Merck updates on Phase 2 trial for aggressive tumor med at ASCO

• Alterations of the MET signaling pathway are present in 3-5% of non-small cell lung cancer patients and correlate with poor prognosis
• New interim data from Phase II VISION study (all lines of treatment) show tepotinib induced objective responses, as assessed by independent review, in 50.0% of patients identified by liquid biopsy (LBx) and 45.1% for patients identified by tissue biopsy (TBx) 
• Median duration of response was 12.4 months for LBx-identified patients and 15.7 months for TBx-identified patients
• Safety results for tepotinib are consistent with those reported in previous studies; most treatment-related adverse events (TRAEs) were Grade 1 and 2, and no Grade 4 or 5 TRAEs were observed

Merck KGaA, Darmstadt, Germany, a leading science and technology company, which operates its biopharmaceutical business as EMD Serono in the US and Canada, today presented updated results from the potentially registrational Phase II VISION study, showing durable anti-tumor clinical activity for the investigational targeted therapy tepotinib* across different lines of treatment in advanced non-small cell lung cancer (NSCLC) patients harboring MET exon 14 skipping mutations detected by liquid biopsy (LBx) or tissue biopsy (TBx). Data were shared in an oral presentation today at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL, US.

“Tepotinib has been designed to potentially improve outcomes in aggressive tumors that have a poor prognosis and harbor these specific alterations,” said Luciano Rossetti, Global Head of Research & Development for the Biopharma business of Merck KGaA, Darmstadt, Germany. “Tepotinib is an important part of our strategic focus on precision medicine, and both the proportion of patients responding and the duration of anti-tumor clinical activity demonstrate the potential of this investigational therapy.”

Discovered in-house at Merck KGaA, Darmstadt, Germany, tepotinib is an investigational, highly potent and selective¹ oral MET kinase inhibitor that is designed to inhibit the oncogenic signaling caused by MET (gene) alterations, including both MET exon 14 skipping mutations and MET amplifications, or MET protein overexpression. Alterations of the MET signaling pathway are found in various cancer types, including 3-5% of NSCLC cases, and correlate with aggressive tumor behavior and poor clinical prognosis.^2-4

“Patients with this NSCLC molecular subtype lack treatment options that have the potential to significantly improve clinical outcomes,” said Paul K. Paik, M.D., primary study investigator and Clinical Director, Thoracic Oncology Service, Memorial Sloan Kettering Cancer Center. “It is noteworthy to see data that are consistent with tepotinib’s previously reported efficacy findings in this patient population, and that also provide valuable new insight into its durable clinical activity across various treatment lines.”

https://finance.yahoo.com/news/merck-kgaa-darmstadt-germany-presents-142500856.html

Misonix Gets FDA OK for Ultrasonic Surgical Platform

 Misonix, Inc. (Nasdaq: MSON) (“Misonix” or the “Company”), a provider of minimally invasive therapeutic ultrasonic medical devices that enhance clinical outcomes, today announced that it received 510(k) clearance by the U.S. Food and Drug Administration (FDA) for Nexus, its revolutionary ultrasonic surgical platform. Misonix will commence the commercialization of the Nexus platform in the United States in July.

Nexus is a next-generation integrated ultrasonic surgical platform that combines all the features of Misonix’s existing solutions, including BoneScalpel, SonicOne and Sonastar, into a single fully integrated platform that will also serve to power future solutions. The Nexus platform is driven by a new proprietary digital algorithm that results in more power, efficiency and control. Nexus uniquely incorporates RF capabilities, allowing for use in general surgery procedures. The device also incorporates Smart Technology that allows for easier setup and use.

Physicians will be able to utilize Nexus’ increased power to improve tissue resection rates, in concert with its proprietary digital algorithm to perform more efficient bone removal procedures. In addition, Nexus’ ease of use will enable physicians to fully leverage Nexus’ impressive capabilities via its digital touchscreen display and smart system setup.

https://www.globenewswire.com/news-release/2019/06/03/1863086/0/en/Misonix-Receives-U-S-FDA-Clearance-for-Nexus-its-Revolutionary-Integrated-Ultrasonic-Surgical-Platform.html

Avenue up on positive late-stage study of IV tramadol

Thinly traded nano cap Avenue Therapeutics (NASDAQ:ATXI) is up 16% premarket on light volume in reaction to a successful second Phase 3 clinical trial evaluating IV tramadol for the treatment of postoperative pain following abdominoplasty (tummy tuck) surgery.

The trial met the primary and all key secondary endpoints, demonstrating comparable efficacy to IV morphine.

The company plans to file its U.S. marketing application in Q4.

https://seekingalpha.com/news/3468555-avenue-16-percent-premarket-positive-late-stage-study-iv-tramadol

Mirati up on Amgen’s KRAS inhibitor data

Mirati Therapeutics (MRTX +32.4%) is up on over 40% higher volume in apparent response to Phase 1 data on Amgen’s KRAS^G12C inhibitor AMG 510 presented at ASCO in Chicago.

Preliminary results showed only partial responses in five of 10 evaluable patients.

Investors appear to perceive the somewhat underwhelming data as a positive for Mirati’s KRAS^G12C inhibitor MRTX849, currently in IND-enabling studies.

#ASCO19

https://seekingalpha.com/news/3468579-mirati-32-percent-amgens-kras-inhibitor-data

Genocea: Positive data from early-stage trial of cancer vaccine

Shares of Genocea Biosciences Inc. GNCA, +59.00% surged 101% in premarket trade Monday after the biotech announced promising data from an early-stage clinical trial of its lead drug candidate, a personalized cancer vaccine. Genocea’s vaccine, called GEN-009, uses neoantigens — antigens corresponding to tumor mutations that a patient’s immune system sees as foreign to the body — to prime the immune system to find and kill tumors. The company is currently running a Phase 1/2 clinical trial to evaluate the vaccine’s safety and efficacy. So far, immune-response data is available for five patients, and the therapy induced T-cell responses to 91% of the vaccine neoantigens given to the patients, according to the company. Also, 47% of the neoantigens were able to elicit ex vivo CD8+ T-cell responses, the company said. Shares of Genocea have gained 144% in the year to date through Friday. The S&P 500 SPX, -0.19% has gained 9.8%.

https://www.marketwatch.com/story/genocea-biosciences-shares-rocket-101-after-biotech-announces-positive-data-from-early-stage-trial-of-cancer-vaccine-2019-06-03

Blueprint Med Shows Anti-Tumor Activity in Updated Trial Data Presented at ASCO

— 60% ORR in post-platinum RET-fusion NSCLC and 63% ORR in RET-mutant MTC patients previously treated with multi-kinase inhibitors; median durations of response not reached —

— Responses observed across treatment-naïve and previously treated patients, and regardless of RET alteration or tumor type —

— Strong activity against brain metastases in NSCLC patients —

— Plan to submit initial NDA to FDA for BLU-667 in RET-fusion NSCLC in first quarter of 2020 —

— Blueprint Medicines to host investor event and webcast on Monday, June 3, 2019 at 6:30 p.m. CT —

Blueprint Medicines Corporation (NASDAQ: BPMC), a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, today announced updated data from the ongoing registration-enabling ARROW trial of BLU-667 in patients with RET-altered cancers. The data presented at the American Society of Clinical Oncology (ASCO) 2019 Annual Meeting show durable clinical activity in patients with RET-altered non-small cell lung cancer (NSCLC), medullary thyroid cancer (MTC) and other cancers. Designed by Blueprint Medicines, BLU-667 is a potent and highly selective oral inhibitor of RET fusions and mutations, including predicted resistance mutations.

Blueprint Medicines will host an investor event on Monday, June 3, 2019 beginning at 6:00 p.m. CT (7:00 p.m. ET) in Chicago to provide a portfolio update, including a review of updated clinical data from the ongoing ARROW trial of BLU-667 in patients with RET-altered cancers and the ongoing registration-enabling NAVIGATOR trial in patients with PDGFRA Exon 18 mutant and fourth-line gastrointestinal stromal tumors (GIST). Formal presentations and the live webcast will begin at 6:30 p.m. CT (7:30 p.m. ET). The event will be webcast live and can be accessed under the “Investors & Media—Events & Presentations” section of Blueprint Medicines’ website at www.BlueprintMedicines.com. A replay of the webcast will be available approximately two hours after the event and will be available for 30 days following the event.

https://www.prnewswire.com/news-releases/blueprint-medicines-highly-selective-ret-inhibitor-blu-667-shows-durable-anti-tumor-activity-in-patients-with-ret-altered-cancers-in-updated-arrow-trial-data-presented-at-asco-2019-300860552.html

Constellation myelofibrosis Phase 2 show positive signs at interim: ASCO

CPI-0610 showed signals of clinical activity, both as a monotherapy and in combination with ruxolitinib, in refractory myelofibrosis (MF) patients — Patients treated with CPI-0610 exhibited improvement in spleen volume, constitutional symptoms, anemia, bone marrow fibrosis, and transfusion dependence — CPI-0610 was generally well-tolerated as a monotherapy and in combination with ruxolitinib — Company to host analyst/investor event and webcast June 4, 2019 at 7:00 AM CDT

Constellation Pharmaceuticals, Inc. (Nasdaq: CNST), a clinical-stage biopharmaceutical company using its expertise in epigenetics to discover and develop novel therapeutics, today announced the presentation of updated interim data from MANIFEST, the Company’s Phase 2 clinical trial of CPI-0610 in MF. The interim data, which highlight the tolerability and potentially disease-modifying activity of CPI-0610, were presented in a poster at the annual meeting of the American Society for Clinical Oncology (ASCO) in Chicago.

Constellation will host an analyst/investor meeting, with an accompanying conference call and webcast, to discuss this interim update in the Jackson Park D room at Hyatt Regency McCormick Place in Chicago at 8:00 AM EDT/7:00 AM CDT on June 4, 2019. The agenda of the meeting will include:

— An overview of myelofibrosis (MF) and the potential impact of Constellation’s BET inhibitor CPI-0610 in treating MF — A review of the interim data from the MANIFEST clinical trial presented in a poster at ASCO on June 3 — A panel discussion with two key opinion leaders in MF: o Dr. Srdan Verstovsek, a medical oncologist at the University of Texas MD Anderson Cancer Center and an investigator in the MANIFEST trial; and o Dr. Raajit Rampal, a hematologic oncologist at Memorial Sloan Kettering Cancer Center

The event will be webcast live and can be accessed on the Investor Relations section of Constellation’s website at http://ir.constellationpharma.com/events–and–presentations/events. Participants may also access the event and participate in the live question-and-answer session by dialing (877) 473-2077 (domestic) or (661) 378-9662 (international) and referring to conference ID 1295319.

https://www.apnews.com/Globe%20Newswire/f49c850ef28b5b0b306e9ef87e53c17d