ArriVent BioPharma Enters Exclusive License with Lepu Biopharma for MRG007, an Antibody Drug Conjugate for the treatment of Gastrointestinal Cancers
ArriVent BioPharma (AVBP) has secured an exclusive global license agreement with Lepu Biopharma for MRG007, a novel antibody drug conjugate (ADC) targeting gastrointestinal cancers, for all territories outside Greater China. The deal includes a $47 million upfront and near-term milestone payment, with potential additional payments up to $1.16 billion based on development, regulatory, and sales milestones, plus tiered royalties.
MRG007 has demonstrated strong antitumor activity in preclinical models of GI cancers and favorable therapeutic index in IND enabling studies. The first Investigational New Drug (IND) submission is planned for the first half of 2025, initially focusing on colorectal, pancreatic, and other GI cancers. The company confirms that the agreement's financial terms, including upfront payment and R&D costs, maintain ArriVent's expected cash runway into 2026.
ArriVent BioPharma (AVBP) ha ottenuto un accordo di licenza globale esclusivo con Lepu Biopharma per MRG007, un nuovo coniugato di farmaci ad anticorpi (ADC) mirato ai tumori gastrointestinali, per tutti i territori al di fuori della Grande Cina. L'accordo include un pagamento iniziale di 47 milioni di dollari e un pagamento per traguardi a breve termine, con potenziali pagamenti aggiuntivi fino a 1,16 miliardi di dollari basati su sviluppo, regolamentazione e traguardi di vendita, oltre a royalties su scala progressiva.
MRG007 ha dimostrato una forte attività antitumorale in modelli preclinici di tumori gastrointestinali e un indice terapeutico favorevole negli studi che supportano la richiesta di nuovi farmaci (IND). La prima richiesta di nuovi farmaci investigativi (IND) è prevista per la prima metà del 2025, con un focus iniziale sui tumori del colon-retto, del pancreas e altri tumori gastrointestinali. L'azienda conferma che i termini finanziari dell'accordo, inclusi il pagamento iniziale e i costi di R&D, mantengono la previsione di liquidità di ArriVent fino al 2026.
ArriVent BioPharma (AVBP) ha asegurado un acuerdo de licencia global exclusivo con Lepu Biopharma para MRG007, un nuevo conjugado de anticuerpos (ADC) dirigido a los cánceres gastrointestinales, para todos los territorios fuera de Gran China. El acuerdo incluye un pago inicial de 47 millones de dólares y un pago a corto plazo por hitos, con pagos adicionales potenciales de hasta 1.16 mil millones de dólares basados en hitos de desarrollo, regulación y ventas, además de regalías escalonadas.
MRG007 ha demostrado una fuerte actividad antitumoral en modelos preclínicos de cánceres gastrointestinales y un índice terapéutico favorable en estudios que habilitan la IND. La primera presentación de Nueva Droga Investigacional (IND) está planificada para la primera mitad de 2025, enfocándose inicialmente en cánceres colorrectales, pancreáticos y otros cánceres gastrointestinales. La compañía confirma que los términos financieros del acuerdo, incluidos el pago por adelantado y los costos de I+D, mantienen la proyección de liquidez de ArriVent hasta 2026.
ArriVent BioPharma (AVBP)는 MRG007, 위장암을 표적으로 하는 새로운 항체 약물 접합체(ADC)에 대해 Lepu Biopharma와 독점 글로벌 라이선스 계약을 체결했습니다. 이 거래는 4,700만 달러의 선불 및 단기 이정표금과 함께 개발, 규제 및 판매 이정표에 따라 최대 11억 6천만 달러 추가 지급 가능성을 포함하며, 단계별 로열티도 포함됩니다.
MRG007은 GI 암의 전임상 모델에서 강력한 항종양 활성을 보여주었으며, IND 허가 연구에서 유리한 치료 지수를 나타냈습니다. 첫 번째 임상 시험 약물 신청(IND)은 2025년 상반기로 예정되어 있으며, 초기에는 대장, 췌장 및 기타 GI 암에 집중할 예정입니다. 회사는 계약의 재무 조건이 선불 지급 및 연구개발 비용을 포함하여 ArriVent의 2026년까지의 현금 흐름을 유지한다고 확인했습니다.
ArriVent BioPharma (AVBP) a obtenu un accord de licence mondiale exclusif avec Lepu Biopharma pour MRG007, un nouvel anticorps conjugué (ADC) ciblant les cancers gastro-intestinaux, pour tous les territoires en dehors de la Grande Chine. L'accord comprend un paiement initial de 47 millions de dollars et un paiement de jalon à court terme, avec des paiements supplémentaires potentiels allant jusqu'à 1,16 milliard de dollars en fonction des jalons de développement, de réglementation et de ventes, ainsi que des royaltees progressives.
MRG007 a démontré une forte activité antitumorale dans des modèles précliniques de cancers gastro-intestinaux et un indice thérapeutique favorable dans les études visant à obtenir l'autorisation de mise sur le marché (IND). La première demande de médicament nouveau investigational (IND) est prévue pour la première moitié de 2025, en se concentrant initialement sur le cancer colorectal, pancréatique et d'autres cancers gastro-intestinaux. La société confirme que les conditions financières de l'accord, y compris le paiement initial et les coûts de R&D, maintiennent la durée de trésorerie attendue d'ArriVent jusqu'en 2026.
ArriVent BioPharma (AVBP) hat eine exklusive globale Lizenzvereinbarung mit Lepu Biopharma für MRG007 gesichert, ein neuartiges Antikörper-Wirkstoff-Konjugat (ADC), das auf gastrointestinalen Krebs abzielt, für alle Gebiete außerhalb von Großchina. Der Deal umfasst eine Vorauszahlung von 47 Millionen Dollar und eine kurzfristige Meilensteinzahlung, sowie potenzielle zusätzliche Zahlungen von bis zu 1,16 Milliarden Dollar, die auf Entwicklungs-, Regulierung- und Verkaufsmeilensteinen basieren, plus gestaffelte Lizenzgebühren.
MRG007 hat in präklinischen Modellen von GI-Krebs eine starke antitumorale Wirkung gezeigt und einen günstigen therapeutischen Index in den IND-gestützenden Studien. Der erste antrag auf Zulassung eines neuen Arzneimittels (IND) ist für die erste Jahreshälfte 2025 geplant, mit anfänglichem Fokus auf kolorektalen, pankreatischen und anderen gastrointestinalen Krebserkrankungen. Das Unternehmen bestätigt, dass die finanziellen Bedingungen des Vertrags, einschließlich der Vorauszahlung und der F&E-Kosten, das erwartete Liquiditätsniveau von ArriVent bis 2026 aufrechterhalten.
- Exclusive global licensing rights secured for MRG007 outside Greater China
- Promising preclinical results showing robust antitumor activity in GI cancers
- Deal structure maintains company's cash runway into 2026
- Near-term development milestone with IND submission planned for 1H 2025
- Significant financial commitment with $47 million in upfront and near-term payments
- Product still in preclinical stage with no human trial data available
- Substantial milestone payment obligations up to $1.16 billion
Insights
This exclusive licensing agreement marks a pivotal strategic expansion for ArriVent in the rapidly growing ADC market. The deal's structure is particularly noteworthy:
The financial implications are multifaceted:
- The maintained cash runway projection into 2026 despite these commitments suggests strong balance sheet management and careful deal structuring
- The milestone-heavy structure aligns payment obligations with development success, reducing upfront risk
- The global rights (excluding Greater China) provide significant market opportunity, particularly in lucrative Western markets
From a strategic perspective, this deal accelerates ArriVent's ADC portfolio expansion just as the ADC market is experiencing unprecedented growth and big pharma interest. The timing is particularly relevant given the recent surge in ADC valuations and licensing deals in the oncology space.
The focus on gastrointestinal cancers, particularly colorectal and pancreatic cancers, targets areas of significant unmet medical need and substantial market opportunity. With the IND submission planned for 1H 2025, this near-term catalyst could serve as a value driver for ArriVent's stock.
The acquisition of MRG007 represents a strategic entry into the high-priority GI cancer space, where current treatment options often fall short. The preclinical profile suggests promising characteristics:
- Demonstrated robust antitumor activity in GI cancer models
- Favorable therapeutic index - a critical factor in ADC development that indicates a potentially wider dosing window between efficacy and toxicity
- Potential application across multiple GI cancers, including difficult-to-treat indications like pancreatic cancer
The ADC technology landscape is rapidly evolving, with next-generation platforms showing improved stability, better payload delivery and reduced off-target effects. MRG007's reported preclinical data suggests it may incorporate some of these advanced features, though specific technical details remain undisclosed.
The focus on GI cancers is particularly strategic given the treatment options and poor prognosis in conditions like pancreatic cancer, where the 5-year survival rates remain dismally low. Success in this space could position ArriVent as a significant player in the oncology market.
- Exclusive global license outside of Greater China for MRG007, a novel antibody drug conjugate (ADC) in development for gastrointestinal (GI) cancers
- First Investigational New Drug (IND) submission planned for 1H 2025
- Expands ArriVent’s growing pipeline of next-generation ADCs
NEWTOWN SQUARE, Pa. and SHANGHAI, Jan. 21, 2025 (GLOBE NEWSWIRE) -- ArriVent BioPharma, Inc. (Company or ArriVent) (Nasdaq: AVBP) a clinical-stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, today announced that it has entered into an exclusive license agreement with Lepu Biopharma Co., Ltd (Stock Code: 02157.HK) for MRG007, an antibody-drug conjugate (ADC) that can target several gastrointestinal (GI) cancers. Under the terms of the agreement, ArriVent obtains the exclusive rights to develop and commercialize MRG007 worldwide outside of Greater China which includes mainland China, Hong Kong, Macau and Taiwan.
"We believe MRG007 is a potential best-in-class ADC for the treatment of GI malignancies based on preclinical and IND enabling studies,” said Bing Yao, Chairman and Chief Executive Officer of ArriVent. “Expanding our pipeline with MRG007 furthers our mission to develop novel medicines for cancers with high unmet needs worldwide and accelerates our ADC portfolio by adding a program which plans to enter the clinic in the near-term. We look forward to collaborating with Lepu Biopharma in advancing this program globally.”
Ziye Sui, Ph.D., Executive Director and Chief Executive Officer of Lepu Biopharma added, “We are very pleased to be working with ArriVent. Lepu Biopharma has been dedicated to promoting the technological advancement of innovative ADCs. We believe MRG007 is one of our potential best-in-class ADC molecules in pre-clinical stage. The agreement is a recognition of our self-dependent R&D capabilities. We look forward to collaborating with ArriVent to advance the development of MRG007 globally and help bring this potential promising therapy to more patients around the world.”
MRG007 has shown robust antitumor activity in preclinical models of GI cancers and a favorable therapeutic index based on IND enabling studies. The first IND submission is planned for the first half of 2025 with an initial clinical development focus in CRC, pancreatic and other GI cancers.
Under the terms of the agreement, Lepu Biopharma has granted ArriVent exclusive global rights to develop, manufacture and commercialize MRG007 outside of Greater China. Lepu Biopharma will receive a one-time upfront payment and near-term milestone payments totaling
About ArriVent
ArriVent is a clinical-stage biopharmaceutical company dedicated to the identification, development, and commercialization of differentiated medicines to address the unmet medical needs of patients with cancers. ArriVent seeks to utilize its team’s deep drug development experience to maximize the potential of its lead development candidate, firmonertinib, and advance a pipeline of novel therapeutics, such as next-generation antibody drug conjugates, through approval and commercialization.
About Lepu Biopharma Co., Ltd.
Lepu Biopharma Co., Ltd. (Stock Code: 02157.HK) is an innovation-driven company focusing on oncology therapeutics, in particular, targeted therapy and oncology immunotherapy, with a strong China foundation and global vision. The company is dedicated to developing innovative ADCs through its advanced ADC technology platform. Lepu Biopharma highly values the continuing build-out of its own commercialization capabilities and is determined to pursue the goal towards strong transformation from core technology to drugs and industrialization. At present, the product pipeline of Lepu Biopharma covers three major areas, namely immunotherapies, ADC targeted therapies and oncolytic virus drugs, including one clinical/commercialization-stage drug candidate, seven clinical-stage drug candidates (six of which are ADC drug candidates) and three clinical-stage combination therapies of the key candidates in its pipeline. The company houses the leading ADC drug candidate pipeline in China.
Forward-Looking Statements
This press release includes certain disclosures that contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 about us and our industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this press release, including statements regarding our beliefs about MRG007, including with respect to its potential as a best-in-class ADC; future results of operations or financial condition; business strategy and plans; expectations with respect to our cash runway; estimates of the potential addressable market and unmet medical need; activity of MRG007 compared to available therapies and other members of the class; anticipated development, regulatory and sales milestones, including the submission of an IND for MRG007; and objectives of management for future operations are forward-looking statements. In some cases, you can identify forward-looking statements because they contain words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” or the negative of these words or other similar terms or expressions. Forward-looking statements are based on ArriVent’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, risks and uncertainties that are described more fully in the section titled “Risk Factors” in our annual report on Form 10-K for the fiscal year ended December 31, 2023, filed with the Securities and Exchange Commission on March 28, 2024 and our other filings with the Securities and Exchange Commission. Forward-looking statements contained in this press release are made as of this date, and ArriVent undertakes no duty to update such information except as required under applicable law.
ArriVent Contact:
Joyce Allaire
LifeSci Advisors, LLC
jallaire@lifesciadvisors.com
Lepu Biopharma Contact:
Tel：+86-21-6768 0899
pr@lepubiopharma.com
FAQ
What are the financial terms of AVBP's licensing agreement for MRG007?
When is AVBP planning to submit the first IND for MRG007?
Which cancer types will MRG007 initially target in clinical development?
What territories are included in AVBP's licensing agreement for MRG007?
How will the MRG007 licensing deal affect AVBP's cash runway?
