On April 9, 2020 Ryvu Therapeutics (WSE:RVU), a clinical-stage biopharmaceutical company developing novel small molecule therapies that address emerging targets in oncology, reported its annual 2019 financial results and provided a corporate update (Press release, Ryvu Therapeutics, APR 9, 2020, View Source [SID1234556243]).

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Major Achievements

In March 2019, the U.S. Food and Drug Administration (FDA) has cleared Ryvu’s IND application to conduct a Phase 1b study of selective CDK8 inhibitor SEL120 in patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (HR-MDS). The first patient enrolled in the Phase 1b study of SEL120, was dosed in September 2019 and the clinical trial is currently open at six sites in the U.S.
In April 2019 Ryvu presented data from multiple oncology programs at the 2019 AACR (Free AACR Whitepaper) Annual Meeting. Poster presentations included SEL120, novel dual A2A/A2B adenosine receptor antagonists and next-generation small molecule direct STING agonists.
In June 2019 posters on the dual PIM/FLT3 inhibitor SEL24/MEN1703 were presented at the 24th EHA (Free EHA Whitepaper) Congress and ASCO (Free ASCO Whitepaper) Annual Meeting.
In August 2019, Setareh Shamsili, M.D., Ph.D. joined Ryvu Therapeutics as the Chief Medical Officer, and in October 2019 was appointed to the Executive Management Board. Dr. Shamsili, a seasoned veteran, brings more than 20 years of clinical oncology and drug development experience to Ryvu.
The corporate split between Ryvu Therapeutics and the Selvita CRO division has been completed, with both companies trading independently on the Warsaw Stock Exchange as of October 16, 2019. During the split each Ryvu shareholder received one Selvita share in addition to each Ryvu share they already held. As of April 7, 2020 the market capitalization of spin-off company reached USD 129 million, up from USD 69 million reference level on the day of the split.
In November 2019, Ryvu presented two poster presentations at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 34th Annual Meeting: the novel, dual A2A/A2B antagonist immunometabolism program, and the small molecule, direct STING agonists immuno-oncology program.
In December 2019, Ryvu presented progress in translational, preclinical studies and introduction to a Phase Ib clinical trials for SEL120, at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting.
Also in December 2019, Ryvu was awarded a grant funding by the Polish National Centre for Research and Development for advancing research on targeted oncology therapies based on the synthetic lethality concept. This provides Ryvu with almost USD 8.3 million of non-dilutive financing. The agreement was signed in February 2020.
Early R&D portfolio has matured to advance projects into clinical development in upcoming years. A preclinical candidate for the A2A/A2B project was selected and non-GLP Tox studies initiated. The STING agonist program advanced to the lead stage with planned preclinical stage in 2020.
Most important milestones in 2020, before the report date

On March 5, 2020 Menarini Group announced successful completion of Phase I clinical study of SEL24/MEN1703 in Acute Myeloid Leukemia, which entitled Ryvu to receive a USD 1.96 million milestone payment. According to the information from Menarini SEL24/MEN1703 will start enrolling patients in the dose expansion Phase 2 study in the US. and in Europe.
On March 25, 2020 the U.S. Food and Drug Administration (FDA) granted an orphan drug designation (ODD) to Ryvu’s SEL120, for the treatment of patients with acute myeloid leukemia (AML).
Throughout 2019, Ryvu presented at numerous investor conferences including: Annual J.P. Morgan Healthcare Conference, Solebury Trout Access event, JP Morgan Conference, H.C. Wainwright 21st Annual Global Investment Conference, Jefferies 2019 Healthcare Conference, UBS 2019 Global Healthcare Conference, Biotech Showcase 2019, Ipopema Biotech Day 2019, Erste Group – Innovation Conference 2019, GPW Innovation Day, 9th Central European Life Science Investment Conference and BIO-Europe 2019.

"The past year has been very productive for Ryvu Therapeutics. We have achieved numerous corporate, research and clinical milestones which set us on a great path into 2020. After the successful spinning out of the CRO activities and creating significant incremental value for Ryvu shareholders, we are operating now as a pure-play small molecule oncology therapeutics company," commented Pawel Przewiezlikowski, Chief Executive Officer of Ryvu.

"With first patients being treated in our Phase I study of SEL120, successful completion of Phase I by SEL24/MEN1703, exciting data for our STING agonist and A2A/A2B antagonist programs, as well as additional non-dilutive financing from grants, we are ready to continue with our mission to discover and develop drugs that will improve the lives of cancer patients and their families."

Ryvu Annual 2019, Financial Results under IFRS

Operating expenses were USD 5.0 million for the quarter ended Dec. 31, 2019, a decrease of USD 0.7 million, compared to USD 5.7 million for the same period ended Dec. 31, 2018. Revenues were USD 2.1 million for the quarter ended Dec. 31, 2019, compared to revenues of USD 3.3 million for the quarter ended Dec. 31, 2018. EBITDA excluding IFRS16 impact for the quarter ended Dec. 31, 2019, was USD 2.4 million, compared to USD 2.0 million for the quarter ended Dec. 31, 2018.

Operating expenses were USD 20.7 million for the twelve months ended Dec. 31, 2019, an increase of USD 4.6 million, compared to USD 16.1 million for the same period ended Dec. 31, 2018. Revenues were USD 8.9 million for the twelve months ended Dec. 31, 2019, compared to revenues of USD 10.2 million for the twelve months ended Dec. 31, 2018. EBITDA excluding IFRS16 impact for the twelve months ended Dec. 31, 2019, was USD 10.2 million, compared to USD 5.0 million for the twelve months ended Dec. 31, 2018.

At Dec. 31, 2019, Ryvu Therapeutics held USD 19.0 million in cash, cash equivalents, and short-term investments.

On April 9, 2020 ViewRay, Inc. (Nasdaq: VRAY) reported details relating to the release of its first quarter 2020 financial results (Press release, ViewRay, APR 9, 2020, View Source [SID1234556242]).

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ViewRay will hold a conference call to discuss results on Thursday, April 30, 2020 at 4:30 p.m. ET / 1:30 p.m. PT. The dial-in numbers are (844) 277-1426 for domestic callers and (336) 525-7129 for international callers. The conference ID number is 8982097. A live webcast of the conference call will be available on the investor relations page of ViewRay’s corporate website at investors.viewray.com.

After the live webcast, a replay will remain available online on the investor relations page of ViewRay’s corporate website, investors.viewray.com, for 14 days following the call. In addition, a telephonic replay of the call will be available until May 7, 2020. The replay dial-in numbers are (855) 859-2056 for domestic callers and (404) 537-3406 for international callers. Please use the conference ID number 8982097.

On April 9, 2020 Vigeo Therapeutics, a clinical-stage biopharmaceutical company developing novel therapeutics to reprogram the tumor immune microenvironment (TIME), reported it has dosed the first patients in its Phase 1b/2 clinical trial evaluating its first in class lead candidate, VT1021, a small peptide with dual targeting activities of CD36 and CD47 (Press release, Vigeo Therapeutics, APR 9, 2020, View Source [SID1234556241]). The Phase 1b/2 study will enroll approximately 75 patients with 15 patients in each of five groups: ovarian cancer, pancreatic cancer, triple negative breast cancer, glioblastoma, and a tissue agnostic group of patients with high CD36 expressing tumors.

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Vigeo is developing therapies that target the TIME via induction of thrombospondin-1 (Tsp-1). Tsp-1 is a naturally occurring, potent anti-tumorigenic protein with a pleiotropic mechanism of action mediated by CD36 and CD47 that has been shown to reprogram the TIME and block tumor growth and progression.

The ongoing open-label, multicenter dose-expansion study (NCT03364400) is designed to evaluate efficacy and confirm the safety and tolerability of VT1021. The study evaluates VT1021 in four selected cancers that have high CD36 expressing tumors and in a group of patients who do not have one of the selected cancer types but nonetheless express high levels of CD36 based on tumor tissue staining.

"Advancing VT1021 in this study is a key milestone for Vigeo and we are excited to commence investigation of this promising agent in five patient groups in tumors that have a high expression of CD36," said Jing Watnick, Ph.D., President and Chief Executive Officer of Vigeo Therapeutics. "In addition to the indication expansion study, we plan to commence multiple combination studies to evaluate VT1021 in combination with chemotherapies and/or anti-PD-1 antibodies. We look forward to providing updates over the course of the study."

"The innovative and promising approach of VT1021 is to induce tumor microenvironment production of Tsp-1, which is a high affinity ligand of two key receptors with potent downstream antitumor activities, CD36 and CD47. As opposed to targeting only one receptor, like CD47, VT1021 exploits multiple antitumor mechanisms that contribute to tumor cell death and immune response enhancement," said Lou Vaickus, MD, FACP interim Chief Medical Officer of Vigeo. "This approach may be beneficial as a monotherapy as well as in combination with other agents, particularly in the classic "cold" tumor environment."

To-date, VT1021 has been shown to be safe and well tolerated with no serious drug related adverse events.

About VT1021
Vigeo’s lead molecule, VT1021, is a small peptide that reprograms the tumor immune microenvironment (TIME) by targeting CD36 and CD47 via Tsp-1 Induction, to stop tumor growth. Pre-clinical results have demonstrated that VT1021, when administered systemically, can cause tumor regression in animal models at both primary and metastatic sites. VT1021 is currently being evaluated in a Phase 1/2, open label, multicenter trial that assesses the drug’s safety, tolerability, and preliminary anti-tumor efficacy. The trial’s dose escalation phase has been completed and the expansion phase is underway. An interim readout is expected in the second half of 2020.

On April 9, 2020 Quanterix Corporation (NASDAQ: QTRX), a company digitizing biomarker analysis to advance the science of precision health, reported that Chief Executive Officer, President and Chairman Kevin Hrusovsky will present at the 19th Annual Needham Healthcare Conference, on April 14, at 11:20 a.m., EDT (Press release, Quanterix, APR 9, 2020, View Source [SID1234556240]). The live webcast will be available in the Investor section of the Quanterix website at View Source Replays of the webcast will be available on the Quanterix website for 90 days following the conference.

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On April 9, 2020 RefleXion Medical, a therapeutic oncology company pioneering the use of biology-guided radiotherapy (BgRT)* to treat all stages of cancer, reported the first sale of its RefleXion X1 machine to the Stanford Cancer Institute (Press release, RefleXion Medical, APR 9, 2020, View Source [SID1234556239]).

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RefleXion Co-Founder and Chief Technology Officer, Sam Mazin, Ph.D., first thought of using positron emission tomography (PET), widely considered the gold standard for diagnosing cancer, to instead treat tumors while attending a radiation physics lecture during his postdoctoral tenure. As the professor explained the difficulty in seeing tumors during cancer treatment, an idea began to form that he would pursue in earnest a few years later.

"The idea was to use individual emissions that make up a partially formed PET image, and are generated by the tumor, as a homing signal or biological marker to quickly guide radiotherapy to that location," explained Mazin. "In essence, turning cancer on itself to destroy it. It has been a rewarding journey from thinking of the idea years ago to co-founding RefleXion, and it is an honor to have Stanford as our first clinical and commercial client."

Mazin’s thought was to use PET in an entirely new way to solve one of the greatest challenges in radiotherapy: treating multiple tumors in the same session, even those in motion, so that radiotherapy could be offered to stage 4 cancer patients, for the first time, as a new treatment choice. RefleXion’s BgRT technology could one day expand radiotherapy from a treatment reserved for early-stage cancer, to an option for patients with multiple solid tumors throughout the body.

A novel modality under development, BgRT uses the biological signature of each tumor to characterize its movement and to track tumors more precisely for radiotherapy delivery. The RefleXion X1 machine with BgRT aims to overcome the technical limitations that currently restrict radiotherapy to one or two tumors. Once developed, RefleXion will scale BgRT to treat all visible tumors, even those that move rapidly due to bodily functions such as breathing or digestion, in the same treatment session.

Last month, RefleXion announced marketing clearance on the X1 machine for image-guided radiotherapy (also known as SBRT, SRS and IMRT), the first steppingstone on the path to BgRT. Installation of the X1 machine at the Stanford Medicine Cancer Center and patient treatments are scheduled to begin over the next few months.