SITC

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

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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

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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.

NanOlogy Clinical and Preclinical Immune Data Presented at NACLC and SITC

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Tuesday, December 19, 2023
Research, Genetics, Clinical Trials, Biotechnology, Health, Pharmaceutical, General Health, Science, Oncology, Spleen, Immunotherapy, Conference, TME, LSAM, American Conference, Flow cytometry, Blood, Mouse, Paclitaxel, Immunomodulation, Society, Poster, Safety, Lung cancer, NK, NMIBC, SITC, Vaccine

NanOlogy LLC , a clinical-stage oncology company, reports data presented as posters during recent oncology conferences.

Key Points: 
  • NanOlogy LLC , a clinical-stage oncology company, reports data presented as posters during recent oncology conferences.
  • The poster was authored by clinical investigators Hiren Mehta , Abhishek Biswas , Sarah Wang , Jason Akulian , Christine Argento , et.al.
  • Summarizing presented data:
    The early phase lung cancer trial demonstrated safety and tolerability of intratumoral (IT) LSAM-PTX in combination with various concurrent therapies, including systemic immunotherapy.
  • Summarizing presented data:
    Immunophenotyping in 3 diverse tumor settings found commonalities in antitumor immunomodulation following local LSAM-DTX, including changes in T cells and MDSCs.

EQS-News: Andera Partners co-leads a €67.5 million ($72 million) oversubscribed Series C round for cancer immunotherapy company Nouscom

Retrieved on: 
Tuesday, December 26, 2023
Immunotherapy, Independent, Partner, Hereditary nonpolyposis colorectal cancer, Vaccine, SITC, Environment, Cancer, Patient, Risk, Merck Group, Affirmative action, Pharmaceutical industry, Andera-ye Olya

Paris, France – November 14, 2023 – Andera Partners, a leading European private equity player, today announces that it is co-leading a €67.5 million ($72 million) oversubscribed Series C financing for Nouscom, a clinical stage immuno-oncology company developing off-the-shelf and personalized viral vector-based cancer vaccines targeting neoantigens.

Key Points: 
  • Paris, France – November 14, 2023 – Andera Partners, a leading European private equity player, today announces that it is co-leading a €67.5 million ($72 million) oversubscribed Series C financing for Nouscom, a clinical stage immuno-oncology company developing off-the-shelf and personalized viral vector-based cancer vaccines targeting neoantigens.
  • Alongside Andera, Bpifrance (through its InnoBio 2 fund) and M Ventures co-led the round, with participation from Revelation Partners, Indaco Venture Partners, Panakès Partners, X-Gen Ventures, and other undisclosed investors together with continued support from existing investors 5AM Ventures, EQT Life Sciences and Versant Ventures.
  • Concurrent with the financing, representatives from Andera Partners, Bpifrance and M Ventures have joined the Nouscom Board of Directors.
  • We look forward to supporting the company towards the further clinical validation of its platform.”

Werewolf Therapeutics Reports Third Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Tuesday, November 14, 2023
Georgetown University, Cytokine, Immunity, Research, Non-Hodgkin lymphoma, Therapeutic index, Hypertelorism, Clinical trial, Patient, Tumor microenvironment, Immunotherapy, Therapy, Cancer, SITC, Society, Vaccine, Pharmaceutical industry, Cryptocurrency, Reinsurance, Jazz

WATERTOWN, Mass., Nov. 14, 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 provided a business update and reported financial results for the third quarter ended September 30, 2023.

Key Points: 
  • “Werewolf has made tremendous strides since last quarter, most notably with the presentation of promising first-in-human data from our lead clinical program, WTX-124.
  • In September 2023, Werewolf hosted a virtual event reviewing the IL-2 landscape and opportunity for WTX-124 among next-generation therapeutic approaches.
  • Financial Results for the Third Quarter of 2023:
    Cash position: As of September 30, 2023, cash and cash equivalents were $130.1 million, compared to $137.5 million as of June 30, 2023.
  • Net loss: Net loss was $8.3 million for the third quarter of 2023, compared to $11.9 million for the same period in 2022.

Medicenna Therapeutics Reports Second Quarter Fiscal 2024 Financial Results and Operational Highlights

Retrieved on: 
Tuesday, November 14, 2023
Doctor of Philosophy, Bispecific monoclonal antibody, Pancreatic cancer, MSI, Brain, Research, Annual general meeting, Glioblastoma, Metalloproteinase, Toronto Stock Exchange, Patient, MDNA, Pakistan Society of Neuro-Oncology, Intellectual property, Pembrolizumab, OTC Markets Group, Neuro-Oncology (journal), Conference, Standard of care, Melanoma, SITC, Survival, Partnership, Cancer, Neoplasm, Bifunctional, TSX, SNO, Microsatellite instability, Decompression (diving), Society, MMR, Patent, Pharmaceutical industry, Cryptocurrency, Immunotherapy

TORONTO and HOUSTON, Nov. 14, 2023 (GLOBE NEWSWIRE) -- Medicenna Therapeutics Corp. (“Medicenna” or the “Company”) (TSX: MDNA; OTC: MDNAF), a clinical-stage company focused on the design and development of novel evolutionary superkines to create revolutionary immunotherapies, today announced financial results and corporate highlights for the second quarter of fiscal 2024, ended September 30, 2023.

Key Points: 
  • We look forward to reporting initial Phase 2 dose expansion data from both the monotherapy and combination arms during the first half of 2024,” concluded Dr.
  • Clinical update from the ABILITY study’s MDNA11 plus pembrolizumab Phase 2 combination arm expected in the first half of 2024.
  • Research and development expenses of $3.1 million were incurred during the quarter ended September 30, 2023, compared with $2.4 million incurred in the quarter ended September 30, 2022.
  • General and administrative expenses of $2.3 million were incurred during the quarter ended September 30, 2023, compared with $2.4 million during the quarter ended September 30, 2022.

Ocean Biomedical (NASDAQ: OCEA) Announces Positive Preclinical Oncology Data for VRON-0300, Presented at SITC 2023 Annual Meeting, and Clinical Updates by 50/50 Joint Venture Partner Virion Therapeutics

Retrieved on: 
Tuesday, November 14, 2023
Yale University, Lung, Canadian Tire money, Brain, Research, AstraZeneca, Therapy, Joint venture, IND, Non-small-cell lung cancer, Disease, Clinical trial, Osimertinib, Patient, HBV, International joint venture, Immunotherapy, Animal, Neoplasm, TKI, Lung cancer, MD, Person, Infection, NSCLC, Human, SITC, BioRxiv, Malaria, Society, EGFR, Brown University Graduate School, Fibrosis, Pharmaceutical industry, Vaccine, CHI3L1, Cancer, Ocean, Virus

These new data demonstrate complete and highly reproducible tumor clearance, and protection upon tumor rechallenge, months after animals cleared their initial tumors.

Key Points: 
  • These new data demonstrate complete and highly reproducible tumor clearance, and protection upon tumor rechallenge, months after animals cleared their initial tumors.
  • VRON-0300 IND-enabling activities are underway, with the goal of filing its first IND within the next 9 months.
  • Virion Therapeutics is developing novel immunotherapies that utilize proprietary genetically encoded checkpoint modifiers (CPMs) to enhance and broaden CD8+ T cells responses.
  • Preclinical studies using CPMs have shown consistent and extraordinary immune responses and clinical activity in different diseases.

Gamida Cell Reports Third Quarter 2023 Financial Results and Provides Company Update

Retrieved on: 
Tuesday, November 14, 2023
Annual general meeting, Bone marrow, Phenotype, ASH, Patient, Cell, Research, NF, Marketing, Therapy, CMS, Diagnosis, Safety, Rituximab, Myelocyte, SITC, CD20, ATM, Kinetics, UCLA Health, Society, Health, Courage, Corporation, Pivotal, UCB, Fibroblast, Whole blood, Immune reconstitution inflammatory syndrome, Partnership, NAM, Ronald Reagan, Medicare, Policy, FDA, Immunotherapy, Survival, Toxic epidermal necrolysis, Cancer immunotherapy, Lymphoma, Mesa, Video game, Pharmaceutical industry, Dentistry, Vaccine, Mobile phone, Transplant, NK

BOSTON, Nov. 14, 2023 (GLOBE NEWSWIRE) -- Gamida Cell Ltd. (Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today reported financial results for the quarter ended September 30, 2023, and provided a business update.

Key Points: 
  • (Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today reported financial results for the quarter ended September 30, 2023, and provided a business update.
  • “The third quarter marked the first patients receiving Omisirge following FDA approval and the point at which Gamida Cell truly transitioned to a commercial-stage company with our first revenue reported,” said Abbey Jenkins, President and Chief Executive Officer of Gamida Cell.
  • The company reported revenue for the delivery of two units of Omisirge in the third quarter of 2023 and projects revenue from a total of four to six units for full year 2023.
  • Annual shareholders meeting: Gamida Cell held its Annual General Meeting of Shareholders in New York City on October 19.