Gastrointestinal Neoplasms

SHANGHAI, March 19, 2024 /PRNewswire/ -- Mabwell (688062.SH), an innovative-driven biopharmaceutical company with entire industry chain, presented the clinical study data of the 9MW2821 for patients with cervical cancer as focused plenary oral presentation at the Society of Gynecologic Oncology (SGO) annual meeting on March 16, 2024. The data showed good efficacy and safety of 9MW2821 in patients with cervical cancer, which is expected to bring new breakthroughs for the treatment of recurrent or metastatic cervical cancer, meeting a large number of unmet clinical needs. 9MW2821 is the first drug to report clinical data for the indication of cervical cancer among the drugs with the same target in the world. Report on Study Data of Nectin-4-Targeting Antibody-drug Conjugate ( ADC ) for the Treatment of Recurrent or Metastatic Cervical Cancer This phase I/II, multicenter, open-label, clinical study was led by Professor Zhang Jian of Fudan University Shanghai Cancer Center, and Professor Yang Huijuan of Fudan University Shanghai Cancer Center represented the study team to give an in-depth report at the meeting. The study results were highly recognized by experts on site. Further clinical study data are expected to provide more treatment options for patients with recurrent or metastatic cervical cancer. Clinical Findings The systemic treatment drug options and efficacy for recurrent or metastatic cervical cancer are relatively limited. The cervical cancer cohort in the phase I/II study of 9MW2821 enrolled patients with Nectin-4-positive recurrent or metastatic cervical cancer who had progressed on or after doublet platinum-containing chemotherapy with or without bevacizumab and received no more than two previous systemic regimens for recurrent or metastatic disease. Eligible patients received intravenous 9MW2821 1.25mg/kg on days 1, 8 and 15 of each 28-day cycle until confirmed disease progression, death, intolerable adverse effects or withdrawal from the study. As of September 25, 2023, in the cervical cancer expansion cohort of the study, the detection rate of Nectin-4 expression was 89.67%, and the rate of Nectin-4 IHC 3+ was 67.82%. A total of 40 patients were enrolled in the study, 57.5% of the patients had previously received platinum-based doublet chemotherapy combined with bevacizumab, and 60% of the patients had previously received platinum-based doublet chemotherapy and immune checkpoint inhibitor therapy. In terms of efficacy, the overall response rate (ORR) and disease control rate (DCR) of 37 patients evaluable for efficacy were 40.54% and 89.19%, respectively, with one complete response (2.70%) and 14 partial responses (37.84%). Median progression-free survival (PFS), overall survival (OS), and duration of response (DOR) were not reached yet. Among patients with Nectin-4 IHC 3+, the ORR and DCR of 26 patients evaluable for efficacy were 50.00% and 92.31%, respectively. Among patients on or after doublet platinum-containing chemotherapy, the ORR and DCR of 21 patients evaluable for efficacy were 38.10% and 85.71%, respectively. In terms of safety, treatment-related adverse events (TRAEs) occurred in 92.50% of participants. Grade3-4 TRAEs occurred in 70.00% of participants, with neutropenia (40.00%), rash (17.50%) and gamma-glutamyl transferase increased (12.50%) being the most frequently reported. Nodeaths related to treatment were reported. The above study results indicate that 9MW2821 has controllable safety and positive efficacy in patients with cervical cancer. About 9MW2821 9MW2821 is the first site-specific conjugated novel ADC targeting Nectin-4 developed by Mabwell using ADC platform and automated high-throughput hybridoma antibody molecular discovery platform, and is the first product to enter clinical study among the products with the same target developed by Chinese companies. Multiple clinical studies of 9MW2821 have been conducted in China to evaluate the safety, tolerability, pharmacokinetic characteristics, and efficacy of 9MW2821 in patients with various advanced solid tumors. The phase III clinical study of 9MW2821 monotherapy has officially been initiated in patients with locally advanced or metastatic urothelial carcinoma who have previously received platinum-based chemotherapy and PD-(L)1 inhibitor therapy. The phase I/II clinical study of 9MW2821 in combination with PD-1 inhibitors is also ongoing, with the first patient already enrolled. The phase II clinical study for the indication of esophageal carcinoma will continue enrollment and evaluation, and communication for the initiation of phase III clinical study will be expedited. 9MW2821 was granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) in February 2024 for the treatment of advanced, recurrent, or metastatic esophageal squamous cell carcinoma. Currently, 9MW2821 is the first therapeutic drug targeting Nectin-4 in the world to disclose clinical efficacy and safety data for indications of cervical cancer and esophageal carcinoma. About Cervical Cancer Cervical cancer is the 4th most common neoplasm and the 4th leading cause of cancer death in females worldwide (excerpted from "Worldwide trends in cervical cancer incidence and mortality, with predictions for the next 15 years, Cancer 2021"). According to the "World Cancer Report 2020" released by the International Agency for Research on Cancer (IARC), there were 600 thousand new cases of cervical cancer worldwide in 2020 and up to 340 thousand deaths caused by cervical cancer. In February 2024, the National Cancer Center published the Cancer Burden Data in China in 2022 on Journal of the National Cancer Center (JNCC), showing that there were 150.7 thousand new cases of cervical cancer and 55.7 thousand deaths in China, ranking 8th and 9th respectively in terms of new cases and number of deaths. Compared with the 119 thousand new cases and 37 thousand deaths released in February 2022 for the same period in 2016, significant increases are observed. About Mabwell Mabwell (688062.SH) is an innovation-driven biopharmaceutical company with the entire value chain of the pharmaceutical industry. We provide more effective and accessible therapy and innovative medicines to fulfill global medical needs. Since 2017, an advanced R&D system which covers target discovery, early discovery, druggability, preclinical, clinical research and manufacturing transformation was established. Mabwell has 14 pipeline products in different stages based on a world-class and state-of-the-art R&D engine, including 10 novel drug candidates and 4 biosimilars. We focus on the therapeutic areas of oncology, auto-immune diseases, metabolic disorders, ophthalmologic diseases and infectious diseases, etc. Of these, 2 products have been approved and commercialized, 2 products have been filed for MA approval, 3 products are in pivotal trials. We have also undertaken 1 national major scientific and technological special project for "Significant New Drugs Development", 2 projects for National Key R&D Programmes, and multiple provincial and municipal science and technological innovation projects. Mabwell's Taizhou factory possesses robust in-house manufacturing capability compliant with international GMP standards regulated by the NMPA, FDA and EMA, and has passed the EU QP Audit. The large-scale manufacturing base located in Shanghai is under construction. Our mission is "Explore Life, Benefit Health" and our vision is "Innovation, from ideas to reality". For more information, please visit . Forward-Looking Statements This press release contains forward-looking statements including, but not limited to, the potential safety, efficacy, regulatory review or approval and commercial success of our product candidates and those relating to the Company's product development, clinical studies, clinical and regulatory milestones and timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. "Forward-looking statements" are statements that are not historical facts and involve a number of risks and uncertainties, which may cause actual results to be materially different from any future results expressed or implied in the forward-looking statements. These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential," "predict," "project," "should," "would," and similar expressions and the negatives of those terms. Forward-looking statements are based on the Company's current expectations and assumptions. Forward-looking statements are subject to a number of risks, uncertainties, and other factors, many of which are beyond the Company's control, including, but not limited to: environment; politic; economy; society; legislation; our dependence on our product candidates, most of which are still in preclinical or various stages of clinical development; our reliance on third-party vendors, such as contract research organizations and contract manufacturing organizations; the uncertainties inherent in clinical testing; our ability to complete required clinical trials for our product candidates and obtain approval from regulatory authorities for our product candidates; our ability to protect our intellectual property; the potential impact of COVID-19; the loss of any executive officers or key personnel. In case one or more of these risks or uncertainties deteriorate, or any assumptions are incorrect, the actual results may be seriously inconsistent with the stated results. The Company cautions all the persons not to place undue reliance on any such forward-looking statements, which speaks only as of the date of this press release. The Company disclaims any obligation, except as specifically required by law and the rules of the applicable Stock authority to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. All forward-looking descriptions, figures and assumptions in this press release are applicable to this statement. SOURCE Mabwell

The collaboration exemplifies DDF's commitment to advancing gastrointestinal cancer research and treatment options for patients. FORT LAUDERDALE, Fla., March 19, 2024 /PRNewswire/ -- Debbie's Dream Foundation: Curing Stomach Cancer (DDF) announces an unprecedented collaboration with Memorial Sloan Kettering Cancer Center (MSK) that marks a significant leap forward in the field of gastric cancer research. Through the visionary efforts and support of DDF, a research fellowship grant has been established at MSK under the guidance of Dr. Yelena Janjigian, Chief of Gastrointestinal Oncology Service at MSK. The "Debbie's Dream Foundation Gastric Cancer Investigator" fellowship will focus on patient care, research, and education specifically for esophageal and gastric cancers. The collaboration is a testament to the shared commitment of DDF and MSK to fueling groundbreaking research and providing top-notch cancer care. Continue Reading Debbie's Dream Foundation: Curing Stomach Cancer Dr. Yelena Janjigian, a distinguished member of DDF's Scientific Medical Advisory Board, emphasized the importance of the DDF and MSK's partnership in shaping the future of gastric cancer research. "This fellowship signifies a commitment to excellence in gastroesophageal cancer research. With the support of DDF, we can provide dedicated time and resources to focus on advancing translational studies. This collaboration is pivotal in our collective efforts to better understand and treat esophageal and gastric cancers." Andrea Eidelman, Chief Executive Officer of DDF, expressed her pride in continuing to fund research that propels the organization's mission forward. "At DDF, we are deeply committed to advancing the landscape of gastric cancer research. This partnership with MSK is a significant step towards realizing our vision of a world without stomach cancer. Through the 'Debbie's Dream Foundation Gastric Cancer Investigator fellowship, we aim to make impactful strides in biomarker development, laboratory research, and translational studies in gastroesophageal cancer." DDF plans to contribute nearly $600,000 to fund this initiative over a three-year period, reinforcing the commitment to long-term support for innovative research. MSK will provide regular progress reports, ensuring transparency and accountability throughout the fellowship. Upon completion of the funding, MSK will recognize DDF for its invaluable contribution to advancing cancer research and patient care. Since 2014, DDF, in partnership with the American Association for Cancer Research (AACR), has invested $1.45 million in research grants to pioneering scientists in the United States. The 2023 AACR-Debbie's Dream Foundation Innovation and Discovery Grant recipients include Drs. Eunyoung Choi, Brent Allen Hanks, and Ryan H. Moy are exploring new targets and biomarkers for gastric cancer. Highlighting a significant milestone, DDF also celebrated Dr. Valerie O'Brien's recent discovery, funded by the 2018 Debbie's Dream Foundation-AACR Fellowship, of a precancerous cell type linked to H. pylori infection, offering new insights and therapeutic directions for gastric cancer. For more information about DDF programs and initiatives, please visit . About Debbie's Dream Foundation: Curing Stomach Cancer DDF is a 501(c)(3) non-profit organization dedicated to raising awareness about gastric cancer, advancing research funding, and providing international education and support to patients, families, and caregivers. DDF's ultimate goal is to make the cure for stomach cancer a reality. DDF was founded in 2009 by Debbie Zelman after she was diagnosed with stage IV incurable gastric cancer in 2008 and given only weeks to live. Debbie is considered a pioneer by many for bringing awareness to the plight of stomach cancer patients worldwide, as well as to the lack of federal funding for stomach cancer research. She did all of this while receiving hundreds of rounds of chemo and daily oral treatments. Debbie passed away on December 23, 2017, at 50, almost a decade later. As a result of her leadership, DDF now has a Scientific and Medical Advisory Board of world-renowned doctors and chapters throughout Canada and Germany. DDF strives to continue Debbie's mission to make her dream a reality. To learn more, visit . Media Contact Brittnay Starks, Communications Director Debbie's Dream Foundation: Curing Stomach Cancer (954) 475-1200 [email protected] SOURCE Debbie's Dream Foundation: Curing Stomach Cancer

Financing includes participation from new and existing investors Net proceeds, along with existing cash, cash equivalents and marketable securities, are expected to extend cash runway into late 2026 and through multiple key clinical milestones for ELVN-001 and ELVN-002 Company to host an event with KOLs on April 11, 2024, to discuss initial proof of concept data from a Phase 1a trial evaluating ELVN-001 in adults with chronic myeloid leukemia (CML) BOULDER, Colo., March 19, 2024 (GLOBE NEWSWIRE) -- Enliven Therapeutics, Inc. (Enliven or the Company) (Nasdaq: ELVN), a clinical-stage precision oncology company focused on the discovery and development of next-generation small molecule kinase inhibitors, today announced that it has entered into a securities purchase agreement for a private investment in public equity (PIPE) financing that is expected to result in gross proceeds of approximately $90 million, before deducting offering expenses. The financing includes participation from new and existing investors, including Commodore Capital, Fairmount, Venrock Healthcare Capital Partners, a biotech investor, a large mutual fund, Rock Springs Capital, Logos Capital, Woodline Partners LP and Acuta Capital Partners. “We appreciate the support from our existing and new high-quality investors and their confidence in our clinical programs,” said Sam Kintz, MBA, Enliven’s Co-founder and Chief Executive Officer. “The additional funding further strengthens our balance sheet and enables us to achieve critical, longer-term clinical milestones as we advance our parallel lead programs, ELVN-001 and ELVN-002. We are particularly excited to share initial proof of concept data for ELVN-001 at our KOL event in a few weeks.” Recent Research and Development Updates and Upcoming Milestones ELVN-001, a highly selective, small molecule kinase inhibitor designed to specifically target the BCR-ABL gene fusion The Company is currently enrolling patients in its Phase 1 clinical trial evaluating ELVN-001 in adults who failed or are intolerant to available therapies known to be active for the treatment of their CML (NCT05304377), and will host a key opinion leader (KOL) event with CML Investigators Professor Michael Mauro of Memorial Sloan-Kettering Cancer Center and Professor Fabian Lang of Goethe University Hospital, on April 11, 2024, to discuss initial proof of concept data from the trial. More details of the event will be announced soon. In the ongoing Phase 1a dose escalation, 10-120mg once daily (QD), ELVN-001 has been well tolerated with anti-CML activity at and above 20mg QD, including both achievement and maintenance of major molecular responses (MMR) by three months in late line patients, and in patients with prior asciminib experience. A maximum tolerated dose (MTD) has not been reached, and there have been no dose reductions. Of note, there have been no ≥ Grade 3 non-hematologic treatment-related adverse events (TRAEs) and of the Grade 1/2 non-hematologic TRAE, none > 11%. At above 20mg QD, ELVN-001 achieved superior target coverage compared to 2nd Generation TKIs. More detailed ELVN-001 data will be presented at the April 11th KOL event. ELVN-002, a potent, highly selective, central nervous system (CNS) penetrant and irreversible HER2 inhibitor with activity against wild type HER2 and various HER2 mutations Following the U.S. Food and Drug Administration’s approval of its Investigational New Drug (IND) application, the Company recently activated its first site to evaluate ELVN-002 in combination with trastuzumab +/- chemotherapeutic agents in adults with HER2+ metastatic breast cancer (MBC) and colorectal cancer (CRC). Dosing of the first patient in the combination study is expected in Q2 2024. The combination trial in patients with HER2+ cancers is supported by the initial data from the ongoing monotherapy trial, which includes: Investigator reported responses (including unconfirmed) in both HER2+ and HER2 mutant tumors, including in patients who have progressed on Enhertu and patients with brain metastases, at doses that have been well tolerated. At the clinically predicted optimal monotherapy dose (n=30), based on current Phase 1a data: The most common reported (>10%) treatment-related adverse events (AEs) were headache, nausea, vomiting and diarrhea. Of note, no Grade 3 diarrhea (0%) and only Grade 1/2 AST/ALT (3%/0%) and rash (3%). Compared to tucatinib, ELVN-002 had >10x target coverage based on pharmacokinetics in cancer patients and preclinical HER2+ efficacy. Phase 1 data and initial proof of concept combination data in HER2+ cancers are expected in 2025. Details of the PIPE Financing Pursuant to the terms of the securities purchase agreement, Enliven has agreed to sell an aggregate of 5,357,144 shares of its common stock at a price of $14.00 per share, representing a premium of approximately 11% to Enliven’s closing price on March 18, 2024, and pre-funded warrants to purchase 1,071,505 shares of its common stock at a price per pre-funded warrant of $13.999. Enliven anticipates the gross proceeds from the private placement to be approximately $90 million, before deducting offering expenses. The PIPE financing is expected to close on or about March 21, 2024, subject to satisfaction of customary closing conditions. Enliven intends to use the net proceeds from the proposed financing to fund research and development of its clinical-stage product candidates, other research programs, working capital and general corporate purposes. The proceeds from this financing, combined with current cash, cash equivalents and marketable securities, are expected to fund current operations into late 2026 and through the following additional key milestones for the Company’s two clinical programs: ELVN-001: In 2025, Phase 1b data including between approximately 60-100 patients across various lines of therapy with significant follow-up By the end of 2025, initial regulatory interactions with the aim of achieving regulatory path clarity regarding the first head-to-head pivotal trial ELVN-002: In 2025, Phase 1 monotherapy data, Phase 1a/b Herceptin combination data in HER2+ CRC, and initial Phase 1a combination data in HER2+ MBC The offer and sale of the foregoing securities are being made in a transaction not involving a public offering and the securities have not been registered under the Securities Act of 1933, as amended (Securities Act), and may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act. Enliven has agreed to registration statement with the Securities and Exchange Commission registering the resale of the shares of common stock and the shares of common stock issuable upon exercise of the pre-funded warrants sold in the PIPE financing. Any offering of the securities under the resale registration statement will only be made by means of a prospectus. This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. About Enliven Therapeutics Enliven Therapeutics is a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule inhibitors to help people with cancer not only live longer, but live better. Enliven aims to address existing and emerging unmet needs with a precision oncology approach that improves survival and enhances overall well-being. Enliven’s discovery process combines deep insights in clinically validated biological targets and differentiated chemistry to design potentially first-in-class or best-in-class therapies. Enliven is based in Boulder, Colorado. Forward-Looking Statements This press release contains forward-looking statements (including within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended) concerning Enliven and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the management of Enliven, as well as assumptions made by, and information currently available to, management of Enliven. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” and other similar expressions or the negative or plural of these words, or other similar expressions that are predictions or indicate future events or prospects, although not all forward-looking statements contain these words. Statements that are not historical facts are forward-looking statements. Forward-looking statements in this press release include, but are not limited to, statements regarding the potential of, and plans and expectations regarding, Enliven’s programs, including ELVN-001 and ELVN-002; Enliven’s pipeline of product candidates; expected milestones for ELVN-001 and ELVN-002, including the expected timing of dosing of ELVN-002 in combination and of data from the clinical trials of ELVN-001 and ELVN-002; statements relating to Enliven’s expected cash runway; the timing and expectation of the closing of the PIPE financing; the satisfaction of customary closing conditions related to the PIPE financing and the anticipated use of proceeds therefrom; and statements by Enliven’s Co-founder and Chief Executive Officer. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various risks and uncertainties, including, without limitation: whether the conditions for the closing of the PIPE financing will be satisfied; the limited operating history of Enliven; the ability to advance product candidates through preclinical and clinical development; the ability to obtain regulatory approval for, and ultimately commercialize, product candidates; the outcome of preclinical testing and early clinical trials for product candidates and the potential that the outcome of preclinical testing and early clinical trials may not be predictive of the success of later clinical trials; Enliven’s limited resources; the risk of failing to demonstrate safety and efficacy of product candidates; Enliven’s limited experience as a company in designing and conducting clinical trials; potential delays or difficulties in the enrollment or maintenance of patients in clinical trials; developments relating to Enliven’s competitors and its industry, including competing product candidates and therapies; the decision to develop or seek strategic collaborations to develop Enliven’s current or future product candidates in combination with other therapies and the cost of combination therapies; the ability to attract, hire, and retain highly skilled executive officers and employees; the ability of Enliven to protect its intellectual property and proprietary technologies; the scope of any patent protection Enliven obtains or the loss of any of Enliven’s patent protection; reliance on third parties, including contract manufacturing organizations, contract research organizations and strategic partners; general market or macroeconomic conditions; Enliven’s ability to obtain additional capital to fund Enliven’s general corporate activities and to fund Enliven’s research and development; and other risks and uncertainties, including those more fully described in Enliven’s filings with the Securities and Exchange Commission (SEC), which may be found in the section titled “Risk Factors” in Enliven’s Annual and Quarterly Reports on Form 10-K and 10-Q filed with the SEC and in Enliven’s future reports to be filed with the SEC. Except as required by applicable law, Enliven undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. This press release contains hyperlinks to information that is not deemed to be incorporated by reference into this press release. Contact: Enliven Investors & Media: Investors ir@enliventherapeutics.com Media Media@enliventherapeutics.com