On April 27, 2021 Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, reported that the Company expects to report business results for the first quarter of 2021 after the market closes on Wednesday, May 5, 2021 (Press release, Supernus, APR 27, 2021, View Source [SID1234578563]).

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Jack Khattar, President and CEO, and Jim Kelly, Executive Vice President and CFO, will host a conference call to present the first quarter 2021 financial and business results on Wednesday, May 5, 2021 at 4:30 p.m. ET. Following management’s prepared remarks and discussion of business results, the call will be open for questions.

A live webcast will be available at www.supernus.com.

Please refer to the information below for conference call dial-in information. Callers should dial in approximately 10 minutes prior to the start of the call.

On April 27, 2021 Shasqi, a clinical-stage biotechnology company developing precision activated oncology therapeutics with its proprietary Click Activated Protodrugs Against Cancer (CAPAC) Platform, reported that it has been awarded a $2 million Direct-to-Phase-2 Small Business Innovation Research (SBIR) grant from the National Cancer Institute (NCI) (Press release, Shasqi, APR 27, 2021, View Source [SID1234578579]). These non-dilutive funds will support immune biomarker analysis of patient samples from Shasqi’s Phase 1 clinical trial of lead candidate SQ3370 as well as manufacturing process development.

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"We are thrilled the NCI sees the potential of SQ3370 as a novel therapy that could meaningfully impact outcomes for patients with solid tumors," said José M. Mejía Oneto, M.D., Ph.D., Founder and CEO of Shasqi. "Our goal at Shasqi is to improve the safety and efficacy of novel and existing standard of care cancer drugs by directly activating them at the tumor. Our approach is designed to improve the therapeutic window of a drug by maximizing the exposure of the drug to the tumor."

Wayne Saville, M.D., Chief Medical Officer of Shasqi commented, "We appreciate the NCI’s support to evaluate the immune signatures in patient samples from our ongoing Phase 1 trial of SQ3370. This information will provide mechanistic insight about the interplay between SQ3370 and changes to local and systemic immune responses observed in our preclinical tumor studies. In addition, funds from this grant will also allow us to fine-tune our current manufacturing process as we continue to advance SQ3370 through clinical studies."

CAPAC and SQ3370:

SQ3370 utilizes Shasqi’s proprietary CAPAC platform, a click chemistry-based approach that activates cancer drugs at a tumor with decreased systemic toxicity. The platform is based on the chemical reaction between an attenuated trans-cyclooctene-modified protodrug and a tetrazine-modified biopolymer. The biopolymer is injected into the target tumor lesion, where it precisely activates an intravenously infused protodrug. Unlike traditional targeted therapies, the CAPAC platform is agnostic to tumor characteristics that can vary from patient to patient, such as biomarker expression and enzymatic activity.

On April 27, 2021 Arch Oncology, Inc., a clinical-stage immuno-oncology company focused on the discovery and development of anti-CD47 biologic therapies, reported that it has closed a $105 million Series C financing co-led by Eventide Asset Management, Cowen Healthcare Investments and current investor 3×5 Partners, who were joined by new investors Adage Capital Management, Point72 Asset Management, Avego Healthcare Capital, FMB Research and Broadfin Holdings (Press release, Arch Oncology, APR 27, 2021, View Source [SID1234578597]). Arch Oncology’s existing investors, including Roche Venture Fund, RiverVest Venture Partners, and Lightchain, also participated in the round. In connection with the financing, Joy Ghosh, Ph.D., Senior Research Analyst at Eventide Asset Management, Eric Pham, Ph.D., Associate at Cowen Healthcare Investments, and Joe Biller, Managing Director at 3×5 Partners, will join the Company’s Board of Directors.

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"This financing enables the clinical progress of our differentiated anti-CD47 product candidate AO-176, currently in Phase 1/2 clinical trials for solid tumors, both as a monotherapy and in combination with paclitaxel, and multiple myeloma. Looking forward, we plan to expand the AO-176 clinical program to include a combination trial with pembrolizumab (KEYTRUDA) in solid tumors, and a combination trial with standard therapies in multiple myeloma. We will also explore other indications and combinations consistent with our novel mechanisms of action," said Laurence Blumberg, M.D., President and Chief Executive Officer of Arch Oncology. "The quality of our new and existing investors is a testament to this pipeline and our mission on behalf of patients with cancer who need better therapeutic options."

AO-176 is an anti-CD47 IgG2 antibody in Phase 1/2 clinical trials for the treatment of patients with select solid tumors and with hematologic malignancies, both as monotherapy and in combination with standard therapies. AO-176 works by blocking the "don’t eat me" signal enabled by CD47’s interaction with SIRPa and inducing phagocytosis. It has a unique combination of features, positioning it to improve upon the safety and efficacy profile among anti-CD47 antibody therapies including: lower binding to normal cells in general and negligible binding to red blood cells; enhanced binding to CD47 in acidic environments found in tumors; and induction of programmed and immunogenic cell death.

"Arch Oncology’s highly differentiated approach to the development of anti-CD47 agents is a promising development in the immuno-oncology space," said John McKearn, Ph.D., Managing Director, RiverVest Venture Partners and Chairman of the Board of Arch Oncology. "We look forward to continuing to support the Company as it develops and advances its robust pipeline of promising drug candidates, including a broad clinical program for AO-176."

On April 27, 2021 Advaxis, Inc. (NASDAQ: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, reported that the Company has achieved the second milestone under its licensing agreement for ADXS31-164, also known as ADXS-HER2, to OS Therapies for evaluation in the treatment of osteosarcoma in humans (Press release, Advaxis, APR 27, 2021, View Source [SID1234578521]).

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Under the terms of the license agreement, OS Therapies, in collaboration with the Children’s Oncology Group (COG), is responsible for the conduct and funding of a clinical study evaluating ADXS-HER2 in recurrent, completely resected osteosarcoma. OS Therapies recently completed a financing, triggering the second milestone payment. Under the agreement, Advaxis has the opportunity to receive additional clinical, regulatory, and sales-based milestone payments as well as royalties on future product sales. Additional details of the financial terms have not been disclosed.

"This funding milestone for OS Therapies brings OST-HER2, originally ADXS-HER2, one step closer to the clinic," said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. "We are confident in the potential of OST-HER2, which had been approved in the U.S. for the adjuvant treatment of osteosarcoma in canines, and are proud to have played a role in the development of this important new candidate for osteosarcoma patients. We look forward to the team at OST advancing the program, building upon our early Phase 1 data evaluating ADXS-HER2."

Mr. Berlin continued, "This milestone payment will provide Advaxis additional capital as we build momentum across our growing ADXS-HOT neoantigen-directed off-the-shelf clinical programs. To date, we have assembled a robust clinical and translational data set which suggests our unique approach has the potential to enhance and/or restore responses to checkpoint inhibitors in lung cancer. We look forward to leveraging these resources as we advance ADXS-503, currently being evaluated in our Phase 1/2 study in NSCLC, and ADXS-504 for early-stage prostate cancer, which is on-track to enter the clinic in Q2 2021."

On April 27, 2021 Voluntis (Euronext Growth Paris, Ticker: ALVTX – ISIN: FR0004183960), a leader in digital therapeutics, reported a collaboration agreement with Eisai (Headquarters: Tokyo) to design and develop innovative digital therapeutics (DTx) to support patients treated for cancer as well as a strategic investment from Eisai in Voluntis (Press release, Debiopharm, APR 27, 2021, View Source [SID1234578548]).

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Collaboration and license agreement further enriching Voluntis’ commercial pipeline

By leveraging Voluntis’ Theraxium technology platform, the two companies will collaborate on novel DTx specifically designed for patients and healthcare professionals to support cancer treatment.

The partners’ goals are to jointly design and develop new DTx, and evaluate their benefits for patients, caregivers and healthcare professionals. Ultimately, the companies would collaborate on the commercialization of the DTx, once authorized for marketing by regulatory authorities. The new assets will be designed with the intent to be commercialized in the US, Japan and European markets. The initiative supports both partners’ strategy of using digital technology to improve treatment experiences and patient outcomes. The DTx will be based on the Theraxium platform, which powers Voluntis’ portfolio of digital therapeutics, including its first-in-class proprietary oncology solution which received marketing authorization in the US and Europe.

In addition to their partnership in oncology, the partners will explore other opportunities of collaboration to develop, evaluate and commercialize digital therapeutics based on the Theraxium platform in the field of neurology, another area of strategic focus for Eisai notably for Alzheimer’s disease and dementia.

Pierre Leurent, CEO of Voluntis, said: "We are delighted to be starting this alliance with Eisai, a life sciences leader driven by an inspiring human health care philosophy. Our teams are eager to contribute to this mission, bringing complementary skills and capabilities to enable this collaboration. We are honored by the trust Eisai has placed in us and see it as a recognition of Voluntis as a trusted global partner for pharmaceutical companies developing digitally-augmented therapies".

Following this strategic agreement, Voluntis increases its global footprint with a new opportunity to commercialize its technology in Japan. The collaboration also enriches the company’s portfolio of pharma-partnered DTx, demonstrating once again the strength of its Theraxium platform, a state-of-the-art technology to accelerate and de-risk the strategic DTx initiatives of leading pharmaceutical players.

Main terms of the strategic investment by Eisai

In addition to the payment made upon execution of the collaboration and licensing agreement, Eisai makes a strategic investment in Voluntis. This transaction will strengthen the partnership between the two companies.

The investment will be carried out through the reserved issuance to Eisai of 100,361 ordinary shares without pre-emptive rights for the existing shareholders of the Company. The issue price of the new shares was set at €4.15 per share. Upon settlement-delivery of the new shares, Eisai will hold ca. 1.1% of Voluntis’s share capital and ca. 0.86% of voting rights.

Kazumasa Nagayama, Chief Strategy Officer of Eisai, said: "Eisai is aiming to become a "Medico Societal Innovator" (a company that changes society through creating medicines and providing solutions) in our Medium-Term Business Plan "EWAY 2025". Partnering with Voluntis, a leading DTx company, is one of our key initiatives to realize it. We expect this alliance will help increase the benefits provided to patients and their families".