somatostatin

Pictured: MRI images of the brain for neurological Six months after treatment with the radiopharmaceutical therapy, 77.8% of patients with meningioma were alive and had not experienced further disease progression, beating the 26% benchmark established in earlier studies. Phase II data presented Sunday at the American Society for Radiation Oncology annual meeting suggest Novartis’ Lutathera may improve progression-free survival in patients with tough-to-treat meningioma brain tumors. Lutathera is a combination of a radionuclide, 177Lu, and a peptide that binds to somatostatin receptors. The combination enables the targeted delivery of radiation therapy. Lutathera received FDA approval for use against gastroenteropancreatic neuroendocrine tumors in 2018. Novartis has yet to expand the label to cover additional diseases but Lutathera is potentially applicable to other tumors that express somatostatin. That potential informed a Phase II trial led by Kenneth Merrell, a radiation oncologist at the Mayo Clinic Alix School of Medicine. The study was designed to show if Lutathera could be an option for people with meningioma, a brain tumor, who progress after treatment with surgery or radiation. Researchers have reported recurrence rates of 40% to 80% for certain grade meningiomas. As the tumor recurs, patients quickly run out of safe and effective salvage treatments. Because nearly all meningiomas express somatostatin, the Mayo Clinic oncologist identified Lutathera as a drug that could provide people with another option. “There is no standard of care or proven option for managing refractory meningioma,” Merrell said in a statement. “Many of these patients continue to experience aggressive tumor growth and significant related complications, and ultimately the illness may prove fatal. It is a very challenging prognosis to manage, and in many cases, we are left with only supportive measures.” The single-arm study enrolled 20 people with surgery- and radiation-refractory meningioma to receive four administrations of Lutathera eight weeks apart. Six months after treatment, 77.8% of the patients were alive and had not experienced further disease progression. The researchers said earlier studies had established 26% as the benchmark for progression-free survival (PFS) after six months. Median PFS in the Lutathera study was 10.7 months. The trial had yet to reach median overall survival at the time of the ASTRO analysis. One year after treatment, 88.5% of patients were alive. No patients experienced grade 4 or 5 adverse events, the most severe side effects, that were attributable to the treatment. Ten patients had moderate, grade 3 hematologic adverse events. There was also one case each of grade 3 hepatitis and seizure that were at least possibly attributable to treatment. Five people stopped taking Lutathera, in two cases because of possible treatment-related adverse events.

Abundant, richly vascularized and functioning islets observed throughout all chambers of Sernova’s Cell Pouch more than 5 years after islet transplantationHistological data confirmation of healthy beta, alpha and delta cells secreting insulin, glucagon, and somatostatin in all Cell Pouch ChambersSernova’s Cell Pouch safely contains its therapeutic cells and provides full retrievability using conventional instruments and methodsPathology confirmed no evidence of detrimental fibrotic tissue associated with Cell Pouch more than 5 years after implantation LONDON, Ontario and BOSTON, Sept. 12, 2024 (GLOBE NEWSWIRE) -- Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-stage biotechnology company focused on the development of regenerative medicine cell therapies for treatment of chronic diseases today announced the presentation of new positive interim data from the ongoing Phase I/II clinical trial evaluating the safety, tolerability, and efficacy of the Sernova Cell Pouch Transplant System containing donor islets in people living with type 1 diabetes (T1D). The data was presented by Piotr Witkowski, M.D., Ph.D., Professor of Surgery and Director of the Pancreatic and Islet Transplant Program at University of Chicago Medicine, who is the Lead Investigator for the study, during an oral session at the 2024 European Association for the Study of Diabetes (EASD) Annual Meeting in Madrid, Spain. All 6 of the patients enrolled in Cohort A of Sernova’s Phase I/II clinical trial with Cell Pouch and donor islets achieved sustained insulin independence after combined islet transplantation into Cell Pouch and intraportally. The first patient to be treated in the trial experienced sustained insulin independence for more than 4 years accompanied by blood sugar levels in the non-diabetic range (HbA1c ≤6.5%). More than 5 years after the first islet transplant, the patient’s Cell Pouches containing the transplanted islets were removed because immune suppression had to be stopped when that patient developed other, non-diabetic health issues not related to Cell Pouch or transplanted islets. The new histological data from those explanted Cell Pouches confirmed abundant, well-vascularized, functioning islets consisting of cells producing insulin, glucagon and somatostatin, throughout all chambers, more than 5 years after being transplanted to Cell Pouch. Additionally, after being in the body for more than 5 years, a pathology examination confirmed there was no evidence of detrimental fibrotic tissue, material degradation or changes in the architecture of the Sernova Cell Pouch. “I am excited to see this evidence of well-vascularized and healthy islets 5 years after transplant to Sernova’s Cell Pouch; these interim findings are very promising,” commented Piotr Witkowski M.D., Ph.D. “This is a major step forward in the development of a contained and retrievable cell therapy for the treatment of T1D. This is the first evidence that I am aware of that demonstrates this level of healthy islet survival and function in an implantable and retrievable system for such a long duration.” “We believe this first-in-world data is significant for Sernova and, more specifically, provides tangible hope for T1D patients that we are a significant step further in our mission of providing a functional cure for this terrible disease; as a Type 1 diabetic myself I could not be more determined to drive our program forward and ultimately onto the market,” said Jonathan Rigby, President and CEO of Sernova. “We look forward to completing Cohort B in the near term and, based on positive data generated thus far, initiating Cohort C of our ongoing trial later this year with an optimized immune suppression regimen. Lastly, we continue to work with our partner Evotec on the development of induced pluripotent stem cell (iPSC)-derived islet-like clusters, which will provide a scalable cell source so that one day we can give patients with T1D their lives back.” ABOUT THE PHASE I/II TRIAL The Phase I/II trial (NCT03513939) is a U.S. prospective, single-arm, multi-cohort study evaluating the safety, tolerability, and efficacy of Sernova’s Cell Pouch in combination with transplanted human-donor islets in people living with type 1 diabetes (T1D). The trial includes participants aged 18-65 with T1D who experience hypoglycemic unawareness and severe hypoglycemic episodes, and who are eligible for donor islet transplantation. The trial is currently divided into two cohorts. Cohort A involved six patients who received the first-generation 8-channel Cell Pouch. Cohort B is evaluating seven patients transplanted with an optimized 10-channel Cell Pouch, which has a 50% greater islet capacity than the Cell Pouch used in Cohort A. As part of the process, patients are implanted with the Cell Pouch subcutaneously. Approximately six weeks later - allowing time to establish a stable immunosuppression therapy for the patient - islets are transplanted into the prevascularized tissue chambers formed by the Cell Pouch. Safety and efficacy are assessed throughout the 12 months following the last islet transplant. Patients still dependent on insulin 6 months after the second islet transplant may qualify for a third transplant via the portal vein. Those who retain implants will be followed for at least three years. The secondary objectives of the trial include the following efficacy endpoints: continuous glucose monitoring, production of C-peptide, insulin use, HbA1c levels, and the frequency of severe hypoglycemic episodes. ABOUT SERNOVA AND ITS CELL POUCH™ TRANSPLANT SYSTEM PLATFORM FOR CELL THERAPY Sernova Corp. is a clinical-stage biotechnology company that is developing therapeutic cell technologies for chronic diseases, including insulin-dependent diabetes, thyroid disease, and blood disorders that include hemophilia A. Sernova is currently focused on developing a ‘functional cure’ for insulin-dependent diabetes with its lead technology, the Cell Pouch Transplant System, a novel implantable and scalable medical device with immune protected therapeutic cells. On implantation, The Cell Pouch forms a natural, vascularized tissue environment in the body allowing long-term survival and function of therapeutic cells that release essential factors that are absent or deficient in patients with certain chronic diseases. Sernova’s Cell Pouch Transplant System has demonstrated its potential to be a ‘functional cure’ for people with T1D in an ongoing Phase I/II clinical study at the University of Chicago. Sernova partnered with Evotec to develop an implantable off-the-shelf iPSC (induced pluripotent stem cells) based islet replacement therapy. This partnership provides Sernova a potentially unlimited supply of insulin-producing cells to treat millions of patients with insulin-dependent diabetes (type 1 and type 2). Sernova’s development pipeline that uses its Cell Pouch Transplant System also includes: a cell therapy for hypothyroid disease resulting from thyroid gland removal and an ex vivo lentiviral Factor VIII gene therapy for hemophilia A. FOR FURTHER INFORMATION, PLEASE CONTACT: Christopher Barnes VP, Investor Relations Sernova Corp. Tel: +1 519-902-7923 Email: christopher.barnes@sernova.com Website: www.sernova.com The TSX has not reviewed this news release and does not accept responsibility for the accuracy or adequacy of this news release. FORWARD-LOOKING INFORMATION This release contains statements that, to the extent they are not recitations of historical facts, may constitute “forward-looking statements” that involve various risks, uncertainties, and assumptions, including, without limitation, statements regarding the prospects, plans, and objectives of the company. Wherever possible, but not always, words such as "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects", "potential for" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should" occur are used to identify forward-looking statements. These statements reflect management’s beliefs with respect to future events and are based on information currently available to management on the date such statements were made. Many factors could cause Sernova’s actual results, performances or achievements to not be as anticipated, estimated or intended or to differ materially from those expressed or implied by the forward-looking statements contained in this news release. Such factors could include, but are not limited to, the company’s ability to secure additional financing and licensing arrangements on reasonable terms, or at all; ability to conduct all required preclinical and clinical studies for the company’s Cell Pouch System and or related technologies, including the timing and results of those trials; ability to obtain all necessary regulatory approvals, or on a timely basis; ability to in-license additional complementary technologies; ability to execute its business strategy and successfully compete in the market; and the inherent risks associated with the development of biotechnology combination products generally. Many of the factors are beyond our control, including those caused by, related to, or impacted by the novel coronavirus pandemic. Investors should consult the company’s quarterly and annual filings available on www.sedarplus.ca for additional information on risks and uncertainties relating to the forward-looking statements. Sernova expressly disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Sanofi will handle global commercialization of a neuroendocrine tumor treatment. Sanofi has made a late entry to the radioligand party, paying 100 million euros ($110 million) upfront for global rights to a neuroendocrine tumor treatment that is nearing a filing for approval.The French drugmaker has stayed on the sidelines as a who’s who of drugmakers, led by Novartis, have placed big bets on radioligand therapies. Sanofi is entering the sector through a deal with RadioMedix and Orano Med for a targeted alpha therapy that is designed to deliver a payload to cells that express somatostatin, a receptor found in most neuroendocrine tumors.In clinical studies, 62.5% of patients who received the drug candidate, called AlphaMedix, had durable responses. The candidate is currently completing phase 2 development, and talks with the FDA about a potential regulatory filing are underway.Sanofi will handle global commercialization of the therapy. The Big Pharma is paying RadioMedix and Orano Med 100 million euros upfront and committing up to 220 million euros in sales milestones for the rights to the asset. Orano Med will be responsible for the manufacturing of AlphaMedix. Dietmar Berger, M.D., Ph.D., global head of development at Sanofi, discussed the decision to license AlphaMedix in a statement. Berger said the early clinical data have shown the treatment’s “differentiated biophysical and clinical profile, reinforcing its potential to be a transformative radioligand therapeutic for patients across multiple difficult-to-treat rare cancers.”Novartis received FDA approval for its radioligand therapy Lutathera in certain neuroendocrine tumors in 2018. RadioMedix allowed enrollment of some patients who had received Lutathera in its phase 2 trial, generating data on AlphaMedix’s use as a first-line option and in people who progress on Novartis’ drug. Lutathera is a beta particle emitter, whereas AlphaMedix is an alpha therapy.Sanofi fielded a question about its appetite for radiopharma on its second-quarter earnings call in July. In response, Houman Ashrafian, Ph.D., head of R&D at Sanofi, noted the resurgence of interest in radioligand therapy and said the company remained “watchful in this space.” Sanofi CEO Paul Hudson added details on what it would take for the company to go from watcher to participant.“We've made trade-offs to stay very focused,” Hudson said. “We would have to feel there was something adding to make us want to go outside of what we do because we are really focused on the areas that we want to win and play.”