On September 9, 2022 CureLab Oncology , a clinical-stage, pre-IPO biotech company, reported the results of its ongoing ex-US clinical trial at this year’s meeting of the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) (Press release, CureLab Oncology, SEP 9, 2022, View Source [SID1234619360]). The trial is assessing an experimental DNA plasmid encoding the human protein, p62 (affectionately codenamed Elenagen), at the N.N. Alexandrov National Cancer Centre, one of the leading cancer centers in Eastern Europe.

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Platinum-resistant ovarian cancer (PROC) is one of the deadliest forms of ovarian cancer and has a very poor prognosis. The FDA approved other novel treatments for PROC based on statistically significant improvements for the delay of progression of the cancer, assessed by the increasing size of a primary tumor and/or the appearance of new metastatic lesions or growth of the existing ones; i.e., progression-free survival (PFS). A statistically significant prolongation of PFS was clearly demonstrated in the trial and continues to extend as the trial continues.

Summary of what CureLab Oncology is presenting at ESMO (Free ESMO Whitepaper) 2022
In the ex-US clinical trial, CureLab Oncology is assessing its experimental plasmid DNA therapeutic, Elenagen, for its ability to extend progression-free survival (PFS) in patients with PROC receiving standard chemotherapy, gemcitabine.
For all patients in the trial receiving the standard of care only, the disease progressed during the first year of observations, with 50% of patients progressing within 2.7 months.
In contrast, the disease did not progress at all for almost 40% of patients receiving the same gemcitabine in combination with weekly intramuscular injections of Elenagen.
In 50% of patients receiving standard of care only, the disease has progressed within 2.7 months, while the time to progression for 50% of patients in the "chemo plus Elenagen" group has increased to 7.2 months.
To date, no patient receiving Elenagen demonstrated any adverse event (AE) or significant adverse event (SAE) greater than grade 1, and all resolved quickly without impact.
So far, the longest PFS in the gemcitabine + Elenagen treatment group is 27 months (and continues to grow), while the disease has progressed in all patients in the gemcitabine-only group within less than 12 months.
"While our data on increasing progression-free survival are already statistically significant (P=0.01), it will take a little longer to reach a statistical significance on overall survival of the patients," said Professor Sergey Krasny, M.D., D.Sc., co-author of the ESMO (Free ESMO Whitepaper) presentation, and a medical director of the study. "However, so far, no single patient receiving gemcitabine alone has lived longer than 18 months, while over 50 percent of patients receiving gemcitabine and Elenagen live longer than that. Also of note is that no person who survived to live 18 months has died at this point in the study."

"Our presentation at ESMO (Free ESMO Whitepaper) 2022 is a great step forward compared to what we presented at ESMO (Free ESMO Whitepaper) 2021. Now, we are certain that Elenagen is increasing progression-free survival for platinum-resistant ovarian cancer patients in the trial," said Alexander Shneider, Ph.D., CEO of CureLab Oncology.

About Elenagen
CureLab’s lead investigational compound is code-named Elenagen, an experimental DNA therapy that consists of a circular piece of DNA called a plasmid that includes a gene for a human protein called p62/SQSTM1. In animal studies and Phase I/II human trials conducted ex-US, Elenagen demonstrated promise in reversing tumor grade, changing the tumor microenvironment, and enhancing the anti-cancer effects of chemotherapy. Experimental results also indicate mitigation of chronic inflammation and stimulation of an immune response to the tumor.

On September 9, 2022 Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on creating and delivering engineered cells as medicines, reported that it will webcast its presentations at two investor conferences in September (Press release, Sana Biotechnology, SEP 9, 2022, View Source [SID1234619348]). The presentations will feature a business overview and update by Steve Harr, Sana’s President and Chief Executive Officer.

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Sana will present at the Morgan Stanley 20th Annual Global Healthcare Conference at 2:55 p.m. ET on Tuesday, September 13, 2022.
Sana will present at the Jefferies Cell and Genetic Medicine Summit at 2:00 p.m. ET on Thursday, September 29, 2022.
The webcasts will be accessible on the Investor Relations page of Sana’s website at View Source A replay of each presentation will be available at the same location for 30 days following the corresponding conference.

On September 9, 2022 Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class therapeutics in hematology and oncology, reported that members of the senior management team will participate and present at the following industry conferences in the U.S. in September (Press release, Antengene, SEP 9, 2022, View Source [SID1234619341]).

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Event: Baird’s 2022 Global Healthcare Conference (in-person)
Date: September 13-14, 2022
Location: New York
Format: Company Presentation (September 14 at 2:35 p.m. ET) and 1×1 Meetings
Participation: In-person

Event: Macquarie’s "Looking into a Post-COVID World" Pan Asia Conference (in-person)
Date: September 28-29, 2022
Format: 1x1s and Group Meetings
Participation: In-person

On September 9, 2022 ViewRay, Inc. (NASDAQ: VRAY) reported that the Company will present at the Morgan Stanley 20th Annual Global Healthcare Conference (Press release, ViewRay, SEP 9, 2022, View Source [SID1234619340]). Scott Drake, President and Chief Executive Officer, and Zach Stassen, Chief Financial Officer, will participate in a fireside chat at 8:00 a.m. Eastern Time on Tuesday, September 13, 2022.

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An audio webcast of the Company’s presentation will be available on the investor relations section of ViewRay’s website at View Source A replay of the webcast will be available for 7 days after the date of the presentation.

On September 9, 2022 Prelude Corporation (PreludeDxä), a leader in molecular diagnostics and precision medicine for early-stage breast cancer, reported that compelling results in 926 women diagnosed with ductal carcinoma in situ (DCIS) identifying patients with low risk of recurrence independent of traditional clinicopathologic risk factors (Press release, PreludeDx, SEP 9, 2022, View Source [SID1234619339]). Study results were presented today at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Special Conference: Rethinking DCIS: An Opportunity for Prevention.

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The DCISionRT test demonstrated that radiation did not significantly reduce the in-breast recurrence (IBR) rate in the low-risk group. However, the elevated/residual-risk group benefited significantly from radiation therapy (RT), with a 17.7% absolute 10-year IBR rate reduction.

"DCISionRT is a major step forward in treatment decision making for DCIS patients," said Rachel Rabinovitch, MD, FASTRO, Professor, Radiation Oncology, University of Colorado. "DCISionRT is the first biosignature specific for radiation therapy efficacy, here in the setting of adjuvant RT for DCIS. This assay can help us confidently identify a true low-risk group after lumpectomy, enabling de-escalation of radiation therapy and a high-risk group, many of whom benefit more than a relative 50% from adjuvant RT. The power of the study demonstrated that you would need to treat 100 patients in the low-risk group to benefit just one patient."

"We are honored to participate in this AACR (Free AACR Whitepaper) Special Conference dedicated solely to enhancing the care of DCIS patients and present our latest clinical data demonstrating the applicability of DCISionRT to guide DCIS treatment decisions," said Dan Forche, President and CEO of PreludeDx. "DCISionRT is an important risk assessment tool to determine which patients can safely omit RT, which patients will benefit greatly from RT, and which patients may need more aggressive therapy."

About DCISionRT for Breast DCIS
DCISionRT is the only risk assessment test for patients with ductal carcinoma in situ (DCIS) that predicts radiation therapy benefit. Patients with DCIS have cancerous cells lining the milk ducts of the breast, but they have not spread into surrounding breast tissue. In the US, over 60,000 women are newly diagnosed with DCIS each year. DCISionRT, developed by PreludeDx on technology licensed from the University of California San Francisco, and built on research that began with funding from the National Cancer Institute, enables physicians to better understand the biology of DCIS. DCISionRT combines the latest innovations in molecular biology with risk-based assessment scores to assess a woman’s individual tumor biology along with other pathologic risk factors and provide a personalized recurrence risk. The test provides a Decision ScoreTM that identifies a woman’s risk as low or elevated. Unlike other risk assessment tools, the DCISionRT test combines protein expression from seven biomarkers and four clinicopathologic factors, using a non-linear algorithm to account for multiple interactions between individual factors in order to better interpret complex biological information. DCISionRT’s intelligent reporting provides a woman’s recurrence risk after breast conserving surgery alone and with the addition of radiation therapy. In turn, this new information may help patients and their physicians to make more informed treatment decisions.