Extramedullary Plasmacytoma

Data showed a 91% ORR with P-BCMA-ALLO1 in an optimized lymphodepletion arm, including a 100% ORR in BCMA-naïve patients, and an 86% ORR in those who had received at least one prior BCMA- and/or GPRC5D-targeting treatment modality Differentiated P-BCMA-ALLO1 safety results with no dose-limiting toxicities, low rates of CRS and ICANS all Grade 2 or less and no graft vs. host disease or Parkinsonism P-BCMA-ALLO1 was recently granted Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA and is being evaluated in a Phase 1/1b clinical trial in patients with relapsed/refractory multiple myeloma who have previously received three or more prior lines of therapy Company to host webcast and conference call tomorrow at 1 p.m. ET / 10 a.m. PT with multiple myeloma experts to review the Phase 1 IMS oral presentation data and provide business updates SAN DIEGO, Sept. 27, 2024 /PRNewswire/ -- Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage allogeneic cell therapy and genetic medicines company advancing differentiated non-viral treatments for patients with cancer and rare diseases, today announced new interim clinical data from its ongoing Phase 1 trial of P-BCMA-ALLO1 in patients with relapsed/refractory multiple myeloma (RRMM). Data1 demonstrated a 91% overall response rate (ORR) and compelling safety results in the 23 heavily pretreated patients in Arm C, an optimized lymphodepletion arm. The new clinical data were presented today in an oral session at the 21st International Myeloma Society (IMS) Annual Meeting in Rio de Janeiro. P-BCMA-ALLO1 is an investigational non-viral, stem cell memory T cell (TSCM)-rich allogeneic CAR-T cell therapy in Phase 1/1b clinical development for the treatment of patients with RRMM. The Company is developing this investigational off-the-shelf allogeneic CAR-T cell therapy with Roche as part of a broader collaboration focused on addressing blood cancers with Poseida's TSCM-rich CAR-T platform. "The compelling and differentiated results from the optimized lymphodepletion arms of the ongoing Phase 1 trial of P-BCMA-ALLO1 showed deep responses and a high response rate in patients with heavily pre-treated relapsed or refractory multiple myeloma, regardless of prior exposure to B-cell maturation antigen (BCMA)-targeting therapy. The high overall response rate of 91% is remarkable because most study participants in my center had rapidly proliferative refractory disease, in contrast with those treated in the pivotal clinical trials of FDA-approved autologous CAR-T therapies. Such patients treated in the current trial of P-BCMA ALLO1 would not have qualified for standard of care autologous CAR T therapy," said Bhagirathbhai R. Dholaria, M.D., Associate Professor of Medicine, Malignant Hematology & Stem Cell Transplantation at Vanderbilt University Medical Center in Nashville, Tenn., and trial investigator. "All patients in the Phase 1 trial have been treated quickly once enrolled, with no waiting for manufacturing, with no need for apheresis or bridging therapy, demonstrating key advantages of allogeneic CAR-T cell therapy." "P-BCMA-ALLO1 is one of the most advanced allogeneic CAR-T in clinical development for multiple myeloma, manufactured using non-viral technology to produce a TSCM-rich therapy that has shown a compelling emerging product profile," said Kristin Yarema, Ph.D., president and chief executive officer of Poseida Therapeutics. "We are encouraged to see such a high overall response rate in an arm of the Phase 1 trial with optimized lymphodepletion, along with standout safety results across all arms, given that the study population was heavily pretreated, high-risk, and in general had many features that historically have led to a poor prognosis. We are excited to build on these data as we advance P-BCMA-ALLO1 in the Phase 1b part of the trial, which is currently enrolling patients." New Interim Clinical Data from Phase 1 P-BCMA-ALLO1 Trial The ongoing open-label, multicenter Phase 1/1b dose-escalation and expansion trial in patients with RRMM is assessing the safety and maximum tolerated dose of P-BCMA-ALLO1 (primary objective) and its anti-myeloma activity (secondary objective). As of September 6, 2024, 72 unique patients were enrolled as an intent-to-treat (ITT) population and were treated across four study arms (S, A, B and C) that included different P-BCMA-ALLO1 doses and lymphodepletion regimen combinations. Study participants were required to have received three or more prior lines of therapy, including a prior proteasome inhibitor, immunomodulatory drug and anti-CD38 monoclonal antibody. The trial enrolled a heavily pretreated patient population with 43% of patients having received prior BCMA-and/or GPRC5D targeting therapy. Most prior BCMA therapies included autologous CAR-T and/or T-cell engagers (TCE). Additionally, 33% of study participants were racial minorities, demonstrating Poseida's commitment to underserved patient populations. In the ITT population, 100% of patients enrolled as of the data cutoff were infused with P-BCMA-ALLO1. No patients required anti-myeloma bridging therapy or prophylaxis with steroids or tocilizumab, and there was no invasive apheresis or manufacturing wait time. The median time from enrollment to the start of study treatment was one day. The ORR across all four study arms was 54%; 11% of patients achieved a complete response (CR) or a stringent complete response (sCR), and 33% achieved a very good partial response or higher (VGPR+). The median duration of response (DoR) was 232 days for study Arms A and B – the cohorts with six or more months of follow-up at the time of data cut-off. Expansion and persistence of the CAR-T cells in patients after infusion has been dependent upon the conditioning dose of cyclophosphamide. P-BCMA-ALLO1 levels measured in the peripheral blood and were much higher in patients in Arm C (cyclophosphamide 750 mg/m2/day) and Arm B (cyclophosphamide 1000 mg/m2/day) than in patients in Arm S (cyclophosphamide 300 mg/m2/day), and Arm A (cyclophosphamide 500 mg/m2/day). Arm C was identified as the optimized lymphodepletion arm based on cellular kinetics, safety and efficacy. Data from Arm C of the Phase 1 P-BCMA-ALLO1 Trial Results from 23 study participants in Arm C were highlighted in the oral session at IMS. Patients received cyclophosphamide 750 mg/m2/day and fludarabine 30 mg/m2/day and approximately 2x106 cells/kg P-BCMA-ALLO1. Some patients were treated in an outpatient setting. Arm C patient details include: Nearly half (48%) were age 65 or older All were heavily pretreated, with a median of six prior lines of anti-myeloma therapy and a maximum of 14 62% of patients had received prior BCMA-targeting therapy 29% had failed both a BCMA CAR-T and a bispecific TCE, and 29% had failed both a BCMA-targeting therapy and the GPRC5D-targeting TCE, talquetamab Approximately two-thirds of patients (62%) had high-risk disease by cytogenetics and 38% had extramedullary disease Efficacy results, which are still evolving, for the 23 patients in Arm C showed: An ORR of 91%, with a 100% ORR in BCMA-naïve patients, an 86% ORR in those who had received at least one prior BCMA-targeting treatment (all had received prior CAR-T and/or TCE), and an 86% ORR in those who had received at least one prior BCMA-targeting treatment and/or talquetamab 22% achieved a CR or an sCR 48% achieved VGPR+ Median DoR could not be estimated at the time of data cut-off because the current median follow-up is less than 3.5 months (for pooled arms A and B, the median DoR was more than seven months (estimated range of five-10 months), with a median time to response of only 16 days) P-BCMA-ALLO1 was well-tolerated with key safety results from Arm C, including: No dose-limiting toxicities, Grade 3 or higher cytokine release syndrome (CRS) or immune effector cell neurotoxicity syndrome (ICANS). The incidence of Grade 1 or 2 CRS was 39% and the incidence of Grade 1 or 2 ICANS was 13% The incidence of infections was 48%, including 30% that were Grade 1 or 2 and 17% that were Grade 3 Rapid cytopenia recovery in the vast majority of cases No graft-vs-host disease (GvHD), hemophagocytic lymphohistiocytosis (HLH), Parkinsonism or cranial neuropathies observed The safety results of P-BCMA-ALLO1 in arm C have been consistent with those observed in the other three arms of the Phase 1 trial, with a total safety database, including 72 unique patients The ongoing P-BCMA-ALLO1 Phase 1/1b trial is enrolling patients using the Arm C lymphodepletion regimen described above, across two dosing cohorts, with dose optimization ongoing in Arm C. Company-Hosted IMS Live Webcast and Conference Call Information Poseida will host a live webcast and conference call tomorrow, Saturday, September 28, 2024, at 1 p.m. ET / 10 a.m. PT. The webcast will feature an expert panel of clinicians who will discuss the new clinical data and multiple myeloma treatment landscape. The panel will be moderated by Dr. Rizvi and include Dr. Dholaria and Thomas G. Martin, M.D., Clinical Professor of Medicine, Adult Leukemia and Bone Marrow Transplantation Program and Associate Director of the Myeloma Program at the University of California, San Francisco (UCSF), and Co-Leader of the Cancer Immunology & Immunotherapy Program at the UCSF Helen Diller Family Comprehensive Cancer Center. The conference call can be accessed by dialing 800-225-9448 or 203-518-9708 (International) with the conference ID PSTX0928. The live webcast can be accessed using the link here, or by visiting the Events and Presentations section of the Poseida website at investors.poseida.com. After the live webcast, the event will remain archived on the Poseida website for approximately 90 days. About P-BCMA-ALLO1 P-BCMA-ALLO1 is an allogeneic CAR-T product candidate licensed to Roche targeting B-cell maturation antigen (BCMA) for the treatment of relapsed/refractory multiple myeloma. This allogeneic program includes a VH-based binder that targets BCMA, and interim clinical data presented at IMS in September 2024 support the Company's belief that T stem cell (TSCM)-rich allogeneic CAR-Ts have the potential to offer effective, safe and reliable treatment addressing unmet needs in multiple myeloma. The U.S. Food and Drug Administration (FDA) has granted P-BCMA-ALLO1 Orphan Drug designation for multiple myeloma and Regenerative Medicine Advanced Therapy (RMAT) designation for adult patients with relapsed/refractory multiple myeloma after three or more prior lines of therapies including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody. P-BCMA-ALLO1 is currently being evaluated in a Phase 1/1b trial in patients with multiple myeloma. Additional information about the Phase 1/1b trial is available at using identifier: NCT04960579. About Poseida Therapeutics, Inc. Poseida Therapeutics is a clinical-stage biopharmaceutical company advancing differentiated allogeneic cell therapies and genetic medicines with the capacity to cure certain cancers and rare diseases. The Company's pipeline includes investigational allogeneic CAR-T cell therapies for both solid tumors and hematologic cancers as well as investigational in vivo genetic medicines that address patient populations with high unmet medical need. The Company's approach is based on its proprietary genetic editing platforms, including its non-viral piggyBac® DNA Delivery System, Cas-CLOVER™ Site-Specific Gene Editing System, Booster Molecule and nanoparticle gene delivery technologies, as well as in-house GMP cell therapy manufacturing. The Company has formed strategic collaborations with Roche and Astellas to unlock the promise of cell therapies for cancer patients. Learn more at and connect with Poseida on X and LinkedIn. Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, expected plans with respect to clinical trials; the potential capabilities and benefits of the Company's technology platforms and product candidates; the quotes from Drs. Dholaria and Yarema; and the Company's plans and strategy with respect to developing its technologies and product candidates. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon the Company's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the fact that interim data from the Company's clinical trials may change as more patient data become available and remain subject to audit and verification procedures that could result in material differences from the final data; the Company's reliance on third parties for various aspects of its business; risks and uncertainties associated with development and regulatory approval of novel product candidates in the biopharmaceutical industry; the Company's ability to retain key scientific or management personnel; the Company's ongoing and planned clinical trials; whether any of the Company's product candidates will be shown to be effective, safe and reliable; and the other risks and uncertainties described in the Risk Factors section of Poseida's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 5, 2024, and in other filings Poseida makes with the SEC from time to time. All forward-looking statements contained in this press release speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. 1 Based on an efficacy cutoff date of September 6, 2024 and a safety cutoff date of July 31, 2024 SOURCE Poseida Therapeutics, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

SHANGHAI and NANJING, China and SAN JOSE, Calif., June 15, 2024 /PRNewswire/ -- IASO biotechnology ("IASO Bio"), a biopharmaceutical company engaged in discovering, developing, manufacturing and marketing innovative cell therapies and antibody products, presented clinical data on the use of Equecabtagene Autoleucel (Eque-cel), the world's first approved fully human CAR-T product, for the treatment of transplant-ineligible patients with high-risk newly diagnosed multiple myeloma (NDMM) in an oral presentation at the 2024 European Hematology Association (EHA) Annual Congress. Presentation Title: Eque-cel, A Novel Fully Human BCMA-Targeting CAR-T Therapy in Patients with High Risk Newly Diagnosed Multiple Myeloma Presentation Type: Oral report Session Date and Time: June 15, 2024, 16:30 - 17:45 (Central European Summer Time) Location: Madrid, Spain Publication Number: S206 Presenter: Professor Bing Chen, Nanjing Drum Tower Hospital The FUMANBA-2 study is a multicenter, open-label, phase I, single-arm study initiated by researchers, with the principal investigators being Professor Lijuan Chen from Jiangsu Province Hospital and Professor Bing Chen from Nanjing Drum Tower Hospital. This study aims to assess the efficacy, safety, and pharmacokinetics/pharmacodynamics characteristics of Eque-cel for the treatment of high-risk NDMM. Subjects must complete four cycles of induction treatment before the infusion of Eque-cel. After the third induction treatment cycle, patients deemed unsuitable for autologous hematopoietic stem cell transplantation (ASCT) by the researcher will undergo peripheral blood mononuclear cell collection and subsequently receive Eque-cel treatment, with an infusion dose of 1×106 CAR-T/kg. The primary endpoints were the proportion of minimal residual disease (MRD) negative subjects and progression-free survival (PFS), and secondary endpoints included overall response rate (ORR), duration of response (DOR), safety, and pharmacokinetics/pharmacodynamics (PK/PD). As of January 25th, 2024, 16 subjects received Eque-cel therapy. High-risk cytogenetics were detected in all subjects, including 62.5 percent double-hit and 12.5 percent triple-hit. 25 percent subjects had extramedullary disease. 37.5 percent subjects had R-ISS stage III disease, among whom 6.3 percent with double-hit and 6.3 percent with triple-hit. Efficacy: After the infusion of Eque-cel, the median follow-up time was 7.46 months (range: 2.8-18.1), the median PFS had not been reached, the 12-month PFS rate was 84.4% (95% CI: 49.31-96.00), all subjects achieved MRD negativity, of which 71.4% (95% CI: 25.8-92.0) maintained MRD negativity for more than 12 months; the overall response rate (ORR) was 100%, with 93.8% achieving stringent complete response (sCR). Safety: After the infusion of Eque-cel, the incidence of grade 1-2 cytokine release syndrome (CRS) was 68.8%, no grade 3 or above CRS was observed, and no immune effector cell-related neurotoxicity syndrome (ICANS) or other neurological toxicities occurred. The median time of CRS occurrence was the 7th day after infusion (range: 2-9 days), and the median duration of CRS was 3 days (range: 1-8 days). The most common grade 3 or above drug-related adverse event wase blood cell count reduction, and the incidence of grade 3 or above infectious disease adverse events was 25.0%. PK/PD: The median peak time of CAR copy number in peripheral blood was 10 days after infusion (range: 7-21 days), with a median peak level of 79,681.299 copies/μg DNA. 81.25% of subjects achieved clearance of free B-cell maturation antigen (sBCMA) within one month after infusion; the median peak time of cytokine detection IL-6 and CRP after infusion were the 7th and 10th day, respectively, and the serum ferritin level did not change significantly. Professor Lijuan Chen from Jiangsu Province Hospital stated: " Eque-cel, as a novel fully human BCMA CAR-T therapy, has shown encouraging efficacy and safety in high-risk patients with newly diagnosed multiple myeloma who are ineligible for transplantation. This is the world's first report on CAR-T therapy being used as a first-line treatment in this specific patient population. For NDMM patients who are not suitable for transplantation, the application of CAR-T therapy as a first-line treatment is expected to further improve the remission rate, extend survival, and improve patient prognosis compared to traditional chemotherapy and other targeted drug treatments. This allows us to see the application potential of Eque-cel in the front-line treatment of MM. Advancing CAR-T therapy to the first line will provide patients with more diverse and promising treatment options. With further research and the continuous improvement of treatment strategies, we look forward to CAR-T therapy benefiting more patients in the future." Professor Bing Chen from Nanjing Drum Tower Hospital stated: "High-risk newly diagnosed multiple myeloma patients have a poor prognosis in standard first-line treatment. For high-risk NDMM patients who do not meet the conditions for ASCT, Eque-cel has shown superior efficacy and safety, achieving deep and sustained remission, with all patients achieving MRD negativity. This opens up a new approach to reverse the poor prognosis of high-risk myeloma patients. Moreover, compared with relapsed/refractory multiple myeloma (RRMM) patients, the incidence and severity of CRS in high-risk NDMM patients treated with Eque-cel are lower, showing a more favorable safety profile. We will further investigate the clinical benefits of Eque-cel for high-risk newly diagnosed multiple myeloma patients with longer follow-up." About IASO Bio IASO Bio is a biopharmaceutical company engaged in the discovery and development of novel cell therapies and biologics for oncology and autoimmune diseases. IASO Bio possesses comprehensive capabilities spanning the entire drug development process, from early discovery to clinical development, regulatory approval, and commercial production. The pipeline in the company includes a diversified portfolio of over 10 novel products, including Equecabtagene Autoleucel (a fully human BCMA CAR-T injection). Equecabtagene Autoleucel received New Drug Application (NDA) approval from China's National Medical Products Administration (NMPA) and U.S. FDA IND approval for the treatment of RRMM. Leveraging its strong management team, innovative product pipeline, GMP production, as well as integrated manufactural and clinical capabilities, IASO aims to deliver transformative, curable, and affordable therapies that fulfil unmet medical needs to patients in China as well as around the world. For more information, please visit or . SOURCE IASO Bio

-- Researchers Shared Findings Including a Clinically Manageable Safety Profile and Anti-leukemic Activity with WU-CART-007 in Patients with R/R T-ALL/LBL and Previously Treated with Existing Therapies -- U.S. Biotech Wugen to Initiate Follow-Up Study Exploring Its Anti-CD7, Off-the-Shelf, Allogeneic CAR-T Cell Therapy in Pediatric and Minimal Residual Disease (MRD) Patients in Q424 -- Company Presented Additional New Data at EHA on WU-CART-007 and WU-NK-101, Its Off-the-Shelf Investigational Memory Natural Killer Cell Therapy ST. LOUIS and SAN DIEGO, June 14, 2024 (GLOBE NEWSWIRE) -- Wugen, Inc., a clinical-stage U.S. biotechnology company developing allogeneic, off-the-shelf cell therapies for the treatment of hematological and solid tumor malignancies, announces positive Phase 2 results for the company’s investigational anti-CD7 CAR-T therapy, WU-CART-007 (“W-T7”), in patients with relapsed/refractory (R/R) t-cell acute lymphoblastic leukemia/lymphoma (T-ALL/LBL). In his presentation today at the European Hematology Association (EHA) 2024 Hybrid Congress in Madrid, lead investigator Ibrahim Aldoss, M.D., City of Hope in Duarte, CA, shared data from this Phase 2 cohort expansion study showing a clinically manageable safety profile as well as evidence of anti-leukemic activity with WU-CART-007 (“W-T7”) in patients with R/R T-ALL/LBL previously treated with existing therapies for their cancers. “Relapsed and refractory T-ALL/LBL is a highly aggressive disease with high rates of relapse and mortality in both children and adults,” Dr. Aldoss said. “These results are exciting and support the potential of this allogeneic CAR-T as a new treatment for patients who still face a refractory illness despite having received the best medicines we have for T-ALL/LBL right now.” “The need for effective, allogeneic treatments that are available at the point of care without delays is urgent for patients with hard-to-treat blood cancers,” said Wugen Chief Medical Officer Jan Davidson-Moncada, M.D., Ph.D. “Wugen is confident we can overcome specific challenges that have existed for CAR-T therapies in targeting T-cell diseases. We are eager to conduct further studies of WU-CART-007, which was invented by Wugen’s Co-founder and Chief Scientific Officer Matt Cooper, Ph.D., to target CD7+ malignancies.” Key Phase 2 Findings The presentation at EHA featured results with the recommended dose (RP2D) of WU-CART-007 administered in 13 patients at a median age 30 years who were heavily pre-treated and had a high burden of disease at the start of the study. A substantial proportion of patients (38%) had progressed or relapsed after allogeneic stem cell transplant. Outcomes following WU-CART-007 treatment in the study surpassed current standard of care1 for R/R T-ALL/LBL and included: Composite complete remission rate (CRc) of 73% (8/11) (primary endpoint).Overall response rate of 91% (10/11; 2 partial response (PR) in patients with extramedullary disease, R/R T-LBL).Duration of response (DOR) (secondary endpoint): Median duration (mDOR) was 6.2 months (95% CI: 1.8, NE);Median follow up was 8.5 months (95% CI: 2.7, NE); 46% (5/11) patients remained in continuous remission at 4.3 to 8.6 months. Seven patients (5 at RP2D) successfully transplanted. Pharmacokinetic analysis exhibited rapid expansion and persistence of an allogeneic cell therapy: At RP2D, WU-CART-007 expansion peaked at Day 10 (223,799 copies/g of DNA) and can be detected out to Day 90. No patient developed drug product-specific anti-HLA antibodies.No anti-drug antibody detected on any patients to date. Phase 1 dose escalation data from this first-in-human global Phase 1/2 clinical trial of WU-CART-007 for the treatment of relapsed or refractory (R/R) T-cell acute lymphoblastic leukemia (T-ALL)/lymphoblastic lymphoma (LBL) were presented last December at the American Society of Hematology meeting. See those findings here. Additional Wugen Data at EHA Researchers presented other new findings with WU-CART-007 and WU-NK 101 in these posters at EHA: Title: Preliminary Effect of Enhanced Lymphodepletion (ELD) on WU-CART-007 in T-ALL/LBLPresenters: Ouiam Bakkacha M.D. and Ben Capoccia Ph.D., Wugen, St. Louis, MOAbstract: P408 Title: WU-NK-101 is an Off-The-Shelf Memory NK Cell with a Time-Resilient, Anti-Tumor Phenotype that can be Detected in R/R AML Patient PBMC After InfusionPresenter: Laura Arthur, Ph.D., Wugen, St. Louis, MOAbstract: P1422 More information is available on the EHA 2024 Hybrid Congress website. About WU-CART-007WU-CART-007 is an allogeneic, off-the-shelf, fratricide-resistant CD7-targeted CAR-T cell therapy engineered to overcome the technological challenges of harnessing CAR-T cells to treat CD7+ hematological malignancies. Wugen is deploying CRISPR/Cas9 gene editing technology to delete CD7 and the T-cell receptor alpha constant (TRAC), preventing CAR-T cell fratricide and mitigating the risk of graft-versus-host-disease (GvHD). WU-CART-007 is manufactured using healthy donor-derived T-cells to eliminate the risk of malignant cell contamination historically observed in the autologous CAR-T setting. WU-CART-007 is currently being evaluated in a global Phase 1/2 clinical trial for the treatment of relapsed or refractory (R/R) T-cell acute lymphoblastic leukemia (T-ALL)/lymphoblastic lymphoma (LBL). Additional information is available on clinicaltrials.gov, identifier NCT# 04984356. WU-CART-007 has received Orphan Drug, Fast Track, Rare Pediatric Disease and Regenerative Medicine Advanced Therapy (RMAT) designations from the U.S. Food and Drug Administration and received PRIME (“Priority Medicines”) designation in the European Union for the treatment of relapsed/refractory (R/R) T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL). RMAT and PRIME designations provide increased agency support to expedite the development and review of promising therapies for patients in need. About WU-NK-101WU-NK-101 is a novel immunotherapy harnessing the power of memory natural killer (NK) cells to treat liquid and solid tumors. Memory NK cells are hyper-functional, long-lasting immune cells that exhibit enhanced anti-tumor activity and a cytokine-induced memory-like (CIML) phenotype. This cell population has a superior phenotype, proliferation capacity, and metabolic fitness, making it better suited for cancer therapy than other NK cell therapies. Wugen is applying its proprietary MonetaTM platform to advance WU-NK-101 as a commercially scalable, off-the-shelf cell therapy for cancer. WU-NK-101 is currently in development for acute myelogenous leukemia (AML). Wugen is planning to initiate solid tumor studies of WU-NK-101 in combination with cetuximab. Studies of WU-NK-101 to date have shown promising robust in vivo activity in various tumor indications, retention of anti-cancer activity in TME, resistance to immune suppression, and enhanced activity with checkpoint inhibitors. WU-NK-101 has received Orphan Drug Designation from the U.S. Food and Drug Administration for the treatment of AML. About Wugen A spin-out of Washington University in St. Louis, Wugen, Inc. is a clinical-stage U.S. biotechnology company developing the next generation of off-the-shelf CAR-T and memory natural killer (NK) cell therapies for cancer. For more information, please visit www.wugen.com. Investor Contact:Mark LewisWugenMlewis@wugen.com+1 314-501-1968 Media Contact:Christine FanelleScient PRchristine@scientpr.com+1 215-595-5211 1 Nelarabine USPI