On June 3, 2021 Invivoscribe, a global leader in precision diagnostics, reported the launch of a new 12-color multiparametric flow cytometry service in Shanghai, China, the newest reference laboratory in their international LabPMM network (Press release, Invivoscribe Technologies, JUN 3, 2021, View Source [SID1234583479]). Flow cytometry has long been the standard of care for many blood cancers including acute myeloid leukemia (AML), but to achieve minimal residual disease (MRD) level sensitivity with limited specimen, powerful 12-color multiparametric flow cytometry (MFC) is needed. By providing the combination of 12-color flow cytometry and next-generation sequencing (NGS) MRD capabilities in the US, in Europe, and also in China, Invivoscribe now offers a comprehensive international solution for our pharma partners.

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Invivoscribe’s globally standardized network of LabPMM reference laboratories offer best in class NGS assays, gene panels, and bioinformatics software, to complement our new MFC panels. The addition of 12-color MFC panels to our existing NGS capabilities, eliminates the need to split primary subject specimens and have them tested in multiple labs. It also allows the same pull of bone marrow to be tested using several complementary technologies, so pharma partners can obtain and compare results leveraging limited samples using targeted assays and technologies for drug development and clinical studies. By offering both MFC and NGS testing in our international laboratories, Invivoscribe can accelerate clinical trials and streamline drug approvals.

"We are very fortunate to have exceptional scientists leading our Flow Cytometry Services," says Tony Lialin, Chief Commercial Officer at Invivoscribe. "Our hematopathologists are domain experts that have an intimate understanding of hematologic malignancies, the markers, and the instrumentation gained from their decades of experience. When we were developing our flow assays we had three goals: (1) to provide partners with one-stop international screening and MRD testing, (2) to leverage our infrastructure to quickly develop panels to meet novel partner needs, and (3) to provide standardized CAP/CLIA testing in all of our ISO 15189 accredited global laboratories. We are excited about our unique offering in Asia and we are well-positioned to help our pharma partners accelerate clinical studies and approval of their novel therapies worldwide."

Leveraging an international network of our wholly-owned clinical reference laboratories, Invivoscribe can rapidly design and validate custom panels, track MRD for a range of oncologic diseases, including solid tumors, and develop and commercialize companion diagnostic assays for pharma partners.

On June 3, 2021 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel therapies for serious rare and ultra-rare genetic diseases, reported that Emil D. Kakkis, M.D., Ph.D., the company’s Chief Executive Officer and President, will present at the Goldman Sachs 42ND Annual Healthcare Conference on Thursday, June 10, 2021 at 3:00 PM ET (Press release, Ultragenyx Pharmaceutical, JUN 3, 2021, View Source [SID1234583495]).

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The live and archived webcast of the presentation will be accessible from the company’s website at View Source The replay of the webcast will be available for 90 days.

On June 3, 2021 Jeffrey Bogart, MD, interim director of the Upstate Cancer Center, reported that it will present findings of a lung cancer treatment clinical trial later this week at one of the largest gatherings of cancer experts in the world (Press release, SUNY Upstate, JUN 3, 2021, View Source [SID1234583512]).

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Bogart, who also serves as chair of the Department of Radiation Oncology at Upstate, will present the results of a clinical trial for patients with small cell lung cancer at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which runs June 4 to 8. Bogart will present evidence that shows when treating small cell lung cancer, once daily radiation therapy treatment for seven weeks is just as effective as twice daily radiation treatment for three weeks.

Bogart was principal investigator of the trial, which included more than 700 patients throughout the United States from 2008 to 2019. About 30,000 people are diagnosed with small cell lung cancer each year. That type of cancer, which is treated with chemotherapy and radiation, accounts for about 15 to 20 percent of all lung cancer patients, Bogart said.

A clinical trial about 30 years ago showed that radiation administered twice a day for three weeks was a more effective treatment than the same dose of radiation once a day for five weeks, Bogart said. Despite undergoing radiation for a shorter period of time – three weeks compared to five – receiving two doses of radiation in one day is difficult for many patients, he said. Twice daily radiation must be administered at least six hours apart, which means the patient has to be at the hospital twice in one day. That’s a tiring regimen and can be difficult for those who don’t live nearby.

The clinical trial, which is the largest trial in limited stage small cell lung cancer ever performed, showed minimal differences between the two regimens.

"Even though the trial from 30 years ago showed that more patients were cured and alive five years later with the twice a day, many patients are not able to make it twice a day and there was some concern that the side effects might be greater with the twice a day," he said. "So most patients in the country, even though we had good evidence to treat twice a day, were treated with once a day. It’s only until this study that we actually have evidence that supports that this is an appropriate thing to do."

Bogart said that prior to this study only about 15 percent of patients nationwide opted for twice daily radiation treatments.

"Before we had the results of this study, because we had good scientific evidence that twice a day was better, I would recommend twice a day for all of my patients," Bogart said. "There were some patients where it was not feasible, but now with the results of this study it opens up the options scientifically. There’s enough support to do either one now. This shows in a scientific fashion that patients are not being undertreated if they have the once a day."

The clinical trial was conducted with patients from across the United States, including at Upstate. The Alliance for Clinical Trials in Oncology, for which Bogart is chair of the Radiation Oncology Committee, oversaw the trial.

The ASCO (Free ASCO Whitepaper) annual meeting is virtual this year and Bogart is scheduled to present on Sunday, June 6. The meeting is attended by more than 40,000 people annually.

"Part of the excitement is that Upstate not only offers clinical trials, we have folks here who are involved in developing and designing and running those clinical trials for the country," Bogart said, noting that hundreds of trial participants were critical to its success. "It’s always good for the patients that were involved to know that their commitment really resulted in something we can use to help guide treatment for future patients."

On June 3, 2021 Resverlogix Corp. ("Resverlogix") (TSX:RVX) and EVERSANA, the pioneer of next generation commercial services to the global life sciences industry, reported a partnership to support planned commercialization of apabetalone in the United States, Canada (where authorization has been granted to conduct clinical studies of apabetalone for COVID-19) and/or potentially expanding to additional global markets, as Emergency Use Authorization and/or a New Drug Application or equivalent is issued or approved (Press release, EVERSANA, JUN 3, 2021, View Source [SID1234583447]).

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In preparation for launch, Resverlogix will utilize EVERSANA’s fully integrated commercialization services that include market access, agency services, clinical and commercial field teams, medical science liaisons, channel management, patient services, health economics and outcomes research, and compliance, with each service optimized by data and predictive analytics.

Apabetalone is an investigational, phase 3 clinical candidate with safety data in more than 4,200 man years of treatment. As previously published, apabetalone has the potential to combat COVID-19 through a unique dual mechanism. First, apabetalone treatment prevents SARS-CoV-2 from infecting human cells; and second, it reduces the inflammation and cytokine storm response, which can result in organ damage and long-term negative impacts. Apabetalone is also being studied for important benefits for patients with high-risk cardiovascular disease, chronic kidney disease and other indications while maintaining a well-described safety profile.

"With EVERSANA’s integrated commercialization solution, we are poised to swiftly and efficiently deliver apabetalone to patients who desperately need it," said Donald McCaffrey, President and CEO of Resverlogix. "We are proud to be on the front line with the global scientific medical community as we fight the ongoing threat of this and future pandemics."

"We believe in apabetalone’s potential to save the lives of patients still facing the tragic impact of COVID-19 and its numerous growing variants as well as the millions of patients facing multiple diseases that have the potential to be treated by this much-needed therapy," said Jim Lang, Chief Executive Officer of EVERSANA. "Our COMPLETE end-to-end commercialization engine is mobilized and ready to move swiftly in anticipation of authorizations and approvals."

There can be no assurance that regulatory approval will be obtained.

On June 3, 2021 Onconova Therapeutics, Inc. (NASDAQ: ONTX) ("Onconova"), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, reported that Onconova has been selected to present at 2021 BIO Digital, being held virtually June 10-11 and 14-18, 2021 (Press release, Onconova, JUN 3, 2021, View Source [SID1234583464]).

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Dr. Steven Fruchtman, President & CEO of Onconova, will provide an overview of the Company’s corporate development objectives as well as recent and upcoming milestones for its lead candidate ON 123300 and the rest of its oncology product candidate pipeline. The presentation will be available to registered attendees beginning at 9:00 am ET on June 10, and on the Company’s website after the event.

Members of the management team will be available for virtual meetings throughout BIO Digital. To request a meeting, please use the BIO One-on-One Partnering system.