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RESMAIN Study Results to be Presented at the EORTC Cutaneous Lymphoma Tumour Group Annual Meeting 23 September 2023

On July 4, 2023 4SC AG (4SC, FSE Prime Standard: VSC) reported that the results from the RESMAIN Study evaluating resminostat (Kinselby) in maintenance treatment of patients with advanced cutaneous T-cell lymphoma (CTCL) will be presented by Professor Dr. Rudolf Stadler at the EORTC Cutaneous Lymphoma Tumour Group Annual Meeting 2023 on Saturday, 23rd September 2023 at 9:10h CEST at The Leiden University Medical Center in the Netherlands (Press release, 4SC, JUL 3, 2023, View Source [SID1234633032]).

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On 23 May 2023 4SC AG informed the market that resminostat (Kinselby) had met the primary endpoint in the RESMAIN study and demonstrated a statistically significant improvement in progression free survival in CTCL patients by ninety seven point six percent (97.6%) with a risk reduction of thirty eight percent (38%) compared to placebo. The study confirmed the already well known safety profile of resminostat (Kinselby) in CTCL.

RESMAIN is a pivotal study, conducted as a multi-center, double blind, randomized, placebo-controlled study, evaluating resminostat for maintenance treatment of patients with advanced-stage cutaneous T-cell lymphoma (CTCL) who have achieved disease control with prior systemic therapy, at 50 clinical centers in 11 European countries and 5 centers in Japan.

If approved by regulatory authorities, resminostat (Kinselby) would be the first histone deacetylase inhibitor approved in Europe for CTCL and the first and only drug approved for maintenance therapy in this disease, making it the Company’s most valuable asset. The positive outcome to RESMAIN creates an opportunity to either sell, license or partner 4SC’s resminostat program for commercialization worldwide (excluding Japan), where Yakult Honsha Co. Ltd, was granted an exclusive license for the development and marketing of resminostat in Japan in 2011.

Dr. Susanne Danhauser-Riedl, Chief Medical Officer of 4SC: "The RESMAIN study is the first randomised controlled trial that has proven the benefit of maintenance treatment in advanced CTCL, and we are very pleased to have successfully demonstrated the positive impact of using resminostat for patients enrolled in this study. We thank the investigators and their staff and in particular the patients that participated in the RESMAIN trial and made this success happen".

IGM Announces Closing of Upsized Public Offering and Concurrent Private Placement and Full Exercise of the Underwriters’ Option to Purchase Additional Shares

On July 3, 2023 IGM Biosciences, Inc. (NASDAQ: IGMS) reported the closing of its previously announced upsized underwritten public offering of 1,597,827 shares of its voting common stock and 9,000,000 shares of its non-voting common stock and including the full exercise of the underwriters’ option to purchase 1,589,673 shares of its voting common stock, at a public offering price of $8.00 per share (Press release, IGM Biosciences, JUL 3, 2023, View Source [SID1234633031]). All of the shares in the public offering were sold by IGM and delivered to purchasers on June 26, 2023, other than with respect to 5,625,000 shares of non-voting common stock, delivery of which occurred on July 3, 2023.

Concurrent with the public offering, IGM closed the sale of 2,812,500 shares of its non-voting common stock in a private placement exempt from the registration requirements of the Securities Act of 1933, as amended (the Securities Act), to certain institutional and other accredited investors affiliated with or managed by Redmile Group, LLC at a sale price equal to $8.00 per share.

The public offering and the concurrent private placement resulted in gross proceeds for IGM of $120.0 million, before deducting the underwriting discounts and commissions and estimated offering expenses payable by IGM.

BofA Securities, Jefferies, Stifel, and Guggenheim Securities acted as joint book-running managers for the public offering.

The securities in the public offering were offered by IGM pursuant to a Registration Statement on Form S-3, filed with the Securities and Exchange Commission (SEC) on November 3, 2022 and declared effective on November 14, 2022. A final prospectus supplement and accompanying prospectus relating to the public offering was filed with the SEC and may be accessed for free through the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to this public offering may also be obtained from: BofA Securities, Attention: Prospectus Department, NC1-0220-02-24, 200 North Tryon Street, Charlotte, North Carolina 28255-0001, or via email: [email protected]; Jefferies LLC, Attention: Equity Syndicate Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; Stifel, Nicolaus & Company, Incorporated, One Montgomery Street, Suite 3700, San Francisco, CA 94104, Attn: Syndicate, or by phone at (415) 364-2720, or by email at [email protected]; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017, by telephone at (212) 518-9544, or by email at [email protected].

The shares of non-voting common stock sold in the concurrent private placement have not been registered under the Securities Act or under any state securities laws and, unless so registered may not be offered or sold in the United States except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and applicable state securities laws.

This press release does not constitute an offer to sell or a solicitation of an offer to buy, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful before registration or qualification under the securities laws of that state or jurisdiction.

Sarepta Therapeutics to Present at Cowen’s 2nd Annual RNA Therapeutics Summit

On July 3, 2023 Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, reported that senior management will participate in a fireside chat at Cowen’s 2nd Annual RNA Therapeutics Summit on Monday, July 10, 2023 at 11:00 a.m. E.T (Press release, Sarepta Therapeutics, JUL 3, 2023, https://investorrelations.sarepta.com/news-releases/news-release-details/sarepta-therapeutics-present-cowens-2nd-annual-rna-therapeutics [SID1234633028]). The fireside chat will be held virtually.

The presentation will be webcast live under the Events & Presentations section of the investor relations section of Sarepta’s website at View Source and will be archived there following the presentation for 90 days. Please connect to Sarepta’s website several minutes prior to the start of the broadcast to ensure adequate time for any software download that may be necessary.

Abeona Therapeutics Announces $25 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules

On July 3, 2023 Abeona Therapeutics Inc. (Nasdaq: ABEO) reported that it has raised $25 million at-the-market from select existing investors, primarily to fund initiation of the Company’s launch preparations in anticipation of the EB-101 Biologics License Application (BLA) submission and potential approval (Press release, Abeona Therapeutics, JUL 3, 2023, View Source [SID1234633027]).

The company has entered into definitive agreements with certain existing institutional investors for the issuance and sale of 3,284,407 shares of its common stock, and in lieu of common stock, pre-funded warrants to purchase 2,919,140 shares of its common stock at an offering price of $4.03 per share (or $4.0299 per pre-funded warrant, which represents the per share offering price for the common stock less the $0.0001 per share exercise price for each pre-funded warrant). The pre-funded warrants will be immediately exercisable at a nominal exercise price of $0.0001 per share and may be exercised at any time until the pre-funded warrants are exercised in full. The closing of the offering is expected to occur on or about July 6, 2023, subject to the satisfaction of customary closing conditions.

The offering was led by Nantahala Capital Management, LLC and included participation by Adage Capital Partners LP and two other existing institutional investors.

Cantor Fitzgerald & Co. is acting as the sole lead-placement agent for the offering. A.G.P./Alliance Global Partners is acting as the co-placement agent for the offering.

The gross proceeds to Abeona from this offering are expected to be approximately $25 million, before deducting the placement agent’s fees and other offering expenses. Abeona intends to use the net proceeds from the offering primarily to fund preparations for commercialization of its product candidate EB-101, as well as for working capital and general corporate purposes. Based on EB-101’s Rare Pediatric Disease designation, Abeona expects to qualify to receive a priority review voucher (PRV) upon BLA approval and subject to final determination by the FDA. The PRV can be used to receive an expedited review process of a subsequent marketing application for a different product or sold to another company to create additional capital to fund the EB-101 launch.

The securities described above are being offered pursuant to a shelf registration statement on Form S-3 (File No. 333-256850) that was filed with the Securities and Exchange Commission (the "SEC") on June 7, 2021 and amended on August 27, 2021 and October 19, 2021, and was declared effective by the SEC on October 22, 2021. The offering is being made only by means of the written prospectus and prospectus supplement that form a part of the registration statement. The prospectus supplement and the accompanying prospectus that form a part of the registration statement have been filed with the SEC and are available on the SEC’s website at www.sec.gov. Copies of the prospectus supplement and the accompanying prospectus may also be obtained by contacting Cantor Fitzgerald & Co., Attention: Equity Capital Markets, 499 Park Avenue, 4th Floor, New York, NY 10022, or by e-mail at [email protected].

Datopotamab deruxtecan met dual primary endpoint of progression-free survival in patients with advanced non-small cell lung cancer in TROPION-Lung01 Phase III trial

On July 3, 2023 Astrazeneca reported positive high-level results from the TROPION-Lung01 Phase III trial showed datopotamab deruxtecan (Dato-DXd) demonstrated a statistically significant improvement for the dual primary endpoint of progression-free survival (PFS) compared to docetaxel, the current standard of care chemotherapy, in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) treated with at least one prior therapy (Press release, AstraZeneca, JUL 3, 2023, View Source [SID1234633020]).

For the dual primary endpoint of overall survival (OS), the data were not mature and an early trend was observed in favour of datopotamab deruxtecan versus docetaxel that did not meet the prespecified threshold for statistical significance at this interim analysis. The trial will continue as planned to assess OS with greater maturity. The investigators and participants will remain blinded to the results.

The safety profile of datopotamab deruxtecan was consistent with previous clinical trials with no new safety signals identified. All grade interstitial lung disease was generally consistent with prior clinical trials, with the majority being low grade. Some Grade 5 events were observed.

Datopotamab deruxtecan is a specifically engineered TROP2-directed DXd antibody drug conjugate (ADC) being jointly developed by AstraZeneca and Daiichi Sankyo.

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: "With TROPION-Lung01, we met the dual primary endpoint of progression-free survival, challenging the entrenched standard of care in a previously treated and unselected patient population that has long deserved an alternative to chemotherapy. These first Phase III trial results from the datopotamab deruxtecan clinical programme provide compelling evidence for the potential role this TROP2-directed antibody drug conjugate can play in treating patients with lung cancer."

Ken Takeshita, MD, Global Head, Oncology R&D, Daiichi Sankyo, said: "We are encouraged by the statistically significant results of the dual primary endpoint of progression-free survival seen with datopotamab deruxtecan and look forward to the final overall survival analysis. We plan to share these data with regulatory authorities to discuss next steps."

More than one million people worldwide are diagnosed with advanced NSCLC each year.1,2 While immunotherapy and targeted therapies have improved outcomes in the 1st-line metastatic setting, most patients eventually experience disease progression and receive chemotherapy.3-5 For decades, chemotherapy has been the last treatment available for patients with advanced NSCLC in the absence of other treatment options and despite limited effectiveness and known side effects.3-5 TROP2 is a protein highly expressed in a large majority of lung cancers. There are currently no TROP2-directed ADCs approved for the treatment of patients with lung cancer.6-8

TROPION-Lung01 enrolled patients with and without actionable genomic alterations, such as EGFR and ALK. Patients with actionable genomic alterations were previously treated with platinum-based chemotherapy and an approved targeted therapy. Patients without actionable genomic alterations were previously treated, concurrently or sequentially, with platinum-based chemotherapy and a PD-1 or PD-L1 inhibitor.

The data will be presented at a forthcoming medical meeting and shared with health authorities.

Notes

Non-small cell lung cancer
More than one million people worldwide are diagnosed with advanced NSCLC each year.1,2 While immunotherapy and targeted therapies have improved outcomes in the 1st-line metastatic setting, most patients eventually experience disease progression and receive chemotherapy.3-5 For decades, chemotherapy has been the last treatment available for patients with advanced NSCLC in the absence of other treatment options and despite limited effectiveness and known side effects.3-5

TROP2 is a protein highly expressed in a large majority of lung cancers.6 There are currently no TROP2-directed ADCs approved for the treatment of patients with lung cancer.7,8

TROPION-Lung01
TROPION-Lung01 is a global, randomised, multicentre, open-label Phase III trial evaluating the efficacy and safety of datopotamab deruxtecan (6.0 mg/kg) versus docetaxel (75 mg/m2) in patients with locally advanced or metastatic NSCLC, with or without actionable genomic alterations, treated with at least one prior therapy. Patients without actionable genomic alterations were previously treated, concurrently or sequentially, with platinum-based chemotherapy and a prior PD-1 or PD-L1 inhibitor. Patients with actionable genomic alterations were previously treated with platinum-based chemotherapy and targeted therapy as approved for their detected genomic alteration.

The dual primary endpoints of TROPION-Lung01 are PFS as assessed by blinded independent central review (BICR) and OS. Key secondary endpoints include investigator-assessed PFS, objective response rate, duration of response, time to response and disease control rate as assessed by both BICR and an investigator, and safety.

TROPION-Lung01 enrolled approximately 600 patients at sites in Asia, Europe, North America and South America. For more information visit ClinicalTrials.gov.

Datopotamab deruxtecan (Dato-DXd)
Datopotamab deruxtecan (Dato-DXd) is an investigational TROP2-directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, datopotamab deruxtecan is one of five lead ADCs in the oncology pipeline of Daiichi Sankyo, and one of the most advanced programmes in AstraZeneca’s ADC scientific platform. Datopotamab deruxtecan is comprised of a humanized anti-TROP2 IgG1 monoclonal antibody, developed in collaboration with Sapporo Medical University, attached to a number of topoisomerase I inhibitor payloads, an exatecan derivative, via tetrapeptide-based cleavable linkers.

A comprehensive development programme is underway globally with more than 12 trials evaluating the efficacy and safety of datopotamab deruxtecan across multiple TROP2-targetable tumours, including NSCLC, triple-negative breast cancer and hormone receptor-positive, HER2-low or negative breast cancer. Beyond the TROPION programme, datopotamab deruxtecan is also being evaluated in novel combinations in several ongoing trials.

In NSCLC, the TROPION-Lung07, TROPION-Lung08 and AVANZAR Phase III trials are evaluating datopotamab deruxtecan and immune checkpoint inhibitor combinations as potential 1st-line treatment options for patients with advanced or metastatic disease, a strategy informed by the results of two early trials. AstraZeneca is also researching a potential diagnostic test to help identify patients most likely to benefit from treatment with datopotamab deruxtecan.