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.

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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.

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.

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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.

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]).

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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].

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]).

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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.

On July 2, 2023 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, autoimmune, metabolic, ophthalmology and other major diseases, and IASO Biotechnology ("IASO Bio"), a clinical-stage biopharmaceutical company engaged in discovering, developing, and manufacturing innovative cell therapies and antibody products, reported that China’s National Medical Products Administration (NMPA) has approved the New Drug Application (NDA) for FUCASO (Equecabtagene Autoleucel, co-developed and co-commercialized by Innovent and IASO Bio, Innovent R&D code: IBI326, IASO Bio R&D code: CT103A), the first fully-human BCMA-directed chimeric antigen receptor (CAR) T cell therapy for adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent (Press release, Innovent Biologics, JUL 2, 2023, View Source [SID1234633034]).

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FUCASO (Equecabtagene Autoleucel) is a BCMA-directed CAR T cell therapy, using lentivirus as a gene vector to transfect autologous T cells. The CAR contains a fully-human scFv, CD8a hinge and transmembrane, and 4-1BB-mediated co-stimulation and CD3ζ activation domains. Based on rigorous selection and screening of the molecular structures, and comprehensive in vivo and in vitro evaluation, FUCASO has demonstrated rapid and potent efficacy as well as prolonged persistency in RRMM patients, providing higher and deeper responses and long-term clinical benefit.

The NDA approval was based on the results from the FUMANBA-1 clinical study (CTR20192510, NCT05066646), a multi-center Phase I/II registrational clinical trial conducted in China to evaluate the efficacy of Equecabtagene Autoleucel in patients with RRMM. In June 2023, updated data from this ongoing study was presented as a poster presentation (Abstract Number: 8025) at the 2023 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), in which Equecabtagene Autoleucel demonstrated remarkable efficacy and favorable safety profiles.

A total of 103 subjects received a dose of 1.0×106 CAR-T cells/kg, with a median follow-up time of 13.8 (0.4, 27.2) months.

Among the 101 evaluable patients, the overall response rate (ORR) was 96%, and the stringent complete response/ complete response (sCR/CR) rate was 74.3%. Median time to response (mTTR) was only 16 days, and the 12-month PFS rate was 78.8%. 95% of the patients achieved minimal residual disease (MRD) negativity, and all sCR/CR patients achieved MRD negativity. Of the 12 patients with prior CAR-T therapy, 9 achieved CR, and 5 achieved sCR (including 4 patients that sustained sCR for over 18 months post-infusion). In 89 patients without prior CAR-T therapy, 78.7% reached sCR/CR.
Of the 103 patients, only one experienced grade ≥3 cytokine release syndrome (CRS), and 2 experienced grade 1-2 immune effector cell-associated neurotoxicity syndrome (ICANS). All patients with CRS or ICANS recovered after the treatment.
Equecabtagene Autoleucel was still detectable in 50% and 40% respectively of the patients who completed 12-month and 24-month follow-ups after infusion. Only 19.4% of the patients were anti-drug antibody (ADA)-positive after Equecabtagene Autoleucel infusion.
The Principal Investigators of FUMANBA-1 study, Prof. Lugui Qiu, MD, Chinese Academy of Medical Science Hematology Hospital, and Prof. Chunrui Li, MD, PhD, Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology: "There’s a significant unmet clinical need for the treatment of multiple myeloma (MM) in China. As a fully-human BCMA CAR-T therapy, FUCASO has demonstrated remarkable efficacy, with evidence of deep and durable response for high-quality survival for MM patients. We believe that FUCASO’s approval will offers clinicians a novel breakthrough option benefiting patients with later-line RRMM."

Dr. Hui Zhou, Senior Vice President of Innovent Biologics, stated, "Multiple myeloma is a common hematology malignant disease with high incidence rate, and relapse and refractory are almost inevitable after current treatments. There’s an urgent unmet need of a treatment with well-tolerated and long persistence for RRMM patients in China. FUCASO, as an innovative fully-human BCMA-directed T cell therapy, has demonstrated robust and long-lasting efficacy and outstanding safety in long-term follow-up data from the registrational clinical study, which underscores its potential to be a pioneering treatment option for patients with RRMM. We are very pleased with the approval of FUCASO and hope it could benefit RRMM patients as the first approved BCMA CAR-T therapy in China."

Ms. Jinhua Zhang, Chairman and Chief Executive Officer of IASO Bio, stated, "We are excited that FUCASO was approved as a new drug, which is a significant milestone for our team. FUCASO is not only IASO Bio’s first commercialized product but is also the world’s first commercially available fully-human CAR-T therapy. Furthermore, FUCASO is the first self-developed and independently manufactured CAR-T cell therapy in China as well as China’s first approved BCMA CAR-T product and first approved cell therapy for the treatment of MM in China. The NMPA’s NDA approval of FUCASO will help us in achieving our strategic goal of bringing groundbreaking treatment options, as well as new hope for a potential cure, to MM patients in need."

About Multiple Myeloma (MM)
Multiple Myeloma (MM) is a blood cancer that often infiltrates the bone marrow causing anemia, kidney failure, immune problems, and bone fractures. For MM patients, common first-line drug treatments include proteasome inhibitors, immunomodulatory drugs, and alkylating agents. While treatment may result in remission, most patients will inevitably enter the relapsed or refractory stage as there’s currently no cure. As a result, there is a significant unmet need for patients with relapsed or refractory multiple myeloma. According to Frost & Sullivan, new MM cases in China rose from 20,100 in 2018 to 22,400 in 2022 and are expected to increase to 25,700 by 2027.

About FUCASO (Equecabtagene Autoleucel)
FUCASO (Equecabtagene Autoleucel) is an innovative fully-human anti- BCMA CAR-T cell therapy which uses lentivirus as a gene vector to transfect autologous T cells. The CAR contains a fully-human scFv, CD8a hinge and transmembrane, and 4-1BB-mediated co-stimulation and CD3ζ activation domains. Based on rigorous selection and screening of the molecular structures, and comprehensive in vivo and in vitro evaluation, FUCASO has demonstrated rapid and potent efficacy as well as prolonged persistency in RRMM patients. FUCASO (Equecabtagene Autoleucel) is approved by China’s NMPA for the treatment of RRMM. Innovent and IASO Bio are responsible for joint development and commercialization of FUCASO (Equecabtagene Autoleucel) for the treatment of RRMM in mainland China.

Furthermore, Equecabtagene Autoleucel received Orphan Drug Designation (ODD) designation from the U.S. Food and Drug Administration (FDA) for the treatment of RRMM and obtained the U.S. FDA IND approval. Equecabtagene Autoleucel also received Regenerative Medicine Advanced Therapy (RMAT) and Fast Track (FT) Designations in February 2023 from the FDA. In addition to multiple myeloma, the NMPA has accepted another IND application for the new extended indication of Neuromyelitis Optica Spectrum Disorder (NMOSD).