On September 2, 2021 Sentinel Oncology reported that it has entered an agreement with the McQuade Center for Strategic Research and Development, LLC (MSRD), a member of the global Otsuka family of pharmaceutical companies to support the clinical development of a first-in-class therapeutic with the potential to treat Fragile X syndrome (FXS), a rare, genetic condition that causes intellectual disability, behavioral and learning challenges, and various physical characteristics (Press release, Sentinel Oncology, SEP 2, 2021, View Source [SID1234587259]).

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"We are delighted to be collaborating with the MSRD team to advance SOL784 into clinical development" said Robert G Boyle, founder and CEO of Sentinel Oncology. "SOL784 targets the underlying disease biology of FXS and we are excited for the prospects of a drug which has the potential to provide real benefits to patients for whom there is an unmet medical need".

On September 2, 2021 Voluntis (Euronext Growth Paris, Ticker: ALVTX – ISIN: FR0004183960), a leader in digital therapeutics, and its reference shareholders (Bpifrance Participations, LBO France Gestion, Debiopharm Innovation Fund, SHAM Innovation Santé, Vesalius Biocapital and Indigo) reported that following the signature of a share purchase agreement with AptarGroup, Inc. (NYSE: ATR) ("Aptar") on July 22, 2021 and the approval of the French Ministry of Economy under the foreign investment clearance regulations, Aptar has completed the acquisition of a majority stake in Voluntis from the company’s reference shareholders and certain members of the management, representing approximately 64.6% of the share capital of Voluntis (on a non-diluted basis), at a price of €8.70 per share (Press release, Debiopharm, SEP 2, 2021, View Source [SID1234587255]).

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In accordance with applicable regulation, Aptar will launch a mandatory cash tender offer to acquire Voluntis’ remaining shares for the same price of €8.70 per share (the "Tender Offer"). The Tender Offer is intended to be filed with the French Markets Authority (the "AMF") in September 2021 and will be subject to the regulatory clearance from the AMF.

If the regulatory conditions are met upon completion of the Tender Offer, Aptar intends to implement a squeeze-out on the remaining outstanding shares of Voluntis. Voluntis’ board of directors (the "Board"), upon the recommendation of its ad hoc committee and in accordance with applicable regulation, appointed Advolis Orfis as independent expert on July 5, 2021, and will issue, notably on the basis of the independent expert’s report opining on the financial terms of the Tender Offer and potential subsequent squeeze-out, a reasoned opinion on the Tender Offer and its consequences on Voluntis, its shareholders and employees.

The independent expert’s report and the Board’s opinion will be included in the draft response offer document that will be prepared by Voluntis in the context of the Tender Offer and submitted to the AMF, which will assess its compliance with applicable regulation.

On September 2, 2021, following resignation of the selling shareholders’ representatives on the Voluntis Board, namely Laurent Higueret (representative of Bpifrance Participations) and Franck Noiret (representative of LBO France Gestion), Gael Touya and Patrick Jeukenne, Aptar’s representatives, have been appointed to replace them in the Board.

The Board has also appointed M. Sai Shankar as deputy CEO of Voluntis, and the current management of Voluntis is otherwise expected to remain the same following the completion of the Tender Offer.

In addition, Voluntis announces that it has fully repaid in advance the bond loan subscribed with Kreos for an amount of € 0.75 million

On September 2, 2021 Scopus BioPharma Inc. (Nasdaq: "SCPS"), a clinical-stage biopharmaceutical company developing transformational therapeutics for serious diseases with significant unmet medical need, reported the launch of Duet Therapeutics (Press release, Scopus BioPharma, SEP 2, 2021, View Source [SID1234587254]).

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Duet Therapeutics integrates the management and clinical development of the immunotherapy assets of Scopus and Olimmune, acquired by Scopus in June 2021. Duet is a wholly-owned subsidiary of Scopus.

Joshua R. Lamstein, Chairman of Scopus, stated, "We are extremely excited to announce the launch of Duet Therapeutics. The integration of the immuno-oncology assets of Scopus and Olimmune creates a comprehensive, industry-leading portfolio of bi-functional cancer-targeting oligonucleotides. Our highly complementary IP-protected technologies all target STAT3 inhibition. We believe our oligonucleotide technologies are unique, highly differentiated and superior to other STAT3 inhibitors currently under development."

Alan Horsager, Ph.D., President and Chief Executive Officer of Duet and President — Immuno-Oncology for Scopus, stated, "Overseeing the integration and clinical development of Duet’s immuno-oncology platform is an extraordinary opportunity. It is a privilege to play a key role in integrating and developing Duet’s drug candidates. Based on the large body of scientific data, we firmly believe our oligonucleotide platform has enormous potential to address one of society’s most significant unmet medical needs — unprecedented treatments, and potentially cures, for many different types of cancer. I can think of no greater professional mission than creating new standards of care, improving patient outcomes and saving lives."

The Duet Platform is comprised of three complementary, underpinning technologies:

• RNA silencing CpG-STAT3siRNA ("DUET-01")
• Antisense CpG-STAT3ASO ("DUET-02")
• Protein degradation CpG-STAT3decoy ("DUET-03")
Dr. Horsager added, "The unique mechanism-of-action of these synthetic oligos comes from simultaneously targeting two intracellular immune pathways, STAT3 and TLR9. The targeted inhibition of STAT3, a master immune checkpoint inhibitor, reawakens immune cells and allows for the full potential of TLR9-driven immune responses."

DUET-01 is in a Phase 1 clinical trial, as a monotherapy, for B-cell non-Hodgkin lymphoma. In 2022, Duet is targeting to file two INDs for DUET-02 in two separate indications: genitourinary and head & neck cancers. Duet is also evaluating combination therapies with checkpoint inhibitors.

On September 2, 2021 The McQuade Center for Strategic Research and Development, LLC (MSRD), a member of the global Otsuka family of pharmaceutical companies, reported that it has entered an agreement with Sentinel Oncology (Sentinel), a drug discovery company (Press release, Sentinel Oncology, SEP 2, 2021, View Source [SID1234587242]).

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The McQuade Center for Strategic Research and Development at Otsuka in the U.S. will support the clinical development of a first-in-class therapeutic with the potential to treat Fragile X syndrome (FXS), a rare, genetic condition that causes intellectual disability, behavioral and learning challenges, and various physical characteristics1.

Under the terms of the agreement, MSRD and Sentinel will collaborate to support the Phase 1a and Phase 1b clinical trials for Sentinel’s investigational compound SOL784 with the opportunity to expand the collaboration after those studies.

"Although there are treatment options for the symptoms of Fragile X syndrome available today, none have been approved by regulatory authorities to address the underlying cause of this rare genetic disorder," said Robert McQuade, PhD, president, McQuade Center for Strategic Research and Development, LLC, and chief strategic officer, Otsuka Pharmaceutical Development & Commercialization, Inc. "Our two organizations share like-minded missions of delivering treatments to patients with unmet medical needs. We are hopeful that our collaboration can lead to the development of a potential therapeutic for people living with this condition."

"We are delighted to be collaborating with the MSRD team to advance SOL784 into clinical development" said Robert G Boyle, founder and CEO of Sentinel Oncology. "SOL784 targets the underlying disease biology of FXS and we are excited for the prospects of a drug which has the potential to provide real benefits to patients for whom there is an unmet medical need"

About Fragile X Syndrome

Fragile X syndrome (FXS) is a rare, genetic condition that causes intellectual disability, behavioral and learning challenges, and various physical characteristics. Though FXS occurs in both genders, males are more frequently affected than females, and generally with greater severity. FXS has been detected in all populations and ethnic groups. While researchers do not have an exact number for how many Americans (males and females) could have full-mutation Fragile X syndrome, estimates range between as few as 38,000 to as high as 87,000 people living with the condition.1

On September 2, 2021 MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), reported that MediciNova will participate in the virtual Morgan Stanley 19th Annual Global Healthcare Conference which will be held from September 9 – 15, 2021 (Press release, MediciNova, SEP 2, 2021, View Source [SID1234587240]). Yuichi Iwaki, MD, PhD, President and Chief Executive Officer, and Geoffrey O’Brien, JD/MBA, Vice President and Executive Officer, will be available for one-on-one meetings at this conference and investors may request a one-on-one meeting through Morgan Stanley.

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