Vipivotide

The Phase 1/2 trial will assess the efficacy and safety of BNT316/ONC-392 in combination with the radioligand therapy lutetium (177Lu) vipivotide tetraxetan (Pluvicto®) in patients with metastatic castration resistant prostate cancer (“mCRPC”) who have progressed on an androgen receptor (“AR”) pathway inhibitor. The trial is expected to enroll 144 patients at clinical trial sites in the United States The study is in furtherance of the strategic collaboration between BioNTech and OncoC4 which includes joint development BNT316/ONC-392 in a range of solid tumor indications ROCKVILLE, Md., Feb. 22, 2024 (GLOBE NEWSWIRE) -- OncoC4, Inc. (“OncoC4”) today announced that the first patient with metastatic castration resistant prostate cancer (“mCRPC”) has been dosed in a Phase 1/2 trial evaluating the anti-CTLA-4 antibody candidate BNT316/ONC-392 (gotistobart) in combination with radioligand therapy, lutetium (177Lu) vipivotide tetraxetan (Pluvicto®). BNT316/ONC-392 is being jointly developed by BioNTech and OncoC4. Prostate cancer is the most common diagnosed cancer and among the leading causes of cancer death in men globally.1 Approximately 10-20% of prostate cancer patients develop castration-resistant prostate cancer.2 These patients often have a poor prognosis, with a median survival of about two years for patients at metastatic disease stage.3 The medical need remains high for new treatment options that increase survival for patients with mCRPC. “Advances in the treatment of mCRPC have demonstrated improved outcomes, but a high unmet need remains for additional well-tolerated targeted therapies that can further extend survival in these patients. We look forward to evaluating BNT316/ONC-392 in combination with radioligand therapy with the aim to further improve outcomes for patients with this advanced stage of disease,” said David R. Wise, M.D., Ph.D., Director of the Perlmutter Cancer Center at NYU Langone Health, and Principal Investigator of the Phase 1/2 trial. The open label, randomized Phase 1/2 trial, PRESERVE-006 (NCT05682443), will assess the safety and efficacy of BNT316/ONC-392 in combination with lutetium (177Lu) vipivotide tetraxetan in patients with mCRPC who have progressed on an androgen receptor (“AR”) pathway inhibitor. The OncoC4-sponsored trial is expected to enroll 144 patients across 20 sites within the United States. The trial will initially evaluate the safety of BNT316/ONC-392 in combination with lutetium (177Lu) vipivotide tetraxetan and help inform the preferred dosage. The Phase 2 part of the trial will evaluate safety and efficacy in patients with metastatic castration resistant prostate cancer with prostate-specific membrane antigen (“PSMA”)-positive scans who have progressed on prior AR targeted agents and are lutetium (177Lu) vipivotide tetraxetan-naïve. The trial will assess whether the combination increases progression free survival over the current standard of care as the primary endpoint. In March 2023, BioNTech and OncoC4 announced entry into a strategic collaboration, which includes joint development of BNT316/ONC-392 in a range of solid tumor indications, with the parties equally sharing development costs for such joint development studies. BioNTech holds the exclusive worldwide commercialization rights for this product candidate. BNT316/ONC-392 is currently being evaluated in multiple ongoing clinical trials in patients with advanced solid tumors, including one ongoing registrational Phase 3 trial, PRESERVE-003 (NCT05671510), which is evaluating BNT316/ONC-392 as monotherapy in patients with metastatic, immunotherapy-resistant non-small cell lung cancer (“NSCLC”). About gotistobart (BNT316/ONC-392) BNT316/ONC-392 (gotistobart) is a next-generation anti-CTLA-4 antibody candidate jointly developed by BioNTech and OncoC4. BNT316/ONC-392 is currently in late-stage clinical development as monotherapy or combination therapy in various cancer indications. The immune checkpoint receptor CTLA-4 inhibits T cell immune response and reduces the activity of T cells in recognizing and eliminating cancer cells.4 This mechanism is also exploited by cancer cells to prevent them from being eliminated by T cells.5 Blocking CTLA-4 may help to preserve T cell activity and enhance anti-tumor activity. BNT316/ONC-392 was designed with the aim to address this mechanism while preserving CTLA-4 recycling and thus the immunosuppressive T cell (regulatory T cells, or “Tregs”) function in the peripheral tissues. The aim with this approach, which is currently under clinical evaluation, is to give rise to fewer immune-related adverse effects. About Prostate Cancer Prostate cancer is the most common diagnosed cancer and leading cause of cancer death in men globally, with an incidence of 1.4 million in 2020.1 Often driven by male sex hormones, called androgens, metastatic castration-resistant prostate cancer (“mCRPC”) is a type of prostate cancer associated with a significant mortality rate that has spread to different parts of the body and no longer responds to androgen blocking therapy.6 The prostate-specific membrane antigen (“PSMA”) is a biomarker expressed on prostate cancer cells that can be targeted with radioligand therapy.7 Up to 30% of men with prostate cancer will develop castration-resistant prostate cancer (“CRPC”) within five years, with approximately 84% at metastatic disease stage at the time of CRPC diagnosis.2, 8 About OncoC4 Based in Rockville, Maryland, OncoC4 is a privately held, late clinical-stage biopharmaceutical company that is actively engaged in the discovery and development of novel biologics for the potential treatment of cancer. Its lead clinical candidate is BNT316/ONC-392, a next generation anti-CTLA-4 antibody that is designed to allow CTLA-4 to recycle and maintain its protective function against autoimmune diseases while enhancing anti-tumor activity at the same time. In addition, OncoC4 has a pipeline of potentially first-in-class preclinical product candidates focusing on the CD24-Siglecs cancer immune evasion pathway. More information: . CONTACTS OncoC4 Investor Contact: Alexandra Folias LifeSci Advisors afolias@lifesciadvisors.com Media Contact: Mari Purpura LifeSci Advisors mpurpura@lifesciadvisors.com _________________________ 1 International Agency for Research on Cancer. GLOBOCAN 2020. Online at: 2 A J, Zhang B, Zhang Z, et al. Cancers (Basel). 2021 Feb 22;13(4):917. doi: 10.3390/cancers13040917. 3 Freedland SJ, Davis Metthew, Epstein AJ, et al. Prostate Cancer Prostatic Dis. 2023 Oct 2. doi: 10.1038/s41391-023-00725-8. Online ahead of print. 4 Seidel JA, Otsuka A, Kabashima K. Front Oncol. 2018 Mar 28:8:86. doi: 10.3389/fonc.2018.00086. eCollection 2018. 5 Front. Immunol., 2021 Aug. 31; Vol. 12 – 2021; 6 American Society of Clinical Oncology (ASCO). Prostate Cancer: Types of Treatment. Available under: (last access: 03.01.2024) 7 Hyväkkä A, Virtanen V, et al. Cancers (Basel). 2021 May 7;13(9):2244. doi: 10.3390/cancers13092244. 8 Kirby M, Hirst c, Crawford ED. Int J Clin Pract. 2011 Nov;65(11):1180-92. doi: 10.1111/j.1742-1241.2011.02799.x.

Overall survival results from pooled exploratory analysis of MONALEESA trials in patients with aggressive HR+/HER2- advanced breast cancer treated with Kisqali® Data from VISION study reporting associations between magnitude of PSA decline from baseline and clinical outcomes with Pluvicto® in patients with mCRPC Overall survival and safety findings for first-line tislelizumab in unresectable hepatocellular carcinoma from RATIONALE 301, the eighth positive clinical trial readout for tislelizumab Basel, August 30, 2022 — Novartis will showcase new data from across its oncology portfolio at the European Society for Medical Oncology (ESMO) Congress 2022 with over 35 accepted abstracts from Novartis-sponsored and investigator-initiated trials including new data in advanced breast cancer and metastatic castration-resistant prostate cancer. “We are excited to share the data being presented across our portfolio of cancer therapies, which reinforce our commitment to pursuing every possible approach to address the urgent and significant unmet medical needs of people living with cancer,” said Jeff Legos, Executive Vice President, Global Head of Oncology & Hematology Development, Novartis. “Our presentations at ESMO will highlight our continued dedication to advancing innovative treatment options for these critical diseases.” Key highlights of data accepted by ESMO: Medicine Abstract Title Abstract Number/ Presentation Details Kisqali® (ribociclib)* Pooled exploratory analysis of survival in patients (pts) with HR+/HER2− advanced breast cancer (ABC) and visceral metastases (mets) treated with ribociclib (RIB) + endocrine therapy (ET) in the MONALEESA (ML) trials​ Abstract #205PPoster SessionSaturday, September 10 Kisqali® (ribociclib)* HARMONIA SOLTI-2101 / AFT-58: A head-to-head phase III study comparing ribociclib (RIB) and palbociclib (PAL) in patients with hormone receptor-positive/HER2-negative/HER2-Enriched (HR+/HER2-/HER2-E) advanced breast cancer (ABC)† Abstract # 272TiPPoster SessionSaturday, September 10 Piqray® (alpelisib) BYLieve trial (alpelisib [ALP] + endocrine therapy [ET]) versus real-world (RW) standard of care (SOC) in patients (pts) with PIK3CA-mutated (mut), hormone receptor-2 positive (HR+), human epidermal growth factor receptor 2-negative (HER2–) advanced 3 breast cancer (ABC) who progressed on cyclin-dependent kinase 4/6 inhibitor (CDKi) 4 therapy (tx) Abstract #222PPoster SessionSaturday, September 10 Tislelizumab​ Final Analysis of RATIONALE-301: Randomized, Phase 3 study of tislelizumab versus sorafenib as first-line treatment for unresectable hepatocellular carcinoma Abstract #LBA36Proffered Paper SessionSaturday, September 1009:15 – 09:25 AM CEST Tislelizumab​ Tislelizumab (TIS) versus docetaxel (TAX) as second- or third-line therapy in previously treated patients (pts) with locally advanced non-small cell lung cancer (NSCLC): Asian versus non-Asian subgroup analysis of the RATIONALE-303 study Abstract #1031PPoster SessionMonday, September 12 Pluvicto™ (lutetium 177Lu vipivotide tetraxetan) (formerly referred to as 177Lu-PSMA-617) Association between prostate-specific antigen decline and clinical outcomes in patients with metastatic castration-resistant prostate cancer in the VISION trial Abstract #1372PPoster SessionSunday, September 11 Pluvicto™ (lutetium 177Lu vipivotide tetraxetan) Radiographic progression-free survival correlation with patient-relevant outcomes: a post hoc analysis of time-to-event endpoints of the VISION trial Abstract #1374PPoster SessionSunday, September 11, Prostate Cancer Quality of life across three countries using a large-scale, fully digital survey of patients with prostate cancer Abstract #1401PPoster SessionSunday, September 11 Canakinumab(ACZ885) CANOPY-A: phase III study of canakinumab (CAN) as adjuvant therapy in patients (pts) with completely resected non-small cell lung cancer (NSCLC) Abstract #LBA49Proffered Paper SessionSunday, September 1109:20 – 09:30 AM CEST Vijoice® (alpelisib) Clinical benefit of alpelisib in pediatric patients with PIK3CA-related overgrowth spectrum (PROS): an EPIK-P1 analysis Abstract #468PPoster SessionMonday, September 12 Product InformationFor full prescribing information, including approved indications and important safety information about marketed products, please visit https://www.novartisoncology.com/news/product-portfolio. 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Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise. About NovartisNovartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 108,000 people of more than 140 nationalities work at Novartis around the world. Find out more at https://www.novartis.com. Novartis is on Twitter. 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