On May 20, 2019 Compugen Ltd. (NASDAQ: CGEN), a leader in predictive discovery and development of first-in-class therapeutics for cancer immunotherapy, reported financial results for the first quarter ended March 31, 2019 (Press release, Compugen, MAY 20, 2019, View Source [SID1234536472]).

"2019 continues to be marked by strong execution and we anticipate reaching additional important milestones in the second half of the year," said Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "Patient recruitment and site engagement in our Phase 1 study for COM701 are progressing as planned, and we now have 10 leading sites participating in our study. Enrollment in the monotherapy dose escalation arm is expected to be completed by the end of the third quarter, clearing the way for us to begin enrolling patients in the monotherapy expansion cohorts later this year. In addition, based on the progress made in the COM701 monotherapy dose escalation arm, we are confident in moving forward with the combination dose escalation arm of the study for which we expect to complete enrollment this year."

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"In parallel, we are also advancing our earlier stage pipeline focused on first-in-class molecules modulating immuno-suppressive cells in the tumor microenvironment, mainly cells from the myeloid lineage, as well as pursuing discovery efforts targeted at identifying proteins and pathways which are involved in immune resistance mechanisms to PD-1 therapies. Our goal is to generate a sustainable pipeline to ensure we have high potential first-in-class assets in addition to COM701, both for internal development as well as for additional partnering opportunities."

Recent Corporate Highlights

Dosed first patient in the combination arm of Phase 1 study, combining escalating doses of COM701 with a fixed dose of Opdivo (nivolumab) in patients with advanced solid tumors. Combination arms of the study are conducted under the clinical collaboration agreement signed with Bristol-Myers Squibb in October 2018.

Presented trial-in-progress posters at the ASCO (Free ASCO Whitepaper)-SITC Clinical Immuno-Oncology Symposium in January and the 2019 AACR (Free AACR Whitepaper) annual meeting in April. At AACR (Free AACR Whitepaper), the Company reported that the fifth dose level patient cohort of COM701 monotherapy has been completed and that no dose-limiting toxicities were found. Clinical and laboratory assessment for safety and tolerability are ongoing for this and earlier dose level patient cohorts.

Awarded by the U.S. Patent and Trademark Office U.S. Patent No. 10,213,505, which covers the composition comprising the COM701 and the backup antibodies and U.S. Patent No. 10,227,408, which covers composition comprising an anti-PVRIG antibody having CDRs of COM701 and backup antibodies.

Published two peer-reviewed papers in Cancer Immunology Research demonstrating the role of PVRIG as a novel immune checkpoint target for cancer immunotherapy.

Financial Results
Revenues for the first quarter of 2019 were $0, compared with $10 million in the comparable period of 2018. The revenues for the first quarter of 2018 reflect the upfront payment of $10 million from the license agreement with MedImmune/AstraZeneca.

R&D expenses for the first quarter ended March 31, 2019 were $6.3 million, compared with $7.1 million for the comparable period in 2018. The decrease in R&D expenses is attributed to the cost reduction measures announced by the Company during the first quarter of 2019. Further reduction in expenses will be reflected over the course of 2019.

Net loss for the first quarter of 2019 was $8.4 million, or $0.14 per basic and diluted share, compared with a net income of $0.1 million, or $0.0 per basic and diluted share, in the comparable period of 2018.

As of March 31, 2019, cash, cash related accounts, short-term and long-term bank deposits totaled $38.2 million, compared with $45.7 million at December 31, 2018. During the three months ended March 31, 2019, the Company sold approximately 961,000 ordinary shares under its "at-the-market" (ATM) facility pursuant to a sales agreement entered into with Cantor Fitzgerald & Co. in May 2018 for aggregate proceeds of $3.4 million, net of commissions to Cantor and expenses related to the offering. The Company has no debt.

Conference Call and Webcast Information
Compugen will hold a conference call to discuss its first quarter 2019 results today, May 20, 2019, at 8:30 a.m. ET. To access the live conference call by telephone, please dial 1-888-668-9141 from the U.S., or +972-3-918-0687 internationally. The conference call will also be available via live webcast through Compugen’s website, located at the following link. Following the live audio webcast, a replay will be available on the Company’s website.

On May 20, 2019 Rainier Therapeutics, Inc., a privately-held clinical stage drug development company, reported the presentation of data from its FIERCE-22 trial where vofatamab, the company’s lead therapeutic stimulates an increase in immune cell activation in patients with metastatic bladder cancer (Press release, Rainier Therapeutics, MAY 20, 2019, View Source [SID1234536488]). The data is being presented in an oral and poster presentation at the 2019 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Bladder Cancer: Transforming the Field Special Conference.

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Researchers at John Hopkins School of Medicine and MD Anderson analyzed RNA from 22 paired biopsy samples from metastatic bladder cancer patients enrolled in Rainier’s Phase 1b / 2 FIERCE-22 trial. Patients who had progressed following platinum-based chemotherapy but had not received prior immune checkpoint inhibitor therapy were eligible to enroll. Tumor biopsies were taken pre- and post-treatment with vofatamab, and prior to the start of combination treatment with pembrolizumab. Patient biopsies were taken to understand changes to gene signatures induced with vofatamab and to correlate this with clinical outcomes.

"The unique design of the trial allowed us to evaluate the effect of FGFR3 inhibition on gene signatures," said David McConkey, Ph.D., John Hopkins School of Medicine. "Vofatamab, an FGFR3 specific antibody, significantly upregulated genes associated with inflammation in both wild-type and FGFR3 mutant tumors. This was associated with an increased response rate to the combination with pembrolizumab in these patients and was particularly marked in patients with luminal biology."

"Tumors that are immunologically ‘cold’ tend to exist in luminal bladder cancer and these patients have historically responded poorly to checkpoint inhibitors. The enhanced response rate seen suggests this combination may provide a valuable new treatment option," said Graeme Currie, Ph.D., Chief Operating Officer, Rainier Therapeutics. "We look forward to presenting interim clinical data from FIERCE-22 at the upcoming 2019 ASCO (Free ASCO Whitepaper) annual meeting."

Key Findings:

Compared to historical data with pembrolizumab, response rates with vofatamab treatment appear higher.
Vofatamab responders had upregulation of genes associated with an inflammatory response in the tumor.
Responses were enriched in the cohort with a luminal gene expression profile (also referred to as "immunologically cold").
About Vofatamab

Vofatamab (formerly B-701) is an antibody specifically targeted against the fibroblast growth factor receptor 3 (FGFR3), a known driver of bladder and potentially other FGFR-driven cancers. Vofatamab is the most advanced targeted antibody specific for FGFR3 known by Rainier Therapeutics to be in clinical development. Vofatamab is currently being evaluated in two clinical trials: FIERCE-22 and FIERCE-21.

FIERCE-22 is a Phase 2 trial evaluating vofatamab in combination with pembrolizumab, an immune checkpoint inhibitor, to determine safety, tolerability and efficacy in the treatment of patients with locally advanced or metastatic bladder cancer, who have progressed following platinum-based chemotherapy and who have not received prior immune checkpoint inhibitor therapy. For additional information on FIERCE-22, please visit www.clinicaltrials.gov (NCT03123055).

On May 20, 2019 STORM Therapeutics ("STORM"), the drug discovery company tackling disease through modulating RNA modifying enzymes, reported that it has raised an additional £14 million bringing the total Series A financing to £30 million (Press release, STORM Therapeutics, MAY 20, 2019, View Source [SID1234561042]).

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The financing includes funding from new investor, Seroba Life Sciences ("Seroba"). STORM’s existing investors, Cambridge Innovation Capital, M Ventures, Pfizer Ventures, Taiho Ventures and IP Group also participated in the fundraise.

This extension follows the company’s rapid progress to date. It will enable STORM to advance its broad pipeline further in preclinical development and accelerate its programmes towards the clinic, supporting STORM’s growth as the leading drug discovery company working on RNA modulating enzymes.

STORM has strengthened its team with the appointment of Dr Mark Albertella as VP Translational Oncology. Mark was previously Director of Biology at Medivir AB and has a successful track record in oncology drug discovery and development at Argenta, OSI Pharmaceuticals, Kudos and AstraZeneca, with over 20 years’ experience in biotech and pharma industry in the UK, US and Europe.

Commenting on the fundraising, Dr Keith Blundy, CEO of STORM Therapeutics, said: "I am pleased to welcome Seroba to our investor syndicate and I would like to thank our existing investors for their continued support. This investment strengthens our Series A and provides further validation and support for STORM’s strategy to continue building a world-leading company harnessing the power of RNA epigenetics – an emerging, innovative area of drug discovery. It comes at an exciting stage as STORM starts translating its unique platform into effective treatments in oncology and beyond. Mark’s expertise in cancer drug discovery and development, encompassing in vitro and in vivo biology, translational and clinical research, will be invaluable to STORM as it progresses its pipeline towards the clinical stage."

Bruno Montanari, Partner at Seroba, added: "We have been closely following the RNA space for some time tracking a number of key players. We believe STORM is maintaining its first-mover advantage in RNA epigenetic modulation and is progressing rapidly in its development, making this an exciting time for us to partner with management and co-investors. We continue to be impressed by the quality and depth of STORM’s science and the significant progress made by the team to advance its platform and pipeline in this fast-moving area of emerging biology."

STORM Therapeutics CEO Keith Blundy will be presenting at the BioEquity Europe 2019 meeting in Barcelona. STORM will present at 9am CEST on Tuesday 21st May as part of the Next Wave sessions.

On May 20, 2019 Constellation Pharmaceuticals, Inc. (Nasdaq: CNST) reported that Dr. Patricia Keller, Senior Scientist at Constellation Pharmaceuticals, presented a poster titled Targeting epigenetic dysregulation in bladder cancer through inhibition of EZH2 at the Bladder Cancer: Transforming the Field meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) in Denver on May 19 (Press release, Constellation Pharmaceuticals, MAY 20, 2019, View Source [SID1234536473]).

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The poster discusses results of Constellation’s work with its second-generation EZH2 inhibitor CPI-0209 in bladder cancer models, exploring whether ARID1A mutation status affected responsiveness to CPI-0209 treatment. ARID1A, a protein that is a key component of the SWI/SNF chromatin remodeling complex, is mutated in about 25% of muscle-invasive bladder cancers.

Constellation used CPI-0209 in long-term phenotypic growth assays in a panel of 21 bladder cancer cell lines, demonstrating preferential treatment sensitivity that correlated with increased cell death in cell lines harboring ARID1A mutations. Transcriptional profiling after CPI-0209 treatment showed widespread activation of EZH2 target gene expression. In vivo, once-daily treatment with CPI-0209 in bladder cell-line derived xenografts harboring ARID1A mutations produced dose-dependent tumor growth inhibition and regression. Treatment with CPI-0209 and the chemotherapeutic agent cisplatin demonstrated combinatorial effects on cell viability in vitro and on tumor growth in vivo. The poster can be viewed in the Investors & Media/Presentations section of our website.

On May 20, 2019 Imago BioSciences, Inc., a clinical-stage biotechnology company developing innovative treatments for myeloid diseases, reported that an abstract describing clinical data regarding their lysine-specific demethylase (LSD1) inhibitor has been selected for an oral presentation at the 24th Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) to be held in Amsterdam, The Netherlands from June 13-16, 2019 (Press release, Imago BioSciences, MAY 20, 2019, View Source [SID1234536489]). The abstract was published on the EHA (Free EHA Whitepaper) website.

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Title: A Phase 2A Study of the LSD1 Inhibitor IMG-7289 For the Treatment of Myelofibrosis
Abstract Number: S832
Date: Saturday, June 15
Time: 12:30-12:45 CEST
Location: Elicium 2

The abstract represents the first report of clinical data on IMG-7289. The protocol of IMG-7289-CTP-102 is an ongoing Phase 1/2a clinical trial of LSD1 inhibitor IMG-7289 in patients with high or intermediate-2 risk myelofibrosis resistant to or intolerant of approved therapy (see clinicaltrials.gov NCT03136185).

In accordance with EHA (Free EHA Whitepaper) policies, abstracts submitted to the Annual Congress of EHA (Free EHA Whitepaper) are embargoed from the time of submission. The terms and conditions for presentation at the Annual Congress of EHA (Free EHA Whitepaper) prohibit any additional disclosure of data or information to be presented at the Annual Congress to be made public before the presentation.

Following the Annual Congress of EHA (Free EHA Whitepaper), a summary of the presentation will be available in the "News" section of Imago’s website.

About IMG-7289

IMG-7289 is a small molecule discovered by Imago BioSciences that inhibits lysine-specific demethylase 1 (LSD1 or KDM1A), an enzyme regulating cytokine expression and sustaining self-renewal in malignant hematopoietic stem/progenitor cells. In non-clinical studies, IMG-7289 demonstrated robust in vivo efficacy as a single agent and in combination with other therapeutic agents across a range of myeloid malignancies models including the myeloproliferative neoplasms which encompass myelofibrosis, essential thrombocythemia and polycythemia vera. IMG-7289 also shows activity against solid tumors in combination with other checkpoint agents in non-clinical models. IMG-7289 is under evaluation for the treatment of acute myeloid leukemia (see clinicaltrials.gov NCT02842827).