Solid 2023 results and the start of a new development cycle

On February 16, 2024 Orano reported its yearly results 2023 (Press release, Orano, FEB 16, 2024, View Source;orano-2023-annual-results.pdf?sfvrsn=2f2a892a_6 [SID1234643763])

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Entry into a material definitive agreement

On February 16, 2024, AIM ImmunoTech Inc. (the "Company", "we", "us" or "our") reported to have entered into a Note Purchase Agreement (the "Note Purchase Agreement") with Streeterville Capital, LLC (the "Investor") and consummated the sale to such Investor of an unsecured Promissory Note (the "Note") with an original principal amount of $3,301,250 in a private placement (the "Private Placement") that closed on February 16, 2024 (Filing, 8-K, AIM ImmunoTech, FEB 16, 2024, View Source [SID1234640251]).

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The Note carries an original issuance discount of $781,250 and the Company agreed to pay $20,000 to the Investor to cover the Investor’s legal and administrative transaction costs, each of which were included in the original principal amount and deducted from the proceeds of the Note received by the Company which resulted in a purchase price received by the Company of $2,500,000.

The Note bears interest at ten percent (10%) per annum compounded daily. The maturity date of the Note is 24 months from the date of its issuance (the "Maturity Date").

We may prepay any or all of the outstanding balance under the Note prior to the Maturity Date, provided that if such prepayment covers less than the entire principal, fees and interest of the Note, the Company will remain subject to the remaining obligations under the Note.

The Note provides for customary events of default, including, among other things, the event of non-payment of principal, interest, fees or other amounts, a representation or warranty proving to have been incorrect when made, failure to perform or observe covenants within a specified period of time, a cross-default to certain other indebtedness of the Company, the bankruptcy or insolvency of the Company or of all or a substantial part of its property, monetary judgment defaults of a specified amount and other defaults resulting in liability of a specified amount. Upon the occurrence of an Event of Default, as defined in Section 4 of the Note, interest would accrue on the outstanding balance beginning on the date the applicable Event of Default occurred at an interest rate equal to the lesser of twenty-two percent (22%) or the maximum rate permitted under applicable law.

Beginning on the date that is six months after the Purchase Price Date, Investor shall have the right, exercisable at any time in its sole and absolute discretion, to redeem any amount of the Note up to $250,000 (such amount, the "Monthly Redemption Amount") per calendar month by providing written notice to the Company (each, a "Redemption Notice"); provided, however, that if the Investor does not exercise any Monthly Redemption Amount in its corresponding month then such Monthly Redemption Amount shall be available for the Investor to redeem in any future month in addition to such future month’s Redemption Amount. Upon receipt of any Monthly Redemption Notice, the Company shall pay the applicable Monthly Redemption Amount in cash to the Investor within three business days of the Company’s receipt of such Monthly Redemption Notice.

The foregoing is only a summary of the material terms of the Note Purchase Agreement and the Note, and does not purport to be a complete description of the rights and obligations of the parties thereunder. Furthermore, the foregoing is qualified in its entirety by reference to such documents, which are filed as Exhibit 10.1 and Exhibit 10.2, respectively, to this Current Report on Form 8-K and incorporated herein by reference.

Immunome Announces Closing of Public Offering and Full Exercise of Underwriters’ Option to Purchase Additional Shares

On February 16, 2024 Immunome, Inc. ("Immunome") (Nasdaq: IMNM), a biotechnology company dedicated to developing first-in-class and best-in-class targeted cancer therapies, reported the closing of its underwritten public offering of 10,000,000 shares of its common stock, including the exercise in full by the underwriters of their option to purchase an additional 1,500,000 shares, at a price to the public of $20.00 per share (Press release, Immunome, FEB 16, 2024, View Source [SID1234640193]). The gross proceeds to Immunome from the offering, before deducting underwriting discounts and commissions and offering expenses, are $230.0 million. All of the shares in the offering were sold by Immunome.

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J.P. Morgan, TD Cowen, Leerink Partners and Guggenheim Securities acted as joint book-running managers for the offering. Wedbush PacGrow acted as lead manager for the offering.

The offering was made pursuant to a shelf registration statement on Form S-3 that was filed with the U.S. Securities and Exchange Commission (the "SEC") on February 13, 2024 and automatically became effective upon filing. A preliminary prospectus supplement and accompanying prospectus relating to the offering were filed with the SEC and are available for free on the SEC’s website located at View Source A final prospectus supplement and accompanying prospectus relating to the offering were filed with the SEC and are available for free on the SEC’s website located at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained from: J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at [email protected]; Cowen and Company, LLC, 599 Lexington Avenue, New York, NY 10022, by email at [email protected] or by telephone at (833) 297-2926; Leerink Partners LLC, Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, or by telephone at (800) 808-7525 ext. 6105, or by email at [email protected]; or Guggenheim Securities, LLC Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017 or by telephone at (212) 518-9544, or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, 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.

CASI PHARMACEUTICALS ANNOUNCES FIRST DOSING OF FOLOTYN® IN CHINA

On February 16, 2024 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company specializing in the development and commercialization of innovative therapeutic and pharmaceutical products, reported the administration of the first dose of FOLOTYN (Pralatrexate Injection) to a patient in China (Press release, CASI Pharmaceuticals, FEB 16, 2024, View Source [SID1234640192]). This remarks a pivotal step in CASI’s commitment to addressing critical medical needs in peripheral T-cell lymphoma in China market.

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FOLOTYN (Pralatrexate) is a dihydrofolate reductase inhibitor indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma ("PTCL"). Compared with methotrexate, pralatrexate could be more effectively internalized into tumor cells which may translate to a greater anti-cancer effect. Clinical studies have demonstrated that pralatrexate has significant activity against PTCL1. With the results of an overall response rate ("ORR") of 52% and a median progression-free survival ("PFS") of 4.8 months from the Chinese registrational study2, in comparison to an ORR of 29% and a median PFS of 3.5 months from the PROPEL study3 in the US. Pralatrexate was approved in the United States, Japan and China as treatment for PTCL. Pralatrexate is a promising treatment option for Chinese patients with relapsed or refractory PTCL.

Dr. Wei-Wu He, CEO of CASI, expressed his enthusiasm for this milestone, "The dosing of the first patient with FOLOTYN in China marks a significant achievement for CASI. It reflects our unwavering commitment to bringing advanced therapeutic options to patients, particularly in therapeutic areas with substantial unmet medical needs. This is a proud moment for our team and a step forward in our mission to transform patient care through innovation."

New Study Demonstrates Predictive Value of Lunit SCOPE IO to Predict Outcomes of Immune Checkpoint Inhibitor Therapy Across Diverse Tumors – published in the JITC

On February 16, 2024 Lunit (KRX:328130.KQ), a leading provider of AI-powered solutions for cancer diagnostics and therapeutics, reported a groundbreaking study published in the Journal for ImmunoTherapy of Cancer (JITC) (Press release, Lunit, FEB 16, 2024, View Source;published-in-the-jitc-302064098.html [SID1234640191]). The study demonstrates the ability of Lunit SCOPE IO, to enable quantitative immune phenotyping from H&E stained slides as a broadly accessible biomarker for immunotherapy.

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The study, conducted on a real-world multicenter cohort of 1,806 Immune Checkpoint Inhibitor (ICI)-treated patients across 27 tumor types, showcases a correlation between the Inflamed Immune Phenotype and positive ICI treatment responses. There is an unmet need for improved immunotherapy biomarkers, and this study highlights the importance of Lunit SCOPE IO’s ability to quantify immune phenotype (IP) as Inflamed, Excluded, or Desert, purely from H&E whole slide images (WSIs).

Utilizing advanced machine learning (ML) models, Lunit SCOPE IO segments tissue into cancer area (CA) and cancer stroma (CS) within WSIs. The model also detects Tumor-Infiltrating Lymphocytes (TILs) using a cell detection model trained on over 17,000 WSIs spanning multiple solid tumor types.

Based on TIL density, the model classifies the tumor into one of three immune phenotypes: Inflamed (IIP; high TIL density within CA), Immune Excluded (IEP; TILs within CS but excluded from CA), and Immune Desert (IDP; low TIL density within both CA and CS).

In an independent real-world dataset of ICI-treated patients, Lunit SCOPE IO demonstrated predictive power for clinical outcomes, including objective response rates (ORR), progression-free survival (PFS), and overall survival (OS). In the study, IIP patients showed significantly favorable clinical outcomes post-ICI treatment. More favorable ORRs (26.3% vs 15.8%), prolonged PFS (5.3 vs. 3.1 months) and OS (25.3 vs. 13.6 months) were observed in IIP patients, irrespective of ICI regimen or programmed death-ligand 1 (PD-L1) expression. The dataset reflected global diversity, with data coming from Stanford University, Samsung Medical Center, Seoul National University Bundang Hospital, Chonnam National University Hospital, and Northwestern Memorial Hospital, and more.

This study paves the way for more precise patient selection with a time-efficient and labor-efficient analysis at scale in immunotherapy. Lunit plans to further validate and deploy Lunit SCOPE IO, ultimately enabling more personalized and effective immunotherapy strategies, especially under the current limitations of traditional biomarkers.

"This study marks a major step towards better biomarkers for immunotherapy driven by AI, analyzing the tumor microenvironment to determine immune phenotype quantitatively and predict patient responses to ICI therapy," said Brandon Suh CEO of Lunit. "Our commitment to advancing cancer care through innovation has never been clearer. By providing a robust tool for personalized treatment strategies, Lunit SCOPE IO promises improved outcomes and could redefine the standard of care for patients in several cancer types where predictive biomarkers are lacking."

Published in the JITC, the official journal of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), the study also contributes to SITC (Free SITC Whitepaper)’s mission of enhancing cancer patient outcomes by advancing the science and application of cancer immunotherapy. SITC (Free SITC Whitepaper) is the world’s leading member-driven organization that includes over 4,650 members from 35 medical specialties across 63 countries worldwide.