Quince Therapeutics Announces Phase 2a Data for LAM-001
Quince Therapeutics announced Phase 2a data evaluating LAM-001, an inhaled formulation of rapamycin, in patients with pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease, presented at the American Thoracic Society conference in Orlando. The company recently acquired LAM-001 through its previously announced acquisition of Orphai Therapeutics, Inc., a clinical-stage biotechnology company developing LAM-001 to treat rare pulmonary diseases. The Phase 2a study was a 24-week, open-label trial conducted across four clinical sites evaluating LAM-001 as an add-on therapy to standard of care in 10 adult patients with PAH and PH-ILD who remained symptomatic despite background therapy. Primary endpoints included change from baseline in peak oxygen uptake at Week 24, safety and tolerability. Secondary endpoints included pulmonary vascular resistance, six-minute walk distance and change in functional class, with change in N-terminal pro-B-type natriuretic peptide assessed as an exploratory endpoint. Treatment with LAM-001 was associated with improvement or stabilization from baseline across multiple clinically relevant measures, including 6MWD, PVR, NT-proBNP and forced vital capacity, supporting potential benefit across exercise capacity, pulmonary hemodynamics, cardiac stress and lung function. Improvements in 6MWD, a clinically meaningful endpoint commonly used in pulmonary hypertension clinical trials and regulatory submissions, were observed alongside favorable changes in hemodynamic and biomarker measures. All evaluable patients also transitioned from Functional Class III to Functional Class II by Week 24. In addition, two patients transitioned to Functional Class I at 16- and 52-week evaluations. LAM-001 was generally well tolerated in patients receiving background standard-of-care therapy. A total of 6 patients were evaluable at the 24-week endpoint, of which 4 were PH-ILD patients. All 4 PH-ILD patients were receiving stable doses of treprostinil therapy before and throughout the study.
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- Acquisition Overview: Quince Therapeutics announced the acquisition of clinical-stage biotech company Orphai Therapeutics, integrating Orphai's lead program LAM-001 into Quince's pipeline to treat rare pulmonary diseases, thereby enhancing its competitive edge in the biopharmaceutical sector.
- Financing Arrangement: The acquisition is accompanied by a private placement financing agreement expected to raise up to $187 million in gross proceeds, including $115 million in upfront proceeds for purchasing non-voting convertible preferred stock, indicating strong market confidence in the deal.
- Equity Exchange Structure: The acquisition is structured as a stock-for-stock merger, where all outstanding equity interests of Orphai will be exchanged for 3.25 million shares of common stock, 67.1 million shares of non-voting convertible preferred stock, and options for 26.33 million shares of common stock, reflecting Quince's recognition of Orphai's value.
- Future Outlook: The transaction is expected to close on May 21, 2026, with Quince's stock price dropping 3.48% to $1.11 following the announcement; despite short-term volatility, the acquisition is poised to expand Quince's therapeutic areas and increase market share in the long run.
- Clinical Trial Results: In a 24-week Phase 2a study involving 10 PH-ILD patients, the use of LAM-001 resulted in a 67.4-meter improvement in six-minute walk distance (6MWD) and a 33.9% reduction in pulmonary vascular resistance (PVR), demonstrating significant lung function improvement and indicating its potential value in treating refractory pulmonary arterial hypertension patients.
- Functional Improvement: All evaluable patients transitioned from Functional Class III to II by Week 24, with two patients achieving Class I status at 16 and 52 weeks, highlighting LAM-001's significant impact on enhancing patients' daily functioning and quality of life.
- Safety Assessment: LAM-001 was well tolerated against a background of standard therapy, with 6 evaluable patients, 4 of whom were PH-ILD patients, maintaining stable doses of treprostinil throughout the study, indicating its safety as an adjunct therapy.
- Future Development Plans: Quince Therapeutics plans to initiate a Phase 2b trial in mid-2026, with topline data expected in the first quarter of 2028, further validating LAM-001's efficacy in PH-ILD, reflecting the company's ongoing commitment to this field.
- Clinical Trial Results: In a 24-week Phase 2a study involving 10 patients with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD), LAM-001 demonstrated a significant improvement in six-minute walk distance (6MWD) by 67.4 meters and a reduction in pulmonary vascular resistance (PVR) by 33.9%, indicating its potential as a new treatment option for patients.
- Functional Improvement: All evaluable patients transitioned from Functional Class III to Class II by Week 24, with some even achieving Class I status at 16 and 52 weeks, suggesting LAM-001's potential to enhance daily functioning and significantly improve patients' quality of life.
- Safety Assessment: LAM-001 was generally well tolerated among patients receiving standard care, with 4 out of 6 evaluable patients being PH-ILD cases, indicating its safe use alongside existing therapies and enhancing its appeal as a potential treatment option.
- Future Research Plans: The company plans to initiate a Phase 2b trial in mid-2026, with topline data expected in the first quarter of 2028, further validating LAM-001's efficacy and safety, demonstrating the company's strong commitment to its development.
- Acquisition Overview: Quince Therapeutics has acquired Orphai Therapeutics in a stock-for-stock merger, which includes 3,258,517 shares of common stock and 67,101.235 shares of Series C non-voting convertible preferred stock, expected to enhance Quince's market position in rare pulmonary diseases.
- Financing Support: The acquisition is accompanied by a private placement financing expected to raise up to $187 million, including $115 million in upfront proceeds, which will support multiple clinical milestones for LAM-001 and ensure operational funding through the end of 2028.
- Clinical Trial Plans: The Phase 2 clinical trial for LAM-001 is planned to initiate in mid-2026 targeting pulmonary hypertension associated with interstitial lung disease (PH-ILD), with data anticipated in Q1 2028, showcasing the company's strategic potential in addressing significant unmet medical needs.
- Market Outlook Analysis: LAM-001 targets PH-ILD and bronchiolitis obliterans syndrome (BOS), affecting approximately 86,000 and 17,000 patients in the U.S. and Europe respectively, indicating its market opportunity as a potential disease-modifying therapy, further solidifying Quince's leadership in the industry.
- Clinical Trial Results: In patients with PH-ILD, the 24-week trial of LAM-001 demonstrated a significant improvement in six-minute walk distance (6MWD) by 67.4 meters and a reduction in pulmonary vascular resistance (PVR) by 33.9%, indicating the drug's potential to provide new treatment options for patients.
- Patient Transition Outcomes: All evaluable patients transitioned from Functional Class III to Class II by Week 24, with two patients achieving Class I status at 16 and 52 weeks, highlighting LAM-001's potential to enhance daily functioning and improve quality of life for patients.
- Safety and Tolerability: LAM-001 showed good tolerability among patients receiving standard background therapy, with 6 evaluable patients, 4 of whom were PH-ILD patients, maintaining stable doses of treprostinil throughout the study, suggesting the drug's safety profile is noteworthy.
- Future Research Plans: The company plans to initiate a Phase 2b trial in PH-ILD in mid-2026, with topline data expected in the first quarter of 2028, further validating LAM-001's efficacy and demonstrating the company's ongoing commitment to rare pulmonary diseases.
- Acquisition Overview: Quince Therapeutics has acquired Orphai Therapeutics in a stock-for-stock merger, which includes 3,258,517 shares of common stock and 67,101.235 shares of Series C non-voting convertible preferred stock, expected to enhance Quince's competitiveness in the rare pulmonary disease sector.
- Financing Support: The acquisition is accompanied by a private placement financing expected to raise up to $187 million, including $115 million in upfront proceeds, which will support multiple clinical milestones for LAM-001 and ensure operational funding through the end of 2028.
- Clinical Trial Plans: Quince plans to initiate a Phase 2b trial of LAM-001 in PH-ILD in mid-2026, with data anticipated in Q1 2028, while also providing Phase 2 data for BOS in Q1 2027, demonstrating the company's proactive approach in pulmonary disease treatment.
- Market Potential: LAM-001 targets approximately 86,000 patients in the U.S. and 120,000 in Europe suffering from PH-ILD, and Quince's acquisition and subsequent R&D efforts will help address this significant unmet medical need, enhancing patient quality of life.










