ALK

Iovance Biotherapeutics Announces FDA has Lifted Clinical Hold on the IOV-LUN-202 Registrational Trial in Non-Small Cell Lung Cancer

Retrieved on: 
Monday, March 4, 2024

In collaboration with the FDA and an independent data monitoring committee, Iovance developed additional safety measures and monitoring.

Key Points: 
  • In collaboration with the FDA and an independent data monitoring committee, Iovance developed additional safety measures and monitoring.
  • Upon reviewing this proposal, the FDA has cleared Iovance to resume patient enrollment in IOV-LUN-202.
  • Iovance expects to complete enrollment of approximately 120 patients in the IOV-LUN-202 registrational cohorts in 2025.
  • Preliminary data from the IOV-LUN-202 trial support the potential benefit of one-time TIL therapy, including the opportunity for more durable responses than available second line chemotherapies.

BeiGene Receives Positive CHMP Opinion for Tislelizumab as Treatment for Non-Small Cell Lung Cancer

Retrieved on: 
Monday, February 26, 2024

As monotherapy for the treatment of adult patients with locally advanced or metastatic NSCLC after prior platinum-based therapy.

Key Points: 
  • As monotherapy for the treatment of adult patients with locally advanced or metastatic NSCLC after prior platinum-based therapy.
  • Patients with EGFR mutant or ALK positive NSCLC should also have received targeted therapies before receiving tislelizumab.
  • Tislelizumab is also under review by the FDA as a first-line treatment for patients with unresectable, recurrent, locally advanced, or metastatic ESCC.
  • BeiGene has launched more than 17 potentially registration-enabling trials with tislelizumab with over 13,000 patients enrolled to-date, of which 15 have already reported positive readouts.

Genprex Collaborators to Present Positive Preclinical Data on the Use of Reqorsa® and on NPRL2 Gene Therapy Utilizing Non-Viral Oncoprex® Delivery System for the Treatment of Lung Cancers at the 2024 AACR Annual Meeting

Retrieved on: 
Wednesday, March 6, 2024

AUSTIN, Texas, March 6, 2024 /PRNewswire/ -- Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced that its research collaborators will present at the upcoming 2024 American Association for Cancer Research (AACR) Annual Meeting being held April 5-10, 2024 in San Diego, California. The collaborators will present positive preclinical data from studies of its lead product candidate, Reqorsa® Immunogene Therapy (quaratusugene ozeplasmid), as well as NPRL2 gene therapy, which both utilize the Company's non-viral Oncoprex® Delivery System for the treatment of lung cancer.

Key Points: 
  • The collaborators will present positive preclinical data from studies of its lead product candidate, Reqorsa® Immunogene Therapy (quaratusugene ozeplasmid), as well as NPRL2 gene therapy, which both utilize the Company's non-viral Oncoprex® Delivery System for the treatment of lung cancer.
  • In this humanized mouse model, researchers investigated the anti-tumor immune responses to NPRL2 gene therapy in pembrolizumab resistant KRAS/STK11mt NSCLC.
  • "Today's bolus of compelling data validates the potential of REQORSA and the ONCOPREX Delivery System as innovative cancer treatments.
  • We look forward to continuing to evaluate the ONCOPREX Delivery System using both REQORSA and NPRL2 as potential treatments for lung cancer."

U.S. Food and Drug Administration Accepts for Priority Review Bristol Myers Squibb’s Application for Augtyro™ (repotrectinib) for the Treatment of Patients with NTRK-Positive Locally Advanced or Metastatic Solid Tumors

Retrieved on: 
Wednesday, February 14, 2024

The filing acceptance is based on results from the registrational Phase 1/2 TRIDENT-1 trial (adult patients with NTRK-positive solid tumors) and CARE study (pediatric patients with NTRK-positive solid tumors).

Key Points: 
  • The filing acceptance is based on results from the registrational Phase 1/2 TRIDENT-1 trial (adult patients with NTRK-positive solid tumors) and CARE study (pediatric patients with NTRK-positive solid tumors).
  • The FDA granted the application Priority Review status and assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 15, 2024.
  • “While great advancements have been made over the last decade, patients with NTRK-positive locally advanced or metastatic solid tumors still experience significant unmet needs.
  • In the TRIDENT-1 study, Augtyro demonstrated clinically meaningful response rates in patients with NTRK-positive locally advanced or metastatic solid tumors.

Annual report 2023: ALK delivers 9% sales growth with profits up 50%

Retrieved on: 
Thursday, February 8, 2024

Revenue increased by 9% to DKK 4,824 million (4,511) based on growth in all sales regions.

Key Points: 
  • Revenue increased by 9% to DKK 4,824 million (4,511) based on growth in all sales regions.
  • Tablet sales increased by 11% to DKK 2,296 million (2,102).
  • European tablet sales regained momentum in the second half-year with 13% growth.
  • ALK expects broad-based growth across sales regions and product groups in 2024 with tablet sales being key to growth.

Genprex Expands Nonclinical Programs into New Therapeutic Indications with Research Collaborators

Retrieved on: 
Wednesday, February 7, 2024

AUSTIN, Texas, Feb. 7, 2024 /PRNewswire/ -- Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced the expansion of its nonclinical programs into new indications through Sponsored Research Agreements and Material Transfer Agreements with multiple academic research collaborators to study TUSC2, the tumor suppressor gene used in Genprex's lead drug candidate, REQORSA (quaratusugene ozeplasmid), and NPRL2, another tumor suppressor gene. The new indications being evaluated include ALK-positive lung cancer and other additional programs that are not disclosed at this time.

Key Points: 
  • The new indications being evaluated include ALK-positive lung cancer and other additional programs that are not disclosed at this time.
  • "Research indicates that the TUSC2 gene used in REQORSA may benefit many types of cancers and potentially the treatment of other diseases.
  • Research collaborators at the Rogel Cancer Center's Judith Tam ALK Lung Cancer Research Initiative are studying the combination of Genprex's REQORSA, which uses the TUSC2 tumor suppressor gene, with various ALK inhibitors.
  • Genprex believes this system allows for delivery of a number of cancer-fighting genes, alone or in combination with other cancer therapies, to combat multiple types of cancer.

ALK’s 2030 CO2 reduction targets have been approved by SBTi

Retrieved on: 
Monday, February 5, 2024

ALK’s near-term carbon reduction targets for scope 1, 2 and 3 have been validated and approved by the Science Based Targets initiative.

Key Points: 
  • ALK’s near-term carbon reduction targets for scope 1, 2 and 3 have been validated and approved by the Science Based Targets initiative.
  • Today, ALK announces that its near-term carbon reduction targets have been confirmed by the Science Based Targets initiative (SBTi) to be in line with what the latest climate science deems necessary to meet the goals of the Paris Agreement – limiting global warming to 1.5°C above pre-industrial levels.
  • ALK commits to reduce absolute scope 1 and 2 greenhouse gas emissions 42% by 2030 from a 2022 base year.
  • To ensure that 80% of scope 3 emissions come from suppliers with science-based targets by 2028, ALK will be engaging with its key suppliers through internal procurement processes.

ALK completes first part of phase 1 trial with peanut SLIT-tablet

Retrieved on: 
Thursday, January 18, 2024

ALK to submit a protocol amendment for Phase 1-2 efficacy trial extension.

Key Points: 
  • ALK to submit a protocol amendment for Phase 1-2 efficacy trial extension.
  • ALK (ALKB:DC / OMX: ALK B / AKBLF) announced today that it has completed the first part of its phase 1 clinical trial (named ‘ALLIANCE’) for its investigational sublingual immunotherapy (‘SLIT’) tablet for the treatment of peanut allergy.
  • The first part of the trial investigated the safety and tolerability of 14 days treatment with the peanut tablet at different starting doses.
  • For further information please contact:
    This information is information that ALK is obliged to make public pursuant to the EU Market Abuse Regulation.

Winona Announces In-Person MeetUp for Women in Menopause at the Style House in the Godfrey Hotel Hollywood

Retrieved on: 
Friday, January 12, 2024

Winona , a leading menopause telehealth company, is pleased to announce its inaugural in-person meetup at Style House, inside the Godfrey Hotel Hollywood, on Thursday, January 25, from 4-7pm.

Key Points: 
  • Winona , a leading menopause telehealth company, is pleased to announce its inaugural in-person meetup at Style House, inside the Godfrey Hotel Hollywood, on Thursday, January 25, from 4-7pm.
  • This groundbreaking event aims to foster community-building and female empowerment for women navigating the transformative period of menopause.
  • To join the event, we invite you to RSVP and stay after the Winona Happy Hour for an evening of food and connection at ALK, also located inside the Godfrey Hotel Hollywood.
  • Winona looks forward to hosting you at Style House inside the Godfrey Hotel Hollywood on Thursday, January 25, 2024 from 4-7pm and at the Winona-sponsored event, Shimmer, from 7-11pm.