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Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, Sept. 20, 2024 /PRNewswire/ -- USA News Group – Cancer rates are rising globally, and the outlook is particularly concerning for men. A recent global study projects an 84% increase in cancer cases and a 93% rise in cancer deaths among men by 2050. According to Our World in Data, cancer has overtaken cardiovascular diseases as the leading cause of death in several wealthy nations. Despite warnings from the American Cancer Society, which found that 44% of cancer deaths in U.S. adults are linked to lifestyle factors, troubling trends continue. Another study revealed that even light drinking is associated with an increase in cancer deaths among older adults in Britain. Meanwhile, behind the scenes, biotech innovators are developing new targets for improved cancer therapies, driving the next wave of breakthroughs in oncology coming from O ncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), G1 Therapeutics, Inc. (NASDAQ: GTHX), Arcellx, Inc. (NASDQ: ACLX), Sanofi (NASDAQ: SNY), and Halozyme Therapeutics, Inc. (NASDAQ: HALO) . Building upon seemingly strong results from its BRACELET-1 breast cancer study, O ncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) continues to make impressive strides toward a pivotal registration-enabling study for its flagship cancer therapy, pelareorep. The BRACELET-1 Phase 2 trial delivered highly encouraging data, reinforcing the potential for pelareorep-based therapies to bring meaningful benefits to patients with HR+/HER2- advanced or metastatic breast cancer. One of the most intriguing results is the median overall survival (OS) in the pelareorep arm, which has not yet been reached—indicating that more than half of the patients were still alive at the end of the study. For comparison, the median OS in the paclitaxel-only control group was 18.2 months. This translates into a two-year survival rate of 64% for patients receiving pelareorep + paclitaxel, nearly double the 33% rate observed in patients treated with paclitaxel alone. The progression-free survival (PFS) results were equally impressive, showing a median of 12.1 months for the combination therapy, compared to 6.4 months for paclitaxel monotherapy. "The fact that the median overall survival was not reached because more than half the patients were still alive at the end of the study is a remarkable achievement for us," said Wayne Pisano, Interim CEO and Chair of Oncolytics' Board of Directors. "It shows just how promising pelareorep treatment can be for extending the lives of breast cancer patients. This is further exemplified by the near doubling of the 2-year survival rate for patients who received pelareorep combination therapy." These results are more than just numbers—they underscore the potential of pelareorep to significantly extend survival times for breast cancer patients, offering renewed hope to those battling this aggressive form of cancer. The positive results from BRACELET-1 mirror those of the earlier IND-213 trial, which led to FDA Fast Track Designation for pelareorep back in 2017, further cementing its status as a therapy with game-changing potential. "Taken together, the BRACELET-1 results provide compelling support for the potential of pelareorep-based combination therapy to benefit patients with advanced or metastatic HR+/HER2- breast cancer," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics. "Having recently discussed with the FDA key design elements for our next breast cancer study, in combination with the strong survival data from the BRACELET-1 and IND-213 studies, we are confident in our plan to conduct a registration-enabling study to assess pelareorep-based combination therapy in patients with advanced HR+/HER2- breast cancer." With such compelling data in hand, Oncolytics is now preparing for the next major milestone: securing funding for a registration-enabling study. This critical step will bring pelareorep closer to becoming an approved treatment option for breast cancer patients, offering a new lifeline in the fight against cancer. Set to be acquired by leading iron deficiency anemia treatment developer Pharmacosmos, commercial-stage oncology company G1 Therapeutics, Inc. (NASDAQ: GTHX) put out its Q2 2024 and operational highlights which included mention of its positive efficacy results from its Phase 2 trial of Trilaciclib in combination with a TROP2 ADC that were presented at the 2024 ASCO annual meeting, as well as final analysis of the Phase 3 PRESERVE 2 trial in 1L metastatic triple negative breast cancer (mTNBC) which showed continued evidence of myeloprotection, but didn't achieve its primary OS endpoint. "We are excited about what will be possible by the combined Pharmacosmos + G1 team as we meet the needs of more cancer patients," said Jack Bailey, CEO of G1 Therapeutics. "This transaction delivers a significant premium to our shareholders and better and broader access to COSELA for the cancer patients we seek to treat. In the meantime, as we move toward closing, our focus remains on accelerating and expanding the growth of the COSELA business in extensive stage small cell lung cancer; the double-digit quarter-over-quarter growth we experienced in vial volume and net revenue represents continued progress in that regard." Reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, Arcellx, Inc. (NASDQ: ACLX) recently put out its Q2 2024 financial results and business updates, which included mention of earning a $68 million milestone payment from Kite, a Gilead company, which Arcellx continues to have momentum with in advancements in anito-cel multiple myeloma. "We continue to make significant strides as we accelerate our business," said Rami Elghandour, Chairman and CEO of Arcellx. "We are thrilled about the momentum across our multiple myeloma program being developed in partnership with Kite. We believe anito-cel has the potential to be a best-in-class treatment option, and with the strength of our Kite partnership, we are well-positioned to change the treatment paradigm for multiple myeloma patients. We look forward to presenting data from the iMMagine-1 study by the end of this year. As iMMagine-1 continues to mature, we're also pleased with the progress in iMMagine-3, which was initiated by our partner Kite. More broadly, we believe that our novel synthetic binder, the D-Domain, which forms the basis of our technology platform and our lead program anito-cel, can be developed in oncology and non-oncology indications." Another joint oncology effort is coming from Sanofi (NASDAQ: SNY) through an exclusive licensing agreement with RadioMedix, and Orano Med to develop lead-212 (212Pb) radioligand therapies (RLTs) against cancer. The specifically focuses on the late-stage project, AlphaMedixTM (212Pb-DOTAMTATE), which currently is being evaluated for the treatment of adult patients with unresectable or metastatic, progressive somatostatin-receptor expressing neuroendocrine tumors (NETs), a rare cancer. AlphaMedixTM is a TAT which consists of a somatostatin receptor-targeting peptide complex radiolabeled with lead-212 (212Pb) that serves as an in vivo generator of alpha particles. "We are excited to develop a leading-edge project in the rapidly evolving field of radioligand therapies in rare cancers," said Dietmar Berger, Chief Medical Officer, Global Head of Development, of Sanofi. "Early results for 212Pb have demonstrated its differentiated biophysical and clinical profile, reinforcing its potential to be a transformative radioligand therapeutic for patients across multiple difficult-to-treat rare cancers. This agreement underscores our efforts to explore innovative collaborations that leverage novel technologies to address the needs of people living with cancer." Halozyme Therapeutics, Inc. (NASDAQ: HALO) is celebrating the FDA approval of Roche's Tecentriq Hybreza™ with its drug delivery technology ENHANZE® for multiple types of cancer. Tecentriq Hybreza™ offers a faster administration option, with a subcutaneous injection that takes about 7 minutes, compared to the 30-60 minutes required for the standard intravenous (IV) infusion of Tecentriq® (atezolizumab). This new treatment will be available in the U.S. for all approved adult uses of the IV version, including certain types of lung, liver, skin, and soft tissue cancers. "We are delighted that Tecentriq Hybreza has been approved in the U.S. for all approved adult indications of the IV treatment," said Dr. Helen Torley, president and CEO of Halozyme. "This approval represents another opportunity for our ENHANZE technology to provide patients and physicians with greater flexibility and a new option for how treatment is administered." The FDA's approval was based on pivotal data from Roche's Phase IB/III IMscin001 study, which showed comparable levels of Tecentriq® in the blood when administered subcutaneously, and a safety and efficacy profile consistent with the IV formulation. Article Source: USA NEWS GROUP [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. 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REDWOOD CITY, Calif.--( BUSINESS WIRE )--Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, today reported business highlights and financial results for the second quarter ended June 30, 2024. “We continue to make significant strides as we accelerate our business,” said Rami Elghandour, Arcellx’s Chairman and Chief Executive Officer. “We are thrilled about the momentum across our multiple myeloma program being developed in partnership with Kite. We believe anito-cel has the potential to be a best-in-class treatment option, and with the strength of our Kite partnership, we are well-positioned to change the treatment paradigm for multiple myeloma patients. We look forward to presenting data from the iMMagine-1 study by the end of this year. As iMMagine-1 continues to mature, we’re also pleased with the progress in iMMagine-3, which was initiated by our partner Kite. More broadly, we believe that our novel synthetic binder, the D-Domain, which forms the basis of our technology platform and our lead program anito-cel, can be developed in oncology and non-oncology indications. We are excited to share that the U.S. Food and Drug Administration has cleared our IND application for the development of anito-cel to treat patients with myasthenia gravis. Our progress this quarter reflects our incredible team and their dedication to advancing our mission of helping as many patients as possible by delivering on the promise of our platform.” Recent Business Progress The Company earned a $68 million clinical milestone payment from Kite Pharma, Inc., a Gilead Company, for iMMagine-1 enrollment. The Company submitted an abstract to present data for the iMMagine-1 study at the 66 th ASH Annual Meeting and Exposition. Kite has initiated the global Phase 3 trial, iMMagine-3. This trial will evaluate anito-cel in patients exposed to an immunomodulatory (lMiD) drug and an anti-CD38 monoclonal antibody. The U.S. Food and Drug Administration (FDA) cleared an Investigational New Drug (IND) application for anito-cel, Arcellx’s BCMA CAR-T therapy, for myasthenia gravis, a chronic autoimmune disease. Arcellx wholly owns and is solely developing this program. Second Quarter 2024 Financial Highlights Cash, cash equivalents, and marketable securities: As of June 30, 2024, Arcellx had cash, cash equivalents, and marketable securities of $646.8 million. Arcellx anticipates that its cash, cash equivalents, and marketable securities will fund its operations into 2027. Collaboration revenue: Collaboration revenue were $27.4 million and $14.3 million for the quarters ended June 30, 2024 and 2023, respectively, an increase of $13.1 million. This increase was primarily driven by an increase in estimated transaction price from the expansion to the license and collaboration agreement with Kite. R&D expenses: Research and development expenses were $41.0 million and $28.3 million for the quarters ended June 30, 2024 and 2023, respectively, an increase of $12.7 million. This increase was primarily driven by increased costs relating to other preclinical pipeline programs and increased personnel costs, which include non-cash stock-based compensation expense. G&A expenses: General and administrative expenses were $21.4 million and $15.5 million for the quarters ended June 30, 2024 and 2023, respectively, an increase of $5.9 million. This increase was primarily driven by increased personnel costs, which include non-cash stock-based compensation expense. Net income or loss: Net losses were $27.2 million and $23.9 million for the quarters ended June 30, 2024 and 2023, respectively. About Arcellx, Inc. Arcellx, Inc. is a clinical-stage biotechnology company reimagining cell therapy by engineering innovative immunotherapies for patients with cancer and other incurable diseases. Arcellx believes that cell therapies are one of the forward pillars of medicine and Arcellx's mission is to advance humanity by developing cell therapies that are safer, more effective, and more broadly accessible. For more information on Arcellx, please visit www.arcellx.com . Follow Arcellx on X @arcellx and LinkedIn. About Generalized Myasthenia Gravis Generalized Myasthenia Gravis (gMG) is a rare autoimmune disease characterized by severe muscle weakness. In gMG, the body’s immune system mistakenly attacks proteins in the neuromuscular junction, disrupting neuromuscular signaling and preventing muscle contraction. Symptoms include muscle weakness, drooping eyelids, impaired chewing, swallowing, and speaking. gMG affects over 70,000 people in the United States and there is no known cure. Forward-looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements in this press release that are not purely historical are forward-looking statements, including, without limitation, Arcellx's plans for the research, pre-clinical and clinical development of its product candidates; the momentum across the multiple myeloma program being developed in partnership with Kite, and the potential to change the treatment paradigm in multiple myeloma; the anticipated timing for the presentation of iMMagine-1 data; the best-in-class potential of anito-cel for patients suffering from multiple myeloma; Arcellx’s belief that the D-Domain can be developed in oncology and non-oncology indications; and the sufficiency of cash, cash equivalents and marketable securities and its ability to fund operations into 2027. The forward-looking statements contained herein are based upon Arcellx's current expectations and involve assumptions that may never materialize or may prove to be incorrect. These forward-looking statements are neither promises nor guarantees and are subject to a variety of risks and uncertainties, including risks that may be found in the section entitled Part II, Item 1A (Risk Factors) in the Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, filed with the Securities and Exchange Commission (SEC) on or about the date hereof, and the other documents that Arcellx may file from time to time with the SEC. These forward-looking statements are made as of the date of this press release, and Arcellx assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. ARCELLX, INC. SELECTED CONSOLIDATED BALANCE SHEET DATA (in thousands) June 30, December 31, 2024 2023 Cash, cash equivalents, and marketable securities $ 646,816 $ 729,185 Total assets 734,306 825,132 Total liabilities 247,142 339,752 Total stockholders' equity 487,164 485,380 ARCELLX, INC. CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (in thousands, except share and per share amounts) Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023 Revenue $ 27,384 $ 14,302 $ 66,640 $ 32,213 Operating expenses: Research and development 40,953 28,327 73,271 61,258 General and administrative 21,424 15,535 44,172 30,972 Total operating expenses 62,377 43,862 117,443 92,230 Loss from operations (34,993 ) (29,560 ) (50,803 ) (60,017 ) Other income, net 8,132 5,424 16,744 8,866 Loss before income taxes (26,861 ) (24,136 ) (34,059 ) (51,151 ) Income tax benefit (expense) (341 ) 282 (341 ) (47 ) Net loss (27,202 ) (23,854 ) (34,400 ) (51,198 ) Other comprehensive loss: Unrealized gain (loss) on marketable securities (280 ) (93 ) (1,339 ) 214 Comprehensive loss $ (27,482 ) $ (23,947 ) $ (35,739 ) $ (50,984 ) Net loss per share attributable to common stockholders—basic and diluted $ (0.51 ) $ (0.50 ) $ (0.65 ) $ (1.08 ) Weighted-average common shares outstanding—basic and diluted 53,516,907 48,106,528 53,137,440 47,441,647