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23andMe Announces Updated Safety and Preliminary Efficacy Data From the Phase 1/2a Study of 23ME-00610, an Investigational Antibody Targeting CD200R1

Retrieved on: 
Monday, November 6, 2023

Updated data from the now completed dose escalation phase continue to showcase the manageable safety profile of 23ME-00610 at the dose levels tested, and highlight preliminary efficacy results in patients with advanced solid tumors.

Key Points: 
  • Updated data from the now completed dose escalation phase continue to showcase the manageable safety profile of 23ME-00610 at the dose levels tested, and highlight preliminary efficacy results in patients with advanced solid tumors.
  • The data was presented in two posters at the Society of Immunotherapy in Cancer Annual Meeting 2023 on Friday, November 3, 2023.
  • The poster presentations are available on the 23andMe Therapeutics and Investor websites.
  • Of the phase 1 patients enrolled across all doses of the dose escalation, there was a 52% stable disease rate.

23andMe Announces Phase 1 Results from the First-in-Human Phase 1/2a Study of 23ME-00610, an Investigational Antibody Targeting CD200R1

Retrieved on: 
Friday, April 14, 2023

23ME-00610 demonstrated an acceptable safety and tolerability profile, with favorable pharmacokinetics (PK) and peripheral saturation of the CD200R1 target.

Key Points: 
  • 23ME-00610 demonstrated an acceptable safety and tolerability profile, with favorable pharmacokinetics (PK) and peripheral saturation of the CD200R1 target.
  • Based on the Phase 1 data, a dose of 23ME-00610 given at 1400 mg intravenously every 3 weeks was selected for evaluation of anti-tumor activity in the ongoing Phase 2a portion of the Phase 1/2a (Phase 2a) 23ME-00610 study.
  • Among study participants, most experienced at least 1 treatment related adverse event (TRAE); the majority were Grade 1 or 2.
  • A RP2D of 1400 mg 23ME-00610 was selected for evaluation in the Phase 2a portion of the study.

23andMe Announces First Patient Dosed for the Phase 2a Portion of its Phase 1/2a Study of 23ME-00610, an Investigational Antibody Targeting CD200R1 in Patients with Advanced Solid Malignancies

Retrieved on: 
Tuesday, February 28, 2023

A cohort of adolescents with locally advanced unresectable, or metastatic solid malignancies will also be enrolled.

Key Points: 
  • A cohort of adolescents with locally advanced unresectable, or metastatic solid malignancies will also be enrolled.
  • The Phase 2a component will include assessment of objective response rate (ORR), progression-free survival (PFS) and overall survival (OS) in the expansion cohorts.
  • 23andMe anticipates that it will present an update from the Phase 1 dose escalation portion of the study at a scientific conference this year.
  • 23andMe scientists study the aggregate, de-identified genetics of these participants, alongside more than 4 billion self-reported health data points.

23andMe Trials-in-Progress Poster Details Expansion Cohorts for 23ME-00610, an Investigational Antibody Targeting CD200R1, at The Society for Immunotherapy of Cancer’s (SITC) 2022 Annual Meeting

Retrieved on: 
Monday, November 7, 2022

A cohort of adolescents with locally advanced unresectable, or metastatic solid malignancies will also be enrolled.

Key Points: 
  • A cohort of adolescents with locally advanced unresectable, or metastatic solid malignancies will also be enrolled.
  • 23andMe has more than 13 million genotyped customers, over 80% of whom consent to participate in research.
  • 23andMe scientists study the aggregate, de-identified genetics of these participants, alongside more than 4 billion self-reported health data points.
  • Title: A Phase 1 Dose Escalation and Expansion Study of the anti-CD200R1 Antibody 23ME-00610 in Patients with Advanced Solid Malignancies.

EQS-News: MorphoSys Presents Preliminary Results from Phase 1/2 Study of Tulmimetostat (CPI-0209) Supporting Its Potential Application in a Broad Array of Advanced Tumors

Retrieved on: 
Friday, October 28, 2022

Advanced cancer patients who have progressed following prior therapies have significant treatment needs that might benefit from a targeted approach with an EZH2 inhibitor.

Key Points: 
  • Advanced cancer patients who have progressed following prior therapies have significant treatment needs that might benefit from a targeted approach with an EZH2 inhibitor.
  • At trial entry, 68% of patients had been treated with at least three prior lines of therapy.
  • Of the 10 evaluable patients with ovarian clear cell carcinoma, four had a partial response and three had stable disease.
  • These initial results support patient selection based on ARID1A and BAP1 in the ongoing Phase 2 expansion study.

Nuvectis Phrama Announces Two Upcoming Poster Presentations at the 34th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics

Retrieved on: 
Tuesday, October 18, 2022

To identify biomarkers that correlated with sensitivity to NXP800 in human tumor xenografts and human cancer cell line panels, a combination of gene expression and protein profiling was used.

Key Points: 
  • To identify biomarkers that correlated with sensitivity to NXP800 in human tumor xenografts and human cancer cell line panels, a combination of gene expression and protein profiling was used.
  • Genetic loss of ARID1a, a component of the SWI/SNF chromatin remodelling complex, was identified as predictive of greater therapeutic responsiveness.
  • Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate.
  • Any forward-looking statements contained in in this press release speak only as of the date of this press release.

Nuvectis Pharma, Inc. to Present at the Roth Inaugural Healthcare Opportunities Conference

Retrieved on: 
Monday, October 3, 2022

This press release contains "forward-looking statements" within the meaning of the federal securities laws, which statements are subject to substantial risks and uncertainties.

Key Points: 
  • This press release contains "forward-looking statements" within the meaning of the federal securities laws, which statements are subject to substantial risks and uncertainties.
  • All statements, other than statements of historical fact, contained in this press release are forward-looking statements.
  • Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate.
  • Any forward-looking statements contained in in this press release speak only as of the date of this press release.

Nuvectis Pharma, Inc. to Present at Upcoming Investment Conferences

Retrieved on: 
Wednesday, September 7, 2022

Nuvectis Pharma, Inc. is a biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical needs in oncology.

Key Points: 
  • Nuvectis Pharma, Inc. is a biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical needs in oncology.
  • This press release contains "forward-looking statements" within the meaning of the federal securities laws, which statements are subject to substantial risks and uncertainties.
  • All statements, other than statements of historical fact, contained in this press release are forward-looking statements.
  • Any forward-looking statements contained in in this press release speak only as of the date of this press release.

Nuvectis Pharma Announces FDA Clearance of IND for NXP800

Retrieved on: 
Tuesday, June 21, 2022

The NXP800 Phase 1 clinical trial is comprised of two parts, a dose escalation study (Phase 1a) to be followed by an expansion study (Phase 1b).

Key Points: 
  • The NXP800 Phase 1 clinical trial is comprised of two parts, a dose escalation study (Phase 1a) to be followed by an expansion study (Phase 1b).
  • The Phase 1a is currently ongoing in the United Kingdom (U.K.) and, with the IND in effect, U.S. clinical sites will now be included.
  • The FDA approval of the IND for NXP800 marks an important milestone towards our mission of developing novel treatments for unmet medical needs in oncology said Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis.
  • Nuvectis licensed exclusive world-wide rights to NXP800, a novel, oral Heat Shock Factor 1 (HSF1) pathway inhibitor, which was discovered at the Institute of Cancer Research in London, England.

Nuvectis Pharma, Inc. Reports First Quarter 2022 Financial Results and Business Highlights

Retrieved on: 
Tuesday, May 10, 2022

FORT LEE, N.J., May 10, 2022 (GLOBE NEWSWIRE) -- Nuvectis Pharma, Inc (NASDAQ: NVCT) ("Nuvectis" or the "Company"), a biopharmaceutical company focused on the development of precision medicines for serious conditions of unmet medical need in oncology, today reported its financial results for the first quarter of 2022 and provided an update on recent business progress.

Key Points: 
  • Importantly, we continue to manage our budget in a judicious and effective fashion as we advance our development programs.
  • Research and development expenses were $1.8 million for the three months ended March 31, 2022, including $0.1 million in non-cash expense.
  • Forward-looking statements are based on Nuvectis Pharma, Inc.'s current expectations, estimates, and projections about future events and trends that we believe may affect our business, financial condition, results of operations, prospects, business strategy, and financial needs.
  • Any forward-looking statements contained in in this press release speak only as of the date of this press release.