Chronic lymphocytic leukemia

Bio-Path Holdings Reports Full Year 2023 Financial Results

Retrieved on: 
Friday, March 8, 2024

“2023 was a year of focused execution, as evidenced by the continued progress across our pipeline of DNAbilize programs,” said Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings.

Key Points: 
  • “2023 was a year of focused execution, as evidenced by the continued progress across our pipeline of DNAbilize programs,” said Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings.
  • As of December 31, 2023, the Company had cash of $1.1 million, compared to $10.4 million as of December 31, 2022.
  • Net cash provided by financing activities for the year ended December 31, 2023 was $2.2 million.
  • ET to review these full-year 2023 financial results and to provide a general update on the Company.

GeoVax Reports 2023 Year-End Financial Results and Provides Business Update

Retrieved on: 
Thursday, February 29, 2024

ATLANTA, GA, Feb. 29, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced its financial results and key operational accomplishments for the year ended December 31, 2023.

Key Points: 
  • ET
    ATLANTA, GA, Feb. 29, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced its financial results and key operational accomplishments for the year ended December 31, 2023.
  • Results to date have demonstrated safety of this therapy and consistent reduction in treated tumors.
  • Cash Position: GeoVax reported cash balances of $6.5 million on December 31, 2023, as compared to $27.6 on December 31, 2022.
  • ET today, February 29, 2024, to review financial results and provide an update on corporate developments.

BeiGene Announces FDA Accelerated Approval of BRUKINSA for the Treatment of Relapsed or Refractory Follicular Lymphoma

Retrieved on: 
Thursday, March 7, 2024

Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory MAHOGANY ( NCT05100862 ) trial, which is underway.

Key Points: 
  • Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory MAHOGANY ( NCT05100862 ) trial, which is underway.
  • The application for R/R FL was also granted Fast Track Designation and Orphan Drug Designation by the FDA.
  • In a recent presentation, BRUKINSA showed sustained PFS benefit versus ibrutinib in a longer term follow up.
  • The global BRUKINSA development program includes more than 5,000 subjects enrolled to date in 29 countries and regions.

BeiGene Announces New Efficacy Analysis Comparing BRUKINSA® vs Acalabrutinib in Relapsed or Refractory Chronic Lymphocytic Leukemia

Retrieved on: 
Thursday, February 29, 2024

The analysis suggests a progression-free survival and complete response advantage for BRUKINSA versus acalabrutinib, as well as potentially improved overall survival.

Key Points: 
  • The analysis suggests a progression-free survival and complete response advantage for BRUKINSA versus acalabrutinib, as well as potentially improved overall survival.
  • These data will be presented during the 28th Annual International Congress on Hematologic Malignancies® in Miami from February 29 - March 3.
  • “Head-to-head randomized clinical trials are the gold standard when it comes to evaluating the potential impact of individual treatments for patients.
  • The global BRUKINSA development program includes more than 5,000 subjects enrolled to date in 29 countries and regions.

Nurix Therapeutics Reports Fourth Quarter and Fiscal Year 2023 Financial Results and Provides a Corporate Update

Retrieved on: 
Thursday, February 15, 2024

NX-2127 exhibited dose-dependent PK, leading to robust and sustained degradation of BTK and biologically relevant degradation of IKZF1 (Ikaros).

Key Points: 
  • NX-2127 exhibited dose-dependent PK, leading to robust and sustained degradation of BTK and biologically relevant degradation of IKZF1 (Ikaros).
  • NX-2127 had a manageable safety profile that was consistent with previous reports for BTK-targeted and immunomodulatory therapies.
  • During the year ended November 30, 2023, Nurix achieved research milestones under its collaborations with Gilead and Sanofi totaling $12.5 million and $7.0 million, respectively.
  • Cash, cash equivalents and marketable securities was $295.3 million as of November 30, 2023, compared to $268.7 million as of August 31, 2023.

L-Nutra Unveils Groundbreaking Study on Fasting Mimicking Diets (FMDs) and Chronic Lymphocytic Leukemia

Retrieved on: 
Tuesday, February 13, 2024

CLL is the most prevalent form of leukemia in Western countries, and this groundbreaking research suggests a promising avenue for more effective treatment options.

Key Points: 
  • CLL is the most prevalent form of leukemia in Western countries, and this groundbreaking research suggests a promising avenue for more effective treatment options.
  • The study focused on the synergistic effects of cyclic fasting combined with proteasome inhibitors, experimental medication showing early promise for the treatment of CLL.
  • This suggests a potential benefit of fasting mimicking diets (FMDs) in treatment of milder CLL cases even without additional interventions.
  • The findings from this study open up potential new possibilities for CLL treatment strategies and food as medicine in general.

Nurix Therapeutics Announces Publication in the Journal Science Identifying a New Class of BTK Mutations That Are Susceptible to NX-2127, a Novel BTK and IKZF1/3 Degrader

Retrieved on: 
Thursday, February 1, 2024

SAN FRANCISCO, Feb. 01, 2024 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical stage biopharmaceutical company developing targeted protein modulation drugs designed to treat patients with cancer and inflammatory diseases, today announced the publication of a manuscript in the journal Science titled: “Kinase Impaired BTK Mutations Are Susceptible to Clinical Stage BTK and IKZF1/3 Degrader NX-2127” that elucidates a previously unappreciated oncogenic scaffold function of BTK responsible for clinical resistance to enzymatic inhibitors and shows that NX-2127, a potent targeted protein degrader with differentiated activity against BTK and IKZF1/3, can overcome this resistance across a broad range of acquired mutations.

Key Points: 
  • “While BTK inhibitors have positively changed clinical outcomes for patients with B-cell malignancies, the emergence of acquired resistance to these medicines is a growing clinical problem,” said Alexey Danilov, M.D., Ph.D.
  • Professor and Co-Director, Toni Stephenson Lymphoma Center, City of Hope National Medical Center.
  • “With the ability to target BTK inhibitor resistance mutations and achieve clinical responses, we believe that BTK degraders have the potential to become the next dominant class of agents in the significant BTK-targeted therapy field.
  • We look forward to presenting additional clinical data from this program, and from our NX-5948 BTK degrader program, which is also being evaluated in patients with CLL, at future medical meetings.”

Regulatory Applications Accepted in the U.S. and Japan for Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel) in Relapsed or Refractory Follicular Lymphoma (FL) and Relapsed or Refractory Mantle Cell Lymphoma (MCL)

Retrieved on: 
Tuesday, January 30, 2024

In the U.S., the FDA has accepted the company’s two supplemental Biologics License Applications (sBLA) for Breyanzi to expand into new indications to include the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) and relapsed or refractory mantle cell lymphoma (MCL) after a Bruton tyrosine kinase inhibitor (BTKi).

Key Points: 
  • In the U.S., the FDA has accepted the company’s two supplemental Biologics License Applications (sBLA) for Breyanzi to expand into new indications to include the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) and relapsed or refractory mantle cell lymphoma (MCL) after a Bruton tyrosine kinase inhibitor (BTKi).
  • The FDA has granted both applications Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of May 23, 2024 for Breyanzi in relapsed or refractory FL and May 31, 2024 for Breyanzi in relapsed or refractory MCL.
  • Japan's MHLW has also accepted Bristol Myers Squibb’s supplemental New Drug Application (sNDA) for Breyanzi for the treatment of relapsed or refractory FL.
  • In both studies, Breyanzi demonstrated a consistent safety profile with no new safety signals reported.

Nurix Therapeutics Receives U.S. FDA Fast Track Designation for NX-5948 for the Treatment of Relapsed or Refractory CLL and SLL

Retrieved on: 
Tuesday, January 16, 2024

“This designation follows encouraging safety and efficacy data from our ongoing Phase 1 clinical trial, demonstrating early promise of clinical benefit with potential for durable outcomes.

Key Points: 
  • “This designation follows encouraging safety and efficacy data from our ongoing Phase 1 clinical trial, demonstrating early promise of clinical benefit with potential for durable outcomes.
  • To qualify, available clinical and non-clinical data need to demonstrate a therapeutic candidate’s potential to address an unmet medical need.
  • A therapeutic candidate that receives Fast Track designation may be eligible for more frequent interactions with the FDA to discuss the candidate’s development plan and, if relevant criteria are met, eligibility for Accelerated Approval and Priority Review.
  • Additional data with higher dose levels and longer treatment duration are expected in 2024.

Nurix Therapeutics Outlines 2024 Strategic Priorities with Advancement of Targeted Protein Modulation Pipeline in Cancer and Autoimmune Diseases

Retrieved on: 
Monday, January 8, 2024

SAN FRANCISCO, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company developing targeted protein modulation drugs designed to treat patients with cancer and inflammatory diseases, today outlined key objectives and anticipated milestones for 2024 and provided an overview of recent progress in a presentation at the 42nd Annual J.P. Morgan Healthcare Conference.

Key Points: 
  • A webcast of Nurix’s ASH presentation is available in the Investors section of the Nurix website under Events and Presentations .
  • Nurix is evaluating daily oral dosing of NX-5948 in a Phase 1a/1b clinical trial in patients with relapsed or refractory B-cell malignancies.
  • Nurix plans to present and publish preclinical work on its wholly owned programs throughout 2024 at appropriate scientific and medical meetings.
  • Research milestones: Nurix expects to achieve multiple research collaboration milestones throughout 2024 from its existing collaborations with Gilead, Sanofi, and Pfizer.