Somatostatinoma

Trial’s Objective Response Rate Endpoint Already Achieved HOUSTON & PARIS--(BUSINESS WIRE)-- RadioMedix and Orano Med, two clinical stage radiopharmaceutical companies, today announced that the last patient has been dosed in the Phase II trial of the targeted alpha emitter therapy, 212Pb-DOTAMTATE (AlphaMedix™). This trial is being conducted to evaluate the safety and effectiveness of AlphaMedix™ in peptide receptor radionuclide therapy (PRRT) of naive patients with somatostatin receptor-expressing neuroendocrine tumors (NET), regardless of the location of the primary tumor. Top-line data from the trial is expected in mid-2024. Remarkably, based on data already collected, the objective response rate (ORR) endpoint has already been achieved and is more than twice as high as the current standard of care. “The completion of the Phase II trial enrolment is a significant milestone in the clinical development of our innovative targeted alpha-emitter radiotherapy, AlphaMedix™, and brings us one step closer to having this drug available to patients,” said Ebrahim Delpassand, MD, Chairman and Chief Executive Officer of RadioMedix. “Previous studies have shown targeted alpha therapy (TAT) with AlphaMedix™ is well-tolerated. The preliminary efficacy data seen to date are very promising, particularly achieving the planned ORR endpoint. As the trial progresses, we believe the ORR could improve further. We look forward to reporting data on the study in 2024, which we believe will show that AlphaMedix™ will provide substantial benefit over currently FDA approved therapies for patients with metastatic or inoperable SSTR-expressing NETs.” This Phase II trial is a multi-center, single arm, non-randomized, open-label basket trial. Forty-one patients with histologically confirmed NETs and positive somatostatin analogue imaging who have not received prior PRRT have been enrolled across four sites in the United States. Treatment consists of four cycles of AlphaMedix™ at 8-week intervals. The primary endpoint of the trial is safety and effectiveness of AlphaMedix™. Efficacy endpoints include objective response rate (ORR) using RECIST v1.1 criteria, progression-free survival (PFS), and overall survival (OS). Additional information about the trial can be found on clinicaltrials.gov: NCT 05153772. Julien Dodet, President, and Chief Executive Officer of Orano Med, noted: “Completing this Phase II trial enrolment on schedule is a great achievement everyone involved and confirms the strong interest of the medical community for targeted alphatherapies with lead-212. We are convinced that targeted alphatherapies, such as AlphaMedixTM, are the future of radiopharmaceutical therapies, providing an increased cytotoxic potential against cancer cells with limited toxicity to surrounding healthy cells. This reinforces Orano Med’s commitment to make innovative lead-212-based therapies available to the medical community and patients worldwide.” About Targeted Alpha Therapy Targeted alpha therapy (TAT) relies on a simple concept: combining the ability of biological molecules to target cancer cells with the short-range cell-killing capabilities of alpha-emitting radioisotopes. Alpha decay consists of the emission of a helium nucleus (alpha particle) together with very high linear energy transfer and a range emission of only few cell layers, resulting in irreparable double strand DNA breaks in cells adjacent only to area of alpha emission. This approach results in an increased cytotoxic potential toward cancer cells while limiting toxicity to nearby healthy cells. As a result, alpha emitters are considered as the most powerful payloads to be found for targeted therapies. About AlphaMedixTM AlphaMedixTM is a radiolabeled SSTR-targeting therapeutic investigational drug for the treatment of NETs patients. The product consists of SSTR-targeting peptide complex radiolabeled with 212Pb that serves as an in vivo generator of alpha-emitting particles. 212Pb isotope is particularly suitable for SSTR therapy applications based upon its half-life, energy, and decay properties. About neuroendocrine tumors Neuroendocrine tumors (NETs) are a heterogeneous group of rare neoplasms that originate from neuroendocrine cells. These neoplasms occur mostly in the gastrointestinal tract and pancreas but can also occur in other tissues including the thymus, lung, and other uncommon sites such as ovaries, heart, and prostate. Most NETs strongly express somatostatin receptors (SSTRs). In the United States, around 12,000 patients are expected to be diagnosed with neuroendocrine tumors, with an average 5-year survival rate of 60% at a metastatic stage. About RadioMedix RadioMedix, Inc. is a clinical-stage biotechnology company, and sponsor of the AlphaMedix™ trial, based in Houston and Humble, Texas. The company is focused on innovative targeted radiopharmaceuticals for diagnosis, monitoring, and therapy of cancer. RadioMedix is developing radiopharmaceuticals for PET imaging and therapy (alpha- and beta-labeled agents). The company established contract service facilities for academic and industrial partners including a drug discovery center for the early probe development, a pre-clinical core facility for in vitro and in vivo evaluation of radiopharmaceuticals, and cGMP and analytical suite for Phase I-III clinical trials, and the large-scale post-approval commercial manufacturing facility, the Spica Center. More information about RadioMedix, visit: . About Orano Med Orano Med is a clinical-stage biotechnology company which develops a new generation of targeted therapies against cancer using the unique properties of lead-212 (212Pb), a rare alpha-emitting radioisotope and one of the more potent therapeutic payloads against cancer cells known as Targeted Alpha-Emitter Therapy (TAT). The company develops several treatments using 212Pb combined with various targeting agents. Orano Med has 212Pb manufacturing facilities, laboratories, and R&D centers in France and in the US and is currently investing to further expand its GMP-manufacturing capacities for 212Pb radiolabeled pharmaceuticals in North America and Europe. More information about Orano Med, visit: . View source version on businesswire.com: Contacts Source: Orano Med View this news release online at:

CORALVILLE, Iowa--( BUSINESS WIRE )--Viewpoint Molecular Targeting ® , Inc., a precision oncology company developing alpha-particle therapies and complementary diagnostic imaging agents, today announced the first dosing of two neuroendocrine tumor patients with therapeutic intent. VMT-α-NET, which is being developed for the treatment and diagnosis of somatostatin receptor subtype 2 (SSTR2) expressing neuroendocrine tumors, was administered to the patients in early December. The dosed patients were diagnosed with confirmed-advanced somatostatin expressing neuroendocrine tumors (NETs). The administration of VMT-α-NET was under the supervision of the patients’ doctor, Dr. Ishida Sen MBBS, Director and Head of Nuclear Medicine at Fortis Hospital, New Delhi, in partnership with BJ Madan, a diagnostic & therapeutic radiopharmaceutical company in New Delhi. No acute adverse reactions were observed in the first 10 days post administration and patients remain stable and in good condition. “Preclinical and clinical data associated with this new radiopharmaceutical demonstrates significant potential to help our NET patients,” noted Dr. Sen. “We are pleased that the patients are doing well, and we have appreciated the professionalism and scientific strength of the Viewpoint team.” Under compassionate use circumstances, VMT-α-NET may be made available to qualified doctors in some countries. In this circumstance, Viewpoint supplied drug precursors and isotopes for the local production of its proprietary radiotherapeutic, VMT-α-NET. “We are highly committed to the rapid development of alpha-particle radionuclide therapy for cancer,” said Viewpoint CEO Thijs Spoor. “We are pleased to support Dr Sen’s team in making this product available for her patients.” The progress of these patients will be followed by Dr. Sen and her team over the coming months. The safety and effectiveness of the treatments will be evaluated by Dr. Sen’s team with laboratory testing, observation of NET-associated symptoms, and repeat medical imaging. In the U.S., VMT-α-NET will imminently enter a Phase 1 imaging and therapy study, to be conducted at various hospitals and clinics. VMT-α-NET, is categorized as an investigational new drug by the U.S. Food and Drug Association and the administration of VMT-α-NET for compassionate use is completely independent from and not within the scope of the Company’s Phase 1 trial. About Viewpoint Molecular Targeting Viewpoint Molecular Targeting is a radiopharmaceutical company developing precision oncology therapeutics and complementary diagnostic imaging agents. The Company’s proprietary technology utilizes the isotope lead-212 to deliver powerful alpha radiation specifically to cancer cells via specialized targeting peptides. Viewpoint is also developing complementary imaging diagnostics that incorporate the same targeting peptides which provide the opportunity to personalize treatment and optimize patient outcomes. For more information about Viewpoint and its emerging treatments, please visit the Company’s website www.viewpointmt.com .

Enrollment for the randomization phase of SPLASH completed prior to EOY 2022, meeting previous guidanceINDIANAPOLIS, Jan. 12, 2023 (GLOBE NEWSWIRE) -- POINT Biopharma Global Inc. (NASDAQ: PNT) (the “Company” or “POINT”), a company accelerating the discovery, development, and global access to life-changing radiopharmaceuticals, today announced the completion of enrollment for the randomization phase in the pivotal phase 3 SPLASH trial, on schedule and meeting previous guidance. SPLASH is a multi-center, randomized, open label assessment of 177Lu-PNT2002 in participants with PSMA-expressing metastatic castration resistant prostate cancer who have progressed on androgen receptor pathway inhibitor therapy and refuse, or are not eligible for, chemotherapy. Enrollment for randomization was completed on schedule with more than 390 participants randomized across 55 SPLASH trial sites in North America, Europe, and the United Kingdom. “We are proud to have reached this important milestone for the PNT2002 program,” said Jessica Jensen, Executive Vice President, Clinical Development of POINT Biopharma. “Our incredibly talented cross-functional team collaborated tirelessly to ensure that, despite the extraordinary circumstances of a pandemic, POINT’s first phase 3 global trial remained on track. Our success is a testament to both the expertise of our team and the level of enthusiasm for radioligand therapy in the oncology community. We are grateful for patients who agreed to be screened for this study, the trial investigators and their hard-working staff, our research partners, and the POINT team for their passion and commitment to the program. We look forward to continuing to work diligently to advance novel treatment options for patients as we accelerate the discovery, clinical development, and manufacturing of radioligand therapies.” On November 14, 2022, POINT announced a set of strategic collaboration agreements with Lantheus Holdings Inc. (NASDAQ: LNTH) related to POINT’s PNT2002 and PNT2003 product candidates, which closed on December 20, 2022. Under the agreements, POINT will fund and complete its phase 3 SPLASH trial for PNT2002, following which Lantheus will file the New Drug Application (NDA) in collaboration with POINT. For PNT2003, POINT recently received the OZM-067 clinical trial data sets from the trial sponsor. POINT will facilitate the analysis of the data sets. Lantheus will prepare and submit the regulatory filings in the U.S. The companies have formed joint steering committees to oversee the clinical studies, regulatory filings, manufacturing, and commercial readiness for both PNT2002 and PNT2003. POINT will develop commercial production capacity and manufacture clinical and commercial supply for both PNT2002 and PNT2003. Lantheus has the rights to commercialize both assets post regulatory approval, excluding certain Asian territories1. [1] Japan, South Korea, China (including Hong Kong, Macau, and Taiwan), Singapore, and Indonesia are retained by POINT. About the SPLASH TrialThe phase 3 SPLASH trial is a multi-center, randomized, open label assessment of PNT2002 in participants with PSMA-expressing metastatic castration resistant prostate cancer (mCRPC) who have progressed on androgen receptor pathway inhibitor (ARPI) therapy and refuse, or are not eligible for, chemotherapy. The randomization phase of the study enrolled over 390 participants across North America, Europe, and the United Kingdom. Participants were randomized 2:1 with those in arm A receiving PNT2002 and those in arm B receiving either abiraterone or enzalutamide. Participants in arm B who experience centrally assessed radiographic progression and meet protocol eligibility will have the option to crossover and receive PNT2002. Patients will be subject to follow-up for up to 5 years from their first PNT2002 dose. The primary endpoint of the study is radiographic progression-free survival. Key secondary endpoints include overall response rate, overall survival, and pharmacokinetics. More information about the trial is accessible at ClinicalTrials.gov, identifier NCT04647526. About the OZM-067 TrialThe OZM-067 trial, sponsored by the University Health Network (UHN), is a prospective single-arm, multi-center study to evaluate the efficacy and safety of lutetium-177 octreotate in patients with 68Ga-DOTATATE-identified, somatostatin receptor-positive neuroendocrine tumors. More information about the trial is accessible at ClinicalTrials.gov, identifier NCT02743741. About POINT Biopharma Global Inc.POINT Biopharma Global Inc. is a globally focused radiopharmaceutical company building a platform for the clinical development and commercialization of radioligands that fight cancer. POINT aims to transform precision medicine by combining a portfolio of radiopharmaceutical assets, a seasoned management team, an industry-leading pipeline, in-house manufacturing capabilities, and secured supply for rare medical isotopes like actinium-225 (225Ac) and lutetium-177 (177Lu). POINT’s active clinical trials include FRONTIER, the phase 1 trial for PNT2004, a pan-cancer program targeting fibroblast activation protein-α (FAP-α), and SPLASH, the phase 3 trial for PNT2002 for people with metastatic castration resistant prostate cancer (mCRPC) after second-line hormonal treatment. More information about the SPLASH trial can be found at https://www.splashtrial.com/. Learn more about POINT Biopharma Global Inc. at https://www.pointbiopharma.com/. Forward Looking StatementsThis press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this press release include, but are not limited to, statements regarding the potential attributes and benefits of POINT’s product candidates and the format and timing of POINT’s product development activities and clinical trials. We cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward-looking statements are subject to a number of significant risks and uncertainties that could cause actual results to differ materially from expected results, including, among others, our ability to obtain funding for our operations, our ability to maintain the license agreements underlying our product candidates, competition, the ability of POINT to grow and manage growth profitably and retain its key employees, the impact of COVID-19 on POINT’s business, the ability to maintain the listing of POINT’s common stock on the NASDAQ, changes in applicable laws or regulations, the possibility that POINT may be adversely affected by other economic, business, and/or competitive factors, and other risks and uncertainties, including those described in POINT's Annual Report on Form 10-K filed with the SEC on March 25, 2022 and subsequent filings with the SEC. Most of these factors are outside of POINT’s control and are difficult to predict. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. The forward-looking statements in this press release represent our views as of the date of this press release. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we have no current intention of doing so except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release. Investor Relations Contact:Daniel PearlsteinAssociate Director, Corporate Strategyinvestors@pointbiopharma.com