Flame Biosciences LLC

The FDA on Friday approved Astellas’ treatment for a type of gastric cancer, marketed as Vyloy (zolbetuximab). The approval came three weeks ahead of its scheduled PDUFA date of Nov. 9. Vyloy targets a protein called Claudin18.2 that is expressed on the surface of some gastric cancer cells. The drug is now approved in combination with chemotherapy for the first-line treatment of locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma. According to the company, Claudin18.2 is expressed by 38% of patients with advanced gastric cancer. The treatment previously won approval in Japan in March based on data from two Phase 3 clinical trials, with Astellas saying at the time ​​that it’s the first of its class to receive approval worldwide. The drug was also authorized in Europe in September and approved by the UK in August. Data from the Phase 3 SPOTLIGHT and GLOW trials showed statistically significant improvements in progression-free survival and overall survival compared to standard of care chemotherapy. But Vyloy had faced hurdles in the US, including a CRL in January a week before its original decision date, after the FDA found “unresolved deficiencies” at a third-party manufacturer. The FDA gave the drug priority review back in July 2023. Astellas did not immediately respond to a request for comment on the approval, pricing and launch details. Other companies are also in the Claudin18.2 space, though further behind: Leap Therapeutics bought out Flame Biosciences last year with a focus on an antibody called FL-301 and a preclinical anti-Claudin18.2/CD137 bispecific. Also in 2023 , AstraZeneca licensed the antibody-drug conjugate CMG901, which is in a Phase 1 trial in China for Claudin18.2-positive solid tumors, including gastric cancer.

GAITHERSBURG, MD / ACCESSWIRE / December 6, 2023 / Remedy Plan Therapeutics ("Remedy Plan"), a small molecule therapeutics start-up company transforming the field of NAMPT inhibition, is pleased to announce the expansion of its leadership team with the appointment of Cassandra Choe-Juliak, M.D., M.S., as the acting Chief Medical Officer (CMO). Dr. Choe-Juliak has more than 17 years of experience in biopharma, most recently as the Chief Medical Officer at Flame Biosciences and at Tiga Therapeutics. She has previously held leadership positions in clinical development at Affimed and Karyopharm Therapeutics. At Karyopharm Therapeutics, she helped lead the clinical development strategy for Selinexor, a first-in-class XPO1 inhibitor in multiple myeloma. "This appointment comes at a pivotal time for Remedy Plan, as we finalize our IND-enabling studies for our hyperbolic NAMPT inhibitor, RPT1G," said Greg Crimmins, Ph.D., CEO and Founder of Remedy Plan Therapeutics. "We are thrilled to welcome Dr. Choe-Juliak to the team. Her extensive background in oncology clinical development and proven track record in advancing therapeutics to the clinic will be important as we begin our clinical program." "Remedy Plan's unique approach is the first that enables the partial inhibition of NAMPT. This allows for cancer cell growth inhibition without the on-target toxicities that have been seen with other NAMPT inhibitors," said Dr. Choe-Juliak. "I am inspired by the pioneering research and excited to help bring RPT1G to patients." Alongside the expansion of its leadership team, Remedy Plan also announced the expansion of its board of directors with the addition of Christian Waage, JD as an Independent Director. Mr. Waage is a biotech executive with more than two decades of experience in the industry. He is currently EVP, Technical Operations and Administration at Gossamer Bio Inc. and has previously held executive positions at Ardea Biosciences, Inc., Receptos Inc. and Celgene Corporation. About Remedy Plan Therapeutics Remedy Plan is a small molecule therapeutics start-up company transforming the field of NAMPT inhibition, with a pioneering approach that allows for allosteric inhibition of NAMPT that is fractional and highly tunable. NAMPT is an enzyme that controls how cells use energy and is core to human biology. NAMPT dysregulation is responsible for more than 20 diseases. Efforts to reduce NAMPT activity to date have resulted in unmanageable toxicities to healthy cells due to the dual role of NAMPT in healthy cell functioning and disease. Remedy Plan's groundbreaking mechanism of action, which provides NAMPT inhibition without severe on-target toxicity, unlocks opportunities to treat a range of diseases caused by NAMPT dysregulation. Remedy Plan is advancing a robust pipeline of tunable NAMPT inhibitors to address NAMPT dysregulation in solid tumors, hematologic malignancies, obesity, and autoimmune disorders. About RPT1G, a novel oncology therapeutic Remedy Plan's lead asset is RPT1G, a clinical drug candidate for the treatment of hematological malignancies. RPT1G has a unique, first-in-class mechanism of action that is optimized to preserve the cellular metabolism in healthy cells, while inhibiting activity in malignant cells. With a favorable efficacy and tolerability pro animals, RPT1G will be advancing to the clinic in 2024. For more information, please visit and follow Remedy Plan on social media: Contact: Parisa Moghaddam-Taaheri, Ph.D. parisa@remedyplan.com, (240) 408-4854 SOURCE: Remedy Plan Therapeutics View source version on accesswire.com:

CAMBRIDGE, Mass., Nov. 13, 2023 /PRNewswire/ -- Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, today reported financial results for the third quarter ended September 30, 2023. "Leap continued to make great strides this quarter including advancing into the 130 patient, randomized controlled Part B of the DeFianCe study evaluating DKN-01 plus bevacizumab and chemotherapy in second-line colorectal cancer, after exceeding our 20% overall response rate threshold in Part A. We are excited by the progress made and plan on presenting new data from Part A at a medical conference in January 2024," said Douglas E. Onsi, President and Chief Executive Officer of Leap. "In addition, we're focused on executing the DisTinGuish study evaluating DKN-01 plus tislelizumab and chemotherapy in first-line gastric cancer, and we expect to complete enrollment into the 160-patient, randomized controlled Part C of the trial this quarter." DKN-01 Development Update Updated data from Part A of the DeFianCe Study of DKN-01 plus bevacizumab and chemotherapy in colorectal cancer patients to be presented at a medical conference in January 2024 . The Company expects to present new long-term follow-up data from Part A of the DeFiance study (NCT05480306), a Phase 2, randomized, open-label, multicenter study of DKN-01 in combination with standard of care bevacizumab and chemotherapy in patients with advanced colorectal cancer who have received one prior systemic therapy for advanced disease. Initial results from Part A indicated an overall response rate (ORR) above 20% with a high disease control rate, which exceeded the benchmarks expected for this population. Subsequently, the study expanded into a 130-patient Part B randomized controlled trial. Part C of the DisTinGuish Study of DKN-01 plus tislelizumab and chemotherapy in gastric cancer patients is ongoing and enrollment is expected to be completed by the end of 2023. The DisTinGuish study (NCT0436380) is a Phase 2, randomized, open-label, multicenter study of DKN-01 in combination with tislelizumab and chemotherapy in first-line patients with advanced gastroesophageal adenocarcinoma. The Company previously presented long-term follow-up data from Part A of the study in June 2023, showing 73% ORR in the modified intent-to-treat population, and 85% ORR in the PD-L1 low-subgroup. The data also demonstrated 19.5 months median overall survival and 11.3 months median progression-free survival. Selected Third Quarter 2023 Financial Results Net Loss was $13.7 million for the third quarter 2023, compared to $15.1 million for the same period in 2022. The decrease was primarily due to decreased research and development expenses and increased interest income. Research and development expenses were $11.5 million for the third quarter 2023, compared to $12.1 million for the same period in 2022. The decrease in research and development expenses was primarily due to a decrease of $2.5 million in manufacturing costs related to clinical trial material and manufacturing campaigns. This decrease was partially offset by an increase of $1.1 million in clinical trial costs and an increase of $0.8 million in payroll and other related expenses due to an increase in headcount of our research and development full-time employees. General and administrative expenses were $3.3 million for the third quarter 2023, compared to $3.2 million for the same period in 2022. The increase in general and administrative expenses was primarily due to an increase of $0.1 million in payroll and other related expenses due to an increase in headcount of our general and administrative full-time employees. Cash and cash equivalents totaled $80.7 million at September 30, 2023. Research and development incentive receivables totaled $0.8 million at September 30, 2023. About Leap Therapeutics Leap Therapeutics (Nasdaq: LPTX) is focused on developing targeted and immuno-oncology therapeutics. Leap's most advanced clinical candidate, DKN-01, is a humanized monoclonal antibody targeting the Dickkopf-1 (DKK1) protein. DKN-01 is being developed in patients with esophagogastric, gynecologic, and colorectal cancers. FL-301, is a humanized monoclonal antibody targeting Claudin18.2, being developed in patients with gastric and pancreatic cancer. Leap also has preclinical antibody programs targeting Claudin18.2/CD137 and GDF15. For more information about Leap Therapeutics, visit or view our public filings with the SEC that are available via EDGAR at or via . FORWARD-LOOKING STATEMENTS This press release contains forward-looking statements within the meaning of the federal securities laws. Such statements are based upon current plans, estimates and expectations of the management of Leap that are subject to various risks and uncertainties that could cause actual results to differ materially from such statements. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Words such as "anticipate," "expect," "project," "intend," "believe," "may," "will," "should," "plan," "could," "continue," "target," "contemplate," "estimate," "forecast," "guidance," "predict," "possible," "potential," "pursue," "likely," and words and terms of similar substance used in connection with any discussion of future plans, actions or events identify forward-looking statements. All statements, other than historical facts, including statements regarding the continuation over time of the clinical collaboration with BeiGene on the ongoing Part C of the DisTinGuish trial, with BeiGene continuing to supply tislelizumab; the expected benefits of the merger with Flame Biosciences; the cash runway into 2025 and the sufficiency of Leap's cash, cash equivalents and short-term investments to fund operations; the anticipated timing for completion of or success of enrollment in clinical trials and release of clinical data, and any outcomes of such trials; the potential, safety, efficacy, and regulatory and clinical progress of Leap's product candidates; our future preclinical and clinical development plans in connection with our programs; the ability to enter into a new strategic partnership for DKN-01 or any of Leap's other programs; the ability of NovaRock Biotherapeutics to conduct the FL-301 clinical trial in China; and any assumptions underlying any of the foregoing, are forward-looking statements. Important factors that could cause actual results to differ materially from Leap's plans, estimates or expectations could include, but are not limited to: (i) Leap's ability to successfully execute its clinical trials and the timing of enrollment in and cost of such clinical trials; (ii) the results of Leap's clinical trials and pre-clinical studies; (iii) Leap's ability to successfully enter into new strategic partnerships for DKN-01 or any of its other programs; (iv) whether any Leap clinical trials and products will receive approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies; (v) exposure to inflation, currency rate and interest rate fluctuations, as well as fluctuations in the market price of Leap's traded securities; and (vi) that the initiation, conduct, and completion of clinical trials, laboratory operations, manufacturing campaigns, and other studies may be delayed, adversely affected, or impacted by global conflict, or supply chain related issues. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or Implied) are made about the accuracy of any such forward-looking statements. Leap may not actually achieve the forecasts disclosed in such forward-looking statements, and you should not place undue reliance on such forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to those set forth under the caption "Risk Factors" in Leap's most recent Annual Report on Form 10-K filed with the SEC, as well as discussions of potential risks, uncertainties, and other important factors in its subsequent filings with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Neither Leap, nor any of its affiliates, advisors or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing Leap's views as of any date subsequent to the date hereof. CONTACT: Douglas E. Onsi President & Chief Executive Officer Leap Therapeutics, Inc. 617-714-0360 [email protected] Matthew DeYoung Investor Relations Argot Partners 212-600-1902 [email protected] SOURCE Leap Therapeutics, Inc.