SITC

Scholar Rock Provides Corporate Update and Highlights Priorities for 2024

Retrieved on: 
Thursday, January 4, 2024
Research, Neurology, Diabetes, Clinical Trials, Cardiology, Biotechnology, Managed Care, Pharmaceutical, Health, Science, Conference, Cure, IND, SAPPHIRE, Spinal muscular atrophy, Clinical trial, Obesity, Standard of care, Annual general meeting, Gongshi, Consequence, Myostatin, DRAGON, Webcast, MPH, Patient, Rock, SMN, SMA, Renal cell carcinoma, SITC, Pharmaceutical industry

Scholar Rock (NASDAQ: SRRK), a late-stage biopharmaceutical company focused on advancing innovative treatments for spinal muscular atrophy (SMA), cardiometabolic disorders, and other serious diseases where protein growth factors play a fundamental role, today provided recent corporate updates and highlighted upcoming priorities for 2024.

Key Points: 
  • Scholar Rock (NASDAQ: SRRK), a late-stage biopharmaceutical company focused on advancing innovative treatments for spinal muscular atrophy (SMA), cardiometabolic disorders, and other serious diseases where protein growth factors play a fundamental role, today provided recent corporate updates and highlighted upcoming priorities for 2024.
  • Planning to announce Phase 3 SAPPHIRE clinical trial topline data in 4Q 2024.
  • Scholar Rock management will highlight these updates in a corporate presentation at the 42nd Annual J.P. Morgan Healthcare Conference on Tuesday, January 9, 2024, at 1:30 p.m. PT (4:30 p.m.
  • A live webcast of the presentation may be accessed by visiting the Investors & Media section of the Scholar Rock website at http://investors.scholarrock.com .

TScan Therapeutics Announces 2024 Clinical Plans and Highlights Recent Progress

Retrieved on: 
Thursday, January 4, 2024
Patient, Food, Acute leukemia, Neoplasm, Immunotherapy, PRAME, Amgen, IND, Collection, MRD, TCR, FDA, Antigen, HLA, Trial of the century, Society, Therapy, MDS, Infrared spectroscopy correlation table, Cancer, Disclosure, ASH, Annual general meeting, HCT, MAGE-C2, Syndrome, Poster, Safety, ALL, Acute myeloid leukemia, C2, AML, MAGE-A1, Food and Drug Administration, HPV16, SITC, Pharmaceutical industry

WALTHAM, Mass., Jan. 04, 2024 (GLOBE NEWSWIRE) -- TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biopharmaceutical company focused on the development of T cell receptor (TCR)-engineered T cell therapies (TCR-T) for the treatment of patients with cancer, today announced its 2024 clinical pipeline plans and highlighted recent corporate achievements.

Key Points: 
  • Additionally, we submitted INDs for two additional TCRs in December and the 30-day review period with the FDA is ongoing.
  • Plans to complete Phase 1 dosing and report clinical and translational data in 2024, and two-year relapse data in 2025.
  • Initiated Phase 1 solid tumor clinical study and expects to dose the first patient in the first quarter of 2024.
  • Plans to continue to build ImmunoBank with additional IND filings throughout 2024.

Beyond Cancer™ Phase 1 Study Clears Cohort 1 in Patients with Advanced Relapsed or Refractory Unresectable Primary or Metastatic Cutaneous or Subcutaneous Solid Tumors

Retrieved on: 
Wednesday, December 27, 2023
Patient, Safety, Immune system, SITC, UNO, Pharmaceutical industry

HAMILTON, Bermuda, Dec. 27, 2023 (GLOBE NEWSWIRE) --  Beyond Cancer, Ltd., an affiliate of Beyond Air, Inc. (NASDAQ: XAIR) and a clinical stage biotechnology company developing ultra-high concentration nitric oxide (UNO) as an immunotherapeutic for solid tumors, today announced that the Phase 1 Study evaluating UNO in advanced, relapsed or refractory unresectable, primary or metastatic cutaneous and subcutaneous solid tumors has cleared the first cohort of 25,000 ppm single dose UNO by the Safety Review Committee with no reported dose limiting toxicities.

Key Points: 
  • The first-in-human, open-label, non-randomized Phase 1 study is being conducted in two parts: Dose Escalation and Dose Expansion.
  • The Dose Escalation consists of three UNO cohorts (25,000, 50,000 and 100,000 ppm) of three to six patients.
  • The Dose Expansion will begin once the recommended dose is determined in the Dose Escalation portion.
  • “The well tolerated administration of UNO is encouraging and the feasibility of UNO administration in patients has been demonstrated.

Evaxion Announces Business Update and Third Quarter 2023 Financial Results

Retrieved on: 
Tuesday, December 19, 2023
MSD, Partnership, Targets, Messenger, MTA, Biomarker, Research and development, WHO, Cancer, Vaccine, Gonorrhea, Merck & Co., Society, Research, AI, ASH, GHI, KOL, Merck, Patient, Infection, Development, Bone marrow, Melanoma, SITC, Pharmaceutical industry

On December 18, 2023, Evaxion priced a bridge financing round, expected to raise aggregate proceeds of approximately $5.3 million.

Key Points: 
  • On December 18, 2023, Evaxion priced a bridge financing round, expected to raise aggregate proceeds of approximately $5.3 million.
  • Cash burn for 2024, excluding financing activities, is expected at the level of $14 million (with Q1 cash burn being significantly higher than other quarters in 2024)
    COPENHAGEN, Denmark, Dec. 19, 2023 (GLOBE NEWSWIRE) -- Evaxion Biotech A/S (NASDAQ: EVAX) (“Evaxion” or the “Company”), a clinical-stage TechBio company specializing in developing AI-Immunology™ powered vaccines, today provided a business update and announced its third quarter 2023 financial results.
  • A key focus for the first months has been to refine the Evaxion strategy with a strong focus on execution and value realization.
  • Evaxion announces a groundbreaking precision vaccine concept for hematological malignancies at the 65th American Society of Hematology (ASH) Annual Meeting.

Provectus Biopharmaceuticals Announces Notice of Allowance of First U.S. Patent of Rose Bengal Sodium for Use as Anticancer and Antiviral Vaccine Adjuvant

Retrieved on: 
Monday, December 18, 2023
Cytokine, AACR, Immunotherapy, Research, The central science, Vaccine, Molecular biology, Patent, MD, Doctor of Philosophy, Pharmacology, Biochemistry, University, Society, T cell, OTCQB, Physiology, Heat shock protein, RBS, Chemokine, SITC

The allowed application would be Provectus’s first patent award in the field of vaccines from the USPTO.

Key Points: 
  • The allowed application would be Provectus’s first patent award in the field of vaccines from the USPTO.
  • Innovate Calgary, the innovation company of the University of Calgary in Alberta, Canada, is a co-assignee.
  • The research underlying the allowed application was led by Dr. Narendran and his lab team (the Narendran Lab).
  • This work also portends the potential benefit of PV-10 in combination with targeted immunotherapies and antibody-drug conjugates for cancer treatment.

EvolveImmune Therapeutics Provides Corporate and Program Update Highlighted by Closing of $37 Million Financing

Retrieved on: 
Wednesday, December 13, 2023
Immunotherapy, Tumor microenvironment, Immunology, Chemistry, CMC, Lead, Therapy, CD2, Society, Control, EVOLVE, Bristol Myers Squibb, ULBP2, SITC, Vaccine

BRANFORD, Conn., Dec. 13, 2023 (GLOBE NEWSWIRE) -- EvolveImmune Therapeutics, an immuno-oncology company developing first-in-category, multifunctional biotherapeutics to overcome the therapeutic challenges of cancer cell resistance to current immune therapy agents, today provided a corporate and program update related to the advancement of its pipeline of first-in-category precision immuno-oncology agents. The company announced the closing of a $37 million financing round, which was supported by existing investors including Pfizer Ventures, Solasta Ventures, and Takeda Ventures, Inc., along with new strategic investor Bristol Myers Squibb.

Key Points: 
  • The company announced the closing of a $37 million financing round, which was supported by existing investors including Pfizer Ventures, Solasta Ventures, and Takeda Ventures, Inc., along with new strategic investor Bristol Myers Squibb.
  • EvolveImmune intends to use the proceeds from this fundraising to support continued platform and pipeline development including the advancement of its lead multi-functional T-cell engager program, EV-104.
  • “This new capital raise comes at an exciting time for EvolveImmune,” said Stephen Bloch, M.D., chief executive officer of EvolveImmune.
  • The platform also takes advantage the company’s understanding of specific tumor cell characteristics to guide tumor antigen prioritization and program differentiation.

Candel Therapeutics Receives FDA Fast Track Designation for CAN-2409 in Pancreatic Cancer

Retrieved on: 
Tuesday, December 12, 2023
Food, Survival, Immunotherapy, Caregiver, Radiation, FDA, Chemoradiotherapy, Injection, MD, Doctor of Philosophy, CADL, Therapy, Cancer, Clinical trial, Standard of care, Society, Annual general meeting, Pancreatic cancer, PDAC, SOC, Overalls, Patient, Valaciclovir, SITC, Pharmaceutical industry

NEEDHAM, Mass., Dec. 12, 2023 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for its lead investigational adenovirus asset CAN-2409 plus prodrug (valacyclovir) for the treatment of patients with pancreatic ductal adenocarcinoma (PDAC) to improve overall survival.

Key Points: 
  • NEEDHAM, Mass., Dec. 12, 2023 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for its lead investigational adenovirus asset CAN-2409 plus prodrug (valacyclovir) for the treatment of patients with pancreatic ductal adenocarcinoma (PDAC) to improve overall survival.
  • “We are pleased with the FDA's decision to grant Fast Track Designation for CAN-2409 in pancreatic cancer,” said Paul Peter Tak, MD, PhD, FMedSci, President and CEO of Candel.
  • Candel remains on track to release updated overall survival data from the interim analysis of this clinical trial in the second quarter of 2024.
  • In parallel, the immunological changes observed in the resected pancreatic tissue after CAN-2409 administration suggested that this investigational treatment can activate an effective immunologic antitumoral response in this otherwise “cold” tumor.

TILT Biotherapeutics Announces Positive Clinical Data in Checkpoint Resistant Metastatic Melanoma Phase I Trial at ESMO Immuno-Oncology 2023

Retrieved on: 
Friday, December 8, 2023
Immunotherapy, TILT, TIL, ESMO, Neoplasm, Tumor microenvironment, University of Copenhagen, Injection, Interleukin, Congress, News, Cancer, CPI, Patient, Potyvirus, Safety, TILS, SITC, Pharmaceutical industry

This is the first-time clinical data with an oncolytic virus in combination with tumor infiltrating lymphocyte therapy has been presented.

Key Points: 
  • This is the first-time clinical data with an oncolytic virus in combination with tumor infiltrating lymphocyte therapy has been presented.
  • TILT’s approach uses oncolytic viruses to selectively replicate in and lyse cancer cells, while simultaneously stimulating immune responses towards the tumor.
  • The data announcement at ESMO-IO relates to 16 patients with checkpoint inhibitor (CPI) resistant progressive metastatic melanoma, who were treated with multiple intravenous and intratumoral injections of TILT-123 and a one- or two- time treatment with TILs.
  • The company has several trials currently underway, reflecting its commitment to pushing the boundaries of cancer treatment (NCT04217473, NCT05271318, NCT05222932).

ONK Therapeutics and NAYA Biosciences Announce Research Partnership to Advance Combination Therapy of Optimally Engineered Off-the-Shelf Natural Killer Cell Therapies and FLEX-NK™ Bispecific Antibodies

Retrieved on: 
Wednesday, December 6, 2023
KO, AACR, Partnership, Survival, Tumor microenvironment, Antigen, Immunotherapy, Research, Kis, Natural killer T cell, Regenerative medicine, SAN, NCR1, Therapy, Fertility, Cancer, HCC, Society, CISH, Patient, GPC3, NK, FLEX, SITC

Specifically, the partnership will explore the combination of ONK’s ONKT105, CISH + TGFβR2 double knock-out (KO), sIL-15 knock-in (KI) allogeneic NK cell therapy with NAYA’s GPC3-targeted NY-303 FLEX-NK™ bispecific antibody.

Key Points: 
  • Specifically, the partnership will explore the combination of ONK’s ONKT105, CISH + TGFβR2 double knock-out (KO), sIL-15 knock-in (KI) allogeneic NK cell therapy with NAYA’s GPC3-targeted NY-303 FLEX-NK™ bispecific antibody.
  • The companies’ R&D teams will collaboratively evaluate ONK’s optimally gene-edited NK cell therapy, ONKT105, with NAYA’s NY-303 bispecific antibody before selecting the best candidates for potential clinical development.
  • ONK has exclusive, worldwide rights to KO of CISH in NK cells, regardless of the source of the NK cells.
  • They redirect and trigger the killing activity of Natural Killer (NK) cells towards their tumor targets using NKp46 activating receptors.

Portage Biotech Reports Results for Fiscal Quarter Ended June 30, 2023, and Business Update

Retrieved on: 
Tuesday, November 28, 2023
PRTG, Adenosine, Lung cancer, ASCO, Research, Acquisition, Fiscal, D&O, Melanoma, Clinical trial, University, Calendar, MD Anderson Cancer Center, A2A, A2B, Patient, G&A, NSCLC, Portage, SITC, Pharmaceutical industry

WESTPORT, Conn., Nov. 28, 2023 (GLOBE NEWSWIRE) -- Portage Biotech Inc. (NASDAQ: PRTG), a clinical-stage immuno-oncology company advancing novel multi-targeted therapies for use as monotherapy and in combination, today reported financial results for the fiscal quarter ended September 30, 2023.

Key Points: 
  • WESTPORT, Conn., Nov. 28, 2023 (GLOBE NEWSWIRE) -- Portage Biotech Inc. (NASDAQ: PRTG), a clinical-stage immuno-oncology company advancing novel multi-targeted therapies for use as monotherapy and in combination, today reported financial results for the fiscal quarter ended September 30, 2023.
  • “The Company is focused on developing its two lead clinical programs and maximizing its resources given market conditions.
  • Portage completed a $6 million financing in October 2023 for continued clinical development, general corporate and working capital purposes.
  • R&D costs increased by approximately $2.7 million to approximately $4.2 million, or approximately 180%, for the Fiscal 2024 Quarter from approximately $1.5 million in the Fiscal 2023 Quarter.