Fast Track | Jotup

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.

AVEO Oncology Enrolls First Patient in Pivotal FIERCE-HN Clinical Trial to Evaluate Ficlatuzumab in Combination with ERBITUX® (cetuximab) in Patients with HPV-negative Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC)

Retrieved on:

Tuesday, January 16, 2024

Ficlatuzumab, Patient, Outline of health sciences, HGF, HNSCC, Survival, Cetuximab, Medicine, Cancer, George Washington School, Optimism, Food, Hepatocyte growth factor, Fast Track, HPV, LG Chem, MPH

BOSTON, Jan. 16, 2024 (GLOBE NEWSWIRE) -- AVEO Oncology (“AVEO”), an LG Chem company, today announced enrollment of the first patient in the FIERCE-HN trial, a global, multicenter, randomized, double-blind, placebo-controlled, phase 3 clinical trial evaluating ficlatuzumab in combination with ERBITUX® (cetuximab), an anti-EGFR antibody, in patients with human papillomavirus (HPV)-negative recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC).

Key Points:

BOSTON, Jan. 16, 2024 (GLOBE NEWSWIRE) -- AVEO Oncology (“AVEO”), an LG Chem company, today announced enrollment of the first patient in the FIERCE-HN trial, a global, multicenter, randomized, double-blind, placebo-controlled, phase 3 clinical trial evaluating ficlatuzumab in combination with ERBITUX® (cetuximab), an anti-EGFR antibody, in patients with human papillomavirus (HPV)-negative recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC).
Ficlatuzumab is AVEO’s investigational antibody that targets hepatocyte growth factor (HGF).
That designation followed AVEO’s June 2021 announcement of positive results from a randomized phase 2 study of ficlatuzumab alone or in combination with cetuximab in patients with pan-refractory, metastatic HNSCC.
“We therefore approach the FIERCE-HN trial with a mix of urgency and optimism, as the combination of ficlatuzumab and cetuximab has the potential to expand the range of viable therapeutic options for this underserved population.”

Taysha Gene Therapies Announces First Pediatric Patient Dosed with TSHA-102 in REVEAL Phase 1/2 Pediatric Trial in Rett Syndrome

Retrieved on:

Wednesday, January 10, 2024

DALLAS, Jan. 10, 2024 (GLOBE NEWSWIRE) -- Taysha Gene Therapies, Inc. (Nasdaq: TSHA), a clinical-stage gene therapy company focused on developing and commercializing AAV-based gene therapies for the treatment of monogenic diseases of the central nervous system (CNS), today announced that the first pediatric patient has been dosed with TSHA-102 in the REVEAL Phase 1/2 pediatric trial in the United States (U.S.) evaluating the safety and preliminary efficacy of TSHA-102 in stage three female patients 5-8 years of age with Rett syndrome. The Company also announced the United Kingdom (U.K.) Medicines and Healthcare products Regulatory Agency (MHRA) has authorized the Clinical Trial Application (CTA) for TSHA-102 in pediatric patients, enabling expansion of the ongoing U.S. REVEAL pediatric trial into the U.K.

Key Points:

Initiation of REVEAL pediatric trial in the U.S. broadens the clinical evaluation of TSHA-102 to female patients 5-8 years old with stage three Rett syndrome
MHRA authorized the CTA for TSHA-102 in pediatric patients with Rett syndrome, enabling expansion of ongoing U.S.
“Dosing the first pediatric patient with Rett syndrome marks an important step forward in our efforts to broaden the clinical evaluation of TSHA-102 to younger patients with earlier stages of Rett syndrome.
“The pediatric trial will build on our ongoing REVEAL adolescent and adult trial, where early data demonstrated improvements across multiple clinical domains in adult patients with the most advanced stage of disease.
TSHA-102 is also being evaluated in the ongoing first-in-human REVEAL Phase 1/2 adolescent and adult trial in females aged 12 and older with Rett syndrome in Canada.

SELLAS Life Sciences Receives FDA Fast Track Designation for SLS009 for Treatment of Relapsed/Refractory Acute Myeloid Leukemia and Provides Updated Data for Phase 2a Study of SLS009 in Relapsed/Refractory Acute Myeloid Leukemia Patients

Retrieved on:

Tuesday, January 9, 2024

Venetoclax, Patient, CRC, MRD, EFS, MD, OS, Acute myeloid leukemia, SLS, COVID, PD, Standard of care, Azacitidine, Food, COVID 19, Disease, Safety, Doctor of Science, Sepsis, Fast Track, FDA, AML, Treatment, CDK9, Pharmaceutical industry

NEW YORK, Jan. 09, 2024 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to SLS009 (formerly GFH009), its novel and highly selective CDK9 inhibitor, for the treatment of relapsed/refractory (r/r) acute myeloid leukemia (AML). The Fast Track Designation is intended to facilitate the development and review of drugs to treat serious conditions and fill an unmet medical need.

Key Points:

The Fast Track Designation is intended to facilitate the development and review of drugs to treat serious conditions and fill an unmet medical need.
Importantly, as of the last follow-up, eight of the nine patients enrolled in the 45 mg cohort were alive.
The first patient enrolled in the study achieved a complete response (CR) and continues on study in the seventh month with full peripheral blood recovery.
Eight patients (89%) remain alive (one patient succumbed to sepsis having previously contracted COVID 19) and six continue treatment.

TCL Joins NEXTGEN TV, Adding More Receiver Options for Consumers at Retail in 2024

Retrieved on:

Monday, January 8, 2024

WASHINGTON, Jan. 8, 2024 /PRNewswire/ -- Pearl TV, the consortium of U.S. broadcast companies leading the nation's transition to NEXTGEN TV and its network partners, today congratulated TCL's participation in the U.S.' NEXTGEN TV transition and its new NEXTGEN TV models coming to retail in 2024. TCL, a Fast Track partner of Pearl TV and the Pearl Network Consortia, joins a growing NEXTGEN TV receiver retail marketplace throughout the country of more than 100 models across Hisense, LG Electronics, Samsung and Sony. With four major television manufacturers supporting NEXTGEN TV in 2024, an expanding upgrade accessory device market, and broadcasters reaching 75% of U.S. households before mid-February, consumers now have more device and content choice when it comes to their news and entertainment.

Key Points:

TCL, a Fast Track partner of Pearl TV and the Pearl Network Consortia, joins a growing NEXTGEN TV receiver retail marketplace throughout the country of more than 100 models across Hisense, LG Electronics, Samsung and Sony.
"As TCL joins NEXTGEN TV, America's broadcasters and other leading manufacturers, the brand is once again underscoring the value and innovation it's known for.
We congratulate and are thrilled to welcome TCL to NEXTGEN TV, and the expanded choices it has created for consumers when they invest in their next television."
Media and analysts interested in meeting with the NEXTGEN TV team at CES 2024 can contact [email protected] , or visit booth #19744, Central Hall, at the show.

FDA Grants Soligenix "Fast Track" Designation for Dusquetide in the Treatment of Oral Lesions of Behçet's Disease

Retrieved on:

Monday, January 8, 2024

Vasculitis, Disease, Food, FDA, NDA, Doctor of Philosophy, Aphthous stomatitis, Shirin David, Conditional sentence, Patient, Radiation, Fast Track, Skin, Mucositis, Pharmaceutical industry

Fast track is a designation that the FDA reserves for a drug intended to treat a serious or life-threatening condition and one that demonstrates the potential to address an unmet medical need for the condition.

Key Points:

Fast track is a designation that the FDA reserves for a drug intended to treat a serious or life-threatening condition and one that demonstrates the potential to address an unmet medical need for the condition.
Fast track designation is intended to facilitate the development and expedite the review of new drugs and biologics.
"We are very pleased to have SGX945 in Behçet's Disease granted fast track designation from the FDA," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix.
"As demonstrated by the granting of the designation, our previous studies with dusquetide in oral mucositis have clearly validated the biologic activity in aphthous ulcers induced by chemotherapy and radiation.

Caribou Biosciences Appoints Tim Kelly as Chief Technology Officer and Highlights Multiple Clinical Catalysts Expected in 2024

Retrieved on:

Sunday, January 7, 2024

-- Caribou to present at 42nd Annual J.P. Morgan Healthcare Conference on Thursday, January 11, at 11:15 am PST --

Key Points:

In addition, Caribou highlighted successful execution across its allogeneic CAR-T cell therapy platform over the past year and provided an outlook on multiple clinical catalysts planned for 2024.
We are excited to kick off 2024 by welcoming Tim Kelly as Caribou’s chief technology officer,” said Rachel Haurwitz, PhD, Caribou’s president and chief executive officer.
Appointed Tim Kelly as Caribou’s chief technology officer, leading the company’s process development and manufacturing organizations.
CB-012: Caribou plans to initiate patient enrollment in the AMpLify Phase 1 clinical trial in r/r AML in H1 2024.

ProfoundBio Announces Rinatabart Sesutecan FDA Fast Track Designation for Patients with Advanced Ovarian Cancer

Retrieved on:

Friday, January 5, 2024

Cancer, FDA, Ovarian cancer, Patient, Food, Therapy, ADC, Fast Track, Pharmaceutical industry

SEATTLE, Jan. 5, 2024 /PRNewswire/ -- ProfoundBio , a clinical-stage biotechnology company developing novel antibody-drug conjugate (ADC) therapeutics for cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for rinatabart sesutecan (Rina-S; PRO1184), a folate receptor alpha (FRα) targeted ADC, for the treatment of patients with FRα-expressing high-grade serous or endometrioid platinum-resistant ovarian cancer.

Key Points:

SEATTLE, Jan. 5, 2024 /PRNewswire/ -- ProfoundBio , a clinical-stage biotechnology company developing novel antibody-drug conjugate (ADC) therapeutics for cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for rinatabart sesutecan (Rina-S; PRO1184), a folate receptor alpha (FRα) targeted ADC, for the treatment of patients with FRα-expressing high-grade serous or endometrioid platinum-resistant ovarian cancer.
Fast Track designation is intended to facilitate the development and expedited review of drugs with demonstrated potential to improve over available therapy for serious conditions with unmet medical need.
"Our receipt of Fast Track designation from the FDA underscores our belief in the tremendous promise of Rina-S as a potential best-in-class FRα ADC to address the significant need for improved treatment options for advanced ovarian cancer," said Naomi Hunder, Chief Medical Officer of ProfoundBio.
"FRα is a highly prevalent antigen in ovarian cancer and Rina-S has shown encouraging antitumor activity and tolerability in our Phase 1 dose escalation study in ovarian and endometrial cancer patients across the full spectrum of FRα expression.

Aqua-Tots Swim Schools Swimming Into the Jersey Shore With Newest Location Coming Soon to Toms River

Retrieved on:

Thursday, January 4, 2024

Interest, School, Social media, Family, Curriculum, Parent, Swimming, Fast Track, Life

TOMS RIVER, N.J., Jan. 04, 2024 (GLOBE NEWSWIRE) -- Aqua-Tots Swim Schools , the largest international swim school franchise, is thrilled to announce its third location coming soon to New Jersey.

Key Points:

TOMS RIVER, N.J., Jan. 04, 2024 (GLOBE NEWSWIRE) -- Aqua-Tots Swim Schools , the largest international swim school franchise, is thrilled to announce its third location coming soon to New Jersey.
Aqua-Tots Swim Schools’ world-renowned curriculum has been trusted by parents since 1991 and is used in 14 countries to create safe and confident swimmers for life.
First-time franchisees, Ruddy and Stephanie Lopez, are excited to bring Aqua-Tots’ proven program to the community of Toms River.
To learn more about swim lessons at Aqua-Tots Toms River or to enroll, please visit aqua-tots.com/toms-river , call 732-917-4743 or email [email protected] .

Enanta Pharmaceuticals to Provide Updates on its Research and Development Programs and 2024 Outlook at the 42nd Annual J.P. Morgan Healthcare Conference

Retrieved on:

Thursday, January 4, 2024

Our foundational capabilities in virology and small molecule drug development transition well to immunology, an adjacent field where we can leverage our core strengths.

Key Points:

Our foundational capabilities in virology and small molecule drug development transition well to immunology, an adjacent field where we can leverage our core strengths.
The company has developed novel, potent and selective oral inhibitors of KIT, which are now being optimized in preclinical development.
Enanta will present new preclinical data on its prototype KIT inhibitor at the J.P. Morgan Conference and is targeting the selection of a development candidate in 2024.
A replay of the webcast will be available following the presentation and will be archived for approximately 60 days.