RECIST

Imugene's oncolytic virotherapy VAXINIA and B cell immunotherapy HER-Vaxx featured at the AACR Annual Meeting 2024

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화요일, 4월 9, 2024
HER2, CD8, Phosphorylation, Survival, Cholangiocarcinoma, Immunotherapy, RECIST, Oncology, MAST, Patient, City, Degranulation, ASX, ADCC, Cancer, Hope, Overalls, Pembrolizumab, PRS, AACR, SPECT, Vaccination, Melanoma, Recurrence, PD-L1, IMU, Medical imaging

Oncolytic virus CF33-hNIS (VAXINIA) alone or in combination with KEYTRUDA is a safe treatment option for advanced cancer patients.

Key Points: 
  • Oncolytic virus CF33-hNIS (VAXINIA) alone or in combination with KEYTRUDA is a safe treatment option for advanced cancer patients.
  • SYDNEY, Australia, April 09, 2024 (GLOBE NEWSWIRE) -- Imugene Limited (ASX: IMU), a clinical stage immuno-oncology company, is pleased to announce poster presentations featuring its CF33 oncolytic virotherapy VAXINIA and B cell immunotherapy HER-Vaxx at the American Association for Cancer Research (AACR) Annual Meeting 5-10 April 2024, in San Diego, CA.
  • HER-Vaxx induced HER2-specific antibodies able to mediate antibody-dependent cell cytotoxicity (ADCC) and inhibit intracellular HER2 phosphorylation and correlated with tumour reduction.
  • The HER-Vaxx induced HER2-specific antibodies demonstrate a similar mechanism of action to HERCEPTINâ validating B cell immunotherapy as an alternative anti-cancer agent to monoclonal antibodies.

Atossa Therapeutics Presents Data from 40mg Cohort of Phase 2 EVANGELINE Clinical Trial Showing 100% Disease Control Rate After 24-Weeks of Treatment with (Z)-Endoxifen

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화요일, 4월 9, 2024
Plasma, MRI, Neoplasm, Atossa, Ki-67, Associate, RECIST, Magnetic resonance imaging, Incidence, Patient, MD, Woman, AACR, Clinical trial, Therapy, Breast cancer, Safety, Division, Recurrence, Exemestane, Annual general meeting, Medical imaging

SEATTLE, April 09, 2024 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) (“Atossa” or the “Company”) today announced promising safety and efficacy data from the Company’s Phase 2 EVANGELINE (Endoxifen Versus exemestANe GosEreLIn) clinical trial.

Key Points: 
  • SEATTLE, April 09, 2024 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) (“Atossa” or the “Company”) today announced promising safety and efficacy data from the Company’s Phase 2 EVANGELINE (Endoxifen Versus exemestANe GosEreLIn) clinical trial.
  • Atossa is a clinical stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology with a focus on breast cancer.
  • The data, which is being presented at the American Association for Cancer Research (AACR) Annual Meeting, is from the 40mg pharmacokinetic (PK) run-in cohort of the study.
  • At 28 days, six of the seven had Ki-67 levels below 10% and stayed on treatment for an additional five months.

FibroGen Announces Topline Results from Phase 1 Monotherapy Study of FG-3246 in Patients with Metastatic Castration-Resistant Prostate Cancer

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화요일, 4월 2, 2024
Neutropenia, Prostate cancer, Survival, RECIST, Prostate-specific antigen, Patient, SAN, Neoplasm, MMAE, Weight loss, Publishing, Peripheral neuropathy, University, CD46, Spacecraft, Society, Safety, ASCO, Adenocarcinoma, Fatigue, ADC, PSA, FDA, Fortis, Lead, Food, Pharmaceutical industry

“We are delighted to showcase the latest encouraging clinical data from the FOR46-001 Phase 1 ADC trial,” said Deyaa Adib, M.D., Chief Medical Officer of FibroGen.

Key Points: 
  • “We are delighted to showcase the latest encouraging clinical data from the FOR46-001 Phase 1 ADC trial,” said Deyaa Adib, M.D., Chief Medical Officer of FibroGen.
  • In the dose-expansion arm of the trial, patients were treated at the 2.7 mg/kg adjusted body weight dosing (AjBW) until disease progression.
  • The completed Phase 1 trial includes a total of 56 patients from the dose-escalation and dose-expansion cohorts.
  • These findings warrant further investigation and hold promise for addressing the therapeutic needs of patients with CD46 positive prostate cancer.

Synthekine Presents Positive Initial Results from Phase 1a/1b Clinical Trial of α/β Biased IL-2, STK-012, for Treatment of Advanced Solid Tumors

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화요일, 4월 9, 2024
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, Arthralgia, Toxicity, Cell, NSCLC, RECIST, HNSCC, Patient, Diarrhea, Maculopapular rash, Lung cancer, Renal cell carcinoma, Injection site reaction, AACR, Nausea, Lymphocyte, Hypotension, RCC, Transaminase, Poster, Itch, CLS, Capillary leak syndrome, Fatigue, Vomiting, NK, Inc., Pharmaceutical industry

Synthekine Inc ., an engineered cytokine therapeutics company, today announced positive initial results from a Phase 1a/1b clinical trial of its α/β biased IL-2 partial agonist, STK-012, for the treatment of advanced solid tumors.

Key Points: 
  • Synthekine Inc ., an engineered cytokine therapeutics company, today announced positive initial results from a Phase 1a/1b clinical trial of its α/β biased IL-2 partial agonist, STK-012, for the treatment of advanced solid tumors.
  • The data were presented at the American Association for Cancer Research (AACR) Annual Meeting 2024 in San Diego.
  • In the results presented, which included 47 patients treated in Phase 1a dose escalation, STK-012 monotherapy demonstrated a favorable safety, efficacy, pharmacokinetic and pharmacodynamic profile.
  • The poster, titled “Initial results from a Phase 1a/1b study of STK-012, a first-in-class α/β IL-2 receptor biased partial agonist in advanced solid tumors (NCT05098132),” will be presented today at AACR from 9 am to 12:30 pm PT.

Kronos Bio Reports Recent Business Progress and Fourth-Quarter and Full-Year 2023 Financial Results

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목요일, 3월 21, 2024
Research, Ovarian cancer, Conference, Survival, AML, Carcinoma, RECIST, Patient, SAN, Multiple myeloma, KRON, Cancer, IRF4, Lung cancer, IND, AACR, Investment, KAT, CDK9, Pharmaceutical industry

SAN MATEO, Calif. and CAMBRIDGE, Mass., March 21, 2024 (GLOBE NEWSWIRE) -- Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to transforming the lives of those affected by cancer, today reported recent business progress and fourth-quarter and full-year 2023 financial results.

Key Points: 
  • “In 2023, we made great progress across our portfolio and business.
  • Kronos Bio extended its expected cash runway by a year, into the second half of 2026, through restructurings and resource optimization.
  • Net Loss: Net loss for the fourth quarter of 2023 was $25.3 million, or $0.43 per share, including non-cash stock-based compensation expense of $5.2 million.
  • Net loss for the full-year 2023 was $112.7 million, or $1.95 per share, including non-cash stock-based compensation expense of $25.0 million.

Immatics Announces Full Year 2023 Financial Results and Corporate Update

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목요일, 3월 21, 2024
Ovarian cancer, Head, Uterine cancer, GSK, Patient, Dendreon, Commercial, Cancer, Bristol Myers Squibb, Neoplasm, Melanoma, TCR, Therapy, Research, MAGEA4, Sarcoma, GMP, Safety, Pharmacokinetics, Amgen, QC, CDMO, Development, Prevalence, Half-life, RECIST, Senior, FDA, Lung cancer, Administration, Conference, Entrepreneurship, Bank, Corr, Messenger, Protein, Pharmacology, Uveal melanoma, Pharmaceutical industry

“Immatics kicked off 2024 with a successful capital raise, providing significant financial runway and additional momentum to advance our ongoing clinical cell therapy and bispecific trials,” said Harpreet Singh, Ph.D., CEO and Co-Founder of Immatics.

Key Points: 
  • “Immatics kicked off 2024 with a successful capital raise, providing significant financial runway and additional momentum to advance our ongoing clinical cell therapy and bispecific trials,” said Harpreet Singh, Ph.D., CEO and Co-Founder of Immatics.
  • For IMA203CD8 GEN2, Immatics cleared dose level 4a (DL4a, up to ~1.6x109 TCR-T cells) in December 2023, which is currently intended to be the target dose for further development.
  • A next data update for both Phase 1b cohorts with IMA203 GEN1 and IMA203CD8 GEN2 is planned for 2H 2024.
  • On September 11, 2023, Immatics announced a strategic multi-platform collaboration with Moderna, combining Immatics’ target and TCR platforms with Moderna’s cutting-edge mRNA technology.

Tempest Reports Year End 2023 Financial Results and Provides Business Update

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화요일, 3월 19, 2024
Research, OS, NCI, Mutation, EP4, Gene expression, Immunotherapy, RECIST, Patient, National Cancer Institute, Pembrolizumab, Society, AACR, Bevacizumab, Therapy, Nivolumab, ASCO, EP2, SITC, PFS, Liver cancer, FDA, Pharmaceutical industry

“2023 was a transformative year for Tempest.

Key Points: 
  • “2023 was a transformative year for Tempest.
  • We announced strong positive randomized data showing the benefit of TPST-1120 combination therapy compared to standard-of-care in first-line liver cancer,” said Stephen Brady, president and chief executive officer of Tempest.
  • Tempest ended the year with $39.2 million in cash and cash equivalents, compared to $31.2 million on December 31, 2022.
  • Based on current cash and operating plan, Tempest expected to have sufficient resources to fund operations into the second quarter of 2025.

Immuneering Announces Positive Topline Results from Phase 1 Portion of its Phase 1/2a Clinical Trial of IMM-1-104 in RAS-Mutant Solid Tumors

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목요일, 3월 14, 2024
Toxicity, Concept, Plasma, Candidate, RECIST, Oncology, RAS, Patient, FACP, City, Cancer, Pancreatic cancer, Neoplasm, Therapy, Safety, Pharmacokinetics, SLD, Pharmaceutical industry

“Today’s results are an important step towards that goal, as we share positive topline data from the Phase 1 portion of our Phase 1/2a clinical trial of IMM-1-104 in advanced RAS-mutant solid tumors.

Key Points: 
  • “Today’s results are an important step towards that goal, as we share positive topline data from the Phase 1 portion of our Phase 1/2a clinical trial of IMM-1-104 in advanced RAS-mutant solid tumors.
  • Immuneering evaluated both 240mg and 320mg QD as prospective doses for the Phase 2a portion of its Phase 1/2a study.
  • The Phase 2a portion is expected to include up to twenty clinical sites and has already dosed its first patient.
  • Initial data from multiple arms of the Phase 2a portion of Immuneering’s Phase 1/2a study of IMM-1-104 expected in 2024.

Agenus Reports Fourth Quarter and Full Year 2023 Results

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목요일, 3월 14, 2024
Biotechnology, Pharmaceutical, Health, Oncology, OS, BOT, Colitis, Inc., Colorectal cancer, PD, RECIST, IST, Partnership, RAS, Patient, MSI, FOLFIRINOX, BMS, Melanoma, MSS, BAL, Cancer, CRC, NLM, TIGIT, Liver disease, Pharmaceutical industry

Agenus Inc. (“Agenus”) (Nasdaq: AGEN), a leader in discovering and developing novel immunological agents to treat various cancers, today provided a corporate update and reported financial results for the fourth quarter and full year 2023.

Key Points: 
  • Agenus Inc. (“Agenus”) (Nasdaq: AGEN), a leader in discovering and developing novel immunological agents to treat various cancers, today provided a corporate update and reported financial results for the fourth quarter and full year 2023.
  • “In 2023, Agenus made significant advances across our BOT/BAL development program.
  • $25 million milestone payment from BMS triggered by the commencement of a Phase 2 study with BMS-986442 in December 2023.
  • For the fourth quarter ended December 31, 2023, we recognized revenue of $84 million and incurred a net loss of $49 million or $0.13 per share.

IDEAYA Announces Clinical Collaboration to Evaluate IDE161 in Combination with KEYTRUDA® (pembrolizumab) in Patients with Endometrial Cancer

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화요일, 3월 12, 2024
MSD, PARG, Apoptosis, Prostate cancer, Endometrial cancer, Colorectal cancer, RECIST, Patient, MSI, Merck & Co., Pembrolizumab, Medicine, MSS, Breast cancer, HRD, Therapy, ADP, PD-1, Pharmaceutical industry

"We are excited to enter this collaboration as it allows study within and beyond the homologous recombination deficient (HRD) setting in endometrial cancer," said Darrin Beaupre, M.D., Ph.D., Chief Medical Officer, IDEAYA Biosciences.

Key Points: 
  • "We are excited to enter this collaboration as it allows study within and beyond the homologous recombination deficient (HRD) setting in endometrial cancer," said Darrin Beaupre, M.D., Ph.D., Chief Medical Officer, IDEAYA Biosciences.
  • "We are very pleased to collaborate with Merck on this trial evaluating IDE161 in combination with KEYTRUDA in patients with MSI-high and MSS endometrial cancer.
  • Under the clinical trial collaboration and supply agreement, Merck will provide KEYTRUDA to IDEAYA, which will be the sponsor of the Phase 1 clinical combination trial.
  • The mechanistic rationale and preclinical data to support the IDE161 and PD-1 clinical combination will be provided as part of a future R&D update.