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

▎药明康德内容团队报道 在刚刚结束的2024年8月份，中国国家药监局药品审评中心（CDE）共计将6款新药纳入突破性治疗品种。其中，有5款新药拟开发用于癌症治疗，这些抗癌在研产品包括HER2小分子抑制剂、靶向Nectin-4的ADC、抗BCMA×CD3双特异性抗体、皮下注射抗PD-L1单抗，以及第三代EGFR-TKI。 纳入“突破性治疗药物”名单的新药往往针对严重疾病，且在前期临床试验中显示效果或安全性明显优于现有治疗手段。本文将根据公开资料对这些新药进行介绍。 图片来源：123RF 勃林格殷格翰、中国生物制药：BI 1810631 片 作用机制：HER2小分子抑制剂 适应症：非小细胞肺癌 勃林格殷格翰（Boehringer Ingelheim）申报的BI 1810631片被CDE纳入突破性治疗品种，用于治疗携带人表皮生长因子受体-2（HER2）既往接受过全身治疗的晚期、不可切除或转移性非小细胞肺癌（NSCLC）成人患者。这是一款口服选择性HER2酪氨酸激酶抑制剂（TKI）。中国生物制药于今年4月通过合作与勃林格殷格翰共同在中国大陆地区研发和商业化多款肿瘤药物管线，包括这款zongertinib（BI 1810631）。 根据勃林格殷格翰新闻稿介绍，本次zongertinib被纳入突破性治疗品种是基于Beamion LUNG-1临床试验结果。其中，1a期试验数据显示，在可评估疗效的41例NSCLC患者中，客观缓解率（ORR）为54%，疾病控制率（DCR）为93%，总体中位缓解持续时间（mDoR）为15.8个月。每日一次剂量递增组NSCLC患者中位无进展生存期（mPFS）12.3个月。1b期研究仅纳入HER2突变阳性的NSCLC患者，首次中期分析已完成，患者的ORR/DCR分别为74%和91%。 迈威生物：9MW2821 作用机制：靶向Nectin-4的ADC 适应症：尿路上皮癌 迈威生物申报的9MW2821被CDE纳入突破性治疗品种，用于既往铂类化疗和PD-(L)1抑制剂治疗失败的局部晚期或转移性尿路上皮癌。9MW2821是一款靶向Nectin-4的抗体偶联药物（ADC），目前已经在中国启动了一线治疗尿路上皮癌的3期关键性注册临床研究。 今年6月，迈威生物在美国临床肿瘤学会年会（ASCO）上口头报告了9MW2821用于多项晚期实体瘤的1/2期临床研究结果及最新进展，研究涉及的适应症包括尿路上皮癌、宫颈癌、食管癌、三阴性乳腺癌等多种晚期实体瘤。其中，在37例可评估疗效的尿路上皮癌患者中，ORR为62.2%，DCR为91.9%，mPFS为8.8个月，mOS为14.2个月。 智翔金泰：GR1803注射液 作用机制：抗BCMA×CD3双特异性抗体 适应症：多发性骨髓瘤 智翔金泰申报的GR1803注射液被CDE纳入突破性治疗品种，针对适应症为既往至少接受过3线治疗（一种蛋白酶抑制剂、一种免疫调节剂和一种抗CD38单抗）的复发难治性多发性骨髓瘤（RRMM）。公开资料显示，GR1803是一款重组人源化抗BCMA×CD3双特异性抗体。该产品治疗RRMM的1期临床研究摘要入选了2024年欧洲血液学协会（EHA）年会。在1期临床研究中，RRMM患者接受该产品每周静脉注射一次，总体客观缓解率（ORR）为85%，其中基线合并髓外浆细胞瘤（EMM）受试者的总体疗效评估ORR为100%。 康宁杰瑞、思路迪：重组人源化PDL1单域抗体Fc融合蛋白注射液 作用机制：皮下注射抗PD-L1单抗 适应症：高肿瘤突变负荷（TMB-H）实体瘤 康宁杰瑞和思路迪药业联合申报重组人源化PD-L1单域抗体Fc融合蛋白注射液——恩沃利单抗被纳入突破性治疗品种，用于既往标准治疗失败且无满意替代治疗的高肿瘤突变负荷（TMB-H）不可切除或转移性实体瘤。值得一提的是，近年来美国FDA批准的“不限癌种”新药项目中，高肿瘤突变负荷（TMB）是被使用的生物标志物之一。 恩沃利单抗注射液（KN035）是一款皮下注射抗PD-L1抗体药物，患者无需进行静脉滴注，可在30秒内完成给药，大幅缩短给药时间，具有在家自主给药潜力。该产品此前在中国获批上市，适用于不可切除或转移性微卫星高度不稳定（MSI-H）或错配修复基因缺陷型（dMMR）的成人晚期实体瘤患者的治疗。 翰森制药：甲磺酸阿美替尼片 作用机制：第三代EGFR-TKI 适应症：非小细胞肺癌 翰森制药甲磺酸阿美替尼片被CDE纳入突破性治疗品种，用于含铂根治性放化疗后未出现疾病进展的不可切除的局部晚期表皮生长因子受体（EGFR）外显子19缺失或外显子21（L858R）置换突变的非小细胞肺癌患者的治疗。阿美替尼是一款第三代EGFR-TKI。值得一提的是，阿美替尼针对该适应症的上市申请已经于8月20日获CDE受理，这也是阿美替尼片在中国提交的第四个适应症上市申请。 根据翰森制药新闻稿介绍，3期HS-10296-304研究已经评估了甲磺酸阿美替尼对比安慰剂治疗NSCLC患者的有效性和安全性，该研究针对的正是本次被纳入突破性治疗品种的适应症，主要研究终点为独立评审委员会评估的PFS。 天泽云泰：VGR-R01 作用机制：基因治疗产品 适应症：结晶样视网膜变性（BCD） 天泽云泰研发的治疗用生物制品VGR-R01拟纳入突破性治疗品种，用于治疗结晶样视网膜变性（BCD）。VGR-R01是一款基因治疗产品。在用药方式上，这款基因治疗通过视网膜下腔注射给药，且只需要注射一次就有望起到相应的长期疗效。 根据天泽云泰新闻稿介绍，该公司针对VGR-R01开展了两项临床研究, 入组了Yuzawa 2期或3期BCD患者，BCVA为≤60个ETDRS字母，即≥0.5 logMAR，中心凹视网膜厚度（CFT）为96~274μm。两项研究结果表明，在2~3期BCD患者中，无论是否已存在视网膜脉络膜萎缩，VGR-R01均可预期使患者获益，包括视力提升与功能性视觉改善。目前，一项多中心的3期研究正在准备中。 除了上述产品，复诺健生物申报的重组人IL12/15-PDL1B单纯疱疹I型溶瘤病毒注射液（Vero细胞）也于8月29日被CDE拟纳入突破性治疗品种，用于经标准治疗失败的晚期肝细胞癌。该项拟突破性治疗品种目前尚在公示中。 期待这些在研新药后续临床研究顺利进行，早日为更多的患者带来新的治疗选择。 参考资料： [1]中国国家药监局药品审评中心（CDE）官网. Retrieved Aug 30，2024, From https://www.cde.org.cn/main/xxgk/listpage/4b5255eb0a84820cef4ca3e8b6bbe20c [2]各公司官网及公开资料 本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权或其他合作需求，请联系wuxi_media@wuxiapptec.com。 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。

BETHESDA, Md. & GAITHERSBURG, Md.--( BUSINESS WIRE )-- Longhorn Vaccines and Diagnostics , a One Health company developing vaccines and diagnostic tools for global public health and zoonosis concerns, provided an update on the company's year-to-date progress, highlighting significant accomplishments supporting its commitment to advancing sample collection technology for infectious diseases, and enhancing global health diagnostics and vaccines. PrimeStore ® Molecular Transport Media (MTM) is a patented, FDA cleared, state-of-the-art ambient temperature molecular diagnostic collection and transport device. Following its critical role during the Covid-19 pandemic, PrimeStore MTM has successfully transitioned to a premier sample collection device for a wide range of infectious diseases, including respiratory infections, sexually transmitted diseases, urinary tract infections, sepsis and gastrointestinal infections. Laboratories worldwide are using PrimeStore MTM to perform molecular testing across these panels using a single, versatile collection device, streamlining diagnostics and improving efficiency in clinical settings and supply chain management. Longhorn is also advancing its pipeline of vaccines and monoclonal antibodies to combat antimicrobial resistance, sepsis and influenza. The Company’s technology is differentiated within the vaccine industry because it takes advantage of multiple well characterized targets in a single vaccine for influenza, and multiple targets that clear bacteria and toxins for the anti-sepsis vaccine. These targets have been chosen based on decades of infectious disease experience. "The breadth of PrimeStore MTM use across human and animal disease testing and surveillance is attributed to the strength of our innovation developed over a decade ago," said Longhorn Vaccines and Diagnostics President Jeff Fischer. "Our team's dedication to advancing first-in-class diagnostic solutions and developing new ways to incorporate key targets into vaccines are driving meaningful change for governments and healthcare organizations globally. We remain committed to developing new approaches to technology that address the evolving needs of healthcare providers and patients worldwide." PrimeStore MTM Advancements in Diagnostics in H1 2024 PrimeStore MTM continues to play a pivotal role in addressing the recent H5N1 dairy outbreak in the US through the collection and testing of infected milk samples for rapid and accurate detection of the virus . With over a decade of extensive testing by the Foreign Animal Disease Laboratory and the Animal and Plant Health Inspection Service (APHIS) , PrimeStore MTM is the trusted sample collection device for high consequence pathogens, supporting the USDA and the dairy industry in managing and mitigating the impact of this outbreak. Longhorn entered into a worldwide distribution agreement with Streck, an established leader in sample collection technology . Over the first six months of the collaboration, Longhorn has realized the partnership is a natural fit for the two companies, as they both focus on providing laboratories with stabilization solutions that optimize their workflow and results. PrimeStore MTM is helping to evolve tuberculosis (TB) testing in Africa by improving accessibility and accuracy . For patients who cannot produce sputum, PrimeStore MTM now facilitates testing through oral swabs, providing a non-invasive alternative that broadens access to diagnostics. Additionally, stool collection for children using PrimeStore MTM has proven to be much less invasive, significantly expanding the ability to diagnose TB in pediatric populations. These advancements can make a profound difference in TB management, particularly in resource-limited settings. PrimeStore MTM is at the heart of the new Prime External Quality Assessment (EQA) panels. These proficiency tests have undergone testing at the three Super-National TB labs across Africa . PrimeEQA TB offers a quicker, more cost-effective, and consistent method compared to standard testing procedures. Through the success of this innovative solution, Governments and non-Governmental Agencies are able to identify laboratories and processes that require additional training or updates, ensuring higher standards of diagnostic accuracy and reliability. The success of PrimeEQA has generated significant interest in developing expanded EQA panels for a wide range of tests and instruments. This demand highlights the critical need for comprehensive quality assurance in diagnostics, and Longhorn is poised to meet this need through our expertise, partnerships and technology. Jeff Fischer explained, “These achievements underscore Longhorn’s ongoing commitment to working with governments, universities, and private laboratories to evaluate PrimeStore MTM against a wide range of pathogens and sample types, and publish that data to ensure that the results can drive improved testing, safer and faster responses to outbreaks, and further scientific development. Our years of working with the USDA, combined with their prior internal evaluation and use of PrimeStore MTM for Highly Pathogenic Avian Influenza, Longhorn is providing APHIS and the dairy industry with an immediate key tool for testing milk as H5N1 virus continues to be discovered in dairy cows.” Developing Vaccines that Combat Highly Infectious Diseases in Animals and Humans New data presented in April at ECCMID 2024 on LHNVD-105, an adjuvanted composite dual peptide vaccine that targets multiple stages of the viral replication process, showcased how unconjugated multi-epitope peptides, formulated with AddaVax™ adjuvant, generated antibodies that were broadly reactive across multiple influenza virus strains when administered to pigs at low doses. Influenza is a prevalent zoonotic respiratory virus, with pigs acting as a middleman for generating new virus strains transferrable to humans, birds, and other swine with pandemic potential. This poses a major public health issue and challenges to the swine industry. At ECCMID 2024, Longhorn also presented data on LHNVD-301, a monoclonal antibody cocktail targeting the heat shock protein and a second cell wall target. It demonstrated strong activity against clinical tuberculosis isolates, confirming the vaccine has the potential to play a significant role in preventing and treating multi-drug resistant tuberculosis infections. Data presented at the World Vaccine Congress in April on LHNVD-110, an unconjugated single peptide vaccine comprised of same set of epitopes contained in the two peptides that make up LHNVD-105, demonstrated that it generated broadly reactive antibodies to human and highly pathogenic avian influenza viruses while neutralizing seasonal and pandemic influenza strains. Using a single peptide provides a more cost-effective and easily scalable approach to a universal influenza vaccine. LHNVD-302 , a sepsis vaccine, moved into the late stage of pre-clinical development. The vaccine continues to generate strong data in animal models with monoclonal antibodies targeting clearance of both the bacteria and the toxins that produce sepsis have moved into extended half-life development. Advances in antibody half-life extension solve a key problem that prevented success in the use of these targets in previous studies. “Based on multiple animal studies demonstrating equivalence, we are shifting our lead universal influenza candidate from a dual peptide formulation to a single peptide formulation, while maintaining all of the same validated targets. While the shift extends the clinical development timeline, it has the potential to bring significant benefits such as reducing development cost, and improving manufacturing efficiency, as well as ensuring the vaccine can be delivered in both developed and underdeveloped markets,” stated Longhorn Vaccines and Diagnostics CEO Gerald Fischer, MD. “I also look forward to seeing us advance our extended half-life anti-sepsis monoclonal antibodies quickly. In my 50 years of developing and testing antibodies for bacterial infections, these antibodies take advantage of the previous clinical success of the targets, while overcoming the dosing challenges that have held them back.” For more information about Longhorn, visit www.LHNVD.com . About Longhorn Vaccines and Diagnostics Longhorn Vaccines and Diagnostics is a closely held One Health company based in Maryland that is developing broad coverage vaccines and diagnostic tools for worldwide public health concerns such as anti-microbial resistance, sepsis and to prevent future pandemics. Since its inception in 2006, Longhorn has focused on developing broad coverage vaccines and diagnostic tools that can impact a pandemic on a global scale and at all socio-economic levels. Since pandemics flow between humans and animals, Longhorn products play a significant role to surveil, diagnose, prevent and treat the next infectious disease. Longhorn’s core product, PrimeStore® Molecular Transport Medium (MTM), is a patented, FDA cleared, state-of-the-art ambient temperature molecular diagnostic collection and transport device that can help governments, global health organizations, and drug manufacturers improve the diagnosis and treatment of highly infectious diseases such as Influenza, SARS-CoV-2, and Mycobacterium tuberculosis (TB). Unlike standard devices for collecting and transporting virus samples, PrimeStore® MTM is the first molecular transport device that can safely deactivate pathogens and stabilize RNA and DNA, allowing enhanced point of care and ambient temperature transport for laboratory based molecular testing and characterization.