Ontorpacept

NEW YORK--( BUSINESS WIRE )--Pfizer Inc. (NYSE: PFE) will present data across its Oncology portfolio and growing pipeline, covering multiple tumor types and novel mechanisms of action at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago from June 2 through June 6. Abstracts include new data from pivotal trials supporting ongoing regulatory reviews for three potential therapies, if approved, and new clinical data for six early pipeline assets. In addition, Pfizer will highlight its ongoing scientific leadership in breast cancer with additional real-world evidence (RWE) for IBRANCE ® (palbociclib) and initial first-in-human results for its novel CDK4- and CDK2-selective inhibitors, respectively, and novel epigenetic modulator KAT6 inhibitor. “At ASCO, Pfizer will present new data across the four key areas of our industry-leading portfolio – breast cancer, genitourinary cancer, hematology, and precision medicine – and for the first time, first-in-human data for some of our most exciting pipeline medicines,” said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology and Rare Disease, Pfizer Global Product Development. “With four anticipated regulatory decisions this year and a growing portfolio of multiple mechanisms of action, Pfizer Oncology is poised to take our scientific innovation to the next level and bring new hope to people with cancer.” Today, Pfizer Oncology has a comprehensive portfolio of 24 approved innovative cancer medicines and biosimilars to treat more than 30 cancer types and an extensive pipeline of more than 30 programs in clinical development. With the recently announced proposed acquisition of Seagen*, a leader in antibody-drug conjugate technology, Pfizer is further accelerating its fight against cancer to deliver the next generation of Oncology breakthroughs. “Placing patients at the center of everything we do is a critical component of advancing cutting-edge science and improving outcomes for patients,” said Dany Habr, M.D., Oncology Chief Medical Affairs Officer, Pfizer. “At ASCO, we look forward to connecting with the entire Oncology community to continue our efforts and shared approaches in making scientific breakthroughs accessible to all people living with cancer, everywhere.” Pfizer’s commitment to advancing scientific innovation will be on display at ASCO 2023 with more than 40 company-sponsored abstracts. Highlights include: 13 abstracts across the comprehensive MagnetisMM clinical trial program reinforcing the efficacy and safety of elranatamab, an investigational subcutaneous B-cell maturation antigen (BCMA)-CD3-targeted bispecific antibody, in relapsed or refractory multiple myeloma (RRMM), including an oral presentation on the first data from patients treated with prior BCMA-targeted therapy. Elranatamab is under Priority Review with the U.S. Food and Drug Administration (FDA) and under review with the European Medicines Agency (EMA) for the treatment of RRMM. Four abstracts, including an oral presentation on new additional data from the Phase 3 TALAPRO-2 study , supporting the potential of TALZENNA ® (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor that plays a role in DNA damage repair, in combination with XTANDI ® (enzalutamide), an androgen receptor signaling inhibitor, in men with metastatic castration-resistant prostate cancer. The FDA has granted Priority Review for the Supplemental New Drug Application (sNDA) for TALZENNA in combination with XTANDI and an application is also under review with the EMA. For the first time, the primary efficacy and safety results from the Phase 2 PHAROS trial exploring BRAFTOVI ® (encorafenib), an oral BRAF kinase inhibitor, given in combination with MEKTOVI ® (binimetinib), an oral MEK inhibitor, in patients with metastatic non-small cell lung cancer harboring a BRAF V600E mutation.** Results from the PHAROS study support the sNDAs for BRAFTOVI and MEKTOVI in this setting that are currently under review by the FDA. Advancements across Pfizer’s leading breast cancer portfolio and pipeline, including a new analysis of real-world evidence for IBRANCE, an oral first-in-class inhibitor of cyclin-dependent kinases (CDKs) 4 and 6, as a first-line treatment of metastatic breast cancer. In addition, the first Phase 1 data for the CDK4-selective inhibitor PF-07220060, the CDK2-selective inhibitor PF-07104091 and the KAT6 inhibitor PF-07248144, all investigational agents for advanced or metastatic hormone-receptor positive breast cancer, will be presented. A complete list of Pfizer-sponsored accepted abstracts is available at https://cdn.pfizer.com/pfizercom/ASCO-Abstract-Chart-5.19.23-Pfizer-Sponsored-Abstracts.pdf . Pfizer is also continuing its commitment to help non-scientists understand the latest findings with the development of abstract plain language summaries (APLS) for company-sponsored research being presented at ASCO, which are written in non-technical language. Those interested in learning more can visit www.Pfizer.com/apls to access the summaries starting May 25. Key Pfizer-sponsored oral and poster discussion presentations at ASCO 2023 include: BREAST CANCER Poster Discussion (Abstract 3009) Saturday, June 3, 1:15-2:45 PM CDT First-in-human first-in-class Phase 1/2a study of the next generation CDK4-selective inhibitor PF-07220060 in patients (pts) with advanced solid tumors, enriched for HR+ HER2- mBC pts who progressed on prior CDK4/6 inhibitors and endocrine therapy. Yap TA Poster Discussion (Abstract 3010) Saturday, June 3, 1:15-2:45 PM CDT First-in-human Phase 1/2a study of a potent and novel CDK2-selective inhibitor PF-07104091 in patients (pts) with advanced solid tumors, enriched for CDK4/6 inhibitor resistant HR+/HER2- breast cancer pts. Yap TA Poster Discussion (Abstract 1018) Sunday, June 4, 11:30 AM-1:00 PM CDT First-line systemic treatment with palbociclib in women aged ≥70 years presenting with hormone receptors-positive advanced breast cancer: Results from the PALOMAGE program. Carola E GENITOURINARY CANCERS Oral Presentation (Abstract 5004) Sunday, June 4, 8:00-11:00 AM CDT TALAPRO-2: Phase 3 study of talazoparib (TALA) + enzalutamide (ENZA) versus placebo (PBO) + ENZA as first-line (1L) treatment for patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) harboring homologous recombination repair (HRR) gene alterations. Agarwal N Poster Discussion (Abstract 5013) Saturday, June 3, 1:15-2:45 PM CDT Patient-reported outcomes (PROs) among men receiving talazoparib (TALA) + enzalutamide (ENZA) vs placebo (PBO) + ENZA as first-line (1L) treatment for metastatic castration-resistant prostate cancer (mCRPC): Results from a phase 3 study (TALAPRO-2). Agarwal N Poster Discussion (Abstract 4515) Saturday, June 3, 3:00-4:30 PM CDT Estimated net benefit of avelumab (AVE) + best supportive care (BSC) vs BSC alone for patients (pts) with advanced urothelial carcinoma (aUC) using a quality-adjusted time without cancer symptoms or toxicity (Q-TWiST) analysis. Powles T Poster Discussion (Abstract 4516) Saturday, June 3, 3:00-4:30 PM CDT Long-term safety of avelumab first-line (1L) maintenance for advanced urothelial carcinoma (aUC) in the JAVELIN Bladder 100 trial. Bellmunt J HEMATOLOGY Oral Presentation (Abstract 8008) Saturday, June 3, 1:15-4:15 PM CDT Efficacy and safety of elranatamab in patients with relapsed/refractory multiple myeloma (RRMM) and prior B-cell maturation antigen (BCMA)-directed therapies: A pooled analysis from MagnetisMM studies. Nooka AK PRECISION MEDICINE Poster Discussion (Abstract 9018) Sunday, June 4, 4:30-6:00 PM CDT Efficacy and safety of encorafenib (enco) plus binimetinib (bini) in patients with BRAF V600E-mutant ( BRAF V600E ) metastatic non-small cell lung cancer (NSCLC) from the phase 2 PHAROS study. Riely G Other/Advanced Cancers Oral Presentation (Abstract 11508) Monday, June 5, 11:30 AM-2:30 PM CDT Safety and clinical activity of TTI-621 in combination with doxorubicin in patients with unresectable or metastatic high-grade leiomyosarcoma: Results from the low-dose expansion cohort. Movva S Poster Discussion (Abstract 3020) Saturday, June 3, 1:15-2:45 PM CDT A first-in-human, phase 1 study of the SHP2 inhibitor PF-07284892 as monotherapy and in combination with different targeted therapies in oncogene-driven treatment-resistant solid tumors. Drilon A *Pfizer and Seagen remain two separate, independent companies prior to closing. Closing of the transaction is subject to fulfillment of customary closing conditions, including approval of Seagen’s stockholders and receipt of necessary regulatory clearances. **Pfizer has exclusive rights to BRAFTOVI and MEKTOVI in the U.S., Canada, and all countries in the Latin American, African, and Middle Eastern regions. Ono Pharmaceutical Co., Ltd. has exclusive rights to commercialize both products in Japan and South Korea, Medison has exclusive rights in Israel, and Pierre Fabre has exclusive rights in all other countries, including Europe and Asia-Pacific (excluding Japan and South Korea). Prescribing Information for Pfizer Medicines Please see full Prescribing Information for BRAFTOVI ® (encorafenib) and full Prescribing Information for MEKTOVI ® (binimetinib) or visit https://braftovimektovi.pfizerpro.com . Please see full Prescribing Information for IBRANCE ® (palbociclib) tablets and full Prescribing Information for IBRANCE ® (palbociclib) capsules or visit https://ibrance.pfizerpro.com . Please see full Prescribing Information for TALZENNA ® (talazoparib) or visit https://talzenna.pfizerpro.com . Please see full Prescribing Information for XTANDI ® (enzalutamide) or visit https://www.xtandihcp.com . About Pfizer Oncology At Pfizer Oncology, we are committed to advancing medicines wherever we believe we can make a meaningful difference in the lives of people living with cancer. Today, we have an industry-leading portfolio of 24 approved innovative cancer medicines and biosimilars across more than 30 indications, including breast, genitourinary, colorectal, blood and lung cancers, as well as melanoma. About Pfizer: Breakthroughs That Change Patients’ Lives At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com . In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News , LinkedIn , YouTube and like us on Facebook at Facebook.com/Pfizer . DISCLOSURE NOTICE: The information contained in this release is as of May 25, 2023. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information about Pfizer’s oncology portfolio of marketed and investigational therapies, including BRAFTOVI ® (encorafenib), MEKTOVI ® (binimetinib) , IBRANCE ® (palbociclib), TALZENNA ® (talazoparib), XTANDI ® (enzalutamide), and elranatamab, an investigational B-cell maturation antigen (BCMA) CD3-targeted bispecific antibody, and Pfizer’s proposed acquisition of Seagen, including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of Pfizer’s oncology portfolio; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when drug applications may be filed in any jurisdictions for any potential indication for Pfizer’s oncology products and product candidates; whether and when any such applications that may be pending or filed may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether any such products will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of Pfizer’s oncology products and product candidates; risks related to the satisfaction or waiver of the conditions to closing the proposed acquisition of Seagen (including the failure to obtain necessary regulatory approvals and failure to obtain the requisite vote by Seagen stockholders) in the anticipated timeframe or at all, including the possibility that the proposed acquisition does not close; the possibility that competing offers for Seagen may be made; risks related to the ability to realize the anticipated benefits of the proposed acquisition of Seagen, including the possibility that the expected benefits from the acquisition will not be realized or will not be realized within the expected time period; the risk that the businesses will not be integrated successfully; disruption from the Seagen transaction making it more difficult to maintain business and operational relationships; negative effects of the consummation of the proposed acquisition of Seagen on the market price of Pfizer’s common stock and/or operating results; significant transaction costs; unknown liabilities; the risk of litigation and/or regulatory actions related to the proposed acquisition or Seagen’s business; risks related to the financing of the Seagen transaction; other business effects and uncertainties, including the effects of industry, market, business, economic, political or regulatory conditions; future exchange and interest rates; changes in tax and other laws, regulations, rates and policies; future business combinations or disposals; the impact of COVID-19 on our business, operations and financial results; and competitive developments. A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results,” as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com .

JERSEY CITY, N.J., June 29, 2022 /PRNewswire/ -- InsightAce Analytic Pvt. Ltd. announces the release of a market assessment report on the ' Global CD47 Targeting Therapeutics Market By Target Disease Indication (Acute Myeloid Leukemia, Non-Hodgkin Lymphoma, Colorectal Cancer, Diffuse Large B-cell Lymphoma, Myelodysplastic Syndromes, Non-Small Cell Lung Cancers, Ovarian Epithelial Cancer, Oral mucositis, Small Cell Lung Cancers, Other Diseases Indications), By Type of molecule(Biologics, Small molecule) - Market Outlook and Industry Analysis 2030.' According to the latest research by InsightAce Analytic, the global CD47 targeting therapeutics market size is expected to record a promising CAGR of 67% during the period of 2022-2030. Request for Sample Pages: One key mechanism of tumour cell immune escape is the overexpression of an immunoglobulin, CD47. CD47 is a transmembrane protein that glycosylates on the surface of different cancer cells and helps survive cancer cells in various cancer types. In many cancer types, the binding of CD47 to signal-regulatory protein α (SIRPα) initiates an inhibitory signalling pathway that prevents malignant cells from phagocytosis by macrophages. Therefore, inhibition of the CD47-SIRPα signalling pathway can enhance the phagocytosis of tumour cells by macrophages. The growth of the global CD47 targeting therapeutics market can be attributed to several factors, such as the increase in adoption of CD47-targeting anti-cancer therapies, growing geriatric population , high prevalence of various cancer types, and rising awareness among people regarding the advantages of targeting therapeutics. Additionally, the increasing R&D investments to improve the understanding of CD47-dependent signalling are anticipated to create new opportunities for the CD47 targeting the therapeutics market over the forecast period. Improved knowledge in this field of research could lead to the innovation of advanced and effective anti-tumour therapies that act through the inhibition of CD47 signalling in cancer cells. For instance, in June 2021, Trillium Therapeutics Inc. (Canada), a company engaged in developing innovative therapies for cancer treatments, developed a checkpoint inhibitor of the innate immune system, TTI-621 (SIRPα-IgG1 Fc), in combination with doxorubicin. TTI-621 binds CD47, an innate immune checkpoint that binds SIRPα and delivers a "don't eat me" signal to suppress macrophage phagocytosis. However, the expensive production and complex manufacturing of target therapies, damage to normal cells while exerting an anti-tumour effect, and strict government regulations for therapy approvals are expected to limit the market adoption during the forecast years. By region, the North America region is expected to witness significant growth over the forecast period (2022-2030) due to the fast adoption of innovative drugs and therapy techniques and the increasing number of cancer patients and cancer mortalities in this region. Request for ToC/Proposal: Major market players operating in the CD47 targeting therapeutics market include Abpro (US), ALX Oncology (US), Apmonia Therapeutics (France), Arch Oncology (US), Aurigene (Bangalore), Bristol Myers Squibb (US), Conjupro biotherapeutics (US), EpicentRx (US), Forty Seven (US) TG Therapeutics, Adagene, Alector, Inc., Apmonia Therapeutics, I-MAB Biopharma Co., Ltd., QLSF Biotherapeutics Inc., Phanes Therapeutics, Inc., Bio-Thera Solutions, among others. Key developments in the market: In Jan 2022, the American Food and Drug Administration gave the next-generation CD47 blocker evorpacept, made by ALX Oncology, was given orphan drug designation ("ODD") for the treatment of patients with gastric cancer and gastroesophageal junction cancer. In Sept 2021, Pfizer Inc. (US) acquired Trillium Therapeutics Inc. (Canada) with its CD47 candidates for US$2.3 billion. This acquisition has enhanced the oncology and haematology portfolios of Pfizer. In June 2021, ALX Oncology (US) entered into a clinical trial collaboration and supply agreement with Eli Lilly and Company (US), an American pharmaceutical company, to evaluate the combination of ALX148, a next-generation CD47 blocker, and CYRAMZA (ramucirumab), Lilly's anti-VEGFR2 antibody, for the treatment of gastric cancer. In Mar 2020, Alector and Innovent Biologics entered into a licencing agreement so that AL008 could be developed and sold in China for oncology indications. The CD47-SIRP-alpha pathway, a potent survival pathway used by tumours to evade the innate immune system, is the target of AL008, a novel antibody product candidate. In Mar 2020, Gilead Sciences, Inc. and Forty Seven, Inc. announced that they have entered into a stratigic agreement pursuant to which Gilead will acquire Forty Seven for $95.50 per share in cash. Market Segments Global CD47 Targeting Therapeutics Market, by Target Disease Indication, 2022-2030 (Valu US$ Mn) Acute Myeloid Leukemia Non-Hodgkin Lymphoma Colorectal Cancer Diffuse Large B-cell Lymphoma Myelodysplastic Syndromes Non-Small Cell Lung Cancers Ovarian Epithelial Cancer Oral mucositis Small Cell Lung Cancers Other Diseases Indications Global CD47 Targeting Therapeutics Market, by Type of Molecule, 2022-2030 (Value US$ Mn) Biologics Small Molecule Global CD47 Targeting Therapeutics Market, by Region, 2022-2030 (Value US$ Mn) North America Europe Asia Pacific Latin America Middle East & Africa North America CD47 Targeting Therapeutics Market, by Country, 2022-2030 (Value US$ Mn) U.S. Canada Europe CD47 Targeting Therapeutics Market, by Country, 2022-2030 (Value US$ Mn) Germany France Italy Spain Russia Rest of Europe Asia Pacific CD47 Targeting Therapeutics Market, by Country, 2022-2030 (Value US$ Mn) India China Japan South Korea Australia & New Zealand Latin America CD47 Targeting Therapeutics Market, by Country, 2022-2030 (Value US$ Mn) Brazil Mexico Rest of Latin America Middle East & Africa CD47 Targeting Therapeutics Market, by Country, 2022-2030 (Value US$ Mn) GCC Countries South Africa Rest of Middle East & Africa Why should buy this report: To receive a comprehensive analysis of the prospects for the global CD47 Targeting Therapeutics Market To receive an clinical trials overview and future product pipeline of the CD47 Targeting Therapeutics Market To analyze CD47 Targeting Therapeutics Market drivers and challenges To get information on the CD47 Targeting Therapeutics Market size (Value US$ Mn) forecast to 2030 To get details regarding investments, mergers & acquisitions in the CD47 Targeting Therapeutics Market industry For More Information at Other Related Reports Published by InsightAce Analytic: Global Novel T-Cell Immunotherapies Market Global Allogeneic Cell Therapy Manufacturing Market Global Regulatory T-Cell (Tregs) Therapies Market Global CAR T-Cell Therapy For Multiple Myeloma Market Global Immuno-Oncology Cell Therapy Market About Us: InsightAce Analytic is a market research and consulting firm that enables clients to make strategic decisions. Our qualitative and quantitative market intelligence solutions inform the need for market and competitive intelligence to expand businesses. We help clients gain a competitive advantage by identifying untapped markets, exploring new and competing technologies, segmenting potential markets, and repositioning products. Our expertise is in providing syndicated and custom market intelligence reports with an in-depth analysis with key market insights in a timely and cost-effective manner. Contact Us: InsightAce Analytic Pvt. Ltd. Tel.: +1 718 593 4405 Email: [email protected] Site Visit: Follow Us on LinkedIn at bit.ly/2tBXsgS Follow Us On Facebook at bit.ly/2H9jnDZ Logo: SOURCE InsightAce Analytic Pvt. Ltd.