Sulfonamides

BeiGene Announces Positive Topline Results from Phase 3 SEQUOIA Trial Comparing BRUKINSA® (Zanubrutinib) to Bendamustine Plus Rituximab in Patients with Treatment-Naïve Chronic Lymphocytic Leukemia

Retrieved on: 
Friday, July 30, 2021

Long-term results from BGB-3111-205 with a median follow-up time of 34 months were reported at the EHA2021 Congress in June 2021.

Key Points: 
  • Long-term results from BGB-3111-205 with a median follow-up time of 34 months were reported at the EHA2021 Congress in June 2021.
  • SEQUOIA is a randomized, multicenter, global Phase 3 trial (NCT03336333) designed to evaluate the efficacy and safety of BRUKINSA compared to B+R in patients with TN CLL or SLL.
  • Patients with del(17p) were not randomized to B+R, as they experience poor clinical outcomes and poor response to chemoimmunotherapy.
  • This cohort of patients with del(17p) achieved significant efficacy with an 18-month PFS of 90.6%, as assessed by investigator.

MediWound Announces Initiation of U.S. Phase I/II Study of MW005 for the Treatment of Basal Cell Carcinoma

Retrieved on: 
Monday, July 26, 2021

YAVNE, Israel, July 26, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company focused on next-generation bio-therapeutics solutions for tissue repair and regeneration, today announced initiation of its phase I/II study of MW005 for the treatment of low-risk Basal Cell Carcinoma (BCC). In parallel, an investigator-initiated phase II trial of MW005 in non-melanoma skin cancers is being conducted at the Soroka Medical Center in Israel. MediWound expects that data from both studies will be available by the end of 2021.

Key Points: 
  • In parallel, an investigator-initiated phase II trial of MW005 in non-melanoma skin cancers is being conducted at the Soroka Medical Center in Israel.
  • We are excited to initiate this U.S. phase I/II study of MW005, which is the first step in this important clinical development program.
  • MW005, a topical biological drug for the treatment of non-melanoma skin cancers, is a clinical-stage product candidate under development.
  • MW005, our topical biological drug for the treatment of non-melanoma skin cancers, is a clinical-stage product candidate under development.

Gilead Submits New Drug Application to U.S. Food and Drug Administration for Lenacapavir, an Investigational, Long-Acting Capsid Inhibitor for the Treatment of HIV-1 in People With Limited Therapy Options

Retrieved on: 
Monday, June 28, 2021

Gilead plans to submit marketing authorization applications for lenacapavir to the European Medicines Agency and other global agencies in the coming months.

Key Points: 
  • Gilead plans to submit marketing authorization applications for lenacapavir to the European Medicines Agency and other global agencies in the coming months.
  • Lenacapavir is a potential first-in-class, long-acting HIV-1 capsid inhibitor in development for the treatment and prevention of HIV-1 infection.
  • GILEAD and the GILEAD logo are trademarks of Gilead Sciences, Inc. All other trademarks are the property of their respective owners.
  • For more information about Gilead, please visit the companys website at www.gilead.com , follow Gilead on Twitter ( @Gilead Sciences ) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

Corcept Therapeutics Settles Patent Litigation with Sun Pharmaceutical

Retrieved on: 
Tuesday, June 15, 2021

The settlement agreement is subject to entry by the Court of a stipulation and order of dismissal related to the litigation.

Key Points: 
  • The settlement agreement is subject to entry by the Court of a stipulation and order of dismissal related to the litigation.
  • As required by law, Corcept and Sun will submit the agreement to theUnited States Federal Trade Commission(FTC) and theUnited States Department of Justice(DOJ) for review.
  • Similar patent litigation brought byCorceptagainst two other companies that have filed ANDAs seeking approval to market generic Korlym remains pending.
  • Corcept has discovered a large portfolio of proprietary compounds, including relacorilant, that selectively modulate the effects of cortisol.

Safety Data Highlighting Low Rates of Adverse Events and Non-Relapse Transplant Related Mortality in Patients Receiving Iomab-B Presented at 2021 SNMMI Virtual Conference

Retrieved on: 
Tuesday, June 15, 2021

Via the monoclonal antibody apamistamab, Iomab-B targets CD45, an antigen widely expressed on leukemia and lymphoma cancer cells, immune cells and stem cells.

Key Points: 
  • Via the monoclonal antibody apamistamab, Iomab-B targets CD45, an antigen widely expressed on leukemia and lymphoma cancer cells, immune cells and stem cells.
  • A bone marrow transplant is often considered the only potential cure for patients with certain blood-borne cancers and blood disorders.
  • The SIERRA trial is over seventy-five percent enrolled and positive single-agent, feasibility and safety data has been highlighted at ASH, TCT, ASCO and SOHO annual meetings.
  • Ongoing combination trials include our CD33 alpha ARC, Actimab-A, in combination with the salvage chemotherapy CLAG-M and the Bcl-2 targeted therapy venetoclax.

AbbVie to Showcase Breadth of Oncology Portfolio and Pipeline at the 2021 ASCO and EHA Annual Congresses

Retrieved on: 
Wednesday, May 19, 2021

In some blood cancers, BCL-2 prevents cancer cells from undergoing their natural death or self-destruction process, called apoptosis.

Key Points: 
  • In some blood cancers, BCL-2 prevents cancer cells from undergoing their natural death or self-destruction process, called apoptosis.
  • VENCLXEXTA/VENCLYXTO targets the BCL-2 protein and works to help restore the process of apoptosis.\nVENCLEXTA/VENCLYXTO is being developed by AbbVie and Roche.
  • It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S.
  • Together, the companies are committed to BCL-2 research and to studying venetoclax in clinical trials across several blood cancers.

Vincerx Pharma Announces FDA Clearance of IND for Phase 1b Study of VIP152 in Chronic Lymphocytic Leukemia and Richter Syndrome

Retrieved on: 
Tuesday, April 20, 2021

\xe2\x80\x9cPreclinical data for VIP152 show highly selective, ATP-independent, inhibition of CDK9 which translates to robust on-target activity across key gene targets.

Key Points: 
  • \xe2\x80\x9cPreclinical data for VIP152 show highly selective, ATP-independent, inhibition of CDK9 which translates to robust on-target activity across key gene targets.
  • Part 1 of the study will enroll CLL patients treated with \xe2\x89\xa52 prior regimens including either a BTKi or venetoclax.
  • The Company expects to initiate the Phase 1b dose-escalation study in 2H 2021.\nThe Phase 1b dose-escalation in CLL and RS builds upon Vincerx\xe2\x80\x99s ongoing first-in-human (FIH) study in patients with advanced cancer.
  • Forward-looking statements speak only as of the date hereof, and Vincerx disclaims any obligation to update any forward-looking statements.\n'

Lilly and Incyte's Baricitinib Improved Hair Regrowth for Alopecia Areata Patients in Second Phase 3 Study

Retrieved on: 
Tuesday, April 20, 2021

In both investigational trials, a statistically significant proportion of patients treated with baricitinib achieved the primary endpoint of hair regrowth across the two dosing regimens at Week 36 compared to patients treated with placebo.

Key Points: 
  • In both investigational trials, a statistically significant proportion of patients treated with baricitinib achieved the primary endpoint of hair regrowth across the two dosing regimens at Week 36 compared to patients treated with placebo.
  • "\nThe BRAVE-AA trial program was designed to evaluate the efficacy and safety of baricitinib in adult patients with severe AA.
  • Based on interim results of the Phase 2 portion of BRAVE-AA1 at Week 12, baricitinib 2-mg and 4-mg once-daily doses were selected for further evaluation in the Phase 3 portion of the study.
  • BRAVE-AA2 is a multicenter, randomized, double-blind, placebo-controlled study evaluating the baricitinib 2-mg and 4-mg dosing regimens versus placebo.

BenevolentAI: Data from Eli Lilly's COV-BARRIER trial shows baricitinib reduced deaths in hospitalised COVID-19 patients by 38%

Retrieved on: 
Thursday, April 8, 2021

The COV-BARRIER results further validate BenevolentAI's AI-derived hypothesis, first published in early February 2020, which prompted additional global trials and investigations into its efficacy as a treatment for critically ill COVID-19 patients.

Key Points: 
  • The COV-BARRIER results further validate BenevolentAI's AI-derived hypothesis, first published in early February 2020, which prompted additional global trials and investigations into its efficacy as a treatment for critically ill COVID-19 patients.
  • In the COV-BARRIER study, baricitinib was given in addition to the standard of care, which included dexamethasone in the majority of patients.
  • The significant reduction in mortality demonstrated in the COV-BARRIER trial follows several published studies confirming baricitnib's therapeutic effect, such as those in EMBO Mol Med , Science Advances , J. Clin.
  • Baricitinib is approved for the treatment of rheumatoid arthritis and other diseases.

BenevolentAI: Data from Eli Lilly's COV-BARRIER trial shows baricitinib reduced deaths in hospitalised COVID-19 patients by 38%

Retrieved on: 
Thursday, April 8, 2021

The COV-BARRIER results further validate BenevolentAI's AI-derived hypothesis, first published in early February 2020, which prompted additional global trials and investigations into its efficacy as a treatment for critically ill COVID-19 patients.

Key Points: 
  • The COV-BARRIER results further validate BenevolentAI's AI-derived hypothesis, first published in early February 2020, which prompted additional global trials and investigations into its efficacy as a treatment for critically ill COVID-19 patients.
  • In the COV-BARRIER study, baricitinib was given in addition to the standard of care, which included dexamethasone in the majority of patients.
  • The significant reduction in mortality demonstrated in the COV-BARRIER trial follows several published studies confirming baricitnib's therapeutic effect, such as those in EMBO Mol Med , Science Advances , J. Clin.
  • Baricitinib is approved for the treatment of rheumatoid arthritis and other diseases.