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".

On April 27, 2021 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a pioneer in T-cell immunotherapy, leveraging its novel allogeneic EBV T-cell platform to develop transformative therapies for patients with serious diseases including solid tumors, hematologic cancers and autoimmune diseases, reported the Company will release first quarter 2021 financial results after market close on Tuesday, May 4, 2021 (Press release, Atara Biotherapeutics, APR 27, 2021, View Source [SID1234578564]). Following the release, the Company will host a live conference call and webcast at 4:30 p.m. EDT to discuss the Company’s financial results and provide a corporate update.

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Analysts and investors can participate in the conference call by dialing 877-407-8291 for domestic callers and 201-689-8345 for international callers, using the conference ID 13717803. A live audio webcast can be accessed by visiting the Investors & Media – News & Events section of atarabio.com. An archived webcast replay will be available on the Company’s website for 30 days.

On April 27, 2021 Guardant Health, Inc. (Nasdaq: GH) reported a strategic collaboration with Daiichi Sankyo, Inc. (Daiichi Sankyo) to pursue regulatory approval and commercialization of the Guardant360 CDx blood test as a companion diagnostic for Enhertu (fam-trastuzumab deruxtecan-nxki), a HER2-directed antibody-drug conjugate (ADC), being studied in the treatment of patients with advanced metastatic non-small cell lung cancer (NSCLC) (Press release, Guardant Health, APR 27, 2021, https://www.businesswire.com/news/home/20210427005136/en/Guardant-Health-Announces-Collaboration-With-Daiichi-Sankyo-to-Develop-Guardant360%C2%AE-CDx-as-a-Companion-Diagnostic-for-Enhertu%C2%AE-in-Advanced-Metastatic-Non-Small-Cell-Lung-Cancer [SID1234578580]).

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"For patients with metastatic non-small cell lung cancer, personalized medicines targeting actionable mutations, as revealed by our Guardant360 liquid biopsy test, have been life-changing," said Helmy Eltoukhy, Guardant Health CEO. "Such medicines may extend overall survival for many patients, and we are excited to work with Daiichi Sankyo, as there remains an unmet medical need to help non-small cell lung cancer patients with HER2 mutations."

The Guardant360 CDx test is FDA-approved to provide comprehensive genomic profiling results to guide treatment in all solid tumors, including NSCLC. Sequencing a broad number of genes to understand the molecular drivers of a patient’s cancer is critical, as the number of treatment-relevant genomic alterations continues to grow.

On April 27, 2021 PTC Therapeutics, Inc. (NASDAQ: PTCT) reported that management will present a company overview at the following conferences (Press release, PTC Therapeutics, APR 27, 2021, View Source [SID1234578598]):

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BofA Securities 2021 Virtual Health Care Conference
Tuesday, May 11th at 8:45 a.m. ET

2021 RBC Capital Markets Global Healthcare Virtual Conference
Tuesday, May 18th at 10:20 a.m. ET

2021 UBS Global Healthcare Virtual Conference
Wednesday, May 26th at 12:00 p.m. ET

The presentations will be webcast live on the Events and Presentations page under the investor relations section of PTC Therapeutics’ website at View Source and will be archived for 30 days following the presentation. It is recommended that users connect to PTC’s website several minutes prior to the start of the webcast to ensure a timely connection.

On April 27, 2021 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") reported that it booked an impairment loss in the fourth quarter of the fiscal year ended March 31, 2021 (April 1, 2020 to March 31, 2021) and that there are differences between the financial forecasts (Full basis), which were reported on October 30, 2020, and the actual results for the fiscal year 2020 (Press release, Astellas, APR 27, 2021, View Source [SID1234578522]).

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(1) Booking and details of impairment loss

Astellas booked an impairment loss of ¥58.8 billion as other expenses in the fourth quarter of fiscal year 2020 not included in the financial forecasts (Full basis) announced on October 30, 2020.

In December 2020, Astellas was notified that the U.S. Food and Drug Administration (FDA) lifted the clinical hold for the ASPIRO clinical trial evaluating investigational gene therapy AT132 in patients with X-linked myotubular myopathy (XLMTM). Astellas then reassessed the development plan and recognized a delay in approval timing in the U.S. and Europe. Astellas also revised the likely approved population from our initial assessment. As a result of these updates, Astellas booked an impairment loss.

Astellas is deeply committed to the continued safe development of AT132 for the families and patients living with XLMTM, a disease with no existing treatments. There is no change to our plan to continue development. We will conduct future discussions with regulators on the path forward toward registration filings for AT132.

(2) The Differences Between Financial Forecasts (announced on October 30, 2020) and Actual results for the Year Ended March 31, 2021 (IFRS basis)

Operating profit and other line items (Full basis) were lower than the forecasts due to the such matters as impairment loss of intangible assets as discussed above.

About Astellas Gene therapies Astellas integrated its wholly owned subsidiary, Audentes Therapeutics, as of April 1, 2021 and establish "Astellas Gene Therapies" within the organization as Astellas Center of Excellence developing genetic medicines with the potential to deliver transformative value for patients. Based on an innovative scientific approach and industry leading internal manufacturing capability and expertise, we are currently exploring three gene therapy modalities: gene replacement, exon skipping gene therapy, and vectorized RNA knockdown and will also advance additional Astellas gene therapy programs toward clinical investigation. We are based in San Francisco, with manufacturing and laboratory facilities in South San Francisco and Sanford, North Carolina.

About X-linked Myotubular Myopathy
XLMTM is a serious, life-threatening, rare neuromuscular disease that is characterized by extreme muscle weakness, respiratory failure and early death. Mortality rates are estimated to be 50 percent in the first 18 months of life. For those patients who survive past infancy, there is an estimated additional 25 percent mortality by the age of 10. XLMTM is caused by mutations in the MTM1 gene that lead to a lack or dysfunction of myotubularin, a protein that is needed for normal development, maturation and function of skeletal muscle cells. The disease affects approximately 1 in 40,000 to 50,000 newborn males.

XLMTM places a substantial burden of care on patients, families and the healthcare system, including high rates of healthcare utilization, hospitalization and surgical intervention. More than 80 percent of XLMTM patients require ventilator support, and the majority of patients require a gastrostomy tube for nutritional support. In most patients, normal developmental motor milestones are delayed or never 3 achieved. Currently, only supportive treatment options, such as ventilator use or a feeding tube, are available. About AT132 for the treatment of X-linked Myotubular Myopathy AT132 is an AAV8 vector containing a functional copy of the MTM1 gene, for the treatment of XLMTM. AT132 may provide patients with significantly improved outcomes based on the ability of AAV8 to target skeletal muscle and increase myotubularin expression in targeted tissues following a single intravenous administration. AT132 has been granted Regenerative Medicine and Advanced Therapy (RMAT), Rare Pediatric Disease, Fast Track, and Orphan Drug designations by the U.S. Food and Drug Administration (FDA), and Priority Medicines (PRIME) and Orphan Drug designations by the European Medicines Agency (EMA).

About the ASPIRO Study
ASPIRO Study (NCT03199469) is multinational, randomized, open-label ascending dose trial to evaluate the safety and preliminary efficacy of AT132 in XLMTM patients less than five years of age. Primary endpoints include safety (adverse events and certain laboratory measures) and efficacy (assessments of neuromuscular and respiratory function). Secondary endpoints include the burden of disease and healthrelated quality-of-life, and muscle tissue histology and biomarkers.