Nektar Therapeutics

Robust Pipeline of 50+ Therapies Reshaping Moderate to Severe Atopic Dermatitis Treatment Landscape

3 days ago

• The moderate to severe atopic dermatitis market is experiencing significant growth with 45+ companies developing over 50 pipeline therapies, driven by rising global prevalence and increased awareness of the condition. • Recent advancements include promising biologics like rezpegaldesleukin (granted FDA fast-track designation), JAK inhibitors such as VC005 and QY201, and novel mechanisms targeting IL-4/IL-13 pathways, offering new hope for patients with inadequate response to current treatments. • Key players including Nektar Therapeutics, Corvus Pharmaceuticals, and Apogee Therapeutics are advancing clinical trials with significant milestones expected in late 2025, potentially transforming the therapeutic landscape for this chronic inflammatory skin condition.

Novel "Off-the-Shelf" CAR NK Cell Therapy Shows Complete Remission in Relapsed AML Patients

25 days ago

• SENTI-202, a first-in-class CAR NK cell therapy using innovative logic-gating technology, achieved complete remission in four of seven evaluable patients with relapsed/refractory acute myeloid leukemia. • Unlike traditional CAR T-cell therapies, SENTI-202 offers an "off-the-shelf" approach using healthy donor cells that can be quickly administered to patients with rapidly progressing AML, addressing a critical treatment gap. • The therapy's dual-targeting mechanism (CD33 and FLT3) combined with an inhibitory receptor that protects healthy cells demonstrates a promising safety profile with durable responses lasting up to eight months.

Mural Therapeutics Discontinues Nemvaleukin Program and Cuts 90% of Workforce Following Clinical Setback

a month ago

• Mural Therapeutics has terminated its lead IL-2 program nemvaleukin after the candidate failed to meet clinical endpoints, forcing the company to reduce its workforce by 90%. • Nemvaleukin joins a growing list of unsuccessful IL-2 candidates, including Nektar Therapeutics and Bristol Myers Squibb's bempegaldesleukin, which failed in melanoma, renal cell carcinoma, and urothelial cancer trials. • The setback represents another significant blow to the IL-2 therapeutic class, following Nektar's 2022 program discontinuation that resulted in a 70% workforce reduction despite an initial $1.9 billion investment.

B-Cell Lymphoma Pipeline Expands with 300+ Therapies in Development for 2025

2 months ago

• DelveInsight's latest report reveals a robust B-cell lymphoma pipeline with over 295 companies developing 300+ therapies, highlighting significant industry investment in this area. • Several major pharmaceutical companies including BeiGene, Celgene, Hoffmann-La Roche, and Allogene Therapeutics have initiated pivotal late-stage clinical trials for novel B-cell lymphoma treatments in March 2025. • Emerging therapies include CAR-T cell approaches, bispecific antibodies, and novel targeted agents, with many incorporating dual-targeting mechanisms to overcome resistance seen with single-target therapies.

Canada Expands Access to Rare Disease Medications Through Provincial Agreements

2 months ago

• The Government of Canada has signed bilateral agreements with Yukon and Nova Scotia, investing over $8.5 million and $39 million respectively over three years to improve access to drugs for rare diseases. • The agreements will provide funding for several specialized medications including Yescarta, a CAR T-cell therapy for B-cell lymphomas, and five additional drugs in Nova Scotia for conditions including mycosis fungoides and von Hippel-Lindau disease. • These initiatives are part of Canada's National Strategy for Drugs for Rare Diseases, which aims to help the one in 12 Canadians living with rare diseases access treatments that can cost between $100,000 and $4 million annually.

Nektar and TrialNet Partner to Test Novel T-Cell Therapy Rezpegaldesleukin in Early-Stage Type 1 Diabetes

3 months ago

• Nektar Therapeutics and TrialNet have announced a collaboration to evaluate rezpegaldesleukin, a first-in-class T regulatory cell stimulator, in patients with new-onset type 1 diabetes. • The Phase 2 randomized trial will enroll approximately 70 adults and children, measuring C-peptide preservation over 12 months to assess the drug's potential to slow disease progression. • Rezpegaldesleukin works by expanding regulatory T cells to restore immune balance, targeting the underlying autoimmune mechanism of type 1 diabetes.

Nurix Therapeutics Appoints Former Ibrutinib Commercial Lead as New CCO Ahead of Pivotal BTK Degrader Trial

4 months ago

Nurix Therapeutics has appointed John Northcott, who led the commercialization of BTK inhibitor ibrutinib, as Chief Commercial Officer. The appointment comes as Nurix prepares to launch a pivotal clinical program for NX-5948, their BTK degrader that has shown a 75.5% objective response rate in heavily pretreated B-cell malignancy patients.

Eirion Therapeutics' ET-02 Shows Promise in Phase 1 Trial for Androgenic Alopecia

4 months ago

• Eirion Therapeutics announced positive results from its first-in-man clinical trial of topical ET-02 for androgenic alopecia. • The Phase 1 trial demonstrated that ET-02 was safe and well-tolerated among participants. • Early results indicated that improvements were observed as early as 5 weeks into the treatment. • The 5% dosage of ET-02 showed a significant increase in non-vellus hair count, marking a potential breakthrough in hair loss treatment.

Nektar's Rezpegaldesleukin Receives FDA Fast Track for Atopic Dermatitis Treatment

4 months ago

• The FDA has granted Fast Track designation to rezpegaldesleukin for moderate-to-severe atopic dermatitis in patients 12 years and older. • Rezpegaldesleukin targets the interleukin-2 receptor complex, stimulating regulatory T cell proliferation to restore immune balance. • Phase 2b REZOLVE-AD study has completed enrollment, with topline data expected in Q2 2025, evaluating EASI score improvements. • Fast Track designation allows for more frequent interactions with the FDA, potentially accelerating the drug's development and approval.

Arvinas Advances Vepdegestrant into Phase 3 Trials for Breast Cancer and Updates Pipeline Milestones

4 months ago

• Arvinas plans to initiate two Phase 3 trials in 2025 for vepdegestrant in ER+/HER2- metastatic breast cancer, one in the first-line setting with atirmociclib and another in the second-line setting with a CDK4/6 inhibitor. • Topline data from the Phase 3 VERITAC-2 monotherapy trial of vepdegestrant in second-line-plus ER+/HER2- metastatic breast cancer is anticipated in the first quarter of 2025. • Arvinas is set to present initial data from the Phase 1 trial of ARV-393 in B-cell lymphomas and file an IND application for a novel PROTAC KRAS G12D degrader in 2025. • Phase 1 trial with PROTAC LRRK2 degrader ARV-102 in patients with Parkinson’s disease has been initiated, with data expected to be presented in the first half of 2025.

UNITY Biotechnology Appoints Federico Grossi as Chief Medical Officer

5 months ago

• UNITY Biotechnology appointed Federico Grossi as Chief Medical Officer, enhancing its leadership with his extensive experience in ophthalmology and drug development. • Dr. Grossi previously led the development of SYFOVRE for geographic atrophy at Apellis Pharmaceuticals, bringing a proven track record to UNITY. • His appointment is timely as UNITY anticipates Phase 2b ASPIRE trial results for UBX1325 in diabetic macular edema (DME). • UNITY aims to leverage Dr. Grossi's expertise to advance its pipeline of senolytic treatments for age-related retinal diseases.

Nuvation Bio's Taletrectinib Gains FDA Priority Review and Expanded Access Program for ROS1+ NSCLC

5 months ago

• The FDA granted priority review to Nuvation Bio's NDA for taletrectinib, a next-generation ROS1 inhibitor, for advanced ROS1+ non-small cell lung cancer, setting a PDUFA date of June 23, 2025. • Taletrectinib demonstrated promising efficacy and tolerability in the TRUST-I and TRUST-II trials, showing durable responses and prolonged progression-free survival in ROS1+ NSCLC patients. • Nuvation Bio has initiated an Expanded Access Program (EAP) in the U.S. for taletrectinib, offering access to eligible patients with advanced ROS1+ NSCLC outside of clinical trials. • The NDA is based on pooled data from the TRUST-I and TRUST-II studies, which included over 300 patients, representing the largest ROS1-positive NSCLC dataset supporting an NDA.

Novel HER2-Targeted Therapies Show Promise in Advanced Breast Cancer

6 months ago

• Trastuzumab duocarmazine significantly improves progression-free survival compared to physician's choice in pretreated HER2-positive metastatic breast cancer patients. • Combining eribulin with trastuzumab and pertuzumab demonstrates non-inferior progression-free survival versus taxanes in first-line HER2-positive advanced breast cancer. • Pertuzumab retreatment with trastuzumab and chemotherapy shows a significant overall survival benefit in HER2-positive locally advanced/metastatic breast cancer.

Rezpegaldesleukin Shows Promise in Treating Atopic Dermatitis and Psoriasis

7 months ago

• Phase 1b studies reveal rezpegaldesleukin's efficacy, safety, and tolerability in patients with atopic dermatitis and psoriasis. • The drug dose-dependently increased regulatory T cells and improved disease outcomes, with effects lasting at least 36 weeks post-treatment. • Biomarker analysis indicates rezpegaldesleukin modulates multiple immunoregulatory pathways, potentially attenuating Th1, Th2, and Th17 responses. • Phase 2b studies in atopic dermatitis and alopecia areata are anticipated to release topline data next year.