Lyell to Highlight Vision for its Next-Generation CAR T-Cell Therapy Pipeline at 43rd Annual JP Morgan Healthcare Conference
Lyell Immunopharma (LYEL) announced significant pipeline updates focusing on IMPT-314, their dual-targeting CD19/CD20 CAR T-cell therapy for large B-cell lymphoma. The company plans to initiate pivotal trials in both 3rd line+ setting (mid-2025) and 2nd line setting (early 2026). Initial clinical data showed promising results with a 94% overall response rate and 71% complete response rate in 3rd-line+ patients.
To optimize resources, Lyell is discontinuing development of LYL119 (ROR1-targeting CAR T-cell product) and IMPT-514 (autoimmune disease program) to focus on IMPT-314 and early-stage solid tumor programs. The company projects net cash use of $175-185 million for 2025, extending their cash runway into 2027. Additional clinical data from ongoing trials will be presented in mid-2025, including mature data from 3rd line+ cohort and initial 2nd line data.
Lyell Immunopharma (LYEL) ha annunciato importanti aggiornamenti sul suo pipeline, concentrandosi su IMPT-314, la loro terapia con CAR T-cell a doppio targeting CD19/CD20 per il linfoma a grandi cellule B. L'azienda prevede di avviare sperimentazioni cliniche pivotal sia in setting di 3a linea+ (metà 2025) che in 2a linea (inizio 2026). I dati clinici iniziali hanno mostrato risultati promettenti con un 94% di tasso di risposta globale e un 71% di tasso di risposta completa nei pazienti di 3a linea+.
Per ottimizzare le risorse, Lyell sta interrompendo lo sviluppo di LYL119 (prodotto CAR T-cell a targeting ROR1) e IMPT-514 (programma per malattie autoimmuni) per concentrarsi su IMPT-314 e programmi per tumori solidi in fase iniziale. L'azienda prevede un utilizzo netto di liquidità di 175-185 milioni di dollari per il 2025, estendendo il loro margine di liquidità fino al 2027. Ulteriori dati clinici da studi in corso verranno presentati nella metà del 2025, inclusi dati maturi dal coorte di 3a linea+ e dati iniziali dalla 2a linea.
Lyell Immunopharma (LYEL) anunció actualizaciones significativas en su pipeline, centrándose en IMPT-314, su terapia con CAR T-células de doble objetivo CD19/CD20 para el linfoma de células B grandes. La compañía planea iniciar ensayos pivotal en entornos de 3a línea+ (mediados de 2025) y 2a línea (principios de 2026). Los datos clínicos iniciales mostraron resultados prometedores con un 94% de tasa de respuesta global y un 71% de tasa de respuesta completa en pacientes de 3a línea+.
Para optimizar recursos, Lyell está descontinuando el desarrollo de LYL119 (producto CAR T-células con objetivo ROR1) e IMPT-514 (programa para enfermedades autoinmunes) para centrarse en IMPT-314 y programas de tumores sólidos en etapas tempranas. La compañía proyecta un uso neto de efectivo de $175-185 millones para 2025, extendiendo su margen de efectivo hasta 2027. Se presentarán datos clínicos adicionales de ensayos en curso a mediados de 2025, incluidos datos maduros del grupo de 3a línea+ y datos iniciales de 2a línea.
Lyell Immunopharma (LYEL)는 대형 B 세포 림프종에 대한 CD19/CD20 이중 표적 CAR T 세포 치료제인 IMPT-314에 대한 주요 파이프라인 업데이트를 발표했습니다. 이 회사는 3차 치료(2025년 중반) 및 2차 치료(2026년 초) 설정에서 중대한 임상 시험을 시작할 계획입니다. 초기 임상 데이터는 3차 치료+ 환자에서 94%의 전체 반응률과 71%의 완전 반응률을 보여주는 유망한 결과를 나타냈습니다.
자원을 최적화하기 위해 Lyell은 LYL119(ROR1 표적 CAR T 세포 제품) 및 IMPT-514(자가면역 질환 프로그램)의 개발을 중단하고 IMPT-314 및 초기 단계 고형 종양 프로그램에 집중할 계획입니다. 이 회사는 2025년 동안 1억 7500만에서 1억 8500만 달러의 순 현금 사용을 예상하여 2027년까지 현금 흐름을 연장할 계획입니다. 진행 중인 시험의 추가 임상 데이터는 2025년 중반에 발표될 예정이며, 여기에는 3차 치료+ 집단의 성숙한 데이터 및 초기 2차 치료 데이터가 포함됩니다.
Lyell Immunopharma (LYEL) a annoncé des mises à jour importantes concernant son pipeline, en se concentrant sur IMPT-314, leur thérapie CAR T-cell à double ciblage CD19/CD20 pour le lymphome à grandes cellules B. L'entreprise prévoit de lancer des essais cruciaux dans des contextes de 3ème ligne+ (mi-2025) et de 2ème ligne (début 2026). Les données cliniques initiales ont montré des résultats prometteurs avec un taux de réponse global de 94% et un taux de réponse complète de 71% chez les patients de 3ème ligne+.
Pour optimiser ses ressources, Lyell interrompt le développement de LYL119 (produit CAR T-cell ciblant ROR1) et d'IMPT-514 (programme pour les maladies auto-immunes) afin de se concentrer sur IMPT-314 et les programmes de tumeurs solides en phase précoce. L'entreprise projette une utilisation nette de liquidités de 175-185 millions de dollars pour 2025, prolongeant ainsi sa marge de liquidités jusqu'en 2027. Des données cliniques supplémentaires issues des essais en cours seront présentées à la mi-2025, y compris des données matures du cohort de 3ème ligne+ et des données initiales de 2ème ligne.
Lyell Immunopharma (LYEL) gab bedeutende Aktualisierungen zu seiner Produktpipeline bekannt, die sich auf IMPT-314 konzentriert, eine dual-targeting CD19/CD20 CAR T-Zelltherapie für das große B-Zell-Lymphom. Das Unternehmen plant die Einleitung von entscheidenden Studien sowohl in der 3. Linie+ (Mitte 2025) als auch in der 2. Linie (Anfang 2026). Erste klinische Daten zeigten vielversprechende Ergebnisse mit einer 94% Gesamtansprechrate und einer 71% vollständigen Ansprache bei Patienten der 3. Linie+.
Um Ressourcen zu optimieren, stellt Lyell die Entwicklung von LYL119 (ROR1-targeting CAR T-Zellprodukt) und IMPT-514 (Programm für Autoimmunerkrankungen) ein, um sich auf IMPT-314 und Programme für solide Tumoren in der Frühphase zu konzentrieren. Das Unternehmen rechnet mit einer Netto-Barraumnutzung von 175-185 Millionen US-Dollar für 2025, was ihre Bargeldreserven bis 2027 verlängert. Zusätzliche klinische Daten aus laufenden Studien werden Mitte 2025 präsentiert, einschließlich ausgereifter Daten aus der 3. Linie+ Kohorte und ersten Daten aus der 2. Linie.
- 94% overall response rate and 71% complete response rate in 3rd-line+ setting for IMPT-314
- Cash runway extended into 2027
- Strategic pipeline focus on promising IMPT-314 program with two pivotal trials planned
- Discontinuation of LYL119 and IMPT-514 programs
- Significant projected cash burn of $175-185 million for 2025
Insights
The strategic pipeline restructuring and financial outlook reveal critical implications for Lyell's market position. The company's expected net cash use of
The accelerated development timeline for IMPT-314, particularly in both 2nd and 3rd line settings for large B-cell lymphoma, represents a significant market opportunity. The impressive initial clinical data showing
The clinical data for IMPT-314 marks a potential breakthrough in CAR-T therapy design. The dual-targeting CD19/CD20 approach with 'OR' logic gate architecture addresses a critical limitation of current CAR-T therapies - antigen escape. The enrichment for CD62L-expressing cells to generate naïve central memory CAR T cells is particularly noteworthy, as it could lead to improved persistence and long-term efficacy.
The strategic pivot away from LYL119 (ROR1-targeting) to focus on IMPT-314 and next-generation solid tumor programs aligns with emerging clinical evidence. The planned expansion into second-line therapy by early 2026 could significantly expand the addressable patient population, especially given the strong initial efficacy signals in more heavily pretreated patients.
This pipeline restructuring positions Lyell strategically in the competitive CAR-T landscape. The focus on IMPT-314's dual-targeting mechanism could differentiate it from current market leaders. The planned clinical data releases in mid and late 2025, followed by pivotal trial initiations, create multiple potential value-inflection points for investors. The company's market cap of
The decision to concentrate on hematologic malignancies while maintaining early-stage solid tumor research represents a balanced approach to risk and opportunity. The extended cash runway into 2027 provides adequate buffer for clinical development milestones while reducing financing risk in the current market environment.
- Accelerating IMPT-314 in large B-cell lymphoma; remain on track to initiate pivotal trial in the 3rd line+ setting in 2025 and expect to initiate a pivotal trial in the 2nd line by early 2026
- Presenting additional data from the ongoing Phase 1-2 trial in 3rd line+ setting and initial clinical data in 2nd line setting in mid-2025
- Discontinuing development of LYL119, a ROR1-targeting CAR T-cell product candidate for solid tumors, to focus resources on acceleration of pivotal trials of IMPT-314 and next-generation solid tumor CAR T cell programs in preclinical development
- Expected net cash use of
$175 million -$185 million for 2025 extends cash runway further into 2027 through multiple value-creating clinical catalysts, including new pivotal programs - Lynn Seely, MD, President and Chief Executive Officer, to present at J.P. Morgan conference on January 15th at 9:00 a.m. PT
SOUTH SAN FRANCISCO, Calif., Jan. 09, 2025 (GLOBE NEWSWIRE) -- Lyell Immunopharma, Inc. (Nasdaq: LYEL), a clinical-stage company advancing a pipeline of next-generation CAR T-cell therapies for patients with cancer, today announced pipeline updates, including its plans to advance IMPT-314, a potentially best-in-class therapy for aggressive large B-cell lymphoma, into pivotal trials. IMPT-314 is an autologous dual-targeting CD19/CD20 chimeric antigen receptor (CAR) T-cell product candidate designed to increase complete response rates and prolong the duration of the responses as compared to the approved CD19‑targeted CAR therapies for the treatment of large B-cell lymphoma.
“Based on the positive initial clinical data reported at ASH and the promising emerging clinical profile, we are accelerating the development of IMPT-314 as a potentially transformative product with differentiated benefit in overall and complete response rates as well as duration of response over first-generation CD19 CAR therapies in patients with aggressive large B-cell lymphoma,” said Lynn Seely, M.D., Lyell’s President and Chief Executive Officer. “Having presented an initial dataset that demonstrated an overall response rate of
Pipeline Focus
Lyell is focused on advancing next-generation CAR T cell therapies with the potential to deliver higher response rates and longer duration of responses for patients with hematologic malignancies and solid tumors. Lyell is developing products enhanced with its novel technologies and manufacturing protocols.
In hematologic malignancies, Lyell is focused on advancing products designed to deliver improved outcomes over first-generation CD19 CAR T cell therapies. Lyell’s lead program, IMPT-314, is a dual-targeting CD19/CD20 CAR T-cell product candidate designed to increase complete response rates and prolong the duration of the responses as compared to the currently approved CD19‑targeted CAR therapies for the treatment of large B-cell lymphoma. IMPT-314 is designed with a true ‘OR’ logic gate to target B-cells that express either CD19, CD20 or both and is manufactured through a process that enriches for CD62L-expressing cells to generate more naïve central memory CAR T cells with enhanced stemlike features and antitumor activity.
To realize the potential of cell therapy for solid tumors, Lyell is also developing next-generation CAR T-cell product candidates enhanced with anti-exhaustion and additional arming technologies, and manufactured with proprietary protocols. These approaches are designed to endow CAR T cells with attributes needed to drive durable tumor cytotoxicity and achieve consistent and long-lasting clinical responses – the ability to resist exhaustion, maintain qualities of durable stemness and function in the hostile tumor microenvironment.
Upcoming Milestones and Financial Outlook
For IMPT-314, a next-generation dual-targeting CD19/CD20 CAR T-cell product candidate for the treatment of large B-cell lymphoma:
- Present data from the ongoing Phase 1-2 trial in mid-2025, including more mature data from the 3rd line+ cohort and initial data from the 2nd line cohort
- Present more mature clinical data from the 2nd line cohort in late 2025
- Initiate a pivotal trial in the 3rd line+ setting in mid-2025
- Initiate a pivotal trial in the 2nd line setting by early 2026
For early-stage solid tumor programs:
- Submit first IND application for a new solid tumor CAR T-cell product candidate in 2026
To accelerate the pivotal trials of IMPT-314 and focus resources on next-generation solid tumor CAR T-cell programs in preclinical development, Lyell has streamlined its operations and is discontinuing development of LYL119, its ROR1-targeting CAR T cell product candidate, and IMPT-514, an autoimmune disease program previously initiated by ImmPACT Bio that was acquired by Lyell in connection with its acquisition of ImmPACT Bio.
Lyell expects net cash use in 2025 to be
J.P. Morgan Healthcare Conference
Members of Lyell’s senior management team will present and participate in the 43rd Annual J.P. Morgan Healthcare Conference on Wednesday, January 15th at 9:00 am PT.
A live webcast of the presentation can be accessed through the Investors section of the Company's website at www.lyell.com. Following the live presentation, a replay of the webcast will be available on the Company's website.
About IMPT-314
IMPT-314 is a next-generation dual-targeting CD19/CD20 CAR T-cell product candidate designed to increase complete response rates and prolong the duration of the responses as compared to the approved CD19‑targeted CAR therapies for the treatment of large B-cell lymphoma.
IMPT-314 is designed with a true ‘OR’ logic gate to target, with high potency, B cells that express either CD19, CD20 or both. IMPT-314 is manufactured to produce a CAR T-cell product with higher proportions of naïve and central memory T cells through a process that enriches for CD62L-expressing cells. This manufacturing process is designed to generate more naïve central memory CAR T cells with enhanced stemlike features and antitumor activity.
IMPT-314 has received Fast Track Designation from the U.S. Food and Drug Administration for the treatment of relapsed/refractory aggressive B-cell lymphoma.
Initial data from 23 patients with relapsed or refractory, CAR T-naive large B-cell lymphoma who received IMPT-314 were reported at the 2024 American Society of Hematology Annual Meeting. The efficacy evaluable population consisted of 17 patients. The overall response rate was
About Lyell
Lyell is a clinical-stage company advancing a pipeline of next-generation CAR T-cell therapies for patients with hematologic malignancies and solid tumors. To realize the potential of cell therapy for cancer, Lyell utilizes a suite of technologies to endow CAR T cells with attributes needed to drive durable tumor cytotoxicity and achieve consistent and long-lasting clinical responses – the ability to resist exhaustion, maintain qualities of durable stemness and function in the hostile tumor microenvironment. Lyell is based in South San Francisco, California with facilities in West Hills, California and Seattle and Bothell, Washington. To learn more, please visit www.lyell.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements expressed or implied in this press release include, but are not limited to, statements regarding: the anticipated benefits IMPT-314, including its potential to increase complete response rates and prolong duration of the responses as compared to approved CD19-targeted CAR therapies for the treatment of B-cell lymphoma; the continued clinical progress of the IMPT-314 trials and expectations around the timing of updated clinical data and the timing and design of pivotal trials of IMPT-314; the timing of the submission of an IND application for a solid tumor CAR T-cell product; Lyell’s expectation regarding its net cash use and cost structure and that its financial position and cash runway will support advancement of its pipeline through multiple clinical milestones into 2027; the ability of Lyell’s technology to generate CAR T cells with attributes needed to drive durable tumor cytotoxicity in the setting of a hostile solid tumor microenvironment, resist exhaustion and maintain qualities of durable stemness to achieve consistent and long-lasting clinical responses; Lyell’s anticipated progress, business plans, business strategy and clinical trials; and other statements that are not historical fact. These statements are based on Lyell’s current plans, objectives, estimates, expectations and intentions, are not guarantees of future performance and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, but are not limited to, risks and uncertainties related to: the inability to recognize the anticipated benefits of Lyell’s recent acquisition of ImmPACT Bio and successful integration of ImmPACT Bio’s business with Lyell’s; the effects of macroeconomic conditions, including any geopolitical instability and actual or perceived changes in interest rates and economic inflation; Lyell’s ability to submit planned INDs or initiate or progress clinical trials on the anticipated timelines, if at all; Lyell’s limited experience as a company in enrolling and conducting clinical trials, and lack of experience in completing clinical trials; Lyell’s ability to manufacture and supply its product candidates for its clinical trials; the nonclinical profiles of Lyell’s product candidates or technology not translating in clinical trials; the potential for results from clinical trials to differ from nonclinical, early clinical, preliminary or expected results; significant adverse events, toxicities or other undesirable side effects associated with Lyell’s product candidates; the significant uncertainty associated with Lyell’s product candidates ever receiving any regulatory approvals; Lyell’s ability to obtain, maintain or protect intellectual property rights related to its product candidates; implementation of Lyell’s strategic plans for its business and product candidates; the sufficiency of Lyell’s capital resources and need for additional capital to achieve its goals; and other risks, including those described under the heading “Risk Factors” in Lyell’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the Securities and Exchange Commission (SEC) on February 28, 2024, and the Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, filed with the SEC on November 7, 2024. Forward-looking statements contained in this press release are made as of this date, and Lyell undertakes no duty to update such information except as required under applicable law.
Contact:
Ellen Rose
Senior Vice President, Communications and Investor Relations
erose@lyell.com
FAQ
What are the response rates for LYEL's IMPT-314 in large B-cell lymphoma?
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Why did LYEL discontinue the LYL119 program?
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