Bullish options flow was detected in MRK stock on January 9, 2020.

Keytruda is the amazing anti-cancer drug that just keeps on giving. Now we’re seeing many companies conducting combination trials with Keytruda, of which Merck benefits from.

On January 8, 2020, Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

“Today’s approval of KEYTRUDA reinforces our company’s commitment to expanding existing treatment options for certain patients with high-risk, non-muscle invasive bladder cancer,” said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. “As the first anti-PD-1 therapy approved in this setting, KEYTRUDA will be a new clinical option for a patient population that previously had limited FDA-approved therapies available.”

Immune-mediated adverse reactions, which may be severe or fatal, can occur with KEYTRUDA, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis and renal dysfunction, severe skin reactions, solid organ transplant rejection, and complications of allogeneic hematopoietic stem cell transplantation (HSCT). Based on the severity of the adverse reaction, KEYTRUDA should be withheld or discontinued and corticosteroids administered if appropriate. KEYTRUDA can also cause severe or life-threatening infusion-related reactions. Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. For more information, see “Selected Important Safety Information” below.

“High-risk, non-muscle invasive bladder cancer is a serious disease, characterized by frequent recurrences and progression,” said Arjun V. Balar, M.D., associate professor of Medicine and director of Genitourinary Medical Oncology at NYU Langone Health’s Perlmutter Cancer Center. “Historically, patients with high-risk, non-muscle invasive bladder cancer with CIS whose cancer is unresponsive to BCG treatment had limited non-surgical treatment options. As a physician who specializes in the management of bladder cancer, it is encouraging to now have a new treatment option for these patients.”

On January 9, 2020, Immutep Limited (IMMP) provided an update on its TACTI-002 and AIPAC studies for its lead product candidate, eftilagimod alpha. The requisite number of predefined patient responses was observed in stage 1 of Part C. The decision by the DMC to recommend opening stage 2 recruitment follows its review of preliminary safety and efficacy data and is based on a predefined efficacy threshold. This allows the Company to now proceed with the recruitment of an additional 19 patients, forming stage 2 of Part C of the study, having now also completed recruitment of the 18 HNSCC patients for stage 1.

The staged approach to patient enrolment is based on the study’s Simon’s two-stage clinical trial design. Stage 1 of Part A was expanded in September 2019. Recruitment is ongoing for Part B with 10 out of 23 patients now participating, and for stage 2 of Part A, where 4 out of 19 patients are now participating.

TACTI-002 is being conducted in collaboration with Merck & Co. (MRK). The Company continues to progress its AIPAC trial which evaluates efti in combination with chemotherapy in 227 metastatic breast cancer patients in a randomized, double blinded, placebo-controlled phase IIb clinical trial. The first progression-free survival read-out remains on track for Q1 CY20 and is expected to be reported in March 2020.

Also on January 9, 2020, BriaCell Therapeutics Corp. (“BriaCell” or the “Company”) (TSX-V:BCT) (OTCQB:BCTXD), a clinical-stage biotechnology company specializing in targeted immunotherapy for advanced breast cancer, is pleased to announce it has identified a new group of patients with high levels of clinical benefit in response to its novel immunotherapy with Merck’s Keytruda.

On January 6, 2020, RBC Capital analyst Randall Stanicky initiated coverage of Merck with a Sector Perform rating and $99 price target, stating that while he believes it has a robust growth story based on the strength of Keytruda, he also believes that is “well understood.”

Breast cancer is subdivided into 3 categories based on its appearance under the microscope: Grade 1 (well differentiated), Grade II (moderately differentiated) and Grade III (poorly differentiated). The Bria-IMT™ cell line was derived from a Grade II tumor biopsy. Upon reanalysis of our clinical data, we learned of correlative patterns of tumor response in Grade I/II breast cancer patient populations. In our view, this seems logical because Bria-IMT™ is derived from a Grade II (moderately differentiated) breast cancer tumor. Importantly, approximately 40% of recurrent breast cancers are Grade I/II.

Monotherapy: The clinical benefit rate in our monotherapy studies for Grade I/II patients with immune responses was 5/7 (71%) despite the fact that these patients were very heavily pre-treated with a median of 7 prior regimens (such as chemotherapy).

Combination study of Bria-IMT™ with KEYTRUDA®: All 3 patients with Grade I/II tumors had clinical benefit (100%). All of these patients had been very heavily pre-treated with 14-15 prior regimens.

Further analysis of our patients with Grade I/II tumors shows that patients with greatest tumor reductions within the Grade I/II subset also had double HLA matches with Bria-IMT™ in both monotherapy and combination study groups. Based on our new findings, we believe we are able to identify a sizeable patient population who will derive significant clinical benefit from treatment with Bria-IMT™, adding further biomarker capability incremental to our HLA-matching hypothesis.

“We believe that we have identified an important and sizeable subgroup of patients who will benefit from our novel immunotherapy treatments. We plan to further validate these findings in subsequent patients, strengthening yet another responder biomarker technique,” stated Dr. Williams, BriaCell’s President and CEO.

On January 6, 2020, Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced an exclusive worldwide research collaboration and license agreement with Taiho Pharmaceutical Co, Ltd., (“Taiho”) and Astex Pharmaceuticals (UK), a wholly owned subsidiary of Otsuka Pharmaceutical Co., Ltd. (“Astex”), focused on the development of small molecule inhibitors against several drug targets, including the KRAS oncogene, which are currently being investigated for the treatment of cancer.

“At Merck we continue to pursue new regimens designed to extend the benefits of highly selective therapies to more patients with cancer,” said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. “This agreement with Taiho and Astex combines our respective small molecule assets and industry-leading expertise in cancer cell signaling to enable development of the most promising drug candidates.”

Under the terms of the agreement, Merck, Taiho and Astex will combine preclinical candidates and their data with knowledge and expertise from their respective research programs. In exchange for providing Merck an exclusive global license to their small molecule inhibitor candidates, Taiho and Astex will receive an aggregate upfront payment of $50 million and will be eligible to receive approximately $2.5 billion contingent upon the achievement of preclinical, clinical, regulatory and sales milestones for multiple products arising from the agreement, as well as tiered royalties on sales. Merck will fund research and development and will be responsible for commercialization of products globally. Taiho has retained co-commercialization rights in Japan and an option to promote in specific areas of South East Asia.

“Taiho has used its unique and proprietary drug discovery platform to generate a number of small molecule inhibitors,” said Teruhiro Utsugi, Ph.D., managing director at Taiho. “This alliance builds on our KRAS research up to now and together with Merck, allows us to combine our expertise to significantly accelerate the global research, development, and commercialization of a number of our mutant KRAS programs by accessing external talent and resources.”

“Together with our Taiho colleagues we are delighted to be working with Merck, one of the global leaders in oncology drug development, on this strategic alliance. This collaboration is another testament to Astex’s position as the leader in fragment-based drug discovery,” said Harren Jhoti, Ph.D., president and CEO of Astex.

KRAS is among the most frequently mutated oncogenes in cancer. It is estimated to occur in more than 90% of pancreatic cancers and approximately 20% of non-small cell lung cancers (NSCLC) and is associated with poorer outcomes.

Taiho Pharmaceutical, a subsidiary of Otsuka Holdings Co., Ltd., is an R&D-driven specialty pharma focusing on the three fields of oncology, allergy and immunology, and urology. Its corporate philosophy takes the form of a pledge: “We strive to improve human health and contribute to a society enriched by smiles.” In the field of oncology in particular, Taiho Pharmaceutical is known as a leading company in Japan for developing innovative medicines for the treatment of cancer, a reputation that is rapidly expanding through their extensive global R&D efforts.

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