Rituximab

The FDA’s first oncologic drugs advisory committee meeting under new commissioner Marty Makary will focus on applications from Johnson & Johnson, Pfizer, Roche and UroGen. The FDA’s Oncologic Drugs Advisory Committee (ODAC) is planning to host its first meeting under new agency commissioner Marty Makary, M.D.As head of the FDA’s oncology department, Richard Pazdur, M.D., represents the only FDA center director left from the prior administration. The biopharma industry will be looking eagerly for signs of policy consistency from the upcoming public meeting.The next meeting will take two days on May 20 and 21, according to a Federal Register notice (PDF). Roche’s application to move Columvi up in the treatment sequence of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) for transplant-ineligible patients and Johnson & Johnson’s bid to expand Darzalex Faspro to high-risk smoldering multiple myeloma will be featured on the first day.On the second day, external advisers to the FDA will discuss UroGen Pharma’s intravesical version of its chemotherapy Jelmyto in low-grade intermediate-risk non-muscle invasive bladder cancer and Pfizer’s request to expand the label of PARP inhibitor Talzenna to include a broader population in metastatic castration-resistant prostate cancer (mCRPC).For Roche, the phase 3 Starglo trial showed that combining Columvi with the chemotherapy regimen GemOx significantly reduced the risk of death by 41% compared with Rituxan and GemOx in DLBCL patients who had tried at least one prior line of therapy and were not eligible for a stem cell transplant.However, an exploratory analysis found that Columvi’s life extension benefit was entirely driven by patients outside the U.S. and Europe, and that there were more deaths within patients in the U.S. and European subgroup in the Columvi arm than those in the control.One possible explanation could be pegged to the availability of highly efficacious later-line treatments such as CAR-T therapies. But the trial’s principal investigator, Jeremy Abramson, M.D., from the Massachusetts General Hospital Cancer Center, argued that the number of patients in that subgroup was too small to draw any conclusions.The European Commission has approved Columvi’s Starglo regimen in April, and the National Comprehensive Cancer Network has added it to its treatment guidelines for certain second-line DLBCL patients, including its highest category 1 recommendation for patients who have relapsed late and are not candidates for transplants, Roche noted in a statement (PDF) Wednesday. As Roche pointed out, Starglo is the first randomized phase 3 study in second-line transplant-ineligible DLBCL to show an overall survival improvement.The FDA is expected to deliver a decision on Columvi’s second-line use by July 20, 2025.As for Pfizer, the focus will likely be on the combination of Talzenna and Astellas-partnered Xtandi in first-line mCRPC who do not have homologous recombination repair (HRR) gene mutations.The FDA in 2023 approved the cocktail in HRR-mutated patients, and Pfizer’s plan is to use a longer follow-up of the overall survival data to cover HRR-nonmutated tumors, for which PARP inhibitors like Talzenna have shown less efficacy.A subgroup analysis of the phase 3 Talapro-2 trial linked Talzenna-Xtandi to a 12.6% reduction in the risk of death versus Xtandi alone among patients whose tumors were HRR-non-deficient or unknown.On Darzalex, J&J’s target indication, smoldering myeloma, isn’t considered a cancer, but it can develop into myeloma.In the phase 3 Aquila trial, patients who received Darzalex Faspro experienced a 51% lower risk of progression or death versus simple monitoring. The drug also had a higher rate of grade 3 or 4 treatment-emergent adverse events, at 40.4%, versus 30.1% for control.During the review, the FDA will likely focus on the benefit-risk calculation of introducing an active drug in an early-stage condition where active monitoring is the standard practice, especially as Darzalex has proven highly effective in first-line multiple myeloma.The industry will know more about the FDA’s intentions soon, as the agency is expected to publish its internal review reports two days before the ODAC meeting. In announcing the gathering, the FDA flagged that it was unable to publish its notice 15 days prior to the meeting due to “technical issues.”The agency “concluded that there are exceptional circumstances that support holding this meeting without the customary 15-day public notice,” it said. Industry watchers have been worried about potential delays at the FDA following recent mass layoffs at the agency. Although critical drug reviewers were spared from the downsizing, reductions affecting supporting roles have raised concerns of operational hiccups.Further, there's an industry concern about possible drug policy changes under Makary. Alongside the job cuts, senior FDA leadership has undergone almost a complete makeover. Pazdur, who has been with the FDA for nearly three decades, has not publicly commented on the oncology office’s agenda since Makary ascended to the office in March.In a short speech for accepting the 2025 AACR Enduring Impact Award for Transformative Service to Cancer Science and Medicine at the American Association for Cancer Research annual meeting on April 27, Pazdur recounted past advancements in cancer drugs and the dawn of the precision oncology era.“I firmly believe that the next 25 years will bring even more transformative advances than the last,” he said.

IND clearance and initiation of global basket trial exploring AlloNK® + rituximab in refractory rheumatoid arthritis, Sjögren’s disease, idiopathic inflammatory myopathies and systemic sclerosis First trial to explore an allogeneic cell therapy in refractory rheumatoid arthritis and Sjögren’s disease in the U.S. Initial safety, translational data, and lead indication selection to be presented by year-end 2025; initial clinical response data in the lead indication to be presented in 1H2026 Longer-term clinical data from Phase 1/2 trial exploring AlloNK + rituximab in B-NHL in heavily pretreated CAR-T naïve patients to be presented at ASGCT, demonstrating complete response rates and median duration of responses in line with approved auto-CAR-T therapies, support deep B-cell depletion Cash runway extension into Q2 2027, with cash, cash equivalents and investments of $166.0 million as of March 31, 2025 SAN DIEGO, May 08, 2025 (GLOBE NEWSWIRE) -- Artiva Biotherapeutics, Inc. (Nasdaq: ARTV) (Artiva), a clinical-stage biotechnology company whose mission is to develop effective, safe, and accessible cell therapies for patients with devastating autoimmune diseases and cancers, today announced financial results for the first quarter ended March 31, 2025, and highlighted recent progress. “We are encouraged by our early experience with AlloNK® in autoimmune disease. We have initiated regulatory submissions globally for our company-sponsored basket trial in refractory rheumatoid arthritis, Sjögren’s disease, myositis and scleroderma. Notably, we are first to announce a company-sponsored allogeneic cell therapy trial in rheumatoid arthritis and Sjögren’s disease in the U.S.; two sizeable indications that could benefit from AlloNK’s potential ease of use and well-tolerated safety profile in the community setting,” said Fred Aslan, M.D., Chief Executive Officer of Artiva. “Since the IPO last July, we have transformed our development team and now have a deep bench of autoimmune expertise to expand and refine the clinical trial infrastructure and development strategy for AlloNK in autoimmune disease. By the end of 2025, we plan on sharing initial safety and translational data supporting AlloNK’s mechanism of action and tolerability profile across multiple autoimmune diseases, as well as announcing our lead indication. In the first half of 2026, we expect to share clinical response data in our lead indication with longer follow-up to substantiate AlloNK’s emerging target product profile, and to have initial insights on registrational approaches.” Dr. Aslan continued, “Our longer-term aggressive B-NHL data is maturing into a leading data set, in line with approved auto-CAR-T therapies, providing proof of concept of AlloNK’s ability to deplete B-cells deeply and durably. We remain well capitalized to generate meaningful data sets and to differentiate ourselves over time from other therapeutic approaches in areas of significant unmet need in the community setting.” Recent Business Highlights AlloNK® (also known as AB-101) Updates Autoimmune clinical program updates: Company-sponsored clinical trials: Phase 2a company-sponsored basket clinical trial: Following Investigational New Drug application clearance by the U.S. Food and Drug Administration, initiating global Phase 2a company-sponsored basket clinical trial for AlloNK + rituximab for refractory rheumatoid arthritis (RA), Sjögren’s disease, idiopathic inflammatory myopathies (myositis, or IIM) and systemic sclerosis (scleroderma, or SSc), with site initiation underwayFirst company-sponsored trial exploring an allogeneic cell therapy in refractory RA and Sjögren’s disease in the U.S.Protocol allows for continuous enrollment with no stagger within dose levels and no hospitalization/inpatient requirement for patients dosed with AlloNKInitiation of regulatory submissions across multiple geographic regions Phase 1/1b company-sponsored trial in systemic lupus erythematosus (SLE) with or without lupus nephritis (LN): Treatment of patients in combination cohort with AlloNK + monoclonal antibodies (mAb) initiated in late 2024Prioritization of patient enrollment in AlloNK + obinutuzumab cohort Currently exploring 1 billion cells per AlloNK dose x 3 weekly doses in company-sponsored trials with plan to escalate to 4 billion cells per AlloNK dose x 3 weekly doses across both trials Investigator-initiated trial (IIT): Ongoing IIT Basket Trial: IIT assessing the safety, tolerability, and clinical activity of AlloNK + rituximab in patients with RA, pemphigus vulgaris, granulomatosis with polyangiitis/microscopic polyangiitis, and SLE. The trial is being conducted by Integral Rheumatology & Immunology Specialists (IRIS), in an outpatient setting at a community rheumatology clinic. Initial tolerability supports prioritization of community sites for clinical development of AlloNK AlloNK + rituximab in B-cell non-Hodgkin lymphoma (B-NHL) updates: Longer-term clinical data from Phase 1/2 trial exploring AlloNK + rituximab in patients with relapsed/refractory B-NHL to be presented at The American Society of Gene & Cell Therapy (ASGCT) 28th annual meeting on May 13, 2025. Abstracts are currently available on the ASGCT websiteUpdated clinical data in heavily pre-treated, CAR-T naïve patients with B-NHL shows prolonged duration of response, with complete response rates and median duration of response in line with approved auto-CAR-T therapies in aggressive B-NHL patients with multiple prior lines of treatment Other program updates: Preclinical data on the ablation of SLE donor B-cells with AlloNK in combination with either an anti-CD19 or anti-CD20 monoclonal antibody presented at the 2025 Pan-American League of Rheumatology Congress (PANLAR) and to be presented at the 16th International Congress on Systemic Lupus Erythematosus (LUPUS 2025), being held May 21-24, 2025, in Toronto, CanadaPoster presentation featuring the scalability and consistency of the manufacturing process for AlloNK to be presented at the ASGCT 28th annual meeting on May 15, 2025 Data highlights consistent and high expression of CD16, uniform expansion across greater than 40 manufacturing lots, and high viability and cytotoxicity after 4 years of shelf life for AlloNK Corporate Updates Appointment of Subhashis Banerjee, M.D., as Chief Medical Officer announced on April 8, 2025, culminating Artiva’s efforts to build a seasoned development team with strong expertise in autoimmune disease and cell therapy Upcoming Milestones By Year-End 2025: Initial safety and translational data for AlloNK + mAb across multiple autoimmune indications from ongoing clinical trials and disclosure of lead autoimmune indication for further development Mechanistic and translational data for AlloNK in autoimmune indicationsInsights into tolerability of AlloNK + mAb, and the patient journey in community rheumatology sites, including the potential ease of use of conditioning regimens with cyclophosphamide and fludarabineDisclosure of lead indication for AlloNK development in autoimmune diseases 1H 2026: Initial clinical response data in the lead autoimmune indication from ongoing clinical trials with longer follow-up to inform registrational strategy First Quarter 2025 Financial Results Cash, Cash Equivalents and Investments. As of March 31, 2025, Artiva had cash, cash equivalents, and investments of $166.0 million which is expected to fund operations into Q2 2027.Research and Development Expenses. Research and development expenses were $17.1 million for the three months ended March 31, 2025, compared to $11.2 million for the three months ended March 31, 2024.General and Administrative Expenses. General and administrative expenses were $5.1 million for the three months ended March 31, 2025, compared to $3.6 million for the three months ended March 31, 2024.Other Income, net. Other income, net, was $1.9 million for the three months ended March 31, 2025, compared to other income, net, of $0.5 million for the three months ended March 31, 2024.Net Loss. Net loss totaled $20.3 million for the three months ending March 31, 2025, as compared to net loss of $14.0 million for the three months ending March 31, 2024, with non-cash stock-based compensation expense of $2.1 million and $1.4 million for the three months ended March 31, 2025 and 2024, respectively. About Artiva Biotherapeutics Artiva is a clinical-stage biotechnology company whose mission is to develop effective, safe and accessible cell therapies for patients with devastating autoimmune diseases and cancers. Artiva’s lead program, AlloNK® (also known as AB-101), is an allogeneic, off-the-shelf, non-genetically modified, cryopreserved NK cell therapy candidate designed to enhance the antibody-dependent cellular cytotoxicity effect of monoclonal antibodies to drive B-cell depletion. AlloNK is currently being evaluated in three ongoing clinical trials for the treatment of B-cell driven autoimmune diseases. This includes two company-sponsored trials, one in systemic lupus erythematosus for patients with or without lupus nephritis, and a basket trial across autoimmune diseases including rheumatoid arthritis and Sjögren’s disease, as well as an investigator-initiated basket trial in B-cell driven autoimmune diseases. Artiva’s pipeline also includes CAR-NK candidates targeting both solid and hematologic cancers. Artiva was founded in 2019 as a spin out of GC Cell, formerly GC Lab Cell Corporation, a leading healthcare company in the Republic of Korea, pursuant to a strategic partnership granting Artiva exclusive worldwide rights (excluding Asia, Australia and New Zealand) to GC Cell’s NK cell manufacturing technology and programs. Artiva is headquartered in San Diego, California. For more information, please visit www.artivabio.com. Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements in this press release that are not statements of historical fact are forward-looking statements. Such forward-looking statements include, without limitation, statements regarding: expectations of Artiva Biotherapeutics, Inc. (the “Company”) regarding the potential benefits, accessibility, ease of use, effectiveness and safety of AlloNK; the Company’s ability to advance AlloNK in autoimmune disease; the Company’s ability to demonstrate progress and clinical validation of its approach; the belief that of Phase 1/2 trial data in B-NHL provides support for B-cell depletion as a MoA and its comparison to approved auto-CAR-T therapies; the Company’s expectations regarding design, timing and availability of data from the Company’s clinical trials or the basket IIT; the timing related to the selection of a lead autoimmune indication; the timing, likelihood or success of the Company's business strategy, as well as plans and objectives of management for future operations; and the Company’s future results of operations and financial position, including cash runway. These forward-looking statements are based on the beliefs of the management of the Company as well as assumptions made by and information currently available to the Company. Such statements reflect the current views of the Company with respect to future events and are subject to known and unknown risks and uncertainties. In light of these risks and uncertainties, the events or circumstances referred to in the forward-looking statements may not occur. These and other factors that may cause the Company’s actual results to differ from current expectations are discussed in the Company’s filings with the Securities and Exchange Commission (the “SEC”), including the section titled “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2025. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date this press release is given. Except as required by law, the Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise. Artiva Biotherapeutics, Inc.Condensed Balance Sheets(Unaudited)(in thousands) March 31, 2025 December 31, 2024Assets Cash, cash equivalents and investments$165,963 $185,428 Property and equipment, net 7,057 6,370 Operating and financing lease right-of-use assets 13,728 14,055 Other assets 4,515 3,728 Total assets$191,263 $209,581 Liabilities and stockholders' equity Accounts payable and accrued expenses$8,411 $8,513 Operating and financing lease liabilities 13,996 14,354 Other liabilities 73 73 Total liabilities 22,480 22,940 Stockholders' equity 168,783 186,641 Total liabilities and stockholders' equity$191,263 $209,581 Artiva Biotherapeutics, Inc.Condensed Statements of Operation and Comprehensive Loss(Unaudited)(in thousands, except share and per share data) Three Months Ended March 31, 2025 2024License and development support revenue$- $251 Operating expenses: Research and development 17,052 11,156 General and administrative 5,119 3,587 Total operating expenses 22,171 14,743 Loss from operations (22,171) (14,492)Other income, net Interest income 1,864 650 Change in fair value of SAFEs — (268)Other income (expense) (4) 147 Total other income, net 1,860 529 Net loss$(20,311) $(13,963)Net loss per share, basic and diluted$(0.83) $(17.24)Weighted-average common shares outstanding, basic and diluted 24,341,978 809,758 Comprehensive loss: Net loss$(20,311) $(13,963)Other comprehensive income (loss) 129 (101)Comprehensive loss$(20,182) $(14,064) ContactsInvestors: Neha Krishnamohan, Artiva Biotherapeutics, ir@artivabio.comMedia: Jessica Yingling, Ph.D., Little Dog Communications Inc., jessica@litldog.com, +1.858.344.8091 Source: Artiva Biotherapeutics, Inc.