Pancreatic cancer

Orphan designation: Mitazalimab Treatment of pancreatic cancer, 16/08/2023 Positive

Retrieved on: 
Sunday, February 4, 2024

Key facts

Key Points: 
  • Key facts
    - Active substance
    - Mitazalimab
    - Intended use
    - Treatment of pancreatic cancer
    - Orphan designation status
    - Positive
    - EU designation number
    - EU/3/23/2821
    - Date of designation
    - Sponsor
    Alligator Bioscience AB
    Patients' organisations
    For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
    European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.
  • EU register of orphan medicines
    The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:
    EMA list of opinions on orphan medicinal product designation
    EMA publishes information on orphan medicinal product designation adopted by the Committee for Orphan Medicinal Products (COMP) on the IRIS online platform:

Orphan designation: Autologous dendritic cells pulsed with allogeneic tumour cell lysate Treatment of pancreatic cancer, 20/06/2023 Positive

Retrieved on: 
Sunday, February 4, 2024

EU/3/23/2790 - orphan designation for treatment of pancreatic cancer

Key Points: 
  • EU/3/23/2790 - orphan designation for treatment of pancreatic cancer
    Autologous dendritic cells pulsed with allogeneic tumour cell lysate
    OrphanHuman
    Amphera BV
    For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
    European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.
  • The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:
    EMA list of opinions on orphan medicinal product designation
    EMA publishes information on orphan medicinal product designation adopted by the Committee for Orphan Medicinal Products (COMP) on the IRIS online platform:

FDA Grants Orphan Drug Designation (ODD) Status to NeoImmuneTech's NT-I7 for Advanced Pancreatic Cancer Treatment

Retrieved on: 
Tuesday, January 30, 2024

Pancreatic cancer has the highest mortality rate of all major cancers with only a 3% relative-survival-rate at 5-years for the advanced form.

Key Points: 
  • Pancreatic cancer has the highest mortality rate of all major cancers with only a 3% relative-survival-rate at 5-years for the advanced form.
  • , Jan. 30, 2024 /PRNewswire/ -- NeoImmuneTech, Inc. (NIT), a T cell-focused therapeutics company, today announced that the U.S. Food and Drug Administration (FDA) has granted NT-I7 (efineptakin alfa) (rhIL-7-hyFc) Orphan Drug Designation (ODD) for the treatment of pancreatic cancer.
  • [1],[4] Advanced pancreatic cancer has a five-year relative-survival-rate of 3%.
  • [5]
    The FDA grants ODD status to medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US.

FibroGen Announces Completion of the Pamrevlumab Arm in Precision Promise, Pancreatic Cancer Action Network’s Phase 2/3 Adaptive Platform Trial for Metastatic Pancreatic Cancer

Retrieved on: 
Thursday, January 25, 2024

Pamrevlumab is the first experimental arm to meet its required threshold for graduation to Stage 2 in the adaptive platform trial.

Key Points: 
  • Pamrevlumab is the first experimental arm to meet its required threshold for graduation to Stage 2 in the adaptive platform trial.
  • The pamrevlumab arm of the study completed Stage 2 of the trial in January 2024.
  • PanCAN’s Precision PromiseSM adaptive platform trial ( NCT04229004 ) is a U.S.-based, seamless Phase 2/3 study that enrolled patients in approximately 24 sites around the country.
  • The pamrevlumab experimental arm was offered to patients with mPDAC as either a first-line (1L) or second-line (2L) treatment option.

Panbela Exceeds 50% Enrollment for Aspire Trial in Pancreatic Cancer, Exceeding Anticipated Timelines with Accelerated Momentum

Retrieved on: 
Thursday, January 25, 2024

ASPIRE is a global randomized, double-blind placebo-controlled clinical trial to evaluate ivospemin in combination with gemcitabine and nab-Paclitaxel in patients with metastatic pancreatic ductal adenocarcinoma.

Key Points: 
  • ASPIRE is a global randomized, double-blind placebo-controlled clinical trial to evaluate ivospemin in combination with gemcitabine and nab-Paclitaxel in patients with metastatic pancreatic ductal adenocarcinoma.
  • Detailed information on the trial can be located at https://clinicaltrials.gov/ct2/show/NCT05254171 .
  • “We’re thrilled to have surpassed 50% enrollment for the ASPIRE trial and to be moving faster than originally projected,” said Jennifer K. Simpson, PhD, MSN, CRNP, President & Chief Executive Officer of Panbela.
  • Panbela is committed to delivering a more effective treatment for pancreatic cancer, a deadly disease with few treatment options.

AIM ImmunoTech Receives Erasmus Medical Center Ethics Board Authorization for Phase 2 Study of Ampligen® for the Treatment of Locally Advanced Pancreatic Cancer

Retrieved on: 
Wednesday, January 24, 2024

OCALA, Fla., Jan. 24, 2024 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced that it has received authorization from the Erasmus Medical Center (“Erasmus MC”) Ethics Committee to open a European site for the ongoing Phase 2 study (“AMP-270”) of Ampligen as a therapy for locally advanced pancreatic cancer.

Key Points: 
  • OCALA, Fla., Jan. 24, 2024 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced that it has received authorization from the Erasmus Medical Center (“Erasmus MC”) Ethics Committee to open a European site for the ongoing Phase 2 study (“AMP-270”) of Ampligen as a therapy for locally advanced pancreatic cancer.
  • “Approval from the governing ethics board is an important step toward enrolling subjects in the European arm of the AMP-270 clinical trial for locally advanced pancreatic cancer,” stated Prof. Casper H.J.
  • van Eijck, MD, PhD, Pancreato-biliary Surgeon at Erasmus MC in the Netherlands.
  • AMP-270 is expected to enroll approximately 90 subjects in the United States and Europe.

AIM ImmunoTech Announces that the First Subject is Enrolled in the Phase 1b/2 Study Evaluating Ampligen® in Combination with AstraZeneca’s Imfinzi® for the Treatment of Late-Stage Pancreatic Cancer

Retrieved on: 
Monday, January 22, 2024

Data strongly suggests Ampligen has therapeutic synergy when combined with checkpoint inhibitors — potentially increasing cancer treatment efficacy and subject survival rates.

Key Points: 
  • Data strongly suggests Ampligen has therapeutic synergy when combined with checkpoint inhibitors — potentially increasing cancer treatment efficacy and subject survival rates.
  • A successful DURIPANC Study could make AIM an especially attractive partnership or buyout target for Big Pharma.
  • Strong positive clinical data from the DURIPANC study would also support our belief that Ampligen could synergistically enhance anti-PD-L1 therapies.
  • The primary objective of the Phase 2 portion is to determine the clinical benefit rate of the combination therapy.

Elicio Therapeutics to Present ELI-002 7P (AMPLIFY-7P) Trial in Progress Poster on Phase 1/2 Study of Lymph Node-Targeted Vaccine at ASCO GI Symposium

Retrieved on: 
Wednesday, January 17, 2024

The poster describes AMPLIFY-7P, a Phase 1 and randomized Phase 2 study of ELI-002 7P, an investigational therapeutic cancer vaccine, administered as an adjuvant monotherapy treatment for patients with KRAS-mutated pancreatic ductal adenocarcinoma (“PDAC”).

Key Points: 
  • The poster describes AMPLIFY-7P, a Phase 1 and randomized Phase 2 study of ELI-002 7P, an investigational therapeutic cancer vaccine, administered as an adjuvant monotherapy treatment for patients with KRAS-mutated pancreatic ductal adenocarcinoma (“PDAC”).
  • “We are progressing our AMP-powered, lymph node-targeted cancer vaccine, ELI-002 7P, as a monotherapy in an adjuvant setting for patients with pancreatic cancer, and recently dosed the first patient in the randomized Phase 2 cohort.
  • AMPLIFY-7P is a Phase 1 and Phase 2 study of ELI-002 7P in patients with RAS mutated pancreatic and colorectal tumors after locoregional treatment.
  • A Phase 2 interim analysis is planned using group sequential design for control of overall alpha 0.10.

Gilead and Arcus Announce Amended Collaboration and Equity Investment

Retrieved on: 
Monday, January 29, 2024

Gilead Sciences, Inc. (Nasdaq: GILD) and Arcus Biosciences, Inc. (NYSE: RCUS) today announced an amendment to their collaboration agreement and a separate equity investment by Gilead of $320 million in Arcus common stock at $21.00 per share.

Key Points: 
  • Gilead Sciences, Inc. (Nasdaq: GILD) and Arcus Biosciences, Inc. (NYSE: RCUS) today announced an amendment to their collaboration agreement and a separate equity investment by Gilead of $320 million in Arcus common stock at $21.00 per share.
  • The equity investment and collaboration amendment enable accelerated growth of the companies’ joint development programs that span multiple indications.
  • Additionally, Johanna Mercier, Chief Commercial Officer at Gilead Sciences, will join the Arcus Board, bringing Gilead’s total director designees to three.
  • The amendment also includes governance enhancements enabling streamlined decision-making and reflecting the continued growth of the collaboration.

RenovoRx Closes $6.1 Million Private Placement

Retrieved on: 
Monday, January 29, 2024

RenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a clinical-stage biopharmaceutical company developing novel precision oncology therapies based on a local drug-delivery platform, today announced that it has closed a private placement (the “private placement” or the “financing”) resulting in gross proceeds of approximately $6.1 million, before deducting offering expenses.

Key Points: 
  • RenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a clinical-stage biopharmaceutical company developing novel precision oncology therapies based on a local drug-delivery platform, today announced that it has closed a private placement (the “private placement” or the “financing”) resulting in gross proceeds of approximately $6.1 million, before deducting offering expenses.
  • RenovoRx insiders, including members of the management team and Board of Directors, participated in the private placement.
  • The warrants are exercisable at a price equal to the per share price paid by the applicable investor and are exercisable for a period of five years following the closing of the private placement.
  • “I have now chosen to join as an investor in this private placement financing.