Tyrosine kinase receptors

ALK and Grandpharma team up to market the first adrenaline autoinjector in China

Friday, July 30, 2021 - 1:51pm

ALK (ALKB:DC / OMX: ALK B / AKABY / AKBLF) to launch its adrenaline autoinjector (AAI), Jext, in China via a partnership with leading supplier of adrenaline, Grandpharma.

Key Points: 
  • ALK (ALKB:DC / OMX: ALK B / AKABY / AKBLF) to launch its adrenaline autoinjector (AAI), Jext, in China via a partnership with leading supplier of adrenaline, Grandpharma.
  • ALK will receive upfront and registration milestone payments totalling EUR 12 million (~DKK 90 million) in return for granting Grandpharma the exclusive rights to Jext in China.
  • ALK will also manufacture and supply Jext and receive revenue from the sale of products to Grandpharma.
  • Grandpharma is the leading supplier of adrenaline ampoules in China today and the company has extensive commercial reach within clinics and emergency care.

Zymeworks Announces First Patient with Advanced HER2-Positive Breast Cancer Dosed with Zanidatamab in Combination with Tukysa® (Tucatinib) and Chemotherapy

Wednesday, July 28, 2021 - 1:30pm

Recent clinical trials have demonstrated the benefit of combining tucatinib with trastuzumab and chemotherapy in patients with metastatic HER2-positive breast cancer, said Neil Josephson, M.D., Interim Chief Medical Officer at Zymeworks.

Key Points: 
  • Recent clinical trials have demonstrated the benefit of combining tucatinib with trastuzumab and chemotherapy in patients with metastatic HER2-positive breast cancer, said Neil Josephson, M.D., Interim Chief Medical Officer at Zymeworks.
  • In addition, zanidatamab potently activates the immune system to elicit antibody-dependent cellular cytotoxicity, antibody-dependent cellular phagocytosis, and complement-dependent cytotoxicity.
  • Tucatinib is a tyrosine kinase inhibitor of HER2 and helps prevent the cancer cells from growing.
  • Zanidatamab is a bispecific antibody, based on Zymeworks Azymetric platform, that can simultaneously bind two non-overlapping epitopes of HER2, known as biparatopic binding.

Fusion Pharmaceuticals Announces FDA Clearance of IND for FPI-1966, an Investigational Radiopharmaceutical for the Treatment of Head and Neck and Bladder Cancers Expressing FGFR3

Wednesday, July 28, 2021 - 9:15pm

We have an opportunity to selectively deliver alpha particles to these tumors and use precision radiation therapy as a new treatment paradigm.

Key Points: 
  • We have an opportunity to selectively deliver alpha particles to these tumors and use precision radiation therapy as a new treatment paradigm.
  • While the currently approved pan-FGFR inhibitor for bladder cancer requires the presence of a specific mutation, our approach requires only over-expression of FGFR3.
  • The information that Fusion posts on this website could be deemed to be material information.
  • As a result, Fusion encourages investors, media and others interested to review the information that Fusion posts there on a regular basis.

HUTCHMED and AstraZeneca Initiate Phase II Trial of ORPATHYS® in Patients with MET Amplified Gastric Cancer

Wednesday, July 28, 2021 - 1:00am

Patients whose tumors harbor MET amplification were treated with ORPATHYS monotherapy, reporting an ORR of 50% (10/20, 95% CI: 28.0, 71.9).

Key Points: 
  • Patients whose tumors harbor MET amplification were treated with ORPATHYS monotherapy, reporting an ORR of 50% (10/20, 95% CI: 28.0, 71.9).
  • ORPATHYS is an oral, potent, and highly selective MET tyrosine kinase inhibitor (TKI) that has demonstrated clinical activity in advanced solid tumors.
  • In 2011, following its discovery and initial development by HUTCHMED, AstraZeneca and HUTCHMED entered a global licensing agreement to jointly develop and commercialize ORPATHYS.
  • Joint development in China is led by HUTCHMED, while AstraZeneca leads development outside of China.

Clinical Utility of ALK Fusion Detection by Liquid Biopsy

Tuesday, July 27, 2021 - 1:00pm

However, detecting ALK fusions using liquid biopsy is challenging, Knobil said.

Key Points: 
  • However, detecting ALK fusions using liquid biopsy is challenging, Knobil said.
  • Most importantly, it was able to demonstrate clinical benefit by guiding patients to positive clinical responses.
  • Bob Li, MD, PhD, MPH, co-director of the Thoracic Liquid Biopsy Program at MSK, remarked, As a continuation of our multiyear collaboration with Resolution Bioscience, this study provides further evidence for the clinical utility of liquid biopsy, here with a focus on ALK fusion detection, for which there is limited data.
  • In addition to detecting common EML4-ALK fusions, liquid biopsy was also able to detect resistance mechanisms like MET amplifications and discover novel fusion partners, including a patient with a PON1-ALK fusion.

Ribon Therapeutics Announces Publication in Cancer Cell of Pre-Clinical and Mechanism of Action Data for RBN-2397

Thursday, July 22, 2021 - 6:00pm

Ribon Therapeutics, a clinical stage biotechnology company developing therapeutics targeting stress support pathways, today announced the first publication in the peer-reviewed journal, Cancer Cell, of preclinical data from its lead asset, RBN-2397, a small molecule inhibitor of PARP7.

Key Points: 
  • Ribon Therapeutics, a clinical stage biotechnology company developing therapeutics targeting stress support pathways, today announced the first publication in the peer-reviewed journal, Cancer Cell, of preclinical data from its lead asset, RBN-2397, a small molecule inhibitor of PARP7.
  • PARP7 is overexpressed in a number of tumors, including squamous cell carcinoma of the lung (SCCL), which represents approximately 30% of all non-small cell lung cancers.
  • PARP7 is the first monoPARP to be targeted therapeutically and RBN-2397 is the first potent and selective PARP7 inhibitor to enter clinical development.
  • Ribon Therapeutics is a clinical stage biotechnology company developing therapeutics targeting novel enzyme families activated under cellular stress conditions that contribute to disease.

Sol-Gel Technologies to Report Second Quarter 2021 Financial Results on August 4th, 2021

Tuesday, July 20, 2021 - 12:05pm

NESS ZIONA, Israel, July 20, 2021 (GLOBE NEWSWIRE) -- Sol-Gel Technologies, Ltd. (Nasdaq: SLGL), a clinical-stage dermatology company focused on identifying, developing and commercializing branded and generic topical drug products for the treatment of skin diseases, will report second quarter 2021 financial results on Wednesday, August 4, 2021 at 7:05 AM ET.

Key Points: 
  • NESS ZIONA, Israel, July 20, 2021 (GLOBE NEWSWIRE) -- Sol-Gel Technologies, Ltd. (Nasdaq: SLGL), a clinical-stage dermatology company focused on identifying, developing and commercializing branded and generic topical drug products for the treatment of skin diseases, will report second quarter 2021 financial results on Wednesday, August 4, 2021 at 7:05 AM ET.
  • Both product candidates are exclusively licensed forU.S.commercialization withGalderma Holding SA.
  • The Companys pipeline also includes SGT-210, an early-stage topical epidermal growth factor receptor inhibitor, erlotinib, under investigation for the treatment ofpalmoplantar keratoderma, and preclinical assets tapinarof and roflumilast.
  • For additional information, please visit www.sol-gel.com .

FDA lifts Partial Clinical Hold on Phase Ib Clinical Trial of RVU120 (SEL120) in Acute Myeloid Leukemia and Myelodysplastic Syndrome

Wednesday, July 14, 2021 - 2:56pm

Following the completion ofthe75mg cohort, the data generated will be reviewed by the agency and a further dose escalation strategy will be established.

Key Points: 
  • Following the completion ofthe75mg cohort, the data generated will be reviewed by the agency and a further dose escalation strategy will be established.
  • The partial clinical hold was issued following Ryvu's recent report to the FDA of a Serious Adverse Event (SAE) involving a patient death that may possibly be related to RVU120.
  • RVU120 is a selective CDK8/CDK19 kinase inhibitor with potential for the treatment of hematological malignancies and solid tumors currently in Phase 1b clinical development for the treatment of acute myeloid leukemia and myelodysplastic syndrome.
  • SEL24 (MEN1703) is a dual PIM/FLT3 kinase inhibitor licensed to the Menarini Group, currently in Phase II clinical studies in acute myeloid leukemia.

AmoyDx® Pan Lung Cancer PCR Panel Receives MHLW Approval as Companion Diagnostic for 9 Targeted Therapies for Use in Patients with Advanced Non-Small Cell Lung Cancer

Wednesday, June 30, 2021 - 5:01am

The AmoyDx PLC Panel has received approval for four driver genes (EGFR, ALK, ROS1, and BRAF) for nine associated targeted therapies in NSCLC.

Key Points: 
  • The AmoyDx PLC Panel has received approval for four driver genes (EGFR, ALK, ROS1, and BRAF) for nine associated targeted therapies in NSCLC.
  • With its high sensitivity and short turnaround time, The AmoyDx PLC Panel is expected to be an important clinical diagnostic in guiding treatment opportunities for NSCLC patients.
  • We are pleased to collaborate with AmoyDx and PREMIA in obtaining approval of the AmoyDx PLC Panel in Japan.
  • Detection of EGFR gene mutations, ALK fusion gene, ROS1 fusion gene, and BRAF gene mutations in nucleic acids extracted from cancer tissue

Angion Announces Results from the Phase 2 ALI-201 Study in Patients with COVID-19 Associated Pneumonia

Tuesday, June 29, 2021 - 9:05pm

The adverse events and overall safety of the trial were consistent with previously published reports in patients hospitalized with severe COVID-19 pneumonia.

Key Points: 
  • The adverse events and overall safety of the trial were consistent with previously published reports in patients hospitalized with severe COVID-19 pneumonia.
  • In contrast, patients in our ongoing trials receive ANG-3777 within 1-3 days after the targeted organ injury.
  • Angion is also currently evaluating ANG-3070, a tyrosine kinase receptor inhibitor for the treatment of fibrotic disease, in Phase 1.
  • Angion undertakes no obligation to update any forward-looking statement in this press release, except as required by law.