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XSpray Pharma achieves significant milestone – demonstrating bioequivalence with absorption advantages compared to Tasigna

On July 11, 2025 Xspray Pharma reported the company has now completed the population pharmacokinetic (PopPK) modeling that constitutes key regulatory documentation ahead of submitting a New Drug Application (NDA) for the product candidate XS003 (Press release, Xspray, JUL 11, 2025, View Source [SID1234655400]). The analysis confirms bioequivalence with the reference drug Tasigna, at less than half the dose – a strong indication marking a potential paradigm shift in the treatment of CML with nilotinib.

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The analysis is based on modeling and simulation of data from a comparative study in healthy volunteers. The developed PopPK model, which simulates repeated dosing until steady state is reached, shows a strong correlation with observed concentrations – supporting its regulatory relevance.

The results confirm formal bioequivalence between XS003 and Tasigna in terms of systemic exposure (AUC and Cmax) – despite the XS003 dose being less than half that of the reference drug. In addition, a clinical study has shown that XS003 has significantly improved food interaction and a more predictable dose response, which can facilitate precise dose adjustments in clinical practice. Previously communicated data showed that bioavailability increased by only 28% with food intake – compared to up to 82% for Tasigna. This absorption stability with food intake may reduce the risk of concentration-dependent side effects, such as abnormal heart rhythm (QTc prolongation), particularly in real-world settings where strict fasting can be difficult to maintain

"The data announced today form the pivotal foundation for our regulatory submission with XS003, this confirms our HyNap platform which can create bioequivalent improved formulations with significantly lower dosing and stable absorption even with food intake. This represents a crucial step forward in our strategy to expand the commercialization of our products," says Per Andersson, CEO of Xspray Pharma.

With these results, Xspray Pharma plans to submit a NDA application in the near future. XS003 will be the company’s second product candidate submitted for FDA approval following Dasynoc, both based on the HyNap technology: An innovative amorphous formulation technique that has shown potential to improve absorption for a range of products including protein kinase inhibitors.

For further information, please contact:

Jacob Nyberg, IR
Xspray Pharma AB (publ)
Tel: + 46 (0) 70 767 08 83
E-mail: [email protected]

Milestone Pharmaceuticals Announces Proposed Public Offering

On July 11, 2025 Milestone Pharmaceuticals Inc. ("Milestone") (Nasdaq: MIST) reported that it has commenced an underwritten public offering (the "Offering") of its common shares, accompanying Series A warrants to purchase common shares (the "Series A Warrants") and accompanying Series B warrants to purchase common shares (the "Series B Warrants"), and, in lieu of common shares to certain investors that so choose, pre-funded warrants to purchase common shares, accompanying Series A Warrants and accompanying Series B warrants (Press release, Milestone Pharmaceuticals, JUL 11, 2025, View Source [SID1234654369]). All securities to be sold in the Offering will be sold by Milestone. The Offering is subject to market and other conditions and there can be no assurance as to whether or when the Offering may be completed, or as to the actual size or terms of the Offering.

Milestone intends to use the net proceeds from the Offering, together with existing cash and cash equivalents, to fund the clinical development and commercial launch of etripamil in its lead indication of paroxysmal supraventricular tachycardia (PSVT), as well as for working capital and other general corporate purposes.

TD Cowen, Piper Sandler & Co. and Wells Fargo Securities are acting as joint book-running managers for the Offering. H.C. Wainwright & Co. is acting as lead manager for the Offering.

The securities described above are being offered by Milestone pursuant to a shelf registration statement on Form S-3 (File No. 333-283162), including a base prospectus, that was declared effective by the U.S. Securities and Exchange Commission (the "SEC") on November 22, 2024. The Offering is being made only by means of a prospectus supplement and accompanying prospectus that form a part of the registration statement. A preliminary prospectus supplement related to the Offering will be filed with the SEC and will be available on the SEC’s website located at www.sec.gov. A copy of the preliminary prospectus supplement and the accompanying prospectus relating to the Offering may also be obtained, when available, from: TD Securities (USA) LLC, 1 Vanderbilt Avenue, New York, NY 10017, by telephone at 855-495-9846, or by email at [email protected]; Piper Sandler, Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, or by telephone at (800) 747-3924, or by email at [email protected]; and Wells Fargo Securities, LLC, 90 South 7th Street, 5th Floor, Minneapolis, MN 55402, or by telephone at 800-645-3751 (option #5), or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of 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 any such state or jurisdiction.

Elegen and Nutcracker Therapeutics to Pilot First Fully Cell-Free Manufacturing Process for RNA-based Personalized Cancer Therapeutics

On July 11, 2025 Elegen, a global leader in next-generation DNA manufacturing, and Nutcracker Therapeutics, a global leader in next-generation RNA design and manufacturing, reported the launch of a pilot program to demonstrate the industry’s first fully synthetic, cell-free manufacturing platform for RNA-based personalized cancer therapeutics (PCTs). The pilot marks another step toward making PCTs more accessible, timely, and scalable (Press release, Nutcracker Therapeutics, JUL 11, 2025, View Source [SID1234654354]).

As late-stage PCT clinical trials progress and therapy developers work to create the next generation of PCTs, the speed, reliability, scaling and cost of traditional production methods pose a major challenge. Specifically, the first step of DNA template production is hindered by the use of bacterial cells in the process, which can be unreliable and introduce contamination that must be removed. The second step of GMP-grade RNA production from the template is impeded by a slow, unreliable, and inefficient process in which only one therapy can be made per GMP suite. Consequently, PCT production is slow, very costly, and does not scale for individualized therapies — a new manufacturing paradigm is needed.

Nutcracker Therapeutic’s NMU-Symphony system, the second generation of its Nutcracker Manufacturing Unit (NMU), brings the fastest, most scalable, and cost-efficient GMP RNA manufacturing platform available today. Fully enclosed and built for speed, it reliably delivers clinical-grade PCTs consistent with just a three-week overall turnaround time, from RNA sequence design to released nanoparticle formulated drug product — cutting traditional timelines in half. By incorporating Elegen’s cell-free GMP-ready DNA template production, the combination of the two platforms will enable an even faster and more scalable synthesis of longer, more complex neo-antigen sequences, while eliminating risks of bioburden and endotoxin contamination.

With a faster, more reliable and lower-cost solution, Elegen and Nutcracker Therapeutics aim to democratize PCTs, making them accessible to more developers and saving critical time for cancer patients, where even days can make a meaningful impact.

"Integrating cell-free DNA with cell-free biochip-based RNA production gives researchers and partners worldwide access to a more reliable, streamlined, and cost-effective platform to rapidly test and advance new therapies," said Matthew Hill, founder and CEO of Elegen. "By eliminating cells from the process, we can accelerate the development and evaluation of new therapeutic modalities, helping patients receive treatment as quickly as possible."

"We’re not just improving our manufacturing process, we’re laying the foundation to democratize PCTs with truly scalable solutions," added Benjamin Eldridge, co-founder and chief technology officer of Nutcracker Therapeutics. "Achieving that vision means giving developers the ability to produce clinical-grade RNA without investing hundreds of millions in infrastructure. This is a key step toward our mission of delivering scalable, low-cost, and rapid formulated RNA manufacturing for individualized therapies."

Elegen’s cell-free ENFINIA DNA with an unparalleled combination of speed, length, accuracy and complexity integrates seamlessly with Nutcracker Therapeutics’ existing RNA-based PCT development process, which leverages artificial intelligence and machine learning technologies through its CodonCracker RNA design software, the NMU-Symphony microfluidics biochip-based system, and ProcessVision technology for real-time performance and quality monitoring. Combined, Elegen and Nutcracker Therapeutic’s technologies enable the efficient, flexible, and GMP-ready production of individualized nanoparticle-formulated RNA therapeutics.

CEL-SCI Announces Pricing of $5.7 Million Offering Priced At-the-Market Under NYSE American Rules

On July 11, 2025 CEL-SCI Corporation ("CEL-SCI" or the "Company") (NYSE American: CVM), a clinical stage cancer immunotherapy company, reported the pricing of a best-efforts offering of 1,500,000 shares of its common stock (Press release, Cel-Sci, JUL 11, 2025, View Source [SID1234654353]). Each share of common stock is being sold at an offering price of $3.82 per share, priced at-the-market under NYSE American rules. Total gross proceeds from the offering, before deducting the placement agent’s fees and other offering expenses, are expected to be approximately $5.7 million. The offering is expected to close on July 14, 2025, subject to satisfaction of customary closing conditions.

The Company intends to use the net proceeds from the offering to fund the continued development of Multikine, general corporate purposes, and working capital.

ThinkEquity is acting as the sole placement agent for the offering.

The securities will be offered and sold pursuant to a shelf registration statement on Form S-3 (File No. 333-265995), including a base prospectus, filed with the U.S. Securities and Exchange Commission (the "SEC") on July 1, 2022, and declared effective on July 15, 2022. The offering will be made only by means of a written prospectus. A final prospectus supplement and accompanying prospectus describing the terms of the offering will be filed with the SEC on its website at www.sec.gov. Copies of the prospectus supplement and the accompanying prospectus relating to the offering may also be obtained, when available, from the offices of ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004.

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 an offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Median Technologies Signs Financial Agreement for up to €37.5 Million New Financing Facility With the European Investment Bank (EIB)

On July 11, 2025 Median Technologies (FR0011049824, ALMDT, PEA-PME scheme eligible, "Median" or the "Company"), manufacturer of eyonis, a suite of artificial intelligence (AI) powered Software as a Medical Device (SaMD) for early cancer diagnosis, and a globally leading provider of AI-based image analyses and central imaging services for oncology drug developers, reported that the Company signed a financial agreement with the European Investment Bank (EIB) for a new financing facility of up to €37.5 million, on July 11, 2025 (Press release, MEDIAN Technologies, JUL 11, 2025, View Source [SID1234654352]).

The signature of the financial agreement is in line with previous announcements on January 24, 2025, and April 24, 2025 stating that Median and the EIB were working to conclude an agreement for a new financing facility.

"We welcome the conclusion of our discussions with the European Investment Bank and the signature of the financial agreement", said Fredrik Brag, CEO and Founder of Median Technologies. "We are very honored to belong to the European innovative ecosystem supported by the EIB, and to contribute to the European technological sovereignty. Proceeds from this new EIB financing facility will strengthen our financial independence to negotiate the best possible options for the commercialization of eyonis LCS in U.S. and in Europe."

Financing Facility Structure

The EIB 2025 financing facility could be drawn in three (3) tranches, i.e., €19 million (Tranche A), €8.5 million (Tranche B) and €10 million (Tranche C).

Median Technologies will request the drawdown of the €19 million Tranche A, as soon as all contractual conditions with respect to such tranche, are satisfied, specifically:

Full issuance of the EIB new Tranche A warrants to the EIB and registration, in accordance with the warrant issuance agreement,
Completion of a share capital increase for an amount at least equal to €16 million (issuance premium included),
Repayment of the first tranche of the previous EIB 2019 loan, for which the maturity has been extended from April to October 2025.
Furthermore, the Company has undertaken to have secured by June 30, 2026, incremental equity financing in a total amount of at least €10 million.

The characteristics of tranche A are:

Maturity of 72 months, and monthly amortization over a period of 36 months after a 36-month grace period,
Annual interest rate of 5%.
The release of the tranche A of €19 million will result in the issuance of warrants which quantity and exercise price will depend on the stock price on the date of issuance. At current trading stock price, and after fulfilment of all drawdown conditions, the total amount of shares resulting from the exercise of the warrants would represent 10% of the share capital.

As stated in the financial agreement, Tranche B and Tranche C disbursements remain at Median’s discretion, subject to certain conditions which are specified in the financial agreement.

Intended use of proceeds

The EIB funds will be to support eyonis Lung Cancer Screening (LCS) progress towards major milestones consisting of commercial launch and sales development in the U.S and in Europe, and to accelerate the expansion of Median’s proprietary suite of Software as a Medical Device, eyonis, for image-based early cancer diagnosis, notably the scientific and clinical development of eyonis IPN for incidental findings of pulmonary nodules, and eyonis HCC, for primary liver cancer early diagnosis.

eyonis LCS progress status and next steps

Regulatory filings for marketing in U.S. and Europe and marketing authorizations:

On May 14, 2025, Median Technologies announced the filing of an application to the U.S. Food and Drug Administration (FDA) for 510(k) clearance of eyonis LCS.
On July 1, 2025, the Company announced the filing of an application for Class IIb CE marking of eyonis LCS.
Given the usual timelines for regulatory review, the U.S. FDA 510(k) clearance for eyonis LCS is expected around the end of Q3 2025, expected to be followed by commercial launch in the US. Median Technologies expects European marketing authorization for eyonis LCS as soon as Q1 2026.
Commercial launch

Median Technologies is actively engaged in discussions with several leading players in AI- diagnostic and imaging equipment manufacturing, for the commercialization of eyonis LCS. Some of these strategic partnerships are expected to be finalized upon FDA marketing authorization of eyonis LCS.
The Company has finalized its US market access strategy, based on a comprehensive mapping of medical institutions involved in screening procedures, particularly in the United States, eyonis LCS’ first and leading market. This mapping has enabled the identification of health institutions generating the highest volume of lung cancer screening procedures, positioning them as key drivers for the commercial launch of eyonis LCS.
Discussions with U.S. payers will be initiated upon FDA marketing authorization. At this stage, preliminary studies have been conducted to estimate the projected economic benefits of using eyonis LCS in lung cancer screening programs. To date, the Company has developed a detailed mapping of payers in the United States. Furthermore, an initial analysis based on a health economics Markov model simulating lung cancer progression over five years and incorporating the performance of eyonis LCS, demonstrates that eyonis LCS enhances early detection and characterization, reduces unnecessary health procedures, and generates significant cost savings for U.S. payers. The results of this preliminary analysis were presented at ISPOR 2025, the leading global conference for health economics and market access, held this past May. Results from the study are available on Median’s website.
Over the past year, the Median eyonis team has built a very substantial network of early adopters composed of key opinion leaders. The team has conducted numerous visits to leading healthcare institutions and actively participated in major medical conferences organized by medical societies in pulmonology, oncology, and radiology, both in the U.S. and Europe, including the Radiological Society of North America (RSNA), the European Radiology Society (ESR), the American Thoracic Society (ATS), the European Society of Thoracic Imaging (ESTI), the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper), and the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper). The Company now enjoys strong recognition of its eyonis LCS technology within the medical community, along with a strong brand image associated with the product. Most of the leading healthcare institutions in contact with Median have expressed interest in participating in future health economics studies, which will be launched following regulatory market approvals.