Immunotherapy

Gritstone bio Announces Positive Preliminary Progression-free Survival and Long-term Circulating Tumor DNA (ctDNA) Data from Phase 2 Portion of Ongoing Phase 2/3 Study of its Personalized Cancer Vaccine, GRANITE, in Front-line Metastatic Microsatellite St

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Monday, April 1, 2024
Lung cancer, Survival, Immunotherapy, Disease, Colorectal cancer, Progression-free survival, Medicine, Patient, Common, DNA, Aes, Cancer, Death, Doctor of Philosophy, Gritstone bio, MD, Kinetics, Induction chemotherapy, MSS, Circulating tumor DNA, VAF, Melanoma, PFS, Vaccine, Data, UCLA, Liver disease, Neoplasm, Pharmaceutical industry

EMERYVILLE, Calif., April 01, 2024 (GLOBE NEWSWIRE) -- Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company working to develop the world’s most potent vaccines, today announced positive preliminary data from the ongoing, signal seeking Phase 2 portion of the Phase 2/3 study evaluating GRANITE, its personalized neoantigen cancer vaccine, in front-line metastatic microsatellite stable colorectal cancer (MSS-CRC). The randomized, controlled, open-label study is designed to quantify the clinical benefit of maintenance therapy with GRANITE (GRT-C901/GRT-R902) in combination with immune checkpoint blockade in addition to fluoropyrimidine/bevacizumab versus fluoropyrimidine/bevacizumab alone. Overall progression free survival (PFS) data show an early trend in benefit for GRANITE patients (HR=0.82, [95% CI, 0.34-1.67]; 62% censored) and extended PFS benefit in high-risk patients (HR=0.52 [95% CI, 0.15-1.38]; 44% censored), in whom progression occurs faster. Circulating tumor DNA (ctDNA) analysis over several months of treatment shows the expected relationship with disease progression and favors GRANITE, while short-term ctDNA response analysis (molecular response as defined per protocol) did not demonstrate a difference between study arms. Gritstone bio successfully manufactured GRANITE product candidate for every eligible patient (i.e., 100% vaccine manufacturing success rate).

Key Points: 
  • Gritstone bio successfully manufactured GRANITE product candidate for every eligible patient (i.e., 100% vaccine manufacturing success rate).
  • “Today's preliminary Phase 2 results are highly encouraging and represent the first randomized trial evidence, albeit early, that a personalized neoantigen-directed vaccine can potentially drive efficacy in a metastatic ‘cold’ tumor.
  • Fortunately, long-term analysis demonstrates the expected correlation of ctDNA with clinical benefit and favors GRANITE patients.
  • This analysis was performed on 44 patients who received study treatment (control and GRANITE arms) and have available baseline ctDNA data.

Adagene Reports Full Year 2023 Financial Results and Provides Corporate Update

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Friday, March 29, 2024
Head, Immunotherapy, HNSCC, Patient, Roche, Lead, Immunoglobulin G, Neoplasm, CRC, Audit committee, PD-1, Observation, Bioinformatics, Colorectal cancer, SAN, Information technology, Pembrolizumab, PRS, Safety, PD-L1, Compensated emancipation, Annual report, Apoptosis, Cervical cancer, Part, Merck, Senior, Bevacizumab, MSS, GAAP, ASCO, PFS, MTD, Liver disease, HCC, Therapeutic index, Endometrial cancer, Progression-free survival, ADS, Net, Regulatory T cell, Research and development, Liver, Pharmaceutical industry

SAN DIEGO and SUZHOU, China, March 29, 2024 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a platform-driven, clinical-stage biotechnology company transforming the discovery and development of novel antibody-based therapies, today reported financial results for the full year 2023 and provided corporate updates.

Key Points: 
  • Both confirmed PRs are sustained after more than one year with repeat dosing while maintaining robust safety profiles.
  • Observation of these clinical activities triggered further expansion into the second stage of the Simon’s 2-stage design for this dose level.
  • Net loss attributable to Adagene Inc.’s shareholders was US$18.9 million for the year ended December 31, 2023, compared to US$80.0 million in 2022.
  • The company encourages investors and others to review its financial information in its entirety and not rely on a single financial measure.

SAB Biotherapeutics Reports Full Year 2023 Operating and Financial Results

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Friday, March 29, 2024
Conference, Editas Medicine, Biotechnology, Exercise, Immunotherapy, Patient, Research, Investment, SABS, Therapy, JDRF, Safety, SAB, Type 1 diabetes, Cryptocurrency

We are grateful for their support in our drive to bring the benefits of SAB-142 to T1D patients in need.

Key Points: 
  • We are grateful for their support in our drive to bring the benefits of SAB-142 to T1D patients in need.
  • A replay of Mr. Reich’s presentation will be archived on the SAB Biotherapeutics website for up to one year.
  • SAB Biotherapeutics held cash and equivalents of $56.6 million at December 31, 2023, compared to $15.0 million at December 31, 2022.
  • SAB reported a net loss of $42.2 million and $18.7 million for the years ended December 31, 2023 and December 31, 2022 respectively.

Candel Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Recent Corporate Highlights

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Thursday, March 28, 2024
OS, Lung cancer, Research, Administration, Conference, Development, Prostate cancer, Survival, Immunotherapy, Fast track (FDA), HGG, Patient, Brain, Standard of care, MD, Society, Insurance, Pancreatic cancer, Clinical trial, Therapy, Breast cancer, SITC, FDA, CADL, Pharmaceutical industry

Research and Development Expenses: Research and development expenses were $7.3 million for the fourth quarter of 2023 compared to $5.0 million for the fourth quarter of 2022, and $24.5 million for the full year 2023 compared to $20.8 million for the full year 2022.

Key Points: 
  • Research and Development Expenses: Research and development expenses were $7.3 million for the fourth quarter of 2023 compared to $5.0 million for the fourth quarter of 2022, and $24.5 million for the full year 2023 compared to $20.8 million for the full year 2022.
  • General and Administrative Expenses: General and administrative expenses were $3.1 million for the fourth quarter of 2023 compared to $3.2 million for the fourth quarter of 2022, and $13.9 million for the full year 2023 compared to $14.1 million for the full year 2022.
  • The change from net other income in the fourth quarter of 2022 to net other expense in the fourth quarter of 2023 was primarily related to the change in the fair value of the Company’s warrant liability.
  • Cash Position: Cash and cash equivalents as of December 31, 2023 were $35.4 million, as compared to $70.1 million as of December 31, 2022.

Theratechnologies to Present Preclinical Data at AACR on Multiple PDCs Showcasing Potential of SORT1+Technology™ Platform

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Thursday, March 28, 2024
Immunotherapy, Patient, Cancer, Senior, AACR, TSX, PDC

The AACR meeting is taking place April 5-10 in San Diego, CA.

Key Points: 
  • The AACR meeting is taking place April 5-10 in San Diego, CA.
  • These preclinical presentations reinforce existing data for sudocetaxel zendusortide to activate anti-PD-L1 immunotherapy tumor cell killing in SORT+1 cancers and provide the first evidence for novel camptothecin-peptide conjugates in the treatment of SORT+1 colorectal cancers.
  • “The studies we are presenting at the AACR 2024 meeting highlight the significant advancements made on our SORT+1 Technology™ platform through careful assessment of investigational compounds, including sudocetaxel zendusortide, which is currently being evaluated in a Phase 1 trial in patients with advanced ovarian cancer,” said Christian Marsolais, Ph.D., Senior Vice President and Chief Medical Officer of Theratechnologies.
  • “These data showcase the potential of our PDC candidates with different payloads as potential future treatment options for a broad range of cancer types.”
    Theratechnologies will present the following data at AACR 2024:

IMUNON Reports 2023 Financial Results and Provides Business Update

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Thursday, March 28, 2024
Transfer, Ovarian cancer, Immunotherapy, Patient, Lung, Vaccine, Good manufacturing practice, Sale, CMC, IND, Bangladesh Technical Education Board, IPR, Investment, Clinical trial, Neoplasm, Research, Primate, DNA, NOL, MD Anderson Cancer Center, Trial of the century, ITT, Safety, MRD, Interim, Silicon Valley Bank, Vaccination, Food, CMOS, Elsevier, CD8, Drug discovery, SVB, CRS, University, Death, SARS-CoV-2, Earnings call, Lassa mammarenavirus, PFS, Immunoglobulin G, FDA, OS, CD4, Temperature, Progression-free survival, COVID-19, Mouse, Messenger, Human, Wistar Institute, Hospital

LAWRENCEVILLE, N.J., March 28, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage drug-development company focused on developing DNA-mediated immuno-oncology therapies and next-generation vaccines, today reported financial results for the year ended December 31, 2023. The Company also provided an update on its clinical development programs with IMNN-001, a DNA-based interleukin-12 (IL-12) immunotherapy in Phase 2 clinical development for the treatment of first-line, locally advanced-stage ovarian cancer, and on its PlaCCine modality, a proprietary mono- or multi-cistronic DNA plasmid and a synthetic DNA delivery technology for the expression of pathogen antigens in preclinical studies for the development of next-generation vaccines.

Key Points: 
  • “We remain on track to report topline results mid-year from the OVATION 2 Study with IMNN-001 in advanced ovarian cancer.
  • In September 2023, the Company announced interim PFS and OS data with IMNN-001 in its OVATION 2 Study.
  • The Company is hosting a conference call to provide a business update, discuss 2023 financial results and answer questions at 10:00 a.m. Eastern time today.
  • To participate in the call, please dial 866-777-2509 (Toll-Free/North America) or 412-317-5413 (International/Toll) and ask for the IMUNON 2023 Earnings Call.

Acumen Pharmaceuticals Reports Financial Results for the Year Ended December 31, 2023 and Business Highlights

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Tuesday, March 26, 2024
Research, Toxicity, Central nervous system, PIN, Administration, Immunotherapy, Emax, Science, Patient, AstraZeneca, Food and Drug Administration, Biomarker, G&A, Plaque, Chemistry, Therapy, Neurogranin, Safety, ABOS, Research and development, Plasma protein binding, Food, Pharmaceutical industry

We delivered the first Phase 1 results from an oligomer-targeted antibody for the treatment of early Alzheimer’s disease, which exceeded expectations.

Key Points: 
  • We delivered the first Phase 1 results from an oligomer-targeted antibody for the treatment of early Alzheimer’s disease, which exceeded expectations.
  • We also expect to initiate a subcutaneous bioavailability study in mid-2024, to extend the product profile and offer administration optionality for patients.
  • Dr. Doherty brings decades of neuroscience-focused research and clinical development expertise to Acumen, from discovery through drug approval.
  • Net loss for the year ended December 31, 2023 was $52.4 million, compared to a net loss of $42.9 million for the year ended December 31, 2022.

Portage Biotech Completes Monetization of Intensity Therapeutics (INTS) shares

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Tuesday, March 26, 2024
Immunotherapy, Society, Therapy, ASCO, SITC, PRTG, Intensity, Annual general meeting, Pharmaceutical industry

WESTPORT, Conn., March 26, 2024 (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 that it has completed selling its equity holding in Intensity Therapeutics (NASDAQ: INTS).

Key Points: 
  • WESTPORT, Conn., March 26, 2024 (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 that it has completed selling its equity holding in Intensity Therapeutics (NASDAQ: INTS).
  • Portage was an early INTS investor and during the past few months, Portage has been able to monetize its equity holdings in INTS and bring in proceeds, net of related expenses, totaling $2.8M of non-dilutive funding.
  • The Company will use the proceeds to further fund its PORT-6 Phase 1a portion of the ADPORT-601 trial.
  • “We are excited with the potential of the Company’s adenosine platform and are focusing our efforts on advancing its ADPORT-201 Phase 1a/1b clinical trial of PORT-6 (adenosine 2A inhibitor) and PORT-7 (adenosine 2B inhibitor) in selected solid tumors.”

Replimune Announces Appointment of Sushil Patel to CEO and Executive Leadership Transitions

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Tuesday, March 26, 2024
Development, Growth, Skin cancer, Immunotherapy, Genentech, Philip, Patient, Lung, RP1, Skin, Cancer, Melanoma, Retirement, Marketing, BLA

WOBURN, Mass., March 26, 2024 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of a novel class of oncolytic immunotherapies, today announced changes to its executive leadership team designed to support the Company’s preparations for the commercial launch of RP1, pending regulatory submission and approval in anti-PD1 failed melanoma.

Key Points: 
  • Sushil Patel, Ph.D., will succeed Philip Astley-Sparke as CEO effective April 1, 2024.
  • Mr. Astley-Sparke will transition from his current role as CEO to Executive Chairman of the Board of Directors.
  • Dr. Patel joined Replimune three years ago initially as Chief Commercial Officer and served most recently as Chief Strategy Officer.
  • Prior to joining Replimune, Dr. Patel served as franchise head for lung, skin and rare cancers at Genentech.

AACR 2024: Brenus Pharma Unveils Promising and Robust Pre-clinical Efficacy Extrapolating Human Conditions with STC-1010

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Tuesday, April 9, 2024
Research, Clinical Trials, Biometrics, Other Health, Biotechnology, Pharmaceutical, Health, Science, Oncology, Other Science, Cancer, Doctor, MSI-H, Metastasis, Communication, Immunotherapy, Colorectal cancer, Patient, MSI, STC, Team, Doctor of Philosophy, Master of Science, MSS, Neoplasm, Vaccine

This communication confirms the ability of Brenus’ next gen immunotherapy, STC-1010, to fight against resistant colorectal tumors with excellent tolerability.

Key Points: 
  • This communication confirms the ability of Brenus’ next gen immunotherapy, STC-1010, to fight against resistant colorectal tumors with excellent tolerability.
  • Additionally, multi-omics analysis of STC-1010 batches confirmed consistent quality and batch-to-batch reproducibility, through standardized and scalable production.
  • STC-1010 was tested in several models extrapolating human conditions (ex-vivo; in-ovo,) using PBMCs from different donors.
  • Results showed a significant immune response activation coupled with a massive and robust tumor killing that has been consistent with our 3 latest STC1010 batches manufactured.