CD276

SHANGHAI, March 11, 2024 /PRNewswire/ -- Mabwell (688062.SH), an innovation-driven biopharmaceutical company with entire industry chain, announced that it will present its next generation ADC platform IDDC™ and the latest study results of multiple novel ADCs (9MW2821, 7MW3711, 9MW2921) developed based on this platform as poster presentation at the 14th World ADC London from March 12-15, 2024 local time. The World ADC Event Series is the largest academic event in the global ADC field. Poster Presentation Poster Title: Mtoxin™ Payload Applied in IDDC™ ADC Platform Significant Increases Therapeutic Index and Overcome MultiDrug Resistance in Various Tumor Booth No.: 26 About the next generation ADC platform IDDC™ IDDC™ is a next generation ADC site-specific conjugation technology platform independently developed by Mabwell, consisting of multiple systematic core patented technologies including the site-specific conjugation process DARfinity™, the site-specific linker IDconnect™, the novel payload Mtoxin™, and the conditional release structure LysOnly™. The next generation ADCs developed based on the above systematic patented technologies have better structural uniformity, quality stability, efficacy, and tolerability. The IDDC™ platform has already been validated in multiple drugs under study. It is anticipated that more ADCs based on this platform will enter the clinical development stage in the future. 9MW2821 - novel Nectin-4-targeting ADC: Mabwell is the first Chinese enterprise to advance 9MW2821 into Phase 3 clinical trials for the treatment of urothelial carcinoma, making it the second globally in terms of progress; 9MW2821 is also the first therapeutic drug in the world with the same target to disclose clinical efficacy data for indications of cervical cancer and esophageal carcinoma. 7MW3711 - novel B7-H3-targeting ADC: Clinical trials have been conducted for 7MW3711 for the indication of advanced solid tumors in China and it has received FDA approval to conduct clinical trials for patients with advanced malignant solid tumors. 9MW2921 - novel Trop-2-targeting ADC: Clinical trials have been conducted for 9MW2921 for the indication of advanced solid tumors in China. 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

MAINZ, Germany, March 11, 2024 – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) will present clinical trial data for selected candidates from its oncology pipeline at the American Association for Cancer Research (“AACR”) Annual Meeting 2024 in San Diego, California, from April 5-10, 2024. The oral and poster presentations will feature BioNTech’s investigational mRNA-based cancer vaccine and novel investigational antibody-drug conjugate (“ADC”) approaches. “This year’s AACR presentations feature candidates from our individualized and off-the-shelf mRNA cancer vaccine platforms, including a late-breaking presentation of longer-term follow-up data with our individualized mRNA-based candidate autogene cevumeran in patients with pancreatic cancer,” said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. “Our investigational mRNA cancer vaccine approaches are an important pillar in our oncology portfolio, aimed at eliminating residual tumor foci and reducing the tumor burden by targeting multiple antigens at once. The data we will be sharing at AACR show how we’re delivering on our commitment to patients through investigating novel treatment approaches.” Highlights of BioNTech’s clinical stage programs to be presented at AACR Annual Meeting 2024: Longer-term follow-up data of activity and immune responses of the investigator-initiated first-in-human Phase 1 trial (NCT04161755) with the mRNA-based individualized neoantigen-specific immunotherapy (“iNeST”) candidate autogene cevumeran (BNT122, RO7198457) in patients with resected pancreatic ductal adenocarcinoma (“PDAC”) will be presented. The results of the Phase 1 trial were published in Nature. The candidate is currently being evaluated in an ongoing randomized Phase 2 trial (NCT05968326) in PDAC and is jointly being developed by BioNTech and Genentech, a member of the Roche Group.BioNTech will present preliminary results on the LuCa-MERIT-1 Phase 1 trial (NCT05142189) with its off-the-shelf, shared tumor-associated-antigen-based mRNA therapeutic cancer vaccine candidate BNT116 in combination with docetaxel in patients with advanced unresectable or metastatic non-small cell lung cancer (“NSCLC”). The data show antitumor activity, consistent induction of immune responses in heavily pre-treated patients with advanced NSCLC, and a manageable safety profile.A trial in progress poster will inform on the global Phase 1/2a trial (NCT05914116) of the topoisomerase-1 inhibitor-based ADC candidate BNT324/DB-1311 targeting the immune checkpoint protein B7H3 in patients with pretreated advanced or metastatic solid tumors. The candidate is being jointly developed by BioNTech and Duality Biologics. BioNTech has established a diversified clinical oncology pipeline of more than 20 clinical programs along mRNA-based therapeutic cancer vaccines, targeted therapies comprising cell therapies and ADCs, and novel immunomodulators in unmet medical need solid tumor indications. These candidates are currently being evaluated in more than 30 clinical studies, including nine programs in advanced Phase 2 trials and two candidates in pivotal Phase 3 trials. BioNTech is advancing the Company’s key programs into late-stage development with the aim to have ten or more potentially registrational trials in its oncology pipeline by the end of 2024. The full abstracts are available on the AACR Annual Meeting website. Click here for further information on BioNTech’s pipeline candidates. Full presentation details: Late-breaking presentationCandidate: Autogene cevumeran (BNT122, RO7198457)Session Title: “Cancer Vaccines: Ready for Prime Time?”Abstract Title: “Personalized RNA neoantigen vaccines induce long-lived CD8+ T effector cells in pancreatic cancer”Abstract Number: CT025Date: Sunday, April 7, 2024 Time: 3:00 PM - 5:00 PM PST PostersCandidate: BNT116Session Title: Phase I Clinical TrialsAbstract Title: "Preliminary results from LuCa-MERIT-1, a first-in-human Phase I trial evaluating the hexavalent TAA-encoding mRNA vaccine BNT116 + docetaxel in patients with advanced non-small cell lung cancer"Location: Poster Section 48Poster Number: CT051 Date: Monday, April 8, 2024 Candidate: BNT324/DB-1311Session Title: Phase I Clinical Trials in Progress 2Abstract Title: “A phase 1/2a, multicenter, open-label, first-in-human study to assess the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of DB-1311 (a B7-H3-targeting ADC) in patients with advanced/metastatic solid tumors”Location: Poster Section 50Poster Number: CT165Date: Monday, April 8, 2024About BioNTech Biopharmaceutical New Technologies (BioNTech) is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. BioNTech exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor (CAR) T cells, several protein-based therapeutics, including bispecific immune checkpoint modulators, targeted cancer antibodies and antibody-drug conjugate (ADC) therapeutics, as well as small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Duality Biologics, Fosun Pharma, Genentech, a member of the Roche Group, Genevant, Genmab, OncoC4, Regeneron and Pfizer. For more information, please visit www.BioNTech.com. BioNTech Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not be limited to, statements concerning: the initiation, timing, progress and results of BioNTech’s research and development programs in oncology, including the targeted timing and number of additional potentially registrational trials; BioNTech’s current and future preclinical studies and clinical trials in oncology, including individualized neoantigen specific immunotherapy (“iNeST”) autogene cevumeran (BNT122, RO7198457) in patients with resected PDAC, mRNA cancer vaccine candidate BNT116 in combination with docetaxel in advanced unresectable or metastatic NSCLC, and ADC candidate BNT324/DB-1311 in advanced or metastatic solid tumors, the nature and characterization of and timing for release of clinical data across BioNTech’s platforms, which is subject to peer review, regulatory review and market interpretation; the planned next steps in BioNTech’s pipeline programs, including, but not limited to, statements regarding timing or plans for initiation or enrollment of clinical trials, or submission for and receipt of product approvals with respect to BioNTech’s product candidates; the ability of BioNTech’s mRNA technology to demonstrate clinical efficacy outside of BioNTech’s infectious disease platform; and the potential safety and efficacy of BioNTech’s product candidates. Any forward-looking statements in this press release are based on BioNTech’s current expectations and beliefs of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include but are not limited to discussions with regulatory agencies regarding timing and requirements for additional clinical trials; and the ability to produce comparable clinical results in future clinical trials. In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond BioNTech’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to: the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preclinical and clinical data, including the data discussed in this release, and including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the nature of the clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; the timing of and BioNTech’s ability to obtain and maintain regulatory approval for BioNTech’s product candidates; BioNTech’s and its counterparties’ ability to manage and source necessary energy resources; BioNTech’s ability to identify research opportunities and discover and develop investigational medicines; the ability and willingness of BioNTech’s third-party collaborators to continue research and development activities relating to BioNTech’s development candidates and investigational medicines; unforeseen safety issues and potential claims that are alleged to arise from the use of products and product candidates developed or manufactured by BioNTech; BioNTech’s and its collaborators’ ability to commercialize and market, if approved, its product candidates; BioNTech’s ability to manage its development and expansion; regulatory developments in the United States and other countries; BioNTech’s ability to effectively scale BioNTech’s production capabilities and manufacture BioNTech’s products and BioNTech’s product candidates; risks relating to the global financial system and markets; and other factors not known to BioNTech at this time. You should review the risks and uncertainties described under the heading “Risk Factors” in BioNTech’s Report on Form 6-K for the period ended September 30, 2023, and in subsequent filings made by BioNTech with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, BioNTech disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on BioNTech’s current expectations and speak only as of the date hereof.CONTACTS Media Relations Jasmina Alatovic +49 (0)6131 9084 1513 Media@biontech.de Investor RelationsVictoria Meissner, M.D.+1 617 528 8293Investors@biontech.de

Five abstracts accepted for poster presentation highlight Company’s proprietary Conditionally Active Biologic (CAB) technologyDifferentiated preclinical activity for CAB anti-Nectin4-antibody drug conjugate (ADC) with superior efficacy to enfortumab vedotin analogue in a patient derived pancreatic cancer modelNo clinical and histopathologic signs of toxicities in non-human primates with conditionally active tetravalent B7-H3 x CD3 T-cell engager (BA3142) SAN DIEGO, March 07, 2024 (GLOBE NEWSWIRE) -- BioAtla, Inc. (Nasdaq: BCAB), a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics for the treatment of solid tumors, today announced preclinical poster presentations at the upcoming 2024 American Association for Cancer Research (AACR) Annual Meeting to be held at the San Diego Convention Center in San Diego, California from April 5–10, 2024. Presentation Details: Poster Title: Using a novel NextGen linker system to generate a Conditionally Active Biologic (CAB) anti-Nectin4-ADC demonstrates improved efficacy in pancreatic PDX cancer models and improved tolerability and toxicity profile in non-human primatesAuthors: Jing Wang, Jian Chen, Gerhard Frey, Haizhen Liu, Charles Xing, Kathryn Woodard, Cathy Chang, William J. Boyle, and Jay M. ShortPoster Number: 743 / 29Session: PO.ET02.06 - Tumor MicroenvironmentDate / Time: Sunday, April 7, 2024 / 1:30 – 5:00 PM PTLocation: Section 29 Poster Title: Novel Conditionally Active Tetravalent B7-H3 x CD3 T-cell Engagers Targeting Solid TumorsAuthors: Ana Paula Cugnetti, Haizhen Liu, Patricia McNeeley, Charles Xing, Kathryn Woodard, Cathy Chang, Gerhard Frey, William J. Boyle, and Jay M. ShortPoster Number: 6340 / 1Session: PO.CL06.08 - Antibodies 2Date / Time: Tuesday, April 9, 2024 / 1:30 – 5:00 PM PTLocation: Section 41 Poster Title: Novel Conditionally Active Biologic (CAB) tetravalent T-cell engagers targeting solid tumorsAuthors: Ana Paula Cugnetti, Haizhen Liu, Patricia McNeeley, Charles Xing, Kathryn Woodard, Cathy Chang, Gerhard Frey, William J. Boyle, and Jay M. ShortPoster Number: 744 / 30Session: PO.ET02.06 - Tumor MicroenvironmentDate / Time: Sunday, April 7, 2024 / 1:30 – 5:00 PM PTLocation: Section 29 Poster Title: Targeting novel senescence markers by Conditionally Active Biologics eliminates senescence-associated secretory phenotype in in vitro and in vivo modelsAuthors: Jian Chen, Jing Wang, Haizhen Liu, Cathy Chang, William J. Boyle and Jay M. ShortPoster Number: 2969 / 16Session: PO.MCB04.02 - Cellular Stress Responses 2Date / Time: Monday, April 8, 2024 / 1:30 – 5:00 PM PTLocation: Section 15 Poster Title: Development of a humanized anti-IL-22 antibody for cancer and inflammation therapyAuthors: Jian Chen, Cathy Chang, Gerhard Frey, Haizhen Liu, Jing Wang, William J. Boyle and Jay M. ShortPoster Number: 1405 / 3Session: PO.IM01.05 - Inflammation, Host Factors, and Epigenetic Influences on Cancer Development and TreatmentDate / Time: Monday, April 8, 2024 / 9:00 AM – 12:30 PM PTLocation: Section 5 A copy of the presentation materials can be accessed on the “Publication” section of the Company’s website at www.bioatla.com once the presentations have concluded. About BioAtla®, Inc. BioAtla is a global clinical-stage biotechnology company with operations in San Diego, California, and in Beijing, China through our contractual relationship with BioDuro-Sundia, a provider of preclinical development services. Utilizing its proprietary Conditionally Active Biologics (CAB) technology, BioAtla develops novel, reversibly active monoclonal and bispecific antibodies and other protein therapeutic product candidates. CAB product candidates are designed to have more selective targeting, greater efficacy with lower toxicity, and more cost-efficient and predictable manufacturing than traditional antibodies. BioAtla has extensive and worldwide patent coverage for its CAB technology and products with greater than 750 patents filed, more than 475 of which have been issued. Broad patent coverage in all major markets include methods of making, screening and manufacturing CAB product candidates in a wide range of formats and composition of matter coverage for specific products. BioAtla has two first-in-class CAB programs currently in Phase 2 clinical testing, mecbotamab vedotin, BA3011, a novel conditionally active AXL-targeted antibody-drug conjugate (CAB-AXL-ADC), and ozuriftamab vedotin, BA3021, a novel conditionally active ROR2-targeted antibody-drug conjugate (CAB-ROR2-ADC). The Phase 2 stage CAB-CTLA-4 antibody, BA3071, is a novel CTLA-4 inhibitor designed to reduce systemic toxicity and potentially enable safer combination therapies with checkpoint inhibitors such as anti-PD-1 antibody. The company’s first bispecific T-cell engager antibody, BA3182, is currently in Phase 1 development. BA3182 targets EpCAM, which is highly and frequently expressed on many adenocarcinomas while engaging human CD3 expressing T cells. To learn more about BioAtla, Inc. visit www.bioatla.com. Internal Contact: Richard Waldron Chief Financial Officer BioAtla, Inc. rwaldron@bioatla.com 858.356.8945 External Contact: Bruce Mackle LifeSci Advisors, LLC bmackle@lifesciadvisors.com