IMC-001(Immunofoco Biotech)

- The first EpCAM targeted CAR-T product obtained US/CN IND approval. - Acceptable safety profiles and preliminary efficacy were observed in Investigator-Initiated Trial (IIT) clinical studies of IMC001. SHANGHAI, Feb. 22, 2024 /PRNewswire/ -- Immunofoco, a company dedicated to developing cell therapy products for solid tumors, announced a significant milestone, that following the approval by the CDE in China for the clinical trial application of IMC001, an EpCAM-targeting autologous CAR-T cell product for infusion, it also received the IND approval from the U.S. FDA, for the treatment of EpCAM-positive advanced gastrointestinal tumors, including but not limited to advanced gastric cancer (GC) and gastroesophageal junction adenocarcinoma (GEJ). EpCAM serves as a biomarker for circulating tumor cells (CTCs), which is highly expressed in both primary and metastatic lesions of gastrointestinal tumors, while its expression in normal tissues is low. It has been identified as a promising therapeutic target for GI tumors with a wide range of expandable indications. IMC001, through targeting EpCAM, is the first CAR-T product utilizing the strategy of "curing the solid tumors by treating them as hematologic malignancies ". In August 2023, the product was granted Orphan Drug Designation (ODD) by the U.S. FDA. The impressive clinical results of IMC001 have been shared at prestigious medical conferences, including being orally presented at the annual meeting of the European Society of Medical Oncology (ESMO) in 2022 and updated during the American Society of Clinical Oncology (ASCO) in 2023. As of January 31, 2024, in the IIT clinical trial for advanced gastric cancer, a safe and effective recommended dose has been identified, with two (2) out of five (5) patients in this dose group achieved partial remission (PR), with an overall response rate (ORR) of 40%. Among them, one PR patient underwent a successful radical surgery for gastric cancer 30 weeks after a single infusion of IMC001 and is still alive 85 weeks after IMC001 treatment. Another PR patient exhibited a 48% reduction in tumor size by week 16. Dr. Crystal Sun, Founder, Chairman, and CEO of Immunofoco, expressed her congratulations and gratitude to the entire team. She highlighted the significance of Immunofoco's achievement: securing dual IND approval for a second CAR-T product targeted for solid tumors in both the U.S. and China. Targeting EpCAM shows great potential for CAR-T treatment of solid tumors as it is highly expressed in primary, metastatic and circulating tumor cells. About 90% of the patients with gastrointestinal tumors exhibit EpCAM expression, which satisfies a broader clinical need. With the US/CN approval of this IND application, IMC001 is now poised to undertake further clinical trials and forge international collaborations, positioning itself as a promising new therapeutic option for patients with advanced GI tumors on a global scale. About Immunofoco Immunofoco has pioneered a clinical strategy focused on "curing the solid tumors by treating them as hematologic malignancies", addressing the challenges in solid tumor treatment, and the clinical advantages of treating hematologic malignancies. To improve the safety of CAR-T products, counteract tumor heterogeneity, and to enhance their effectiveness in tumor amplification and infiltration, we have developed innovative platforms such as Peri Cruiser®, SNR, and T-Booster. Driven by the clinical outcomes, our company maintains an extensive spectrum of product pipeline. Notably, our IMC002 (CLDN18.2 CAR-T) product obtained ODD from the U.S. FDA in July 2022, and its IND application has been approved in both the U.S. and China in April 2023. Similarly, our IMC001 (EpCAM CAR-T) product obtained ODD from the U.S. FDA in August 2023, with its IND application has been approved in both the U.S. and China in February 2024. The IMC008 (SNR CAR-T) product has rapidly moved to the IIT stage and received two ODD approval from the U.S. FDA in August 2023, for the treatment of gastric cancer and pancreatic cancer, respectively. Embodying the ethos of "collaboration, aspiration, and dedication for the best clinical results," our company brings together industry talents and experts to develop innovative cell therapies that offer enduring survival benefits for patients with solid tumors. For further details about Immunofoco, please visit our website at . SOURCE Immunofoco

IMC-001, a PD-L1 monoclonal antibody selected from Sorrento’s G-MAB library, demonstrated impressive therapeutic effects in patients with heavily treated NK/T-cell lymphoma with a 60% objective response rateAchieved 100% complete remission in patients with an objective response rateLong-term safety and durable response are demonstrated in patients who continued on treatment for over a year SAN DIEGO, Dec. 05, 2022 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) is pleased to announce the results of a Phase II NK/T-cell lymphoma study of IMC-001, a PD-L1 monoclonal antibody licensed to ImmuneOncia Therapeutics, LLC (“ImmuneOncia”) (Seongnam, South Korea). ImmuneOncia is a biotechnology company specializing in immuno-oncology drug development, jointly established by Yuhan Corporation of Korea and Sorrento. In addition to IMC-001, ImmuneOncia has a wide range of new products in the pipeline, such as IMC-002, a CD47 antibody, and IMC-201, a bispecific antibody. The Phase II NK/T-cell lymphoma study was selected for an oral presentation at the Asian Congress of the European Society for Medical Oncology (ESMO Asia 2022) in Singapore on December 4th, 2022. The clinical data demonstrated that in patients with heavily treated NK/T-cell lymphoma, 6 of 10 evaluable patients (60%) not only achieved an objective response, but all 6 patients with an objective response also achieved a complete remission with IMC-001. Additionally, 4 of these 6 patients stayed on treatment for over a year, which provides encouraging indication of long-term IMC-001 treatment safety and durable efficacy. NK/T-cell lymphoma is a rare cancer that is most prevalent in Asian countries, including China and Korea, and is typically treated with a regimen of radiation and chemotherapy. NK/T-cell lymphoma has a high recurrence rate of 75% within two years. Due to the absence of standard-of-care treatment for relapsed/refractory cases, NK/T lymphoma represents a high unmet medical need and significant market opportunity. To date, no single immuno-oncology drug has obtained approval in this indication. Professor Won Seog Kim of Samsung Medical Center, the presenter and Principal Investigator of the IMC-001 study, commented, “The complete remission and response rate of 60% of IMC-001 significantly outperformed currently available drugs for the treatment, and very rare adverse events of grade 3 or higher also limit concerns over the side effects, making it a leader among PD-L1 drugs. We expect these results to satisfy the criteria for approval.” Heung Tae Kim, Chief Executive Officer of ImmuneOncia said, “This achievement sets a new standard for the second-line treatment of NK/T-cell lymphoma, which has high unmet needs. ImmuneOncia is preparing additional clinical trials to expand its indications in solid cancer.” Henry Ji, Ph.D., Chief Executive Officer of Sorrento commented, “We expect to leverage these data to create momentum to secure additional partnership and co-development opportunities for IMC-001 in regions with a high incidence of NK/T-cell lymphoma, such as China, as well as in other indications.” IMC-001 is a PD-L1 antibody, a fully human immune checkpoint inhibitor, that serves as the basis of the current immuno-oncology market. This antibody activates the anticancer functions of T cells by strongly inhibiting the binding between PD-1 expressed on T cells and PD-L1 expressed on the surface of cancer cells. Moreover, it can mediate ADCC (antibody-dependent cellular cytotoxicity) against tumor cells, as it maintains the Fc effector function using human IgG1. About Sorrento Therapeutics, Inc. Sorrento is a clinical and commercial stage biopharmaceutical company developing new therapies to treat cancer, pain (non-opioid treatments), autoimmune disease and COVID-19. Sorrento's multimodal, multipronged approach to fighting cancer is made possible by its extensive immuno-oncology platforms, including key assets such as next-generation tyrosine kinase inhibitors (“TKIs”), fully human antibodies (“G-MAB™ library”), immuno-cellular therapies (“DAR-T™”), antibody-drug conjugates (“ADCs”), and oncolytic virus (“Seprehvec™”). Sorrento is also developing potential antiviral therapies and vaccines against coronaviruses, including STI-1558, COVISHIELD™ and COVIDROPS™, COVI-MSC™; and diagnostic test solutions, including COVIMARK™. Sorrento's commitment to life-enhancing therapies for patients is also demonstrated by our effort to advance a TRPV1 agonist, non-opioid pain management small molecule, resiniferatoxin (“RTX”), and SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (SEMDEXA™), a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, and to commercialize ZTlido® (lidocaine topical system) 1.8% for the treatment of postherpetic neuralgia (PHN). RTX has been cleared for a Phase II trial for intractable pain associated with cancer and a Phase II trial in osteoarthritis patients. Positive final results from the Phase III Pivotal Trial C.L.E.A.R. Program for SEMDEXA™, its novel, non-opioid product for the treatment of lumbosacral radicular pain (sciatica), were announced in March 2022. ZTlido® was approved by the FDA on February 28, 2018. For more information visit www.sorrentotherapeutics.com Forward-Looking Statements This press release and any statements made for and during any presentation or meeting contain forward-looking statements related to Sorrento Therapeutics, Inc., under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements regarding the development of and prospects of IMC-001 (PD-L1 antibody); the potential for IMC-001 to become a leader among PD-L1 drugs; the expectation of Phase II results to satisfy criteria for approval; potential side effects, tolerability, long-term toxicity, safety and durability of response of IMC-001; ImmuneOncia’s plans for additional clinical trials and plans for any future partnership and co-development opportunities for IMC-001, including in other regions or indications. Risks and uncertainties that could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements, include, but are not limited to: risks related to Sorrento's technologies and prospects, including, but not limited to risks related to safety and efficacy of IMC-001 and seeking regulatory approval for IMC-001; clinical development risks, including risks in the progress, timing, cost, and results of clinical trials and product development programs; risks of difficulties or delays in obtaining regulatory approvals; risks that clinical study results may not meet any or all endpoints of a clinical study and that any data generated from such studies may not support a regulatory submission or approval; risks that prior test, study and trial results, including those for IMC-001 and any topline or preliminary results, may not be replicated in continuing or future studies and trials; risks of manufacturing and supplying drug product; risks related to leveraging the expertise of its employees, subsidiaries, affiliates and partners to assist Sorrento in the execution of its product candidates’ strategies; risks related to the global impact of COVID-19; and other risks that are described in Sorrento's most recent periodic reports filed with the Securities and Exchange Commission, including Sorrento's Annual Report on Form 10-K for the year ended December 31, 2021 and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission, including the risk factors set forth in those filings. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and we undertake no obligation to update any forward-looking statement in this press release except as required by law. Media and Investor RelationsContact: Brian CooleyEmail: mediarelations@sorrentotherapeutics.com Sorrento® and the Sorrento logo are registered trademarks of Sorrento Therapeutics, Inc. G-MAB™, DAR-T™, Seprehvec™, SOFUSA™, COVISHIELD™, COVIDROPS™, COVI-MSC™, COVIMARK™ and Fujovee™ are trademarks of Sorrento Therapeutics, Inc. SEMDEXA™ (SP-102) is a trademark of Semnur Pharmaceuticals, Inc. A proprietary name review by the FDA is planned. ZTlido® is a registered trademark owned by Scilex Pharmaceuticals Inc. All other trademarks are the property of their respective owners. ©2022 Sorrento Therapeutics, Inc. All Rights Reserved.