On December 5, 2022 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a synthetic lethality focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to IDEAYA’s development program investigating darovasertib, a potential first-in-class protein kinase C (PKC) inhibitor, for use in combination with crizotinib, an investigational cMET inhibitor, for the treatment of adult patients with metastatic uveal melanoma (Press release, , DEC 5, 2022, View Source [SID1234624811]).

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"We are extremely pleased to receive the U.S. FDA Fast Track designation as we prepare to initiate a potential Phase 2/3 registrational trial to evaluate the darovasertib and crizotinib combination in patients with MUM. The Fast Track designation acknowledges MUM as a serious condition and the potential for the darovasertib / crizotinib combination to treat this unmet medical need," said Dr. Darrin Beaupre, Senior Vice President and Chief Medical Officer at IDEAYA Biosciences.

Fast Track is a U.S. FDA process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Under the Fast Track designation, the darovasertib / crizotinib development program in MUM is eligible for various expedited regulatory review processes, including generally more frequent FDA interactions (e.g., meetings, written communications), potential eligibility for rolling review of a New Drug Application (NDA) and potential accelerated approval and priority review of an NDA.

Darovasertib was previously also designated as an Orphan Drug by the U.S. FDA in Uveal Melanoma (UM), including in MUM, entitling IDEAYA to certain potential tax credits, exemptions from user fees, and statutory marketing exclusivity.

IDEAYA is targeting initiation of a potential registration-enabling trial for the darovasertib and crizotinib combination in MUM in Q1 2023, subject to FDA feedback and guidance.

IDEAYA is also planning to initiate a company-sponsored Phase 1 clinical trial in Q4 2022 to evaluate darovasertib monotherapy in neoadjuvant UM patients. The preliminary development approach contemplates clinical endpoints such as organ preservation and/or vision preservation proximal to primary interventional treatments. Additional information on the company’s plans to evaluate darovasertib, including scientific insights and clinical development opportunities in the neoadjuvant setting, will be highlighted in an Investor R&D Day webcast being hosted by IDEAYA on December 12, 2022, at 8:00 am – 9:30 am ET. Registration is available at View Source or View Source

On December 5, 2022 BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (OTCQB: BVAXF) ("BioVaxys" or "Company") reported that Co-Founder, President & Chief Operating Officer Kenneth Kovan will be presenting at the MedInvest Oncology Investor Conference held in New York City on December 14-15, 2022 (Press release, BioVaxys Technology, DEC 5, 2022, View Source [SID1234624810]).

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In partnership with the National Foundation for Cancer Research, the MedInvest Oncology Investor Conference is the preeminent indication-specific investor conference. The attendees are active investors in the oncology space and oncology-focused companies seeking investment and partnering opportunities, and include leading life science and oncology venture capitalists, family offices, pharma executives, private and public cancer companies and foundations. The National Cancer Institute is this year’s Conference Presenting Partner, with speakers such as Greg Simon, who recently was the President of the Biden Cancer "Moonshot" Initiative, leading immunologists and oncologists from Memorial Sloan Kettering and other institutions, and global pharma R&D.

Details of the presentation are as follows:

When: Wednesday, December 14, 2022 @ 4:10PM ESTWhere: Dorsey & Whitney LLP, 51 West 52nd Street, New York, NY
"BioVaxys is honored to be selected to speak at the MedInvest Oncology Investor Conference alongside a prestigious group of oncologists, investors, and life science companies. We look forward to sharing how we are leveraging our haptenized protein platform to create autologous cancer immunotherapies for ovarian cancer and other malignancies," said Mr. James Passin, CEO and Co-Founder of BioVaxys.

Mr. Kovan has over 30 years of experience in biopharma. Prior to founding BioVaxys Technology Corp., he served as Corporate Development Partner with gene editing leader Horizon Discovery plc in the United Kingdom, and is Managing Principal & Owner of Bingham Hill Ventures, a life sciences advisory practice he founded in 2012. He is an experienced former biotech CEO, and founder of biotechnology companies including Avax Technologies, Inc. Mr. Kovan’s professional background includes technology transfer with Thomas Jefferson University, Strategic Marketing with SmithKline Beecham, and Global New Product Development with Wyeth-Ayerst. Mr. Kovan has a broad international business background, having launched pharma brands in Latin American and Asia/Pacific markets and led pharma development projects in Europe.

On December 5, 2022 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported that it will host a webcast on Monday, December 12, 2022, at 10:00 a.m. ET to discuss new data from the TakeAim Leukemia trial of emavusertib, including data presented at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (Press release, , DEC 5, 2022, View Source [SID1234624809]).

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This presentation will include data for 28 additional evaluable AML/MDS patients:

11 patients treated with monotherapy in targeted populations (now 24 patients total)
13 patients treated with monotherapy in non-target populations (now 34 patients total)
4 patients treated with the combination of emavusertib and venetoclax (4 patients total)
Patients in a targeted population are those with FLT3, U2AF1, or SF3B1 mutations.

The call led by James Dentzer, President and CEO, will include a presentation by Robert Martell, M.D., Head of Curis R&D and commentary by Eric Winer, M.D., Clinical Investigator at the Dana-Farber Cancer Institute. The speakers and additional members of Curis leadership will be available to answer questions at the end of the event.

To access the live call, please dial (888) 346-6389 from the United States or (412) 317-5252 from other locations, shortly before 10:00 a.m. ET.

A live webcast will be available under "Events & Presentations" in the Investors section of the Company’s website at www.curis.com. A replay of the webcast will be available on the Curis website shortly after completion of the call.

On December 5, 2022 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage oncology company reported preliminary results from the KRYSTAL-7 Phase 2 trial and KRYSTAL-1 Phase 1b cohort evaluating adagrasib (400mg twice daily) concurrently combined with pembrolizumab in patients for the treatment of first-line NSCLC harboring a KRASG12C mutation across all PD-L1 subgroups (Press release, Mirati, DEC 5, 2022, View Source [SID1234624807]). These data are the first to demonstrate the tolerability and feasibility of a concurrent combination regimen of a KRASG12C inhibitor and a PD-1/L1 checkpoint inhibitor.

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Summary of Clinical Results

The KRYSTAL-7 and KRYSTAL-1 trials represent the largest dataset evaluating a KRASG12C inhibitor in combination with a PD-1/L1 checkpoint inhibitor as a first-line treatment for patients with NSCLC harboring a KRASG12C mutation.
75 patients were enrolled and evaluable for safety with a median follow-up of 3.5 months (duration of treatment: 2 months). Treatment-related adverse events (TRAEs) were Grade 1-2 (39%), Grade 3 (40%) and Grade 4 (4%); there were no Grade 5 TRAEs observed. TRAEs led to discontinuation of both adagrasib and pembrolizumab in 2 patients and only pembrolizumab in 2 patients; there were no patients who discontinued only adagrasib due to a TRAE.
Increases in alanine transaminase (ALT)/ aspartate transaminase (AST) were consistent with either agent as a monotherapy with Grade 3 TRAEs being highest grade and total incidence of Grade 3 liver function test (LFT) increases of 9%. Median time from onset to an increase in ALT and AST was 26 and 37 days, respectively and only 1 patient experienced new onset treatment-related ALT/AST increase after 3 months.
Of patients who were clinically evaluable and received at least one on-study scan (n=53), adagrasib and pembrolizumab demonstrated promising preliminary clinical activity across all PD-L1 subgroups with an objective response rate (ORR) of 49%.
In a subset of response-evaluable patients enrolled at least 6 months prior to the data cutoff date, 6 of 26 clinical responses occurred at second on-study scan or later, and the ORR was 56%.
7 evaluable patients enrolled in the KRYSTAL-1 Phase 1b cohort (with a median follow-up of 19.3 months) reported an ORR of 57% and a disease control rate (DCR) of 100%. The four patients who responded maintained response for over nine months while two continued to receive treatment and remain in response beyond 18 months.
Safety in the KRYSTAL-1 Phase 1b cohort was consistent with what has been observed in KRSTYAL-7 and demonstrated a manageable safety profile with no Grade 4-5 TRAEs.
"Initial results across all cohorts suggest the concurrent combination of adagrasib and pembrolizumab may provide a chemotherapy-free option for treatment-naïve NSCLC with a manageable safety profile and encouraging clinical activity," said Pasi A. Jänne, MD, PhD, Dana Farber Cancer Institute. "Across all evaluated cohorts, liver-related TRAEs were predominantly low grade and occurred early in treatment, with limited new onset after 3 months."

"We look forward to progressing our clinical development in the first line setting with a goal of providing better options for patients with NSCLC harboring a KRASG12C mutation," said Chuck Baum, president, founder, and head of research and development, Mirati Therapeutics, Inc. "This data further underscores the potential of adagrasib as a well-tolerated treatment option for patients. Based on these data, we look forward to initiating a Phase 3 trial."

The data (Presentation #LBA4) will be presented in an oral presentation on Dec. 7 at 2:05 p.m.-2:15 p.m. CET / 8:05 a.m.-8:15 a.m. ET during the Proffered Paper session 1 at the European Society for Medical Oncology Immuno-Oncology (ESMO IO) Congress 2022.

Virtual Investor Event
Mirati Therapeutics will host an Investor Event on Wednesday, December 7, 2022, at 5:00 p.m. CET / 11:00 a.m. ET.

Company executives will provide an overview of the adagrasib and pembrolizumab combination data presented 2022 ESMO (Free ESMO Whitepaper) Immuno-Oncology Annual Congress.

Investors and the general public are invited to register and listen to a live webcast of the event through the "Investors and Media" section on Mirati.com. A replay of the event will be available shortly after the conclusion of the event.

About Adagrasib (MRTX849)
Adagrasib is an investigational, highly selective, and potent oral small-molecule inhibitor of KRASG12C that is optimized to sustain target inhibition, an attribute that could be important to treat KRASG12C-mutated cancers, as the KRASG12C protein regenerates every 24-48 hours. Studies of adagrasib have shown that the drug has a long half-life and extensive tissue distribution, and is well tolerated. In clinical trials, adagrasib also has shown, central nervous system penetrance and single-agent responses in non-small cell lung cancer (NSCLC), colorectal cancer, pancreatic cancer and other solid tumors with KRASG12C mutations. Adagrasib is being evaluated in several clinical trials in combination with other anti-cancer therapies in patients with advanced solid tumors. Registration-enabling studies are ongoing in NSCLC and colorectal cancer. For more information visit Mirati.com/science.

On December 5, 2022 Yumanity Therapeutics, Inc. ("Yumanity" or the "Company") (Nasdaq: YMTX) reported that its Board of Directors has declared a special dividend in connection with the previously announced asset sale to Janssen Pharmaceutica NV ("Janssen") and merger with Kineta, Inc. ("Kineta") (Press release, Yumanity Therapeutics, DEC 5, 2022, View Source [SID1234624806]).

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The special dividend, which the Company estimates will be in range of $1.34 to $1.43 per share of Yumanity common stock, will be payable in cash on or before December 29, 2022 to stockholders of record at the close of business on December 15, 2022. The special dividend will be equal to the gross proceeds of the asset sale to Janssen, net of amounts used or retained for Yumanity’s outstanding obligations and minimum cash requirement associated with the closing of the merger with Kineta. Yumanity’s minimum cash requirement has been reduced from $10 million to $7.5 million as part of a recent amendment to the merger agreement. The exact amount of the special dividend will be calculated after Yumanity’s outstanding obligations and net cash position as of the actual closing date of the merger are determined.

Payment of the special dividend is conditioned upon the closing of both the asset sale to Janssen and merger with Kineta, which remain subject to the approval of Yumanity’s stockholders and other closing conditions. The special meeting of Yumanity’s stockholders to consider and vote upon the asset sale and merger is scheduled for December 13, 2022.

Every stockholder’s vote is important, regardless of the number of shares held. Accordingly, Yumanity requests that each stockholder of record as of November 4, 2022, complete, sign, date and return a proxy card (online or by mail) as soon as possible to ensure that the stockholder’s shares will be represented at the special meeting. Stockholders who hold shares in "street name" (i.e., those stockholders whose shares are held of record by a broker, bank or other nominee) should contact their broker, bank or nominee to ensure that their shares are voted.

If any Yumanity stockholder does not receive the Proxy Statement, such stockholder should (i) confirm his or her Proxy Statement’s status with his or her broker or (ii) contact Bob Marese of MacKenzie Partners at [email protected] or John Bryan of MacKenzie Partners at [email protected]. Banks and brokers can place a collect call to Bob Marese at 212-929-5405 or John Bryan at 212-929-5735.