On December 5, 2022 MEI Pharma, Inc. (Nasdaq: MEIP), a clinical-stage pharmaceutical company focused on advancing new therapies for cancer, reported that it plans to initiate a realignment of its clinical development efforts following the discontinuation of global development outside Japan of its PI3K delta inhibitor, zandelisib (Press release, MEI Pharma, DEC 5, 2022, View Source [SID1234624812]). As part of the realignment, the company plans to streamline its organization towards the development of two earlier clinical-stage assets, voruciclib and ME-344. Following completion of the workforce reductions, MEI expects its existing cash, cash equivalents and marketable securities will be sufficient to fund operations through clinical data milestones for both voruciclib and ME-344. The company further announced that it has engaged Torreya Partners as financial advisor to help explore additional strategic opportunities.

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"In light of the determination we made with our global partner, Kyowa Kirin, to discontinue development of zandelisib outside of Japan after a recent meeting with FDA, we have had to make some tough decisions. We intend to continue development of our earlier-stage clinical assets, streamline MEI’s operations towards these efforts, and consider additional strategic opportunities," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "As we move forward with the planned development of voruciclib and ME-344, two investigational candidates representing potential treatments for various hematological and solid tumor cancers, I want to express my deep gratitude to the MEI team. I am very proud of our work, and the simply exemplary efforts, to develop zandelisib. I also want to recognize the collaborative efforts of our partner, Kyowa Kirin, and sincerely thank all the healthcare providers and patients that contributed to zandelisib’s development."

Expected Drug Candidate Pipeline Developments

Voruciclib – Oral cyclin-dependent kinase 9 (CDK9) inhibitor for the treatment of B-cell malignancies and acute myeloid leukemia, as well as solid tumors.

After initiating dosing of the first patient in November, continue advancing the dosing of patient cohorts evaluating voruciclib in combination with Venclexta (venetoclax) in patients with acute myeloid leukemia in the ongoing Phase 1 study.
Provide a clinical data update in CY2023.
Continue preclinical evaluation of the role CDK9 in cMYC regulation in solid tumors expressing KRAS mutations to support potential clinical development as a treatment for solid tumors.
ME-344 – Tumor selective mitochondrial inhibitor for the treatment of solid tumors.

Initiate a Phase 1b study evaluating ME-344 plus Avastin (bevacizumab) in relapsed colorectal cancer patients in the first half of calendar year 2023.
Strategic Realignment Overview

MEIP plans to streamline its organization towards the continued clinical development of voruciclib and ME-344. As a result, it plans to initiate a staggered workforce reduction, initially representing approximately 30% of the current workforce in connection with the wind down of the zandelisib development program outside of Japan, which costs are shared with Kyowa Kirin, our global development partner. Following completion of the zandelisib wind down and associated workforce reductions, MEI expects that, along with any additional workforce reductions to be determined to fully align resources going forward, its existing cash, cash equivalents and marketable securities will be sufficient to fund operations through clinical data milestones for both voruciclib and ME-344.

About Voruciclib

Voruciclib is an orally administered Cyclin-dependent kinase 9 (CDK9) inhibitor being clinically investigated for hematological malignancies. Potential applications in solid tumors are also being actively explored. CDK9 has important functions in cell cycle regulation, including the modulation of two therapeutic targets in cancer: myeloid leukemia cell differentiation protein ("MCL1") and the MYC proto-oncogene protein ("MYC") which regulates cell proliferation and growth. Voruciclib is currently being evaluated in a Phase 1b trial evaluating dose and schedule in patients with acute myeloid leukemia ("AML") and B-cell malignancies. Applications in solid tumors are also being considered where MYC is dysregulated.

About ME-344

ME-344 is a tumor selective mitochondrial inhibitor drug candidate targeting the OXPHOS pathway involved in the production of adenosine triphosphate, or ATP, in the mitochondria. It is in clinical development to treat solid tumors. Although clinical investigation of ME-344 has demonstrated single agent activity in patients with solid tumors, using it in combination with other cancers therapies is thought to hold more significant potential for patients. Data reported at the 2018 ASCO (Free ASCO Whitepaper) conference from an investigator-initiated, multi-center, randomized study of ME-344 in combination with the VEGF inhibitor bevacizumab (Avastin) in women with demonstrated biologic activity in the ME-344 treatment group supporting further clinical investigation.

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.