials.gov Identifier: NCT03184571) is being sponsored by BerGenBio. MSD, a tradename of Merck & Co., Inc., Kenilworth, New Jersey, USA, will continue to supply KEYTRUDA for use in the study under a collaboration agreement signed in March 2017.

Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "We recently reported positive data from this phase II clinical trial at WCLC. Patients that were AXL positive reported a clinical response rate of 40%. Most notably, this included PD-L1 negative patients who do not benefit from KEYTRUDA monotherapy. These data strengthen our confidence in bemcentinib’s mode of action, as well as the value of AXL inhibition to enhance patient outcomes to KEYTRUDA immunotherapy. Additional combination data in NSCLC, including bemcentinib with targeted and chemotherapy, also presented at WCLC provide further proof supporting the concept that AXL is a key player in mediating resistance to therapy and immune evasion, and that bemcentinib has the potential to become a
cornerstone therapy in this challenging indication. We look forward to reporting outcome and biomarker data at upcoming leading medical congresses."

* James Lorens et al. Ph II Study of Oral Selective AXL Inhibitor Bemcentinib (BGB324) in Combination with Pembrolizumab in Patients with Advanced NSCLC(abstract P2.04-27)

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

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About NSCLC
It is estimated that more than 230,000 new cases of lung cancer will be diagnosed in the US in 2018 and it is the leading cause of cancer deaths. 65% of NSCLCs are of adenocarcinoma pathology. Although various treatments exist for NSCLC, they are often curtailed by acquired resistance to therapy and immune evasion. Novel treatments overcoming these mechanisms in NSCLC are urgently required.

About the BGBC008 trial
The BGBC008 trial is a phase II multi-centre open-label study of bemcentinib in combination with KEYTRUDA (pembrolizumab) in previously treated, immunotherapy naïve, patients with advanced adenocarcinoma of the lung, the most common form of non-small cell lung cancer (NSCLC). The objective of the trial is to determine the anti-tumour activity of this novel drug combination and responses will be correlated with biomarker status (including AXL kinase and PD-L1 expression).

On October 5, 2018 Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) reported that it will release its third quarter 2018 financial results on Thursday, November 1, 2018 at 7:00 a.m. ET (Press release, Teva, OCT 5, 2018, View Source;p=RssLanding&cat=news&id=2370421 [SID1234529812]).

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Teva will host a conference call and live webcast on the same day, at 8:00 a.m. ET to discuss its third quarter 2018 results and overall business environment. A Question & Answer session will follow this discussion.

In order to participate, please dial the following numbers (at least 10 minutes before the scheduled start time):

United States 1 (866) 966-1396
International +44 (0) 2071 928000
For a list of other international toll-free numbers, click here.
Passcode: 7193665
A live webcast of the call will also be available on Teva’s website at: ir.tevapharm.com Please log in at least 10 minutes prior to the conference call in order to download the applicable software.

Following the conclusion of the call, a replay of the webcast will be available within 24 hours on the Company’s website. The replay can also be accessed until November 30, 2018, 9:00 a.m. ET by calling United States 1 (866) 331-1332 or International +44 (0) 3333-009785; passcode: 7193665.