GEP-NET

RadioMedix and Orano Med receive FDA Breakthrough Therapy Designation for AlphaMedixTM in gastroenteropancreatic neuroendocrine tumors First Targeted Alpha Therapy to receive a Breakthrough Therapy Designation

Retrieved on: 
Monday, February 12, 2024
Oncology, Health, FDA, Clinical Trials, Radiology, Pharmaceutical, Toxicity, BTD, MD, GEP-NET, News, Breakthrough therapy, Breakthrough, Safety, Patient, RECIST, Alpha, PRRT, Pharmaceutical industry

AlphaMedixTM is a Targeted Alpha Therapy currently in Phase 2 clinical development, which consists of an SSTR-targeting peptide complex radiolabeled with lead-212 (212Pb) that serves as an in vivo generator of alpha particles.

Key Points: 
  • AlphaMedixTM is a Targeted Alpha Therapy currently in Phase 2 clinical development, which consists of an SSTR-targeting peptide complex radiolabeled with lead-212 (212Pb) that serves as an in vivo generator of alpha particles.
  • AlphaMedixTM is the first Targeted Alpha Therapy to receive Breakthrough Therapy Designation.
  • “The FDA's Breakthrough Therapy Designation underscores AlphaMedixTM potential as an innovative treatment that could redefine how patients with neurendocrine tumors are treated.
  • “Receiving FDA Breakthrough Therapy Designation for AlphaMedixTM is a great achievement for everyone involved and confirms the strong interest of the medical community for Targeted Alpha Therapies with lead-212.

Perspective Therapeutics Reports Third Quarter Fiscal 2023 Results and Recent Business Highlights

Retrieved on: 
Tuesday, November 14, 2023
Lung, Lutetium (177Lu) oxodotreotide, Seed, EANM, Patient, Clinical study report, Research, Radiation therapy, Marketing, Stony Brook University, UPMC Hillman Cancer Center, Medullary thyroid cancer, Growth, Congress, University, Fortis Healthcare, Pelvic exenteration, Radiation, PRRT, Toxicity, IND, GEP-NET, MTC, Melanoma, Perspective, CATX, Communication, NET, Society, ASTRO, Therapy, NETS, Wilfrid Sellars, Brain, Biology, Nuclear Medicine and Biology, Glomus tumor, NYSE, PET/CT, SPECT/CT, Clinical trial, MC1R, Prostate cancer, NIH, Survival, UPMC, GEP, Rare-earth element, Medical imaging, Pharmaceutical industry, Medical device, Cryptocurrency, Nuclear medicine, Brachytherapy

Two additional patients were enrolled in the third quarter for a total of 9 GEP-NET patients and 2 medullary thyroid cancer (MTC) patients.

Key Points: 
  • Two additional patients were enrolled in the third quarter for a total of 9 GEP-NET patients and 2 medullary thyroid cancer (MTC) patients.
  • Third quarter 2023 revenue was the highest since the second quarter of 2022, with a return to growth over the third quarter of 2022.
  • Total operating expenses for the quarter ended September 30, 2023 were $11.3 million, compared to $4.6 million for the same period in 2022, an increase of 144%.
  • Cash and cash equivalents as of September 30, 2023 was $18.0 million as compared to $43.9 million on December 31, 2022.

RayzeBio to Present at European Society for Medical Oncology (ESMO) Congress

Retrieved on: 
Wednesday, October 18, 2023
SSA, SAN, Congress, Safety, European Society for Medical Oncology, ESMO, Poster, GEP-NET, Pharmaceutical industry

SAN DIEGO, Oct. 18, 2023 (GLOBE NEWSWIRE) -- RayzeBio, Inc. (Nasdaq: RYZB), a targeted radiopharmaceutical company developing an innovative pipeline against validated solid tumor targets, today announced that it will be presenting interim safety and efficacy data from the Phase 1b portion of the ACTION-1 Trial for RYZ101 (Ac225 DOTATATE) at the upcoming European Society of Medical Oncology (ESMO) Congress, being held in Madrid between 20-24 October 2023.

Key Points: 
  • SAN DIEGO, Oct. 18, 2023 (GLOBE NEWSWIRE) -- RayzeBio, Inc. (Nasdaq: RYZB), a targeted radiopharmaceutical company developing an innovative pipeline against validated solid tumor targets, today announced that it will be presenting interim safety and efficacy data from the Phase 1b portion of the ACTION-1 Trial for RYZ101 (Ac225 DOTATATE) at the upcoming European Society of Medical Oncology (ESMO) Congress, being held in Madrid between 20-24 October 2023.
  • The poster will be made available in the “Posters & Presentations” section of the RayzeBio website at Rayzebio.com/pipeline/posters-presentations following the presentation.
  • Title: Poster 1198P: Phase 1b portion of the ACTION-1 phase 1b/3 trial of RYZ101 in gastroenteropancreatic neuroendocrine tumors (GEP-NET) progressing after 177Lu somatostatin analogue (SSA) therapy: safety and efficacy findings

RayzeBio Announces First Patient Dosed in Phase 3 ACTION-1 Study, Evaluating RYZ101 (Actinium-225 DOTATATE) in Neuroendocrine Tumors

Retrieved on: 
Wednesday, May 31, 2023
Oncology, Health, Radiology, Research, Science, Pharmaceutical, Biotechnology, DOTATATE, Sunitinib, GEP-NET, Everolimus, SOC, PFS, HIV disease progression rates, Patient, Standard of care, University of Texas Health Science Center Department of Radiology, Pharmaceutical industry, Medical imaging

“Patients with GEP-NETs have very limited options upon progression after Lutetium-177 labelled somatostatin analogue therapy,” said Dr. Thomas Hope, M.D., Vice Chair of Clinical Operations and Strategy in the Department of Radiology.

Key Points: 
  • “Patients with GEP-NETs have very limited options upon progression after Lutetium-177 labelled somatostatin analogue therapy,” said Dr. Thomas Hope, M.D., Vice Chair of Clinical Operations and Strategy in the Department of Radiology.
  • Patients randomized to SOC are allowed to crossover to RYZ101 upon disease progression.
  • “We are very encouraged by the continued interest in and potential of RYZ101.
  • I look forward to working with the GEP-NET community to advance RYZ101 in this important therapeutic indication.

RayzeBio to Present at Upcoming Medical Conferences

Retrieved on: 
Monday, May 22, 2023
Oncology, Health, Radiology, Research, Science, Pharmaceutical, Biotechnology, Somatostatin, GEP-NET, ASCO, Society of Nuclear Medicine and Molecular Imaging, Hepatocellular carcinoma, IL, SSA, Society, Carcinoma, American Society of Clinical Oncology, Pharmaceutical industry

RayzeBio, Inc., a targeted radiopharmaceutical company developing an innovative pipeline against validated solid tumor targets, today announced that the Company will be presenting data for its lead clinical program, RYZ101 (Ac225 DOTATATE) at two upcoming medical conferences as well as presentations on preclinical programs.

Key Points: 
  • RayzeBio, Inc., a targeted radiopharmaceutical company developing an innovative pipeline against validated solid tumor targets, today announced that the Company will be presenting data for its lead clinical program, RYZ101 (Ac225 DOTATATE) at two upcoming medical conferences as well as presentations on preclinical programs.
  • 2023 American Society for Clinical Oncology (ASCO) annual meeting: June 2 - 6 in Chicago, IL
    Title: ACTION-1 phase 1b/3 trial of RYZ101 in somatostatin receptor subtype 2–expressing (SSTR2+) gastroenteropancreatic neuroendocrine tumors (GEP-NET) progressing after 177Lu somatostatin analogue (SSA) therapy: Initial safety analysis.
  • Australian and New Zealand Society of Nuclear Medicine (ANZSNM): May 26 - 28 in Adelaide, Australia
    Title: Anti-tumor activity of RYZ101 in somatostatin receptor-expressing preclinical models of small-cell lung cancer.
  • Title: Novel peptide binder to Glypican-3 for targeted radiopharmaceutical therapy of hepatocellular carcinoma.

ITM to Present Phase III COMPOSE Poster and Host Satellite Symposium on Radiotheranostics in NET cancer at ENETS Conference

Retrieved on: 
Thursday, March 16, 2023
Conference, Therapy, Division, NETS, Endocrine oncology, Vall d'Hebron University Hospital, ITM, University of Utah, Professor, Gastrointestinal tract, NET, Patient, III, GEP-NET, History, Nuclear medicine, Huntsman Cancer Institute, Biomarker, Doctor of Philosophy, Hospital trust, Associate professor, University, Medical imaging, MD

COMPOSE evaluates the company’s lead radiopharmaceutical candidate, ITM-11 (n.c.a.

Key Points: 
  • COMPOSE evaluates the company’s lead radiopharmaceutical candidate, ITM-11 (n.c.a.
  • 177Lu-edotreotide) compared to standard of care in patients with well-differentiated high grade 2 and grade 3 somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (G2+G3 SSTR+ GEP-NETs).
  • ITM will also host a hybrid in-person and virtual radiotheranostics satellite symposium titled “Transforming the Therapeutics Landscape for Neuroendocrine Tumors” featuring presentations and discussions between leading endocrine oncology and nuclear medicine clinicians and researchers.
  • ITM will host a medical exhibition booth, as well as a virtual booth during the conference.

DEBIOPHARM APPLIES EXTENDED-RELEASE FORMULATION EXPERTISE TO REDUCE TREATMENT FREQUENCY BURDEN FOR ACROMEGALY & GEP-NET PATIENTS

Retrieved on: 
Thursday, January 12, 2023
Endometriosis, Prostate cancer, CPP, GEP-NET, Quality of life, Safety, SSAS, Octreotide, SSA, Injection, Patient, Degenerative disease, Rare, Puberty, Breast cancer, Health, Endocrinology, Pharmaceutical industry, Debiopharm, Acromegaly

LAUSANNE, Switzerland, Jan. 12, 2023 /PRNewswire/ -- Debiopharm (www.debiopharm.com), a Swiss-based, global biopharmaceutical company, today announced that the first patient was dosed with Debio 4126, a 3-month extended-release formulation of octreotide, in their open-label, non-randomized, single-arm, multicenter phase 1b study (Debio 4126-102). The study is composed of two patient cohorts – 1 group of patients with acromegaly and 1 group with functioning GEP-NETs Patients will receive 4 injections of Debio 4126 for a total treatment duration of 48 weeks.

Key Points: 
  • - Debiopharm is developing Debio 4126, a novel 3-month extended-release octreotide formulation, to optimize acromegaly and GEP-NET patient care by reducing injection frequency, which translates into an improved quality of life and less time spent with medical visits.
  • One of them (study Debio 4126-102) is a phase 1b study in patients with acromegaly or GEP-NETs.
  • If successful, Debio 4126 will equip healthcare professionals with a new, more convenient option for treating acromegalic and GEP/NET patients.
  • "Going into this 2-year long phase 1b trial, we look forward to ascertaining the benefits of this extended-release formulation.

DEBIOPHARM APPLIES EXTENDED-RELEASE FORMULATION EXPERTISE TO REDUCE TREATMENT FREQUENCY BURDEN FOR ACROMEGALY & GEP-NET PATIENTS

Retrieved on: 
Thursday, January 12, 2023
Endometriosis, Prostate cancer, CPP, GEP-NET, Quality of life, Safety, SSAS, Octreotide, SSA, Injection, Patient, Degenerative disease, Rare, Puberty, Breast cancer, Health, Endocrinology, Pharmaceutical industry, Debiopharm, Acromegaly

LAUSANNE, Switzerland, Jan. 12, 2023 /PRNewswire/ -- Debiopharm (www.debiopharm.com), a Swiss-based, global biopharmaceutical company, today announced that the first patient was dosed with Debio 4126, a 3-month extended-release formulation of octreotide, in their open-label, non-randomized, single-arm, multicenter phase 1b study (Debio 4126-102). The study is composed of two patient cohorts – 1 group of patients with acromegaly and 1 group with functioning GEP-NETs Patients will receive 4 injections of Debio 4126 for a total treatment duration of 48 weeks.

Key Points: 
  • - Debiopharm is developing Debio 4126, a novel 3-month extended-release octreotide formulation, to optimize acromegaly and GEP-NET patient care by reducing injection frequency, which translates into an improved quality of life and less time spent with medical visits.
  • One of them (study Debio 4126-102) is a phase 1b study in patients with acromegaly or GEP-NETs.
  • If successful, Debio 4126 will equip healthcare professionals with a new, more convenient option for treating acromegalic and GEP/NET patients.
  • "Going into this 2-year long phase 1b trial, we look forward to ascertaining the benefits of this extended-release formulation.

ITM Receives FDA Fast Track Designation for Radionuclide Therapy Candidate ITM-11 (n.c.a. 177Lu-edotreotide) in Neuroendocrine Tumors (GEP-NETs)

Retrieved on: 
Thursday, October 27, 2022
Therapy, Radiopharmaceutical, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, GEP-NET, Safety, Progression-free survival, Cancer, B cell, Fast track (FDA), CEO, Food, Neoplasm, Garching (Munich U-Bahn), III, Patient, PFS, Quality of life, ITM, Research, Review, NDA, FDA, Radionuclide, Pancreas, Fast Track, Gastrointestinal tract, Radiation, Pharmaceutical industry, Medical imaging

ITM-11 is being evaluated as a Targeted Radionuclide Therapy in two phase III clinical trials, COMPETE and COMPOSE .

Key Points: 
  • ITM-11 is being evaluated as a Targeted Radionuclide Therapy in two phase III clinical trials, COMPETE and COMPOSE .
  • The FDA Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and address an unmet medical need.
  • The Fast Track designation enables ITM to have more frequent interactions with the FDA to discuss the ITM-11 development path.
  • The rolling submission will allow ITM to submit completed sections of an application for review by FDA, rather than wait until all sections are completed.

Phanes Therapeutics announces FDA IND clearance for PT217, an anti-DLL3/anti-CD47 bispecific antibody being developed for patients with small cell lung cancer and other neuroendocrine cancers

Retrieved on: 
Friday, October 14, 2022
SAN, DLL3, Protein engineering, Risk, Therapy, IND, US Foods, MD Anderson Cancer Center, Patient, Cytokine release syndrome, CMC, Program, Mortality, Multimedia, SCLC, Cancer, Technology, Food, Squamous cell carcinoma, Mab, Pharmacokinetics, CEO, Safety, ADC, Survival, NEPC, University, CD47, GEP-NET, TAAS, FDA, Neutralizing antibody, View, Pharmaceutical industry, Vaccine

PT217 has recently been granted an orphan drug designation by the FDA for the treatment of SCLC.

Key Points: 
  • PT217 has recently been granted an orphan drug designation by the FDA for the treatment of SCLC.
  • "With a strong pipeline targeting both the adaptive and innate immunity and the bispecific antibody technology platforms we have built, Phanes is well positioned to make important impacts in delivering innovative cancer therapies."
  • The Phase I study will evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of PT217 in subjects with advanced or refractory cancers.
  • Patients with the following tumor types will be eligible for screening: unresectable SCLC, large cell neuroendocrine cancer (LCNEC), neuroendocrine prostate cancer (NEPC) and gastroenteropancreatic neuroendocrine tumors (GEP-NET).