CLL

Studies Highlight Both Novel Treatments and Enduring Value of Older Approaches

Retrieved on: 
Sunday, December 10, 2023

SAN DIEGO, Dec. 10, 2023 /PRNewswire/ -- Research findings being presented at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition highlight new treatment approaches that are enabling patients to live longer or better, judicious uses of older treatment approaches, and how a powerful, relatively new prognostic tool is helping identify patients who are more or less likely to benefit from both older and newer treatments.

Key Points: 
  • Two other studies presented in this session spotlight ways in which a novel prognostic tool is demonstrating its value across a range of blood cancers.
  • The researchers used MRD to determine how long patients in the targeted-agents group should continue treatment.
  • These cells develop into specialized blood cells, such as red and white blood cells and platelets, that also carry the mutation.
  • By comparison, progression-free survival (PFS) for patients receiving the standard of care was 76.8% with a death rate of 7%.

Jaypirca® (pirtobrutinib) Now Approved by U.S. FDA for the Treatment of Adult Patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Who Have Received at Least Two Lines of Therapy, Including a BTK Inhibitor and a BCL-2 Inhibitor

Retrieved on: 
Friday, December 1, 2023

INDIANAPOLIS, Dec. 1, 2023 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) approved Jaypirca® (pirtobrutinib, 100 mg & 50 mg tablets) for the treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a Bruton's tyrosine kinase (BTK) inhibitor and a BCL-2 inhibitor. Jaypirca was approved under the FDA's Accelerated Approval pathway based on overall response rate (ORR) and duration of response (DOR) from the open-label, single-arm, multicohort, international, Phase 1/2 BRUIN trial.1 Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.1

Key Points: 
  • The labeling for Jaypirca contains warnings and precautions for infections, hemorrhage, cytopenias, cardiac arrhythmias, second primary malignancies, and embryo-fetal toxicity.
  • "The treatment landscape for CLL has been dramatically improved by the introduction of covalent BTK inhibitors and BCL-2 inhibitors.
  • Patients with active central nervous system (CNS) involvement by lymphoma or allogeneic hematopoietic stem cell transplantation (HSCT) within 60 days were excluded.
  • Patients in the efficacy-eligible population had received a median of five prior lines of therapy (range: 2 to 11).

Cancer Drug Parity Act Gains Strong Support from Leading Healthcare Organizations

Retrieved on: 
Wednesday, November 8, 2023

The International Myeloma Foundation (IMF), which leads the Coalition to Improve Access to Cancer Care (CIACC), fervently supports the Cancer Drug Parity Act, recognizing its profound impact on myeloma patients and their families.

Key Points: 
  • The International Myeloma Foundation (IMF), which leads the Coalition to Improve Access to Cancer Care (CIACC), fervently supports the Cancer Drug Parity Act, recognizing its profound impact on myeloma patients and their families.
  • The Cancer Drug Parity Act would put the needs of patients first to ensure that patients, along with their healthcare providers, can choose the treatment option they deem is most appropriate”.
  • ONS is proud to support the Cancer Drug Parity Act and commends the bill’s sponsors for their leadership in ensuring parity for oral cancer treatments.”
    Recognizing the pressing need for equitable access to cancer treatments, Lisa Lacasse, president of the American Cancer Society Cancer Action Network (ACS CAN), emphasized the critical issue of disparities in cost-sharing for oral chemotherapy medications.
  • For more information on the Cancer Drug Parity Act and its potential impact on cancer care, please visit https://www.access2cancercare.org/ .

U.S. Food and Drug Administration Accepts for Priority Review Bristol Myers Squibb’s Application for Breyanzi (lisocabtagene maraleucel) for Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

Retrieved on: 
Thursday, November 9, 2023

The FDA has granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 14, 2024.

Key Points: 
  • The FDA has granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 14, 2024.
  • Priority Review designation underscores the high unmet need and the significant advancement Breyanzi may offer this patient population for which there is no standard of care and limited treatment options.
  • “This FDA acceptance brings us one step closer to offering these patients, for the first time, a personalized, T-cell based treatment option.
  • TRANSCEND CLL 004 is the first pivotal multicenter study to show clinical benefit with a CD19-directed CAR T cell therapy in patients with relapsed or refractory CLL after progression following treatment with a BTKi and BCL2i.

GeoVax Reports Third Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Wednesday, November 8, 2023

ET

Key Points: 
  • ET
    ATLANTA, GA, Nov. 08, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced financial results for the third quarter ended September 30, 2023 and provided a business update.
  • GEO-CM04S1 demonstrated potent antibody and cellular immunity in immunocompromised patients in a recent publication in the journal, Vaccines, in August 2023.
  • Cash Position: GeoVax reported cash balances of $12,687,041 at September 30, 2023, as compared to $27,612,732 at December 31, 2023.
  • ET today, November 8, 2023, to review financial results and provide an update on corporate developments.

Adaptive Biotechnologies Announces New Translational Collaboration to Measure Minimal Residual Disease with clonoSEQ® Assay Across BeiGene’s Lymphoid Malignancy Pipeline

Retrieved on: 
Tuesday, November 7, 2023

“Adaptive is pleased to partner with BeiGene to support the clinical development and potential regulatory approval of their investigational therapies in lymphoid malignancies,” said Mary Pat Lancelotta, Senior Vice President, BioPharma at Adaptive Biotechnologies.

Key Points: 
  • “Adaptive is pleased to partner with BeiGene to support the clinical development and potential regulatory approval of their investigational therapies in lymphoid malignancies,” said Mary Pat Lancelotta, Senior Vice President, BioPharma at Adaptive Biotechnologies.
  • It has been included in global, label-enabling studies for a multitude of therapies approved over the past several years and is also now widely adopted in the clinic.
  • This multi-year agreement will cover existing and future programs and adds to Adaptive’s growing list of translational collaborations with biopharmaceutical companies.
  • Adaptive will receive an upfront payment and will be eligible to receive future milestone payments upon achievement of specific regulatory milestones in certain geographies.

NovalGen announces one oral and one poster presentation at the 65th American Society of Hematology Annual Meeting

Retrieved on: 
Thursday, November 2, 2023

LONDON, Nov. 02, 2023 (GLOBE NEWSWIRE) -- NovalGen Ltd (“NovalGen”), a biopharmaceutical company developing breakthrough immunotherapies, alongside an Autoregulation platform, today announces the online publication of two abstracts submitted to the American Society of Hematology Annual meeting, to be held December 9-12, 2023 in San Diego, USA.

Key Points: 
  • “We are pleased to announce our forthcoming oral presentation on the hematological arm of the NVG-111-01 Phase I clinical study (NCT04763083).
  • Building upon these achievements, we are advancing the development of NVG-111 into solid tumor indications,” said Professor Amit Nathwani, Founder and CEO of NovalGen.
  • This mitigates adverse events but also facilitates the administration of higher doses over extended durations, thereby expanding the therapeutic index.
  • NovalGen have shown that applying AR to TCEs does not affect the potency, but significantly reduces toxicity in pre-clinical models.

Autolus Therapeutics to Present Clinical Data Updates at the American Society of Hematology (ASH) Annual Meeting 2023 in Two Oral Presentations and Two Poster Presentations

Retrieved on: 
Thursday, November 2, 2023

Additionally, we will be presenting the first AUTO8 clinical data from the MCARTY Phase I study in multiple myeloma.”

Key Points: 
  • Additionally, we will be presenting the first AUTO8 clinical data from the MCARTY Phase I study in multiple myeloma.”
    Session Title: 704.
  • In this session, pooled analysis of data from all patients treated to date in the FELIX study will be presented, with an extended follow up.
  • In the MCARTY study, we demonstrate dual CD19/BCMA targeting, alongside feasibility of clinical grade manufacture by double-transduction.
  • Additionally, obe-cel has been tested in patients with R/R B-cell chronic lymphocytic leukemia (B-CLL) and R/R B-cell non-Hodgkin lymphoma (B-NHL).

Biomea Fusion Announces Two Poster Presentations at Upcoming ASH Annual Meeting 2023

Retrieved on: 
Thursday, November 2, 2023

Both BMF-219 and BMF-500 were originated in-house with Biomea’s proprietary FUSION™ system platform, which discovers and designs next-generation covalent-binding small molecule product candidates.

Key Points: 
  • Both BMF-219 and BMF-500 were originated in-house with Biomea’s proprietary FUSION™ system platform, which discovers and designs next-generation covalent-binding small molecule product candidates.
  • Methods: Doses of BMF-219 are escalated independently for each indication, initially in single-subject cohorts followed by a “3 + 3” design.
  • A subsequent amendment introduced quotas for KMT2Ar (MLL1r), NPM1 and other known menin-dependent mutations: CEBP/A, MLL1-PTD, MN1, NUP98, NUP214, PICALM-AF10, SETBP1.
  • The study was initiated in July 2023 and will enroll ~110 participants at approximately 30 sites.

Biomea Fusion Reports Third Quarter 2023 Financial Results and Corporate Highlights

Retrieved on: 
Monday, October 30, 2023

Both studies are now open for enrollment more than a quarter ahead of schedule.

Key Points: 
  • Both studies are now open for enrollment more than a quarter ahead of schedule.
  • Finally in this quarter, we also initiated the clinical study of our second, Biomea-discovered investigational covalent inhibitor, BMF-500, a novel FLT3 inhibitor.
  • Continued to advance development candidates derived from Biomea’s proprietary FUSION™ System platform to discover novel covalently binding small molecules.
  • G&A expenses were $17.1 million for the nine months ended September 30, 2023 compared to $15.2 million for the same period in 2022.