Daiichi Sankyo unveiled about the collaboration between them and AstraZeneca for antibody drug conjugate, DS-1062. This news has created absolute havoc in the Pharma market.
As per the agreement, AstraZeneca will pay Daiichi Sankyo up to $6 billion in total consideration, including a $1 billion upfront payment for New Global Development and Commercialization for Daiichi Sankyo’s DS-1062. This is the second collaboration happening between the two Pharma giants. Previously they collaborated to jointly develop and commercialize ENHERTU (a HER2 directed ADC) in March 2019.
Key Takeaways by Mellalta Meets
Daiichi Sankyo’s DS-1062 Development Strategy
Daiichi Sankyo’s DS-1062 is one of the three lead DXd ADCs in the oncology pipeline of Daiichi Sankyo. It is a TROP2-directed antibody drug conjugate (ADC), designed using Daiichi Sankyo’s proprietary DXd ADC technology with the highest development stage of Phase II.
In ASCO 2020, in its first-in-human Phase I study, DS-1062 has shown efficacy and the antibody drug conjugate well tolerated up to 8 mg/kg, and a dose effect on antitumor activity was observed over 2.0-10.0 mg/kg in heavily pre-treated with prior progression on standard treatment. The study is still ongoing in patients with unresectable Non-Small Cell Lung cancer and Triple Negative Breast Cancer refractory to/relapsed from standard treatment with measurable disease.
Another study has been newly announced by Daiichi is a Phase II multicenter, randomized study of DS-1062a in advanced or metastatic non-small cell lung cancer with actionable genomic alterations and previously treated with kinase inhibitor therapy and platinum based chemotherapy with or without prior immunotherapy. The study will begin from October 2020. This study is in collaboration with Gustave Roussy .
- Dosage which will get checked for DS-1062a are 8.0 mg/kg and 6.0 mg/kg
- DS-1062a will be administered as an intravenous (IV) infusion once every 3 weeks at 2 cycles
Secret Sauce by Daiichi: DS-1062 will also be checked in combination with PD-L1 therapy and several other undisclosed therapies [Click here]
Daiichi has also recently collaborated with Gustave Roussy and has signed a multi-year and multi-study research collaboration. The interest of the collaboration is to check the possible combinations of the two antibody-drug conjugates i.e DS-1062 (a TROP2 directed DXd ADC) and patritumab deruxtecan (a HER3 directed DXd ADC) for the treatment of patients with lung and breast cancer respectively.
- Trials will be done at several sites in France [expected]
- Enrollment upto 100 patients [expected]
- The studies will also be conducted primarily to analyze biomarker expression and tumor sensitivity; the role of receptor biology in the pharmacological activity of the Daiichi Sankyo DXd ADC platform, as well as the factors contributing to treatment resistance; immunogenicity and mechanism of action
- Additional research to be conducted under the collaboration includes several studies exploring multiple
therapeutic combinations for DS-1062
DS-1062 Phase 3 study
Phase 3 pivotal study is planned for NSCLC vs Standard of care in late 2021 and could be completed in the fourth quarter of 2024.
Power Agreement with AstraZeneca
Under the agreement AstraZeneca will pay Daiichi Sankyo an upfront payment of $1 billion, of which $350 million is due upon execution, $325 million after 12 months and $325 million after 24 months. Contingent payments of up to $5 billion include $1 billion for accomplishing of future regulatory milestones, and $4 billion for sales-related milestones. Total payments under the agreement have the potential to reach up to $6 billion.
AstraZeneca with Daiichi Sankyo will jointly commercialize DS-1062 worldwide according to the agreement. However, rights for commercializing the drug in japan will be kept by Daiichi Sankyo, itself.
And as Sunao Manabe, Representative Director, President and CEO of Daiichi Sankyo Company, Limited said,
“DS-1062, one of our lead DXd ADCs that will form a pillar of our next mid-term business plan, has the potential to become a best-in-class TROP2 ADC in multiple tumors, including lung and breast cancers”
Impact of this agreement
Since the first Astra deal with Daiichi Sankyo last March, Daiichi’s stock has more than doubled and it’s now the second-biggest pharmaceutical company in Japan by market capitalization, edging past Takeda Pharmaceutical Co. The collaboration will hugely impact AstraZeneca’s pipeline, as of now they have six potential blockbusters in oncology, with more to come in their early and late pipelines.
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