Enrollment of patients in bispecific ADC solid tumor clinical trials has been completed, triggering another milestone payment for Merck

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The enrollment of patients in the phase 1 dose escalation and expansion study of M1231 adult metastatic solid tumors has been completed.

It is worth mentioning that the product candidate M1231 provided by Sutro is a bispecific antibody drug conjugate (ADC).

Recommended reading: Merck's investment in bispecific ADC reached a milestone in clinical supply to treat solid tumorsYimai Meng broke the news that the two companies reached a cooperation agreement in 2014, according to the agreement Sutro to manufacture antibodies and linkers for early clinical supply, and is eligible Get further payments and tiered privilege usage fees worldwide, as well as certain additional one-time usage fees.

Merck will be responsible for drug products, clinical development, and commercialization of the candidate product after obtaining regulatory approval.

 Sutro CEO Bill Newell said: "The robustness and flexibility of our cell-free platform and wholly-owned manufacturing facility make it possible for the discovery and early clinical supply of M1231.

The continued progress of the program shows that both parties have made the move to promote the development of M1231.
Commitment represents an important achievement in jointly solving the unmet medical needs of cancer patients through cooperation.

"Sutro Research President and Chief Scientific Officer Dr.
Trevor Hallam added: "Our partnership demonstrates the combined strength of Sutro and Merck, and continues to expand the development of antibody-drug conjugates.

M1231 is the first research-type bispecific ADC.
By targeting MUC1 and EGFR at the same time, M1231 is more targeted to tumors while reducing its toxicity to normal tissues.

"Focus on protein conjugates.
Sutro Biopharma, Inc.
is located in South San Francisco.
It is a clinical stage drug discovery, development and manufacturing company.

Sutro uses precise protein engineering and rational design to advance the next generation of tumor therapy.

M1231 is A bispecific antibody conjugate (ADC) that also targets MUC1-EGFR for the treatment of solid tumors.

M1231 is developed based on Sutro’s XpressCF® and XpressCF+™ technology platforms and relies on the German Merck’s strand-exchange.
The bispecific anti-like molecule produced by the engineering domain (SEED) platform.
In addition, M1231 also utilizes Sutro's proprietary linker.

Sutro utilizes the proprietary and integrated cell-free protein synthesis platform XpressCF® to couple with specific locations The platform XpressCF+™ has developed four candidate products.

In addition to the joint development of M1231 with Merck, there are two internal R&D pipelines STRO-001 and STRO-002 of Sutro, and the candidate product CC-99712 jointly developed with Bristol Myers Squibb.

▲ XpressCF ® technology platform (picture source: sutrobio) Sutro’s XpressCF® platform is a cell-free protein production technology that does not require repeated adjustments to new cell lines, avoiding some of the limitations of traditional protein production, and at the same time Produce a single protein with a yield of g/L in 8-10 hours.

The XpressCF® platform can provide customized therapeutic protein design, manufacturing and development, and also supports the insertion of unnatural amino acid sequences.

XpressCF+™ allows customized therapeutic proteins, including 20 kinds of natural amino acids, and proteins synthesized from unnatural amino acids.

The protein containing unnatural amino acids developed using XpressCF+™ can be coupled with one or more chemical substances at a specific site, making the protein-drug coupling homologous.

▲ Sutro's R&D pipeline (picture source: sutrobio) STRO-001 is an ADC targeting CD74, and was awarded the title of multiple myeloma orphan drug by the FDA in October 2018.

The current phase 1 clinical study is mainly aimed at patients with advanced B-cell malignancies including multiple myeloma and non-Hodgkin's lymphoma.

STRO-002 is an ADC targeting folate receptor alpha (FolRα) and is currently being studied in phase 1 clinical trials for patients with ovarian cancer and endometrial cancer.

On May 19, Sutro updated part of the data of STRO-002's dose escalation queue in the Phase 1 study, and other dose escalation data will be announced on the 2021 ASCO.

Recommended reading: FolRα ADC has positive clinical data in the treatment of ovarian cancer, launching an attack on solid tumorsYimai Meng revealed that CC-99712 is an ADC targeting BCMA, developed by Sutro and BMS in cooperation, and has been awarded by the FDA mainly for multiple occurrences Orphan drug for sexual myeloma.

So far, Sutro has designed a variety of tumor immunotherapies, ADCs, vaccine memory bispecific antibodies, etc.
The selected targets are all clinically verified targets that have poor therapeutic effects.

In addition to developing internal pipelines, Sutro also works with partners (such as Merck, BMS, etc.
) to develop better tumor drugs to kill tumor cells more effectively without damaging healthy cells.

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