This study is investigating the optimal dose and the advantage in combining investigational immunotherapy drugs known as Retifanlimab, INCAGN02385 and INCAGN02390 to improve the responses to CAR T-cell therapy. Additionally, the study will investigate that triple checkpoint blockade of PD-1, TIM-3 and LAG-3 molecules will overcome CAR T-cell therapy resistance in patients with suboptimal responses.

Start Date30 Apr 2024

Sponsor / Collaborator

The University of Alabama at Birmingham

NCT06160206 / Not yet recruitingPhase 2IIT

A Phase II Open Label, Randomized Study Testing the Efficacy of Retifanlimab in Combination With Bevacizumab and Hypofractionated Radiotherapy in Patients With Recurrent GBM

This phase II trial tests how well retifanlimab with bevacizumab and hypofractionated radiotherapy, compared to bevacizumab and hypofractionated radiotherapy alone, works in treating patients with glioblastoma that has come back after a period of improvement (recurrent). A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as retifanlimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Giving retifanlimab with bevacizumab and hypofractionated radiotherapy may work better in treating patients with recurrent glioblastoma than bevacizumab and hypofractionated radiotherapy alone.

Start Date30 Apr 2024

Sponsor / Collaborator

National Cancer Institute

NCT06320405 / Not yet recruitingPhase 1/2

A Phase Ib/II Study of Axatilimab in Combination With Retifanlimab and Paclitaxel for the Treatment of Patients With Advanced Solid Tumors

This phase I/II trial tests the safety, side effects, and effectiveness of axatilimab in combination with retifanlimab and paclitaxel for the treatment of patients with a solid tumor that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Axatilimab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Immunotherapy with monoclonal antibodies, such as retifanlimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Giving axatilimab in combination with retifanlimab and paclitaxel may be safe, tolerable and/or effective in treating patients with advanced or metastatic solid tumors.

Start Date01 Apr 2024

Sponsor / Collaborator

OHSU Knight Cancer Institute

[+2]

100 Clinical Results associated with Retifanlimab

100 Translational Medicine associated with Retifanlimab

100 Patents (Medical) associated with Retifanlimab

Literatures (Medical) associated with Retifanlimab

31 Dec 2024·mAbs

Antibodies to watch in 2024

Article

Author: Reichert, Janice M ; Crescioli, Silvia ; Kaplon, Hélène ; Wang, Lin ; Visweswaraiah, Jyothsna ; Chenoweth, Alicia

The 'Antibodies to Watch' article series provides an annual summary of commercially sponsored monoclonal antibody therapeutics currently in late-stage clinical development, regulatory review, and those recently granted a first approval in any country. In this installment, we discuss key details for 16 antibody therapeutics granted a first approval in 2023, as of November 17 (lecanemab (Leqembi), rozanolixizumab (RYSTIGGO), pozelimab (VEOPOZ), mirikizumab (Omvoh), talquetamab (Talvey), elranatamab (Elrexfio), epcoritamab (EPKINLY), glofitamab (COLUMVI), retifanlimab (Zynyz), concizumab (Alhemo), lebrikizumab (EBGLYSS), tafolecimab (SINTBILO), narlumosbart (Jinlitai), zuberitamab (Enrexib), adebrelimab (Arelili), and divozilimab (Ivlizi)). We briefly review 26 product candidates for which marketing applications are under consideration in at least one country or region, and 23 investigational antibody therapeutics that are forecast to enter regulatory review by the end of 2024 based on company disclosures. These nearly 50 product candidates include numerous innovative bispecific antibodies, such as odronextamab, ivonescimab, linvoseltamab, zenocutuzumab, and erfonrilimab, and antibody-drug conjugates, such as trastuzumab botidotin, patritumab deruxtecan, datopotamab deruxtecan, and MRG002, as well as a mixture of two immunocytokines (bifikafusp alfa and onfekafusp alfa). We also discuss clinical phase transition and overall approval success rates for antibody therapeutics, which are crucial to the biopharmaceutical industry because these rates inform decisions about resource allocation. Our analyses indicate that these molecules have approval success rates in the range of 14-32%, with higher rates associated with antibodies developed for non-cancer indications. Overall, our data suggest that antibody therapeutic development efforts by the biopharmaceutical industry are robust and increasingly successful.

21 Jul 2023·American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists

Retifanlimab-dlwr.

Article

01 Jun 2023·Drugs

Retifanlimab: First Approval.

Review

Author: Kang, Connie

Retifanlimab (retifanlimab-dlwr; ZYNYZ^TM) is a programmed cell death 1 receptor-blocking antibody that is being developed by Incyte Corporation for the treatment of solid tumours, both as monotherapy and in combination with other agents. Retifanlimab recently received accelerated approval for the treatment of adults with metastatic or recurrent locally advanced Merkel cell carcinoma. This article summarizes the milestones in the development of retifanlimab leading to this first approval for Merkel cell carcinoma.

News (Medical) associated with Retifanlimab

09 Apr 2024

·www.globenewswire.com

BriaCell Showcases Data Demonstrating Unmatched Progression-Free Survival (PFS) and Clinical Efficacy in Antibody-Drug Conjugate (ADC) Resistant and Central Nervous System (CNS) Metastatic Breast Cancer at the 2024 AACR

PFS of 4.2 months in Phase 2 ADC resistant patients receiving Bria-IMT™ pivotal Phase 3 formulation is twice that of controls in similar studies PFS results reinforced by larger number of prior treatments in Bria-IMT™ population than in comparable studies Bria-IMT™ PFS compares favorably to their most recent treatment PFS in 48% of patients Clinical benefit rate of 56% in evaluable patients71% intracranial objective response rate (iORR) in heavily pretreated patientsFindings support clinical efficacy of Bria-IMT™ and highlight its significant potential in managing CNS metastatic disease in advanced breast cancerAdditional preclinical anti-cancer data of Bria-OTS+™ and Bria-PROS+™ will be presented tomorrow 9:00 AM - 12:30 PM PST; Abstract Presentation Number: 6753 PHILADELPHIA and VANCOUVER, British Columbia, April 09, 2024 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, is presenting positive clinical data from its lead product candidate, Bria-IMT™, in two posters of its three poster sessions during the 2024 American Association for Cancer Research (AACR) Annual Meeting held from April 5-10 at San Diego Convention Center, San Diego, CA. “We are extremely impressed by the unprecedented survival and clinical benefit data for Bria-IMT™ in patients who have failed ADCs,” stated lead author Chaitali S. Nangia, MD, Partner at Hoag Medical Group. “ADCs are the latest treatments for very difficult-to-treat advanced metastatic breast cancer. However, some patients experience resistance with rapid disease progression. To our knowledge, there are no effective treatment options in this patient population for whom the progression-free survival prognosis is only a few weeks. Finding an alternative well-tolerated treatment option that is effective is a matter of life and death for these patients.” “Our clinical data further validates Bria-IMT™’s novel mechanism of action to generate potent immune responses in breast cancer patients who failed ADCs leading to clinically relevant survival and treatment benefit in these patients,” commented Dr. Giuseppe Del Priore, BriaCell’s CMO. “We look forward to building upon the body of evidence with additional clinical data in the coming months from the ongoing pivotal registration trial.” “We are excited about the safety and efficacy data to date with Bria-IMT™ and expect that Bria-IMT™ will generate positive effects on survival and clinical benefit in the Phase 3 study in advanced breast cancer patients whose medical needs remain unmet,” commented Dr. William V. Williams, BriaCell’s President and CEO. The posters are summarized below and linked here: https://briacell.com/scientific-publications/. Poster 1 – Title: Efficacy of Bria-IMT™ regimen in inducing CNS metastasis regressionAbstract Presentation Number: CT204 Superior clinical benefit of Bria-IMT™ regimen - alone or combined with an immune check point inhibitor (CPI) in advanced breast cancer patients with CNS metastatic disease Clinical efficacy: 71% (5/7) intracranial objective response rate (iORR), defined as the percentage of patients who achieve a complete response (complete disappearance) or partial response (volume reduction of 30% or more) in intracranial tumors, achieved in patients with central nervous system (CNS) metastases treated with the Bria-IMT™ regimen, either alone or in combination with an immune checkpoint inhibitor (i.e. PD-1 inhibitor pembrolizumab or retifanlimab). These patients failed multiple prior treatments including 2 antibody-drug conjugates in one case. Clinical benefit is observed across all subsets of breast cancer.Safety profile: Absence of both interstitial lung disease (ILD), a common serious adverse event with ADCs, and no Bria-IMT™-related treatment discontinuations underscore Bria-IMT™'s excellent tolerability and favorable safety profile. In summary, Bria-IMT™’s tumor reductions observed in all breast cancer subtypes in patients with intracranial disease underlines its potential clinical effectiveness in managing CNS metastatic disease in advanced breast cancer. BriaCell will continue to monitor the data in this subgroup of patients including a pre-planned subgroup analysis in the current pivotal Phase 3 study in advanced metastatic breast cancer. Treatment of patients with CNS metastatic disease represents a potential additional indication for market approval of Bria-IMT™. Poster 2 – Title: Efficacy and safety of SV-BR-1-GM after progression on ADC in metastatic breast cancer patientsAbstract Presentation Number: CT206 Notable progression-free survival benefit of Bria-IMT™ in ADC resistant advanced metastatic breast cancer Phase 2 clinical data of the Bria-IMT™ regimen in 23 advanced metastatic breast cancer patients who failed multiple prior treatments including ADCs and CPIs (median of 6 prior treatments) are presented. Progression-free Survival Benefit: Median progression free survival (PFS), defined as the length of time during which a patient’s cancer does not get worse, in heavily pre-treated patients of 3.5 months is comparable to that seen in similar studies in patients with a history of fewer prior treatments (median of 4)1,2. Similarly, median PFS of 4.2 months in patients receiving the Bria-IMT™ pivotal phase 3 formulation is approximately twice the PFS figures reported for treatment of physician’s choice (TPC) in other similar studies. These PFS results suggest superior clinical efficacy considering the larger number of prior treatments in Bria-IMT™ patients vs those of the other studies.Clinical efficacy: PFS is similar or better than that of the last regimen in 48% (11/23) of the patients suggesting Bria-IMT™ effectiveness in delivering clinical and survival benefits in these patients. Additionally, a clinical benefit rate (CBR), defined as percentage of patients whose disease shrinks or remains stable over a certain time, of 56% is observed in evaluable patients further highlighting clinical benefit.Subset specific clinical benefits: Study data to date suggests clinical benefit for multiple breast cancer subtypes including HR+/HER2- (the most common breast cancer subtype, testing positive for estrogen and/or progesterone receptors and negative for human epidermal growth factor receptor 2 or HER2) with a CBR following treatment, of 63% (5 of 8 patients); HER2+ subtype (a positive test for HER2) with a 100% CBR (2 of 2 patients) and HR-/HER2 low subtype (a negative test for estrogen and/or progesterone receptor and a negative test for HER2) showing a CBR of 66% (2 of 3 patients).Safety profile: There are no incidents of interstitial lung disease - a well-documented serious adverse event associated with ADCs, - in either ADC naïve or ADC treated patients, and no treatment-related discontinuations of Bria-IMT™. In summary, the data to date shows that Bria-IMT™ provides prolonged progression-free survival and clinical benefits in heavily pre-treated, ADC resistant breast cancer patients compared with those in other similar studies. BriaCell will be monitoring ADC resistant patients in its ongoing pivotal Phase 3 study of Bria-IMT™ and CPI in advanced metastatic breast cancer. ________________________1 Cortes J et al. Eribulin monotherapy versus treatment of physician’s choice in patients with metastatic breast cancer (EMBRACE): a phase 3 open-label randomized study. Lancet (2011) 377: 914–232 Bardia A et al. Final results from the randomized phase III ASCENT clinical trial in metastatic triple-negative breast cancer and association of outcomes by human epidermal growth factor receptor 2 and trophoblast cell surface antigen 2 expression. J Clin Oncol (2024) 00:1-7 About BriaCell Therapeutics Corp. BriaCell is a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care. More information is available at https://briacell.com/. Safe Harbor This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements, including those about presenting three posters at the 2024 AACR, and the contents of such posters; the positive clinical data from BriaCell’s Bria-IMT™ being presented in two posters during the 2024 AACR; the clinical efficacy of Bria-IMT™ and its potential clinical effectiveness in managing CNS metastatic disease in advanced breast cancer; the unprecedented survival and clinical benefit data for Bria-IMT™; Bria-IMT™’s ability to generate potent immune responses in breast cancer patients who failed ADCs, leading to clinically relevant survival and treatment benefit; BriaCell’s ability to build upon their current body of evidence with additional clinical data in the coming months from the ongoing registration trial; Bria-IMT™’s ability to generate positive effects on survival and clinical benefit in the Phase 3 study in advanced breast cancer patients; Bria-IMT™'s tolerability and favorable safety profile; Bria-IMT™'s significant potential in managing CNS metastatic disease in advanced breast cancer; BriaCell monitoring the data in a subgroup of patients including a pre-planned subgroup analysis in the current pivotal Phase 3 study in advanced metastatic breast cancer; the treatment of patients with CNS metastatic disease representing a potential additional indication for market approval of Bria-IMT™; Bria-IMT™’s effectiveness in delivering clinical and survival benefits in patients; the Bria-IMT™ data representing a clinical benefit for multiple breast cancer subtypes including HR+/HER2; and BriaCell’s monitoring of ADC resistant patients in their ongoing pivotal Phase 3 study of Bria-IMT™ and CPI in advanced metastatic breast cancer, are based on BriaCell’s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully under the heading “Risks and Uncertainties” in the Company's most recent Management’s Discussion and Analysis, under the heading "Risk Factors" in the Company's most recent Annual Information Form, and under “Risks and Uncertainties” in the Company's other filings with the Canadian securities regulatory authorities and the U.S. Securities and Exchange Commission, all of which are available under the Company's profiles on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov. Forward-looking statements contained in this announcement are made as of this date, and BriaCell Therapeutics Corp. undertakes no duty to update such information except as required under applicable law. Neither the Toronto Stock Exchange nor its Regulation Services Provider (as that term is defined in the policies of the Toronto Stock Exchange) accepts responsibility for the adequacy or accuracy of this release. Contact Information Company Contact:William V. Williams, MDPresident & CEO1-888-485-6340info@briacell.com Media Relations:Jules AbrahamCORE IRjulesa@coreir.com Investor Relations Contact:CORE IRinvestors@briacell.com

Phase 3ImmunotherapyPhase 2Clinical Result

03 Apr 2024

·www.biospace.com

MacroGenics Provides Phase 2 TAMARACK Study Early Interim Safety Data and Plans for Future Disclosures

Early interim safety data from Phase 2 TAMARACK study, including comparison to retrospective analysis from Phase 1 study,as submitted in ASCO abstract Company plans to provide updated interim data, including safety and preliminary efficacy, by May 31 Company plans to provide additional clinical data – including rPFS – in the Fall of 2024 ROCKVILLE, MD, April 03, 2024 (GLOBE NEWSWIRE) -- MacroGenics, Inc., (NASDAQ: MGNX), a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing innovative antibody-based therapeutics for the treatment of cancer, today provided an update on the Phase 2 TAMARACK study of vobramitamab duocarmazine (vobra duo, previously known as MGC018) in patients with metastatic castration-resistant prostate cancer (mCRPC). As previously disclosed, safety data from the Company’s ongoing TAMARACK Phase 2 study was submitted in early February to the American Society of Clinical Oncology (ASCO) for presentation at the upcoming Annual Meeting that begins May 31. The abstract containing this early interim data, based on a January 4, 2024 data cut-off, was not accepted. The submitted abstract is provided below. “While the TAMARACK data will not be presented at the ASCO Annual Meeting, we intend to maintain our previously disclosed plan to share further TAMARACK interim data, including updated safety and preliminary efficacy, by the end of May,” said Scott Koenig, M.D., Ph.D., President and Chief Executive Officer. “This updated information will be based upon a future data cut-off. In addition, we still anticipate presenting updated clinical data – including radiographic progression-free survival, or rPFS, the study’s primary endpoint – in the Fall of 2024.” Abstract as submitted on February 6, 2024: “Title Vobramitamab duocarmazine (vobra duo), a B7-H3 directed antibody drug conjugate (ADC) in metastatic castration resistant prostate cancer (mCRPC): Early data from the Phase 2 TAMARACK study. Background Vobra duo (MGC018) is an ADC with a duocarmycin-based DNA-alkylating payload. Vobra duo targets B7-H3, which is highly expressed in multiple tumor types including prostate cancer and has limited expression in normal tissue. Phase 1 testing (NCT03729596) of vobra duo at 3.0 mg/kg Q3W demonstrated anti-tumor activity in mCRPC, although adverse events resulted in high rates of dose modifications and early treatment discontinuation. Lowering the starting dose may improve tolerability, extend treatment duration, and enhance effectiveness. Methods TAMARACK is an ongoing randomized, open-label, Phase 2 dose selection study assessing the efficacy, safety, and tolerability of two dose levels of vobra duo (2.0 mg/kg and 2.7 mg/kg IV Q4W). The study enrolled patients (pts) with mCRPC previously treated with abiraterone, enzalutamide, or apalutamide; prior docetaxel was allowed. The primary endpoint is investigator-assessed PFS at 6 months. Results At data cutoff (Jan 4, 2024), 182 pts with mCRPC enrolled on TAMARACK, of which 177 received vobra duo. Enrolled pts were 46 to 89 years of age (median 70.5) with ECOG performance status ≤ 2. Thirty (16.5%) had visceral disease at baseline, 109 (59.9%) had RECIST-evaluable disease, and 98 (53.8%) received prior docetaxel. At this early data cut, pts have received a median of 3 (range 1 to 7) cycles of vobra duo; treatment is ongoing in 156 (85.7%). A summary of treatment-emergent adverse events (TEAEs) is presented below. Vobra duo 2.0 mg/kg (n=91) Vobra duo 2.7 mg/kg (n=86) Any TEAE 85 (93.4%) 82 (95.3%) TEAE Grade ≥ 3 23 (25.3%) 27 (31.4%) Serious AE 11 (12.1%) 17 (19.8%) Drug Interruption due to AE 10 (11.0%) 16 (18.6%) Drug Discontinuation due to AE 4 (4.4%) 2 (2.3%) Fatal AE 0 0 The most common (≥10%) TEAEs regardless of dose were asthenia (40.7%), nausea (27.7%), fatigue (20.3%), decreased appetite (19.2%), anemia (17.5%), constipation (16.4%), diarrhea (14.7%), headache (13.0%), neutropenia (12.4%), and peripheral edema (10.7%). In the subset (n = 95) of TAMARACK pts on treatment for ≥ 12 weeks or who discontinued study treatment within 12 weeks, TEAEs led to drug interruption in 12 (12.6%) and discontinuation in 5 (5.3%) pts. This compares favorably to the rate of drug interruption (58.5%) and discontinuation (14.6%) observed at 12 weeks in pts with mCRPC who received vobra duo at 3.0 mg/kg Q3W on the Phase 1 study. Following the pre-specified interim analysis for futility on both arms, the IDMC recommended continuing the study as planned without modification. Conclusions Preliminary safety data from TAMARACK suggest that reducing the dose and frequency of vobra duo improves its safety and tolerability in men with mCRPC. The authors anticipate sharing preliminary efficacy data and updated safety data at the conference. Clinical trial information: NCT05551117.” MacroGenics would like to thank the abstract authors, including: Johann S. De Bono, Carole Helissey, Karim Fizazi, Eric Voog, Pablo Maroto-Rey, Guilhem Roubaud, Emmanuel S. Antonarakis, Shahneen Sandhu, Neal D. Shore, Raffaele Ratta, Begoña Pérez Valderrama, Christof Vulsteke, Galina Marr, Ashley Ward, Enxu Zhao, Josep M. Piulats, on behalf of the TAMARACK Investigators. About MacroGenics, Inc. MacroGenics (the Company) is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics' technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company's website at . MacroGenics and the MacroGenics logo are trademarks or registered trademarks of MacroGenics, Inc. Cautionary Note on Forward-Looking Statements Any statements in this press release about future expectations, plans and prospects for MacroGenics (“Company”), including statements about the Company’s strategy, future operations, clinical development of the Company’s therapeutic candidates, including initiation and enrollment in clinical trials, expected timing of results from clinical trials, discussions with regulatory agencies, commercial prospects of or product revenues from MARGENZA and the Company’s product candidates, if approved, manufacturing services revenue, milestone or opt-in payments from the Company’s collaborators, the Company’s anticipated milestones and future expectations and plans and prospects for the Company, as well as future global net sales of TZIELD and the Company’s ability to achieve the milestone payments set forth under the terms of the agreement with DRI (or its successors or assigns with respect to such agreement), and other statements containing the words “subject to”, "believe", “anticipate”, “plan”, “expect”, “intend”, “estimate”, “potential,” “project”, “may”, “will”, “should”, “would”, “could”, “can”, the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: risks that TZIELD, vobramitamab duocarmazine, lorigerlimab, ZYNYZ, MARGENZA or any other product candidate’s revenue, expenses and costs may not be as expected, risks relating to TZIELD, vobramitamab duocarmazine, lorigerlimab, ZYNYZ, MARGENZA or any other product candidate’s market acceptance, competition, reimbursement and regulatory actions; our ability to provide manufacturing services to our customers; the uncertainties inherent in the initiation and enrollment of future clinical trials; the availability of financing to fund the internal development of our product candidates; expectations of expanding ongoing clinical trials; availability and timing of data from ongoing clinical trials; expectations for the timing and steps required in the regulatory review process; expectations for regulatory approvals; expectations of future milestone payments; the impact of competitive products; our ability to enter into agreements with strategic partners and other matters that could affect the availability or commercial potential of the Company's product candidates; business, economic or political disruptions due to catastrophes or other events, including natural disasters, terrorist attacks, civil unrest and actual or threatened armed conflict, or public health crises such as the novel coronavirus (referred to as COVID-19 pandemic); and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof. CONTACTS: Jim Karrels, Senior Vice President, CFO 1-301-251-5172 info@macrogenics.com

Clinical ResultASCOPhase 1Phase 2ADC

20 Mar 2024

·www.fiercepharma.com

#FierceMadness is back: Get voting in the 2024 drug name tournament

This year we’re taking the branded drug names that were officially approved by the FDA in 2022 and 2023 - now it's your turn to vote for your winner. LAUNCHED: Wednesday, March 20, 7:00 a.m. ET It’s March, so it’s time for some #FierceMadness. Last year, we channeled the NCAA tournament for the best pharma ad campaigns, but, this year, we’re looking for the best of the best in drug names. Here’s how it works. We’ve chosen 64 of the most distinctive drug names to come out of the FDA’s 2022 and 2023 crop of new approvals. Whittling down to 64 from the 92 drug names available was our staff challenge, but now it’s up to you, readers, to deliberate and vote down to the final winner. Remember, this isn’t about the drugs themselves—neither how well they may work (or not) nor any controversies in how they may have been approved. Our goal is to assess their marketing suitability, considering how well they perform in their respective field and against competitors. Ready to play? Check out the bracket here (PDF) and see the full Madness 64 list below. Then vote is via our poll here. You can vote from now until Friday, March 22, at 6 p.m. ET. Check back here Monday, March 25, for your results, and the chance to vote in the next round. After that, we’ll be back with a new round each Wednesday and Monday through Monday, April 8, when you can vote for your championship winner. Any remote robo-voting will be noted, and those votes will be discarded. Please play fair. Don’t forget to tell us why you picked what you picked in the voting poll comments section—and what you think each drug name really sounds like. We’ll include the funniest and most out-of-the-box comments in our recaps every round, so make 'em good! New this year: Our sister publication Fierce Biotech is also running its own Madness tournament for the best of the best in biotech company names. Check out and vote in its championship here. Good luck, and happy Madness! #FierceMadness 2024: The full bracket of 64 Jesduvroq vs. Lamzede Jesduvroq Maker: GSK Indication: Anemia due to chronic kidney disease Sounds like: When you hit your finger with a hammer, but it’s in front of your children so you’re trying not to swear Lamzede Maker: Chiesi Indication: Non-central nervous system manifestations of alpha-mannosidosis Sounds like: A vegan meal Pluvicto vs. Lunsumio Pluvicto Maker: Novartis Indication: Prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer following other therapies Sounds like: A new planet Lunsumio Maker: Roche Indication: Relapsed or refractory follicular lymphoma, a type of non-Hodgkin lymphoma Sounds like: A Japanese wrestler Briumvi vs. Camzyos Briumvi Maker: TG Therapeutics Indication: Relapsing forms of multiple sclerosis Sounds like: A sixth-generation cheese Camzyos Maker: Bristol Myers Squibb Indication: Obstructive hypertrophic cardiomyopathy Sounds like: A Spanish holiday resort Voquezna vs. Mounjaro Voquezna Maker: Phathom Pharmaceuticals Indication: Helicobacter pylori infection Sounds like: A sports drink with a kick Mounjaro Maker: Eli Lilly Indication: Lowering blood sugar levels in Type 2 diabetes Sounds like: A legendary medieval sword fighter Vtama vs. Amvuttra Vtama Maker: Dermavant Indication: Plaque psoriasis Sounds like: A mouthful Amvuttra Maker: Alnylam Indication: Polyneuropathy of hereditary transthyretin-mediated amyloidosis Sounds like: A pope’s gift Xenpozyme vs. Daxxify Xenpozyme Maker: Sanofi Indication: Acid sphingomyelinase deficiency Sounds like: An alien protein Daxxify Maker: Revance Indication: The treatment of cervical dystonia and for the temporary improvement of frown lines Sounds like: A ray gun to make you sassy Fruzaqla vs. Sotyktu Fruzaqla Maker: Takeda Pharmaceuticals Indication: Refractory, metastatic colorectal cancer Sounds like: A European swear word Sotyktu Maker: Bristol Myers Squibb Indication: Moderate to severe plaque psoriasis Sounds like: Gesundheit! Terlivaz vs. Imjudo Terlivaz Maker: Mallinckrodt Pharmaceuticals Indication: Improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function Sounds like: A Hungarian dance Imjudo Maker: AstraZeneca Indication: Unresectable hepatocellular carcinoma Sounds like: A self-confident martial artist Elahere vs. Vabysmo Elahere Maker: ImmunoGen Indication: Recurrent ovarian cancer that is resistant to platinum therapy Sounds like: An inebriated attempt at Hawaiian Vabysmo Maker: Roche Indication: Neovascular (wet) aged-related macular degeneration and diabetic macular edema Sounds like: A new way of saying fantastic Pyrukynd vs. Rystiggo Pyrukynd Maker: Agios Indication: Hemolytic anemia in pyruvate kinase deficiency Sounds like: A drunk Scrabble game Rystiggo Maker: UCB Indication: Generalized myasthenia gravis in adults who are anti-acetylcholine receptor- or anti-muscle-specific tyrosine kinase antibody-positive Sounds like: An Italian village Beyfortus vs. Xdemvy Beyfortus Maker: AstraZeneca Indication: To prevent respiratory syncytial virus lower respiratory tract disease Sounds like: A medieval stronghold Xdemvy Maker: Tarsus Pharmaceuticals Indication: Demodex blepharitis Sounds like: Elon Musk’s drunk attempt at renaming his business Tzield vs. Rezlidhia Tzield Maker: Provention Bio Indication: Delay the onset of stage 3 Type 1 diabetes Sounds like: An electronic barrier Rezlidhia Maker: Rigel Pharmaceuticals Indication: Relapsed or refractory acute myeloid leukemia with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation Sounds like: A new Disney princess Krazati vs. Leqembi Krazati Maker: Mirati Therapeutics Indication: KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer in adults who have received at least one prior systemic therapy Sounds like: A crazy party Leqembi Maker: Eisai Indication: Alzheimer’s disease Sounds like: An inspirational French aphorism Cibinqo vs. Brenzavvy Cibinqo Maker: Pfizer Indication: Refractory, moderate to severe atopic dermatitis Sounds like: A game of cheeky bingo Brenzavvy Maker: TheracosBio Indication: Glycemic control in adults with Type 2 diabetes mellitus as an adjunct to diet and exercise Sounds like: Heard in a copy of "Pirates of the Caribbean" Jaypirca vs. Skyclarys Jaypirca Maker: Eli Lilly Indication: Relapsed or refractory mantle cell lymphoma in adults who have had at least two lines of systemic therapy, including a BTK inhibitor Sounds like: A strong coffee Skyclarys Maker: Biogen Indication: Friedreich’s ataxia Sounds like: A high-rise building Zavzpret vs. Paxlovid Zavzpret Maker: Pfizer Indication: Migraine treatment Sounds like: A Turkish fast-food restaurant Paxlovid Maker: Pfizer Indication: Mild to moderate COVID-19 in adults at high risk for progression to severe COVID-19 Sounds like: A bizarre Pac-Man sequel Inpefa vs. Columvi Inpefa Maker: Lexicon Pharmaceuticals Indication: Heart failure Sounds like: An anti-fascist offshoot group Columvi Maker: Roche Indication: Diffuse large B-cell lymphoma, not otherwise specified, or large B-cell lymphoma arising from follicular lymphoma after two or more lines of systemic therapy Sounds like: An ancient Roman detective Daybue vs. Zynyz Daybue Maker: Acadia Indication: Rett syndrome Sounds like: How my five-year-old insists debut is spelled Zynyz Maker: Incyte Indication: Metastatic or recurrent locally advanced Merkel cell carcinoma Sounds like: Drug naming companies may be running out of ideas Rezzayo vs. Qalsody Rezzayo Maker: Melinta Therapeutics Indication: Candidemia and invasive candidiasis Sounds like: A phrase used when you’ve had a great nap in the day Qalsody Maker: Biogen Indication: Amyotrophic lateral sclerosis in adults who have a SOD1 gene mutation Sounds like: From the makers of “Better Call Saul” comes “better Qalsody” Elfabrio vs. Veozah Elfabrio Maker: Chiesi Indication: Fabry disease Sounds like: The lost Spanish Mario brother Veozah Maker: Astellas Indication: Moderate to severe hot flashes caused by menopause Sounds like: A Broadway play Epkinly vs. Zurzuvae Epkinly Makers: AbbVie/Genmab Indication: Relapsed or refractory diffuse large B-cell lymphoma and high-grade B-cell lymphoma after two or more lines of systemic therapy Sounds like: Someone who watches too many streaming episodes Zurzuvae Makers: Sage/Biogen Indication: Postpartum depression Sounds like: A mouthful Izervay vs. Talvey Izervay Maker: Iveric Bio Indication: Geographic atrophy secondary to age-related macular degeneration Sounds like: A new app for scanning the land Talvey Maker: Johnson & Johnson Indication: Relapsed or refractory multiple myeloma who have received at least four prior therapies Sounds like: A little too close to talc… Elrexfio vs. Veopoz Elrexfio Maker: Pfizer Indication: Relapsed or refractory multiple myeloma who have received at least four prior lines of therapy Sounds like: A new dinosaur found in Mexico Veopoz Maker: Regeneron Pharmaceuticals Indication: Patients 1 year old and older with CD55-deficient protein-losing enteropathy Sounds like: Double-plus good! Zilbrysq vs. Ojjaara Zilbrysq Maker: UCB Indication: Generalized myasthenia gravis in adults who are anti-acetylcholine receptor antibody positive Sounds like: Absolute zero Ojjaara Maker: GSK Indication: Intermediate or high-risk myelofibrosis in adults with anemia Sounds like: “What’s my name?” Exxua vs. Pombiliti Exxua Maker: Fabre-Kramer Pharmaceuticals Indication: Major depressive disorder Sounds like: Someone who’s always leaving Pombiliti Maker: Amicus Indication: Late-onset Pompe disease Sounds like: The ability to treat Pompe disease (this feels a little on the nose) Rivfloza vs. Velsipity Rivfloza Maker: Novo Nordisk Indication: Urinary oxalate levels in patients 9 years and older with primary hyperoxaluria type 1 and relatively preserved kidney function Sounds like: An exuberant DJ Velsipity Maker: Pfizer Indication: Moderately to severely active ulcerative colitis in adults Sounds like: A deodorant brand you wouldn’t want to buy Bimzelx vs. Omvoh Bimzelx Maker: UCB Indication: Moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy Sounds like: Throwing away unwanted antacids Omvoh Maker: Eli Lilly Indication: Ulcerative colitis Sounds like: A new age prayer Loqtorzi vs. Defencath Loqtorzi Maker: Coherus Biosciences Indication: Recurrent or metastatic nasopharyngeal carcinoma when used together with or following other therapies Sounds like: How you close the door in a magical kingdom Defencath Maker: CorMedix Indication: Reduce the incidence of catheter-related bloodstream infections in adults with kidney failure receiving chronic hemodialysis Sounds like: A Dungeons and Dragons character Augtyro vs. Ryzneuta Augtyro Maker: Bristol Myers Squibb Indication: ROS1-positive non-small cell lung cancer Sounds like: A virtual reality game where you’re the bad guy Ryzneuta Maker: Acrotech Biopharma Indication: Neutropenia Sounds like: Getting rid of someone’s charisma Truqap vs. Ogsiveo Truqap Maker: AstraZeneca Indication: Breast cancer that meets certain disease criteria Sounds like: A limit on truth Ogsiveo Maker: SpringWorks Indication: Progressing desmoid tumors who require systemic treatment Sounds like: Oh, give us a go! Quviviq vs. Ztalmy Quviviq Maker: Idorsia Indication: Insomnia Sounds like: A producer asking a biotech founder turned politician to get ready for his TV appearance Ztalmy Maker: Marinus Indication: Seizures in cyclin-dependent kinase-like 5 deficiency disorder Sounds like: A nefarious Yevgeny Zamyatin character Opdualag vs. Wainua Opdualag Maker: Bristol Myers Squibb Indication: Unresectable or metastatic melanoma Sounds like: A Russian prison Wainua Maker: AstraZeneca Indication: Polyneuropathy of hereditary transthyretin-mediated amyloidosis Sounds like: A Premier League footballer

100 Deals associated with Retifanlimab

External Link

KEGG	Wiki	ATC	Drug Bank
D11827	-	-	DB15766

R&D Status

Indication	Highest Phase	Country/Location	Organization
Non-Small Cell Lung Cancer	Phase 3	-	Incyte Corp. More
Recurrent Squamous Cell Carcinoma of the Head and Neck	Phase 2	BE More	Incyte Biosciences International SARL More
Head and Neck Neoplasms	Phase 2	US More	Incyte Biosciences International SARL More
Metastatic Solid Tumor	Phase 1	-	Incyte Corp. More
Advanced Malignant Solid Neoplasm	Phase 1	US More	MacroGenics, Inc. More

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04634825 (CTgov)	Phase 2	Squamous cell carcinoma of head and neck metastatic \| Squamous Cell Carcinoma of Head and Neck	62	Enoblituzumab+Retifanlimab (Retifanlimab Cohort)	bhrgwymlej(wzklwrbhqk) = jqsmmzzlls jhtrsxisaj (zqhuyzlojz, zrodotfmbx - ubgzklaqpa) View more	-	20 Dec 2023
NCT04634825 (CTgov)	Phase 2		62	Enoblituzumab+Tebotelimab (Tebotelimab Cohort)	lvzabiidne(pnhjxspurz) = reyzqhtqat hhidtszoeo (jgnfuswnbt, ujczfqjenu - fjuvoxnaax) View more	-	20 Dec 2023
NCT03059823 (POD1UM-101, ESMO2023) Manual	Phase 1	Mismatch repair-deficient Endometrial Carcinoma \| Microsatellite instability-high Endometrial Carcinoma MSI-High \| Deficient DNA Mismatch Repair (dMMR)	76	Retifanlimab 500 mg	mnuhojjfdf(sayfmaorjk) = olsvpxjqzc gyqflkbnog (zjjfccduva, 32 - 55)	Positive	22 Oct 2023
NCT04225039 (ASCO2023) Manual	Phase 2	Recurrent Glioblastoma	32	INCAGN01876+Retifanlimab+FSRT (single-arm, primary efficacy cohort)	zvtlkdhdly(bfolequvyf) = yoydqgwkml rscfolidge (hfajkhbxah, 2.1 - 6.2) View more	Negative	26 May 2023
NCT04225039 (ASCO2023) Manual	Phase 2	Recurrent Glioblastoma	32	INCAGN01876+Retifanlimab+FSRT (two-arm neoadjuvant window-of-opportunity cohort)	zvtlkdhdly(bfolequvyf) = wqmwrkkrxj rscfolidge (hfajkhbxah ) View more	Negative	26 May 2023
NCT04370704 (ASCO2023) Manual	Phase 1/2	HR-positive/HER2-low Solid Tumors	21	INCAGN02385 350 mg+INCAGN02390 400 mg	zzozsobdzi(eeoeqswkwp) = occurred in 1 pt in part 1 (grade [G] 3 vasculitis) and 1 pt in part 2 (G3 myocarditis and pericardial effusion) kyoojftlij (euxuiekkjr ) View more	Positive	26 May 2023
NCT04370704 (ASCO2023) Manual	Phase 1/2	HR-positive/HER2-low Solid Tumors	21	retifanlimab 500 mg+INCAGN02385 350 mg+INCAGN02390 400 mg		Positive	26 May 2023
NCT04577014 (ASCO2023) Manual	Phase 2	Locally Advanced Soft Tissue Sarcoma First line	43	Retifanlimab+gemcitabine+docetaxel	dvoewxhrgh(bqkspkawdi) = wmtlolnfix juqjrgtjzk (lowwbzjnqn ) View more	Positive	26 May 2023
NCT04231981 (ORPHEUS, ASCO2023) Manual	Phase 2	Squamous Cell Carcinoma of the Penis	18	Retifanlimab	uvvftnagtj(egkkbvylsj) = iztonoedgb mbsypszhkc (oyctgnqnuf, 5.8 - 39.2) View more	Positive	26 May 2023
NCT03599713 (CTgov)	Phase 2	Metastatic Merkel Cell Carcinoma	107	retifanlimab (Chemotherapy: Naïve)	nbfmupeleo(kasjicwbuj) = yqkysbuees rjzzvwdhqb (yavbgrtqlc, fpjwzqnvdz - axszjkmrbm) View more	-	03 May 2023
NCT03599713 (CTgov)	Phase 2	Metastatic Merkel Cell Carcinoma	107	retifanlimab (Chemotherapy: Refractory)	yqgrhfjqvx(hjnakebsbz) = geetwllvuz wfrcqivequ (ivrsevrkax, muzgxzqjfc - xzksvqjvig) View more	-	03 May 2023
NCT03599713 (POD1UM-201, FDA) Manual	Phase 2	Metastatic Merkel Cell Carcinoma	65	RETIFANLIMAB	qfhzznzlnu(uozspnahkz) = ggpfsiskij rgchrwixlw (pyhxjuwmpp, 40 - 65) View more	Positive	22 Mar 2023
NCT03532295 (ESMO2022) Manual	Phase 2	Recurrent Glioblastoma IDH1 Wild-type \| IDH2 Wild-type	25	bevacizumab+hypofractionated radiotherapy (HFRT)+retifanlimab	qdlgyznndw(qdldakbmoy) = jyvwegigke jnhariiplc (irslfsmqdr, 46.7 - 86.1) View more	Positive	09 Sep 2022
NCT04082364 (MAHOGANY, Pubmed) Manual	Phase 2/3	HER2 Positive Gastroesophageal Adenocarcinoma First line HER2 Positive \| PD-L1 Positive	43	Margetuximab+Retifanlimab	zgjsijhfah(yypukovjes) = puxfqjuutc hzzxlvrvfw (zkktzozftq ) View more	Positive	24 Aug 2022

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