On January 9, 2023 -Schrödinger, Inc. (Nasdaq: SDGR), whose physics-based computational platform is transforming the way therapeutics and materials are discovered, reported an update on its progress across the business and announced its strategic priorities for 2023 (Press release, Schrodinger, JAN 9, 2023, View Source [SID1234626136]).
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"We are very proud of our achievements in 2022 across all areas of our business. We continued to enhance the capabilities of our platform, we made great progress in our existing collaborations and added new ones, and we advanced our first internal product candidate, SGR-1505, to the clinic. Our successes further validate the ability of our physics-based methods to accelerate discovery of novel drug candidates for important targets with best-in-class potential," stated Ramy Farid, Ph.D., chief executive officer at Schrödinger. "We are very excited about the opportunities we have this year to increase adoption of our software, to improve the capabilities of our platform and to advance our collaborative and proprietary pipeline. The successes of companies in which we have equity positions further validates our technology and provides yet another potential source of value creation."
New Updates
Today Schrödinger announced several new developments, including the following:
Schrödinger and Bristol Myers Squibb amended their discovery, development and commercialization collaboration to include a new discovery program in neurology. Schrödinger received an additional upfront payment for the new program and is eligible to receive discovery, development and commercialization milestones, as well as royalties on net sales, similar to the terms of the original agreement.
Schrödinger reported a new program targeting LRRK2, a genetically validated target with therapeutic potential for the treatment of Parkinson’s disease. In 2022, Schrödinger generated cryo-electron microscopy structures of LRRK2 which is helping to accelerate the identification of novel LRRK2 inhibitors. Schrödinger expects to select a development candidate for this program in 2024.
Schrödinger and Otsuka Pharmaceutical Co., Ltd., a leading healthcare company in Japan, together with Otsuka’s subsidiary Astex Pharmaceuticals, announced an innovative multi-part agreement that includes a collaboration to discover molecules for an emerging CNS disease target, as well as a knowledge-transfer program and expanded licensing agreement for Schrödinger’s platform for Otsuka’s new drug discovery facility. Under the terms of the drug discovery portion of the agreement, Schrödinger will be responsible for drug design through lead optimization and Otsuka will be responsible for all other drug discovery and clinical development activities. Schrödinger received an upfront payment and will be eligible to receive discovery, development and regulatory milestones, as well as tiered royalties on net sales of any products emerging from the drug discovery collaboration in all markets.
2022 Achievements
Today Schrödinger also highlighted several 2022 achievements, including the following:
Pipeline
Received FDA clearance for the investigational new drug (IND) application for SGR-1505, a MALT1 inhibitor, and opened enrollment for the Phase 1 clinical trial in patients with relapsed or refractory B cell malignancies
Presented new preclinical data on its potent and selective CDC7 inhibitor, SGR-2921, at the American Society of Hematology (ASH) (Free ASH Whitepaper) 64th Annual Meeting
Presented preclinical data from its Wee1 program at the American Association of Cancer Research Annual Meeting
Entered into an agreement with Eli Lilly and Company for the discovery and optimization of small molecule compounds addressing an undisclosed target
Initiated six new internal programs in oncology and immunology
Progress at Companies with Equity Ownership by Schrödinger
In December, Nimbus announced a definitive agreement with Takeda under which Takeda agreed to acquire Nimbus’s TYK2 inhibitor, NDI-034858, which is being evaluated for the treatment of multiple autoimmune diseases following positive results from the Phase 2b clinical trial in psoriasis. Schrödinger has an equity stake in Nimbus and subject to certain conditions, including the approval of Nimbus’s board of directors, expects to receive a cash distribution from Nimbus following the closing of the transaction, which is expected in the first half of 2023 and is contingent on completion of review under antitrust laws, including the Hart-Scott-Rodino Antitrust Improvements Act of 1976. A recent post on Schrödinger’s blog, Extrapolations, describes how NDI-034858 was developed using Schrödinger’s physics-based computational platform.
Morphic Therapeutic made significant progress advancing MORF-057, an oral α4β7 integrin inhibitor, for the treatment of ulcerative colitis (UC), including reporting positive Phase 1 clinical data and initiating a Phase 2b study in patients with moderate-to-severe UC.
In December, Ajax Therapeutics presented positive preclinical data on AJ1-10502, a next generation Type II JAK2 inhibitor, at the ASH (Free ASH Whitepaper) Annual Meeting. The preclinical data showed that AJ1-10502 demonstrated enhanced selectivity and improved efficacy compared to ruxolitinib in multiple disease models of myeloproliferative neoplasms.
Platform
Schrödinger scientists continued to make significant advances to the company’s platform. This includes expanding the number and types of targets for which the platform is enabled, increasing hit rates in hit discovery, and enhancing the predictive accuracy of key drug-like properties of molecules. Schrödinger scientists were authors on 22 publications in peer-reviewed life sciences and material science journals, including a co-authored manuscript describing how Schrödinger’s predictive computational methods accelerated Nimbus’s discovery of potent, selective TYK2 inhibitors.
Business
Appointed Geoffrey Porges, MBBS., as chief financial officer to lead all aspects of the company’s financial operations, investor relations and corporate affairs activities, as well as oversee business development and strategic planning for the company’s proprietary pharmaceuticals and biopharmaceutical collaborations.
Entered into a three-year collaboration with Eonix LLC to accelerate the discovery and design of materials for safer, energy dense lithium ion batteries.
Acquired and integrated XTAL BioStructures, Inc., enabling Schrödinger to pursue scientific advancements in the field of structural biology and enhance its ability to produce high quality target structures for drug discovery.
2023 Strategic Priorities
Today Schrödinger outlined the following strategic priorities for 2023:
Complete dose-escalation portion of the Phase 1 clinical trial of SGR-1505
Submit IND for SGR-2921 and initiate Phase 1 dose-escalation trial
Select Wee1 inhibitor development candidate and initiate IND-enabling studies
Advance LRRK2 program toward development candidate status
Enter into at least one new multi-target drug discovery collaboration
Advance and disclose additional unpartnered proprietary drug development programs
Publish new preclinical data from wholly-owned programs in peer-reviewed forums
Leverage new structural biology capabilities and advance computational technologies to enable new targets for drug discovery
Advance and publish validation of technology enabling discovery of novel biologics
Enter into at least one new materials science collaboration
Schrödinger will report its fourth quarter and full-year financial results and provide 2023 financial guidance on Tuesday, February 28, 2023, after the financial markets close. The company will host a conference call and webcast at 4:30 p.m. ET.