Dendritic cell (DC) vaccine(Instituto Oncológico Dr. Rosell)

Eisai is the latest drugmaker to show an interest in antibody-drug conjugates—and has identified BlissBio’s phase 1/2 asset BB-1701 as its way in. Eisai is joining the HER2 antibody-drug conjugate (ADC) gold rush. After seeing AstraZeneca and Daiichi Sankyo validate the approach, Eisai has struck a $2 billion biobucks deal with Bliss Biopharmaceutical for a spot alongside BioNTech in the chasing pack.  AstraZeneca and Daiichi have linked their HER2-directed ADC Enhertu to improved outcomes in multiple settings, including patients with breast cancer that have low levels of the receptor. The data supported an explosive launch, with sales growing (PDF) more than 140% last year to turn the product into a blockbuster, and a clutch of companies see space for me-too drugs.  Eisai is the latest drugmaker to show an interest in the sector—and has identified BlissBio’s phase 1/2 asset BB-1701 as its way in. In return for an upfront fee of undisclosed size, Eisai has secured the chance to co-develop the HER2-directed ADC with BlissBio through the option period.  If Eisai exercises its option, the Japanese drugmaker will receive ex-China rights to BB-1701. The option exercise payment and development and commercial milestones are collectively worth up to $2 billion. Neither party has disclosed the size of the upfront or  option fees. Earlier this year, BioNTech paid $170 million upfront and committed up to $1.5 billion in milestones for a HER2 ADC and another candidate.    BlissBio took BB-1701 into the clinic early in 2020 and has now tested the ADC in more than 100 patients with a range of tumor types in the U.S. and China. The development program will now benefit from the support of Eisai. If Eisai takes up its option on BB-1701, it will join biotechs including Ambrx, BioNTech, GeneQuantum Healthcare and Jiangsu HengRui Medicine in the pack of companies with potential rivals to Enhertu in development.

AU ZH, Switzerland, April 14, 2023 (GLOBE NEWSWIRE) -- Araris Biotech AG, a company pioneering a proprietary antibody-drug conjugate (ADC)-linker technology, today announced the company will deliver two poster presentations at this year’s American Association for Cancer Research (AACR) 2023 Annual Meeting, being held April 14-19, 2023 at the Orange County Convention Center in Orlando, Florida. The presentations will highlight late-breaking preclinical data on anti-Nectin-4 and anti-HER2 ADCs generated using the company’s proprietary linker technology. Both ADCs demonstrated improved anti-tumor activity compared to respective FDA approved ADCs in head-to-head in-vivo studies. "The preclinical data highlighted in these two presentations demonstrate that we can develop stable and highly efficacious ADCs with a low drug-load that have an excellent exposure, which we believe may enable us to address key dose-limiting toxicities,” said Philipp Spycher, Ph.D., co-founder and chief executive officer of Araris Biotech AG. “Our ADCs have the potential to address challenges seen amongst other currently approved ADC therapies, such as limited efficacy and tolerability, in addition to being able to display favorable biophysical properties. We are looking forward to studying our linker technology further and continuing to advance our Nectin-4 program.” The poster presentation titled “Novel peptide linker-based Nectin-4 targeting ADC shows improved tolerability with long-lasting anti-tumor efficacy at low doses” will be presented on April 18, 2023 from 9:00 a.m. to 12:30 p.m. ET. The poster will be presented by Isabella Attinger-Toller, Ph.D. co-founder and chief technology officer at poster board number 12, abstract number LB219. Poster presentation highlights: Generated an anti-Nectin-4 ADC based on enfortumab as the targeting antibody with monomethyl auristatin E (MMAE) as the payload using Araris’ peptide linker and site-specific enzymatic conjugation approach Resulting ADC had a drug-to-antibody-ratio (DAR) of 2. By comparison, the approved enfortumab-vedotin (EV) used a higher payload amount, with a DAR of 4. Araris’ ADC demonstrated potent cell cytotoxicity similar to EV, despite using lower drug load, as well as excellent stability in mouse and human sera exemplified by the absence of payload deconjugation or linker cleavage. EV showed significant payload deconjugation Using a breast cancer model, Araris’ ADC demonstrated a complete tumor regression lasting for more than 100 days. EV administered at the same payload dose showed only a short and transient (20 day) tumor regression with no animal reaching a complete response. Despite higher in vivo exposure and extremely efficient anti-tumor response at low payload doses, there was no increased toxicity from the Araris ADC. Overall tolerability improved compared to EV The poster presentation titled “Inducing significant and efficient tumor growth inhibition vs. trastuzumab deruxtecan with low drug-load Topoisomerase 1 inhibitor ADC using novel peptide linkers for payload conjugation” will be presented on April 18, 2023 from 9:00 a.m. to 12:30 p.m. ET. The poster will be presented by Philipp Spycher, Ph.D. co-founder and chief executive officer at poster board number 14, abstract number LB221. Poster presentation highlights: Generated an anti-HER2 ADC based on trastuzumab as the targeting antibody with Topoisomerase 1 (Topo1) inhibitor as payload, using Araris’ peptide linker and site-specific enzymatic conjugation approach Resulting ADC had a drug-to-antibody-ratio (DAR) of 2. By comparison, the approved Trastuzumab deruxtecan used a higher payload amount, with a DAR of 8. Araris’ ADC demonstrated potent cell cytotoxicity despite using lower drug load, as well as a pharmacokinetic-pro to the naked antibody. Trastuzumab deruxtecan showed faster clearance. Using a colon cancer model, the Araris ADC demonstrated superior anti-tumor activity compared to Trastuzumab deruxtecan, injected at the same payload doses. Araris’ ADC resulted in complete tumor regression lasting the entirety of the study (80 days) and was well tolerated. About Araris Biotech AG Araris Biotech AG is pioneering the development of its novel antibody-drug conjugate (ADC)-linker technology to enable efficient and precise production of ADCs. Its linker platform enables the attachment of any drug payload to ‘off the shelf’ antibodies, without the need for prior antibody engineering. The resulting ADCs have shown very high activity at low doses and an improved therapeutic index compared to FDA-approved ADCs. Araris is a spin-off company from the Paul Scherrer Institute (PSI) and ETH Zurich. For more information, please visit or follow Araris on Twitter and LinkedIn. Corporate Contact: Philipp Spycher, Ph.D. Chief Executive Officer info@ararisbiotech.com Media Contact: Veronica Eames LifeSci Communications, LLC veames@lifescicomms.com 646-970-4682