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IDEAYA Biosciences has exercised its option to exclusively license Biocytogen's potential first-in-class B7H3/PTK7 topo-I-payload bispecific antibody-drug conjugate IDE034. The agreement between the two, signed in July and worth up to $406.5 million for Biocytogen, positions IDEAYA to advance IDE034 into clinical trials as early as 2025."This programme achieves several strategic objectives for IDEAYA," remarked CEO Yujiro Hata, "including the potential for monotherapy activity, application in multiple priority solid tumour types of lung and colorectal cancer, and the ability to enable wholly-owned rational combinations with our internal pipeline," including the company's PARG inhibitor IDE161. IDE034 is designed to target the co-expression of B7H3 and PTK7, two cell surface proteins frequently found in solid tumours like lung, colorectal, and head-and-neck cancers. Chief Scientific Officer Michael White said the compound has shown "robust monotherapy tumour regressions in multiple preclinical models." Am IND application is expected to be filed next year.Biocytogen's proprietary RenLite platform was used to generate IDE034. The Chinese biotech also inked a deal this year worth up to $325.5 million with SOTIO, granting the latter an option to license multiple fully-human bispecific antibodies generated with the RenLite technology.The emergence of bispecific ADCs as a promising modality in oncology has fueled about eight industry tie-ups in the last year, with at least around a dozen candidates now in clinical testing, including a handful of Phase I programmes from Bristol Myers Squibb, AstraZeneca and Merck KGaA that target two different antigens. For more, see – Spotlight On: Bispecific ADCs are gaining traction.

Lonza’s Synaffix unit has licensed its antibody-drug conjugate (ADC) technology to BigHat Biosciences following a series of successful preclinical proof-of-concept studies. The deal — terms of which were not disclosed — allows BigHat to integrate Synaffix's site-specific ADC technology with its AI/machine learning-driven antibody design platform, dubbed Milliner. Since debuting in 2019, BigHat has raised over $100 million in funding and has signed research collaborations with Amgen and Merck & Co, as well as acquiring Frugi Biotechnology for an undisclosed sum. BigHat's 1st clinical programmeThe companies noted that Milliner was used to design a highly differentiated antibody that was paired with Synaffix's GlycoConnect, HydraSpace and toxSYN technologies to generate a next-generation ADC. BigHat said that the programme is at the IND-enabling stage and on track to be the firm's first clinical-stage asset."We are excited to combine Synaffix's conjugation and linker-payload technologies with our custom-designed antibody to create a next-generation ADC for patients with high unmet medical need," remarked BigHat CEO Mark DePristo. The company will also be able to leverage Lonza's ‘DNA-to-IND’ service for streamlined delivery of ADC entities prepped to enter the clinic.Synaffix — acquired last year by Lonza — has forged ADC deals with several biotechs in the past, including Mersana, Genmab, Emergence Therapeutics, MacroGenics and SOTIO.

Ideaya Bioscience has entered into an option and license agreement for a potential first-in-class bispecific ADC program with Beijing-based biotech Biocytogen Pharmaceuticals. Biocytogen's B7H3/PTK7 topo-I-payload ADC program has the potential to be developed as a monotherapy agent in multiple solid tumor types and used in combination with programs in San Francisco-based Ideaya's pipeline targeting DNA damage repair (DDR) therapies, including PARG inhibitor IDE161. Under the terms of the deal, Biocytogen will receive an upfront fee and upon Ideaya's potential exercise of the option, an exercise fee totaling up to $6.5 million. Biocytogen will be eligible to receive total potential milestone payments of $400 million, including development and regulatory milestone payments of up to $100 million. Earlier this month, Biocytogen licensed multiple bispecific antibodies generated with the company's proprietary RenLite platform to Czech biotech Sotio, with Sotio aiming to broaden its next-gen ADC portfolio. With both the bispecific antibody and the ADC sectors maturing, bispecific ADCs are positioned as a next-gen ADC approach.The modality has the potential to eliminate some of the clinical challenges associated with ADCs, such as off-target toxicity and drug resistance.