NextEra Energy third-quarter 2021 financial results available on company’s website

On October 20, 2021 NextEra Energy, Inc. (NYSE: NEE) reported that has posted its third-quarter 2021 financial results in a news release available on the company’s website by accessing the following link: www.NextEraEnergy.com/FinancialResults (Press release, Nextera, OCT 20, 2021, View Source [SID1234591615]).

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Jim Robo, chairman and chief executive officer of NextEra Energy, Rebecca Kujawa, executive vice president, finance and chief financial officer of NextEra Energy, and other members of the company’s senior management team will discuss the company’s third-quarter 2021 financial results during an investor presentation to be webcast live, beginning at 9 a.m. ET today. The listen-only webcast will be available on NextEra Energy’s website by accessing the following link: www.NextEraEnergy.com/FinancialResults. Also discussed during the investor presentation will be financial results for NextEra Energy Partners, LP (NYSE: NEP). A replay will be available for 90 days by accessing the same link as listed above.

OncoSec Provides Business Update

On October 20, 2021 OncoSec Medical Incorporated (NASDAQ: ONCS) (the "Company" or "OncoSec"), a clinical-stage biotechnology company focused on developing cytokine-based intratumoral immunotherapies to stimulate the body’s immune system to target and attack cancer, reported that Chris Twitty, Ph.D., Chief Scientific Officer, will be stepping down to pursue a new opportunity with a private oncology company (Press release, OncoSec Medical, OCT 20, 2021, View Source [SID1234591668]).

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Margaret Dalesandro, Ph.D., Chair of the Board of Directors and Member of the Leadership Committee of OncoSec, remarked, "On behalf of the Board of Directors and the other members of the Leadership Committee, we are grateful to Dr. Twitty for leading OncoSec’s R&D team over the last five years and we thank him for his contributions to our significant progress towards bringing TAVO to patients."

Sandra Aung, Ph.D., Chief Clinical Development Officer, added, "We continue to be encouraged with the maturing data from the KEYNOTE-695 study and look forward to engaging with the health authorities on what we believe is an effective therapy for these patients with no standard of care options."

The formal analysis of KEYNOTE-695 and top-line results of the primary endpoint, Overall Response Rate (ORR) by blinded independent central review (BICR) based on RECIST, will be announced in the first quarter of 2022.

TAVO updated data from the KEYNOTE-695 clinical trial will be made available at 7am EST on Friday, November 12, 2021, in a poster presentation at The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting in Washington D.C. The SITC (Free SITC Whitepaper) poster presentation is # 383, entitled: ‘Durable responses with intratumoral electroporation of plasmid interleukin 12 plus pembrolizumab in patients with advanced melanoma progressing on an anti-PD-1 antibody: updated data from Keynote 695.’ OncoSec will make the poster presentation available on its website following publication at SITC (Free SITC Whitepaper) 2021 and will host a SITC (Free SITC Whitepaper) symposium KOL webinar on November 12 at 7am EST for SITC (Free SITC Whitepaper) attendees and investors. Please click here to register for the webinar.

Dr. Herbert Kim Lyerly, Duke University School of Medicine, OncoSec Board of Directors and Member of the Leadership Committee, added, "As an oncologist focused on intra-tumoral cytokine immunotherapies, TAVO is an active drug with a remarkable safety profile, which will serve a PD-1 refractory patient population for whom there are no approved therapies. We are excited to update the community at SITC (Free SITC Whitepaper) 2021."

There will also be updated TAVO data from the ongoing KEYNOTE-890 clinical trial at the 2021 San Antonio Breast Cancer Symposium (SABCS), December 7-10, 2021, in a poster presentation abstract #2196, entitled: ‘Trial in progress: Phase 2 study of intratumoral plasmid interleukin-12 (tavokinogene telseplasmid; TAVO) plus electroporation in combination with pembrolizumab with or without chemotherapy in patients with inoperable locally advanced or metastatic triple-negative breast cancer (KEYNOTE-890/OMS-I141).’ OncoSec will make the poster available on its website following publication at SABCS 2021.

Lastly, regarding the CEO search, the Leadership Committee continues to meet with high quality candidates and expects to name a new CEO in the near-term.

HepaRegeniX initiates a preclinical collaboration with the Netherlands Cancer Institute to explore the potential of its 2nd MKK4 inhibitor HRX-0233 for use in cancer combination therapy

On October 20, 2021 HepaRegeniX GmbH, a clinical stage company developing novel therapies for the treatment of acute and chronic liver diseases, reported a collaboration with the Netherlands Cancer Institute (NKI) to investigate HepaRegeniX’ new drug candidate HRX-0233 in preclinical in vivo models with Kirsten rat sarcoma virus (KRAS) mutant tumors. Under the partnership, NKI will conduct the preclinical research to find the most promising combinations of the small molecule inhibitor of Mitogen-Activated Protein (MAP) Kinase Kinase 4 (MKK4) with other inhibitors of the MAP kinase pathway. Preliminary data obtained by Prof. Bernards’ group at the NKI have shown promising results in cell culture experiments.1

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"It is exciting to see our second MKK4 inhibitor candidate now entering the late preclinical development phase with the aim to learn more about the additional therapeutic potential of our new drug candidate HRX-0233 for patients with KRAS gene mutated cancers," said Dr. Wolfgang Albrecht, Managing Director of HepaRegeniX. "Prof. Bernards and his group at the NKI are experts in cancer research, especially when it comes to uncovering synthetic lethal drug combinations, where the specific gene mutation and a drug efficiently kill the cancer cells."

"HepaRegeniX has successfully discovered and developed drug candidates for the novel molecular target MKK4. Its inhibitor HRX-0233 shows promising initial results in synergy with other kinase-inhibitors in KRAS mutant tumors in vitro," added Prof. René Bernards, Researcher of NKI and principal investigator at the Oncode Institute. "We are looking forward to the outcome and see a high value for this new small molecule in fighting KRAS mutant tumors."

The mutation of the KRAS gene is present in 90 % of pancreatic, 40 % of lung, and 50 % of colorectal cancers and one of the most common oncogenic drivers. KRAS mutant tumors have a very poor response to current therapies.

(Press release, HepaRegeniX, OCT 20, 2021, View Source [SID1234666461])

BioCryst to Report Third Quarter 2021 Financial Results on November 3

On October 20, 2021 BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) reported that the company will report its third quarter 2021 financial results on Wednesday, November 3, 2021 (Press release, BioCryst Pharmaceuticals, OCT 20, 2021, View Source [SID1234591580]).

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BioCryst management will host a conference call and webcast at 8:30 a.m. ET that day to discuss the financial results and provide a corporate update.

The live call may be accessed by dialing 877-303-8027 for domestic callers and 760-536-5165 for international callers and using conference ID # 2592545. A live webcast of the call and any slides will be available online at the investors section of the company website at www.biocryst.com. A telephone replay of the call will be available by dialing 855-859-2056 for domestic callers or 404-537-3406 for international callers and entering the conference ID # 2592545.

New Ultra-Sensitive Leukemia Blood Test Delivered by Sysmex Inostics

On October 20, 2021 Sysmex Inostics reported that it has developed a new CLIA-validated liquid biopsy test for the detection of Minimal Residual Disease (MRD) in Acute Myeloid Leukemia (AML) (Press release, Sysmex Inostics, OCT 20, 2021, View Source [SID1234591600]). A global leader and pioneer in blood-based, ultra-sensitive molecular testing for oncology, the company’s new test uses a targeted Next Generation Sequencing (NGS) panel.

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"The new test, AML-MRD-SEQ, offers clinical trial sponsors, and eventually physicians and patients, an early signal for the presence of cancer cells following initial therapy. This new liquid biopsy solution is a major step in developing treatment strategies to support the fight against a devastating disease," said Shinichi Sato, CEO of Sysmex Inostics, Inc.

This new test, AML-MRD-SEQ, adds to the portfolio of ultra-sensitive Plasma-Safe-SeqS technology NGS tests available through Sysmex Inostics’ CLIA lab services in Baltimore, Maryland.

Previous generations of AML MRD tests were only able to detect a limited number of mutations that have an established therapeutic indication. AML-MRD-SEQ offers a more expansive panel covering 68 regions across 20 genes, including established MRD markers such as NPM1, and demonstrating significant potential for use as an investigational tool for other markers with prognostic values that are not yet well-established. The new highly sensitive AML-MRD-SEQ test with broader genomic coverage offers the opportunity for early intervention and clinical trial enrollment.

"Sysmex Inostics’ mission is to develop new innovative tools and expand partnerships with top-tier global biopharmaceutical companies to further advance drug development and treatments for the benefit of oncology patients worldwide," Sato concluded.

AML-MRD-SEQ offers reliable detection of molecular MRD with 50 to 100 times greater sensitivity versus other currently available NGS pan-heme tests.1,2 Such ultra-sensitive detection of low-level mutant molecules allows clinical trial sponsors to execute on clinical development timelines more efficiently.

AML is one of the deadliest blood cancers, resulting in more than 10,000 lives lost in the U.S. each year.3 Because AML relapses usually result in a poor prognosis, it is necessary to test patients for MRD after initial treatment as a prognostic indicator of therapeutic effectiveness and relapse risk. Applying Sysmex Inostics’ ultra-sensitive liquid biopsy NGS technology, Plasma-Safe-SeqS, to the detection of gene mutations associated with AML MRD enables accelerated clinical development timelines, cost savings, and improved outcomes throughout the clinical trial process.

A recent market research report states that the liquid biopsy market is estimated to achieve an annual growth rate of more than 35% over the next few years, reaching $4 billion by 2024.4 The analysis notes that an increasing focus on personalized medicine for cancer care is driving the tremendous growth.