LAMP-1

Poster presentation describes the development of SNAP CAR platform technology as a "universal" CAR therapy with the potential to target multiple antigens through combinatorial use of different adaptors WEXFORD, Pa., Oct. 31, 2023 /PRNewswire/ -- Coeptis Therapeutics Holdings, Inc. (NASDAQ: COEP) ("Coeptis" or "the Company"), a biopharmaceutical company developing innovative cell therapy platforms for cancer, today announced that research demonstrating the potential of the SNAP-CAR T-cell platform to target multiple antigens, including HER2 and CD20, through combinatorial use of different adaptors will be the subject of a poster presentation at the Society for Immunotherapy of Cancer's 38th Annual Meeting (SITC 2023). SITC 2023 is being held Nov. 1–5, 2023, at San Diego Convention Center in San Diego. The poster presentation titled, "SNAP CAR T cells for programmable antigen targeting," describes research involving SNAP-CAR, a "universal" CAR T cell therapy platform, that demonstrates the technology's versatile antigen targeting abilities both in vitro and in vivo in human tumor xenograft models. In vitro experiments showed potent and specific SNAP-CAR function with co-administered adaptors targeting HER2, EGFR, and CD20 on cancer cell lines including activation of CD69 and CD107a markers, specific target cell lysis, and IFN-gamma production. Additionally, the researchers tested SNAP-CAR T cells in vivo in a human leukemia tumor xenograft NSG mouse model targeting HER2, observing that SNAP-CAR T cells were able to significantly reduce tumor burden, leading to a lack of detectable tumors in the majority of mice. Further, in another leukemia model targeting the CD20 antigen, SNAP-CAR T cells showed significant inhibition of tumor growth. Finally, evaluating two anti-HER2 adaptors with distinct binding epitopes in a human ovarian cancer xenograft model, the researchers observed a significant tumor reduction with both adaptors compared to adaptor only and SNAP-CAR T cell only controls. "These findings suggest SNAP-CAR can potentially enable the development of T-cell therapies that can be tuned by adaptor dose and targeted toward multiple antigens through combinatorial use of different adaptors, potentially avoiding toxicities and relapse due to antigen loss," commented Jason Lohmueller, Ph.D., Assistant Professor of Surgery and Immunology in the Division of Surgical Oncology Research, University of Pittsburgh. "While still early in its development, we continue to see vast potential for the SNAP-CAR platform for treating both liquid and solid tumor malignancies." "The data being presented at SITC 2023 encapsulates the groundbreaking research being conducted at the University of Pittsburgh, which demonstrates the potential of SNAP-CAR T-cells to reduce tumor burden and tumor growth in numerous cancers, including HER2-expressing and CD20-expressing cancers," said Dave Mehalick, President and CEO of Coeptis Therapeutics. "Coeptis is energized more than ever to forge the path forward with the powerful SNAP-CAR platform to develop T-cell and NK-cell technologies for various undertreated cancer indications." Details of the presentation are as follows: About Coeptis Therapeutics Holdings, Inc. Coeptis Therapeutics Holdings, Inc., together with its subsidiaries including Coeptis Therapeutics, Inc. and Coeptis Pharmaceuticals, Inc., (collectively "Coeptis"), is a biopharmaceutical company developing innovative cell therapy platforms for cancer that have the potential to disrupt conventional treatment paradigms and improve patient outcomes. Coeptis' product portfolio and rights are highlighted by assets licensed from Deverra Therapeutics, including an allogeneic cellular immunotherapy platform and DVX201, a clinical-stage, unmodified natural killer cell therapy technology. Additionally, Coeptis is developing a universal, multi-antigen CAR T technology licensed from the University of Pittsburgh (SNAP-CAR), and the GEAR™ cell therapy and companion diagnostic platforms, which Coeptis is developing with VyGen-Bio and leading medical researchers at the Karolinska Institutet. Coeptis' business model is designed around maximizing the value of its current product portfolio and rights through in-license agreements, out-license agreements and co-development relationships, as well as entering into strategic partnerships to expand its product rights and offerings, specifically those targeting cancer. The Company is headquartered in Wexford, PA. For more information on Coeptis visit . About the Emerging Growth Conference The Emerging Growth conference is an effective way for public companies to present and communicate their new products, services and other major announcements to the investment community from the convenience of their office, in a time efficient manner. The Conference focus and coverage includes companies in a wide range of growth sectors, with strong management teams, innovative products & services, focused strategy, execution, and the overall potential for long term growth. Its audience includes potentially tens of thousands of Individual and Institutional investors, as well as Investment advisors and analysts. All sessions will be conducted through video webcasts and will take place in the Eastern time zone. Cautionary Note Regarding Forward-Looking Statements  This press release and statements of our management made in connection therewith contain or may contain "forward-looking statements" (as defined in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended). Forward-looking statements include statements concerning our plans, objectives, goals, strategies, future events or performance, and underlying assumptions, and other statements that are other than statements of historical facts. When we use words such as "may," "will," "intend," "should," "believe," "expect," "anticipate," "project," "estimate" or similar expressions that do not relate solely to historical matters, we are making forward-looking statements. Forward-looking statements are not a guarantee of future performance and involve significant risks and uncertainties that may cause the actual results to differ materially and perhaps substantially from our expectations discussed in the forward-looking statements. Factors that may cause such differences include but are not limited to: (1) the inability to maintain the listing of the Company's securities on the Nasdaq Capital Market; (2) the risk that the integration of the Deverra licensed assets will disrupt current plans and operations of the Company; (3) the inability to recognize the anticipated benefits of the newly-licensed assets, which may be affected by, among other things, competition, the ability of the Company to grow and manage growth economically and hire and retain key employees; (4) the risks that the Company's products in development or the newly-licensed assets fail clinical trials or are not approved by the U.S. Food and Drug Administration or other applicable regulatory authorities; (5) costs related to integrating the newly-licensed Deverra assets and pursuing the contemplated asset development paths; (6) changes in applicable laws or regulations; (7) the possibility that the Company may be adversely affected by other economic, business, and/or competitive factors; and (8) the impact of the global COVID-19 pandemic on any of the foregoing risks and other risks and uncertainties identified in the Company's filings with the Securities and Exchange Commission (the "SEC"). The foregoing list of factors is not exclusive. All forward-looking statements are subject to significant uncertainties and risks including, but not limited, to those risks contained or to be contained in reports and other filings filed by the Company with the SEC. For these reasons, among others, investors are cautioned not to place undue reliance upon any forward-looking statements in this press release. Additional factors are discussed in the Company's filings made or to be made with the SEC, which are available for review at . We undertake no obligation to publicly revise these forward-looking statements to reflect events or circumstances that arise after the date hereof unless required by applicable laws, regulations, or rules. CONTACTS Coeptis Therapeutics, Inc. Andy Galy, Sr. VP of Communications [email protected] Tiberend Strategic Advisors, Inc. Investors Daniel Kontoh-Boateng [email protected] Media David Schemelia [email protected] SOURCE Coeptis Therapeutics

ITI-3000 Demonstrated a Favorable Safety and Tolerability Pro > Patients showed encouraging immunological responses, which will be further confirmed with a Phase II trial ROCKVILLE, Md.--(BUSINESS WIRE)--Immunomic Therapeutics, Inc. (ITI), a privately-held clinical-stage biotechnology company pioneering the development of LAMP-mediated nucleic acid-based immunotherapy, today announced safety and tolerability results from its phase 1 clinical trial evaluating ITI-3000, a plasmid DNA (pDNA) vaccine, targeting patients with Merkel cell carcinoma (MCC), a rare but aggressive form of skin cancer that is typically caused by the Merkel cell polyomavirus (MCPyV). ITI-3000 was granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) in November 2022. "The reporting of results from our phase 1 trial of ITI-3000 in patients with MCC, marks the achievement of a significant milestone in our mission to create a therapeutic solution for this rare, yet highly aggressive skin cancer," stated D.G. Kim, Chief Executive Officer of ITI. "As we expected, ITI-3000 proved to be safe and well tolerated in the study, with no dose-limiting toxicities, no reported treatment-related adverse events or serious adverse reactions. As we are encouraged by the immunological responses in patients, we look forward to continuing the development of ITI-3000. The advancement of this program is paving the way for the expansion of our pipeline via our UNITE® platform." The phase 1 clinical trial was a six-patient, single center, open label, first-in-human (FIH) study, investigating the safety, tolerability and immunogenicity of ITI-3000 in patients with polyomavirus-positive Merkel cell carcinoma (MCC). Participants received 4 doses of ITI-3000 vaccine, one 4 mg dose every month for four months. Participants in the study were those who are both diagnosed and had completed standard of care (SOC) surgical and/or radiation therapy at least one year prior to enrollment in the study, and who had no evidence of active disease (NEAD). Participants who were previously diagnosed with MCC and had recurrence but exhibited no evidence of active disease (NEAD) for more than two years prior to enrollment, were also included in the study. Additional information regarding the phase 1 trial may be found at clinicaltrials.gov, using identifier: NCT05422781. About ITI-3000 ITI-3000 leverages the company’s investigational UNiversal Intracellular Targeted Expression (UNITE®) platform, powered by LAMP (Lysosome Associated Membrane Protein), which fuses sequences from the mutated form of the large T antigen (LT) of the MCPyV into the sequence of the LAMP-1 gene. This lysosomal targeting technology has been shown to result in enhanced antigen presentation and a potent immune response. About Immunomic Therapeutics, Inc. Immunomic Therapeutics, Inc. (ITI) is a privately-held, clinical-stage biotechnology company pioneering the development of vaccines through its proprietary technology platform UNITE®, which is designed to utilize the body’s natural biochemistry to develop vaccines that generate broad immune responses. ITI is primarily focused on applying the UNITE platform to oncology indications, where it could potentially have broad applications, including development of antigen-derived antibodies as biologics in a number of cancers. The company has built a pipeline leveraging UNITE with programs in oncology, animal health, infectious disease, and allergy. ITI maintains its headquarters in Rockville, Maryland. For more information, please visit . Forward-Looking Statements This press release includes statements relating to the current progress of the ITI-3000 program for Merkel cell carcinoma and ITI’s technology platform and development efforts. These statements and other statements regarding our future plans and goals constitute "forward-looking statements" and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control and which may cause results to differ materially from expectations, including, without limitation, whether we are able to capitalize on the Fast Track Designation for the ITI-3000 program, receive additional accelerated review from the FDA, achieve positive results in our clinical trials to develop an immunotherapy that is successful in treating MCC, and be able to advance the utilization of our UNITE® platform. You are cautioned not to place undue reliance on these forward-looking statements, which are based on our expectations as of the date of this press release and speak only as of the origination date of this press release. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

-Top-Line Data Expected in the Second Quarter of 2025- ROCKVILLE, Md.--(BUSINESS WIRE)-- Immunomic Therapeutics Inc., a privately held, clinical-stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms, today announced dosing of the first patient in its Phase 1 clinical trial evaluating ITI-1001, a plasmid DNA (pDNA) vaccine, for the treatment of Glioblastoma Multiforme (GBM), a rare but aggressive form of brain cancer. The study is being conducted at the Dana-Farber Cancer Institute in Boston, Massachusetts and is being led by Dr. David Reardon, Clinical Director, Center for Neuro-Oncology. "Dosing of the first patient in the Phase 1 clinical trial of ITI-1001 in patients with GBM is a significant clinical development milestone for Immunomic, representing the first time this pDNA vaccine is being administered in humans,” stated Dr. Teri Heiland, Chief Scientific Officer of Immunomic Therapeutics. "We are eager to evaluate the safety and preliminary efficacy in this patient population, who have only limited treatment options for this devastating disease and expect to read out top-line data in the second quarter of 2025.” The single-center, open label, First-In-Human Phase 1 clinical trial is designed to evaluate the safety, tolerability, immunogenicity and preliminary efficacy of 8 mg of ITI-1001 in newly diagnosed GBM patients having unmethylated MGMT promoter mutations. For more information on the Phase 1 trial of ITI-1001 in GBM, please visit , NCT05698199 About ITI-1001 ITI-1001 is an investigational plasmid DNA vaccine therapy that leverages Immunomic’s proprietary UNITE® platform to treat patients with newly diagnosed GBM. ITI-1001 is designed to target the pp65, IE-1 and gB viral antigens of Cytomegalovirus (CMV) which are expressed in GBM, but not in normal brain cells. About UNITE® ITI’s UNITE platform leverages the ability to engineer chimeric proteins, directing antigen presenting cells to present antigens to the immune system through a targeted pathway and driving a robust immune response. UNITE vaccines are distinct in that they combine two components: nucleic acid constructs that encode a specific antigen and an endogenous Lysosomal Associated Membrane Protein (LAMP-1) sequence. The UNITE platform harnesses LAMP-1 as a means of presenting the vaccine target to the immune system, resulting in antibody production, inflammatory cytokine release, and establishing critical immunological memory, something that other vaccine approaches commonly lack. This approach could put UNITE technology at the crossroads of immunotherapies in multiple indications, including cancer, human allergy, animal health, and infectious disease. Preclinical data is currently being developed to explore whether LAMP-1 nucleic acid constructs may amplify and activate the immune response in highly immunogenic tumor types and be used to create immune responses in tumor types that otherwise do not provoke an immune response. About Immunomic Therapeutics, Inc. Immunomic Therapeutics, Inc. (ITI) is a privately-held, clinical-stage biotechnology company pioneering the development of vaccines through its proprietary technology platform UNITE®, which is designed to utilize the body’s natural biochemistry to develop vaccines that generate broad immune responses. ITI is primarily focused on applying the UNITE platform to oncology indications, where it could potentially have broad applications, including development of antigen-derived antibodies as biologics in a number of cancers. The company has built a pipeline leveraging UNITE with programs in oncology, animal health, infectious disease, and allergy. ITI maintains its headquarters in Rockville, Maryland. For more information, please visit . Forward-Looking Statements This press release includes statements relating to the current progress of the ITI-1001 program for Glioblastoma Multiforme (GBM) and ITI’s technology platform and development efforts. These statements and other statements regarding our future plans and goals constitute "forward-looking statements" and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control and which may cause results to differ materially from expectations, including, without limitation, whether we are able to capitalize on the ITI-1001 program, achieve positive results in our clinical trials to develop an immunotherapy that is successful in treating GBM, and be able to advance the utilization of our UNITE® platform. You are cautioned not to place undue reliance on these forward-looking statements, which are based on our expectations as of the date of this press release and speak only as of the origination date of this press release. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.