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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

MEDSIR & Debiopharm Announce the First Patient Dosed in the WIN-B Trial Exploring the Combination of Debio 0123 & Gilead’s Trodelvy® in Advanced Breast Cancer

On February 25, 2025 Debiopharm (www.debiopharm.com), a privately-owned, Swiss-based biopharmaceutical company aiming to establish tomorrow’s standards of care to cure cancer and infectious diseases, and MEDSIR (www.medsir.org), a Spanish and US-based, international and innovative research organization in clinical oncology, reported that the first patient has been dosed in the WIN-B clinical trial evaluating the safety and efficacy of Debio 0123 plus Trodelvy in people with hormone receptor positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) and triple-negative advanced or metastatic breast cancers (Press release, Debiopharm, FEB 25, 2025, View Source [SID1234650565]). The WIN-B trial is sponsored by MEDSIR and fully funded by Debiopharm. Gilead Sciences, Inc. (Gilead) is providing supply of Trodelvy.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

In late May 2024, Debiopharm and MEDSIR announced a collaboration to evaluate the clinical combination of Debio 0123, an oral, brain-penetrant, highly selective WEE1 kinase inhibitor and Trodelvy, a Trop-2-directed ADC currently approved in more than 50 countries for second-line or later metastatic TNBC patients and in more than 40 countries for certain patients with pre-treated HR+/HER2- metastatic breast cancer. Prior to this clinical collaboration, promising preclinical data results were disclosed at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in 2024 under the title, "Anti-tumor activity of Debio 0123 in combination with sacituzumab govitecan in preclinical models of breast cancer" [1].

"Exploring novel combinations can lead to breakthroughs for cancer patients. We are delighted that this research exploring the combination of our WEE1 inhibitor with Trodelvy is moving forward with the first patient dosed. We are looking forward to seeing the potential benefits of this combination therapy for patients with a critical unmet medical need such as advanced-stage breast cancer," said Esteban Rodrigo Imedio, Executive Medical Director, Oncology, Debiopharm.

HR+/HER2- is the most common type of breast cancer, accounting for 70% of all cases. It groups estrogen-receptor (ER) and/or progesterone-receptor (PR) expressing cells. Almost one in three cases of early-stage breast cancer eventually become metastatic, and among patients with HR+/HER2- metastatic disease, the five-year relative survival rate is only 30%. Over time, patients with HR+/HER2- metastatic breast cancer can become resistant to endocrine-based therapy, and can ultimately develop resistance to even more recently approved therapies, such as Trodelvy. For patients treated with single-agent chemotherapy, prognosis remains poor [2], underscoring the urgent need for innovative treatment options like those being evaluated in WIN-B. [3-4].

Triple-negative breast cancer (TNBC) is an aggressive type of breast cancer that accounts for 10-15% of all breast cancers. It is called "triple negative" as it does not express ER, PR or HER2 receptors. Because of its aggressive nature, TNBC has a high risk of metastasis either at diagnosis or at time of relapse after initial curative therapy, which explains the poor prognosis many TNBC patients face. Compared to other types of breast cancer, relapse rates as well as the mortality rate five years after diagnosis is significantly higher [5-6].

"This collaboration with Debiopharm and Gilead represents an exciting step forward in developing new treatment options for hard-to-treat breast cancers. Together, we’re committed to moving patient care forward through fostering important partnerships in oncology. I believe our work with Debio 0123 and Trodelvy holds great promise for patients with hard-to-treat cancers," said Dr. Javier Cortés, MEDSIR Senior Scientific Lead.

The combination of Debio 0123 and sacituzumab govitecan-hziy is investigational and not approved by any health authority globally. The safety and efficacy of this combination has not been established.

Trodelvy and Gilead are trademarks of Gilead Sciences, Inc., or its related companies.

About Debio 0123

Debio 0123 is a brain-penetrant, highly selective WEE1 kinase inhibitor. WEE1 is a key regulator of the G2/M and S phase checkpoints, activated in response to DNA damage, allowing cells to repair their DNA before resuming their cell cycle. WEE1 inhibition, particularly in combination with DNA damaging agents, induces an overload of DNA breaks. In conjunction with abrogation of other checkpoints such as G1, the compound pushes the cells through cell cycle without DNA repair, promoting mitotic catastrophe and inducing apoptosis of cancer cells. Currently investigated in clinical trials for solid tumors in monotherapy and combination, Debio 0123 is being developed to respond to high unmet needs of patients living with the burden of difficult-to-treat cancers.

Immunome to Present at Upcoming March Conferences

On February 25, 2025 Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies, reported that it will participate in the following investor conferences in March 2025 (Press release, Immunome, FEB 25, 2025, View Source [SID1234650564]):

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

TD Cowen 45th Annual Health Care Conference
Conference Dates: March 3-5, 2025
Presentation Date/Time: March 4, 2025, 1:10 p.m. ET

Leerink Partners Global Healthcare Conference 2025
Conference Dates: March 10-12, 2025
Presentation Date/Time: March 10, 2025, 1:40 p.m. ET

Live webcast links for both presentations will be available on the events tab of Immunome’s investor website. Replay links of the presentations will also be available on the website for 30 days following the live broadcast.