Douglas BTD Destroyer

Merus Announces Financial Results for the Third Quarter 2023 and Provides Business Update

Retrieved on: 
Thursday, November 2, 2023
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UTRECHT, The Netherlands and CAMBRIDGE, Mass., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics®), today announced financial results for the third quarter and provided a business update.

Key Points: 
  • In the planned trial, patients will be randomized to petosemtamab monotherapy or investigators’ choice of single agent chemotherapy or cetuximab.
  • Merus also continues to enroll patients with previously untreated advanced PD-L1+ HNSCC with petosemtamab 1500 mg in combination with Keytruda®.
  • Initial safety data from this single arm cohort may support the initiation of a first-line registration trial with this combination.
  • Merus achieved a milestone and received a payment of $2.5 million related to the advancement of this program in the third quarter of 2023.

ENHERTU® Granted Two Breakthrough Therapy Designations in U.S. for Patients Across Multiple HER2 Expressing Cancers

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Thursday, August 31, 2023
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ENHERTU is a specifically engineered HER2 directed antibody drug conjugate (ADC) being jointly developed and commercialized by Daiichi Sankyo (TSE: 4568) and AstraZeneca (LSE/STO/Nasdaq: AZN).

Key Points: 
  • ENHERTU is a specifically engineered HER2 directed antibody drug conjugate (ADC) being jointly developed and commercialized by Daiichi Sankyo (TSE: 4568) and AstraZeneca (LSE/STO/Nasdaq: AZN).
  • The new medicine needs to have shown encouraging preliminary clinical results that demonstrate substantial improvement on a clinically significant endpoint over available medicines.
  • ENHERTU previously received BTDs for three indications in breast cancer, including HER2 low metastatic breast cancer, second-line HER2 positive metastatic breast cancer and later-line HER2 positive metastatic breast cancer.
  • Two additional BTDs for ENHERTU were granted for HER2 (ERBB2) mutant metastatic non-small cell lung cancer (NSCLC) and HER2 positive metastatic gastric cancer.

Ascentage Pharma's Novel Drug Olverembatinib Recommended for a Breakthrough Therapy Designation in China for the Treatment of SDH-Deficient GIST, the Second BTD for the Drug

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Wednesday, May 31, 2023
TKI, GIST, E pluribus unum, Priority review, Science, Malignancy, Drug development, Gastrointestinal tract, CML, New Drug Application, American Society of Clinical Oncology, Succinate dehydrogenase, NDA, Cancer, Quality of life, SDH, Mutation, CHB, BTD, BCR-ABL, Prognosis, Research, John-Ross Rizzo, Multimedia, CBR, Bangladesh Technical Education Board, ASCO, KIT, Patient, PDGFRA, Douglas BTD Destroyer, Annual general meeting, National Medical Products Administration, CDE, EFS, Center for Drug Evaluation and Research, Notifiable disease, Gastrointestinal stromal tumor, Society, NMPA, Hepatitis, Pharmaceutical industry, Silviculture

To date, olverembatinib has been granted two Priority Review Designations that underscored the drug's promising therapeutic utility.

Key Points: 
  • To date, olverembatinib has been granted two Priority Review Designations that underscored the drug's promising therapeutic utility.
  • Drugs that have been granted BTDs are prioritized by the CDE in communications and exchange, and in receiving guidance to advance the drug development progress.
  • Furthermore, BTD-designated drugs will be eligible for Priority Review status and conditional approvals upon submission of a New Drug Application (NDA).
  • Antitumor activity of olverembatinib (HQP1351) in patients (pts) with tyrosine kinase inhibitor (TKI)–resistant succinate dehydrogenase (SDH)–deficient gastrointestinal stromal tumor (GIST).

Bold Therapeutics Extends South Korea Option Agreement for BOLD-100, a First-in-Class Anti-Resistance Therapeutic

Retrieved on: 
Thursday, January 13, 2022
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VANCOUVER, British Columbia, Jan. 13, 2022 /PRNewswire/ --Bold Therapeutics, a clinical-stage biopharmaceutical company developing BOLD-100, is pleased to announce an extension of the option agreement with an undisclosed publicly traded South Korean biopharmaceutical company, originally executed in May 2020, for development and commercialization rights to BOLD-100 in South Korea.

Key Points: 
  • VANCOUVER, British Columbia, Jan. 13, 2022 /PRNewswire/ --Bold Therapeutics, a clinical-stage biopharmaceutical company developing BOLD-100, is pleased to announce an extension of the option agreement with an undisclosed publicly traded South Korean biopharmaceutical company, originally executed in May 2020, for development and commercialization rights to BOLD-100 in South Korea.
  • Bold Therapeutics' BOLD-100 is a first-in-class ruthenium-based small molecule therapeutic that (1) alters the unfolded protein response (UPR) through selective GRP78 inhibition; and (2) induces reactive oxygen species (ROS) which causes DNA damage and cell cycle arrest.
  • "As our partner is one of the fastest growing and most respected pharmaceutical companies in South Korea, we are honored to extend this option agreement that allows us to further leverage their substantial expertise in oncology development," said E. Russell McAllister, CEO of Bold Therapeutics.
  • For more information about Bold Therapeutics, please visit the company's website at www.bold-therapeutics.com