Anbogen Receives FDA Clearance to Initiate Phase 1/2 Trial of ABT-301 Triplet Therapy for Advanced Colorectal Cancer
This open-label, multi-center international study plans to enroll 66 patients with proficient mismatch repair (pMMR) or non-microsatellite instability-high (non-MSI-H) mCRC to evaluate the safety and preliminary efficacy of the triplet therapy. Enrollment is planned in Taiwan and Australia. Tislelizumab, a PD-1 monoclonal antibody, used in this trial is provided by BeOne Medicines (formerly known as BeiGene). Further details on this collaboration were disclosed by Anbogen in a press release dated September 27, 2024.
ABT-301 is an oral HDAC1/2/3 inhibitor. Preclinical studies have shown that it promotes CD8+ cytotoxic T cell infiltration and activity, enhances antigen presentation, and inhibits M-MDSCs cells, effectively modulating the tumor microenvironment and converting "cold tumors" into "hot tumors" to improve the efficacy of immune checkpoint inhibitors. ABT-301 also exhibits pro-apoptotic, anti-angiogenic, and tumor metabolic regulation effects. As a single-molecule, multi-modality anti-cancer agent, ABT-301 aims to enhance tumor treatment when combined with the two antibody drugs.
Notably, in a previous Phase 1 monotherapy clinical trial involving 23 participants, ABT-301 did not exhibit neutropenia or cardiac toxicity, which are commonly observed in other HDAC inhibitors—further supporting its suitability for use in combination immunotherapy.
Approximately 95% of mCRC patients are pMMR or non-MSI-H types—commonly referred to as "cold tumors"—which respond poorly to current immunotherapies. Only around 5% of patients with deficient mismatch repair (dMMR) or microsatellite instability-high (MSI-H) "hot tumors" typically benefit from immune checkpoint inhibitors. According to GlobalData, an estimated 370,000 new pMMR/non-MSI-H patients in second-line or later settings are diagnosed annually across the U.S., China, Japan, and the top five European markets (UK, France, Germany, Spain, and Italy), representing a potential market size of USD $9 billion.
Anbogen stated that the FDA's IND approval marks a key milestone in the development of ABT-301, demonstrating the safety profile of the triplet therapy and advancing it into clinical stages. The company emphasized that the study targets the majority of patients (over 90%) with poor responses to immunotherapy, aiming to provide a novel treatment option and address this unmet clinical need.
Looking ahead, Anbogen will continue to advance the clinical development of ABT-301 while pursuing global licensing and strategic partnerships to accelerate commercialization and market entry. The company is also launching its Series B fundraising to attract strategic partners committed to advancing innovative cancer therapies and global expansion.
About Anbogen Therapeutics
Anbogen Therapeutics is a clinical-stage biotechnology company committed to developing precision oncology therapies that improve the lives of cancer patients worldwide. The company currently has two core assets:
ABT-301, a HDAC1/2/3 inhibitor with immune-modulating capabilities, enhances the tumor microenvironment and boosts immune responses. It significantly improves the efficacy of immune checkpoint inhibitors (ICIs) in metastatic colorectal cancer (mCRC), offering a new treatment pathway for the majority of patients who do not benefit from ICIs.
ABT-501 is a novel Peptide Drug Conjugate (PDC) that targets LHRH-receptor tumors using a proprietary delivery system. It has shown strong efficacy and safety in triple-negative breast cancer models, with potential for broader cancer applications.
For more information, please visit Anbogen's official website at www.anbogen.com.
View original content:https://www.prnewswire.com/apac/news-releases/anbogen-receives-fda-clearance-to-initiate-phase-12-trial-of-abt-301-triplet-therapy-for-advanced-colorectal-cancer-302520494.html
SOURCE Anbogen Therapeutics
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
7 minutes ago
- Yahoo
Helios Technologies Announces Definitive Agreement to Sell its Australian-Based Hydraulic Fluid Power Solutions and Service Provider Business
SARASOTA, Fla., August 04, 2025--(BUSINESS WIRE)--Helios Technologies, Inc. (NYSE: HLIO) ("Helios" or the "Company"), a global leader in highly engineered motion control and electronic controls technology, announced today that it has executed a definitive agreement for the sale of Custom Fluidpower ("CFP") to Questas Group ("Questas"). The all-cash transaction valued at approximately $83 million AUD (~$54 million USD) is subject to final working capital and other customary closing adjustments. The transaction value represents an increase of approximately $48 million AUD above the acquisition price paid for CFP by the Company in August 2018. Questas, is headquartered in Sydney, Australia, and has approximately 850 employees across 37 locations. Helios will also enter into a long-term exclusive distribution agreement with Questas, subject to annual growth targets tied to market conditions, assuring the continuity of Sun Hydraulics' strategic position in the Australian hydraulics market through CFP's extensive engineering, distribution, and service network. "This planned divestiture of CFP demonstrates our commitment to value creation as we refine our operating model, instilling financial discipline and driving improved returns on invested capital," said Sean Bagan, President, Chief Executive Officer, and Chief Financial Officer of Helios. "Since Helios' purchase of the business in 2018, CFP's sales have expanded every year growing to $92 million AUD ($61 million USD) in 2024 and impressively earnings have more than doubled during that same period. As we assess our business models, we recognize that its position as a leading fluid power distributor and service provider aligns more effectively with our value-added distribution customer base. We are excited that CFP will remain an ongoing customer and continue to build upon the long-standing relationship with Sun Hydraulics. I would like to thank the employees of CFP and recognize them for their dedication and successful efforts in growing the business. While the divestiture will reduce Helios' sales and earnings run rates, it will improve margin rates within our Hydraulics segment and at a consolidated level." "We are delighted to welcome CFP into the Questas group of companies. The CFP team brings deep expertise in system design, custom manifolds, cartridge valves, and hydraulic-release brakes—solutions we previously sourced externally. CFP strengthens our value proposition to customers, significantly advancing our ability to serve the full hydraulics lifecycle," said Mark Taylor, Group Chief Executive Officer of Questas Group. "Questas has extensive experience in the Australian hydraulics market and carve-out expertise, which we believe will unlock new potential for the CFP business. This transaction allows us to focus on our core manufacturing capabilities in the APAC region while leveraging CFP as our key distribution partner to service the Australian market. We remain committed to our 'in the region for the region' strategy and believe the structure going forward positions us to better meet customer needs in Australia and across the entire APAC region. We also believe the move will help provide broader growth opportunities for the CFP team and position CFP to deliver enhanced value for its customers with Questas' backing," Mr. Bagan concluded. Helios expects to use the net proceeds from the transaction consistent with its stated capital allocation priorities, including debt repayment, disciplined organic investment into the business, and return of capital to shareholders. Helios will begin reporting CFP as held for sale in the Company's consolidated financial statements for the second quarter of 2025 through the closing date. The Company expects the transaction to close in the next 60 to 90 days, subject to the satisfaction of customary closing conditions. Squire Patton Boggs is serving as legal counsel to the Company in connection with the sale of CFP. About Questas Group Headquartered in Sydney, NSW, Questas Group is a proudly Australian-owned and trusted partner for hydraulic, pump, and engine solutions. With approximately 850 staff across 37 locations Australia-wide, we've been a driving force in the industry for over 30 years, serving the mining, construction, agricultural, oil and gas, and general industrial sectors. For more information please visit: About Helios Technologies Helios Technologies is a global leader in highly engineered motion control and electronic controls technology for diverse end markets, including construction, material handling, agriculture, energy, recreational vehicles, marine and health and wellness. Helios sells its products to customers in over 90 countries around the world. Its strategy for growth is to be the leading provider in niche markets, with premier products and solutions through innovative product development and acquisition. The Company has paid a cash dividend to its shareholders every quarter since becoming a public company in 1997. For more information please visit: and follow us on LinkedIn. FORWARD-LOOKING INFORMATION This news release contains "forward‐looking statements" within the meaning of Section 21E of the Securities Exchange Act of 1934. Forward-looking statements in this release, including statements about the transaction and our strategic plans as well as the financial impact to the Company resulting therefrom, and our ability to close the transaction and the timing of the closing, are subject to risks that could cause actual results to differ materially from those suggested by the statements. These risks include, but are not limited to, the ability to successfully complete the divestiture of CFP on a timely basis, including receipt of required approvals and satisfaction of other conditions, the risk that the gain on sale of the assets could ultimately be less than we currently expect, and the ability of the Company to use the proceeds of the transaction consistent with its stated capital allocation priorities. Further information concerning these and other risks is included in Helios' filings with the SEC, including its Form 10-K for the year ended December 28, 2024, and subsequent Form 10-Q filings. Helios disclaims any obligation to update any forward-looking statements except as required by law. View source version on Contacts Investor and Media contacts: Tania AlmondVice President, Investor Relations and Corporate Communication(941) Deborah PawlowskiAlliance Advisors LLC(716) 843-3908dpawlowski@ Sign in to access your portfolio
Bloomberg
36 minutes ago
- Bloomberg
Australia Activates Blackrock's A$1B Super Battery Which Will Be World's Most Powerful
Australia's A$1 billion ($648 million) Waratah Super Battery has begun operations and is expected to have the world's largest power output when fully commissioned later this year. With 350 megawatts already online, the 850-megawatt battery operated by Blackrock Inc. -owned Akaysha Energy will help buffer grid shocks during outages, according to a statement by the New South Wales Government.
Business Wire
38 minutes ago
- Business Wire
Bristol Myers Squibb's Application for Breyanzi (lisocabtagene maraleucel) Accepted for Priority Review by U.S. Food and Drug Administration (FDA) in Fifth Cancer Type for Relapsed or Refractory Marginal Zone Lymphoma (MZL)
PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental biologics license application (sBLA) for Breyanzi ® (lisocabtagene maraleucel; liso-cel) as a potential treatment for adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least two prior lines of systemic therapy. The FDA has granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of December 5, 2025. BMY announces an FDA acceptance of the regulatory filing with priority review for their personalized treatment option for adult patients with relapsed or refractory marginal zone lymphoma #MZL Share 'While initial therapy for MZL can be effective, multiple relapses over the course of several years are common, leaving patients in need of a new treatment option that can provide high, lasting response rates,' said Rosanna Ricafort, vice president, Senior Global Program Lead for Hematology and Cell Therapy, Bristol Myers Squibb. 'This FDA acceptance brings us one step closer to potentially standardizing CAR T cell therapy as a treatment option for MZL, while building on our commitment to bring this personalized therapy to as many eligible patients as possible.' The application is based on results from the primary analysis of the MZL cohort in TRANSCEND FL, an open-label, multicenter, Phase 2, single-arm study, which was shared in an oral presentation during the 2025 International Conference on Malignant Lymphoma (ICML) in June 2025. The development progress of Breyanzi reflects BMS' continued efforts to collaborate across the healthcare ecosystem, with the ultimate goal of reaching more patients and democratizing access to cell therapy. Recently, the FDA approved streamlined patient monitoring requirements and the removal of the REMS program for Breyanzi, easing known barriers to treatment and administration while maintaining patient safety. About TRANSCEND FL TRANSCEND FL (NCT04245839) is an open-label, global, multicenter, Phase 2, single-arm study to determine the efficacy and safety of Breyanzi in patients with relapsed or refractory indolent B-cell non-Hodgkin lymphoma, including follicular lymphoma and marginal zone lymphoma. The primary outcome measure is overall response rate. Secondary outcome measures include complete response rate, duration of response, and progression-free survival. About MZL Marginal zone lymphoma (MZL) is the third most common lymphoma, accounting for about 7% of all non-Hodgkin lymphoma cases. Most patients with MZL are at a median age of 67 years when they are diagnosed. MZL develops when white blood cells cluster together to form lumps in a person's lymph nodes or organs. Initial therapy often leads to remission, but relapse is common, sometimes occurring several times over many years. A small portion of MZL cases transform into diffuse large-B-cell lymphoma, a more aggressive lymphoma. About Breyanzi Breyanzi is a CD19-directed CAR T cell therapy with a 4-1BB costimulatory domain, which enhances the expansion and persistence of the CAR T cells. Breyanzi is made from a patient's own T cells, which are collected and genetically reengineered to become CAR T cells that are then delivered via infusion as a one-time treatment. The treatment process includes blood collection, CAR T-cell creation, potential bridging therapy, lymphodepletion, administration, and side-effect monitoring. Breyanzi is approved in the U.S. for the treatment of relapsed or refractory large B-cell lymphoma (LBCL) after at least one prior line of therapy, has received accelerated approval for the treatment of relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior lines of therapy and relapsed or refractory follicular lymphoma (FL) in the third-line plus setting, and is approved for the treatment of relapsed or refractory mantle cell lymphoma (MCL) in the third-line plus setting. Breyanzi is also approved in Japan, the European Union (EU), Switzerland, the United Kingdom, and Canada for the treatment of relapsed or refractory LBCL after at least one prior line of therapy; in Japan for the treatment of patients with relapsed or refractory high-risk FL after one prior line of systemic therapy, and in patients with relapsed or refractory FL after two or more lines of systemic therapy; and in the EU for the treatment of relapsed or refractory FL after two or more lines of systemic therapy. Bristol Myers Squibb's clinical development program for Breyanzi includes clinical studies in several types of lymphoma. For more information, visit Breyanzi U.S. FDA-Approved Indications BREYANZI is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of: adult patients with large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B, who have: refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation (HSCT) due to comorbidities or age; or relapsed or refractory disease after two or more lines of systemic therapy. Limitations of Use: BREYANZI is not indicated for the treatment of patients with primary central nervous system lymphoma. adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least 2 prior lines of therapy, including a Bruton tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). adult patients with relapsed or refractory follicular lymphoma (FL) who have received 2 or more prior lines of systemic therapy. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least 2 prior lines of systemic therapy, including a Bruton tyrosine kinase (BTK) inhibitor. Breyanzi U.S. Important Safety Information WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, AND SECONDARY HEMATOLOGICAL MALIGNANCIES Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving BREYANZI. Do not administer BREYANZI to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab with or without corticosteroids. Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving BREYANZI, including concurrently with CRS, after CRS resolution, or in the absence of CRS. Monitor for neurologic events after treatment with BREYANZI. Provide supportive care and/or corticosteroids as needed. T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including BREYANZI. Cytokine Release Syndrome Cytokine release syndrome (CRS), including fatal or life-threatening reactions, occurred following treatment with BREYANZI. In clinical trials of BREYANZI, which enrolled a total of 702 patients with non-Hodgkin lymphoma (NHL), CRS occurred in 54% of patients, including ≥ Grade 3 CRS in 3.2% of patients. The median time to onset was 5 days (range: 1 to 63 days). CRS resolved in 98% of patients with a median duration of 5 days (range: 1 to 37 days). One patient had fatal CRS and 5 patients had ongoing CRS at the time of death. The most common manifestations of CRS (≥10%) were fever, hypotension, tachycardia, chills, hypoxia, and headache. Serious events that may be associated with CRS include cardiac arrhythmias (including atrial fibrillation and ventricular tachycardia), cardiac arrest, cardiac failure, diffuse alveolar damage, renal insufficiency, capillary leak syndrome, hypotension, hypoxia, and hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS). Ensure that 2 doses of tocilizumab are available prior to infusion of BREYANZI. Neurologic Toxicities Neurologic toxicities that were fatal or life-threatening, including immune effector cell-associated neurotoxicity syndrome (ICANS), occurred following treatment with BREYANZI. Serious events including cerebral edema and seizures occurred with BREYANZI. Fatal and serious cases of leukoencephalopathy, some attributable to fludarabine, also occurred. In clinical trials of BREYANZI, CAR T cell-associated neurologic toxicities occurred in 31% of patients, including ≥ Grade 3 cases in 10% of patients. The median time to onset of neurotoxicity was 8 days (range: 1 to 63 days). Neurologic toxicities resolved in 88% of patients with a median duration of 7 days (range: 1 to 119 days). Of patients developing neurotoxicity, 82% also developed CRS. The most common neurologic toxicities (≥5%) included encephalopathy, tremor, aphasia, headache, dizziness, and delirium. CRS and Neurologic Toxicities Monitoring Monitor patients daily for at least 7 days following BREYANZI infusion for signs and symptoms of CRS and neurologic toxicities and assess for other causes of neurological symptoms. Continue to monitor patients for signs and symptoms of CRS and neurologic toxicities for at least 2 weeks after infusion and treat promptly. At the first sign of CRS, institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids as indicated. Manage neurologic toxicity with supportive care and/or corticosteroid as needed. Advise patients to avoid driving for at least 2 weeks following infusion. Counsel patients to seek immediate medical attention should signs or symptoms of CRS or neurologic toxicity occur at any time. Hypersensitivity Reactions Allergic reactions may occur with the infusion of BREYANZI. Serious hypersensitivity reactions, including anaphylaxis, may be due to dimethyl sulfoxide (DMSO). Serious Infections Severe infections, including life-threatening or fatal infections, have occurred in patients after BREYANZI infusion. In clinical trials of BREYANZI, infections of any grade occurred in 34% of patients, with Grade 3 or higher infections occurring in 12% of all patients. Grade 3 or higher infections with an unspecified pathogen occurred in 7%, bacterial infections in 3.7%, viral infections in 2%, and fungal infections in 0.7% of patients. One patient who received 4 prior lines of therapy developed a fatal case of John Cunningham (JC) virus progressive multifocal leukoencephalopathy 4 months after treatment with BREYANZI. One patient who received 3 prior lines of therapy developed a fatal case of cryptococcal meningoencephalitis 35 days after treatment with BREYANZI. Febrile neutropenia developed after BREYANZI infusion in 8% of patients. Febrile neutropenia may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad- spectrum antibiotics, fluids, and other supportive care as medically indicated. Monitor patients for signs and symptoms of infection before and after BREYANZI administration and treat appropriately. Administer prophylactic antimicrobials according to standard institutional guidelines. Avoid administration of BREYANZI in patients with clinically significant, active systemic infections. Viral reactivation: Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against B cells. In clinical trials of BREYANZI, 35 of 38 patients with a prior history of HBV were treated with concurrent antiviral suppressive therapy. Perform screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing. In patients with prior history of HBV, consider concurrent antiviral suppressive therapy to prevent HBV reactivation per standard guidelines. Perform screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing. In patients with prior history of HBV, consider concurrent antiviral suppressive therapy to prevent HBV reactivation per standard guidelines. Prolonged Cytopenias Patients may exhibit cytopenias not resolved for several weeks following lymphodepleting chemotherapy and BREYANZI infusion. In clinical trials of BREYANZI, Grade 3 or higher cytopenias persisted at Day 29 following BREYANZI infusion in 35% of patients, and included thrombocytopenia in 25%, neutropenia in 22%, and anemia in 6% of patients. Monitor complete blood counts prior to and after BREYANZI administration. Hypogammaglobulinemia B-cell aplasia and hypogammaglobulinemia can occur in patients receiving BREYANZI. In clinical trials of BREYANZI, hypogammaglobulinemia was reported as an adverse reaction in 10% of patients. Hypogammaglobulinemia, either as an adverse reaction or laboratory IgG level below 500 mg/dL after infusion, was reported in 30% of patients. Monitor immunoglobulin levels after treatment with BREYANZI and manage using infection precautions, antibiotic prophylaxis, and immunoglobulin replacement as clinically indicated. Live vaccines: The safety of immunization with live viral vaccines during or following BREYANZI treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during BREYANZI treatment, and until immune recovery following treatment with BREYANZI. Secondary Malignancies Patients treated with BREYANZI may develop secondary malignancies. T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including BREYANZI. Mature T cell malignancies, including CAR-positive tumors, may present as soon as weeks following infusion, and may include fatal outcomes. Monitor lifelong for secondary malignancies. In the event that a secondary malignancy occurs, contact Bristol Myers Squibb at 1-888-805-4555 for reporting and to obtain instructions on collection of patient samples for testing. Immune Effector Cell-Associated Hemophagocytic Lymphohistiocytosis-Like Syndrome (IEC-HS) Immune Effector Cell-Associated Hemophagocytic Lymphohistiocytosis-Like Syndrome (IEC-HS), including fatal or life-threatening reactions, occurred following treatment with BREYANZI. Three of 89 (3%) safety evaluable patients with R/R CLL/SLL developed IEC-HS. Time to onset of IEC-HS ranged from 7 to 18 days. Two of the 3 patients developed IEC-HS in the setting of ongoing CRS and 1 in the setting of ongoing neurotoxicity. IEC-HS was fatal in 2 of 3 patients. One patient had fatal IEC-HS and one had ongoing IEC-HS at time of death. IEC-HS is a life-threatening condition with a high mortality rate if not recognized and treated early. Treatment of IEC-HS should be administered per current practice guidelines. Adverse Reactions The most common adverse reaction(s) (incidence ≥30%) in: LBCL are fever, cytokine release syndrome, fatigue, musculoskeletal pain, and nausea. The most common Grade 3-4 laboratory abnormalities include lymphocyte count decrease, neutrophil count decrease, platelet count decrease, and hemoglobin decrease. CLL/SLL are cytokine release syndrome, encephalopathy, fatigue, musculoskeletal pain, nausea, edema, and diarrhea. The most common Grade 3-4 laboratory abnormalities include neutrophil count decrease, white blood cell decrease, hemoglobin decrease, platelet count decrease, and lymphocyte count decrease. FL is cytokine release syndrome. The most common Grade 3-4 laboratory abnormalities include lymphocyte count decrease, neutrophil count decrease, and white blood cell decrease. MCL are cytokine release syndrome, fatigue, musculoskeletal pain, and encephalopathy. The most common Grade 3-4 laboratory abnormalities include neutrophil count decrease, white blood cell decrease, and platelet count decrease. Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide. Bristol Myers Squibb: Unlocking the Full Potential of Cell Therapy A pioneer in harnessing the immune system to fight cancer and an established leader in cell therapy, Bristol Myers Squibb is uniquely positioned to unlock the full potential of this technology across blood cancers and within new frontiers, including autoimmune disease. Bristol Myers Squibb is currently the only company with two approved CAR T cell therapies with two distinct targets, available in major markets around the world. Our bold vision for the future is one in which hundreds of thousands of patients can be treated with cell therapy's transformational potential. The building blocks to realize this ambition—a promising and differentiated pipeline, extensive translational and clinical data sets, a deep bench of talent, and robust manufacturing capabilities—are in our cells. We are laser-focused on advancing the field of cell therapy toward a true revolution for patients. Learn more about the science behind cell therapy and ongoing progress at Bristol Myers Squibb here. Cautionary Statement Regarding Forward-Looking Statements This press release contains 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that Breyanzi (lisocabtagene maraleucel) may not receive regulatory approval for the additional indication described in this release in the currently anticipated timeline or at all, any marketing approvals, if granted, may have significant limitations on their use, and, if approved, whether Breyanzi for such indication will be commercially successful. No forward-looking statement can be guaranteed. It should also be noted that acceptance of the sBLA does not change the standards for FDA approval. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb's business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2024, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.
