IDEAYA Announces Development Candidate Nomination of IDE034, a Potential First-in-Class B7H3/PTK7 Topo-I-Payload Bispecific ADC and Option Exercise with Biocytogen
IDEAYA Biosciences announced the nomination of IDE034 as a development candidate, a potential first-in-class B7H3/PTK7 topo-I-payload bispecific antibody drug conjugate (BsADC). The company exercised its option for an exclusive worldwide license from Biocytogen Pharmaceuticals, targeting an IND-filing in 2025 for first-in-human trials. IDE034 shows promise as both a monotherapy and in combination with IDEAYA's PARG inhibitor IDE161. B7H3/PTK7 co-expression in lung, colorectal, and head and neck cancers has been reported at 30%, 46%, and 27%, respectively. The licensing agreement includes upfront and option exercise fees, along with additional milestone payments, totaling $406.5 million.
IDEAYA Biosciences ha annunciato la nomina di IDE034 come candidato per lo sviluppo, un potenziale primo farmaco anticorpo bispecifico (BsADC) B7H3/PTK7 con payload topo-I. L'azienda ha esercitato l'opzione per un contratto di licenza esclusivo a livello mondiale da Biocytogen Pharmaceuticals, puntando a un deposito di IND nel 2025 per i primi trial sull'uomo. IDE034 mostra promettentemente sia come monoterapia sia in combinazione con l'inibitore PARG IDE161 di IDEAYA. È stato riportato che la coespressione di B7H3/PTK7 nei tumori polmonari, colorettali e testa-collo è rispettivamente del 30%, 46% e 27%. L'accordo di licenza include spese iniziali e di esercizio opzione, insieme a pagamenti di milestone aggiuntivi, per un totale di 406,5 milioni di dollari.
IDEAYA Biosciences anunció la nominación de IDE034 como candidato para el desarrollo, un potencial anticuerpo biespecífico (BsADC) B7H3/PTK7 con un fármaco de carga topo-I. La empresa ejerció su opción para una licencia mundial exclusiva de Biocytogen Pharmaceuticals, apuntando a una presentación de IND en 2025 para los primeros ensayos en humanos. IDE034 muestra promesas tanto como monoterapia como en combinación con el inhibidor PARG IDE161 de IDEAYA. Se ha informado que la coexpresión de B7H3/PTK7 en cánceres de pulmón, colorrectal y de cabeza y cuello es del 30%, 46% y 27%, respectivamente. El acuerdo de licencia incluye tarifas iniciales y de ejercicio de opción, junto con pagos por hitos adicionales, totalizando 406,5 millones de dólares.
IDEAYA 바이오사이언스는 IDE034를 개발 후보로 지명했다고 발표했습니다. 이는 잠재적인 B7H3/PTK7 topo-I-페이로드 이중 특이성 항체 약물 접합체(BsADC)입니다. 이 회사는 Biocytogen Pharmaceuticals로부터 독점적인 전 세계 면허 옵션을 행사하여 2025년 인체 첫 시험을 위한 IND 제출을 목표로 하고 있습니다. IDE034는 단독 요법과 IDEAYA의 PARG 억제제 IDE161과의 병행 사용 모두에서 유망한 성과를 보입니다. 폐, 대장, 그리고 두경부 암에서 B7H3/PTK7의 공동 발현 비율은 각각 30%, 46%, 27%로 보고되었습니다. 라이선스 계약에는 선불 및 옵션 행사 수수료와 추가 마일스톤 지급이 포함되어 총 4억 6천 5백만 달러에 달합니다.
IDEAYA Biosciences a annoncé la nomination de IDE034 en tant que candidat au développement, un potentiel anticorps bispécifique (BsADC) de classe première avec un payload topo-I B7H3/PTK7. L'entreprise a exercé son option pour une licence mondiale exclusive auprès de Biocytogen Pharmaceuticals, visant un dépôt d'IND en 2025 pour les premiers essais sur l'homme. IDE034 montre des promesses tant en monothérapie qu'en combinaison avec l'inhibiteur de PARG IDE161 d'IDEAYA. La coexpression de B7H3/PTK7 dans les cancers du poumon, colorectal et de la tête et du cou a été signalée respectivement à 30 %, 46 % et 27 %. L'accord de licence comprend des frais initiaux et d'exercice d'option, ainsi que des paiements d'étape supplémentaires, totalisant 406,5 millions de dollars.
IDEAYA Biosciences kündigte die Nominierung von IDE034 als Entwicklungskandidat an, ein potenzielles Antikörper-Drogenkonjugat (BsADC) mit doppelter Spezifität B7H3/PTK7 und Topo-I-Payload. Das Unternehmen nutzte seine Option für eine exklusive weltweite Lizenz von Biocytogen Pharmaceuticals und strebt eine IND-Einreichung im Jahr 2025 für die ersten klinischen Studien am Menschen an. IDE034 zeigt sowohl als Monotherapie als auch in Kombination mit dem PARG-Inhibitor IDE161 von IDEAYA vielversprechende Ergebnisse. Die Co-Expression von B7H3/PTK7 in Lungen-, Kolon- und Kopf-Hals-Krebs wurde mit 30 %, 46 % und 27 % berichtet. Der Lizenzvertrag beinhaltet Vorauszahlungen und Optionsausübungskosten sowie zusätzliche Meilensteinzahlungen, die insgesamt 406,5 Millionen Dollar betragen.
- IDE034 nominated as a development candidate, showing potential as a first-in-class BsADC.
- Exclusive worldwide license for IDE034 exercised from Biocytogen.
- Targeting IND-filing in 2025 for first-in-human trials.
- Potential for IDE034 as monotherapy and in combination with IDE161.
- Total licensing and milestone payments for IDE034 could reach $406.5 million, posing a significant financial commitment.
Insights
The nomination of IDE034 as a development candidate represents a significant advancement in targeted cancer therapy. The B7H3/PTK7 bispecific ADC platform shows promising potential with substantial tumor regression in preclinical models. The co-expression rates in major cancer types -
The deal structure, valued at up to
This strategic licensing deal strengthens IDEAYA's oncology pipeline with their 6th development candidate. The financial terms are structured favorably with milestone-based payments, limiting upfront capital requirements while maintaining worldwide rights. The addressable market is substantial across multiple solid tumor indications, particularly in lung and colorectal cancers which represent major commercial opportunities.
The partnership with Biocytogen validates their platform technology while giving IDEAYA full commercial control. The potential for combination therapy with their internal pipeline asset IDE161 could create significant value through wholly-owned combinations, maximizing future revenue potential without profit-sharing complications.
- Nominated IDE034 (BCG034) as a development candidate, a potential first-in-class B7H3/PTK7 topo-I-payload bispecific antibody drug conjugate (BsADC)
- Option exercised for an exclusive worldwide license for IDE034 from Biocytogen
- Targeting an IND-filing for IDE034 in 2025 to enable first-in-human clinical evaluation of B7H3/PTK7 topo-I-payload BsADC program
- IDE034 has the potential to be developed as a monotherapy and in combination with IDEAYA's PARG inhibitor IDE161
- B7H3/PTK7 co-expression in lung, colorectal, and head and neck cancer, has been reported at approximately
30% ,46% and27% , respectively
"We are pleased to nominate development candidate IDE034, a promising potential first-in class B7H3/PTK7 topo-I-payload bispecific ADC, which has demonstrated robust monotherapy tumor regressions in multiple preclinical models. The co-expression of B7H3/PTK7 in several solid tumors, including double-digit percent prevalence in lung, colorectal, and head and neck cancers, highlights the potential addressable market, both as monotherapy and in combination with PARG inhibitor IDE161," said Michael White, Ph.D., Chief Scientific Officer of IDEAYA Biosciences. "We are excited to nominate our 6th development candidate in IDE034 and this program achieves several strategic objectives for IDEAYA, including the potential for monotherapy activity, application in multiple priority solid tumor types of lung and colorectal cancer, and the ability to enable wholly-owned rational combinations with our internal pipeline," said Yujiro S. Hata, Chief Executive Officer and Founder, IDEAYA Biosciences.
"We are excited to have IDEAYA exercise their option to license the worldwide rights to our B7H3/PTK7 BsADC IDE034 with a proprietary topoisomerase linker-payload. This important milestone in our partnership further validates Biocytogen's RenLite® platform and brings us one step closer to making an impact on patients with solid tumors. We look forward to our continued partnership with IDEAYA as they advance this program to the clinic," added Dr. Yuelei Shen, President and CEO of Biocytogen.
IDEAYA is targeting an Investigational New Drug (IND) submission to the
The option was exercised for an exclusive worldwide license from Biocytogen pursuant to the option and license agreement between IDEAYA and Biocytogen. IDEAYA will pay Biocytogen upfront and option exercise fees, along with additional development and regulatory milestone payments, commercial milestone payments, and royalties on net sales, totaling
B7H3/PTK7 has been reported to be co-expressed in multiple solid tumor types, including in lung, colorectal, and head and neck cancers at approximately
About IDEAYA Biosciences
IDEAYA is a precision medicine oncology company committed to the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics. IDEAYA's approach integrates capabilities in identifying and validating translational biomarkers with drug discovery to select patient populations most likely to benefit from its targeted therapies. IDEAYA is applying its research and drug discovery capabilities to synthetic lethality – which represents an emerging class of precision medicine targets.
About Biocytogen
Biocytogen (HKEX: 02315) is a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies. Founded on gene editing technology, Biocytogen leverages genetically engineered proprietary RenMice® (RenMab™/ RenLite®/ RenNano®/ RenTCR-mimic™ ) platforms for fully human monoclonal/bispecific/multispecific antibody discovery, bispecific antibody-drug conjugate discovery, nanobody discovery and TCR-mimic antibody discovery, and has established a sub-brand, RenBiologics™, to explore global partnerships for an off-the-shelf library of >400,000 fully human antibody sequences against approximately 1000 targets for worldwide collaboration. As of June 30, 2024, approximately 150 therapeutic antibody and multiple clinical asset co-development/out-licensing/transfer agreements and nearly 50 target-nominated RenMice® licensing projects have been established with over 60 global pharmaceutical and biotech companies, including several partnerships with multinational pharmaceutical companies (MNCs). Biocytogen pioneered the generation of drug target knock-in humanized models for preclinical research, and currently provides a few thousand off-the-shelf animal and cell models under the company's sub-brand, BioMice™, along with preclinical pharmacology and gene-editing services for clients worldwide. Headquartered in
Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements related to (i) the timing of a potential IND filing, (ii) potential development strategies, (iii) the estimated potential addressable market and (iv) the potential therapeutic benefits of IDEAYA therapeutics. Such forward-looking statements involve substantial risks and uncertainties that could cause IDEAYA's preclinical and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including IDEAYA's programs' early stage of development, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, IDEAYA's ability to successfully establish, protect and defend its intellectual property, and other matters that could affect the sufficiency of existing cash to fund operations. IDEAYA undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of IDEAYA in general, see IDEAYA's Annual Report on Form 10-K dated February 20, 2024 and any current and periodic reports filed with the
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SOURCE IDEAYA Biosciences, Inc.
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