Schrödinger Hosts Platform Day

On October 6, 2022 Schrödinger (Nasdaq: SDGR), whose physics-based computational platform is transforming the way therapeutics and materials are discovered, reported a detailed review of its technology platform, the impact of this platform across a growing portfolio of collaborative and proprietary drug discovery programs, areas for future innovation, and the opportunities for value creation during its Platform Day today, October 6, from 10:00 a.m. – 12:00 p.m. ET (Press release, Schrodinger, OCT 6, 2022, View Source [SID1234621769]).

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"We have a 30-year history of continuing scientific innovation that has resulted in a very powerful technology platform that can accurately predict molecular properties by combining the accuracy of physics-based modeling with the speed of machine learning," said Ramy Farid, chief executive officer at Schrödinger. "Moreover, our physics-based methods allow us to extrapolate beyond characterized chemical space to find the molecules that are beyond the limits of current knowledge. We look forward to highlighting our work in the life sciences today."

New Collaboration with Lilly
Today Schrödinger also announced that it has entered into a collaboration with Eli Lilly and Company. Under the terms of the agreement, Schrödinger will be responsible for the discovery and optimization of small molecule compounds addressing the target. Lilly will be responsible for the completion of preclinical development, clinical development and commercialization. Schrödinger will receive an upfront payment and will be eligible to receive up to $425 million in discovery, development and commercial milestone payments. Schrödinger is also eligible to receive low single- to low double-digit royalties on net sales of any products emerging from the collaboration in all markets.

Collaborations and Proprietary Pipeline Update
Schrödinger is advancing a portfolio of 12 active collaboration projects and 18 proprietary programs. In today’s presentation, six case studies are being highlighted that demonstrate how Schrödinger leverages the platform to overcome molecular design challenges. These case studies include the following:

Discovery of a potential best-in-class acetyl-CoA carboxylase (ACC) inhibitor program in collaboration with Nimbus Therapeutics; the program was acquired by Gilead and is progressing in a Phase 2b trial in patients with compensated cirrhosis due to nonalcoholic steatohepatitis (NASH)
Discovery of a selective TYK2 inhibitor, NDI-034858, in collaboration with Nimbus Therapeutics, which is currently progressing in Phase 2b trials in patients with moderate to severe psoriasis
Discovery of MORF-057, an oral, small molecule ɑ4β7 inhibitor, in collaboration with Morphic Therapeutic, which is currently progressing in a Phase 2a trial in patients with moderate to severe ulcerative colitis and is expected to enter a Phase 2b trial in the fourth quarter of this year
Discovery and development of Schrödinger’s proprietary MALT1 inhibitor, SGR-1505, which is expected to enter a Phase 1 clinical study in patients with relapsed/refractory B-cell lymphoma in the fourth quarter of this year
Discovery and development of Schrödinger’s proprietary CDC7 inhibitor, SGR-2921, which is advancing through IND-enabling studies to support a planned IND submission in the first half of 2023
Discovery and development of Schrödinger’s proprietary Wee1 inhibitor program, which is currently undergoing studies required for selection of a development candidate expected in the fourth quarter of this year
Opportunities for Future Innovation within the Platform
Schrödinger is highlighting the near- and longer-term opportunities for continued innovation of its physics-based computational platform. These opportunities include the following:

Increasing the number and type of discovery targets the platform can advance through hit identification (Hit ID), including structure-based drug discovery for nearly all targets and Hit ID for historically undruggable targets
Improving the effectiveness and efficiency with which the platform can advance targets through lead optimization, including more comprehensive support for ADME-Tox optimization and de novo design
Expanding the applicability of the platform to new high-value areas, including preclinical development and formulations, new modalities and materials design
"The metrics for all aspects of our business are positive – our software business is growing, our collaborations are increasing, we have more milestone and royalty opportunities than ever before, and we are expanding our proprietary pipeline," said Geoffrey Porges, MBBS., chief financial officer at Schrödinger. "We view our balanced business model as a strength and see significant opportunities for value creation from the platform in the near, medium and long term."

Event Information
Schrödinger’s Platform Day is a hybrid event, with limited in-person attendance available to members of the investment community, and a simultaneous webcast is available for individual investors and other interested parties who wish to join virtually.

The live presentation can be accessed under "News & Events" in the investors section of Schrödinger’s website, View Source and will be archived for approximately 90 days. To participate in the live webcast, please register for the event here. It is recommended that participants register at least 15 minutes in advance of the event.

Sorrento Therapeutics to Participate in Key Opinion Leader Panel Discussion on “New Horizons for the Treatment of Non-small Cell Lung Cancer”

On October 6, 2022 Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") reported that Dr. Mike A. Royal, Chief Medical Officer, will participate in an upcoming Key Opinion Leader (KOL) Panel Discussion that will focus on the great unmet need in non-small cell lung cancer and the potential of abivertinib, a novel, third-generation, EGFR/BTK inhibitor (Press release, Sorrento Therapeutics, OCT 6, 2022, View Source [SID1234621768]). Details are as follows:

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The KOL Panel Discussion will be archived and can be accessed on the Investor Relations section of Sorrento’s website under Events, where you can also learn more about the panel participants’ backgrounds and biographies. (Events Calendar – Sorrento Therapeutics).

Tempest to Present at Emerging Technologies for IO Targeting and Discovery Summit

On October 6, 2022 Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage oncology company developing first-in-class1 therapeutics that combine both targeted and immune-mediated mechanisms, reported that Dara Burdette, Ph.D., Senior Director of Discovery Research at Tempest, will present on the company’s TREX1 pipeline asset and will serve as chairperson for the "New Approaches to Solid Tumor Targeting" session at the Emerging Technologies for IO Targeting and Discovery Summit taking place October 13-14, 2022 in Boston, MA (Press release, Tempest Therapeutics, OCT 6, 2022, View Source [SID1234621765]).

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TREX1 Presentation

Dr. Burdette’s presentation will describe the company’s approach to identify and characterize novel small molecule inhibitors of the 3’-5’ DNA repair exonuclease, TREX1. TREX1 inhibits cGAS/STING signaling and is induced in tumor cells due to genetic instability or therapeutic intervention. Tempest’s program aims to generate an anti-tumor response through selectively activating the STING pathway in advanced metastatic cancers with orally available small molecule inhibitors of TREX1.

Presentation details:

In addition, Nicholas DeVito, M.D., a medical oncologist and medical instructor in the laboratory of Dr. Brent Hanks, M.D., Ph.D. at Duke University School of Medicine, will be giving a presentation describing pre-clinical results with TPST-1495, Tempest’s clinical-stage dual inhibitor of the EP2 and EP4 prostaglandin E2 receptors, in mice bearing tumors with designated gene expression profiles.

Imvax to Present New Data on Tumor-Derived Immunotherapy Platform at 2022 SITC Meeting

On October 6, 2022 Imvax, Inc., a clinical-stage biotechnology company developing personalized, whole tumor-derived immunotherapies, reported two poster presentations at the 2022 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Meeting in Boston, MA, from November 10-12, 2022 (Press release, Imvax, OCT 6, 2022, View Source [SID1234621762]).

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At the meeting, Imvax will present data providing new insights into the mechanism of action of the company’s most advanced product candidate, IGV-001, for the treatment of glioblastoma. The company also will share in vivo data supporting the antitumor activity of Imvax’s tumor-derived immunotherapy platform for ovarian, liver and bladder cancers.

First participant imaged in Phase II SAR-Bombesin prostate cancer trial in the US

On October 6, 2022 Clarity Pharmaceuticals (ASX: CU6) ("Clarity"), a clinical stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, reported it has successfully imaged its first participant in the US-based diagnostic 64Cu SAR-Bombesin trial (SABRE NCT05407311)1 for patients with PSMA-negative prostate cancer (Press release, Clarity Pharmaceuticals, OCT 6, 2022, View Source [SID1234621758]).

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SABRE (Copper-64 SAR-BisPSMA in Biochemical Recurrence of prostate cancer) is a Phase II Positron Emission Tomography (PET) imaging trial of participants with PSMA-negative biochemical recurrence (BCR) of prostate cancer following definitive therapy. It is a multi-centre, single arm, non-randomised, open-label trial of 64Cu-labelled SAR-Bombesin in 50 participants. The primary objectives of the trial are to investigate the safety and tolerability of the product as well as its ability to correctly detect recurrence of prostate cancer.

Dr Luke Nordquist, CEO, Urologic Medical Oncologist and Principal Investigator at the Urology Cancer Center and GU Research Network in Omaha, Nebraska, commented, "We are very excited to have recruited and imaged the first participant in this trial which will explore the clinical benefits of the novel SAR-Bombesin agent. Based on the promising preclinical and clinical data to date, SAR-Bombesin shows great potential for improving the diagnosis and treatment for not only patients with prostate cancer that are PSMA negative, but also across broader prostate cancer indications.

"SABRE is the third trial with Clarity’s Targeted Copper Theranostics (TCTs) that GURN is recruiting into. This momentum is underpinned by our belief that the TCTs are the next-generation products that will enable the radiopharmaceutical field to overcome the manufacturing and supply chain challenges associated with the current products in the market and facilitate the expansion of radiopharmaceuticals into the large global oncology market. We look forward to generating data from the trial to validate the potential clinical benefits for large patient populations and improve patient care."

Clarity’s Executive Chairman, Dr Alan Taylor, commented, "We are very excited to progress the SABRE trial in the United States as we are already seeing an improved treatment paradigm in the management of PSMA-negative disease for patients with SAR-Bombesin who were imaged under the Therapeutic Goods Agency’s Special Access Scheme in Australia2.

"Given the data to date indicates the potential diagnostic and therapeutic benefits of SAR-Bombesin, we look forward to generating further evidence as we accelerate the product to market. Subject to the outcome of the SABRE trial, Clarity is planning to launch a pivotal Phase III diagnostic trial for first product approvals in the US. We are also preparing to run a theranostic trial with an Investigational New Drug (IND) application scheduled for submission to the US Food and Drug Administration (FDA) later this year. We look forward to progressing our SAR-Bombesin program and potentially providing a large patient population with accurate and precise detection and treatment of their prostate cancer," said Dr Taylor.

Clarity’s Prostate Cancer clinical trial program overview

About SAR-Bombesin
SAR-Bombesin is a highly targeted pan-cancer radiopharmaceutical with broad cancer application. It targets the gastrin-releasing peptide receptor (GRPr) present on cells of a range of cancers, including but not limited to prostate, breast and ovarian cancers. GRPr is found in approximately 75-100% of prostate cancers, including prostate cancers that don’t express PSMA (PSMA-negative)3-7. The product utilises Clarity’s proprietary sarcophagine (SAR) technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-Bombesin is a Targeted Copper Theranostic (TCT) that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu) for therapy.

About Prostate Cancer
Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death worldwide8. The National Cancer Institute estimates in 2022 there will be 268,490 new cases of prostate cancer in the US and around 34,500 deaths from the disease9.

Approximately 20% of prostate cancers with BCR are PSMA-PET negative10-13. These patients are therefore unlikely to respond to therapeutic PSMA-targeted products and currently have few treatment options available to them. Given the prostate cancer indication is one of the largest in oncology, there is a significant unmet medical need in this segment.