ORR

SpringWorks Therapeutics Announces Positive Topline Results from the Phase 2b ReNeu Trial of Mirdametinib in NF1-PN

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목요일, 11월 16, 2023
NDA, Medicine, Vomiting, Disease, Safety, Food, Therapy, Rash, MEK, European Commission, Aes, First grade, Civil service commission, Patient, Solar cycle 24, FDA, New Drug Application, ORR, Diarrhea, Nausea, Cancer, Pain, Orphan drug, NF1, MRI, Quality of life, Fast Track, Sympathetic nervous system, Nursing, Pharmaceutical industry

The ReNeu trial enrolled 114 patients in two cohorts (pediatric and adult) across 50 sites in the U.S.

Key Points: 
  • The ReNeu trial enrolled 114 patients in two cohorts (pediatric and adult) across 50 sites in the U.S.
  • Mirdametinib was generally well tolerated in the ReNeu trial, with the majority of adverse events (AEs) being Grade 1 or Grade 2.
  • “We are extremely pleased that the results of our ReNeu trial demonstrate a compelling clinical profile across measures of both safety and efficacy.
  • SpringWorks plans to submit a New Drug Application (NDA) for mirdametinib to the FDA in the first half of 2024.

Provectus Biopharmaceuticals Provides Updated Data on Cancer Immunotherapy PV-10 for Advanced Cutaneous Melanoma

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수요일, 11월 15, 2023
AJCC, Safety, OTCQB, PRN, Progression-free survival, RECIST, Patient, PFS, Pembrolizumab, CRS, CB, ORR, Metastasis, Birth control, Pension fund

KNOXVILLE, TN, Nov. 15, 2023 (GLOBE NEWSWIRE) -- Provectus (OTCQB: PVCT) today provided updated data from an ongoing Phase 1b/2 clinical trial of investigational cancer immunotherapy PV-10 (rose bengal sodium) in combination with standard of care immune checkpoint blockade (CB) for the treatment of advanced cutaneous melanoma ( NCT02557321 ).

Key Points: 
  • KNOXVILLE, TN, Nov. 15, 2023 (GLOBE NEWSWIRE) -- Provectus (OTCQB: PVCT) today provided updated data from an ongoing Phase 1b/2 clinical trial of investigational cancer immunotherapy PV-10 (rose bengal sodium) in combination with standard of care immune checkpoint blockade (CB) for the treatment of advanced cutaneous melanoma ( NCT02557321 ).
  • Initial results from CB-naïve patients in the main study cohort illustrated potential clinical benefit across all stages of metastasis.
  • Longer-term follow-up of an expanded patient population has been assessed.
  • Participants must have had at least 1 injectable lesion and at least 1 measurable target lesion and been a candidate for pembrolizumab.

Affimed Reports Third Quarter 2023 Financial Results and Highlights Operational Progress

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화요일, 11월 14, 2023
Webcast, Record, Safety, Annual general meeting, Cytokine release syndrome, Research, Type, Silicon Valley Bank, ASH, Non-Hodgkin lymphoma, CRS, International, Bank statement, Book, Silicon, Insurance, Patient, Genentech, FDA, Hodgkin lymphoma, Lung cancer, International Financial Reporting Standards, GVHD, Monroe Dunaway Anderson, International Accounting Standards Board, IASB, Cholangiocarcinoma, ORR, Roivant Sciences, Cancer, Trial of the century, Financial toxicity, Haematopoietic system, HL, EST, AML, Society, NHL, PTCL, NK, NSCLC, Cryptocurrency, Medical device, Vaccine, Pharmaceutical industry, Rare-earth element, Audit, Euro, Affimer

MANNHEIM, Germany, Nov. 14, 2023 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD) (“Affimed” or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today reported financial results and provided an update on clinical and corporate progress for the third quarter of 2023.

Key Points: 
  • MANNHEIM, Germany, Nov. 14, 2023 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD) (“Affimed” or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today reported financial results and provided an update on clinical and corporate progress for the third quarter of 2023.
  • Total revenue for the quarter ended September 30, 2023, was €2.0 million compared with €14.9 million for the quarter ended September 30, 2022.
  • Affimed prepares and reports consolidated financial statements and financial information in accordance with IFRS as issued by the IASB.
  • Affimed will host a conference call and webcast on November 14, 2023, at 8:30 a.m. EST / 14:30 CET to discuss third quarter 2023 financial results and corporate developments.

Immatics Announces Third Quarter 2023 Financial Results and Business Update

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화요일, 11월 14, 2023
Senior, Entrepreneurship, CRS, Peptide, Regenerative Medicine Advanced Therapy, Patient, Triple-negative breast cancer, Cell, Research, Pharmacology, Therapy, Conference, ORR, Neurotoxicity, Infrared spectroscopy correlation table, Cytokine release syndrome, Uveal melanoma, Bristol Myers Squibb, Safety, Head, Cancer, Administration, CD4, PRAME, Uterine cancer, Lung cancer, Melanoma, Ovarian cancer, Half-life, Development, SAB, BRAF, CD8, MAGEA4, Cytopenia, TCR, Protein, FDA, DLT, Messenger, Cmax, Toxic epidermal necrolysis, Sarcoma, CMC, Neoplasm, Vaccine, Medical imaging, Pharmaceutical industry, Cryptocurrency, Fine chemical, Drug, Moderna, NSCLC

“Immatics has had a strong quarter and made steady progress both in terms of the advancement of our clinical programs and in business development.

Key Points: 
  • “Immatics has had a strong quarter and made steady progress both in terms of the advancement of our clinical programs and in business development.
  • An update on the clinical development plan is expected in the first quarter of 2024.
  • An update on the clinical development plan is expected in the first quarter of 2024.
  • On September 11, Immatics announced a strategic multi-platform collaboration with Moderna, combining Immatics’ target and TCR platforms with Moderna’s cutting-edge mRNA technology.

ALX Oncology Reports Third Quarter 2023 Financial Results and Provides Corporate Update

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월요일, 11월 13, 2023
Paclitaxel, Trastuzumab, SAN, Spacecraft, Investment, Exercise, Administration, Insurance, Patient, Research and development, PD-1, GAAP, ORR, RAINBOW, CD47, Cancer, Pons, Stomach, News, Pharmaceutical industry, Life insurance

SOUTH SAN FRANCISCO, Calif., Nov. 13, 2023 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., (“ALX Oncology” or “the Company”) (Nasdaq: ALXO), an immuno-oncology company developing therapies that block the CD47 immune checkpoint pathway, today reported financial results for the third quarter ended September 30, 2023, and provided a corporate update.

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., Nov. 13, 2023 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., (“ALX Oncology” or “the Company”) (Nasdaq: ALXO), an immuno-oncology company developing therapies that block the CD47 immune checkpoint pathway, today reported financial results for the third quarter ended September 30, 2023, and provided a corporate update.
  • ALX Oncology achieved a significant corporate development milestone during the third quarter with the realignment of the Company’s leadership team.
  • Third Quarter 2023 Financial Results:
    Cash, Cash Equivalents and Investments: Cash, cash equivalents and investments as of September 30, 2023, were $196.4 million.
  • A reconciliation of GAAP to non-GAAP financial results can be found at the end of this news release.

IO Biotech Announces 2023 Third Quarter Results

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월요일, 11월 13, 2023
SCCHN, Neck, Research, Annual general meeting, Therapy, Head, CFO, Amgen, ESMO, Patient, IDO1, PFS, Vaccine, Pembrolizumab, Immunotherapy, Conference, ORR, Melanoma, MD, SITC, Lung cancer, Doctor of Philosophy, Congress, Neoplasm, Society, WCLC, Pharmaceutical industry, Cryptocurrency

“Our focus for 2023 has been to successfully execute multiple clinical trials for our novel, investigational therapeutic cancer vaccine, IO102-IO103.

Key Points: 
  • “Our focus for 2023 has been to successfully execute multiple clinical trials for our novel, investigational therapeutic cancer vaccine, IO102-IO103.
  • Encouraging preliminary data from this basket trial were presented at the IASLC 2023 World Conference on Lung Cancer (WCLC) in September 2023 and at the ESMO Congress in October 2023.
  • General and administrative expenses were consistent at $5.8 million for the three months ended September 30, 2023 and 2022, respectively.
  • Cash and cash equivalents as of September 30, 2023, were $165.5 million, compared to $142.6 million at December 31, 2022.

RayzeBio Reports Third Quarter 2023 Financial Results and Provides Corporate Update

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월요일, 11월 13, 2023
SSTR2, SAN, GMP, Initial public offering, Investment, Liver cancer, ESMO, Administration, Patient, Radiopharmaceutical, Research, GPC3, ORR, IPO, Cancer, R, Research and development, Growth, HCC, PR, Pharmaceutical industry, IND

SAN DIEGO, Nov. 13, 2023 (GLOBE NEWSWIRE) -- RayzeBio, Inc. (Nasdaq: RYZB), a targeted radiopharmaceutical company developing an innovative pipeline against validated solid tumor targets, today reported financial results for the third quarter ended September 30, 2023 and provided an update on key corporate initiatives.

Key Points: 
  • SAN DIEGO, Nov. 13, 2023 (GLOBE NEWSWIRE) -- RayzeBio, Inc. (Nasdaq: RYZB), a targeted radiopharmaceutical company developing an innovative pipeline against validated solid tumor targets, today reported financial results for the third quarter ended September 30, 2023 and provided an update on key corporate initiatives.
  • As part of the IPO and subsequently at ESMO in October 2023, RayzeBio reported the interim results of the Phase 1b portion of the ACTION-1 clinical trial, where RayzeBio enrolled a total of 17 patients.
  • Research and Development (R&D) Expenses: R&D expenses for the third quarter of 2023 were $18.2 million, compared to $18.8 million for the third quarter of 2022.
  • Net Loss: Net loss for the third quarter of 2023 was $18.2 million, compared to the net loss for the third quarter of 2022 which was $20.4 million.

Vaccinex Reports Third Quarter 2023 Financial Results and Provides Corporate Update

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월요일, 11월 13, 2023
Encephalitis, Nature, HD, Eurosport 1, Patient, Research, Neuron, Dementia, Conference, Cash, ORR, Cognition, Drug discovery, Cancer, Doctor of Philosophy, Form 10-Q, Glial fibrillary acidic protein, FCMI, Prevalence, Astrocyte, GFAP, Microglia, Blood, Head and neck cancer, Three Months, Completeness, Risk, PFS, Merck, L.L.C, SEMA4D, Clinical trial, Security, Drug, Drug development, Patent, SIGNAL, Biomarker, Brain, CCR8, Plasma, Disease, Private placement, Neurodegenerative disease, Private, Neoplasm, G protein-coupled receptor, Cryptocurrency, Pharmaceutical industry, Medical imaging, Vaccine, HNSCC

ROCHESTER, N.Y., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating neurodegenerative disease and cancer through the inhibition of SEMA4D, today announced financial results for the third quarter ended September 30, 2023 and provided a corporate update on progress in key programs.

Key Points: 
  • ROCHESTER, N.Y., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating neurodegenerative disease and cancer through the inhibition of SEMA4D, today announced financial results for the third quarter ended September 30, 2023 and provided a corporate update on progress in key programs.
  • The potential impact of the AD program on Vaccinex valuation and financial resources make this Vaccinex’s most important near-term catalyst.
  • On August 22, 2023, Vaccinex completed a Private Placement and issued approximately 0.20 million shares1 of common stock for aggregate proceeds of $0.7 million.
  • Similarly, on September 22, 2023, Vaccinex completed a Private Placement and issued approximately 0.25 million shares of common stock for aggregate proceeds of $0.6 million.

Gracell Biotechnologies Reports Third Quarter 2023 Unaudited Financial Results and Provides Corporate Update

Retrieved on: 
월요일, 11월 13, 2023
Molecule, Multiple myeloma, Webcast, Safety, Research, SAN, Phenotype, ASH, IND, Investment, Exercise, Rejuvenation, SCR, IIT, Patient, CD19, SMART, Indian Institutes of Technology, SLE, TME, Conference, ORR, Cancer, BCMA, Acute lymphoblastic leukemia, Society, Lender option borrower option, Graceling, Pharmaceutical industry, Vaccine, Birth control, Security (finance), Cryptocurrency, Broadcasting

ET today

Key Points: 
  • ET today
    SAN DIEGO, Calif. and SUZHOU and SHANGHAI, China, Nov. 13, 2023 (GLOBE NEWSWIRE) -- Gracell Biotechnologies Inc. (NASDAQ: GRCL) (“Gracell” or the “Company”), a global clinical-stage biopharmaceutical company dedicated to developing innovative and highly efficacious cell therapies for the treatment of cancer and autoimmune diseases, today reported third quarter unaudited financial results for the period ended September 30, 2023, and provided corporate updates.
  • We look forward to presenting an update with more details at ASH 2023,” commented Dr. William (Wei) Cao, founder, Chairman and CEO of Gracell.
  • Financial Results for Third Quarter Ended September 30, 2023
    As of September 30, 2023, the Company had RMB1,707.9 million (US$234.1 million) in cash and cash equivalents and short-term investments.
  • Interest income for the three months ended September 30, 2023 was RMB9.9 million (US$1.4 million), compared to RMB3.6 million for the corresponding prior year period.

IN8bio to Present Data Highlighting Potential of INB-200 and INB-400 to Treat Patients with Newly Diagnosed Glioblastoma Multiforme at Society for Neuro-Oncology 28th Annual Meeting

Retrieved on: 
금요일, 11월 10, 2023
Arm, Safety, Progression-free survival, ODD, TTP, Disease, GBM, Patient, Cleveland Clinic, PFS, Pakistan Society of Neuro-Oncology, FDA, Immunotherapy, Glioblastoma, ORR, University, MD, Cancer, Tips, Society, SNO, Autotransplantation, DRI, Pharmaceutical industry

NEW YORK, Nov. 10, 2023 (GLOBE NEWSWIRE) -- IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies, today announced that the Company will present two posters at the Society for Neuro-Oncology (SNO) 28th Annual Meeting, taking place November 15-19, 2023, in Vancouver, British Columbia. The posters highlight the potential of IN8bio’s DeltEx Drug Resistant Immunotherapy (DRI), genetically modified and chemotherapy-resistant gamma-delta T cells to treat patients with newly diagnosed glioblastoma multiforme (GBM). The first poster is a TIPs poster detailing the study design for INB-400, the company-sponsored Phase 2 trial and the second will be a “late-breaker” poster providing updated clinical data from the Phase 1 INB-200 trial.

Key Points: 
  • The posters highlight the potential of IN8bio’s DeltEx Drug Resistant Immunotherapy (DRI), genetically modified and chemotherapy-resistant gamma-delta T cells to treat patients with newly diagnosed glioblastoma multiforme (GBM).
  • “We are encouraged by the safety and preliminary efficacy signal we have seen in our Phase 1 trial treating GBM patients with autologous, genetically modified gamma-delta T cells.
  • The University of Louisville and The Cleveland Clinic are the first clinical sites activated to enroll patients.
  • GBM remains a disease with significant unmet need, with limited treatment options and poor associated outcomes.