OnCARlytics patent allowance in China

On February 26, 2025 Imugene Limited (ASX: IMU), a clinical-stage immuno-oncology company, reported receipt of a Notice of Allowance from the Chinese Patent Office, for City of Hope’s patent application number 201880064280.9 which protects the CD19-expressing oncolytic virus, onCARlytics (Press release, Imugene, FEB 26, 2025, View Source [SID1234650549]).

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The patent, titled "ONCOLYTIC VIRUS EXPRESSING A CAR T CELL TARGET AND USES THEREOF" protects the method of composition and method of use of onCARlytics through to 2038.

Exclusively licensed to Imugene, OnCARlytics is a CD19-expressing oncolytic virus that enters solid tumour cells and forces them to express the CD19 protein on the cell surface, presenting a target for CD19 targeting therapies.

Imugene’s OASIS dose escalation trial of onCARlytics is being conducted at up to ten sites in the United States, with up to approximately 40 patients proposed to take part in the trial.

Imugene MD & CEO Leslie Chong said: "Intellectual property has remained a priority for our innovative range of immuno-oncology assets, and to have onCARlytics protected in a major market like China is an integral part of this strategy."

Neogap Therapeutics awarded ScaleReady™ G-Rex Grant to advance personalised cancer immunotherapy

On February 26, 2025 Neogap Therapeutics AB, a Swedish clinical-stage biotechnology company, reported that it has been awarded a USD 125,000 ScaleReady G-Rex Grant to optimise the development and manufacturing of its innovative personalised cancer immunotherapy, pTTL (Press release, Neogap Therapeutics, FEB 26, 2025, View Source;g-rex-grant-to-advance-personalised-cancer-immunotherapy,c4110383 [SID1234650547]). The funding supports Neogap’s efforts to further advance the manufacturing of their cell therapy product by developing a bioreactor process able to support large-scale manufacturing.

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The G-Rex Grant is part of ScaleReady’s USD 20 million programme aimed at advancing Cell and Gene Therapy (CGT) development and manufacturing. With this funding, Neogap Therapeutics will optimise manufacturing for pTTL (personalised Tumour Trained Lymphocytes), an ATMP (Advanced Therapy Medicinal Product) that combines EpiTCer technology with the PIOR AI platform.

Designed to target neoantigens with precision, pTTL uses the patient’s immune cells to generate tumour-specific T cells. It is currently being evaluated in a Phase I/IIa clinical trial in patients with advanced colorectal cancer.

"We are very excited to have been selected for this significant grant from ScaleReady and look forward to incorporating the G-Rex platform into our pTTL manufacturing process," says Kristine Bylund, Head of Cell Therapy Production and Development at Neogap Therapeutics. "Our development team has already completed preliminary experiments, and this grant will allow us to continue the development of a robust and cost-effective bioreactor process required to meet our quality and safety standards for clinical production, bringing us closer to our goal of delivering personalised medicine to patients in need."

"We are fortunate to have the opportunity to help Neogap develop a cost-effective G-Rex centric manufacturing process to create personalised Tumour Trained Lymphocytes. Neogap’s novel approach has the potential to make a highly favorable impact on clinical outcomes for patients with advanced colorectal cancer and are grateful for the opportunity to participate," says John Wilson, CEO of Wilson Wolf and co-inventor of G-Rex. ​

About Neogap’s immunotherapy, pTTL
pTTL (personalised Tumour Trained Lymphocytes) is a cell-based immunotherapy that enhances the patient’s own T cells to fight cancer. The therapy combines advanced DNA analysis with T-cell expansion in a precision treatment for solid tumours. It is based on Neogap’s patented technologies, PIOR and EpiTCer. The goal is to provide patients with a tailored and innovative therapy that meets their specific needs.

From head and neck squamous cell carcinoma to liver cancer! Anyouping® has been approved for two major indications

On February 25, SinocellTech reported that its independently developed recombinant humanized anti- PD-1 IgG4 monoclonal antibody, fenolimab (Anyouping , SCT – I10A ), combined with the recombinant humanized anti -VEGF monoclonal antibody bevacizumab, received official approval from the China National Medical Products Administration ( NMPA ) for the first-line treatment of patients with unresectable or metastatic hepatocellular carcinoma ( HCC ) who have not received prior systemic therapy (Press release, Sinocelltech, FEB 25, 2025, View Source [SID1234656253]). Following its approval as a first-line treatment for recurrent/metastatic head and neck squamous cell carcinoma, SinocellTech secured its second indication in the PD-1 arena .

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Orion’s Annual reports 2024

On February 25, 2025 Orion reported annual report for the year 2024 (Presentation, Orion, FEB 25, 2025, View Source [SID1234654276]).

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BridgeBio Prices Offering of $500 Million Convertible Senior Notes due 2031 to Refinance Senior Secured Debt

On February 25, 2025 BridgeBio Pharma, Inc. (Nasdaq: BBIO) (the "Company," "we" or "BridgeBio") reported the pricing of $500 million aggregate principal amount of 1.75% convertible senior notes due 2031 (the "notes") in a private offering (the "offering") to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act") (Press release, BridgeBio, FEB 25, 2025, View Source [SID1234650624]). In connection with the offering, the Company granted the initial purchasers an option to purchase up to an additional $75 million aggregate principal amount of notes. The sale of the notes is expected to close on February 28, 2025, subject to customary closing conditions.

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The Company estimates that the net proceeds from the sale of the notes will be approximately $489.5 million (or approximately $563.0 million if the initial purchasers exercise their option to purchase additional notes in full), after deducting the initial purchasers’ discounts and estimated offering expenses payable by the Company. The Company intends to use a portion of the net proceeds from the offering to repay all outstanding borrowings under and terminate its Financing Agreement, dated as of January 17, 2024, with the lenders party thereto and Blue Owl Corporation, as administrative agent, as amended (the "Financing Agreement"), and pay any fees related thereto. The termination of the Financing Agreement, which accounted for approximately $51.5 million of cash paid for interest in 2024 and contains various restrictive covenants, will provide the Company with reduced pro forma interest expense and greater operational flexibility.

The Company intends to use approximately $48.3 million of the remaining net proceeds from the offering to repurchase 1,405,411 shares of its common stock from certain purchasers of the notes in privately negotiated transactions effected through one of the initial purchasers or an affiliate thereof and entered into concurrently with the pricing of the notes (such transactions, the "share repurchases"). The agreed to purchase price per share of the Company’s common stock in the share repurchases is equal to the last reported sale price of the Company’s common stock of $34.35 per share on the Nasdaq Global Select Market on February 25, 2025. The share repurchases could increase (or reduce the size of any decrease in) the market price of the Company’s common stock, and could have resulted in a higher effective conversion price for the notes. The Company expects to use the remaining net proceeds from the offering for general corporate purposes.

The notes will bear interest at a rate of 1.75% per year, payable semi-annually in arrears on March 1 and September 1 of each year, beginning September 1, 2025. The notes will mature on March 1, 2031, unless earlier converted, redeemed or repurchased. Prior to December 2, 2030, the notes will be convertible only upon satisfaction of certain conditions and during certain periods. Thereafter, the notes will be convertible at any time until the close of business on the second scheduled trading day immediately preceding the maturity date. The notes will be convertible at the option of the holders, subject to certain conditions and during certain periods, into cash, shares of the Company’s common stock or a combination of cash and shares of the Company’s common stock, with the form of consideration determined at the Company’s election.

The conversion rate will initially be 20.0773 shares of the Company’s common stock per $1,000 principal amount of notes (equivalent to an initial conversion price of approximately $49.81 per share of the Company’s common stock). The initial conversion price of the notes represents a premium of approximately 45.0% over the last reported sale price of the Company’s common stock of $34.35 per share on February 25, 2025.

The Company may not redeem the notes prior to March 6, 2028. On or after March 6, 2028 and on or before the 41st scheduled trading day immediately before the maturity date of the notes, the Company may redeem for cash all or any portion of the notes, at its option at any time, and from time to time, if (i) the last reported sale price per share of the Company’s common stock has been at least 130% of the conversion price then in effect for at least 20 trading days (whether or not consecutive), including the trading day immediately preceding the date on which the Company provides notice of redemption, during any 30 consecutive trading day period ending on, and including, the trading day immediately preceding the date on which the Company provides notice of redemption and (ii) certain other conditions are satisfied. The redemption price will be equal to 100% of the principal amount of the notes being redeemed, plus accrued and unpaid interest to, but excluding, the redemption date.

Holders of the notes will have the right to require the Company to repurchase all or a portion of their notes at 100% of their principal amount, plus any accrued and unpaid interest, upon the occurrence of certain events.

When issued, the notes will be the Company’s senior unsecured obligations and will rank senior in right of payment to any of the Company’s unsecured indebtedness that is expressly subordinated in right of payment to the notes; equal in right of payment to any of the Company’s unsecured indebtedness that is not so subordinated; effectively junior in right of payment to any of the Company’s secured indebtedness and obligations to the extent of the value of the assets securing such indebtedness; and structurally junior to all indebtedness and other liabilities (including trade payables) of the Company’s subsidiaries.

The notes and the shares of common stock issuable upon conversion of the notes, if any, are not being registered under the Securities Act, or the securities laws of any other jurisdiction. The notes and the shares of common stock issuable upon conversion of the notes, if any, may not be offered or sold in the United States except in transactions exempt from, or not subject to, the registration requirements of the Securities Act and any applicable state securities laws.

This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities described herein, 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 such jurisdiction.