On June 22, 2022 The Menarini Group ("Menarini") and Radius Health, Inc. ("Radius") (NASDAQ: RDUS) (collectively, the "Companies") reported that Menarini, with support from Radius, has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for elacestrant in patients with ER+/HER2- advanced or metastatic breast cancer (Press release, Radius, JUN 22, 2022, View Source [SID1234616179]).

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As part of the submission, the Companies have requested Priority Review with the FDA. If Priority Review is granted, the Companies anticipate that the FDA would conduct an 8-month review, incorporating a 6-month priority designation review.

The NDA submission is based on positive phase 3 data from the EMERALD study that was previously announced on October 20, 2021. EMERALD met both of its primary endpoints, which were progression-free survival (PFS) in the overall population and PFS in the estrogen receptor 1 (ESR1) mutation subgroup as compared to standard of care (SoC) with the options of fulvestrant or an aromatase inhibitor.

Elacestrant is the first and currently only investigational oral SERD to show positive topline results in a pivotal trial for the treatment of ER+/HER2- advanced or metastatic breast cancer in postmenopausal women, and men. Notably, these results showed elacestrant is also active in patients whose tumors harbor an ESR1 mutation, one of the key resistance mechanisms that develops in later treatment lines of metastatic breast cancer.

Following the completion of EMERALD, data from the study was presented at the San Antonio Breast Cancer Symposium (SABCS) on December 8, 2021, published in the Journal of Clinical Oncology (JCO) on May 18, 2022, and further subset analyses were presented at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on June 6, 2022.

Elcin Barker Ergun, the Chief Executive Officer of Menarini, commented, "We are excited about the potential for elacestrant to be approved for treatment of patients with advanced or metastatic ER+/HER2- breast cancer, which constitutes about 70% of breast cancer and remains an area of significant unmet medical need." Barker Ergun continued, "Elacestrant has shown statistically significant efficacy over current standard of care medications both for overall population and in patients whose tumors harbor an ESR1 mutation, one of the most difficult to treat mechanisms of acquired resistance that develops in the later stages of metastatic/advanced breast cancer."

Chhaya Shah, SVP of Clinical and Regulatory at Radius, commented, "We enrolled and completed the EMERALD trial in a high-quality manner, delivered positive topline results, and prepared the submission of the NDA to the FDA. The submission is a significant milestone for both companies, and we appreciate the strong, collaborative effort of many hard-working employees at Radius and Menarini, investigators, patients, and their families. Together we look forward to advancing elacestrant and providing the opportunity to benefit patients."

Nassir Habboubi, Global Head of Pharma R&D of Menarini Group, added, "The Menarini and Radius teams have done an excellent job working together since our partnership began in July of 2020." Habboubi continued, "We plan to test elacestrant in earlier treatment lines, combination trials, and metastatic breast cancer that has metastasized to the brain. These details are to be communicated by us throughout 2H 2022 and 1H 2023."

With the submission of the NDA, based on the original agreement of the Companies, Menarini takes over activities and will be responsible for registration and commercialization. Menarini plans to use its fully owned subsidiary in the U.S., Stemline Therapeutics, to commercialize elacestrant if approved by the FDA.

About Elacestrant (RAD1901) and EMERALD Phase 3 Study

Elacestrant is an investigational selective estrogen receptor degrader (SERD), out-licensed to Menarini Group, which is being evaluated for potential use as a once daily oral treatment in patients with ER+/ HER2- advanced breast cancer. In 2018, elacestrant received fast track designation from the FDA. Preclinical studies completed prior to EMERALD indicate that the compound has the potential for use as a single agent or in combination with other therapies for the treatment of breast cancer. The EMERALD Phase 3 trial is a randomized, open label, active-controlled study evaluating elacestrant as second- or third-line monotherapy in ER+/HER2- advanced/metastatic breast cancer patients. The study enrolled 477 patients who have received prior treatment with one or two lines of endocrine therapy, including a CDK 4/6 inhibitor. Patients in the study were randomized to receive either elacestrant or the investigator’s choice of an approved hormonal agent. The primary endpoint of the study was progression-free survival (PFS) in the overall patient population and in patients with estrogen receptor 1 gene (ESR1) mutations. Secondary endpoints included evaluation of overall survival (OS), objective response rate (ORR), and duration of response (DOR).

On June 22, 2022 The U.S. National Science Foundation reported a new funding opportunity of nearly $29 million through the Improving Undergraduate STEM Education: Hispanic-Serving Institutions Program, also known as the HSI program (Press release, National Science Foundation, JUN 22, 2022, View Source [SID1234616178]). Through this new solicitation, NSF introduces the HSI Program Network Resource Centers and Hubs, or HSI-Net, which seeks to establish two centers and up to five hubs to develop the infrastructure needed to generate and disseminate new knowledge, successful practices and effective design principles arising from research on and work at HSIs.

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Through the HSI-Net, NSF’s goal is to create a robust national ecosystem consisting of multi-sector partners supporting and sharing knowledge and successful models of undergraduate STEM education at HSIs, building institutional capacity, and effectively broadening participation of students that are historically underrepresented in STEM.

"Enhancing the quality and accessibility of STEM education is far too complex of a challenge for a one-size-fits-all solution and it is imperative that we engage in creative and meaningful partnerships with HSIs at speed and at scale to meet the STEM needs of our nation," said NSF Director Sethuraman Panchanathan. "If we are to successfully advance America’s future STEM workforce, we must enhance educational opportunities, build capacity and increase student participation, retention and career sustainability at our nation’s academic institutions. NSF’s investments in this program will do just that."

NSF’s investment in the HSI-Net will establish:

The HSI Center for Community Coordination, designed to create coordination mechanisms, foster communication, organize collaborations and strengthen connections between HSIs in the U.S. and its territories and its stakeholders, including current and new awardees.

The HSI Center for Evaluation, Research, and Synthesis, designed to develop tools and approaches to support the HSI community in culturally responsive evaluation practices, assessments, research and synthesis efforts.

Up to five HSI Program Resource Hubs, designed to support innovative initiatives addressing key areas of need in the HSI community and to effectively serve the HSI STEM community and its stakeholders.

Together, these centers and hubs will promote excellence in research that impacts the HSI community, including STEM education and broadening participation research. They will conduct activities designed to support and foster collaborations and partnerships in the HSI community, expand student and faculty development and growth, and promote the advancement of historically underrepresented groups in STEM.

"The HSI program is designed to serve the diverse HSI community with unique needs and their students and faculty," said Erika T. Camacho, director of the HSI program. "Through the creation of the HSI-Net, we are supporting community transformation efforts at HSIs to collectively contribute to research on HSIs and their capacity to address equity in education and intentionally serve their students to better prepare them to address future challenges. The HSI-Net will allow us to further impact the STEM research enterprise and workforce for the success and prosperity of our nation."

Since its founding in 2017, the HSI program has made a significant impact on the quality and accessibility of undergraduate STEM education for Hispanic and Latino students. The program now supports more than 150 projects that enable institutions to better serve students from groups historically underrepresented in the sciences and expand the pathways available to them for graduate education and STEM careers.

As part of the White House Initiative on Advancing Educational Equity, Excellence, and Economic Opportunity for Hispanics, the NSF HSI program team will host a workshop at the upcoming White House Initiative Latino Economic Summit to be held at Malcom X College, 1900 W. Jackson Boulevard, Chicago, June 23, 9:30 a.m. CDT. This session will offer insight into NSF’s funding priorities for advancing excellence in undergraduate STEM education and investments that enhance educational opportunities, build capacity and increase student uptake and career pathways throughout the nation’s Hispanic-serving institutions.

NSF anticipates that approximately up to $29 million will be available for continuing or standard awards in response to the HSI-Net solicitation, subject to the availability of funds.

On June 22, 2022 Leidos (NYSE: LDOS), a FORTUNE 500 science and technology leader, reported that the Defense Enclave Services (DES) contract awarded by the Defense Information Systems Agency (DISA) was upheld by the Government Accountability Office (GAO) after a thorough and disciplined review (Press release, Leidos, JUN 22, 2022, View Source [SID1234616176]). The single-award, indefinite delivery, indefinite quantity contract was initially awarded in February 2022 and holds a total estimated value of $11.5 billion if all options are exercised. It includes a four-year base period of performance followed by three two-year option periods.

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"We are pleased the Government Accountability Office has affirmed the Defense Information Systems Agency’s award," said Gerry Fasano, Leidos Defense Group President. "Leidos is deeply committed to DISA’s critical mission, and never stopped preparing for the program’s success. Our robust and continuous preparation has positioned us to start delivering benefits to the user base on or ahead of the current planned schedule, and we look forward to leveraging our decades of technological expertise to support mission success."

Through the DES contract, Leidos will support DISA’s mission by consolidating enterprise IT services at a global scale and by providing standardized, responsive and cost-effective solutions. The program involves a wide range of IT services for more than 370,000 users spanning 22 Department of Defense (DoD) agencies and field activities with over 500 sites both in the U.S. and abroad. This work will focus on mission value and user experience, while improving cybersecurity, network availability, and reliability for Fourth Estate agencies.

DISA is headquartered at Fort George G. Meade in Maryland and supports joint warfighters, national level leaders, and other mission and coalition partners across the full spectrum of military operations with information sharing capabilities, command and control solutions and global enterprise infrastructure.

On June 22, 2022 IMV Inc. (NASDAQ: IMV; TSX: IMV), a clinical-stage company developing a portfolio of immune-educating therapies based on its novel DPX platform to treat solid and hematologic cancers, reported the drawdown of the remaining US$10 million available under its existing US$25 million debt facility led by Horizon Technology Finance Corporation (Nasdaq: HRZN) ("Horizon") (Press release, IMV, JUN 22, 2022, View Source [SID1234616175]). This drawdown has been made available as the Company achieved a predetermined milestone following site activation in its Phase 2b AVALON trial in platinum-resistant ovarian cancer.

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"The execution of our clinical team to launch the AVALON trial has permitted us to access this capital in a timely manner," said Andrew Hall, Chief Executive Officer of IMV. "Our balance sheet has been strengthened by this debt facility. It provides operating cash into the second quarter of 2023, as per our current business plan, to continue to advance the development of our lead compound in Diffuse Large B-Cell Lymphoma (DLBCL) and ovarian cancer, while building incremental value through our DPX technology platform."

"Horizon is pleased to continue supporting IMV as the company makes important progress with the AVALON trial," said Gerald A. Michaud, President of Horizon. "We believe in IMV’s mission of building a new class of effective cancer immunotherapies that preserve patients’ quality of life."

US$15 million of the US$25 million facility was already drawn down in December 2021, of which CAD$4.5 million was used to pay off IMV’s existing term loan with the government of Nova Scotia. The remaining proceeds from this facility are being used to support the ongoing clinical development of key investigational product candidates within IMV’s pipeline and for general working capital purposes.

In connection with this financing, IMV has agreed to issue warrants (the "Loan Warrants") to purchase up to 568,180 common shares of the Company (the "Shares") at an exercise price of US$1.32 per Share until December 17, 2031. 454,544 Loan Warrants were issued on December 17, 2021, and the balance of 113,636 Loan Warrants have been issued in connection with the drawdown of the additional US$10 million available under this facility. The Loan Warrants and the Shares issuable upon exercise thereof will be subject to a statutory hold period of four months following the issuance of the Loan Warrants in accordance with applicable securities laws. For the purpose of Toronto Stock Exchange ("TSX") approval, the Company is relying on the exemption set forth in Section 602.1 of the TSX Company Manual, which provides that the TSX will not apply its standards to certain transactions involving eligible interlisted issuers on a recognized exchange, such as NASDAQ, provided that the transaction is being completed in compliance with the requirements of such other recognized exchange.

The securities offered have not been and will not be registered under the U.S. Securities Act of 1933, as amended (the "U.S. Securities Act"), or any state securities laws, and may not be offered or sold to, or for the account or benefit of, persons in the United States or U.S. persons (as such term is defined in Regulation S under the U.S. Securities Act) absent registration under the U.S. Securities Act and all applicable state securities laws, or compliance with an exemption from such registration requirements. This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, nor shall there be any sale of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful.

ON June 22, 2022 EORTC reported that Glioma is a type of brain cancer that is rare and difficult to treat (Press release, EORTC, JUN 22, 2022, View Source [SID1234616174]). Until quite recently, gliomas were considered to be incurable and often became rapidly fatal, but now two trials have shown that the addition of chemotherapy to radiotherapy (RT) can improve both disease control and survival in the long term for patients with a glioma. The results* are reported in the Journal of Clinical Oncology today (Wednesday 22 June).

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The two trials (EORTC 26951 and RTOG 9402) were launched 25 years ago. Patients with two types of glioma who had not undergone radiotherapy or chemotherapy were enrolled, and randomised to either RT with or without six cycles (EORTC) or four cycles (RTOG) of the chemotherapy drugs procarbazine, lomustine, and vincristine (PCV). In a joint paper, the researchers have now provided updates of these trials.

After a very long-term follow-up – a median of nearly 20 years – results from the EORTC trial showed that overall survival among patients randomised to PCV-RT as opposed to RT alone was 57% at 10 years, 51% at 15 years, and 37% 20 years after treatment in the first group as opposed to 43%, 26%, and 14% in the group that received RT alone. Results from the RTOG study were very similar. Progression-free survival (the time the patient lives without the disease getting worse) was also improved among patients with PCV-RT as opposed to RT alone.

"These trials have provided exciting, practice-changing results," said Dr Martin van den Bent, from the Brain Tumour Centre, Erasmus University Hospital, Rotterdam, The Netherlands. "They also demonstrate the critical importance of publicly funded networks in conducting clinical trials, particularly where long intervals are required for the data to be fully mature. Such long-term trials are not feasible for a commercial sponsor, but they are essential if we are to be able to make progress in the treatment of rare diseases."

It will be important to understand any long-term adverse effects of PCV-RT, the researchers say. Will there be effects on cognitive function? How long will patients be able to continue to live independently after treatment? Further trials are underway to study these issues. "But in the meantime, we are delighted to have been able to provide robust proof of the extension of disease-free and overall survival for these patients through the use of PCV-RT, and to show that the outlook for them is very much more promising than was thought as recently as a decade ago," says Dr van den Bent.