This phase II trial tests the safety, side effects, and best dose of TTI-621 (closed to enrollment) or TTI-622 in combination with pembrolizumab in treating patients with diffuse large B-cell lymphoma that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). TTI-621 and TTI-622 are called fusion proteins. A fusion protein includes two specialized proteins that are joined together. In TTI-621 and TTI-622, one of the proteins binds with other proteins found on the surface of certain cells that are part of the immune system. The other protein targets and blocks a protein called CD47. CD47 is present on cancer cells and is used by those cells to hide from the body's immune system. By blocking CD47, TTI-621 and TTI-622 may help the immune system find and destroy cancer cells. Pembrolizumab is a monoclonal antibody directed against human cell surface receptor PD-1 (programmed death-1 or programmed cell death-1) that works by helping the body's immune system attack the cancer and may interfere with the ability of cancer cells to grow and spread. Giving TTI-621 (closed to enrollment) or TTI-622 in combination with pembrolizumab may kill more cancer cells in patients with relapsed or refractory diffuse large B-cell lymphoma.

Start Date19 Apr 2023

Sponsor / Collaborator

Mayo Clinic

NCT04996004

/ TerminatedPhase 2

A Phase I/II Study of TTI-621 in Combination With Doxorubicin in Patients With Unresectable or Metastatic High-Grade Leiomyosarcoma

The purpose of this study is to learn about the safety and effects of the study medicine (called Ontorpacept or TTI-621) when given alone and when given in combination with doxorubicin for people with leiomyosarcoma. Leiomyosarcoma is a tumor of the smooth muscles.
This study is seeking participants who have:
* leiomyosarcoma that is advanced or has spread to other parts of the body (metastatic)
* not received prior treatment with anthracyclines (a drug commonly used in patients with some kinds of cancer, including leiomyosarcoma)
* not received more than one prior treatment for their leiomyosarcoma During the first 18 weeks of this study, participants will receive doxorubicin by IV infusion (given directly into a vein) at the study clinic every 3 weeks for a total of 6 doses. Participants will also receive Ontorpacept (TTI-621) by IV infusion at the study clinic on the same day as doxorubicin and again one week later for the first 18 weeks.
After the first 18 weeks, participants will stop receiving doxorubicin but will continue receiving Ontorpacept (TTI-621) as IV infusion every 14 days at the study clinic. They will keep receiving Ontorpacept (TTI-621) until their cancer is no longer responding to treatment.
We will examine the experiences of participants receiving Ontorpacept (TTI-621) in combination with doxorubicin in the first 18 weeks and then Ontorpacept (TTI-621) by itself after the doxorubicin is stopped. This will help us determine if the study medicine Ontorpacept (TTI-621) given with doxorubicin and then by itself is safe and effective.
Participants will be involved in the study for approximately one year, depending on how their cancer responds to the study treatment. They will have study visits about 12 times in the first 18 weeks (when the study medicine Ontorpacept is given with doxorubicin) and then every two weeks after the doxorubicin is stopped and the study medicine Ontorpacept (TTI-621) is given by itself.

Start Date22 Jun 2021

Sponsor / Collaborator

Pfizer Inc.

NCT02890368

/ TerminatedPhase 1

A Phase 1 Dose Escalation Trial of Intratumoral Injections of TTI-621 in Subjects With Relapsed and Refractory Percutaneously-Accessible Solid Tumors and Mycosis Fungoides

This is a multicenter, open-label, phase 1 study conducted to test intratumoral injections of TTI-621 in subjects that have relapsed and refractory percutaneously accessible solid tumors or mycosis fungoides.
The study will be performed in two different parts. Part 1 is the Dose Escalation phase and Part 2 is the Dose Expansion phase.
The purpose of this study is to characterize the safety profile of TTI-621 and to determine the optimal dose and delivery schedule of TTI-621. In addition, the safety and antitumor activity of TTI-621 will be evaluated in combination with other anti-cancer agents or radiation.

Start Date01 Sep 2016

Sponsor / Collaborator

Pfizer Inc.

100 Clinical Results associated with Ontorpacept

100 Translational Medicine associated with Ontorpacept

100 Patents (Medical) associated with Ontorpacept

Literatures (Medical) associated with Ontorpacept

05 Nov 2026·BRITISH JOURNAL OF CANCER

A Phase 1/2 study of ontorpacept (TTI-621) in combination with doxorubicin in patients with unresectable or metastatic high-grade leiomyosarcoma

Article

Author: Wei, Caimiao ; Mangla, Ankit ; Davis, Lara E ; Bouyoucef-Cherchalli, Dalila ; Attia, Steven ; Zhang, Hong ; Monga, Varun ; Allgood, Victoria ; Bailey, Howard H ; Chawla, Sant ; Milhem, Mohammed ; Chugh, Rashmi ; Movva, Sujana ; Pomerance, Ilan ; Bruns, Ingmar ; Kuttschreuter, Luke ; Lin, Gloria H Y ; Druta, Mihaela

BACKGROUND:

Ontorpacept, a recombinant signal regulatory protein alpha (SIRPα)-blocking fusion protein, has antitumour activity by disrupting CD47-SIRPα signalling. This Phase 1/2 study examined ontorpacept with doxorubicin in patients with leiomyosarcoma.

METHODS:

Eligible patients were ≥18 years with metastatic or locally advanced high-grade soft-tissue sarcomas (high-grade leiomyosarcoma in Phase 2). In Phase 1, patients received escalating doses of ontorpacept plus doxorubicin. Phase 2 dose expansion evaluated ontorpacept doses 0.2, 1.0, and 2.0 mg/kg plus doxorubicin. The primary endpoints were safety (Phase 1); and objective response rate (ORR) (Phase 1/2).

RESULTS:

Seventy-six patients were enrolled (Phase 1, n = 9; Phase 2, n = 67). No dose-limiting toxicities occurred in Phase 1. The most common treatment-related adverse events were neutrophil count decreased/neutropenia (grade ≥3 in 66% of patients). In Phase 1, one patient receiving ontorpacept 2.0 mg/kg had a confirmed partial response. In Phase 2, six patients receiving ontorpacept 0.2 mg/kg (ORR, 18.8%; 95% CI, 7.2-36.4) and one patient receiving 2.0 mg/kg (ORR, 4.5%; 95% CI, 0.1-22.8) had confirmed partial responses.

CONCLUSIONS:

This first study of CD47 inhibition with chemotherapy in leiomyosarcomas shows manageable safety, supporting further investigation of ontorpacept dosing and schedule, in combination with doxorubicin and as monotherapy.

01 Oct 2021·Nature reviews. Drug discovery

Pfizer’s COVID-19 vaccine secures first full FDA approval

Author: Mullard, Asher

CD47 is a marker of self protein that is typically expressed at low levels by healthy cells throughout the body.When CD47 binds to SIRP α on macrophages, it inhibits phagocytosis.Activate macrophages. With TTI-621, the decoy is fused to an IgG1 Fc region.

01 Apr 2020·Seminars in oncologyQ3 · MEDICINE

Just eat it: A review of CD47 and SIRP-α antagonism

Q3 · MEDICINE

Review

Author: Oronsky, Bryan ; Reid, Tony ; Carter, Corey ; Knox, Susan J ; Brinkhaus, Franck

The mammalian immune system consists of two distinct arms, nonspecific innate and more specific adaptive, with the innate immune response as the first line of defense and protection, which primes and amplifies subsequent adaptive responses. On the basis of this binary immune interplay, stimulation of T cells through checkpoint inhibitors (CIs), which bypasses innate involvement, seems likely to engender suboptimal or incomplete anticancer immunity, given that the successful induction of effect or responses depends on two-way innate/adaptive coordination. Indeed, the majority of patients-70%-80%, do not respond to CIs, which is potentially problematic if access to more optimal standard therapies is withheld or delayed in favor of ineffective or only marginally effective anti-PD-1/PD-L1 treatment. Therefore, stimulation of the innate immune response in combination with CIs (or other inducers of T cell cytotoxicity) has the potential to make the immune system "whole" and thereby to enhance and broaden the anti-tumor activity of PD-1/PD-L1 inhibitors for example, in relatively nonimmunogenic or "cold" tumor types. A critical innate macrophage immune checkpoint and druggable target is the antiphagocytic and "marker of self" CD47-SIRPα pathway, which is co-opted by cancer cells to mediate escape from immune-mediated clearance and checkpoint inhibition. This review summarizes the status of key CD47 antagonists in clinical trials, including the biologics, Hu5F9-G4 (5F9), TTI-621, and ALX148, as well as the small molecule, RRx-001, now in a Phase 3 clinical trial, which has not been previously included in CD47-SIRPα reviews focused on biologics. Hu5F9-G4 (5F9), TTI-621, ALX148, and RRx-001 are chosen as compounds with potentially promising data that have advanced the farthest in clinical development.

News (Medical) associated with Ontorpacept

05 May 2026

·www.fiercebiotech.com

Pfizer’s $2.3B Trillium bet ends in failure as remaining CD47 blocker scrapped along with T-cell engager

Pfizer also revealed it has ended work on its only clinical-stage T-cell engager.\n Pfizer’s $2.3 billion bet on Trillium Therapeutics doesn’t look like it will ever pay out, with the Big Pharma abandoning the second and final clinical-stage candidate from that acquisition.The buyout back in 2021 gave Pfizer ownership of a pair of CD47 inhibitors, which were rechristened ontorpacept and maplirpacept. While ontorpacept made it into a phase 2 study for soft tissue cancers, the therapy slipped out of Pfizer’s pipeline last year.Maplirpacept faced its own problems. A mid-stage study of the CD47 blocker in combination with Incyte’s Monjuvi and Bristol Myers Squibb’s Revlimid for B-cell lymphoma was scrapped last year due to recruitment problems. Pfizer persevered with phase 1 and 2 studies of the drug for blood cancers, but the pharma revealed in its first quarter financial results on May 5 that it has finally decided to drop maplirpacept completely. With it went the last hopes of salvaging something from the $2.3 billion Trillium acquisition.The company made the decision “in the context of the Pfizer oncology portfolio,” a spokesperson told Fierce Biotech this morning.“These decisions are not due to safety concerns, regulatory requests, or any study conduct issues,” they added.Despite various other bold attempts across the sector, there remain no approved drugs that target the CD47 receptor, a protein embedded in cell membranes that instructs macrophages not to destroy the cell. Cancer cells take advantage of CD47 to evade the immune system, so inhibiting the receptor’s activity could enable macrophages to see and destroy the malignant cells.Gilead Sciences had its own high-profile failure when it spent $4.9 billion in 2020 to acquire Forty Seven and the biotech’s lead asset, the CD47 inhibiting antibody magrolimab. After years of failed trials, clinical holds from the FDA and even patient deaths, Gilead finally dumped magrolimab for good in 2024.Meanwhile, this morning’s first-quarter earnings results for Pfizer also revealed that the Big Pharma has pulled back from another cancer modality. The company has called time on PF-08046052, an EGFR-targeting T-cell engager (TCE) that Pfizer had been evaluating in a phase 1 study for advanced solid tumors.A spokesperson told Fierce that this had been a “business decision” and was not related to safety concerns.Pfizer doesn’t appear to list any other TCEs in its pipeline, despite the modality being a red-hot area of pharma dealmaking this year. Pfizer’s spokesperson didn’t directly answer Fierce’s question on whether the pharma will continue to explore any other TCEs.The end of the road for PF-08046052 follows Fierce’s reporting last month that Pfizer had discontinued PF‑08046037, an immunostimulatory drug conjugate with a TLR7 agonist payload. The hope had been that PF‑08046037’s payload would engage TLR7, a protein found in immune cells, which would in turn activate antigen-presenting cells.A final asset thrown on the scrapheap by Pfizer this morning was PF-07905428, an investigational topical drug that the company had taken into a phase 1 trial as an acne treatment.The pharma made the call on PF-07905428 based on a “combination of factors, including phase 1 study results and pipeline prioritization efforts,” according to a spokesperson.

Phase 1AcquisitionPhase 2Immunotherapy

15 Jul 2023

·www.prnewswire.com

Leiomyosarcoma Pipeline Research Report 2023: Comprehensive Insights About 10+ Companies and 10+ Pipeline Drugs - Assessment by Product Type, Stage, RoA, and Molecule Type

DUBLIN, July 14, 2023 /PRNewswire/ -- The "Leiomyosarcoma - Pipeline Insight, 2023" clinical trials has been added to ResearchAndMarkets.com's offering. "Leiomyosarcoma - Pipeline Insight, 2023" report provides comprehensive insights about 10+ companies and 10+ pipeline drugs It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. The companies and academics are working to assess challenges and seek opportunities that could influence Leiomyosarcoma R&D. The therapies under development are focused on novel approaches to treat/improve Leiomyosarcoma. Leiomyosarcoma Emerging Drugs Chapters This segment of the Leiomyosarcoma report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases. Leiomyosarcoma: Pipeline Development Activities The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Leiomyosarcoma therapeutic drugs key players involved in developing key drugs. Pipeline Development Activities The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Leiomyosarcoma drugs. Leiomyosarcoma Emerging Drugs ADI PEG20: Polaris Group ADI-PEG 20 is a first-in-class therapeutic approach to deplete arginine and starve cancer cells. Because arginine is one of the 20 amino acids that are essential for protein synthesis and survival of cells, some cancer cells become dependent upon the external supply of arginine to survive and grow. ADI-PEG 20 is designed to deplete the external supply of arginine, which causes arginine-dependent cancer cells to die while leaving the patient's normal cells unharmed. Currently, it is in Phase III stage of clinical trial evaluation to treat Leiomyosarcoma. AL-3818: Advenchen Laboratories AL3818 is a novel small molecule PTK inhibitor being developed by Advenchen Laboratories. Advenchen Laboratories is conducting a Phase III study to evaluate the safety and efficacy of AL3818 (anlotinib) hydrochloride in the treatment of metastatic or advanced alveolar soft part sarcoma (ASPS), leiomyosarcoma (LMS), and synovial sarcoma (SS). Leiomyosarcoma: Therapeutic Assessment This segment of the report provides insights about the different Leiomyosarcoma drugs segregated based on following parameters that define the scope of the report, such as: Phases Late stage products (Phase III) Mid-stage products (Phase II) Early-stage product (Phase I) along with the details of Pre-clinical and Discovery stage candidates Discontinued & Inactive candidates Route of Administration Products have been categorized under various ROAs such as Oral Parenteral intravenous Subcutaneous Topical. Molecule Type Products have been categorized under various Molecule types such as Monoclonal Antibody Peptides Polymer Small molecule Gene therapy Product Type Leiomyosarcoma Report Assessment Pipeline Product Profiles Therapeutic Assessment Pipeline Assessment Inactive drugs assessment Unmet Needs Key Players Merck Advenchen Laboratories Trillium Therapeutics PTC Therapeutics PharmaMar Philogen EMD Serono Incyte Corporation Clovis Oncology, Inc. Key Products Avelumab AL3818 Pembrolizumab TTI-621 PTC596 ET-743 L19-hTNF M6620 Itacitinib Rucaparib For more information about this clinical trials report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

Phase 3Phase 2Phase 1Gene Therapy

25 May 2023

·www.businesswire.com

Pfizer Presents Scientific Advancements from its Leading Oncology Portfolio at ASCO 2023 Annual Meeting

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 .

Clinical ResultPhase 2ASCOPhase 3Phase 1

100 Deals associated with Ontorpacept

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Large B-cell lymphoma	Phase 2	United States	Pfizer Inc.	15 Mar 2023
Leiomyosarcoma	Phase 2	United States	Pfizer Inc.	22 Jun 2021
Breast Cancer	Phase 1	United States	Pfizer Inc.	01 Sep 2016
HPV-related carcinoma	Phase 1	United States	Pfizer Inc.	01 Sep 2016
Human Papillomavirus Infection	Phase 1	United States	Trillium Therapeutics, Inc.	01 Sep 2016
Merkel Cell Carcinoma	Phase 1	United States	Pfizer Inc.	01 Sep 2016
Soft Tissue Sarcoma	Phase 1	United States	Pfizer Inc.	01 Sep 2016
Squamous Cell Carcinoma	Phase 1	United States	Pfizer Inc.	01 Sep 2016
Unresectable Melanoma	Phase 1	United States	Pfizer Inc.	01 Sep 2016
Mycosis Fungoides	Phase 1	United States	Pfizer Inc.	01 Sep 2016

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04996004 (TTI-621-03, CTgov)	Phase 2	Leiomyosarcoma	76	Doxorubicin+Ontorpacept (Phase I: Ontorpacept 0.2 mg/kg + Doxorubicin)	mufuzdduqt = eioclpvfhd wupugqcihl (jwqlwsohod, nefydsrjaa - dqbdogzouf) View more	-	11 Dec 2024
				Doxorubicin+Ontorpacept (Phase I: Ontorpacept 0.7 mg/kg + Doxorubicin)	mufuzdduqt = hzciqooaqb wupugqcihl (jwqlwsohod, avaxkoktfz - zgvsfoycfx) View more
NCT04996004 (ASCO 12023 \| ASCO 22023) Manual	Phase 1/2	Leiomyosarcoma	23	doxorubicin 75 mg/m^2+TTI-621 0.2 mg/kg	khdovotaok(bztipceosu) = blpbyrhmou dpvyuysvcd (mqfmjfpumy ) View more	Positive	26 May 2023
NCT04996004 (TTI-621-03, ASCO2022)	Phase 1/2	Leiomyosarcoma	-	Doxorubicin	mfxffvfued(drndrdkxeq) = moxedfzlab zecaimbvuu (msmdioabyr ) View more	-	02 Jun 2022
NCT02890368 (Pubmed \| Lancet Haematol) Manual	Phase 1	Mycosis Fungoides \| Sezary Syndrome CD47	35	pembrolizumab+pegylated interferon alpha-2a+TTI-621	lovnzzdsuh(ntojmmmplm) = cyedcazfpr opynkcuaju (snlgjzaaji ) View more	Positive	01 Nov 2021
NCT02663518 (Pubmed \| Clin Cancer Res)	Phase 1	Hematologic Neoplasms	164	TTI-621	cuvrwctacq(tivmjpibpz) = ycaxmhrqcn ptvbesmmoj (ckypgkgdhl )	-	15 Jan 2021
				Rituximab	cuvrwctacq(tivmjpibpz) = fcxqkbxwii ptvbesmmoj (ckypgkgdhl )
NCT02890368 (ASH 12018 \| ASH 22018) Manual	Phase 1	Mycosis Fungoides \| Sezary Syndrome	22	TTI-621	ykuluyrxoo(sbrwbendji) = in 5/5 (100%) monotherapy patients for which post-induction therapy assessments were conducted. htvqpyunkj (rgldksgrrn ) View more	Positive	29 Nov 2018
				pegylated interferon-α2a+TTI-621
NCT02890368 \| NCT02663518 (SITC2017)	Phase 1	Hematologic Neoplasms CD47 \| SIRPÎ± \| FcRs	-	TTI-621 (SIRPÎ±Fc) 0.2 mg/kg	tgspbzvaqt(swukdwhlfi) = An induction of peripheral T cell clonality was observed in the majority of subjects exhibiting objective responses following IV TTI-621 pmcpjgbkhu (lrgrpywckr )	Positive	07 Nov 2017
				TTI-621 (SIRPÎ±Fc) 0.1 mg/kg in combination with Rituximab
NCT02890368 (AACR2017)	Phase 1	B-Cell Lymphoma	56	TTI-621 at 10 mg/kg	eppqourkpv(wquzduwfhq) = TTI-621 dramatically increased the phagocytosis of Toledo cells by both M1 and M2 TAMs to a similar extent ex vivo qivvodaiju (tifupscrgo )	Positive	01 Jul 2017
				TTI-621 at 1 mg/kg
NCT02663518 (first-in-human, ASCO_SITC2017)	Phase 1	Hematologic Neoplasms CD47 \| serum cytokines	18	TTI-621	gekomvmwbd(dnwctxkjxn) = oamcwqxspv loytvzrifh (zztkyobyyp )	Positive	01 Mar 2017
NCT02663518 (TTI-621-01, ASCO2016)	Phase 1	Hematologic Neoplasms	250	TTI-621	akvfdqcsmw(jcyigzvaha) = mighergbqx zkxwomqjjj (qqswodkzuk )	-	20 May 2016

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