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Pliant Therapeutics, Inc. reports clinical and corporate developments for a clinical-stage biopharmaceutical company focused on integrin-based therapeutics. Its lead program, PLN-101095, is an oral small-molecule dual-selective inhibitor of αvβ8 and αvβ1 integrins being developed for solid tumors, including immune checkpoint inhibitor-refractory advanced or metastatic disease.
Company updates commonly cover Phase 1 and Phase 1b oncology data, scientific-conference presentations, combination studies with pembrolizumab, financial results, and healthcare investor-conference participation. Pliant also describes preclinical platform work using integrin receptor-binding molecules for tissue-specific delivery and internalization of drug payloads, including programs directed to skeletal muscle cells, adipocytes, and renal cells.
Pliant Therapeutics (Nasdaq: PLRX), a late-stage biotechnology company focused on fibrotic diseases, has appointed Gary Palmer, M.D., MBA as Senior Vice President of Medical Affairs. Dr. Palmer, with over 25 years of global leadership experience, will lead the company's global medical affairs activities, including scientific communications and patient advocacy.
Dr. Palmer's extensive background includes leadership roles at Bristol Myers Squibb, where he led the Worldwide Immunology, Fibrosis and Neuroscience Medical Affairs team. He has also held senior positions at Myovant Sciences, Actelion, Eisai Pharmaceuticals, and Pfizer. His expertise spans pulmonary medicine, immunology, and neurology, with experience in supporting successful and orphan disease products.
Éric Lefebvre, M.D., Chief Medical Officer at Pliant, highlighted Dr. Palmer's experience in building best-in-class Medical Affairs organizations as beneficial for Pliant's growth and portfolio advancement towards commercial stage.
Pliant Therapeutics, Inc. (Nasdaq: PLRX) has announced the granting of stock options to Gary Palmer, M.D., the company's newly appointed Senior Vice President of Medical Affairs. The grant, made on September 30, 2024, includes options to purchase 120,000 shares of common stock as a material inducement to his employment.
The stock options have an exercise price of $11.21 per share, equal to the closing price of Pliant's common stock on the grant date. The options will vest over 4 years, with 25% vesting on the one-year anniversary and the remaining shares vesting monthly at a rate of 1/48th over the subsequent 36 months. The stock options have a 10-year term and are subject to the terms and conditions of the Company's 2022 Inducement Plan.
Pliant Therapeutics (Nasdaq: PLRX) presented data from its bexotegrast program at the European Respiratory Society International Congress 2024. Key findings include:
1. Reduction in type 1 collagen deposition in IPF patients after 12 weeks of bexotegrast treatment, suggesting antifibrotic effects and favorable lung remodeling.
2. Integrated safety summary showing bexotegrast was well-tolerated in Phase 2a trials for IPF and PSC.
3. Preclinical data demonstrating antifibrotic effects in lung slices from various ILD patients, supporting further investigation in ILD-associated progressive pulmonary fibrosis.
4. Post-hoc biomarker analysis revealing reduced levels of ILD progression markers in IPF patients receiving bexotegrast.
Pliant Therapeutics (Nasdaq: PLRX), a clinical-stage biotechnology company focused on developing novel therapeutics for fibrotic diseases, has announced its participation in four major investor events in September 2024. These include:
1. 2024 Wells Fargo Healthcare Conference on September 4
2. H.C. Wainwright 26th Annual Global Investment Conference on September 11
3. 2024 Cantor Global Healthcare Conference on September 17
4. Stifel 2024 Virtual Immunology and Inflammation Summit on September 18
Key executives, including the CEO, CFO, and CMO, will participate in fireside chats at these events. Live webcasts will be available on Pliant's Investor Relations website, with replays archived for 30 days after each event.
Pliant Therapeutics (Nasdaq: PLRX) announced four upcoming presentations at the European Respiratory Society (ERS) International Congress 2024 in Vienna, Austria from September 7-11, 2024. The presentations focus on bexotegrast, a dual αVβ6/αVβ1 integrin inhibitor for treating fibrotic diseases.
Key presentations include:
- Evaluation of bexotegrast's antifibrotic activity in non-IPF interstitial lung disease
- Bexotegrast's effect on type 1 collagen deposition in IPF patients after 12 weeks
- Safety and tolerability of bexotegrast in Phase 2 trials for IPF and primary sclerosing cholangitis
- Post-hoc biomarker analysis in IPF patients receiving bexotegrast over 12 weeks
These presentations highlight Pliant's progress in developing novel therapeutics for fibrotic diseases, particularly idiopathic pulmonary fibrosis (IPF).
Pliant Therapeutics (Nasdaq: PLRX) reported positive results from its Phase 2a PET imaging trial for bexotegrast in IPF patients, showing reduced lung collagen, improved FVC, and reduced cough severity. The company also shared positive long-term data from the INTEGRIS-PSC 320 mg cohort, demonstrating continued antifibrotic and anti-cholestatic activity at 24 weeks.
The BEACON-IPF Phase 2b trial is on track for full enrollment in Q1 2025, with data expected mid-2026. Pliant's pipeline includes PLN-101095 for solid tumors and PLN-101325 for muscular dystrophies. Financially, Q2 2024 saw R&D expenses of $45.6 million, G&A expenses of $15.0 million, and a net loss of $55.9 million. The company ended the quarter with $438.1 million in cash and investments.
Pliant Therapeutics (Nasdaq: PLRX) announced its participation in the Canaccord Genuity 44th Annual Growth Conference. The event will feature a fireside chat with Keith Cummings, M.D., Chief Financial Officer, and Éric Lefebvre, M.D., Chief Medical Officer. The chat is scheduled for Wednesday, August 14, 2024, at 1:00 p.m. Eastern Time at the Intercontinental Hotel in Boston, Massachusetts.
Interested parties can access a live webcast of the fireside chat through Pliant's website Investor Relations' Events & Presentation page. A replay of the webcast will be available on the company's website for 30 days after the event concludes.
Pliant Therapeutics (Nasdaq: PLRX) announced positive 24-week data from the 320 mg cohort of INTEGRIS-PSC, a Phase 2a trial of bexotegrast in primary sclerosing cholangitis (PSC) patients. Key findings include:
1. Safety: Bexotegrast was well-tolerated up to 40 weeks with no treatment-related severe or serious adverse events.
2. Efficacy: Improvement in liver stiffness at Week 24 compared to placebo, statistically significant improvement in alkaline phosphatase (ALP) levels, and continued improvement in hepatocyte function and bile flow.
3. FDA Guidance: The FDA supports a 52-week, dose-ranging Phase 2b trial using non-invasive endpoints for the next steps in PSC development.
These results suggest bexotegrast's potential for disease stabilization in PSC, a rare liver disease with no FDA or EMA-approved therapies.
Pliant Therapeutics (Nasdaq: PLRX) has appointed Steve Krognes to its Board of Directors as announced on June 13, 2024. Krognes brings over 30 years of financial and corporate strategy experience in the biopharmaceutical industry. His prior roles include Chief Financial Officer at Denali Therapeutics and Genentech, and Global Head of Mergers and Acquisitions at Roche. Krognes' financial expertise and strategic leadership are expected to complement Pliant’s existing board, aiding in the company's evolution as a late-stage clinical entity. Currently, Krognes serves on several other boards, including Denali Therapeutics, Guardant Health, argenx, and ClavystBio. He holds an MBA from Harvard Business School and a B.S. in Economics from Wharton School, University of Pennsylvania.
Pliant Therapeutics (Nasdaq: PLRX) announced an inducement grant under Nasdaq Listing Rule 5635(c)(4) on June 12, 2024. The company granted stock options for 120,000 shares to Dr. Chohee Yun, the newly appointed Senior VP of Clinical Development. These options have an exercise price of $11.51 per share, aligned with the closing price on June 10, 2024. The options will vest over four years: 25% on the first anniversary and the remainder monthly over the next three years. The options have a 10-year term and are governed by the 2022 Inducement Plan.