On April 15, 2021 Sutro Biopharma, Inc. (NASDAQ: STRO), a clinical-stage drug discovery, development and manufacturing company focused on the application of precise protein engineering and rational design to create next-generation cancer and autoimmune therapeutics, reported that Merck, known as MSD outside the United States and Canada, will make to Sutro a $15 million milestone payment for the initiation of an IND enabling toxicology study for the first program in its collaboration to develop novel cytokine derivative therapeutics for cancer and autoimmune disorders (Press release, Sutro Biopharma, APR 15, 2021, View Source [SID1234578102]). In July 2018, Sutro entered into a collaboration with Merck to jointly discover and develop best-in-class immune-modulating cytokine derivatives for both oncology and autoimmune indications.

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"The advancement of this first candidate into an IND enabling toxicology study represents an important preclinical milestone in our collaboration, led by Merck’s deep understanding and leadership within immuno-oncology and Sutro’s strength in precise protein design and optimization through its proprietary cell-free synthesis approaches," said Bill Newell, Chief Executive Officer of Sutro. "We are pleased with the continued progress in our collaboration with Merck and will continue our efforts towards developing novel therapeutics to improve outcomes and expand much-needed treatment options for cancer patients."

Under the terms of the 2018 Merck collaboration agreement, Sutro has been primarily responsible for preclinical research and development of cytokine derivatives utilizing Sutro’s proprietary cell-free protein synthesis and site-specific conjugation platforms, XpressCF and Xpress CF+. Merck has exclusive worldwide rights to therapeutic candidates derived from the collaboration. In March 2020, Merck exercised its option to extend the first research term of the program by one year, which generated a payment of $5.0 million to Sutro.

On April 15, 2021 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a synthetic lethality-focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported that the company plans to issue a pre-market press release and conduct a webcast on Friday, April 16, 2021, to discuss clinical data from the ongoing Phase 1/2 trial evaluating darovasertib (IDE196) as monotherapy and darovasertib and binimetinib combination in patients with metastatic uveal melanoma (MUM) (ClinicalTrials.gov Identifier: NCT03947385) (Press release, Ideaya Biosciences, APR 15, 2021, View Source [SID1234578101]).

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IDEAYA will host a Darovasertib Investor Day, including a conference call and webcast with participation of leading clinical investigators, at 8:00 a.m. ET on Friday, April 16, 2021. The link to the webcast of the conference call will be posted on the Investor Relations Events section of the Company’s website at: View Source The update may also be accessed by dialing 1-866-248-8441 (domestic) or 1-720-452-9102 (international) five minutes prior to the start of the call and providing the passcode 2793795. An archived replay will be accessible for 90 days following the event.

IDEAYA also announced the International Nonproprietary Name (INN) for IDE196 is "darovasertib" as registered with the World Health Organization (WHO)’s Programme and Classification of Medical Products.

On April 15, 2021Transcenta Holding Limited (Transcenta), a clinical stage global biotherapeutics company with fully-integrated capabilities in discovery, development and manufacturing of antibody-based therapeutics, reported that preclinical data of TST005, a bi-functional anti-PD-L1 and TGF-β trap fusion protein, in a poster during the 2021 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting, being held from April 10th to 15th and May 17th to 21st (Press release, Transcenta, APR 15, 2021, View Source [SID1234578100]).

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Title:
The preclinical characterization of TST005, a bi-functional anti-PD-L1 and TGF-β trap fusion protein

Abstract Number: 972
Poster Number: 917

Session Category:
Antibody Technologies

Session Title:
Experimental and Molecular Therapeutics

Poster launch time:
April 10th, 2021, 8:30 a.m.ET, U.S. time

About TST005
TST005, is a bi-functional anti-PD-L1 and TGF-β trap fusion protein designed to simultaneously target two immuno-suppressive pathways, transforming growth factor β-(TGF-β) and programmed cell death ligand-1 (PD-L1), that are commonly used by cancer cells to evade the immune system. TST005 consists of a high affinity PD-L1 antibody fused with an engineered TGF-β Receptor Type II protein in its C-terminal. TST005 lacks FcR binding and has reduced risk of FcR mediated killing of PD-L1 expressing effector T cells. TST005’s PD-L1 high binding activity and enhanced TGF-β trap stability enables the targeted delivery of TGF-β trap into PD-L1 expressing tumors, thereby minimizing off-target toxicities of systemic inhibition of TGF-β signaling. TST005 displayed potent activity in vitro in reversing TGF-β induced T-cell suppression. In multiple syngeneic tumor models, TST005 induced significant increase of CD8 T-cell infiltration into PD-L1 expressing tumors and displayed dose-dependent tumor growth inhibition. TST005 is well tolerated in non-human primates and displayed a linear PK profile. TST005 is a potential novel bi-functional immunotherapy candidate with improved therapeutic window.

On April 15, 2021 Prestige BioPharma and Pharmapark LLC reported that the two companies have entered into a binding agreement for the exclusive partnership and supply for the commercialization of Prestige BioPharma’s Bevacizumab biosimilar in the Russian Federation (Press release, Prestige BioPharma, APR 15, 2021, View Source [SID1234578099]).

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Prestige’s Bevacizumab (HD204) is a mAb biosimilar to Roche’s Avastin, an inhibitor of vascular endothelial growth factor (VEGF), which is used in combination with other therapies to treat patients with multiple forms of cancer including metastatic colorectal cancer, advanced non-small-cell lung cancer, advanced kidney cancer, certain types of epithelial cancers and cancers of the cervix. HD204 is currently in Phase III clinical development with active recruitment ongoing within the pivotal efficacy and safety trial SAMSON-II. Positive results were previously reported from the Phase I clinical trial (SAMSON-I) which evaluated the pharmacokinetics, safety and immunogenicity of HD204 to Avastin.

The partnership arrangement includes the exclusive rights for Pharmapark to commercialize the Bevacizumab biosimilar in the Russian Federation, leveraging the company’s strong sales and marketing capabilities and experience in successfully bringing new biosimilars to market. Whilst the terms of the deal are not being disclosed, Prestige BioPharma will assume responsibility for product commercial supply out of its manufacturing facilities in Osong, Korea, while Pharmapark will be responsible for local registration, sales and marketing in the Russian Federation with the option to manufacture the product in Russian Federation in line with the Russian import substitution strategy.

This agreement expands upon the existing collaboration between Prestige BioPharma and Pharmapark LLC with the companies signing a license agreement in July 2019 for Prestige BioPharma’s Herceptin biosimilar.

On April 15, 2021 Brooklyn ImmunoTherapeutics, Inc. (NYSE American: BTX) ("Brooklyn"), a biopharmaceutical company focused on exploring the role that cytokine-based therapy can have in treating patients with cancer, reported it has paid $1 million towards the acquisition of a license for Factor Bioscience’s and Novellus’ mRNA Gene Editing and Cell Therapies technology and has extended through May 21, 2021 its option exercise period for entering into a related license agreement with Factor Bioscience and Novellus (Press release, Brooklyn ImmunoTherapeutics, APR 15, 2021, View Source [SID1234578098]).

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If a license agreement is completed, it would allow Brooklyn to utilize an extensively patented process to seek to develop gene edited compounds using mRNA, which preclinical data suggest to be more efficient, non-immunogenic and non-mutagenic, for treatment of several solid tumor and liquid indications, sickle cell anemia, as well as a number of additional inherited disorders. Gene editing is an investigational technique that is used to add, delete, or correct a patient’s genetic material in an effort to treat a disease. Research suggests that editing genes in patients could potentially result in cures for a number of genetic diseases. The licensed platform would include mRNA cell reprogramming, mRNA-based gene editing, a proprietary gene editing protein, and the proprietary ToRNAdo lipid delivery system that provides efficient delivery of mRNA ex vivo and in vivo to skin, brain, eye and lung tissue.

If Brooklyn does not enter into the license agreement by May 21, 2021, it will be entitled to be reimbursed for the $1 million payment.