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Kyn Therapeutics Announces Initiation of Phase 1b/2 Clinical Studies of ARY-007 in Collaboration with Merck

On December 19, 2018 Kyn Therapeutics, a biotechnology company advancing new immunometabolism therapies for treating cancer, reported the initiation of two clinical trials of ARY-007 (also known as Grapiprant), an EP4 receptor antagonist, in collaboration with Merck (known as MSD outside the United States and Canada) (Press release, KYN Therapeutics, DEC 19, 2018, View Source [SID1234532156]). ARY-007 will be assessed in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) in checkpoint-refractory and -resistant solid tumors, an area of high unmet medical need.

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Prostaglandin E2 (PGE2) has been shown to contribute to an immunosuppressive environment in cancer by enhancing the activity of regulatory immune cells and suppressing the activity of effector immune cells. EP4 is a high-affinity receptor of PGE2 and is known to facilitate these immunosuppressive activities. ARY-007 is an oral, potent and highly selective antagonist of EP4. In preclinical models, EP4 inhibition leads to antitumor activity and also significantly enhances the antitumor activity of checkpoint inhibitors. While in development for a non-oncology indication, ARY-007 was found to be well-tolerated in multiple studies which enrolled approximately 1000 human subjects.

The Phase 1b/2 multicenter, open-label, single arm clinical trials are designed to assess the safety and efficacy of ARY-007 in combination with pembrolizumab in patients with advanced or progressive Microsatellite Stable (MSS) Colorectal Cancer (CRC), and with advanced or metastatic PD-1/L1 refractory Non-Small Cell Lung Cancer (NSCLC) adenocarcinoma. MSS CRC is inherently resistant to anti-PD-1 therapies – these agents have only shown activity in the microsatellite instability-high (MSI-H) subset of CRC. The NSCLC study is enrolling patients who have progressed while on PD-1 or PD-L1 therapy. Both studies incorporate a robust translational biomarker strategy.

"The Kyn team believes immunometabolism pathways hold great promise as therapeutics that could deliver breakthrough improvements for patients non-responsive to immunotherapy regimens. We believe EP4 is the right target and ARY-007 is the right molecule for overcoming the immunosuppressive effects of PGE2 in these cancers where increased pathway expression is associated with poor outcome," said Mark Manfredi, Ph.D., president and chief executive officer of Kyn Therapeutics. "We welcome the opportunity to collaborate with Merck as we initiate clinical studies."

About ARY-007
ARY-007 is an orally available, potent and highly selective antagonist of the EP4 receptor, a component of the prostaglandin E2 (PGE2) pathway which significantly influences the composition of the tumor microenvironment. In preclinical studies, inhibition of EP4 has been shown to boost the immune response through modulation of multiple immune cell types, and in combination with checkpoint inhibitors has yielded significant reduction in tumor growth relative to either agent alone.

MiNA Therapeutics Announces Enrolment of Patients in Expansion of Phase Ib Trial Evaluating MTL-CEBPA in Combination with Sorafenib

On December 19, 2018 MiNA Therapeutics, the pioneer in RNA activation therapeutics, reported that enrolment of the first patients treated with MTL-CEBPA in combination with Sorafenib in OUTREACH, the multi-centre Phase 1b clinical trial in patients with advanced liver cancer (Press release, MiNA Therapeutics, DEC 19, 2018, View Source [SID1234532155]). The study is designed to assess the safety, tolerability and clinical activity of MTL-CEBPA in combination with Sorafenib. OUTREACH is currently being conducted at multiple clinical trials sites in the United Kingdom, Singapore and Taiwan.

Evaluation of MTL-CEBPA in combination with Sorafenib follows the evaluation of MTL-CEBPA as a single agent in 38 patients with advanced liver cancer. Preliminary clinical results of MTL-CEBPA as a single agent presented in June 2018 at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting showed encouraging safety, pharmacology and clinical activity. Furthermore in September 2018 at the International Liver Cancer Association (ILCA) Conference, investigators reported complete tumour responses in patients off-study when subsequently administered Sorafenib. Sorafenib is the standard of care for first line treatment of advanced liver cancer.

Robert Habib, CEO of MiNA Therapeutics, commented, "We are encouraged by our initial clinical evaluation of MTL-CEBPA as a single agent and are excited about its potential in combination with approved therapies that on their own have demonstrated only modest benefit to patients. We look forward to continue to collaborate with our clinical investigators and evaluating the combination of MTL-CEBPA and Sorafenib into the expansion of the OUTREACH trial."

MTL-CEBPA consists of a double stranded RNA formulated in a liposomal nanoparticle and is designed to activate the CEBPA gene. The CEBPA gene encodes CCAAT/enhancer binding protein alpha (C/EBP-α), a transcription factor that acts as a master regulator of cell lineage determination and differentiation in several tissues including myeloid cells, liver cells and adipose tissue. In cancer, C/EBP-α plays important roles in regulating both tumour growth and the tumour immune microenvironment.

NICE Expands Recommendation for the Oncotype DX Breast Recurrence Score® Test to More Patients with Early-Stage Breast Cancer Within the United Kingdom

On December 19, 2018 Genomic Health, Inc. (NASDAQ: GHDX) reported that the National Institute for Health and Care Excellence (NICE) in the United Kingdom has issued its updated guidance again recommending the Oncotype DX Breast Recurrence Score test for use in clinical practice to guide adjuvant chemotherapy treatment decisions for certain patients with early-stage breast cancer (Press release, Genomic Health, DEC 19, 2018, View Source [SID1234532154]). Further, NICE expanded its recommendation to include patients with micrometastases, indicating that some cancer cells have spread to the lymph nodes.

"Oncotype DX is the only test that provides specific information about an individual patient’s response to chemotherapy, correctly identifying the important minority of patients who will receive substantial treatment benefit and the majority of patients who will not benefit from chemotherapy," said Simon D H Holt, Honorary Consultant Surgical Oncologist, Peony Breast Care Unit at Prince Philip Hospital in Llanelli, UK. "This test allows us to target treatment much more effectively and should be routinely used for all eligible patients."

The recommendation of the Oncotype DX Breast Recurrence Score test in NICE’s updated guidance is based on the test’s unique ability to predict who will benefit from chemotherapy and who will not. Importantly, NICE acknowledges Oncotype DX as the only test that reduces the overall number of patients who receive chemotherapy, as well as the only test supported by long-term patient outcomes evidence, including the recently published landmark TAILORx study. Further, NICE also found the Oncotype DX test to be the most cost-effective tool in guiding chemotherapy treatment.

"We believe this positive endorsement from NICE reflects the growing global recognition of the unique value Oncotype DX provides," said Torsten Hoof, senior vice president, international, Genomic Health. "As we continue to experience an increasing impact of the TAILORx study results on clinical practice, we believe we are one step closer to broadening Oncotype DX access through increased reimbursement in Western Europe and around the world."

The predictive value of the Oncotype DX Breast Recurrence Score test was also recently acknowledged by Germany’s health technology assessment body, the Institute for Quality and Efficiency in Health Care (IQWiG), which concluded that only the Oncotype DX test has sufficient evidence to guide breast cancer adjuvant chemotherapy decisions based on the TAILORx study results.

Additionally, the U.S. National Comprehensive Cancer Network (NCCN) categorized Oncotype DX as the only "preferred" test for chemotherapy treatment decision-making for node-negative, early-stage breast cancer patients in its 2018 updated treatment guidelines.

About Oncotype DX

The Oncotype DX portfolio of breast, colon and prostate cancer tests applies advanced genomic science to reveal the unique biology of a tumor in order to optimize cancer treatment decisions. The company’s flagship product, the Oncotype DX Breast Recurrence Score test, is the only test that has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer. Additionally, the Oncotype DX Breast DCIS Score test predicts the likelihood of recurrence in a pre-invasive form of breast cancer called DCIS. In prostate cancer, the Oncotype DX Genomic Prostate Score test predicts disease aggressiveness and further clarifies the current and future risk of the cancer prior to treatment intervention. With more than 950,000 patients tested in more than 90 countries, the Oncotype DX tests have redefined personalized medicine by making genomics a critical part of cancer diagnosis and treatment. To learn more about Oncotype DX tests, visit www.OncotypeIQ.com, www.MyBreastCancerTreatment.org or www.MyProstateCancerTreatment.org.

Aurinia to Present at the 37th Annual J.P. Morgan Healthcare Conference in San Francisco

On December 19, 2018 Aurinia Pharmaceuticals Inc., (NASDAQ:AUPH)(TSX:AUP) reported its Chairman and Chief Executive Officer, Richard M. Glickman, will present a company overview at the 37th Annual J.P. Morgan Healthcare Conference in San Francisco, CA on Thursday, January 10, 2019 at 10:00am PST, 1pm EST (Press release, Aurinia Pharmaceuticals, DEC 19, 2018, View Source [SID1234532153]).

The presentation will be webcast live and can be accessed via the investor section of the Aurinia website, www.auriniapharma.com. A replay of will also be archived on the site following the event.

Seattle Genetics to Present at the J.P. Morgan Healthcare Conference

On December 19, 2018 Seattle Genetics, Inc. (NASDAQ:SGEN) reported that management will present at the 37th Annual J.P. Morgan Healthcare Conference on Monday, January 7, 2019 at 2:30 p.m. Pacific Time (Press release, Seattle Genetics, DEC 19, 2018, View Source [SID1234532152]). Both the presentation and question and answer session that follows at 3:00 p.m. will be webcast live and available for replay from Seattle Genetics’ website at www.seattlegenetics.com in the Investors section.