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]

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]).

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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.

On July 10, 2025 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported the closing of its previously announced upsized underwritten public offering of 25,555,556 shares of its common stock, which includes 3,333,333 shares issued pursuant to the exercise in full by the underwriters of their option to purchase additional shares of common stock in the offering (Press release, Cogent Biosciences, JUL 10, 2025, View Source [SID1234654328]). The public offering price was $9.00 per share. The aggregate gross proceeds to Cogent from this offering were approximately $230 million, including proceeds from the exercise in full by the underwriters of the option to purchase additional shares, before deducting underwriting discounts and commissions and other offering expenses. All of the shares in the offering were sold by Cogent.

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Cogent intends to use the net proceeds from the offering for continued development, regulatory and commercial preparation activities relating to bezuclastinib and other product candidates, activities to support the planned commercial launch of bezuclastinib as well as for working capital and general corporate purposes.

J.P. Morgan, Leerink Partners and Guggenheim Securities acted as joint book-running managers for the offering. LifeSci Capital also acted as lead manager for the offering.

The shares described above were offered pursuant to an automatic shelf registration statement on Form S-3ASR (File No. 333-269707), which was filed with the Securities and Exchange Commission (SEC) on February 10, 2023 and automatically became effective upon filing.

A final prospectus supplement and accompanying base prospectus relating to and describing the terms of the offering were filed with the SEC on July 9, 2025 and may be obtained from the SEC’s website at www.sec.gov, or by request to J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by email at [email protected] and [email protected]; Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at [email protected]; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Ave., New York, NY 10017, or by telephone at (212) 518-9544, or by email at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, 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 that state or jurisdiction.

On July 10, 2025 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, reported that its wholly-owned subsidiary, CNSide Diagnostics, LLC ("CNSide") will be showcasing two presentations at the upcoming SNO/ASCO CNS Metastases Conference on August 14-16, 2025, in Baltimore, MD (Press release, Plus Therapeutics, JUL 10, 2025, View Source [SID1234654330]).

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The CNSide data highlights its ability to quantify tumor cells and deliver actionable insights," said Michael Rosol, Ph.D., Plus Therapeutics’ Chief Development Officer. "The diagnostic assay is an exciting advancement for enhancing CNS metastases management and driving therapies like REYOBIQ in our ReSPECT-LM dose optimization trial."

Presentations:

Title CSF Tumor Cell (CSF-TC) Detection, Quantification and Biomarker Assessment Helps in Clinical Management of Breast Cancer and Non-Small Cell Lung Cancer Patients Having Leptomeningeal Disease (BIOM-04), (FORESEE Study, NCT05414123)

Presenter
Priya Kumthekar, M.D.

Date/Time Thursday, August 14, 2025, 7:15 – 9:00 p.m. ET

Location Grand Ballroom VI

Title The Oncogenic Flip in Patients with Leptomeningeal Metastatic Disease (LMD): Longitudinal Detection in Cerebrospinal Fluid Tumor Cells (CSF-TCs) Reveals Implications for Differential Treatment of the LMD Tumor, (BIOM-03)

Presenter
Priya Kumthekar, M.D.

Date/Time Friday, August 15, 2025, 3:25 – 4:50 p.m. ET

Location Grand Ballroom I-V

On July 10, 2025 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW, BCTXZ) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care reported updated results from its ongoing Phase 2 study of Bria-IMT in combination with check point inhibitor in patients with advanced metastatic breast cancer (MBC) (Press release, BriaCell Therapeutics, JUL 10, 2025, View Source [SID1234654347]).

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BriaCell is pleased to report the sustained complete resolution of temporal lobe brain metastasis and continued orbital (behind the eye) tumor reduction after > 18 months of treatment in the Phase 2 study. The metastatic tumor initially caused proptosis –a visibly bulging of the eye. As previously reported, the heavily pre-treated MBC patient had demonstrated a complete resolution of a temporal lobe brain metastasis and a significant response in a right orbital metastasis at 8 months, then at 11 months. The patient has now maintained both responses for more than 18 months, with no evidence of brain tumor recurrence and ongoing tumor shrinkage in the orbital lesion.

This patient had failed eight prior treatment regimens, including an antibody-drug conjugate (ADC), before initiating therapy with Bria-IMT plus checkpoint inhibition. She has now completed 29 treatment cycles and has been on BriaCell’s Phase 2 study for over 21 months. Serial imaging at 8, 11, and now 20 months have confirmed no detectable disease in the right temporal lobe, along with continued response in the orbital lesion. Additionally, the patient’s tumor markers have remained markedly reduced from baseline, further supporting the sustained radiologic response.

"These encouraging results continue to suggest that our novel Bria-IMT regimen may provide durable immunotherapeutic benefit in late-stage breast cancer patients with brain metastases who have exhausted other options," stated Dr. William V. Williams, BriaCell’s President & CEO. "The long-term response observed in this patient reinforces the potential of Bria-IMT to improve outcomes while maintaining a favorable tolerability profile."