On October 5, 2019 Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical stage biotechnology company focused on the development of novel cancer therapeutics, reported two new clinical trial collaborations to evaluate Pfizer’s palbociclib, also known as IBRANCE, and the investigational dual-mechanism poly (ADP-ribose) polymerase (PARP) inhibitor talazoparib, each in combination with Calithera’s glutaminase inhibitor CB-839 (Press release, Calithera Biosciences, OCT 5, 2018, View Source [SID1234535235]). As part of the collaboration, Pfizer will provide palbociclib and talazoparib, as well as financial support.

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"Tumor metabolism is a unique therapeutic approach that exploits the way in which cancer cells utilize nutrients to grow and survive," said Susan Molineaux, PhD, President and Chief Executive Officer of Calithera. "CB-839, a novel glutaminase inhibitor, has the potential to be developed in combination with palbociclib or talazoparib to improve patient outcomes. We look forward to collaborating with Pfizer on the combination clinical trials planned in the first quarter of 2019.

" Preclinical data suggest that CB-839, which is designed to starve tumor cells of the key nutrient glutamine, synergizes with CDK4/6 inhibitors by enhancing cell cycle arrest and blocking cancer cell proliferation. The combination of CB-839 with CDK4/6 inhibitors has demonstrated synergistic activity in a number of preclinical cancer models, including colorectal cancer (CRC), non-small cell lung carcinoma (NSCLC), triple negative breast cancer (TNBC) and ER+ breast cancer. Based on these data, Calithera will initiate a Phase 1/2 clinical trial of the combination of CB-839 plus palbociclib in patients with KRAS mutated CRC and patients with KRAS mutated NSCLC in the first quarter of 2019.

CB-839 also synergizes with PARP inhibitors to impair DNA synthesis, enhance DNA damage, and block cancer cell proliferation. The combination of CB-839 with PARP inhibitors has demonstrated synergistic activity in a number of preclinical cancer models, including renal cell carcinoma (RCC), TNBC, CRC, NSCLC, ovarian cancer and prostate cancer. Based on these data, Calithera will initiate a Phase 1/2 clinical trial of the combination of CB-839 plus talazoparib in patients with RCC, and TNBC in the first quarter of 2019

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.

– END –

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 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported that it will report third quarter 2018 results on Tuesday, October 23, 2018, before the market opens (Press release, Quest Diagnostics, OCT 5, 2018, View Source [SID1234529799]). It will hold its quarterly conference call to discuss the results beginning at 8:30 a.m. Eastern Time on that day.

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The conference call can be accessed by dialing 888-455-0391 within the U.S. and Canada, or 773-756-0467 internationally, using the passcode: "Investor." The earnings release and live webcast will be posted on www.QuestDiagnostics.com/investor. The company suggests participants dial in approximately 10 minutes before the call.

A replay of the call may be accessed online at www.QuestDiagnostics.com/investor or by phone at 866-483-9044 for domestic callers or 203-369-1586 for international callers, no passcode is required. Telephone replays will be available from approximately 10:30 a.m. Eastern Time on October 23, 2018 until midnight Eastern Time on November 6, 2018.

Anyone listening to the call is encouraged to read the company’s periodic reports on file with the Securities and Exchange Commission, including the discussion of risk factors and historical results of operations and financial condition in those reports.

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 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.