Interleukin 12

Sanyou Bio Congratulates KangaBio on their IND Approval for Next-Generation IL-12 Prodrug Cancer Immunotherapy

Retrieved on: 
Sunday, November 5, 2023

SHANGHAI, Nov. 4, 2023 /PRNewswire/ -- On October 26, 2023, KangaBio announced that the U.S. FDA has granted official approval for their independent R&D clinical trial application (IND) for KGX101.

Key Points: 
  • SHANGHAI, Nov. 4, 2023 /PRNewswire/ -- On October 26, 2023, KangaBio announced that the U.S. FDA has granted official approval for their independent R&D clinical trial application (IND) for KGX101.
  • The KGX101 clinical trials will be carried out simultaneously in both United States and Australia.
  • Sanyou Bio congratulates our partner, KangaBio on reaching this significant milestone.
  • Sanyou Bio is pleased to have played a role in KangaBio's preclinical efficacy evaluations for KGX101, revealing promising in vivo anti-tumor efficacy and safety outcomes.

PDS Biotech Announces Interim Safety and Immune Response Data from Phase 1/2 Clinical Trial Evaluating Novel Antibody Drug Conjugate PDS0301 Combined with Docetaxel to Treat Metastatic Prostate Cancer

Retrieved on: 
Wednesday, October 11, 2023

Decrease in prostate specific antigen (PSA) levels was seen in all patients at all three tested doses of PDS0301.

Key Points: 
  • Decrease in prostate specific antigen (PSA) levels was seen in all patients at all three tested doses of PDS0301.
  • Data to be presented by National Cancer Institute as an oral presentation at Cytokines 2023.
  • While all doses of PDS0301 were well-tolerated, the 12.0 mcg/kg dose of PDS0301 with chemotherapy provided the best combination of immune response and tolerability.
  • Interim data highlights to be presented at Cytokines 2023 include:
    All doses of the combination were well-tolerated with one patient experiencing Grade 4 neutropenia.

PDS Biotech Strengthens Intellectual Property Portfolio Governing A Combination of Versamune® and PDS0301

Retrieved on: 
Tuesday, July 11, 2023

The intellectual property provides broad protection for treatments utilizing Versamune® based therapies, including PDS0101, in combination with PDS0301 as a potential treatment for cancer.

Key Points: 
  • The intellectual property provides broad protection for treatments utilizing Versamune® based therapies, including PDS0101, in combination with PDS0301 as a potential treatment for cancer.
  • This patent expands PDS Biotech’s market coverage and adds to the world-wide patent portfolio including the patent granted by the United States Patent and Trademark Office (USPTO), U.S. Patent No.
  • “This newly allowed patent adds to the intellectual property governing Versamune® based therapies in combination with PDS0301, which we believe represent a potentially transformative treatment approach for advanced cancer patients,” said Dr. Frank Bedu-Addo, CEO of PDS Biotech.
  • PDS Biotech’s exclusive rights to the combination of PDS0101 and PDS0301 permits it to design compositions and methods that overcome tumor immune suppression utilizing a different mechanism from checkpoint inhibitors.

OncoNano Presents Compelling Data for ONM-501 and a Novel Tumor Specific Delivery Technology at AACR Annual Meeting 2023

Retrieved on: 
Tuesday, April 18, 2023

OncoNano Medicine, Inc. presented three posters at the American Association for Cancer Research (AACR) Annual Meeting 2023.

Key Points: 
  • OncoNano Medicine, Inc. presented three posters at the American Association for Cancer Research (AACR) Annual Meeting 2023.
  • The posters detail positive nonclinical data for ONM-501, the Company’s dual-activating STING (STimulator of INterferon Genes) agonist and lead therapeutic development candidate, formulated with the company’s OMNI™ polymer technology as well as positive data for encapsulated bispecific antibody and cytokine using ON-BOARD™ tumor specific delivery technology.
  • This novel mechanism provides potent anti-tumor efficacy as a monotherapy and in combination with anti-PD1 in multiple preclinical mouse models with both “hot” and “cold” tumor microenvironments.
  • The promising data that we presented at AACR 2023 suggest our technology may provide a solution to overcome the clinical application limitations of these highly potent protein therapeutics.”

PDS Biotech to Host Interleukin 12 (IL-12) Immunocytokine-Focused KOL Roundtable on April 21, 2023

Retrieved on: 
Wednesday, April 12, 2023

FLORHAM PARK, N.J., April 12, 2023 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, announced it will host a Key Opinion Leader (KOL) Roundtable on Interleukin-12 (IL-12) for analysts, investors and the scientific community from 8:00 to 9:00 AM, ET on April 21, 2023.

Key Points: 
  • FLORHAM PARK, N.J., April 12, 2023 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, announced it will host a Key Opinion Leader (KOL) Roundtable on Interleukin-12 (IL-12) for analysts, investors and the scientific community from 8:00 to 9:00 AM, ET on April 21, 2023.
  • This PDS Biotech-sponsored event will focus on the potential of an IL-12 immunocytokine in oncology and the clinical results and promise demonstrated to date with PDS0301, the company’s novel investigational tumor-targeting IL-12 fusion protein.
  • The novel investigational antibody targeted IL-12 enhances the proliferation, potency and longevity of T cells in the tumor microenvironment while also limiting its presence in the blood, which appears to promote tolerability and safety.
  • A replay will be available on the company website for 90 days following the webcast.

PDS Biotech Announces the Publication of PDS0301 Study Linking Induced Changes in Immune Responses with Clinical Outcomes in International Immunopharmacology Journal

Retrieved on: 
Wednesday, March 1, 2023

The clinical study assessed immune changes in relation to the dose level and dosing schedule of PDS0301 (NHS-IL12), a novel investigational fusion protein consisting of a tumor-targeting antibody conjugated to Interleukin 12 (IL-12).

Key Points: 
  • The clinical study assessed immune changes in relation to the dose level and dosing schedule of PDS0301 (NHS-IL12), a novel investigational fusion protein consisting of a tumor-targeting antibody conjugated to Interleukin 12 (IL-12).
  • The study also evaluated the correlation of several treatment-related immunological changes with clinical responses.
  • “Importantly, this study appears to demonstrate the safety and tolerability of biologically active doses of PDS0301 and reports increases in specific immune cells that were associated with PDS0301 administration and improved clinical outcomes."
  • The publication also summarizes clinical results from a study combining PDS0301, with a checkpoint inhibitor and PDS0101, PDS Biotech’s HPV-targeted immunotherapy that has been shown to promote induction of multifunctional, tumor-infiltrating killer T-cells.

PDS Biotech Completes Successful Meeting with FDA for Triple Combination of PDS0101, PDS0301 and a Commercial Immune Checkpoint Inhibitor

Retrieved on: 
Monday, February 27, 2023

There remains a critical unmet medical need to develop new treatment options for patients who have failed treatment with ICIs.

Key Points: 
  • There remains a critical unmet medical need to develop new treatment options for patients who have failed treatment with ICIs.
  • In recent interactions with the FDA, PDS Biotech has confirmed the required contents of the study design for a potential registrational trial of the combination of PDS0101, PDS0301 and a commercial immune checkpoint inhibitor.
  • PDS0101, PDS Biotech’s lead candidate, is a Versamune® based investigational immunotherapy designed to stimulate a potent targeted T cell attack against HPV16-positive cancers.
  • “We are pleased with the guidance from the FDA on key elements of a study design to progress the development of our assets, PDS0101 and PDS0301, in combination with a commercial immune checkpoint inhibitor,” said Dr. Frank Bedu-Addo, Chief Executive Officer of PDS Biotech.

Werewolf Therapeutics Announces Initiation of Patient Dosing in Phase 1 Study of WTX-330

Retrieved on: 
Friday, February 24, 2023

WATERTOWN, Mass., Feb. 24, 2023 (GLOBE NEWSWIRE) -- Werewolf Therapeutics, Inc. (the “Company” or “Werewolf”) (Nasdaq: HOWL), an innovative biopharmaceutical company pioneering the development of conditionally activated therapeutics engineered to stimulate the body’s immune system for the treatment of cancer, today announced that the first patient has been dosed in a Phase 1 clinical trial evaluating WTX-330, the Company’s lead INDUKINETM molecule targeting Interleukin-12 (IL-12). The Phase 1 clinical trial is a first-in-human, multi-center, open-label trial that will evaluate WTX-330 in patients with advanced or metastatic solid tumors or lymphoma resistant to checkpoint inhibitors or for which checkpoint inhibitors are not approved.

Key Points: 
  • “Dosing the first patient in our Phase 1 trial of WTX-330 marks the second INDUKINE molecule arising from our PREDATORTM protein engineering platform to enter the clinic.
  • Our continued transition into a clinical stage company comes at an exciting time for Werewolf following the initiation of a Phase 1/1b clinical study of WTX-124 last year,” said Daniel J. Hicklin, Ph.D., Werewolf’s Founder and Chief Executive Officer.
  • In preclinical studies, WTX-330 exhibited excellent anti-tumor activity and a favorable pharmacokinetic and tolerability profile.
  • For additional information about the trial, please visit www.clinicaltrials.gov using the Identifier: NCT05678998

Innovative Spinal Biomaterial Demonstrates Early Healing in Retrospective Study

Retrieved on: 
Thursday, September 8, 2022

that validates ZFUZE as the first homogenous new biomaterial introduced in more than 20 years.

Key Points: 
  • that validates ZFUZE as the first homogenous new biomaterial introduced in more than 20 years.
  • The ZFUZE retrospective study was conducted by Paul Kraemer, MD, at the Indiana Spine Group and consisted of 41 patients who underwent TLIF [define] single and double level lumbar interbody fusions.
  • "Maybe the most important thing about the study was there were no exclusion criteria," Dr. Kraemer said.
  • Medical Metrics LLC performed third-party radiographic fusion analysis via CT scan for 91.4% fusion rates at an early 8-month timepoint.

Interleukin 12 Subunit Beta (Cytotoxic Lymphocyte Maturation Factor 40 kDa Subunit or CLMF p40 or IL12 Subunit p40 NK Cell Stimulatory Factor Chain 2 or IL12B) Drugs Development Research Report 2021 - ResearchAndMarkets.com

Retrieved on: 
Wednesday, August 11, 2021

The "Interleukin 12 Subunit Beta (Cytotoxic Lymphocyte Maturation Factor 40 kDa Subunit or CLMF p40 or IL12 Subunit p40 NK Cell Stimulatory Factor Chain 2 or IL12B) - Drugs in Development, 2021" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Interleukin 12 Subunit Beta (Cytotoxic Lymphocyte Maturation Factor 40 kDa Subunit or CLMF p40 or IL12 Subunit p40 NK Cell Stimulatory Factor Chain 2 or IL12B) - Drugs in Development, 2021" report has been added to ResearchAndMarkets.com's offering.
  • Interleukin 12 Subunit Beta - Drugs in Development, 2021 provides in depth analysis on Interleukin 12 Subunit Beta targeted pipeline therapeutics.
  • The report analyses the pipeline products across relevant therapy areas under development targeting Interleukin 12 Subunit Beta (Cytotoxic Lymphocyte Maturation Factor 40 kDa Subunit or CLMF p40 or IL12 Subunit p40 NK Cell Stimulatory Factor Chain 2 or IL12B).
  • The report reviews latest news and deals related to Interleukin 12 Subunit Beta (Cytotoxic Lymphocyte Maturation Factor 40 kDa Subunit or CLMF p40 or IL12 Subunit p40 NK Cell Stimulatory Factor Chain 2 or IL12B) targeted therapeutics.