On June 9, 2021 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported it has entered into a procurement agreement with the United States government for molnupiravir (MK-4482) (Press release, Merck & Co, JUN 9, 2021, View Source [SID1234583778]). Molnupiravir is currently being evaluated in a Phase 3 clinical trial, the MOVe-OUT study, for the treatment of non-hospitalized patients with laboratory-confirmed COVID-19 and at least one risk factor associated with poor disease outcomes. Merck is developing molnupiravir in collaboration with Ridgeback Biotherapeutics.

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"Merck is pleased to collaborate with the U.S. government on this new agreement that will provide Americans with COVID-19 access to molnupiravir – an investigational oral therapy being studied for outpatient use early in the course of disease – if it is authorized or approved," said Rob Davis, president, Merck. "In addition to this agreement with the U.S. government, we are actively engaged in numerous efforts to make molnupiravir available globally to fulfill Merck’s commitment to widespread access."

Through the agreement, if molnupiravir receives Emergency Use Authorization (EUA) or approval by the U.S. Food and Drug Administration (FDA), Merck will receive approximately $1.2 billion to supply approximately 1.7 million courses of molnupiravir to the United States government. Merck has been investing at risk to support development and scale-up production of molnupiravir and expects to have more than 10 million courses of therapy available by the end of 2021.

Merck also plans to submit applications for emergency use or approval to regulatory bodies outside of the U.S. and is currently in discussions with other countries interested in advance purchase agreements for molnupiravir. Merck is committed to providing timely access to molnupiravir globally and intends to implement a tiered pricing approach based on World Bank data that recognizes countries’ relative ability to finance their public health response to the pandemic.

As part of its access strategy, Merck has also entered into non-exclusive voluntary licensing agreements for molnupiravir with established generic manufacturers to accelerate availability of molnupiravir in 104 low- and middle-income countries (LMICs) following approvals or emergency authorization by local regulatory agencies.

In addition to developing molnupiravir, Merck is contributing to the pandemic response by collaborating with Johnson & Johnson to support the manufacture of its COVID-19 vaccine.

This procurement of molnupiravir will be supported in whole or in part with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, in collaboration with the DOD Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) under contract number W911QY21C0031.

About Molnupiravir

Molnupiravir (EIDD-2801/MK-4482) is an investigational, orally bioavailable form of a potent ribonucleoside analog that inhibits the replication of multiple RNA viruses including SARS-CoV-2, the causative agent of COVID-19. Molnupiravir has been shown to be active in several models of SARS-CoV-2, including for prophylaxis, treatment and prevention of transmission, as well as SARS-CoV-1 and MERS. EIDD-2801 was invented at Drug Innovations at Emory (DRIVE), LLC, a not-for-profit biotechnology company wholly owned by Emory University, and with partial funding support from the U.S. government. Since licensed by Ridgeback, all funds used for the development of EIDD-2801 by Ridgeback have been provided by Wayne and Wendy Holman and Merck.

The Phase 3 portion (Part 2) of the MOVe-OUT study, evaluating the potential of molnupiravir to reduce the risk of hospitalization or death, is ongoing. Merck currently anticipates that, pending favorable results from MOVe-OUT, the earliest possible submission for an Emergency Use Authorization for molnupiravir will be in the second half of 2021. Merck and Ridgeback Biotherapeutics plan to share further findings from the ongoing molnupiravir development program with regulatory agencies as they become available. For more information on the molnupiravir clinical trial please visit View Source

In addition, Merck plans to initiate a clinical program to evaluate molnupiravir for post- exposure prophylaxis in the second half of 2021.

On June 9, 2021 Magellan Rx Management, a division of Magellan Health, Inc. (NASDAQ: MGLN), reported annualized savings of over $40 million for five health plan customers who were early adopters of its oncology biosimilar medical benefit drug management solution (Press release, Magellan Health Services, JUN 9, 2021, View Source [SID1234583777]). This comprehensive approach encourages the use of oncology therapeutic biosimilars over more expensive reference products, when clinically appropriate. Savings figures are expected to grow even further as more customers have adopted the program since its inception and the market shift to biosimilars accelerates.

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"Magellan Rx continues to be a market leader and disrupter in delivering leading-edge solutions for the evolving healthcare landscape, and our health plan partners are recognizing real savings through these programs while maintaining a high quality level of care for their members," said Steve Cutts, PharmD, senior vice president and general manager, specialty, Magellan Rx Management. "We have been tracking the emergence of biosimilars and started to deliver biosimilar-first solutions as early as 2016. It’s our commitment to staying ahead of the trend that has made us a trusted partner in medical benefit management for nearly two decades."

Health plan customers implemented the program, which focuses on promotion of biosimilars for three oncology products, on or before January 1, 2020. Most of the current savings were achieved with the first two products that had biosimilar availability (see graphic), and preliminary results with the third product are promising. According to Magellan Rx’s internal data, these biosimilars can cost payers up to 40% less than their respective reference brands.

"We knew we wanted to collaborate with a medical pharmacy expert," said Carly Rodriguez, pharmacy director at Moda Health, a health plan that implemented the program with success. "We were looking for a partner that would do more than save our plan on rising specialty costs, but that would continue to support our members with Moda’s signature quality of care. In partnering with Magellan Rx, we know we have the right experts on our side and we anticipate expanding the program to additional biosimilar agents, as clinically appropriate."

These positive results, after just one year, reflect the growing need for management programs that deliver lower cancer treatment costs for payers and patients while maintaining high standards of care. Magellan Rx develops cost-effective and leading-edge strategies for medical benefit drug management across several categories, offering flexible solutions that can also operate outside of the traditional payer-PBM relationship. Health plans can leverage the extensive clinical expertise and experience at Magellan Rx by delegating specialty and medical drug management services while retaining a separate PBM. Read more about Magellan Rx’s total specialty drug management solutions. To learn more about Magellan Rx Management’s history of biosimilar management, visit, Magellan Insights.

On June 9, 2021 Sapience Therapeutics, Inc., a biotechnology company focused on the discovery and development of peptide therapeutics to address difficult to treat oncology indications, reported that the company will present and participate in 1×1 meetings with investors and potential partners at BIO Digital 2021 being held June 10-11 and June 14-18, 2021 (Press release, Sapience Therapeutics, JUN 9, 2021, View Source [SID1234583775]). The presentation will be available to registered conference attendees for on-demand viewing.

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Dr. Barry Kappel, President and Chief Executive Officer, will present an overview of the company and provide an update on Sapience’s lead program, ST101. ST101 is a first-in-class peptide antagonist of C/EBPβ that is currently in a Phase 1/2 clinical study in patients with advanced unresectable and metastatic solid tumors (NCT04478279). C/EBPβ is a transcription factor overexpressed or activated in many cancers, but not active in most normal cells, providing a unique therapeutic opportunity.

To schedule a meeting with the Sapience management team at this conference, please visit the BIO Digital partnering system or email [email protected].

About ST101
ST101 is a peptide antagonist of C/EBPβ, and in July 2020 it entered into a Phase 1/2 clinical study in patients with advanced unresectable and metastatic solid tumors (NCT04478279). C/EBPβ is a transcription factor overexpressed or activated in many cancers, but not active in normal cells (post-differentiation), providing a unique therapeutic opportunity. In tumors, C/EBPβ promotes survival and proliferation and regulates cellular differentiation. ST101 significantly decreases the expression of C/EBPβ target genes/proteins involved in oncogenesis including BCL-2, BIRC5/survivin, cyclins and ID family of proteins. As a result, ST101 induces selective cancer cell cytotoxicity across a variety of tumor types, including but not limited to breast cancer, melanoma, prostate cancer, GBM, lung cancer, and AML.

About BIO
BIO is the world’s largest advocacy organization representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the BIO International Convention, the world’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world.

On June 9, 2021 Medigene AG (Medigene, FSE: MDG1, Prime Standard), a clinical stage immuno-oncology company focusing on the development of T cell immunotherapies, reported that compelling new pre-clinical data on its lead T cell receptor (TCR) candidate "TCR-4" targeting solid tumors combined with its PD1-41BB switch receptor to overcome the highly immunosuppressive solid tumor microenvironment (Press release, MediGene, JUN 9, 2021, https://www.pressetext.com/news/20210609044 [SID1234583776]). The data underpins Medigene’s decision to advance TCR-4 in PRAME-positive cancer.

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The presentations are being made as part of the TCR-based Therapies Summit, a Digital Event being held 8-10 June 2021. Both the presentation and the poster can be found on Medigene’s website: View Source

TCR-4 which specifically targets the PRAME cancer antigen in the context of HLA-A2 was combined with Medigene’s lead functional T cell enhancer, the PD1-41BB switch receptor, and evaluated pre-clinically against a set of key performance hurdles to determine safety and efficacy.

The safety of the TCR-T cells carrying both TCR-4 and PD1-41BB was demonstrated in vitro. There was no off-target toxicity: cells which did not express the target antigen PRAME, including a panel of normal healthy tissues (such as lung, bone, heart and kidney among others), were not killed. Furthermore, no toxicity was observed against HLA-A2 negative cells.

TCR-T cells carrying both TCR-4 and PD1-41BB demonstrated enhanced anti-cancer efficacy both in vitro and in vivo. In vitro, they were functionally more active against tumor cells expressing the PRAME target, producing increased levels of key cytokines (messenger molecules) and improving the sustainability of repeated killing activity. The improved performance was echoed in vivo. We had previously shown that TCR-T cells with TCR-4 alone were sufficient to eliminate PD-L1 negative melanoma tumors in vivo (AACR 2021). The new data come from a more challenging in vivo model of aggressively growing, PD-L1 positive melanoma and show that only TCR-T cells carrying the combination of both TCR-4 and PD1-41BB could eliminate tumors with these highly immunosuppressive characteristics.

Dolores Schendel, Chief Executive Officer and Chief Scientific Officer at Medigene: "Tumors expressing PD-L1 are highly immunosuppressive making them the most challenging solid cancers in medicine. The results we have presented show the exquisite specificity and compelling functional potency of our enhanced TCR-T cells carrying the TCR-4 plus PD1-41BB combination against aggressively growing PRAME positive, PD-L1 positive solid tumor cells. This data gives Medigene the critical evidence it needs to select this impressive product candidate for further development towards clinical trials."

On June 9, 2021 Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics, reported that it has commenced an initial public offering in the United States of 3,000,000 American Depositary Shares ("ADSs") pursuant to a registration statement on Form F-1 (File No. 333-255447), as amended, that has been filed with the U.S. Securities and Exchange Commission (the "Offering") (Press release, Molecular Partners, JUN 9, 2021, View Source [SID1234583774]). In connection with the Offering, Molecular Partners expects to grant the underwriters a 30-day option to purchase additional ADSs of up to 15% of the total number of ADSs placed in the Offering (i.e. up to 450,000 additional ADSs). Each ADS will represent one Molecular Partners ordinary share. The new ordinary shares underlying the ADSs will be issued from Molecular Partners’ authorized capital under exclusion of the existing shareholders’ pre-emptive rights. The terms of the Offering have not been determined, and the Offering is subject to market and other conditions, and there can be no assurance as to whether or when the Offering may be completed or as to the actual size or terms of the Offering.

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The number of ADSs to be offered and the price for the ADSs in the proposed Offering will be determined on the pricing date (expected for the week of June 14, 2021). The final price of the offered ADSs will be determined largely on the basis of the closing price of Molecular Partners’ shares on the Swiss Stock Exchange on the pricing date translated into U.S. dollars at the then prevailing exchange rate and using an ADS to share ratio of one to one. Application has been made to list the ADSs on the Nasdaq Global Market in the United States under the ticker symbol "MOLN" and the new ordinary shares underlying the ADSs on the SIX Swiss Exchange ("SIX"). The new shares will rank pari passu with Molecular Partners’ existing shares which are already listed on the SIX pursuant to the International Reporting Standard.

J.P. Morgan, SVB Leerink and Cowen are acting as joint book-running managers for the proposed offering. RBC Capital Markets is acting as the bookrunner for the proposed offering. Kempen & Co is acting as the lead manager for the proposed offering.

The securities referred to in this release are to be offered only by means of a prospectus. Copies of the preliminary prospectus relating to the offering may be obtained, when available, for free by visiting EDGAR on the SEC website at www.sec.gov. Alternatively, from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, telephone: 1-866-803-9204; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at 1-800-808-7525, ext. 6105, or by e-mailing [email protected]; Cowen and Company, LLC (c/o Broadridge Financial Services), 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department, by telephone at (833) 297-2926 or by email at [email protected].

A registration statement on Form F-1 relating to these securities has been filed with the U.S. Securities and Exchange Commission but has not yet become effective. The securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. In connection with the listing of the ordinary shares on the SIX, the registration statement on Form F-1, once declared effective, constitutes a foreign prospectus within the meaning of article 54 paras. 2 and 3 of the Swiss Financial Services Act of June 15, 2018 ("FinSA") and article 70 paras. 2-4 of the Swiss Financial Services Ordinance of November 6, 2019 ("FinSO").

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. There is no intention or permission to publicly offer, solicit, sell or advertise, directly or indirectly, any securities of Molecular Partners in or into Switzerland within the meaning of FinSA.