Bortezomib

FN Media Group News Commentary PALM BEACH, Fla., May 9, 2024 /PRNewswire/ -- The incidence of pancreatic cancer is increasing globally, which is driving the growth of the market. As of 2023, the American Cancer Society predicts that 64,050 Americans will be diagnosed with pancreatic cancer. It is estimated that 50,550 people will die from pancreatic cancer (26,620 men and 23,930 women). Pancreatic cancer is an aggressive form of cancer, and it is often not detected until it is in an advanced stage. Additionally, the treatment options for pancreatic cancer are limited, and the survival rate is low. These factors are contributing to the rise in pancreatic cancer cases, which in turn is driving the growth of the pancreatic cancer market. A recent report from Research Nester projected that the global pancreatic cancer market size is slated to expand at ~18% CAGR between 2024 and 2036. The market is poised to garner a revenue of USD 36 billion by the end of 2036, up from a revenue of ~USD 6 billion in the year 2023. The report said: "Advancements in diagnosis and treatment options for pancreatic cancer are also driving the growth of the market. As researchers gain a better understanding of the different types of pancreatic cancer, they are developing more targeted treatments that are more likely to be effective with fewer side effects. Additionally, new treatment options, such as immunotherapy and targeted therapies, are improving patient outcomes and extending survival rates." Active biotech and pharma companies in the markets this week include Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), Zai Lab Limited (NASDAQ: ZLAB), Notable Labs, Ltd. (NASDAQ: NTBL), Cardiff Oncology, Inc. (NASDAQ: CRDF), Johnson & Johnson (NYSE: JNJ). Research Nester concluded: "The pancreatic cancer market in North America is garner the largest revenue by the end of 2036 due to several demographic changes, including an aging population and increased incidence of obesity and diabetes. In the US, there are 37.3 million diabetics (11.3[R3] % of the population); 28.7 million are diagnosed with diabetes, including 28.5 million adults. As the population ages, there will be a higher prevalence of chronic diseases such as diabetes and obesity, which are risk factors for pancreatic cancer. Additionally, the aging population will lead to an increase in the number of people with pre-existing conditions that can increase the risk of developing pancreatic cancer. Obesity and diabetes are known risk factors for pancreatic cancer, and as these conditions become more prevalent, the number of cases of pancreatic cancer is expected to increase." Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) Receives Regulatory Clearance to Evaluate Pelareorep in Combination with Modified FOLFIRINOX +/- an anti-PD-L1 Inhibitor in Pancreatic Cancer US$5 million PanCAN grant provides important support for the fifth cohort of the GOBLET study Study of modified OLFIRINOX/pelareorep/atezolizumab (Tecentriq ®) combination expands existing pancreatic cancer program First patient expected to be enrolled in Q2 2024 Oncolytics Biotech ® Inc., a leading clinical-stage company specializing in immunotherapy for oncology, will commence enrollment into a new GOBLET study pancreatic cancer cohort following both German regulatory and ethics approvals. This cohort will evaluate pelareorep in combination with modified FOLFIRINOX (mFOLFIRINOX) with or without the PD-L1 immune checkpoint inhibitor atezolizumab (Tecentriq ® ) in newly diagnosed patients with pancreatic ductal adenocarcinoma (PDAC). It is supported by a US$5M Therapeutic Accelerator Award from the Pancreatic Cancer Action Network (PanCAN), an innovative program established to accelerate the development of new treatments for pancreatic cancer. The chemotherapy regimens of mFOLFIRINOX or gemcitabine + nab-paclitaxel are the two most common standards of care for pancreatic cancer. Oncolytics has already reported data with the combination of gemcitabine and nab-paclitaxel ( link to the PR , link to the poster ) that surpassed historical outcomes. Positive results from a combination with mFOLFIRINOX could greatly enhance pelareorep's potential in addressing pancreatic cancer. "Oncolytics is pleased to announce receipt of regulatory clearance to initiate the mFOLFIRINOX cohort in patients with newly diagnosed metastatic PDAC. We appreciate the opportunity to collaborate with PanCAN, Roche, and AIO on this cohort, which is expected to initiate enrollment in the second quarter," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics. "We believe that working with PanCAN will help to further enrich Oncolytics' clinical relationships with the pancreatic cancer community. We are also grateful for PanCAN's Therapeutic Accelerator Award, which is enabling the evaluation of this combination therapy." "The Therapeutic Accelerator Award program has been an important part of PanCAN's approach to advancing innovative treatments for pancreatic cancer. We incorporated input from leading scientists and clinicians in the field of pancreatic cancer to select Oncolytics as a recipient of this award," said Anna Berkenblit , MD, MMSc, Chief Scientific and Medical Officer at PanCAN. "Increasing patient access to clinical trials is vital to developing improved treatment options, so we are pleased that Oncolytics has received regulatory clearance for the pelareorep/mFOLFIRINOX combination and is poised to enroll the first patient in this cohort. We hope that the results from this study lead to improved outcomes for patients with pancreatic cancer." Dirk Arnold , M.D., Ph.D., Director of Asklepios Tumorzentrum Hamburg and primary investigator of the GOBLET trial, commented, "Oncolytics has taken a very strategic approach to the development of pelareorep in pancreatic cancer by focusing its clinical studies on combinations with the most widely used treatment regimens. My experience to date with the GOBLET study, including the positive metastatic PDAC and encouraging anal cancer data reported last year, makes me enthusiastic to initiate enrollment in the mFOLFIRINOX cohort." "We previously reported very encouraging results in pancreatic cancer patients for the combination of pelareorep, gemcitabine/nab-paclitaxel, and atezolizumab, and we plan to begin a registration-enabling study of this regimen later this year. The new pelareorep/mFOLFIRINOX cohort offers the opportunity to expand pelareorep's role in pancreatic cancer. If the mFOLFIRINOX combination shows a compelling efficacy signal, this therapeutic approach could also be advanced to a registration-enabling study, providing two opportunities for pelareorep-based treatment to benefit pancreatic cancer patients," said Thomas Heineman , M.D., Ph.D., Chief Medical Officer at Oncolytics. "In addition, translational research studies planned for this cohort will help to further elucidate pelareorep's mechanism of action, including its ability to shape the tumor microenvironment (TME). Notably, we will evaluate the correlation between tumor responses and the expansion of tumor-infiltrating lymphocytes (TILs) in the blood, an effect that was observed in earlier pancreatic cancer studies. We look forward to initiating enrollment into the mFOLFIRINOX/pelareorep study cohort in the second quarter of this year." CONTINUED… Read these full press releases and more news for ONCY at: Other recent developments in the biotech industry of note for cancer events include: Zai Lab Limited (NASDAQ: ZLAB) recently announced financial results for the first quarter of 2024, along with recent product highlights and corporate updates. "Our first quarter results demonstrate strong commercial execution and pipeline progress across our potential first- and best-in-class product portfolio," said Dr. Samantha Du, Founder, Chairperson, and Chief Executive Officer of Zai Lab. "The launch of VYVGART is off to an impressive start with $13.2 million of sales in the first quarter. Looking ahead, we expect to accelerate commercial performance for the remainder of the year and are preparing for three new potential launches in 2024. We are also excited by the progress of our late-stage pipeline and we are on track to achieve the objectives outlined in our five-year strategic plan, including significant revenue growth and profitability by the end of 2025." "Our net revenues grew 39% y-o-y or 43% y-o-y at CER in the first quarter, driven by strong execution with the launch of VYVGART and uptake of our existing portfolio," said Josh Smiley, President and Chief Operating Officer of Zai Lab. "With VYVGART's launch in gMG at the end of last year, and multiple new products and indications expected to launch over the near-term, we are now entering a period of robust growth for Zai Lab. Our significant growth, coupled with our focus on driving efficiencies and productivity across the organization, will drive the evolution of Zai Lab into a profitable, high growth business by the end of 2025. Furthermore, we will continue to focus on expanding our global portfolio through our internal discovery activities and strategic business development," Mr. Smiley concluded. Notable Labs, Ltd. (NASDAQ: NTBL), a clinical-stage precision oncology company developing new cancer therapies identified by its Predictive Precision Medicine Platform (PPMP), recently reported financial results for the year ended December 31, 2023 and provided a business update. "The last year has been a time of great accomplishment for Notable. We built a strong clinical validation dataset, starting with a poster presented at the American Association for Cancer Research (AACR 2023); became a publicly listed company, following the closing of a reverse merger in October 2023; and reported successful PPMP clinical data from the Phase 2 fosciclopirox study that showcased the ability of our platform to accurately predict patient outcomes for specific therapeutics," said Thomas Bock, M.D., Chief Executive Officer of Notable. "The performance of our platform in accurately predicting the outcome of the fosciclopirox study has enabled us to enhance the clinical trial plan for our lead product candidate, volasertib, in development for patients with relapsed/refractory acute myeloid leukemia (r/r AML). In our upcoming Phase 2 trial, we will be utilizing the platform to enrich the study's enrollment with patients predicted to respond to volasertib, which we believe will result in more rapid enrollment, shorter time to efficacy data and, ultimately, increased probability of success." Cardiff Oncology, Inc. (NASDAQ: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, recently announced financial results for the first quarter ended March 31, 2024, and provided a business update. "During the start of 2024, we presented several important new data sets supporting our first-line RAS-mutated mCRC strategy and the broader opportunity for onvansertib," said Mark Erlander, Ph.D., Chief Executive Officer of Cardiff Oncology. "The data from the ONSEMBLE trial replicated, in a second independent and randomized dataset, the bev naïve signal from our earlier Phase 1b/2 KRAS-mutated mCRC trial. And the Phase 1b data published in the peer-reviewed journal Clinical Cancer Research, and the additional data we presented in one of our five posters at AACR, further substantiated our lead program in RAS-mutated mCRC. The additional AACR posters also point toward new indications for onvansertib in RAS wild-type mCRC, small cell lung cancer and ovarian cancer. Looking ahead, we believe that our upcoming data readout from our first-line trial in RAS-mutated mCRC has the potential to serve as a key value inflection point for our company and revolutionize the treatment of RAS-mutated mCRC, an area with no new treatments approved in over two decades." Johnson & Johnson (NYSE: JNJ) recently announced that the U.S. Food and Drug Administration (FDA) has approved CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide. With this approval, CARVYKTI® becomes the first and only B-cell maturation antigen (BCMA)-targeted therapy approved for the treatment of patients with multiple myeloma as early as first relapse. FDA approval is based on positive results from the Phase 3 CARTITUDE-4 study, which demonstrated that the earlier use of CARVYKTI® reduced the risk of disease progression or death by 59 percent compared to standard therapies—pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd)—in adults with relapsed and lenalidomide-refractory multiple myeloma who received one to three prior lines of therapy. The study, which was presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting and published in The New England Journal of Medicine, also included and reported key secondary results such as overall response (OR) and overall survival (OS). 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The companies share design of global Phase 3 trial, iMMagine-3; will evaluate anito-cel in patients exposed to both an immunomodulatory (lMiD) drug and an anti-CD38 monoclonal antibody Anito-cel will be manufactured from Kite’s Frederick, Maryland facility for iMMagine-3 as the successful technical transfer is complete Remain on track to present preliminary data from the iMMagine-1 trial by end of the year REDWOOD CITY, Calif. & SANTA MONICA, Calif.--(BUSINESS WIRE)-- Arcellx, Inc. (NASDAQ: ACLX) and Kite, a Gilead Company (NASDAQ: GILD), today announced several key operational updates on their partnered anitocabtagene autoleucel (anito-cel) multiple myeloma program. Anito-cel is the first BCMA CAR T to be investigated in multiple myeloma that utilizes Arcellx’s novel and compact D-Domain binder. The companies shared the design of a global, Phase 3 randomized controlled clinical trial, iMMagine-3, which Kite expects to start in the second half of this year. The trial will compare the efficacy and safety of anito-cel randomized against the standard of care (SOC) in patients with relapsed and/or refractory multiple myeloma (rrMM) who have received one to three prior lines of therapy, including an immunomodulatory drug (lMiD) and an anti-CD38 monoclonal antibody. Kite’s facility in Frederick, Maryland will manufacture anito-cel for this trial. This follows the completion of the technical transfer from a third-party contract manufacturing organization to Kite, as well as the transfer of the Investigational New Drug (IND) application for anito-cel, which has been cleared by the U.S. Food and Drug Administration. “Our global iMMagine-3 trial will evaluate anito-cel as a second through fourth line treatment in patients with multiple myeloma who were previously exposed to both an immunomodulatory drug and an anti-CD38 monoclonal antibody,” said Rami Elghandour, Arcellx’s Chairman and Chief Executive Officer. “The iMMagine-3 study allows us to maximize the impact of anito-cel as it captures what will become the largest second line patient population based on the current treatment paradigm, as anti-CD38 therapies move to front line treatment. This population represents an emerging significant unmet clinical need allowing us to provide access to a unique patient population. In addition, the completion of the technical transfer to Kite allowed us to accelerate our development program and launch iMMagine-3 globally, which will enable broader and earlier patient access to anito-cel.” “We are pleased to start the Phase 3 pivotal trial, iMMagine-3, in the second half of this year given the tremendous unmet need that remains in patients with relapsed and/or refractory multiple myeloma,” said Cindy Perettie, Executive Vice President, Kite. “As we prepare for this pivotal program, we look forward to leveraging our manufacturing expertise to further position anito-cel as a potential best-in-class cell therapy. We know manufacturing quality, reliability, and speed are critically important as every day matters for these patients.” About iMMagine-3 Global Phase 3 Randomized Controlled Clinical Trial iMMagine-3 is a phase 3, randomized controlled trial designed to compare the efficacy and safety of anitocabtagene autoleucel (anito-cel) with SOC in patients with relapsed and/or refractory multiple myeloma (rrMM) who have received one to three prior lines of therapy, including an immunomodulatory drug (lMiD) and an anti-CD38 monoclonal antibody. iMMagine-3 will enroll approximately 450 adult patients. Prior to randomization, investigator’s choice of SOC regimens include: pomalidomide, bortezomib, and dexamethasone (PVd); daratumumab, pomalidomide, and dexamethasone (DPd); carfilzomib, daratumumab and dexamethasone (KDd); or carfilzomib and dexamethasone (Kd). Patients in the anito-cel arm will undergo leukapheresis and optional bridging therapy (with the SOC regimen selected by the investigator prior to randomization) followed by lymphodepleting chemotherapy (fludarabine 30 mg/m2/d and cyclophosphamide 300 mg/m2/d for 3 days) and one infusion of anito-cel (115×106 CAR+ T cells) on Day 1. The primary endpoint is progression free survival (PFS) per blinded independent review according to the 2016 IMWG uniform response criteria for MM with the hypothesis that anito-cel will prolong PFS compared to SOC. Key secondary endpoints include complete response rate (CR/sCR), minimal residual disease negativity, overall survival, and safety. The iMMagine-3 trial is expected to initiate in the second half of 2024 at ~130 study sites across North America, Europe, and rest of world. About Arcellx and Kite Collaboration Arcellx and Kite, a Gilead Company, formed a global strategic collaboration to co-develop and co-commercialize Arcellx's anito-cel candidate for the treatment of patients with relapsed or refractory multiple myeloma currently in a pivotal Phase 2 trial. Kite and Arcellx will jointly develop and commercialize the anito-cel asset in the United States, and Kite will commercialize the product outside the United States. About anitocabtagene autoleucel (anito-cel) Anito-cel is a BCMA CAR T that utilizes a novel binder (or CAR) known as the D-Domain. Its small size (8kDa) facilitates high T-cell transduction and expression, resulting in more CAR positive cells and more CARs expressed per T-cell. Anito-cel has been granted Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy designations by the U.S. Food and Drug Administration. About Kite Kite, a Gilead Company, is a global biopharmaceutical company based in Santa Monica, California, focused on cell therapy to treat and potentially cure cancer. As the global cell therapy leader, Kite has treated more patients with CAR T-cell therapy than any other company. Kite has the largest in-house cell therapy manufacturing network in the world, spanning process development, vector manufacturing, clinical trial production, and commercial product manufacturing. About Gilead Sciences Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Gilead acquired Kite in 2017. 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. Arcellx's lead product candidate, anito-cel (formerly CART-ddBCMA), is being developed for the treatment of relapsed or refractory multiple myeloma (rrMM) in a Phase 2 pivotal trial. Arcellx is also developing its dosable and controllable CAR T therapy, ARC-SparX, through two Phase 1 programs, ACLX-001 for rrMM and ACLX-002 in relapsed or refractory acute myeloid leukemia and high-risk myelodysplastic syndrome. For more information on Arcellx, please visit . Follow Arcellx on X (Twitter) at @arcellx and LinkedIn. Arcellx 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 Arcellx's expectations regarding the timing, design and outcomes of clinical trials for its product candidates, including expected timing of presentation on clinical data and the breadth and uniqueness of the patient population being addressed; expectations around manufacturing; and the potential impact of its product candidates and platforms on patients and cell therapy. 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 March 31, 2024, filed with the Securities and Exchange Commission (SEC) on May 9, 2024, and other documents that Arcellx files 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. Gilead Forward-Looking Statements This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead’s ability to realize the anticipated benefits from the collaboration with Arcellx; Gilead and Kite’s ability to increase its CAR T-cell therapy manufacturing capacity, timely manufacture and deliver such therapies (or otherwise reduce the time to manufacture such therapies), or produce an amount of supply sufficient to satisfy demand for such therapies, including the production of anito-cel for the iMMagine-3 clinical trial and any future commercial manufacturing; the ability of Gilead and Kite to initiate, progress or complete clinical trials within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional clinical studies, including those involving anito-cel; uncertainties relating to regulatory applications and related filing and approval timelines, including FDA approval of anito-cel for treatment of multiple myeloma; the risk that CAR T-cell therapy will not be broadly accepted by physicians, patients, hospitals, cancer treatment centers, payers and others in the medical community; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead and Kite, and Gilead and Kite assume no obligation and disclaim any intent to update any such forward-looking statements. View source version on businesswire.com: Contacts Arcellx Contacts: Investors: Myesha Lacy ir@arcellx.com 510-418-2412 Media: Andrea Cohen Sam Brown Inc. andreacohen@sambrown.com 917-209-7163 Gilead/Kite Contacts: Investors: Jacquie Ross investor_relations@gilead.com Media: Tracy Rossin trossin@kitepharma.com Source: Arcellx, Inc. View this news release online at: