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 Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") and its development partners reported that they have advanced into clinical development (Phase 1b through Phase 3 clinical trials) a number of fully human monoclonal antibodies (mAbs) for the treatment of COVID-19 and various cancers (Press release, Sorrento Therapeutics, APR 27, 2021, View Source [SID1234578547]). This demonstrates the potential of the deep pipeline generated from Sorrento’s proprietary G-MAB library, invented by Dr. Henry Ji, the Chairman and CEO of Sorrento. This G-MAB library is based on the use of RNA transcription for amplification of the antibody variable domains from over 600 donors. These donors were from both sexes and of multiple ethnicities, leading to a broad diversity of antibodies. In-depth analysis of deep sequencing DNA data showed that the G-MAB library contains more than 20 quadrillion (1016) distinct antibody sequences. The G-MAB library has fostered the development of several early and late-stage oncology programs that are currently in Phase 2 and Phase 3 clinical trials and neutralizing mAbs currently in a Phase 2 clinical trial directed against the spike protein of COVID-19 viruses.

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Two independent anti-PD-L1 mAbs are now in Phase 2 and Phase 3 clinical studies. A PD-L1 mAb (STI-3031, also known as IMC-001) was licensed to ImmuneOncia Therapeutics, Inc. ("ImmuneOncia"), a joint venture between Sorrento and Seoul-based Yuhan Corporation. IMC-001 has completed a Phase 1b study in patients with metastatic or locally-advanced solid tumors and is nearing completion of a Phase 2, open-label, "Neo-Chance" study in patients with resectable gastric cancer, esophageal cancer and liver cancer. ImmuneOncia has also started to enroll patients in a Phase 2 study in relapsed or refractory extranodal NK/T cell lymphoma, nasal type. Sorrento has filed an IND in the U.S. and received clearance from the FDA to proceed with a Phase 2a study for STI-3031 for advanced urothelial carcinoma.

A second antibody, Socazolimab, is licensed to Lee’s Pharmaceutical Holdings Limited in the Greater China territory, and has been cleared to begin a multicenter Phase 3 trial as a potential first-line treatment for patients with extensive-stage small-cell lung cancer. Professor Shun Lu (Shanghai Chest Hospital) is the Principal Investigator. Additionally, Phase 1b studies in several other indications have been completed for this product candidate, including: recurrent metastatic cervical cancer, advanced urothelial carcinoma, and high-grade osteosarcoma after adjuvant chemotherapy for maintenance. In addition, a Phase 1b/2 study has been initiated as a potential neoadjuvant treatment option for esophageal carcinoma. For cervical cancer, a pivotal study has been completed with a breakthrough therapy designation granted by the National Medical Products Administration (NMPA) in China. Sorrento intends to open an IND in the U.S. with the intent to have an end-of-phase 3 meeting or pre-NDA discussion with the FDA for various cancer indications.

Sorrento previously announced FDA clearance to commence a Phase 1b study in various relapsed or refractory solid tumors with an anti-CD47 antibody (STI-6643) (a CD-47 checkpoint inhibitor interacting with SIRPα). In preclinical studies, STI-6643 appears to have a beneficial toxicity profile (e.g., reduced hemolysis) without a priming mechanism while maintaining potent anti-tumor activity. Additionally, Sorrento licensed a separate promising anti-CD47 antibody (IMC-002) to ImmuneOncia, which has initiated a Phase 1b study in patients with metastatic or locally-advanced solid tumors and relapsed or refractory lymphomas.

Sorrento previously announced the formation of its subsidiary company – Adnab, Inc.,– which is focused on developing and commercializing ADNAB platform products for hematological malignancies and solid tumors based on an exclusive license from the Mayo Clinic. Sorrento intends to combine a variety of its proprietary mAbs in conjunction with the ADNAB technology platform, which was developed by Dr. Svetomir Markovic, M.D., Ph.D., and his research team at Mayo Clinic. This effort will potentially result in multiple next-generation ADNAB products. Since ADNABs can be designed to have one or two mAbs on the external surface, in addition to a chemotherapeutic payload, the cytotoxic payload can potentially be delivered preferentially to targeted cancer cell types. Sorrento expects to develop a number of innovative ADNABs in anticipation of filing INDs for clinical trials later in 2021.

"These are very exciting times for Sorrento," said Dr. Ji. "These therapeutic antibody examples demonstrate that we are leveraging the G-MAB library to bring product candidates rapidly from preclinical development through the IND process and into clinic trials."

On April 27, 2021 Constellation Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company using its expertise in epigenetics to discover and develop novel therapeutics, reported that it will host a conference call at 8:00 AM EDT on May 10, 2021, to discuss its first quarter 2021 results and provide a business update (Press release, Constellation Pharmaceuticals, APR 27, 2021, https://ir.constellationpharma.com/news-releases/news-release-details/constellation-pharmaceuticals-host-conference-call-discuss-2 [SID1234578546]). The event will be webcast live and can be accessed on the Investor Relations section of Constellation’s website at View Source To participate in the live question-and-answer session, please dial (877) 473-2077 (domestic) or (661) 378-9662 (international) and refer to conference ID 8798968.

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On April 27, 2021 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, reported that Fred Schwarzer, Chief Executive Officer, will participate in a fireside chat at the Truist Securities Life Sciences Summit on May 4, 2021 at 4:20 p.m. EDT (Press release, IGM Biosciences, APR 27, 2021, View Source [SID1234578545]). The conference will be held in a virtual meeting format.

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A live webcast of the event will be available on the "Events and Presentations" page in the "Investors" section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 90 days following the presentation.

On April 27, 2021 Immunomic Therapeutics, Inc. (ITI) reported that it will participate at the World Vaccine Congress Washington being held virtually May 4-6, 2021. CEO and Co-Founder Bill Hearl, Ph.D., will present a talk titled, "Adaptive T-cell immunotherapy for newly diagnosed glioblastoma: Using targeted antigen presentation to enhance immune responses," at 15:00 on May 4, 2021 (Press release, Immunomic Therapeutics, APR 27, 2021, View Source [SID1234578543]).

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In addition, Immunomic Therapeutics’ Why We Vax, a non-profit whose mission is to help educate communities with research backed facts on vaccines, board member, Dr. Michael Miller will be participating on a panel titled, "Vaccinating Against Misinformation," at 14:00 on May 6, 2021.

"Vaccines are one of the safest, most widely-adopted health care practices in the world. Why We Vax will help spread the message that vaccines are rigorously tested and provide the best defense against diseases, particularly indicative during this unprecedented time," said Dr. William Hearl, Why We Vax Chairman, Immunomic Therapeutics CEO, and experienced vaccinologist.

The World Vaccine Congress Washington is a multi-faceted conference experience with over 300 industry leading speakers, exclusive interviews, world leading presentations, live panel debates, and virtual face to face meetings.

Presentation details are as follows:

Dr. Bill Hearl Presentation:
Title: Adaptive T-cell immunotherapy for newly diagnosed glioblastoma: Using targeted antigen presentation to enhance immune responses
Track: Cancer Immunotherapy
Date and Time: Tuesday, May 4, 2021 15:00

Why We Vax’ Board Member Michael Miller Panel Participation:
Title: Vaccinating Against Misinformation
Track: Vaccine Safety
Date and Time: Thursday, May 6, 2021 14:00

About UNITE

ITI’s investigational UNITE platform, or UNiversal Intracellular Targeted Expression, works by fusing pathogenic antigens with the Lysosomal Associated Membrane Protein, an endogenous protein in humans, for immune processing. In this way, ITI’s vaccines (DNA or RNA) have the potential to utilize the body’s natural biochemistry to develop a broad immune response including antibody production, cytokine release and critical immunological memory. This approach could put UNITE technology at the crossroads of immunotherapies in a number of illnesses, including cancer, allergy and infectious diseases. UNITE is currently being employed in Phase II clinical trials as a cancer immunotherapy. ITI is also collaborating with academic centers and biotechnology companies to study the use of UNITE in cancer types of high mortality, including cases where there are limited treatment options like glioblastoma and acute myeloid leukemia. ITI believes that these early clinical studies may provide a proof of concept for UNITE therapy in cancer, and if successful, set the stage for future studies, including combinations in these tumor types and others. Preclinical data is currently being developed to explore whether LAMP nucleic acid constructs may amplify and activate the immune response in highly immunogenic tumor types and be used to create immune responses to tumor types that otherwise do not provoke an immune response.

About ITI-1000 and the Phase 2 (ATTAC-II) Study

ITI-1000 is an investigational dendritic cell vaccine therapy currently in a Phase 2 clinical trial (ATTAC-II) for the treatment of GBM. ITI-1000 was developed using Immunomic’s proprietary investigational lysosomal targeting technology, UNITE, in the context of cell therapy. In May 2017, Immunomic exclusively licensed a patent portfolio from Annias Immunotherapeutics for use in combination with UNITE and ITI-1000, allowing Immunomic to combine UNITE with a patented and proprietary CMV immunotherapy platform. The ATTAC-II study (NCT02465268) is a Phase II randomized, placebo-controlled clinical trial enrolling patients with newly diagnosed GBM that will explore whether dendritic cell (DC) vaccines, including ITI-1000, targeting the CMV antigen pp65 improves survival. This study is enrolling up to 120 subjects at 3 clinical sites in the United States. For more information on the ATTAC-II study, please visit www.clinicaltrials.gov.