Large-cell lung carcinoma

In a KRAS G12C-mutated NSCLC cell line, Calu-1, Hillstream BioPharma Demonstrated Significantly Greater Tumor Inhibition Combining Pembrolizumab, an anti-PD-1 antibody, and HSB-1216, a Ferroptosis Inducer

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금요일, 2월 10, 2023

BRIDGEWATER, N.J., Feb. 10, 2023 (GLOBE NEWSWIRE) -- Hillstream BioPharma, Inc. (Nasdaq: HILS) ("Hillstream" or the "Company"), a biotechnology company developing therapeutic candidates targeting drug resistant and devastating cancers using ferroptosis, an emerging new anti-cancer mechanism resulting in iron mediated cell death, and immuno-oncology targeted novel biologics, today announced initial results evaluating the synergy of HSB-1216 with immune checkpoint inhibitors in KRAS G12C-mutated non-small cell lung cancer (NSCLC) cells, Calu-1, with Pembrolizumab, an anti-PD-1 antibody. The study demonstrated significantly greater tumor inhibition of Calu-1 cells, when grown with human PBMCs (SEB-activated) and treated with HSB-1216 and Pembrolizumab.

Key Points: 
  • The study demonstrated significantly greater tumor inhibition of Calu-1 cells, when grown with human PBMCs (SEB-activated) and treated with HSB-1216 and Pembrolizumab.
  • Lung cancer remains one of the leading causes of cancer-related deaths worldwide with NSCLC accounting for approximately 80–85% of all cases.
  • anti-PD-1/PDL-1 therapeutics have substantially improved overall survival with an acceptable safety profile in NSCLC patients, however, not all patients respond.
  • Several combination strategies are under evaluation, including evaluation of chemotherapy, targeted therapies and other modalities in combination with immunotherapy.

Oncotelic Announces Initiation of Clinical Study in Non-Small Lung Cell Cancer

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월요일, 2월 6, 2023

We have submitted to US FDA a protocol for the study with approximately 30 patients with non-small cell lung cancer in collaboration with the Fred Hutchinson Cancer Center and a large pharmaceutical company in the field of immuno-oncology (IO).

Key Points: 
  • We have submitted to US FDA a protocol for the study with approximately 30 patients with non-small cell lung cancer in collaboration with the Fred Hutchinson Cancer Center and a large pharmaceutical company in the field of immuno-oncology (IO).
  • The study will be combining our oligodeoxynucleotide OT-101 and a US FDA approved anti-PD-L1 checkpoint inhibitor.
  • Near term, the Company is planning to initiate up to 7 clinical studies in various oncology indications along with ‘Centers of Excellence’ and major pharmaceutical companies.
  • For more information on the Fred Hutchinson Cancer Center and how you or someone you know can enroll in a trial, please visit: https://www.fredhutch.org/en/research/clinical-trials.html

Ocean Biomedical and Aesther Healthcare Acquisition Corp. Announce Publication of Discovery Data for a Major Anti-Tumor Pathway in Malignant Melanoma and Other Cancers

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월요일, 1월 30, 2023

Providence, RI and New York, NY, Jan. 30, 2023 (GLOBE NEWSWIRE) -- Ocean Biomedical and Aesther Healthcare Acquisition Corp. (NASDAQ: AEHA) announced today the discovery of a second major anti-tumor pathway and therapeutic approach that targets CTLA-4, inhibiting the metastasis of malignant melanoma cells to the lung using a novel bispecific antibody approach. This major regulating mechanism discovery, recently published in Frontiers in Immunology, by Ocean Biomedical’s Scientific Co-founder and Brown University’s Emeritus Dean of Medicine and Biological Sciences, Dr. Jack A. Elias, builds on his team’s prior discoveries that target Chitinase 3-like-1 (CHI3LI) and its role in inhibiting T-cell proliferation. Additionally, this promising research reveals a third anti-tumor pathway targeting T-cell co-stimulation using the inducible co-stimulator (ICOS) and its ligand ICOSL, and Cluster of Differentiation 28 (CD28) and its ligands B7-1 and B7-2. Ocean Biomedical’s novel approach to tumor suppression, focused on controlling CHI3LI, other immune checkpoint inhibitors, and T-cell co-stimulators, has potential application for tumor suppression across multiple cancer pathways.

Key Points: 
  • Ocean Biomedical’s novel approach to tumor suppression, focused on controlling CHI3LI, other immune checkpoint inhibitors, and T-cell co-stimulators, has potential application for tumor suppression across multiple cancer pathways.
  • “If you control CH3L1, you don’t just control one anti-cancer pathway, you simultaneously control many anti-cancer pathways.
  • Malignant melanoma, a very serious skin cancer with a 22.5% five-year survival for patients with Stage IV disease, can metastasize to other organs.
  • We look forward to working with Ocean Biomedical to bring all of these therapies to patients, for the long-term shareholder value and the continued advancement of medical science.”

C4 Therapeutics Announces First Patient Dosed in Phase 1/2 Clinical Trial Evaluating CFT1946, an Orally Bioavailable BiDAC™ Degrader, in BRAF V600 Mutant Solid Tumors

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월요일, 1월 30, 2023

“Dosing the first patient in the CFT1946 Phase 1/2 clinical trial marks the first degrader to enter clinical development to target BRAF-driven cancers.

Key Points: 
  • “Dosing the first patient in the CFT1946 Phase 1/2 clinical trial marks the first degrader to enter clinical development to target BRAF-driven cancers.
  • Many of these patients are typically treated with BRAF inhibitors and have few treatment options once resistance emerges,” said Adam Crystal, M.D., Ph.D., chief medical officer of C4 Therapeutics.
  • The initial arm of the Phase 1 portion of the study will evaluate CFT1946 as a single agent in patients with BRAF V600 mutant solid tumors.
  • As the Phase 1 trial progresses, an additional arm of the trial will evaluate CFT1946 in combination with trametinib, also in patients with BRAF V600 mutant solid tumors.

Tango Therapeutics Announces FDA Clearance of Investigational New Drug Application for TNG462; Provides Additional Business Updates

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수요일, 1월 25, 2023

The Company also announced that TNG908 was granted Orphan Drug Designation (ODD) for the treatment of malignant glioma and provided additional business highlights.

Key Points: 
  • The Company also announced that TNG908 was granted Orphan Drug Designation (ODD) for the treatment of malignant glioma and provided additional business highlights.
  • “The IND clearance for TNG462 is a critical step toward addressing the significant unmet need of patients with MTAP-deleted solid tumors,” said Barbara Weber, M.D., President and Chief Executive Officer of Tango Therapeutics.
  • We look forward to results from these trials to optimize our development plans for these programs.”
    TNG462 IND cleared; first-in-human clinical trial initiation expected in mid-2023.
  • The FDA has granted Orphan Drug Designation (ODD) to TNG908 for the treatment of malignant glioma.

TScan Therapeutics Announces FDA Clearance of Three Investigational New Drug Applications for the Treatment of Solid Tumors

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월요일, 1월 23, 2023

WALTHAM, Mass., Jan. 23, 2023 (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 that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) applications for T-Plex, TSC-204-A0201, and TSC-204-C0702.

Key Points: 
  • Each unique TCR-T will be filed as a secondary IND and will reference the primary T-Plex IND.
  • MAGE-A1 is a cancer-associated antigen overexpressed in 45% of head and neck cancers and 50% of melanoma, cervical, and non-small cell lung cancers.
  • TScan believes that TSC-204-C0702 is the first clinical program in MAGE-A1 for an HLA type other than A*02:01.
  • With the FDA clearance of T-Plex, along with two MAGE-targeting TCRs, we are now one step closer to bringing bespoke cell therapies to patients.

Pulmobiotics Highlights Nature Biotechnology Publication of Preclinical Data Demonstrating Clearance of Antibiotic-resistant Lung Infection

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목요일, 1월 19, 2023

BARCELONA, Spain, Jan. 19, 2023 (GLOBE NEWSWIRE) -- Pulmobiotics SL, a biotechnology company pioneering novel live biotherapeutics for the treatment of lung diseases, and the Centre for Genomic Regulation (CRG), an international biomedical research institute of excellence whose mission is to discover and advance knowledge for the benefit of society, public health and economic prosperity, today announced the publication of preclinical results demonstrating that treatment using Pulmobiotics’ engineered live biotherapeutic significantly reduced antibiotic-resistant Pseudomonas aeruginosa infections in the lungs of mice, thereby improving survival rates, and dissolved biofilms formed on endotracheal tubes of patients with ventilator-associated pneumonia (VAP). These data highlight a promising new approach to treat antibiotic-resistant Pseudomonas aeruginosa lung infections, a leading cause of mortality in hospital settings, and could offer a potential alternative to the use of antibiotics that enable antibiotic resistance, a global public health crisis. Importantly, these data also support the application of Pulmobiotics’ synthetic biology research platform to discover and develop novel live biotherapeutics for the treatment of other serious lung diseases.

Key Points: 
  • Importantly, these data also support the application of Pulmobiotics’ synthetic biology research platform to discover and develop novel live biotherapeutics for the treatment of other serious lung diseases.
  • This publication is the first time data has been described for a live biotherapeutic for the treatment of lung infection caused by Pseudomonas aeruginosa.
  • The results are published in Nature Biotechnology and this research is supported by the European Research Council through an H2020 project and “la Caixa” Foundation through the CaixaResearch Health Call.
  • Treatment led to a significant reduction in Pseudomonas aeruginosa bacterial load with the Pulmobiotics treatment alone or in combination with ceftolozane/taxobactam antibiotics.

Junshi Biosciences Announces Toripalimab as Perioperative Treatment for Operable NSCLC Patients Met Primary Endpoint in Phase 3 Clinical Study

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수요일, 1월 18, 2023

The Independent Data Monitoring Committee (IDMC) has determined that the primary endpoint of event-free survival (“EFS”) has met the pre-defined efficacy boundary.

Key Points: 
  • The Independent Data Monitoring Committee (IDMC) has determined that the primary endpoint of event-free survival (“EFS”) has met the pre-defined efficacy boundary.
  • Junshi Biosciences will communicate with regulatory authorities regarding matters related to the supplemental New Drug Application in the near future.
  • Perioperative I-O therapy covering the whole process, including pre- and post-surgery, is expected to be a better treatment model for patients.
  • Based on the interim analysis, compared with chemotherapy alone, toripalimab in combination with chemotherapy as perioperative treatment for phase III operable NSCLC patients and toripalimab monotherapy for consolidation therapy thereafter may significantly extend EFS of patients.

Summit Therapeutics Closes Deal with Akeso Inc. to In-License Breakthrough Innovative Bispecific Antibody

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금요일, 1월 20, 2023

Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” “we,” or the “Company”) today announced that we have completed the closing of our previously announced definitive agreement with Akeso Inc. (HKEX Code: 9926.HK, “Akeso”) to in-license its breakthrough bispecific antibody, ivonescimab.

Key Points: 
  • Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” “we,” or the “Company”) today announced that we have completed the closing of our previously announced definitive agreement with Akeso Inc. (HKEX Code: 9926.HK, “Akeso”) to in-license its breakthrough bispecific antibody, ivonescimab.
  • Summit is initiating development activities for SMT112 and will do so first in non-small cell lung cancer (NSCLC) indications.
  • In exchange for these rights, Summit committed to an upfront payment of $500 million to be paid in two installments.
  • In conjunction with the closing of the deal, Dr. Michelle Xia, Co-Founder, Chairwoman, and CEO of Akeso, has been appointed to the board of directors of Summit.

Asher Bio Announces Dosing of First Patient in Phase 1a/1b Clinical Trial of AB248, a Cis-targeted IL-2 Immunotherapy Product Candidate, for the Treatment of Locally Advanced or Metastatic Solid Tumors

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화요일, 1월 17, 2023

AB248, a CD8-targeted interleukin-2 (IL-2), is Asher Bio’s lead compound and first to enter the clinic for the treatment of patients with solid tumors.

Key Points: 
  • AB248, a CD8-targeted interleukin-2 (IL-2), is Asher Bio’s lead compound and first to enter the clinic for the treatment of patients with solid tumors.
  • As previously announced, Asher Bio is conducting this Phase 1a/1b trial under a clinical trial collaboration and supply agreement with Merck (known as MSD outside the United States and Canada).
  • “We are delighted to begin clinical evaluation of AB248, our most advanced product candidate,” said Craig Gibbs, Ph.D., Chief Executive Officer of Asher Bio.
  • In order to overcome these challenges, Asher Bio developed an innovative cis-targeting approach to deliver IL-2 only to a specific immune cell subset.