Biocytogen Announces Option and License Agreement with IDEAYA Biosciences for Potential First-in-Class B7H3/PTK7 Topo-I-Payload Bispecific ADC Program

Rhea-AI Summary

Biocytogen and IDEAYA Biosciences have entered into an option and license agreement for a potential first-in-class B7H3/PTK7 bispecific antibody drug conjugate (BsADC) program. The agreement grants IDEAYA an option for an exclusive worldwide license for the program, which targets B7H3/PTK7 co-expression found in multiple solid tumor types. Biocytogen will receive an upfront fee and potential milestone payments totaling $406.5 million, including $100 million in development and regulatory milestones, plus single-digit royalties on net sales.

The BsADC program has the potential to be developed as a monotherapy and in combination with IDEAYA's DNA Damage Repair (DDR) pipeline, including IDE161 (PARG inhibitor). A development candidate nomination is targeted for H2 2024. This collaboration leverages Biocytogen's RenLite® platform and proprietary linker-payload technology to enhance ADC precision and potency.

Positive

• Potential first-in-class B7H3/PTK7 BsADC program with applications in multiple solid tumor types
• Total potential payments of $406.5 million, including $100 million in development and regulatory milestones
• Single-digit royalties on net sales for Biocytogen
• Combination opportunities with IDEAYA's DNA Damage Repair (DDR) pipeline
• Development candidate nomination targeted for H2 2024

Negative

• None.

Insights

Biotechnology Analyst

This collaboration between Biocytogen and IDEAYA Biosciences marks a significant step in the development of a potentially groundbreaking cancer therapy. The B7H3/PTK7 bispecific antibody-drug conjugate (BsADC) program targets a unique combination of proteins expressed in various solid tumors, potentially offering a new treatment avenue for patients with options.

The deal structure, with an upfront fee and potential milestone payments totaling $406.5 million, reflects the high expectations for this program. The double-digit prevalence of B7H3/PTK7 co-expression in lung, colorectal and head and neck cancers suggests a substantial market opportunity. However, investors should note that the program is still in early stages, with a development candidate nomination targeted for H2 2024.

The potential synergy with IDEAYA's DNA Damage Repair (DDR) pipeline, particularly the PARG inhibitor IDE161, could enhance the therapeutic efficacy and broaden the application of this BsADC. This aligns with the growing trend of combination therapies in oncology, potentially increasing the program's value proposition.

For Biocytogen, this deal validates their RenLite® platform and proprietary linker-payload technology, potentially attracting more partnerships and bolstering their position in the competitive ADC landscape. For IDEAYA, it expands their portfolio beyond small molecule DDR-based therapies, diversifying their approach to precision oncology.

Investors should monitor the progress towards the development candidate nomination in H2 2024, as this will be a important milestone in assessing the program's potential. The collaboration also highlights the increasing interest in bispecific ADCs as a promising modality in cancer treatment, potentially signaling a broader industry trend.

Financial Analyst

The option and license agreement between Biocytogen and IDEAYA Biosciences represents a significant financial opportunity for both companies. The deal structure, with a total potential value of $406.5 million, including $100 million in development and regulatory milestones, demonstrates the high expectations for this B7H3/PTK7 BsADC program.

For Biocytogen, this agreement provides immediate revenue through the upfront fee and potential future cash flows from milestone payments and royalties. This deal structure mitigates some of the financial risks associated with drug development while still maintaining upside potential. The single-digit royalties on net sales, if the product reaches the market, could provide a steady long-term revenue stream.

IDEAYA's investment in this program aligns with their strategy to expand their oncology portfolio. While the upfront costs are not disclosed, the potential $406.5 million in total payments suggests a significant commitment. Investors should consider how this impacts IDEAYA's cash burn rate and funding requirements for their existing pipeline.

The market potential for this therapy, given its applicability across multiple solid tumor types, could be substantial. However, it's important to note that the program is still in early stages, with significant R&D costs and regulatory hurdles ahead. The targeted development candidate nomination in H2 2024 provides a near-term milestone for investors to gauge progress.

This collaboration also highlights the increasing value of innovative platforms in biotechnology. Biocytogen's RenLite® platform and proprietary linker-payload technology could attract further partnerships, potentially creating additional revenue streams. For both companies, this deal could enhance their attractiveness to investors and potentially impact their valuation multiples in the biotechnology sector.

• Biocytogen granted IDEAYA an option for an exclusive worldwide license for potential first-in-class B7H3/PTK7 topo-I-payload bispecific antibody drug conjugate (BsADC) program
• B7H3/PTK7 co-expression found in multiple solid tumor types, including double-digit percent prevalence in lung, colorectal, and head and neck cancers
• Rational combo opportunities with IDEAYA’s DNA Damage Repair (DDR) pipeline, including IDE161 (PARG)
• Targeting development candidate nomination in H2 2024

BEIJING, China & SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen, HKEX: 02315), a global biotech company focusing on the discovery of novel antibody/ADC therapeutics, announced that it has entered into an option and license agreement for a potential first-in-class B7H3/PTK7 BsADC program with IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics.

“We are thrilled to announce our collaboration with IDEAYA to explore the promising combination of our potential first-in-class ADC and IDEAYA’s DDR small molecules,” said Dr. Yuelei Shen, President and CEO of Biocytogen. “This partnership leverages our cutting-edge RenLite^® platform and proprietary linker-payload technology to enhance the precision and potency of ADCs. IDEAYA's strong determination and rich experience in drug development make us confident that this therapy could be rapidly advanced to benefit patients.”

“The potential first-in-class B7H3/PTK7 topo-I-payload BsADC program has the potential to be developed as a monotherapy agent in multiple solid tumor types, and advances IDEAYA’s broader corporate strategy to enable wholly-owned first-in-class rational combinations at the intersection of ADCs and small molecule DDR-based therapies to deliver greater benefit for patients,” said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences.

The agreement grants IDEAYA an option for an exclusive worldwide license from Biocytogen for a potential first-in-class B7H3/PTK7 topo-I-payload BsADC program. B7H3/PTK7 has been found to be co-expressed in multiple solid tumor types, including double-digit percent prevalence in lung, colorectal, and head and neck cancers, among others.

Under the terms of the agreement, Biocytogen will receive an upfront fee and upon an option exercise by IDEAYA, be entitled to receive an option exercise fee, development and regulatory milestones and commercial milestone payments, as well as single-digit royalties on net sales. Total potential upfront, option exercise and milestone payments equal an aggregate of $406.5 million, including development and regulatory milestones of $100.0 million.

Based on preclinical data, the potential first-in-class B7H3/PTK7 topoisomerase-I-inhibitor-payload BsADC program has the potential to be developed as a monotherapy agent and used in combination with multiple programs in IDEAYA’s pipeline targeting DDR-based therapies, including PARG inhibitor IDE161. A development candidate nomination for the B7H3/PTK7 topoisomerase-I-inhibitor payload BsADC program is targeted for the second half of 2024.

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^TM/ RenLite^®/ RenNano^®/ RenTCR-mimic^TM ) 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^TM, 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 December 31, 2023, 103 therapeutic antibody and multiple clinical asset co-development/out-licensing/transfer agreements and 47 target-nominated RenMice^® licensing projects have been established around the globe, 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^TM, along with preclinical pharmacology and gene-editing services for clients worldwide. Headquartered in Beijing, Biocytogen has branches in China (Haimen Jiangsu, Shanghai), USA (Boston, San Francisco), and Germany (Heidelberg). For more information, please visit http://en.biocytogen.com.cn.

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240731406265/en/

Biocytogen Contacts

Antibody assets and platforms: BD-Licensing@biocytogen.com

Media: pr@bbctg.com.cn



Investor and Media Contact

IDEAYA Biosciences

Andres Ruiz Briseno

SVP, Head of Finance and Investor Relations

investor@ideayabio.com

Source: Biocytogen Pharmaceuticals (Beijing) Co., Ltd.

FAQ

What is the focus of the agreement between Biocytogen and IDEAYA Biosciences?

The agreement focuses on a potential first-in-class B7H3/PTK7 bispecific antibody drug conjugate (BsADC) program, granting IDEAYA an option for an exclusive worldwide license.

What is the total potential value of the agreement for Biocytogen?

The total potential value of the agreement for Biocytogen is $406.5 million, including upfront fees, option exercise fees, and milestone payments, plus single-digit royalties on net sales.

When is the development candidate nomination for the B7H3/PTK7 BsADC program targeted?

The development candidate nomination for the B7H3/PTK7 BsADC program is targeted for the second half of 2024.

How does this agreement align with IDEAYA's (IDYA) corporate strategy?

This agreement advances IDEAYA's strategy to enable first-in-class rational combinations of ADCs and small molecule DDR-based therapies, aiming to deliver greater benefit for patients.

What types of cancers show B7H3/PTK7 co-expression according to the press release?

B7H3/PTK7 co-expression has been found in multiple solid tumor types, with double-digit percent prevalence in lung, colorectal, and head and neck cancers, among others.