Squamous cell carcinoma

Indaptus Therapeutics Announces Initiation of First-In-Human, Open Label, Dose Escalation and Expansion Multicenter Phase 1 Clinical Trial of Decoy20 in Patients with Advanced Solid Tumors

Retrieved on: 
Tuesday, December 13, 2022
Immunotherapy, Liver, Cell, Neoplasm, Annual report, MTD, Incidence, Inflammation, Therapy, Security (finance), Government, TLR, Spleen, Safety, Immunology, Science, HBV, Squamous cell carcinoma, Toxicity, Toxicology, HIV, Immune system, Infection, IND, Cancer, Risk, Index (publishing), Patient, Gram-negative bacteria, Pharmaceutical industry, Vaccine, Decoy

NEW YORK, Dec. 13, 2022 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc. (Nasdaq: INDP, “Indaptus” or “the Company”), a biotechnology company focused on discovering and developing transformative therapeutics for patients, today announces the initiation of INDP-D101, its first-in-human, open label, dose escalation and expansion, multicenter Phase 1 clinical trial of its lead compound Decoy20 in patients with advanced/metastatic solid tumors.

Key Points: 
  • NEW YORK, Dec. 13, 2022 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc. (Nasdaq: INDP, “Indaptus” or “the Company”), a biotechnology company focused on discovering and developing transformative therapeutics for patients, today announces the initiation of INDP-D101, its first-in-human, open label, dose escalation and expansion, multicenter Phase 1 clinical trial of its lead compound Decoy20 in patients with advanced/metastatic solid tumors.
  • We look forward to advancing to the expansion portion of the trial once the appropriate dose is identified,” said Boyan Litchev, M.D., Chief Medical Officer, Indaptus.
  • The Phase 1 study will begin with a single dose escalation part followed by an expansion part with continuous administration of Decoy20.
  • The study will enroll patients with advanced/metastatic solid tumors, who have exhausted the other known treatment options.

Alpha Tau to Present at Biotech Showcase and Participate in LifeSci Advisors Corporate Access Event During J.P. Morgan Healthcare Conference in San Francisco in January 2023

Retrieved on: 
Tuesday, December 13, 2022
Conference, Squamous cell carcinoma, Biotechnology, Neoplasm, CFO, Research, Alpha Sigma Tau, Alpha, Pharmaceutical industry, Tel Aviv University

Both in-person events are taking place in parallel with the 41st Annual J.P. Morgan Healthcare Conference which will be held January 9-12, 2023 in San Francisco, California.

Key Points: 
  • Both in-person events are taking place in parallel with the 41st Annual J.P. Morgan Healthcare Conference which will be held January 9-12, 2023 in San Francisco, California.
  • Uzi Sofer, CEO of Alpha Tau and Raphi Levy will also host 1x1 institutional investor meetings.
  • Location: Hilton San Francisco Union Square in San Francisco; Yosemite A (Ballroom Level)
    LifeSci Partners Corporate Access Event:
    Uzi Sofer, CEO and Raphi Levy, CFO will be hosting 1x1 institutional investor meetings.
  • To schedule a meeting on the online system managed by LifeSci Partners, please click here to register for the conference.

ORYZON Presents Final Data From Phase IIa ALICE Trial in Unfit AML Patients with First-line Treatment of Iadademstat and Azacitidine in Oral Presentation at ASH-2022

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Monday, December 12, 2022
Vall, ORY, Hematological Cancer Research Investment and Education Act, Sale, CR, CRS, ASH, FLT3, AML, MD, PR, Clinical trial, Person, Azacitidine, Safety, Mercado, Cancer, Public expenditure, MRD, Society, Paclitaxel, LSD1, Wilms' tumor, Squamous cell carcinoma, BCL2, Conference, CNMV, SOC, TP53, CRADA, ISIN, OS, Prospectus, ORR, Spanish, Disease, Genomics, Development, Patient, NET, ESMO, Communication, Fox Chase Cancer Center, Cooperative research and development agreement, Acute myeloid leukemia, Medulloblastoma, Phases of clinical research, IND, NCI, Pharmaceutical industry, SCLC, EU, ALICE

Of note, responses were seen in patients with a diverse array of AML mutations, suggesting a broad applicability for iadademstat in AML.

Key Points: 
  • Of note, responses were seen in patients with a diverse array of AML mutations, suggesting a broad applicability for iadademstat in AML.
  • All FLT3+ patients included in ALICE (100%; 3 out of 3) and a high proportion of TP53+ patients (75%; 6 out of 8) responded.
  • Dr. Carlos Buesa, Oryzon’s CEO, said: "These final results confirm a strong synergy between iadademstat and azacitidine in combination.
  • In a recently completed Phase IIa trial in elder 1L-AML patients (ALICE trial), iadademstat has shown encouraging safety and efficacy data in combination with azacitidine (see Salamero et al., ASH 2022 abstract).

Kronos Bio Announces Selection of Recommended Phase 2 Dose for its Oral CDK9 Inhibitor, KB-0742, After Reaching Target Engagement Goal with Acceptable Safety Profile in Ongoing Phase 1/2 Clinical Trial

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Wednesday, December 7, 2022
SYK, Squamous cell carcinoma, Cohort study, CDK9, Enzyme, Bio, Chordoma, Sarcoma, SAN, Security (finance), Ovarian cancer, RNA polymerase II, RNA polymerase, Cancer, Cmax, Large-cell lung carcinoma, MYC, KRON, Research, Plasma, PK, Kronos, Drug, COVID-19, CDK, Patient, Pharmaceutical industry

SAN MATEO, Calif. and CAMBRIDGE, Mass., Dec. 07, 2022 (GLOBE NEWSWIRE) -- Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to transforming the lives of those affected by cancer, today announced that data from the ongoing dose-escalation stage of its Phase 1/2 clinical trial of KB-0742, the company’s cyclin dependent kinase 9 (CDK9) inhibitor being developed to treat MYC-amplified and transcriptionally addicted solid tumors, support a recommended Phase 2 dose (RP2D) of 60 mg.

Key Points: 
  • This level of target engagement is consistent with demonstrating anti-tumor activity based on preclinical models.
  • A total of 26 patients have been enrolled and treated in the dose escalation phase of the study.
  • The long plasma half-life enables KB-0742 to achieve sustained pharmacologically active concentrations while avoiding potentially toxic peak (Cmax) concentrations.
  • Kronos Bio is a biopharmaceutical company that is advancing two investigational compounds in clinical trials for patients with cancer.

Zai Lab Partner Mirati Therapeutics Presents Late-Breaking Results Evaluating Concurrent Adagrasib and Pembrolizumab in First-Line Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)

Retrieved on: 
Monday, December 5, 2022
Squamous cell carcinoma, LFT, ESMO, Colorectal cancer, Coronavirus, Data, Clinical trial, Pancreatic cancer, Health, Incidence, Dana–Farber Cancer Institute, Lung cancer, Degenerative disease, CET, Safety, SCLC, Congress, Cancer, PD-1, Large-cell lung carcinoma, Central nervous system, Doctor of Philosophy, European Society for Medical Oncology, ORR, MD, AST, DCR, Alanine transaminase, Infection, Oncology, Research, ALT, Mutation, Trae tha Truth, Death, COVID-19, World Health Organization, Patient, KRAS, Communications satellite, Pharmaceutical industry, Medical imaging, Mirati, NSCLC

TRAEs led to discontinuation of both adagrasib and pembrolizumab in 2 patients and only pembrolizumab in 2 patients; there were no patients who discontinued only adagrasib due to a TRAE.

Key Points: 
  • TRAEs led to discontinuation of both adagrasib and pembrolizumab in 2 patients and only pembrolizumab in 2 patients; there were no patients who discontinued only adagrasib due to a TRAE.
  • In clinical trials, adagrasib also has shown, central nervous system penetrance and single-agent responses in non-small cell lung cancer (NSCLC), colorectal cancer, pancreatic cancer and other solid tumors with KRASG12C mutations.
  • Mirati company executives will provide an overview of the adagrasib and pembrolizumab combination data presented 2022 ESMO Immuno-Oncology Annual Congress.
  • Lung cancer consists of NSCLC in approximately 85% of cases and small cell lung cancer (SCLC) in approximately 15% of cases.

Circle Pharma Appoints Stephen Kelsey, MB ChB, MD, to its Board of Directors

Retrieved on: 
Thursday, December 15, 2022
Research, Venture Capital, Professional Services, Biotechnology, Health, Pharmaceutical, Other Science, Science, Oncology, Therapy, Lymphoma, Medivation, University, JD, Rb, Cell cycle, IND, Doctor of Philosophy, Royal London Hospital, Drug discovery, Cancer, Circle, Research, Imetelstat, Genentech, NYSE, Geron Corporation, Cell, MRNA, Pharmacia, Pharma, Squamous cell carcinoma, St. Bartholomew's, Hoffmann-La Roche, PFE, Leukemia, Cyclin A, Hematological Cancer Research Investment and Education Act, Pharmaceutical industry, Pfizer

Circle Pharma, a company focused on developing macrocycle therapeutics against targets previously considered to be undruggable, has appointed Stephen Kelsey as an independent member of its Board of Directors.

Key Points: 
  • Circle Pharma, a company focused on developing macrocycle therapeutics against targets previously considered to be undruggable, has appointed Stephen Kelsey as an independent member of its Board of Directors.
  • Dr. Kelsey has had key roles in the development of many oncology therapeutics including Sutent, Perjeta, Kadcycla, Erivedge and imetelstat.
  • Im delighted to welcome Steve to our Board, said David J. Earp, JD, PhD, Circles president and CEO.
  • Im excited to join Circles Board and to help the company bring its promising therapies to cancer patients.

QIAGEN receives FDA approval for companion diagnostic to Mirati Therapeutics’ KRAZATI in non-small cell lung cancer

Retrieved on: 
Tuesday, December 13, 2022
FDA, Pharmaceutical, Health, Oncology, Therapy, QGEN, NGS, Large-cell lung carcinoma, Cancer, NSCLC, RAS, EGFR, Physician, Squamous cell carcinoma, Life, BRAF, Knowledge, Partnership, Molecular diagnostics, NYSE, Clinical Cancer Research, Growth, SRL Diagnostics, FGFR, Blood, Biotechnology, IVD, PIK3CA, Precision medicine, Food, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Lung, DNA, Science, Lung cancer, PCR, Breast cancer, Automation, KRAS, RNA, Mutation, Protein, Research, FDA, CRC, Colorectal cancer, Pharmaceutical industry, Medical device, Medical imaging, Uranium, Patient, Insight, QIAGEN, Pharma

QIAGEN (NYSE:QGEN; Frankfurt Prime Standard: QIA) has announced the U.S. Food and Drug Administration (FDA) approval of its therascreen KRAS RGQ PCR kit (therascreen KRAS kit) as a companion diagnostic test to Mirati Therapeutics drug KRAZATI (adagrasib) for non-small cell lung cancer (NSCLC).

Key Points: 
  • QIAGEN (NYSE:QGEN; Frankfurt Prime Standard: QIA) has announced the U.S. Food and Drug Administration (FDA) approval of its therascreen KRAS RGQ PCR kit (therascreen KRAS kit) as a companion diagnostic test to Mirati Therapeutics drug KRAZATI (adagrasib) for non-small cell lung cancer (NSCLC).
  • It builds on the companys experience in KRAS companion diagnostic test development and commercialization, which reaches back more than a decade.
  • Cancer drugs submitted to the FDA for approval are ideally already paired with companion diagnostics during their clinical trials.
  • The program enables diagnostic labs to implement the activities necessary to prepare new companion diagnostic testing services for commercial launch before FDA approval is granted.

First patient cells collected in XNK's preclinical bladder cancer study

Retrieved on: 
Thursday, December 15, 2022
Therapy, Squamous cell carcinoma, NK, MD Anderson Cancer Center, Immunotherapy, Transitional epithelium, Bladder cancer, University, Karolinska University Hospital, Patient, Cancer, Multiple myeloma, Radiation, American Cancer Society, Survival rate, World Health Organization, MM, Death, AML, Trial of the century, Acute myeloid leukemia, Transitional cell carcinoma, Pharmaceutical industry

This is the company's first solid tumor indication and complements the ongoing Phase II clinical study in multiple myeloma (MM) and the preclinical proof-of-concept study in acute myeloid leukemia (AML) using patient samples from The University of Texas MD Anderson Cancer Center.

Key Points: 
  • This is the company's first solid tumor indication and complements the ongoing Phase II clinical study in multiple myeloma (MM) and the preclinical proof-of-concept study in acute myeloid leukemia (AML) using patient samples from The University of Texas MD Anderson Cancer Center.
  • Between 10-15 patients with advanced urothelial cancer will be enrolled in the study and will donate cells before and after chemotherapy treatment.
  • More than 80,000 new cases of bladder cancer are expected in the US in 2022 alone, according to the American Cancer Society.
  • It is the 4th most common form of cancer in men and the American Cancer Society estimates that bladder cancer will cause over 17,000 deaths in 2022 in US alone.

First patient cells collected in XNK's preclinical bladder cancer study

Retrieved on: 
Thursday, December 15, 2022
Therapy, Squamous cell carcinoma, NK, MD Anderson Cancer Center, Immunotherapy, Transitional epithelium, Bladder cancer, University, Karolinska University Hospital, Patient, Cancer, Multiple myeloma, Radiation, American Cancer Society, Survival rate, World Health Organization, MM, Death, AML, Trial of the century, Acute myeloid leukemia, Transitional cell carcinoma, Pharmaceutical industry

This is the company's first solid tumor indication and complements the ongoing Phase II clinical study in multiple myeloma (MM) and the preclinical proof-of-concept study in acute myeloid leukemia (AML) using patient samples from The University of Texas MD Anderson Cancer Center.

Key Points: 
  • This is the company's first solid tumor indication and complements the ongoing Phase II clinical study in multiple myeloma (MM) and the preclinical proof-of-concept study in acute myeloid leukemia (AML) using patient samples from The University of Texas MD Anderson Cancer Center.
  • Between 10-15 patients with advanced urothelial cancer will be enrolled in the study and will donate cells before and after chemotherapy treatment.
  • More than 80,000 new cases of bladder cancer are expected in the US in 2022 alone, according to the American Cancer Society.
  • It is the 4th most common form of cancer in men and the American Cancer Society estimates that bladder cancer will cause over 17,000 deaths in 2022 in US alone.

Datopotamab Deruxtecan Showed Encouraging and Durable Efficacy in Patients with Heavily Pretreated HR Positive, HER2 Low or Negative Metastatic Breast Cancer

Retrieved on: 
Thursday, December 8, 2022
Research, Clinical Trials, Biotechnology, Health, Pharmaceutical, General Health, Other Science, Science, Oncology, Immunoglobulin G, Lead, ORR, TNBC, Breast cancer, Sankyo, Large-cell lung carcinoma, Female, Immunotherapy, Sapporo Medical University, National Cancer Institute, Daiichi Sankyo, HER2, Cleavage, Patient, Cancer, SEER, OS, IHC, NSCLC, ADC, Cardiovascular disease, PFS, HR, AstraZeneca, Safety, Sustainable development, NCCN, Veni, vidi, vici, Quality of life, Survival, Squamous cell carcinoma, DXD, Control, Neoplasm, Pharmaceutical industry, Medical imaging, Birth control, Wood drying

Daiichi Sankyo and AstraZeneca have a broad clinical development program for datopotamab deruxtecan in breast cancer, including the ongoing pivotal TROPION-Breast01 phase 3 trial evaluating datopotamab deruxtecan in patients with HR positive, HER2 low or negative, inoperable or metastatic breast cancer previously treated with chemotherapy.

Key Points: 
  • Daiichi Sankyo and AstraZeneca have a broad clinical development program for datopotamab deruxtecan in breast cancer, including the ongoing pivotal TROPION-Breast01 phase 3 trial evaluating datopotamab deruxtecan in patients with HR positive, HER2 low or negative, inoperable or metastatic breast cancer previously treated with chemotherapy.
  • The dose escalation portion of the trial enrolled patients with non-small cell lung cancer (NSCLC) to assess the safety and efficacy of datopotamab deruxtecan to determine the recommended dose for expansion (6 mg/kg).
  • The dose expansion part of TROPION-PanTumor01 is enrolling several different cohorts including patients with NSCLC, triple negative breast cancer (TNBC), HR positive, HER2 low or negative breast cancer, small cell lung cancer, urothelial, gastric, pancreatic, castration-resistant prostate and esophageal cancer.
  • A comprehensive development program called TROPION is underway globally with more than 10 trials evaluating the efficacy and safety of datopotamab deruxtecan across multiple TROP2 targetable tumors, including NSCLC, TNBC and HR positive, HER2 low or negative breast cancer.