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.

On June 9, 2021 KemPharm, Inc. (NASDAQ: KMPH), a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, reported its expected addition to the broad-market Russell 3000 Index and the Russell 2000 Index in accordance with the 2021 Russell indexes annual reconstitution (Press release, KemPharm, JUN 9, 2021, View Source [SID1234583773]). KemPharm’s anticipated inclusion in the Russell indexes will be effective after the U.S. market opens on Monday, June 28, 2021.

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"The expected addition of KemPharm to the Russell indexes is the latest milestone during what has been a truly transformational year for the Company. In just the last six months, we have received FDA approval for our lead drug candidate AZSTARYS, completed a series of financial transactions that allowed KemPharm to up-list our stock to The Nasdaq Capital Market, extinguished all of our debt, and procured a substantial amount of new capital," stated Travis Mickle, Ph.D., President and CEO of KemPharm. "The Russell indexes are widely used investment benchmarks for index funds and active portfolio strategies. Our inclusion is an important validation and should help our efforts to propel long-term shareholder value, expand awareness of KemPharm within the investment community, increase the liquidity of our stock, and broaden our shareholder base."

The annual reconstitution of the Russell indices is conducted by FTSE Russell, a leading global index provider, and captures the 4,000 largest U.S. equities as of May 7, objectively ranking them by total market capitalization and style attributes. Membership in the U.S. all-cap Russell 3000 Index remains in place for one year and means automatic inclusion in the appropriate growth and value style indexes. Inclusion in the Russell 3000 Index also means automatic inclusion in either the large-cap Russell 1000 Index or the small-cap Russell 2000 Index. Approximately $10.6 trillion in assets are benchmarked against Russell’s U.S. indices.

About FTSE Russell:

FTSE Russell is a global index leader that provides innovative benchmarking, analytics and data solutions for investors worldwide. FTSE Russell calculates thousands of indices that measure and benchmark markets and asset classes in more than 70 countries, covering 98% of the investable market globally. Approximately $17.9 trillion is currently benchmarked to FTSE Russell indexes that are used by institutional and retail investors globally. FTSE Russell is wholly owned by the London Stock Exchange Group. For more information, visit www.ftserussell.com.

About AZSTARYS:

AZSTARYS is an FDA-approved, once-daily product for the treatment of attention deficit hyperactivity disorder (ADHD) in patients age six years or older. AZSTARYS consists of SDX, KemPharm’s prodrug of d-methylphenidate (d-MPH), co-formulated with immediate release d-MPH.

The complete approved prescribing information for AZSTARYS may be downloaded in PDF format here: View Source

On June 9, 2021 Allarity Therapeutics A/S ("Allarity" or the "Company") reported the publication of an e-Poster titled ‘A novel drug response predictor (DRP) mRNA biomarker for the multi tyrosine kinase inhibitor dovitinib’ at the European Association for Cancer Research (EACR) 2021 Virtual Congress held from 9 – 12 June 2021 (Press release, Allarity Therapeutics, JUN 9, 2021, View Source [SID1234583772]). The e-Poster is also available on the Company’s website on: View Source

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The e-Poster describes Allarity’s latest research into the Company’s novel companion diagnostic for dovitinib, known as the Dovitinib-DRP (Drug Response Predictor), and details the identified 58 genes (out of 25,000 expressed genes) that are relevant to the sensitivity or resistance of cancer cell lines to the drug.

Among the identified genes predictive of response/resistance to dovitinib are those associated with FGFR, PDGF, VEGF, PI3K/Akt/mTOR and topoisomerase pathways. About half of the identified 58 genes have no previously published link to known biology of dovitinib action in tumor cells. Accordingly, the findings presented in the e-Poster confirm many of pathways known to be targeted by dovitinib, but also identifies novel mechanisms of drug resistance, such as ABC transporter F1. The results presented in the e-Poster provide a deeper understanding of why the Dovitinib-DRP is predictive of drug response/resistance to dovitinib and has the potential to serve as a companion diagnostic for the drug.

Dovitinib is Allarity’s most advanced clinical asset. The Company plans to file a New Drug Application ("NDA") with the U.S. Food and Drug Administration (FDA) for the approval of dovitinib for the treatment of renal cell carcinoma (RCC, kidney cancer) during 2021 in patients selected with the Dovitinib-DRP. The Company previously submitted, in April 2021, a premarket approval application (PMA) to the U.S. FDA for use of the Dovitinib-DRP as a companion diagnostic to select RCC patients most likely to respond to dovitinib. The Dovitinib-DRP, if approved by the U.S. FDA, will be the first clinically validated, complex gene expression signature used as a companion diagnostic to select patients most likely to respond to a given cancer therapeutic.

Dr. Steen Knudsen, Ph.D., CSO of Allarity Therapeutics commented, "We often find that half of the genes in a DRP constitute known biology while the other half can be considered new, unknown biology reflecting the interaction between a drug and the target cell. That is part of the strength of the DRP platform and we are pleased to share these new findings with the scientific community attending the EACR conference, as we continue to advance our DRP for dovitinib as a companion diagnostic for the drug."