GB004 / Whitehawk Therapeutics - LARVOL DELTA

GOSSAMER BIO, INC. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS (form 10-Q) (Market Screener) - "Research and development expenses were $44.5 million for the three months ended September 30, 2022, compared to $43.2 million for the three months ended September 30, 2021...offset by a decrease of $7.8 million of costs associated with preclinical studies and clinical trials for GB004, a decrease of $1.8 million of costs associated with preclinical studies for other discontinued programs, and a decrease of $1.2 million of costs associated with preclinical studies and clinical trials for other programs."

Commercial • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

AADI BIOSCIENCE, INC. Management's Discussion and Analysis of Financial Condition and Results of Operations. (form 10-Q) (Market Screener) - "The Gossamer License Agreement will terminate, effective July 24, 2022. We fully impaired the intangible asset, $3.7 million, of which the Gossamer License Agreement for GB004 is the sole underlying asset, during the three and six months ended June 30, 2022."

Licensing / partnership • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

SHIFT-UC: A Study With GB004 in Adult Subjects With Active Ulcerative Colitis (UC) (clinicaltrials.gov) - P2 | N=236 | Terminated | Sponsor: GB004, Inc. | Trial completion date: Feb 2023 ➔ Jun 2022 | Active, not recruiting ➔ Terminated | Trial primary completion date: Feb 2023 ➔ Jun 2022; Study terminated due to lack of treatment benefit.

Trial completion date • Trial primary completion date • Trial termination • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Gossamer Bio Announces GB004 Topline Results from Phase 2 SHIFT-UC Study in Ulcerative Colitis and Provides Corporate Update (Businesswire) - P1 | N=195 | SHIFT-UC (NCT04556383) | Sponsor: GB004, Inc. | "Gossamer Bio, Inc...announced topline results from its Phase 2 SHIFT-UC Study clinical trial studying GB004 in patients with mild-to-moderate active ulcerative colitis (UC). Neither GB004 treatment arm met the primary or secondary endpoints at week 12. Based on the totality of the available data, Gossamer will terminate the ongoing treat-through and open-label extension portions of the Phase 2 SHIFT-UC Study for lack of treatment benefit."

P2 data • Trial termination • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Editorial: protecting hypoxia-inducible factor 1a and gut integrity with GB004-a promising therapeutic approach for ulcerative colitis? Authors’ reply. (PubMed, Aliment Pharmacol Ther) - No abstract available

Journal • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis • HIF1A

Randomised clinical trial: a phase 1b study of GB004, an oral HIF-1α stabiliser, for treatment of ulcerative colitis. (PubMed, Aliment Pharmacol Ther) - P1b, P2 | "Results from this phase 1b trial support evaluation of the full therapeutic potential of GB004 for the treatment of UC. A phase 2 study (NCT04556383) is ongoing. Clinicaltrials.gov NCT03860896."

Clinical • Journal • P1 data • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis • HIF1A

Editorial: protecting hypoxia-inducible factor-1α and gut integrity with GB004-a promising therapeutic approach for ulcerative colitis? (PubMed, Aliment Pharmacol Ther) - No abstract available

Journal • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis • HIF1A

Gossamer Bio Announces Fourth Quarter and Full-Year 2021 Financial Results and Provides Business Update (Businesswire) - "Research and Development (R&D) Expenses: For the quarter ended December 31, 2021, R&D expenses were $40.9 million compared to R&D expenses of $38.9 million for the same period in 2020. R&D expenses for the full year ended December 31, 2021, were $170.3 million compared to $160.9 million for the full year ended December 31, 2020. The increase was primarily attributable to an increase of clinical trial and preclinical study costs associated with...GB004...and preclinical programs."

Commercial • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

SHIFT-UC: A Study With GB004 in Adult Subjects With Active Ulcerative Colitis (UC) (clinicaltrials.gov) - P2 | N=195 | Active, not recruiting | Sponsor: GB004, Inc. | Trial primary completion date: Mar 2022 ➔ Feb 2023

Trial primary completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Gossamer Bio Announces Third Quarter 2021 Financial Results and Provides Corporate Update (Businesswire) - "GB004: Oral, Gut-Targeted HIF-1α Stabilizer for Inflammatory Bowel Disease (IBD)...12-week topline data from the SHIFT-UC study are expected in the second quarter of 2022. 36-week topline data from the treat-through portion of the SHIFT-UC study are expected in the fourth quarter of 2022."

P2 data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

SHIFT-UC: A Study With GB004 in Adult Subjects With Active Ulcerative Colitis (UC) (clinicaltrials.gov) - P2; N=195; Active, not recruiting; Sponsor: GB004, Inc.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

[VIRTUAL] ASSESSMENT OF COMPOSITE ENDPOINTS COMPRISING SYMPTOMATIC, HISTOLOGIC, ENDOSCOPIC, AND MOLECULAR IMPROVEMENT IN A PHASE 1B STUDY OF GB004, A GUT-TARGETED, HYPOXIA-INDUCIBLE FACTOR (HIF)-1Α STABILIZER, IN MILD-TO-MODERATE ULCERATIVE COLITIS: Discussion (UEGW 2021) - No abstract available

P1 data • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

[VIRTUAL] ASSESSMENT OF COMPOSITE ENDPOINTS COMPRISING SYMPTOMATIC, HISTOLOGIC, ENDOSCOPIC, AND MOLECULAR IMPROVEMENT IN A PHASE 1B STUDY OF GB004, A GUT-TARGETED, HYPOXIA-INDUCIBLE FACTOR (HIF)-1Α STABILIZER, IN MILD-TO-MODERATE ULCERATIVE COLITIS (UEGW 2021) - P2 | "GB004 demonstrated preliminary evidence of an effect across a breadth and depth of multiple aspects of UC disease burden, as defined by concurrent achievement of SI, HI/MH, and MI at 28 days relative to placebo. Use of composite endpoints may decrease placebo response and enhance signal detection. SHIFT-UC, a Phase 2 study of GB004 as a tablet formulation in mild to moderate UC, is ongoing and will further evaluate GB004’s efficacy, including the exploratory composite endpoint of disease clearance (clinical remission and MH) (EudraCT 2020-002306-12; NCT04556383)."

P1 data • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Gossamer Bio Announces Second Quarter 2021 Financial Results and Provides Corporate Update (Businesswire) - "Enrollment is ongoing in the SHIFT-UC Study, a Phase 2 clinical trial in patients with active UC despite treatment with 5-ASAs...Topline data from the SHIFT-UC study are expected in the first half of 2022, subject to developments in the ongoing COVID-19 pandemic. Additional post-hoc analysis of clinical data from the completed GB004 Phase 1b in patients with active UC will be presented at the United European Gastroenterology (UEG) Virtual Week 2021 being held virtually from October 3 – 5, 2021."

Enrollment status • P1 data • P2 data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Gossamer Bio Announces GB004 Clinical Trial Data Presentations at 2021 Virtual Congress of the European Crohn’s and Colitis Organisation (Businesswire) - "Gossamer Bio, Inc...announced that it will present data related to GB004 at the 2021 Virtual Congress of the European Crohn’s and Colitis Organisation (ECCO), to be held virtually from July 2-3 and 8-10. On July 8, William Sandborn, M.D., will present a digital oral presentation, which will include target engagement and pharmacodynamic biomarker data from the completed GB004 Phase 1b clinical trial in patients with mild-to-moderate ulcerative colitis."

P1 data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

[VIRTUAL] Target engagement and pharmacodynamic biomarker analysis following treatment with the oral gut-targeted HIF-1α stabilizer GB004 in a Phase 1b trial in Active Ulcerative Colitis (ECCO-IBD 2021) - P2 | "A Phase 2 study of GB004 in patients with mild-to-moderate UC (SHIFT-UC, NCT04556383) is currently ongoing. Sponsored by GB004, Inc., a wholly owned subsidiary of Gossamer Bio, Inc."

Biomarker • P1 data • PK/PD data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis • HIF1A • ITGA6 • MPO • TJP1

[VIRTUAL] GB004 drives protective effects on immune cells and epithelial cells using human ex vivo monolayer and co-culture systems (ECCO-IBD 2021) - P2 | "Targeting both barrier function and local colonic inflammation represents a multi-faceted approach to treatment of inflammatory bowel disease. A phase 2 clinical study of GB004 is ongoing in patients with ulcerative colitis (NCT04556383)."

Preclinical • Inflammatory Bowel Disease • Ulcerative Colitis • CXCL11 • CXCL8 • HIF1A • TJP1 • TNFA

[VIRTUAL] GB004 EXHIBITS PROTECTIVE EFFECTS DIRECTLY ON EPITHELIAL CELLS USING EX VIVO ORGANOID AND MONOLAYER CULTURES (DDW 2021) - P1b | "GB004 demonstrates direct protective effects on mouse and human-derived organoid and 2D monolayer epithelial cultures in vitro by reducing cell apoptosis, preserving tight junctions, and improving barrier integrity. Data generated in human intestinal-derived monolayers support direct barrier integrity effects similar to data generated in mouse organoid assays and efficacy studies in mouse colitis. A phase 1b study of GB004 was recently completed in patients with ulcerative colitis (NCT03860896)."

Preclinical • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • CLDN1 • HIF1A • IFNG • TNFA

[VIRTUAL] PHARMACOLOGICAL HIF-1 STABILIZATION PROMOTES INTESTINAL EPITHELIAL HEALING THROUGH REGULATION OF Α-INTEGRIN EXPRESSION AND FUNCTION (DDW 2021) - "However, integrins function as αβ-dimers and α-integrin-matrix binding is critical for cell migration.We hypothesized that HIF-1 stabilization accelerates epithelial migration through integrin-dependent pathways.We aimed to examine functional and post-translational activity of α-integrins, during HIF-1-mediated intestinal epithelial healing.Wound healing was assessed via migration and proliferation rates in T84 cell monolayers over 24 hours with or without prolyl hydroxylase inhibitor (PHDi) (GB-004), which stabilizes HIF-1...PHDi treatment accelerated wound closure via migration (+6.10% ± 0.55, p<0.0001) and proliferation (+8.81% ± 1.84, p<0.0001) within 12 hours and this was associated with increased integrin-α2 (1.54-fold ± 0.48, p=0.0070) and α6 (1.62-fold ± 0.34, p=0.0230) protein expression. Accelerated wound closure was significantly inhibited by functional blockade of integrins-α2 (-7.58% ± 2.16, p=0.0058) and α6 (-9.45% ±..."

Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • HIF1A

Gossamer Bio Announces First Quarter 2021 Financial Results and Provides Corporate Update (Businesswire) - "Enrollment ongoing in the SHIFT-UC Study, a Phase 2 clinical trial in patients with active UC despite treatment with 5-ASAs. The primary endpoint is proportion of patients with clinical remission at week 12. Topline data from the SHIFT-UC study are expected in the first half of 2022...Research and Development (R&D) Expenses: For the quarter ended March 31, 2021, R&D expenses were $41.8 million, compared to R&D expenses of $41.4 million for the same period in 2020."

Commercial • Enrollment status • P2 data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Gossamer Bio Announces Fourth Quarter and Full-Year 2020 Financial Results and Provides Business Update (Businesswire) - "GB004:...Enrollment ongoing in the SHIFT-UC Study...Topline data from the SHIFT-UC study are expected in the first half of 2022, subject to developments in the ongoing COVID-19 pandemic...Research and Development (R&D) Expenses: For the quarter ended December 31, 2020, R&D expenses were $38.9 million compared to R&D expenses of $42.6 million for the same period in 2019...The increases were primarily due to an increase in expenses for GB004, seralutinib, GB1275 and preclinical programs."

Commercial • Enrollment status • P2 data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Ministry of Food and Drug Safety approved two clinical trials, including ulcerative colitis treatment [Google translation] (Health Korea News) - "The Ministry of Food and Drug Safety approved two clinical trials, including a treatment for ulcerative colitis...PSICRO Korea will conduct phase 2 clinical trials of 'GB004' at Dong-A University Hospital, Wonju Severance Hospital, Gangbuk Samsung Hospital, Haeundae Paik Hospital, Chilgok Kyungpook National University Hospital, and Seoul St. Mary's Hospital."

New P2 trial • Non-US regulatory • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Gossamer Bio to Host Webcast Focused on its Inflammatory Bowel Disease Program, GB004, on February 18, 2021 (Businesswire) - "Gossamer Bio, Inc...announced that it will host a conference call and webcast for investors and analysts on Thursday, February 18, 2021 at 11:00am ET to discuss GB004...for the treatment of inflammatory bowel disease (IBD), including ulcerative colitis (UC). Gossamer management will present alongside key IBD and HIF biology opinion leaders, including: William Sandborn..."

Review • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Pharmacological HIF-1 stabilization promotes intestinal epithelial healing through regulation of α-integrin expression and function. (PubMed, Am J Physiol Gastrointest Liver Physiol) - "Wound healing was assessed in T84 monolayers over 24 hours with/without prolyl-hydroxylase inhibitor (PHDi) (GB-004), which stabilizes HIF-1...PHDi-treatment increased α6 protein levels in colonocytes of TNBS mice and induced α6 staining in regenerating crypts and re-epithelialized inflammatory lesions. Together these data demonstrate a role for HIF-1 in regulating both integrin-α2 and α6 responses during intestinal epithelial healing."

Journal • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • HIF1A

A Study With GB004 in Adult Subjects With Active Ulcerative Colitis (UC) (clinicaltrials.gov) - P2; N=195; Recruiting; Sponsor: GB004, Inc.; Trial completion date: Apr 2022 ➔ Feb 2023

Clinical • Trial completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis