Pancreatic cancer

Erasca Announces Two Clinical Trial Collaboration and Supply Agreements for Trametinib to Evaluate Naporafenib Combination in SEACRAFT-1 and SEACRAFT-2 Trials

Retrieved on: 
Wednesday, February 14, 2024

SAN DIEGO, Feb. 14, 2024 (GLOBE NEWSWIRE) -- Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, today announced two clinical trial collaboration and supply agreements (CTCSAs) with Novartis (NYSE: NVS) for the MEK inhibitor trametinib (MEKINIST®).

Key Points: 
  • Erasca is sponsoring the trials, and Novartis is supplying trametinib at no cost.
  • “Both trials are supported by compelling anti-tumor activity with a tolerable and manageable adverse event profile demonstrated in clinical data generated by Novartis.
  • Both RAS Q61X solid tumors and NRASm melanoma represent high unmet needs with no approved targeted therapies for these respective mutation types.
  • Erasca is exploring whether naporafenib in combination with trametinib can improve outcomes and help provide meaningful therapeutic benefit for these advanced solid tumor indications.

Oncolytics Biotech® Initiates Enrollment Expansion of GOBLET Anal Cancer Cohort

Retrieved on: 
Wednesday, February 14, 2024

SAN DIEGO and CALGARY, Alberta, Feb. 14, 2024 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a clinical-stage immunotherapeutics company focused on oncology, today announced the expansion of enrollment for the anal cancer cohort of the GOBLET study evaluating pelareorep in combination with atezolizumab (Tecentriq®) in patients with second-line or later unresectable squamous cell carcinoma of the anal canal (SCCA). The study was expanded based on positive data from Stage 1 of the study, presented at the 2nd International Multidisciplinary Anal Cancer Conference (IMACC) in November 2023 (link to the PR, link to the poster).

Key Points: 
  • "These exciting clinical data, which exceed the Simon two-stage success criteria, provide strong support to expand the evaluation of pelareorep in patients with advanced anal cancer.
  • "We begin the Stage 2 expansion with substantial optimism for patients and the potential of pelareorep, especially considering the initial efficacy signal observed for pelareorep-based therapy in pancreatic cancer.
  • There is currently no established standard therapy for patients with anal carcinoma who have failed first-line treatment.
  • Pembrolizumab for previously treated advanced anal squamous cell carcinoma: results from the non-randomised, multicohort, multicentre, phase 2 KEYNOTE-158 study.

Oncolytics Biotech® Initiates Enrollment Expansion of GOBLET Anal Cancer Cohort

Retrieved on: 
Wednesday, February 14, 2024

SAN DIEGO and CALGARY, Alberta, Feb. 14, 2024 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a clinical-stage immunotherapeutics company focused on oncology, today announced the expansion of enrollment for the anal cancer cohort of the GOBLET study evaluating pelareorep in combination with atezolizumab (Tecentriq®) in patients with second-line or later unresectable squamous cell carcinoma of the anal canal (SCCA). The study was expanded based on positive data from Stage 1 of the study, presented at the 2nd International Multidisciplinary Anal Cancer Conference (IMACC) in November 2023 (link to the PR, link to the poster).

Key Points: 
  • "These exciting clinical data, which exceed the Simon two-stage success criteria, provide strong support to expand the evaluation of pelareorep in patients with advanced anal cancer.
  • "We begin the Stage 2 expansion with substantial optimism for patients and the potential of pelareorep, especially considering the initial efficacy signal observed for pelareorep-based therapy in pancreatic cancer.
  • There is currently no established standard therapy for patients with anal carcinoma who have failed first-line treatment.
  • Pembrolizumab for previously treated advanced anal squamous cell carcinoma: results from the non-randomised, multicohort, multicentre, phase 2 KEYNOTE-158 study.

Ipsen’s Onivyde® regimen, a potential new standard-of-care first-line therapy in metastatic pancreatic adenocarcinoma, approved by FDA  

Retrieved on: 
Tuesday, February 13, 2024

PARIS, FRANCE, 13 February 2024 - Ipsen (Euronext: IPN; ADR: IPSEY) announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application for Onivyde® (irinotecan liposome injection) plus oxaliplatin, fluorouracil and leucovorin (NALIRIFOX) as a first-line treatment in adults living with metastatic pancreatic adenocarcinoma (mPDAC).

Key Points: 
  • PARIS, FRANCE, 13 February 2024 - Ipsen (Euronext: IPN; ADR: IPSEY) announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application for Onivyde® (irinotecan liposome injection) plus oxaliplatin, fluorouracil and leucovorin (NALIRIFOX) as a first-line treatment in adults living with metastatic pancreatic adenocarcinoma (mPDAC).
  • This is the second approval for an Onivyde regimen in mPDAC, following the FDA’s approval in 2015 of Onivyde plus fluorouracil and leucovorin following disease progression with gemcitabine-based therapy.
  • “The results from the Phase III NAPOLI 3 trial represent the first positive data for an investigational regimen in first-line metastatic pancreatic adenocarcinoma versus the currently approved nab-paclitaxel and gemcitabine regimen," said Christelle Huguet, EVP and Head of Research and Development, Ipsen.
  • In the clinical trial, diarrhea was managed following institutional guidelines and appropriate antidiarrheal medications.9
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Curasight announces acceleration of therapeutic strategy to strengthen position as a radiopharmaceutical theranostic company

Retrieved on: 
Tuesday, February 13, 2024

COPENHAGEN, Denmark, Feb. 13, 2024 /PRNewswire/ -- Curasight A/S ("Curasight" or the "Company" (XSAT: CURAS) announces today that it is accelerating and expanding its clinical therapeutic strategy with the addition of a new Phase I/IIa trial to include a total of five cancer indications in a so called basket trial design.

Key Points: 
  • COPENHAGEN, Denmark, Feb. 13, 2024 /PRNewswire/ -- Curasight A/S ("Curasight" or the "Company" (XSAT: CURAS) announces today that it is accelerating and expanding its clinical therapeutic strategy with the addition of a new Phase I/IIa trial to include a total of five cancer indications in a so called basket trial design.
  • To strengthen the Company's capital structure and secure funding for the acceleration of clinical activities, Curasight intends to launch a rights issue during the first quarter of 2024.
  • By launching this basket trial, we can accelerate development of both uTRACE and uTREAT (theranostic) in parallel and potentially have therapeutic efficacy data already during 2025.
  • Under the terms of the deal, Curasight is responsible for development until regulatory approval with Curium responsible for manufacturing and commercialisation.

Curasight announces acceleration of therapeutic strategy to strengthen position as a radiopharmaceutical theranostic company

Retrieved on: 
Tuesday, February 13, 2024

COPENHAGEN, Denmark, Feb. 13, 2024 /PRNewswire/ -- Curasight A/S ("Curasight" or the "Company" (XSAT: CURAS) announces today that it is accelerating and expanding its clinical therapeutic strategy with the addition of a new Phase I/IIa trial to include a total of five cancer indications in a so called basket trial design.

Key Points: 
  • COPENHAGEN, Denmark, Feb. 13, 2024 /PRNewswire/ -- Curasight A/S ("Curasight" or the "Company" (XSAT: CURAS) announces today that it is accelerating and expanding its clinical therapeutic strategy with the addition of a new Phase I/IIa trial to include a total of five cancer indications in a so called basket trial design.
  • To strengthen the Company's capital structure and secure funding for the acceleration of clinical activities, Curasight intends to launch a rights issue during the first quarter of 2024.
  • By launching this basket trial, we can accelerate development of both uTRACE and uTREAT (theranostic) in parallel and potentially have therapeutic efficacy data already during 2025.
  • Under the terms of the deal, Curasight is responsible for development until regulatory approval with Curium responsible for manufacturing and commercialisation.

Pancreatic Cancer Treatments Poised for Major Advances in 2024

Retrieved on: 
Wednesday, February 7, 2024

VANCOUVER, BC, Feb. 7, 2024 /PRNewswire/ -- USA News Group  -  One of the more worrying storylines of 2023 was the rising incidence of early-onset pancreatic cancer. As well, the deadly disease showed pancreatic cancer rates rising faster among women, causing increased alarm amongst doctors. Thankfully, 2023 also gave a lot of hope in terms of new treatments for the market that could reach US$36 billion by 2036, such as a potential mRNA vaccine, and other developments from biotech companies to lead into 2024, like Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC), Incyte Corporation (NASDAQ:INCY), Tango Therapeutics, Inc. (NASDAQ:TNGX), RayzeBio, Inc. (NASDAQ:RYZB) and its buyer Bristol-Myers Squibb Company (NYSE:BMY).

Key Points: 
  • VANCOUVER, BC, Feb. 7, 2024 /PRNewswire/ -- USA News Group -  One of the more worrying storylines of 2023 was the rising incidence of early-onset pancreatic cancer .
  • As well, the deadly disease showed pancreatic cancer rates rising faster among women , causing increased alarm amongst doctors.
  • After closing out 2022 with another fast track designation , Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC) and its flagship asset pelareorep continues to make strides in the battle against pancreatic cancer.
  • The results were enough to garner the support of the Pancreatic Cancer Action Network (PanCAN), who selected pelareorep to receive the US$5 million Therapeutic Accelerator Award .

Pancreatic Cancer Treatments Poised for Major Advances in 2024

Retrieved on: 
Wednesday, February 7, 2024

VANCOUVER, BC, Feb. 7, 2024 /PRNewswire/ -- USA News Group  -  One of the more worrying storylines of 2023 was the rising incidence of early-onset pancreatic cancer. As well, the deadly disease showed pancreatic cancer rates rising faster among women, causing increased alarm amongst doctors. Thankfully, 2023 also gave a lot of hope in terms of new treatments for the market that could reach US$36 billion by 2036, such as a potential mRNA vaccine, and other developments from biotech companies to lead into 2024, like Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC), Incyte Corporation (NASDAQ:INCY), Tango Therapeutics, Inc. (NASDAQ:TNGX), RayzeBio, Inc. (NASDAQ:RYZB) and its buyer Bristol-Myers Squibb Company (NYSE:BMY).

Key Points: 
  • VANCOUVER, BC, Feb. 7, 2024 /PRNewswire/ -- USA News Group -  One of the more worrying storylines of 2023 was the rising incidence of early-onset pancreatic cancer .
  • As well, the deadly disease showed pancreatic cancer rates rising faster among women , causing increased alarm amongst doctors.
  • After closing out 2022 with another fast track designation , Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC) and its flagship asset pelareorep continues to make strides in the battle against pancreatic cancer.
  • The results were enough to garner the support of the Pancreatic Cancer Action Network (PanCAN), who selected pelareorep to receive the US$5 million Therapeutic Accelerator Award .

Autonomix Medical, Inc. Receives Ethics Committee Authorization for Proof-of-Concept Human Clinical Study Evaluating Proprietary Ablation Technology for Treatment of Pancreatic Cancer Pain

Retrieved on: 
Tuesday, February 6, 2024

THE WOODLANDS, TX, Feb. 06, 2024 (GLOBE NEWSWIRE) -- Autonomix Medical, Inc. (NASDAQ: AMIX) (“Autonomix” or the “Company”) a medical device company focused on advancing innovative technologies to revolutionize how diseases involving the nervous system are diagnosed and treated, today announced that it has received authorization from the Uzbekistan Ethics Committee to open the clinical trial site for its proof-of-concept human clinical study evaluating the use of transvascular ablation for the treatment of pancreatic cancer pain. The Company is on track to commence enrollment in the first quarter of 2024.

Key Points: 
  • “Our team remains focused on the successful execution of our clinical path forward for this potentially groundbreaking technology.
  • We are making solid progress with the study and expect to initiate enrollment imminently,” commented Lori Bisson, Chief Executive Officer of Autonomix.
  • The primary objective of the proof-of-concept study is to successfully ablate relevant somatic nerves and mitigate pain in patients with pancreatic cancer pain utilizing RF ablation in a transvascular approach to the nerves in the region.
  • Twenty (20) subjects will be enrolled at one clinical trial site in Uzbekistan for the study.

RenovoRx CEO Issues Letter to Shareholders

Retrieved on: 
Tuesday, February 6, 2024

(“RenovoRx” or the “Company”) (Nasdaq: RNXT), a clinical-stage biopharmaceutical company developing novel precision oncology therapies based on a local drug-delivery platform, today provided a letter to shareholders from Chief Executive Officer, Shaun Bagai.

Key Points: 
  • (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a clinical-stage biopharmaceutical company developing novel precision oncology therapies based on a local drug-delivery platform, today provided a letter to shareholders from Chief Executive Officer, Shaun Bagai.
  • 2023 was a pivotal year for RenovoRx, and we believe our accomplishments bode well for the achievement of our anticipated 2024 milestones.
  • TIGeR-PaC is an ongoing Phase III randomized multi-center study evaluating our lead product candidate, RenovoGem™ for the treatment of LAPC.
  • RenovoGem is a novel oncology drug-device combination product utilizing our TAMP administration technology combined with the FDA-approved cancer drug, gemcitabine.