Mosunetuzumab

The study met its primary endpoint of overall survival with a 41% reduction in the risk of death in people with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) treated with Columvi plus chemotherapy1 This Columvi combination could provide a much-needed off-the-shelf treatment option for people with transplant-ineligible R/R DLBCL Data were featured in the congress Press Briefing and presented today in the Plenary Abstracts Session at EHA 2024 as a late-breaking oral presentation 15 June 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today statistically significant and clinically meaningful results from its Phase III STARGLO study of Columvi® (glofitamab) in combination with gemcitabine and oxaliplatin (GemOx) versus MabThera®/Rituxan® (rituximab) in combination with GemOx (R-GemOx) for people with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have received at least one prior line of therapy and are not candidates for autologous stem cell transplant, or who have received two or more prior lines of therapy.1 Data were featured in the congress Press Briefing and presented today in the Plenary Abstracts Session at the European Hematology Association (EHA) 2024 Congress as a late-breaking oral presentation.1 "The results from STARGLO are the first to show the potential of a CD20xCD3 bispecific antibody to make a difference in second or later-line DLBCL in people who are ineligible for transplant and have limited options," said Jeremy Abramson, M.D., Director, Jon and Jo Ann Hagler Center for Lymphoma at the Massachusetts General Hospital Cancer Center, and principal investigator of the STARGLO study. "Glofitamab in combination with GemOx showed clinically significant improvement in overall survival, as well as key secondary endpoints, and the benefits were reinforced with an additional 11 months of follow-up.” The primary analysis (median follow-up of 11.3 months) confirmed that the study met its primary endpoint of overall survival (OS), demonstrating that patients treated with Columvi plus GemOx lived significantly longer, with a 41% reduction in the risk of death (hazard ratio [HR]=0.59, 95% CI: 0.40-0.89, p=0.011) versus R-GemOx.1 Median OS was not reached with the Columvi regimen versus nine months for R-GemOx.1 Safety of the combination appeared consistent with the known safety profiles of the individual medicines. Pre-specified exploratory subgroup analyses showed comparable results, including consistency across the clinically relevant stratification factors of line of therapy (second-line versus third-line+) and outcome of last therapy (relapsed versus refractory). Regional inconsistencies were observed, however interpretation is limited given the exploratory nature of these analyses and small subgroups with wide confidence intervals. “This marks a first step in advancing Columvi combinations in earlier settings to address the urgent need for the 40% of people who will relapse or have refractory disease and who have limited options,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Moreover, patients do not have to wait to start treatment with Columvi. This could be particularly important for patients with highly aggressive disease who are at risk of rapid disease progression.” The Columvi combination also met its key secondary endpoints, with a 63% reduction in risk of disease worsening or death (progression-free survival, PFS) compared to R-GemOx (HR=0.37; 95% CI: 0.25–0.55, p1 A follow-up analysis was conducted after all patients had completed therapy (median follow-up of 20.7 months), which showed continued benefit in both primary and secondary endpoints.1 Median OS for people treated with the Columvi combination was 25.5 months, nearly double what was seen for people treated with R-GemOx at 12.9 months, and more than twice as many patients experienced a complete response (58.5% versus 25.3%, respectively).1 Adverse event (AE) rates were higher with the Columvi combination versus R-GemOx, noting higher median number of cycles received with Columvi combination (11 versus 4). One of the most common AEs was cytokine release syndrome, which was generally low grade (Any Grade: 44.2%, Grade 1: 31.4%, Grade 2: 10.5%, Grade 3: 2.3%) and occurred primarily in Cycle 1.1 Columvi is the first CD20xCD3 bispecific antibody to demonstrate a survival benefit in DLBCL in a randomised Phase III trial, demonstrating the potential of this type of therapeutic combination to improve survival outcomes in earlier lines of treatment. The standard second-line therapy for R/R DLBCL patients has historically been high-dose chemotherapy followed by stem-cell transplant, however, not everyone with R/R DLBCL is a candidate due to age or coexisting medical conditions. Newer therapies are also becoming available, but barriers remain for many, and alternative treatment options are needed for these patients. Columvi is given as a fixed-duration treatment, offering people with R/R DLBCL a treatment end date and the possibility of a treatment-free period, unlike continuous treatments. Results from the STARGLO study will be submitted to global health authorities, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency. Columvi is also being investigated in other aggressive, hard-to-treat lymphomas and was recently granted Breakthrough Therapy Designation by the FDA for the treatment of adult patients with relapsed or refractory mantle cell lymphoma who have received at least two prior therapies based on results from the Phase I/II NP30179 study. The STARGLO study [GO41944; NCT04408638] is a Phase III, multicentre, open-label, randomised study evaluating the efficacy and safety of Columvi® (glofitamab) in combination with gemcitabine plus oxaliplatin (GemOx) versus MabThera®/Rituxan® (rituximab) in combination with GemOx in patients with relapsed or refractory diffuse large B-cell lymphoma who have received at least one prior line of therapy and who are not candidates for autologous stem cell transplant, or who have received two or more prior lines of therapy.2 Outcome measures include overall survival (primary endpoint), progression-free survival, complete response rate, objective response rate, duration of objective response (secondary endpoints), and safety and tolerability.2 STARGLO is intended as a confirmatory study to convert Columvi’s accelerated approval in the US and conditional marketing authorisation in the EU to full approvals for people with R/R DLBCL after two or more lines of systemic therapy based on the pivotal Phase I/II NP30179 study. Columvi is a CD20xCD3 T-cell engaging bispecific antibody designed to target CD3 on the surface of T-cells and CD20 on the surface of B-cells. Columvi was designed with a novel 2:1 structural format. This T-cell engaging bispecific antibody is engineered to have one region that binds to CD3, a protein on T-cells, a type of immune cell, and two regions that bind to CD20, a protein on B-cells, which can be healthy or malignant. This dual-targeting brings the T-cell in close proximity to the B-cell, activating the release of cancer cell-killing proteins from the T-cell. Columvi is part of Roche’s broad and industry-leading CD20xCD3 T-cell-engaging bispecific antibody clinical development programme that also includes Lunsumio® (mosunetuzumab), which aims to provide tailored treatment options that suit the diverse needs, preferences, and experiences of people with blood cancers and healthcare systems. Roche is investigating Columvi as a monotherapy and in combination with other medicines for the treatment of diffuse large B-cell lymphoma (DLBCL) and other blood cancers. This includes the Phase III SKYGLO [NCT06047080] trial investigating Columvi in combination with Polivy® (polatuzumab vedotin), MabThera®/Rituxan® (rituximab), cyclophosphamide, doxorubicin and prednisone in previously untreated DLBCL. DLBCL is the most common form of non-Hodgkin lymphoma (NHL), accounting for about one in three cases of NHL.3 DLBCL is an aggressive (fast-growing) type of NHL.3 While it is generally responsive to treatment in the frontline, as many as 40% of people will relapse or have refractory disease, at which time salvage therapy options are limited and survival is short.4 Improving treatments earlier in the course of the disease and providing much needed alternative options could help to improve long-term outcomes. Approximately 160,000 people worldwide are diagnosed with DLBCL each year.3,5 Roche has been developing medicines for people with malignant and non-malignant blood diseases for more than 25 years; our experience and knowledge in this therapeutic area runs deep. Today, we are investing more than ever in our effort to bring innovative treatment options to patients across a wide range of haematologic diseases. Our approved medicines include MabThera®/Rituxan® (rituximab), Gazyva®/Gazyvaro® (obinutuzumab), Polivy® (polatuzumab vedotin), Venclexta®/Venclyxto® (venetoclax) in collaboration with AbbVie, Hemlibra® (emicizumab), Lunsumio® (mosunetuzumab) and Columvi® (glofitamab). Our pipeline of investigational haematology medicines includes T-cell engaging bispecific antibody cevostamab, targeting both FcRH5 and CD3, Tecentriq® (atezolizumab), and crovalimab, an anti-C5 antibody engineered to optimise complement inhibition. Our scientific expertise, combined with the breadth of our portfolio and pipeline, also provides a unique opportunity to develop combination regimens that aim to improve the lives of patients even further. Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice. In recognising our endeavour to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the fifteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. References [1] Abramson J, et al. Glofitamab plus Gemcitabine and Oxaliplatin (Glofit-GemOx) for Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL): Results of a Global Randomized Phase III trial (STARGLO). Presented at: EHA Hybrid Congress; 2024 Jun 3-16. Abstract #LB3438. [2] ClinicalTrials.gov. A Phase III Study Evaluating Glofitamab in Combination With Gemcitabine + Oxaliplatin vs Rituximab in Combination With Gemcitabine + Oxaliplatin in Participants With Relapsed/Refractory Diffuse Large B-Cell Lymphoma: NCT04408638 [Internet; cited May 2024]. Available from: https://classic.clinicaltrials.gov/ct2/show/NCT04408638. [3] UpToDate. Patient education: Diffuse large B cell lymphoma in adults (Beyond the Basics). [Internet; cited May 2024]. Available from: https://www-uptodate-com.libproxy1.nus.edu.sg/contents/diffuse-large-b-cell-lymphoma-in-adults-beyond-the-basics. [4] Sehn LH, et al. Diffuse Large B-Cell Lymphoma. N Engl J Med. 2021;384(9):842-858. [5] World Health Organization. Numbers derived from GLOBOCAN 2022. Non-Hodgkin Lymphoma Factsheet [Internet; cited May 2024]. Available from: https://gco-iarc-who-int.libproxy1.nus.edu.sg/media/globocan/factsheets/cancers/34-non-hodgkin-lymphoma-fact-sheet.pdf.

Preliminary safety and efficacy with sustained objective responses observed in patients with lymphoma treated with MT-601 in Phase 1 APOLLO study Study participant with Non-Hodgkin’s Lymphoma who relapsed within 90 days of anti-CD19 CAR T cell therapy remains in complete response nine months after MT-601 treatment Company received approval from United States Adopted Name (USAN) council and International Nonproprietary Names (INN) expert committee for “neldaleucel” as nonproprietary name for MT-601 HOUSTON, May 15, 2024 (GLOBE NEWSWIRE) -- Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company focusing on developing next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumors, today reported corporate updates and financial results for the first quarter ended March 31, 2024. “We are pleased to report a strong start to the first quarter of 2024, marked by continued advances in our clinical programs,” said Juan Vera, M.D., President and Chief Executive Officer of Marker Therapeutics. “Building on our positive results, we continue to observe objective responses in our Phase 1 APOLLO study investigating MT-601 in patients with lymphoma who have relapsed or are ineligible for CAR T therapy. We recently announced that our first patient treated in this study achieved a complete response, which was maintained nine months after initial treatment with MT-601. This patient relapsed within 90 days of CAR T therapy, indicating that MT-601 has superior durability in this study participant. In April, our Principal Investigator at City of Hope National Medical Center was invited to share his findings from the APOLLO trial at a medical conference, where he presented data from two additional study participants and that three out of three subjects treated at City of Hope demonstrated objective responses. While we plan to provide a more comprehensive clinical update on the APOLLO study in the second half of this year, we are encouraged by these preliminary results, which underscore the potential benefit of MT-601 in patients with lymphoma.” “Another significant milestone this quarter was to receive approval from the United States Adopted Name (USAN) council and International Nonproprietary Names (INN) expert committee for “neldaleucel” as nonproprietary drug name for MT-601. Having made these steady advances, we are confident that we are well positioned to achieve our near- and long-term goals related to MT-601 in patients with lymphoma,” concluded Dr. Vera. PROGRAM UPDATES & EXPECTED MILESTONES MT-601 (Lymphoma) Phase 1 multicenter APOLLO trial (clinicaltrials.gov identifier: NCT05798897), investigating MT-601 in patients with lymphoma who relapsed or are ineligible for anti-CD19 CAR T cell therapies, was selected as lead program based on promising preliminary clinical results and non-clinical proof-of-concept data (Press Release, January 8, 2024). Three patients were treated at City of Hope National Medical Center as part of the APOLLO study: First study participant treated with MT-601 had diffuse large B cell lymphoma (DLBCL) and failed four prior lines of therapy, including a relapse within 90 days of anti-CD19 CAR T cell therapy (Breyanzi) (Press Release, June 12, 2023). Without prior lymphodepletion, this participant achieved a complete response eight weeks after the second infusion of MT-601 and remains in complete response nine months after initial treatment with MT-601 (Press Release, April 8, 2024). Another study participant had transformed follicular Non-Hodgkin’s Lymphoma (NHL) and failed 12 lines of therapy, including bispecific T cell engager therapy (mosunetuzumab) for follicular NHL, and anti-CD19 CAR T cells (Yescarta) after transformation into DLBCL. At the time of MT-601 infusion, only follicular NHL persisted in this patient. Eight weeks after initial infusion with MT-601 without prior lymphodepletion, the study participant achieved a complete response, which remains three months following treatment with MT-601(Press Release, April 8, 2024). The third study participant treated had DLBCL with cutaneous involvement and was not eligible for CAR T cell therapy. This participant achieved a partial response eight weeks after MT-601 treatment without prior lymphodepletion with all lesions decreasing in size including one that has completely resolved (Press Release, April 8, 2024). Treatment was well tolerated among all patients with no significant treatment-related adverse events including cytokine release syndrome or neurotoxicity. All patients continue to be observed for durability of response. The Company is enrolling additional patients in the Phase 1 APOLLO trial and expects to report further data in the second half of 2024. MT-601 designated non-proprietary name “neldaleucel” by United States Adopted Name (USAN) Counsel and International Nonproprietary Names (INN) Expert Committee. MT-601 (Pancreatic) Investigational New Drug (IND) application cleared by U.S. Food and Drug Administration (FDA) for multicenter Phase 1 trial of MT-601 in patients with metastatic pancreatic cancer in combination with front-line chemotherapy. Clinical advancement will be pending additional financial support from non-dilutive grant activities. MT-401-OTS (Acute Myeloid Leukemia or Myelodysplastic Syndrome) To streamline resources and to reduce time to treatment, Marker decided to discontinue the patient-specific part of the Acute Myeloid Leukemia (AML) program and to focus on a ready for use “Off-the-Shelf” product (Press Release, January 8, 2024). U.S. FDA has granted an Investigational New Drug (IND) to investigate MT-401 as an “Off-the-Shelf” (MT-401-OTS) product in patients with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS). MT-401-OTS is manufactured from healthy donors, and Marker has established a cellular inventory with ongoing efforts of expanding it further. Granted Orphan Drug Designation from the European Medicines Agency (EMA) and U.S. FDA. Marker has non-clinical proof-of-concept data supporting the clinical benefits of MT-401-OTS in AML and secured $2M in non-dilutive funding from the NIH Small Business Innovation Research (SBIR) program to support the clinical investigation of MT-401-OTS in patients with AML. Clinical program initiation of MT-401-OTS anticipated for the second half of 2024. FIRST QUARTER 2024 FINANCIAL HIGHLIGHTS Cash Position and Guidance: At March 31, 2024, Marker had cash and cash equivalents of $11.3 million. The Company believes that its existing cash and cash equivalents will fund its operating expenses into the fourth quarter of 2025, inclusive of available drawdowns from grant funds. R&D Expenses: Research and development expenses were $2.6 million for the quarter ended March 31, 2024, compared to $3.4 million for the quarter ended March 31, 2023. G&A Expenses: General and administrative expenses were $1.2 million for the quarter ended March 31, 2024, compared to $2.2 million for the quarter ended March 31, 2023. Net Loss: Marker reported a net loss of $2.4 million for the quarter ended March 31, 2024, compared to a net loss of $4.9 million for the quarter ended March 31, 2023. About multiTAA-specific T cells The multi-tumor associated antigen (multiTAA)-specific T cell platform is a novel, non-genetically modified cell therapy approach that selectively expands tumor-specific T cells from a patient's/donor’s blood capable of recognizing a broad range of tumor antigens. Since multiTAA-specific T cells are not genetically engineered, Marker believes that its product candidates will be easier and less expensive to manufacture, with reduced toxicities, compared to current engineered CAR-T and TCR-based approaches, and may provide patients with meaningful clinical benefits. As a result, Marker believes that its portfolio of T cell therapies has a compelling product profile, as compared to current gene-modified CAR-T and TCR-based therapies. About Marker Therapeutics, Inc. Marker Therapeutics, Inc. is a Houston, TX-based clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumors. Clinical trials that enrolled more than 200 patients across various hematological and solid tumor indications showed that the Company’s autologous and allogeneic multiTAA-specific T cell products were well tolerated and demonstrated durable clinical responses. Marker’s goal is to introduce novel T cell therapies to the market and improve patient outcomes. To achieve these objectives, the Company prioritizes the preservation of financial resources and focuses on operational excellence. Marker’s unique T cell platform is strengthened by non-dilutive funding from U.S. state and federal agencies supporting cancer research. To receive future press releases via email, please visit: . Forward-Looking Statements This release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements in this news release concerning the Company’s expectations, plans, business outlook or future performance, and any other statements concerning assumptions made or expectations as to any future events, conditions, performance or other matters, are “forward-looking statements.” Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: our research, development and regulatory activities and expectations relating to our non-engineered multi-tumor antigen specific T cell therapies; the effectiveness of these programs or the possible range of application and potential curative effects and safety in the treatment of diseases; and the timing, conduct and success of our clinical trials of our product candidates, including MT-601 and MT-401-OTS. Forward-looking statements are by their nature subject to risks, uncertainties and other factors which could cause actual results to differ materially from those stated in such statements. Such risks, uncertainties and factors include, but are not limited to the risks set forth in the Company’s most recent Form 10-K, 10-Q and other SEC filings which are available through EDGAR at WWW.SEC.GOV. The Company assumes no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release. Marker Therapeutics, Inc. Condensed Consolidated Balance Sheets (Unaudited) March 31, December 31, 2024 2023 ASSETS Current assets: Cash and cash equivalents $ 11,323,428 $ 15,111,450 Prepaid expenses and deposits 917,009 988,126 Other receivables 1,851,462 1,027,815 Total current assets 14,091,899 17,127,391 Total assets $ 14,091,899 $ 17,127,391 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable and accrued liabilities $ 1,949,700 $ 1,745,193 Related party payable 353,965 1,329,655 Total current liabilities 2,303,665 3,074,848 Total liabilities 2,303,665 3,074,848 Stockholders' equity: Preferred stock, $0.001 par value, 5 million shares authorized, 0 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively — — Common stock, $0.001 par value, 30 million shares authorized, 8.9 million issued and outstanding as of March 31, 2024 and December 31, 2023, respectively 8,910 8,891 Additional paid-in capital 450,458,009 450,329,515 Accumulated deficit (438,678,685 ) (436,285,863 ) Total stockholders' equity 11,788,234 14,052,543 Total liabilities and stockholders' equity $ 14,091,899 $ 17,127,391 Marker Therapeutics, Inc. Condensed Consolidated Statements of Operations (Unaudited) For the Three Months Ended March 31, 2024 2023 Revenues: Grant income $ 1,244,061 $ 1,234,336 Total revenues 1,244,061 1,234,336 Operating expenses: Research and development 2,575,015 3,376,497 General and administrative 1,218,063 2,167,318 Total operating expenses 3,793,078 5,543,815 Loss from operations (2,549,017 ) (4,309,479 ) Other income (expenses): Interest income 156,195 84,654 Loss from continuing operations (2,392,822 ) (4,224,825 ) Discontinued operations: Loss from discontinued operations, net of tax — (742,751 ) Income (loss) from discontinued operations — (742,751 ) Net loss $ (2,392,822 ) $ (4,967,576 ) Net earnings (loss) per share: Loss from continuing operations, basic and diluted $ (0.27 ) $ (0.48 ) Income (loss) from discontinued operations, basic and diluted $ — $ (0.09 ) Net loss per share, basic and diluted $ (0.27 ) $ (0.57 ) Weighted average number of common shares outstanding: Basic 8,901,962 8,721,031 Diluted 8,901,962 8,721,031 Marker Therapeutics, Inc. Condensed Consolidated Statements of Cash Flows (Unaudited) For the Three Months Ended March 31, 2024 2023 Cash Flows from Operating Activities: Net loss $ (2,392,822 ) $ (4,967,576 ) Less: loss from discontinued operations, net of tax - (742,751 ) Net loss from continuing operations (2,392,822 ) (4,224,825 ) Reconciliation of net loss to net cash used in operating activities: Stock-based compensation 79,417 659,913 Changes in operating assets and liabilities: — — Prepaid expenses and deposits 71,117 36,452 Other receivables (823,647 ) 1,319,118 Related party receivable — (1,000,000 ) Related party payable (975,690 ) Accounts payable and accrued expenses 204,507 111,171 Net cash used in operating activities - continuing operations (3,837,118 ) (3,098,171 ) Net cash used in operating activities - discontinued operations — (2,790,124 ) Net cash used in operating activities (3,837,118 ) (5,888,295 ) Cash Flows from Investing Activities: Net cash provided by (used in) investing activities - discontinued operations — (112,608 ) Net cash provided by (used in) investing activities — (112,608 ) Cash Flows from Financing Activities: Proceeds from issuance of common stock, net — 619,974 Proceeds from stock options exercise 49,096 — Net cash provided by financing activities 49,096 619,974 Net increase (decrease) in cash and cash equivalents (3,788,022 ) (5,380,929 ) Cash and cash equivalents at beginning of the period 15,111,450 11,782,172 Cash and cash equivalents at end of the period $ 11,323,428 $ 6,401,243 Contacts TIBEREND STRATEGIC ADVISORS, INC. Investors Daniel Kontoh-Boateng (862) 213-1398 DBOATENG@TIBEREND.COM