PSCA

LOS ANGELES--( BUSINESS WIRE )--Researchers with City of Hope ® , one of the largest cancer research and treatment organizations in the United States, will present new findings at the AACR Annual Meeting, which will take place April 5 to 10 in San Diego. This year, City of Hope doctors and scientists will also present data during AACR’s Press Program and a clinical trials plenary session: Monday, April 8, 2024, at 8:30 a.m. Research by Ajay Goel, Ph.D., M.S. , City of Hope professor and chair, Department of Molecular Diagnostics and Experimental Therapeutics, and Caiming Xu, Ph.D., a postdoctoral fellow in Goel’s lab, will be presented at an AACR press conference. The abstract is titled “ An exosome-based liquid biopsy for non-invasive, early detection of patients with pancreatic ductal adenocarcinoma: A multicenter and prospective study .” Sunday, April 7, 2024, at 1 to 3 p.m. Sumanta Kumar Pal, M.D. , City of Hope chair, kidney and bladder cancer disease team, will present on “ CTX130 allogeneic CRISPR-Cas9-engineered chimeric antigen receptor (CAR) T cells in patients with advanced clear cell renal cell carcinoma: Long-term follow-up and translational data from the Phase 1 COBALT-RCC study ” during a clinical trials plenary session called, Beyond Immune Checkpoint Inhibition: Novel Immunotherapy Strategies . Additional data presentations include: “Multi-omics characterization of molecular features and global-local genomic ancestry analysis of colorectal cancer in Hispanic-Latinos” Minisymposium session 3932: Monday, April 8, 2024, 3:35 to 3:50 p.m. To investigate why Hispanic/Latino colorectal cancer (CRC) patients in Los Angeles face mortality rates up to 20% higher than their Caucasian counterparts, City of Hope’s Enrique Velazquez Villarreal, M.D., Ph.D., M.P.H., M.S. , City of Hope assistant professor, Department of Integrative Translational Sciences, and John D. Carpten, Ph.D. , City of Hope's chief scientific officer, Irell & Manella Cancer Center Director's Distinguished Chair and Morgan & Helen Chu Director's Chair of the Beckman Research Institute, along with a team of researchers, searched for mutations in CRC tumors by utilizing molecular profiling technologies. Results yielded important insights into the molecular characterization of CRC tumors and the multifaceted clinical and genomic heterogeneity within Hispanic/Latino populations, as well as crucial information on CRC tumor heterogeneity and the tumor microenvironment. “Microbiome modification impacts PSCA directed chimeric antigen receptor (CAR) T cell therapy for prostate cancer” Poster presentation 6676/7: Wednesday, April 10, 2024, 9 a.m. to 12:30 p.m. John Murad, Ph.D., a staff scientist in the laboratory of Saul J. Priceman, Ph.D. , City of Hope associate professor, Department of Hematology & Hematopoietic Cell Transplantation, and colleagues developed methods to evaluate the impact of microbiome manipulation in the team’s established syngeneic PSCA+ prostate cancer mouse model. They found that the model was sensitive to microbiome modulation and that the use of patient-derived human fecal matter transfers can significantly impact PSCA-CAR T cell directed anti-tumor responses. Late-Breaking Presentation Wednesday, April 10, 2024, from 9 a.m. to 12:30 p.m. Stephen Gruber, M.D., Ph.D., M.P.H. , vice president, City of Hope National Medical Center, Evan and Ming Hsieh Family Director’s Chair of the Center for Precision Medicine and medical oncologist, will report on findings from an international team of researchers’ work investigating “ Artificial intelligence measures of tumor infiltrating lymphocytes predict colorectal cancer-specific and overall survival .” His presentation is titled “Late-Breaking Research: Bioinformatics, Computational Biology, Systems Biology, and Convergent Science 3.” Symposiums and Educational Sessions Marcel van den Brink, M.D., Ph.D. , president of City of Hope Los Angeles and City of Hope National Medical Center, and Deana and Steve Campbell Chief Physician Executive Distinguished Chair, will lead a major symposium as chair of The Microbiome and Treatment Response to Cancer Therapy , to be held on Tuesday, April 9, 2024, from 10:15 a.m. to 11:45 a.m. He will also present on “ The role of the intestinal microbiome in cancer immunotherapy ,” discussing clinical and preclinical studies that demonstrate how changes in the gut microbiome can affect outcomes after hematopoietic cell transplantation and CAR T cell therapy. John D. Carpten, Ph.D. , will chair and serve as a featured speaker for the presentation “ Molecular Profiling in Breast Cancer and Racial/Ethnic Minorities: Dedicated to the Memory of Edith P. Mitchell .” Michael Caligiuri, M.D. , City of Hope professor, Division of Leukemia, Department of Hematology & Hematopoietic Cell Transplantation, is the chair for an educational session on Saturday, April 6, 2024, from 12:30 to 2 p.m. titled, The Road to Entrepreneurship . Industry experts will discuss how to get started, review criteria and find investors. Michael Caligiuri, M.D. , will also chair the inaugural AACR event called From Cancer Discoveries to Patients on April 4 and 5. The event brings together leaders in clinical research, biotech and the investment community as part of AACR’s commitment to expediting the advancement of lifesaving cancer discoveries. About City of Hope City of Hope's mission is to make hope a reality for all touched by cancer and diabetes. Founded in 1913, City of Hope has grown into one of the largest cancer research and treatment organizations in the U.S. and one of the leading research centers for diabetes and other life-threatening illnesses. City of Hope research has been the basis for numerous breakthrough cancer medicines , as well as human synthetic insulin and monoclonal antibodies. With an independent, National Cancer Institute-designated comprehensive cancer center at its core, City of Hope brings a uniquely integrated model to patients spanning cancer care, research and development, academics and training, and innovation initiatives. City of Hope’s growing national system includes its Los Angeles campus, a network of clinical care locations across Southern California, a new cancer center in Orange County, California, and cancer treatment centers and outpatient facilities in the Atlanta, Chicago and Phoenix areas. City of Hope’s affiliated group of organizations includes Translational Genomics Research Institute and AccessHope™ . For more information about City of Hope, follow us on Facebook , X , YouTube , Instagram and LinkedIn .

Vaccine was shown to induce immunity against Prostate Stem Cell Antigen (PSCA) previously Full protein targeting expands the Self-Assembling Vaccine (SAV) platform's potential targets NEW YORK, Nov. 20, 2023 /PRNewswire/ -- Voltron Therapeutics, Inc., a Lucius Partners portfolio company, today announced that it has finalized the protocol for a Dose-Ranging Efficacy Study of VTX-0P4, a protein-based cancer vaccine targeting Prostate Stem Cell Antigen (PSCA). PSCA is a key target in the treatment of Prostate Cancer. The ability of the SAV to target full proteins, as well as peptides, demonstrates that Voltron's vaccine platform has the potential to target dozens of oncology and infectious disease targets – collectively multi- billions of dollars of market potential. The pre-clinical trial is expected to commence in December. Voltron recently demonstrated immunogenicity against PSCA in a double blind pre-clinical trial conducted at the Vaccine and Immunotherapy Center at the Massachusetts General Hospital. In that trial VTX-0P4 significantly augmented T-Cell responses when compared to controls against this important tumor target while, once again, exhibiting a very clean safety profile. The magnitude of these responses were comparable to those seen in the Company's prior HPV E6/E7 studies, which subsequently translated into significant increases in survival and reductions in tumor progression in a mouse model of HPV induced cancer. This strongly suggests VTX-0P4 can address PSCA or other tumor antigen expressing cancers with a full protein approach. Pat Gallagher, Voltron's Chief Executive Officer commented, "In our HPV-related cancer proof of concept trial, Voltron validated that targeting hot spot epitopes, E6/E7, can lead to highly statistically significant increases in survival, reduced tumor growth, and increased tumor infiltration by beneficial immune T Cells. By using a full protein in our PSCA trial to attack solid tumors of interest, we are systematically moving into more complex targeting approaches that provide increased flexibility in developing treatments for additional cancer types and infectious diseases. As with our HPV design, this trial will also evaluate the specific vaccine as monotherapy and in combination with a Checkpoint Inhibitor (PD-1)." The SAV Platform's novel mechanism of action offers a promising solution for rapid development and production of vaccines at a reduced cost. It utilizes the same backbone for all vaccines, but with different 'targeting warheads,' allowing cost-effective production for specific cancer or infectious disease targets. With the SAV, 'targeting warheads' may potentially include different types of antigens including proteins, peptides, polysaccharides or nucleic acids. Importantly, utilizing the same core immune activating component across all the vaccines, MTBHSP70, reduces regulatory risks by largely eliminating off-target inflammation inherent in standard adjuvants. Additionally, this utilizes an expression system Voltron has already translated to good manufacturing processes production for clinical testing. "We are excited to initiate Voltron's PSCA pre-clinical efficacy trial," said James Ahern, Managing Partner of Laidlaw & Company and co-founder of Lucius Partners. "With success, we will have two immune-oncology vaccines that potentially address six unique cancers to move toward first-in-human trials. We will continue to build on our successful programs to address patient needs and create shareholder value." About Voltron Therapeutics, Inc. Voltron Therapeutics, Inc., a Delaware corporation, was founded in 2017 to lead and accelerate the development of the Vaccine and Immunotherapy Center (VIC), and the Massachusetts General Hospital's novel Self Assembling Vaccine technology in a variety of indications, including in Oncology and Emerging Infectious Diseases. Voltron holds an exclusive worldwide license to this technology. With the work of our world class team of researchers and development team, this technology has shown positive results in certain pre-clinical studies and initial proof of concept in two infectious diseases (including Lassa Fever) as well as three oncology indications (HPV Related Cancers). For more information, please visit . About Lucius Partners, LLC Lucius Partners is a consultancy that provides a broad suite of services to help healthcare companies grow, achieve milestones and generate value for their shareholders. Forward Looking Statements This press release includes "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release include, but are not limited to, statements that relate to the advancement and development of the VaxCelerate Platform, the commencement of clinical trials, the availability of data from clinical trials and other information that is not historical information. When used herein, words such as "anticipate", "being", "will", "plan", "may", "continue", and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Voltron's current expectations and various assumptions. Voltron believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Voltron may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, market conditions and any Voltron filings made with the Securities and Exchange Commission. Consequently, forward-looking statements should be regarded solely as Voltron's current plans, estimates and beliefs. Investors should not place undue reliance on forward-looking statements. Voltron cannot guarantee future results, events, levels of activity, performance or achievements. Voltron does not undertake and specifically declines any obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by law. Contact: Chris Bastardi [email protected] 917-484-1587 Julie Roginsky [email protected] SOURCE Lucius Partners

SYDNEY, Oct. 3, 2023 /PRNewswire/ -- Clarity Pharmaceuticals (ASX: CU6) ("Clarity"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, is pleased to announce the dosing of the first patient in its theranostic 64Cu/67Cu SAR-Bombesin Phase I/II trial in metastatic castrate resistant prostate cancer (mCRPC). No issues were observed during the administration of 6GBq of 67Cu SAR-Bombesin and the participant continues to be followed for further safety and efficacy assessments as per protocol. COMBAT, which derives from "Copper-67 SAR-Bombesin in metastatic castrate resistant prostate cancer (NCT05633160)1 is a dose escalation and cohort expansion trial for up to 38 participants. 64Cu SAR-Bombesin is used to visualise gastrin-releasing peptide receptor (GRPr)-expressing lesions and select candidates for subsequent 67Cu SAR-Bombesin therapy. The aim for the trial is to determine the safety and efficacy of 67Cu SAR-Bombesin in participants with GRPr expressing mCRPC who are ineligible for therapy with 177Lu PSMA-617. These patients are unlikely to benefit from prostate-specific membrane antigen (PSMA)-targeted agents and represent a significant unmet need for both imaging and therapy. Doses of up to 14GBq of 67Cu SAR-Bombesin, in up to four cycles, are planned to be investigated in this trial (pending safety reviews). Clarity's Executive Chairperson, Dr Alan Taylor, commented, "SAR-Bombesin has already resulted in improvements to the management of prostate cancer for patients with PSMA-negative or low PSMA expressing lesions through diagnostic trials and we hope to confirm its safety and efficacy in this theranostic trial. We look forward to progressing the COMBAT trial and building on the compelling data from our preclinical and clinical studies to date. Combined with the logistical and manufacturing benefits of Targeted Copper Theranostics and with commercial quantities of the 67Cu radioisotope now being routinely produced domestically in the US, we see a clear path to bringing SAR-Bombesin and SAR-bisPSMA to the prostate cancer patient population in need of novel treatments." About SAR-Bombesin SAR-Bombesin is a highly targeted pan-cancer radiopharmaceutical with broad cancer application. It targets the gastrin-releasing peptide receptor (GRPr) present on cells of a range of cancers, including but not limited to prostate, breast and ovarian cancers. GRPr is found in up to 100% of prostate cancers, including prostate cancers that don't express PSMA (PSMA-negative)2-6. The product utilises Clarity's proprietary sarcophagine (SAR) technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-Bombesin is a Targeted Copper Theranostic (TCT) that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu) for therapy. 64Cu SAR-Bombesin and 67Cu SAR-Bombesin are unregistered products. Individual results may not represent the overall safety and efficacy of the products. The data outlined in this announcement has not been assessed by health authorities such as the US Food and Drug Administration (FDA). A clinical development program is currently underway to assess the efficacy and safety of these products. There is no guarantee that these products will become commercially available. About Prostate Cancer Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death worldwide7. The American Cancer Institute estimates in 2023 there will be 288,300 new cases of prostate cancer in the US and around 34,700 deaths from the disease8. Approximately 25% of mCRPC patients have low or no uptake of a PSMA-targeting tracer.9 These patients are therefore unlikely to respond to therapeutic PSMA-targeted products and currently have few treatment options available to them. Given the prostate cancer indication is one of the largest in oncology, there is a significant unmet medical need in this segment. The SAR-Bombesin product could offer valuable imaging and therapeutic options for not only PSMA-negative patients, but also the large number of patients that have the target receptor on their cancers. About Clarity Pharmaceuticals Clarity is a clinical stage radiopharmaceutical company focused on the treatment of serious disease. The Company is a leader in innovative radiopharmaceuticals, developing targeted copper theranostics based on its SAR Technology Platform for the treatment of cancer in children and adults. References 1. ClinicalTrials.gov NCT05633160, 2. Markwalder R, Reubi JC. Gastrin-releasing peptide receptors in the human prostate: relation to neoplastic transformation. Cancer research. 1999;59(5):1152-1159. 3. Fleischmann A, Waser B, Reubi JC. High expression of gastrin-releasing peptide receptors in the vascular bed of urinary tract cancers: promising candidates for vascular targeting applications. Endocrine-related cancer. 2009;16(2):623-633. 4. Ananias HJ, van den Heuvel MC, Helfrich W, de Jong IJ. Expression of the gastrin-releasing peptide receptor, the prostate stem cell antigen and the prostate-specific membrane antigen in lymph node and bone metastases of prostate cancer. The Prostate. 2009;69(10):1101-1108. 5. Reubi JC, Wenger S, Schmuckli-Maurer J, Schaer JC, Gugger M. Bombesin receptor subtypes in human cancers: detection with the universal radioligand (125)I-[D-TYR(6), beta-ALA(11), PHE(13), NLE(14)] bombesin(6-14). Clin Cancer Res. 2002;8(4):1139-1146. 6. Sun B, Halmos G, Schally AV, Wang X, Martinez M. Presence of receptors for bombesin/gastrin-releasing peptide and mRNA for three receptor subtypes in human prostate cancers. The Prostate. 2000;42(4):295-303. 7. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries <> 8. American Cancer Society, Cancer Statistics Center, 9. Vlachostergios PJ, Niaz MJ, Sun M, et al. Prostate-Specific Membrane Antigen Uptake and Survival in Metastatic Castration-Resistant Prostate Cancer. Frontiers in oncology. 2021;11. This announcement has been authorised for release by the Executive Chairperson. SOURCE Clarity Pharmaceuticals