OncoC4, Inc.

▎Armstrong 2024年10月18日，BioNTech与合作伙伴OncoC4收到FDA通知，不分暂停CTLA-4的三期临试验，公司认为此次不分暂停是因为NSCLC三期临床的鳞癌、非鳞癌患者出现差异结果，已经入组的患者将继续接受治疗，但会暂停新的受试者入组。 BNT316从昂科免疫引进，为一种差异化设计的pH敏感性CTLA-4抗体。 BNT-316进展最快的即此次暂停入组的NSCLC三期临床，后续还有卵巢癌、前列腺癌等多个适应症在不同的临床开发阶段。 总结 对于非小细胞肺癌来说，鳞癌、非鳞癌的差异很大，Trop2 ADC等也表现出临床疗效的巨大差异。预计BNT-316在分析后，会调整后续的临床方案。 Armstrong技术全梳理系列 GPRC5D靶点全梳理； CD40靶点全梳理； CD47靶点全梳理； 补体靶向药物技术全梳理； 补体药物：眼科治疗的重要方向； Claudin 6靶点全梳理； Claudin 18.2靶点全梳理； 靶点冷暖，行业自知； 中国大分子新药研发格局； 被炮轰的“me too”； 佐剂百年史； 胰岛素百年传奇； CUSBEA：风雨四十载； 中国新药研发的焦虑； 中国生物医药企业的研发竞争； 中国双抗竞争格局； 中国ADC竞争格局； 中国双抗技术全梳理； 中国ADC技术全梳理； Ambrx技术全梳理； Vir Biotech技术全梳理； Immune-Onc技术全梳理； 亘喜生物技术全梳理； 康哲药业技术全梳理； 科济药业技术全梳理； 恺佧生物技术全梳理； 同宜医药技术全梳理； 百奥赛图技术全梳理； 腾盛博药技术全梳理； 创胜集团技术全梳理； 永泰生物技术全梳理； 中国抗体技术全梳理； 德琪医药技术全梳理； 德琪医药技术全梳理2.0； 和铂医药技术全梳理； 荣昌生物技术全梳理； 再鼎医药技术全梳理； 药明生物技术全梳理； 恒瑞医药技术全梳理； 豪森药业技术全梳理； 正大天晴技术全梳理； 吉凯基因技术全梳理； 基石药业技术全梳理； 百济神州技术全梳理； 百济神州技术全梳理第2版； 信达生物技术全梳理； 信达生物技术全梳理第2版； 中山康方技术全梳理； 复宏汉霖技术全梳理； 先声药业技术全梳理； 君实生物技术全梳理； 嘉和生物技术全梳理； 志道生物技术全梳理； 道尔生物技术全梳理； 尚健生物技术全梳理； 康宁杰瑞技术全梳理； 科望医药技术全梳理； 科望医药技术全梳理2.0； 岸迈生物技术全梳理； 礼进生物技术全梳理； 康桥资本技术全梳理； 余国良的抗体药布局； 荃信生物技术全梳理； 安源医药技术全梳理； 三生国健技术全梳理； 仁会生物技术全梳理； 乐普生物技术全梳理； 同润生物技术全梳理； 宜明昂科技术全梳理； 派格生物技术全梳理； 迈威生物技术全梳理； Momenta技术全梳理； NGM技术全梳理； 普米斯生物技术全梳理； 普米斯生物技术全梳理2.0； 三叶草生物技术全梳理； 贝达药业抗体药全梳理； 泽璟制药抗体药全梳理； 恒瑞医药抗体药全梳理； 齐鲁制药抗体药全梳理； 石药集团抗体药全梳理； 豪森药业抗体药全梳理； 华海药业抗体药全梳理； 科伦药业抗体药全梳理； 百奥泰技术全梳理； 凡恩世技术全梳理。

Merger expands OncoC4’s wholly owned immunotherapy pipeline and establishes in-house clinical manufacturing capabilities Adds IND-ready AI-081, a PD-1/VEGF bispecific antibody with best-in-class potential and clinical-stage assets including next-generation siglec agonist AI-071 Both companies are co-founded by CEO, Yang Liu and CMO, Pan Zheng and have a similar shareholder base ROCKVILLE, Md., Sept. 25, 2024 (GLOBE NEWSWIRE) -- OncoC4, Inc., a late-stage biopharmaceutical company developing novel medicines for cancer, and AcroImmune, a biopharmaceutical company developing immunotherapy drugs for malignant tumor and inflammatory disease, today announced that the companies, which are under common control, have entered into a definitive merger agreement to combine in an all-stock transaction (the Merger). Under the terms of the agreements, OncoC4 will acquire 100% of the outstanding equity interests of AcroImmune. Upon completion of the Merger, the combined company is expected to operate under the name OncoC4, Inc., will be headquartered in Rockville, Maryland, and led by Yang Liu, PhD, Co-Founder, Chief Executive Officer (CEO). Both OncoC4 and AcroImmune were co-founded by Drs. Yang Liu and Pan Zheng and have a similar shareholder base. “This Merger seamlessly bolsters OncoC4’s wholly owned immunotherapy pipeline and adds investigational new drug (IND)-ready PD-1/VEGF bispecific antibody AI-081 with best-in-class potential and clinical stage assets with near-term catalysts including next-generation siglec agonist AI-071,” said Yang Liu, PhD, Co-Founder, CEO and Chief Scientific Officer (CSO) of OncoC4. “Additionally, the Merger will also expand OncoC4’s geographical footprint and establish in-house clinical manufacturing capabilities including R&D, clinical, and manufacturing sites in China.” Dr. Liu continued, “Collectively, these synergies further strengthen the potential of OncoC4 to deliver differentiated and novel immunotherapies spanning multiple modalities for difficult to treat solid tumors and hematological malignancies. We look forward to continued advancement across our innovative pipeline with several upcoming early and late-stage clinical milestones over the next 12 months.” Dr. Pan Zheng, MD, PhD, OncoC4’s Chief Medical Officer (CMO) and cofounder of OncoC4 and AcroImmune added, “A bispecific targeting PD-1 and VEGF holds potential to broaden the horizon of checkpoint therapy across cancers. AI-081 consists of fully owned and high affinity binding motifs to PD-1 and VEGF that are designed to be best in-class among an emerging class of potentially transformative cancer therapies. We are very excited to file an IND application for AI-081 in the fourth quarter of the year.” OncoC4’s Pipeline Programs and Expected Upcoming Milestones Newly Added Wholly Owned Programs AI-081 – A potentially best-in-class bispecific antiboy against PD-1 and VEGF that has demonstrated high potency and in vivo anti-tumor activity in preclinical models IND filing expected in Q4 2024 AI-071 – A Phase 2 ready, next-generation siglec agonist that is designed for broad siglec coverage with potential application across immunotherapy treated indications. Siglec is a novel innate immune checkpoint discovered by OncoC4 founders with broad application for cancer and excessive inflammation. Initiation of Phase 2 trial for acute respiratory failure expected in Q4 2024Initiation of Phase 2 trial for immune related adverse events expected in Q1 2025 Legacy OncoC4 Wholly Owned Programs CD24 Siglec Program – Novel innate immune checkpoint discovered by OncoC4 founders with broad application for the treatment of cancer and excessive inflammation. ONC-841 – First-in-class anti-Siglec 10 mAb designed for broader impact across innate and adaptive immunity in tumor microenvironment Initiated Phase 1 trial in solid tumors in Q3 2024 Cancer Specific CD24 Platform Program – CD24 is a potent ‘don’t eat me’ signal used by tumors to evade innate immune destruction and an oncogene overexpressed in 70% of all human cancers. OncoC4’s cancer-specific mAb targets a neo-CD24 epitope with application across multiple therapeutic modalities. ONC-782 – CAR-T cell therapy for solid and hematological malignancies Initiation of Phase 1 Investigator Initiated Trial in China expected in 2H 2024 ONC-783 – Bispecific mAb for hematological malignancies IND enabling studies initiated in Q2 2024 ONC-784 – ADC for solid tumors IND enabling studies to be initiated in Q1 2025 Partnered Programs Gotistobart (BNT316/ONC392) is a next-generation anti-CTLA-4 antibody candidate in joint late-stage clinical development with BioNTech as a monotherapy and in combination in multiple ongoing solid tumor indications. Designed for improved toxicity and ability to overcome immune suppression in the tumor microenvironment by depleting regulatory T cells to turn immunologically cold tumors hot. About OncoC4 Based in Rockville, Maryland, OncoC4 is a privately held, late-stage biopharmaceutical company that is actively engaged in the discovery and development of novel biologicals for cancer treatment. Its lead clinical candidate is gotistobart (BNT316/ONC-392), a next generation anti-CTLA-4 antibody that allows CTLA-4 to recycle and maintain its protective function against autoimmune diseases while enhancing anti-tumor activity at the same time. In March 2023, OncoC4 announced a strategic collaboration with BioNTech to co-develop and commercialize ONC-392 in multiple solid tumor indications. OncoC4 received $200M upfront and is eligible to receive development, regulatory, and commercial milestone payments in addition to double digit royalties. In addition, OncoC4 has a pipeline of first-in-class and best-in-class assetstargeting both novel and well validated oncology targets. For more information, please visit www.oncoc4.com. Investor Contact: Alexandra FoliasLifeSci Advisorsafolias@lifesciadvisors.com Media Contact: Kristin Politi, Ph.D. LifeSci Communicationskpoliti@lifescicomms.com

MAINZ, Germany, September 05, 2024 – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) will present clinical trial data for selected assets from its multi-platform oncology pipeline at the European Society for Molecular Oncology (“ESMO”) Congress 2024 in Barcelona, Spain from September 13-17, 2024. The oral and poster presentations will feature programs across BioNTech’s clinical pipeline, including mRNA-based cancer vaccines, next-generation immunomodulators and targeted therapy approaches. “We believe that the future of cancer treatment will be driven by the combination of modalities, including immunomodulators, targeted and mRNA-based therapies,” said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. “At this year’s ESMO, we will present data from three clinical trials with BNT327/PM8002, one of the key backbones for our combination treatment strategy. This bispecific antibody will be an element in multiple novel combination treatment approaches that may open up new synergistic mechanisms of action. Our mRNA platforms are another important component of our combination strategy. At ESMO, we will present clinical data that further support the proof of concept of our mRNA-based FixVac approach, which targets non-mutated tumor-associated antigens, showing early clinical activity across various indications.” Highlights of BioNTech’s clinical stage programs to be presented at ESMO Congress 2024: Updates on several Phase 2 and Phase 1/2 clinical trials evaluating BNT327/PM8002 in various indications as monotherapy and in combination with chemotherapy will be presented. BNT327/PM8002 is an investigational bispecific antibody combining PD-L1 checkpoint inhibition with VEGF-A neutralization for vascular normalization and immunostimulation in the microenvironment of the tumor. Two oral presentations and one poster will provide clinical data updates for cohorts with advanced non-small cell lung cancer (“NSCLC”), locally advanced/metastatic triple-negative breast cancer (“TNBC”) and advanced renal cell carcinoma. BNT327/PM8002 is being developed in collaboration with Biotheus Inc. (“Biotheus”).Preliminary data from an ongoing clinical Phase 2 trial (NCT04534205) evaluating BNT113 in combination with PD-1 blockade and data from an investigator-initiated Phase 1/2 clinical trial (NCT03418480) evaluating BNT113 as monotherapy in HPV16-driven cancers will be presented. The data show immunogenicity and antitumor activity in heavily pre-treated patients in several HPV16-positive indications, including head and neck cancer, and a manageable safety profile. BNT113 is an investigational lipoplex-formulated uridine mRNA immunotherapy encoding E6 and E7 antigens of HPV16.Preliminary data of the randomized Phase 2 clinical trial (NCT05446298) with BNT316/ONC-392 (gotistobart), an investigational anti-CTLA-4 antibody, in combination with pembrolizumab in patients with platinum-resistant recurrent ovarian cancer (“PROC”) will be presented in a late-breaking session. BNT316/ONC-392 is being developed in collaboration with OncoC4, Inc. (“OncoC4”).Follow-up data of activity and immune responses from the ongoing first-in-human Phase 1 clinical trial (NCT04503278) with BNT211 in patients with relapsed/refractory CLDN6+ solid tumors will be presented. BNT211 combines autologous CAR-T cells directed against the oncofetal antigen Claudin-6 (“CLDN6”) and an CLDN6-encoding CAR-T cell amplifying mRNA vaccine (“CARVac”). The data update shows signs of antitumor activity across all indications and an increased persistence of cancer-specific CAR-T cells when combined with CARVac, for example in patients with testicular and ovarian cancers. The safety profile is consistent with the previously published data of CAR-T therapies. BioNTech has established a diversified clinical oncology pipeline including mRNA-based therapeutic cancer vaccines, targeted therapies comprising cell therapies and ADCs, and novel immunomodulators in unmet medical need solid tumor indications. These investigational treatments are currently being evaluated in more than 32 clinical trials, including eight programs in advanced Phase 2 trials and two assets in pivotal Phase 3 trials globally. BioNTech is advancing the Company’s key programs into late-stage development with the aim of having ten or more potentially registrational trials in its oncology pipeline by the end of 2024. The full abstracts are available on the ESMO Congress website. Click here for further information on BioNTech’s pipeline assets. Full presentation details: Late-breaking presentationAsset: BNT316/ONC-392 (gotistobart)Session title: Mini oral session 1: Gynaecological cancers (ID 166)Room: Burgos Auditorium - Hall 5Presentation title: “A randomized, Phase 2, dose optimization of gotistobart, a pH-sensitive anti-CTLA-4, in combination with standard dose pembrolizumab in platinum-resistant recurrent ovarian cancer: safety, efficacy and dose optimization (PRESERVE-004/GOG-3081)”Presentation number: LBA32Date: Sunday, September 15, 2024 Lecture time: 09:10 AM – 09:15 AM CEST Mini oral presentationsAsset: BNT113Session title: Mini oral session: Investigational immunotherapyRoom: Granada Auditorium - Hall 6Presentation title: “HARE-40: A phase I/II trial of therapeutic HPV vaccine (BNT113) in patients with HPV16 driven carcinoma”Presentation number: 999MODate: Monday, September 16, 2024 Lecture time: 11:15 AM – 11:20 AM CEST Asset: BNT211Session title: Proffered paper session 2: Developmental therapeuticsRoom: Salamanca Auditorium - Hall 5Presentation title: “Updated results from BNT211-01 (NCT04503278), an ongoing, first-in-human, Phase 1 study evaluating safety and efficacy of CLDN6 CAR T cells and a CLDN6-encoding mRNA vaccine in patients with relapsed/refractory CLDN6+ solid tumors”Presentation number: 611ODate: Sunday, September 15, 2024 Lecture time: 03:45 PM – 03:55 PM CEST Asset: BNT327/PM8002Session title: Mini oral session: NSCLC metastaticRoom: Santander Auditorium - Hall 5Presentation title: “A Phase II Safety and Efficacy Study of PM8002/BNT327 in Combination with Chemotherapy in Patients with EGFR-mutated Non-Small Cell Lung Cancer (NSCLC)”Presentation number: 1255MODate: Saturday, September 14, 2024 Lecture time: 10:20 AM – 10:25 AM CEST Asset: BNT327/PM8002Session title: Mini oral session 2: Breast cancer, metastaticRoom: Barcelona Auditorium - Hall 2Presentation title: “A Phase Ib/II Study to Assess the Safety and Efficacy of PM8002/BNT327 in Combination with Nab-Paclitaxel for First Line Treatment of Locally Advanced or Metastatic Triple-Negative Breast Cancer”Presentation number: 348MODate: Monday, September 16, 2024 Lecture time: 08:35 AM – 08:40 AM CEST PostersAsset: BNT113Poster title: " Exploratory efficacy and translational results from the safety run in of AHEAD-MERIT, a phase II trial of first line pembrolizumab plus the fixed-antigen cancer vaccine BNT113 in advanced HPV16+ HNSCC "Room: Hall 6Poster number: 877PDate: Saturday, September 14, 2024 Asset: BNT314/GEN1059Poster title: “Phase 1/2 dose escalation/expansion trial to evaluate safety and preliminary efficacy of DuoBody-EpCAMx4-1BB (BNT314/GEN1059) alone or in combination with an immune checkpoint inhibitor in patients with malignant solid tumors”Room: Hall 6Poster number: 1072TiPDate: Saturday, September 14, 2024 Asset: BNT323/DB-1303Poster title: “DYNASTY-Breast02: A Phase 3 trial of BNT323/DB-1303 vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer”Room: Hall 6Poster number: 436TiPAbstract number: 7363Date: Monday, September 16, 2024 Asset: BNT327/PM8002Poster title: “A Phase Ib/IIa Trial to Evaluate the Safety and Efficacy of PM8002/ BNT327, a Bispecific Antibody Targeting PD-L1 and VEGF-A, as a Monotherapy in Patients with advanced renal cell carcinoma”Room: Hall 6Poster number: 1692PDate: Sunday, September 15, 2024 About BioNTechBiopharmaceutical New Technologies (BioNTech) is a global 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 and specialized pharmaceutical collaborators, including Biotheus, DualityBio, Fosun Pharma, Genentech, a member of the Roche Group, Genevant, Genmab, MediLink, OncoC4, Pfizer and Regeneron. 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 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 and its collaborators’ current and future preclinical studies and clinical trials in oncology, including the investigational lipoplex-formulated uridine mRNA immunotherapy BNT113, the investigational bispecific antibodies BNT327/PM8002 and BNT314/GEN1059, the investigational anti-CTLA-4 antibody BNT316/ONC-392 (gotistobart) in combination with pembrolizumab, the investigational CAR-T cell therapy BNT211, and the investigational ADC therapy BNT323/DB-1303; 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 and potential commercialization 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. 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 based on BioNTech’s current expectations and beliefs of future events, and are neither promises nor guarantees. 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 and adversely 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 clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; the ability to produce comparable clinical results in future clinical trials; the timing of and BioNTech’s ability to obtain and maintain regulatory approval for its product candidates; discussions with regulatory agencies regarding timing and requirements for additional clinical trials; 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 its production capabilities and manufacture its products and 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 June 30, 2024, and in subsequent filings made by BioNTech with the SEC, which are available on the SEC’s website at www.sec.gov. These forward-looking statements speak only as of the date hereof. 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. CONTACTS Media Relations Jasmina Alatovic +49 (0)6131 9084 1513 Media@biontech.de Investor RelationsVictoria Meissner, M.D.Investors@biontech.de