On November 12, 2025 Pillar Biosciences, Inc., the leader in Decision Medicine, reported the launch of oncoReveal Lymphoid, a research-use-only (RUO) next-generation sequencing (NGS) kit designed to enable laboratories to perform rapid tumor profiling of lymphoid malignancies.

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The oncoReveal Lymphoid panel interrogates 84 genes of interest, including full coding DNA sequence (CDS) of 29 genes with a single-tube, fully automatable NGS workflow that can be performed by any NGS-equipped molecular laboratory.

"We are excited to launch oncoReveal Lymphoid, specifically designed to meet the needs of local laboratories looking for rapid and efficient NGS-based testing solutions to help interrogate lymphomas," said ShiPing Zou, Sr. Director of Product Management at Pillar Biosciences. "oncoReveal Lymphoid is compatible with our current heme-oncology offerings including oncoReveal Myeloid and oncoReveal Heme Fusion. "Together, this suite of products provides full coverage of heme oncology tumor profiling needs for molecular pathology labs."

Pillar’s oncoReveal Lymphoid panel uses their proprietary Stem-Loop Inhibition-Mediated amplification (SLIMamp) technology, a tiled amplicon-based library prep chemistry designed to provide highly accurate genetic profiles down to 2% variant allele frequency (VAF). oncoReveal Lymphoid is powered by PiVAT, an automated secondary bioinformatics software that supports the identification of somatic mutations from DNA with high sensitivity and specificity. Pillar Biosciences’ proprietary PiVAT technology is fully compatible with third-party clinical reporting solutions.

(Press release, Pillar Biosciences, NOV 12, 2025, View Source [SID1234659850])

On November 11, 2025 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that the company will present five abstracts at the 2025 Society for Neuro-Oncology (SNO) Annual Meeting taking place November 19-23 in Honolulu, Hawaii. The presentations will feature both clinical and preclinical research evaluating Modeyso (dordaviprone), as well as new preclinical data featuring JZP3507 (formerly ONC206) in central nervous system (CNS) tumors, reflecting Jazz’s growing impact and innovation in neuro-oncology.

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Key presentations include:

New translational research characterizing potential molecular pathways associated with sensitivity to dordaviprone and exploring how targeted combination strategies may help to enhance response.
Preclinical data evaluating how dordaviprone may influence the tumor immune environment to inform future research on rational immunotherapy combinations.
"These presentations at SNO represent the collective progress of our dedicated research team within Jazz and our academic collaborators who share a relentless commitment to improving outcomes for patients living with devasting brain tumors," said Joshua E. Allen, Ph.D., chief scientific officer, oncology, Jazz Pharmaceuticals. "The SNO presentations provide new insights into how treatment might be further optimized in the future for patients with brain cancer. The continued advancement of Modeyso and our ongoing research across many areas, including the JZP3507 (ONC206) program, reflect our belief that through scientific innovation and persistence, we will continue to bring new hope to patients and families who urgently need better options."

The full SNO abstracts are available here. The full list of Jazz presentations at SNO 2025 are:

Topic

Author

Presentation Details

EGFR metabolically suppresses differentiation in H3 K27M-mutant diffuse midline glioma

Sunjong Ji, Robert Doherty, Mateus Mota, Siva Kumar Natarajan, Daniel de la Nava, Peter Sajjakulnukit, Erik R. Peterson, Tiffany Adam, Michael Niculcea, Katie Vo, Kelsey Wink, Subramaniam Bavani, Yadavilli Sridevi, Javad Nazarian, Joanna J. Phillips, Sabine Mueller, Mariella Filbin, David A. Solomon, Daniel R. Wahl, Costas Lyssiotis, Tingting Qin, Alexander Beck, Pavithra Viswanath, Nicholas Nuechterlein, Sebastian M. Waszak, Sriram Venneti, Carl Koschmann

Type: Oral Abstract

Session: Pediatric Abstracts
– Session I

Date: Friday, November 21,
10:49-10:54 a.m. HST

Number: TMET-51

Dordaviprone (ONC201) in a pediatric patient with recurrent H3 K27M-mutant diffuse glioma and leptomeningeal disease

Gabriel Batistella, Felipe D’Almeida Costa, Tomás Freddi, Nicholas Wojtynek, David Korones

Type: Poster

Session: Poster and Networking Session

Date: Friday, November 21, 11:30 a.m.-12:45 p.m. HST

Number: CTP-15

Allosteric ClpP agonist ONC206 alters mitochondrial metabolism and stress response to elicit apoptosis in meningioma

Andrew K. Lee, Cristina Maranto, Scott Foster, Varun V. Prabhu, Joshua E. Allen

Type: Poster

Session: Poster and Networking Session

Date: Saturday, November 22, 11:45 a.m.-1:05 p.m. HST

Number: TMET-26

ONC206 inhibits tumor growth and is a potential novel therapeutic strategy for refractory medulloblastoma

Theophilos Tzaridis, Jingbo Liu, Joshua E. Allen, Varun V. Prabhu, Robert J. Wechsler-Reya, Tobey MacDonald

Type: Poster

Session: Poster and Networking Session

Date: Saturday, November 22, 11:45 a.m.-1:05 p.m. HST

Number: EXTH-70

Leveraging the immunomodulatory effects of dordaviprone (ONC201) to induce long-term survival response in diffuse midline glioma patients and models

Clara Savary, Mika L. Persson, Evangeline R. Jackson, Ryan J. Duchatel, Tuan Vo, Izac J. Findlay, Alicia M. Douglas, Liesl Bramberger, Daniel de la Nava, Bryce C. Thomas, Holly P. McEwen, Tyrone S. Beitaki, Laura Rodriguez de la Fuente, Yolanda Colino-Sanguino, Fatima Valdes Mora, Martin R. Larsen, Pouya Faridi, Jeff Holst, Jemma Mayall, Cassie N. Kline, Andrea T. Franson, Sriram Venneti, Hubert Hondermarck, Jay Horvat, Brett Nixon, Rodrigo Cartaxo, Javad Nazarian, Esther Hulleman, Sabine Mueller, Nicholas A. Vitanza, Carl Koschmann, Marta M. Alonso, Tiago Ferreira Carvalheiro, Jasper van der Lugt, Matthew D. Dun

Type: Oral Abstract

Session: CNS Rare Tumor Abstracts – Session II

Date: Sunday, November 23, 11:34-11:39 a.m. HST

Number: DDDR-38

About H3 K27M-Mutant Diffuse Midline Glioma
H3 K27M-mutant diffuse midline glioma is a rare and highly aggressive brain tumor that primarily affects the midline structures of the brain and spinal cord.1,2 It is characterized by a specific genetic mutation (H3 K27M) that disrupts epigenetic regulation and drives tumor growth.4 Most commonly diagnosed in children and young adults, patients with this type of glioma often face an extremely poor prognosis, with limited therapeutic options and very low survival rates following recurrence.3 Median survival is approximately one year from diagnosis and 5.1 months after progressing following frontline therapy.7

About Modeyso (dordaviprone)
Modeyso (dordaviprone) (formerly known as ONC201) is approved by the U.S. Food and Drug Administration (FDA) for the treatment of H3 K27M-mutant diffuse midline glioma in adult and pediatric patients one year of age and older with progressive disease following prior therapy.4 Modeyso is an oral small molecule administered once weekly. Modeyso is a mitochondrial caseinolytic protease P (ClpP) agonist and also inhibits the dopamine-2 (D2) receptor. In vitro, dordaviprone activated the integrated stress response, induced apoptosis, and altered mitochondrial metabolism, leading to restored histone H3 K27 trimethylation in H3 K27M-mutant diffuse glioma.4

Modeyso received accelerated approval in August 2025 based on a pre-specified integrated efficacy analysis of 50 adult and pediatric patients with recurrent H3 K27M-mutant diffuse midline glioma enrolled across five open-label clinical studies (ONC006, ONC013, ONC014, ONC016, and ONC018). Continued approval may be contingent upon verification and description of clinical benefit, including in the ongoing Phase 3 ACTION trial (NCT05580562), which is evaluating the safety and clinical benefit of dordaviprone 5 in newly diagnosed patients with H3 K27M-mutant diffuse glioma following radiotherapy. Modeyso was developed by Chimerix prior to its acquisition by Jazz Pharmaceuticals in April 2025.

Modeyso (dordaviprone) is only approved in the United States.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS
Hypersensitivity
MODEYSO can cause severe hypersensitivity reactions.

In the pooled safety population, Grade 3 hypersensitivity reactions occurred in 0.3% of patients receiving MODEYSO. Signs and symptoms of hypersensitivity may include rash, hives, fever, low blood pressure, wheezing, or swelling of the face or throat.

Inform patients about the signs and symptoms of hypersensitivity reactions and instruct them to seek immediate medical attention if symptoms occur.

If clinically significant hypersensitivity or anaphylaxis occur, immediately interrupt MODEYSO and initiate appropriate medical treatment and supportive care. Based on the severity of the adverse reaction, temporarily interrupt or permanently discontinue MODEYSO.

QTc Interval Prolongation
MODEYSO causes concentration-dependent QTc interval prolongation, which can increase the risk for ventricular tachyarrhythmias (e.g. torsades de pointes) or sudden death.

In patients who received MODEYSO and underwent at least one post baseline ECG, QTcF increase of >60 msec compared to baseline and QTcF >500 msec occurred in 6% and 1.2% of patients, respectively.

Monitor ECGs and electrolytes prior to initiation and periodically during treatment, as clinically indicated. Increase the frequency of monitoring in patients with congenital long QT syndrome, existing QTc prolongation, a history of ventricular arrhythmias, electrolyte abnormalities, heart failure, or who are taking strong or moderate CYP3A4 inhibitors.

Avoid concomitant use with other agents known to prolong the QT interval. If concomitant use cannot be avoided, increase the frequency of monitoring and separate administration of MODEYSO and QT-prolonging product.

Interrupt or reduce the dose of MODEYSO in patients who develop QT prolongation; permanently discontinue in patients with signs of life-threatening arrhythmias.

Embryo-Fetal Toxicity
MODEYSO can cause fetal harm when administered to a pregnant woman.

Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with MODEYSO and for 1 month after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with MODEYSO and for 1 month after the last dose.

ADVERSE REACTIONS

Serious adverse reactions occurred in 33% of the 376 patients who received MODEYSO. Serious adverse reactions in >2% of patients included hydrocephalus (5%), vomiting (4.3%), headache (3.2%), seizure (2.4%), and muscular weakness (2.1%). Fatal adverse reactions occurred in 1% of patients who received MODEYSO, including cardiac arrest (0.5%), intracranial hemorrhage (0.3%), and encephalopathy (0.3%).

The most common adverse reactions (≥20%) reported in clinical trials with MODEYSO were fatigue (34%), headache (32%), vomiting (24%), nausea (24%), and musculoskeletal pain (20%). The most common (≥2%) Grade 3 or 4 laboratory abnormalities were decreased lymphocytes (7%), decreased calcium (2.7%), and increased alanine aminotransferase (2.4%).

DRUG INTERACTIONS
Strong and Moderate CYP3A4 Inhibitors
Avoid concomitant use of MODEYSO with strong and moderate CYP3A4 inhibitors. If concomitant use cannot be avoided, reduce the MODEYSO dose as recommended and monitor for toxicity.

Strong and Moderate CYP3A4 Inducers
Avoid concomitant use of strong and moderate CYP3A4 inducers with MODEYSO.

USE IN SPECIFIC POPULATIONS
Lactation
There are no data on the presence of MODEYSO in human milk because of the potential for serious adverse reactions from MODEYSO in breastfed children, advise women not to breastfeed during treatment with MODEYSO and for 1 week after the last dose.

Pediatric Use
The safety and effectiveness of MODEYSO have not been established in patients less than 1 year of age. Dosing has not been established for patients weighing less than 22 pounds (10 kg).

Please refer to the full Prescribing Information, available here, including both Patient Information and Instructions for Use, for complete safety and administration information.

(Press release, Jazz Pharmaceuticals, NOV 11, 2025, View Source [SID1234659762])

On November 11, 2025 EirGenix Inc.(TWSE: 6589) reported that it has entered into a second global exclusive licensing agreement with international biosimilar leader Sandoz AG (SIX:SDZ/OTCQX:SDZNY) for the commercialization of its independently developed breast cancer biosimilar, EG1206A (Pertuzumab Biosimilar to Roche Perjeta), covering all territories except Taiwan, Mainland China, Macau, South Korea, Mongolia, Brunei, Cambodia, Indonesia, Laos, Myanmar, the Philippines, and Japan. The agreement further strengthens the two companies’ collaborative development of the HER2 biosimilar product. Under the terms of the agreement, EirGenix will receive a total up to USD 152 million of upfront and milestone payments. In addition, EirGenix will also be entitled to a profit share once the product is launched in the licensed territory plus potential sales incentives based on market performance. EirGenix will be responsible for product development, manufacturing, and supply.

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EG1206A has completed its pharmacokinetic (PK) clinical study, and last month received positive feedback from both the U.S. FDA and the European Medicines Agency (EMA), confirming that the product qualifies for an abbreviated development pathway, allowing for the waiver of Phase III comparative efficacy trials. This agreement marks another major milestone and breakthrough in EirGenix’s biosimilar development efforts. This partnership further strengthens the existing collaboration between Sandoz and EirGenix. The two companies previously signed a global commercialization agreement for EG12014 (Trastuzumab Biosimilar in both 150 mg and 420 mg formulations). EG12014 has already been approved by the European Commission and is currently under BLA review by the U.S. FDA.

Globally, there are approximately 2.3 million breast cancer patients, of which about 20% are diagnosed with HER2-positive disease. The Trastuzumab and Pertuzumab combination therapy has become the current standard of care for these patients. Recent studies also suggest that Pertuzumab combined with Trastuzumab deruxtecan (Enhertu) may become the new first-line treatment for HER2-positive metastatic breast cancer, indicating strong potential for future market expansion of EG1206A. In addition to its first-generation product EG12014 already on the market, the launch of second-generation EG1206A will further enhance treatment options for patients with HER2-positive breast cancer. According to Roche’s 2024 annual report, global sales of Perjeta reached CHF 3.62 billion (~ USD 4 billion).

Sandoz is the global leader in affordable medicines, with a growth strategy driven by its Purpose: pioneering access for patients. More than 20,000 people of 100 nationalities work together to ensure 900 million patient treatments are provided by Sandoz, generating substantial global healthcare savings and an even larger social impact. Its leading portfolio of approximately 1,300 products addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to 1886. Its history of breakthroughs includes Calcium Sandoz in 1929, the world’s first oral penicillin in 1951, and the world’s first biosimilar in 2006. In 2024, Sandoz recorded net sales of USD 10.4 billion.

EirGenix has successfully utilized reverse engineering technologies to develop multiple biosimilar products. This new agreement underscores EirGenix’s global competitiveness, technical excellence, and internationalization capabilities. With regulatory trends increasingly favorable, EirGenix is accelerating the development of four HER2-targeted antibody programs, expanding its in-house product pipeline as well as CDMO services for additional biosimilar projects. As global demand for biosimilar R&D and manufacturing continues to grow, EirGenix’s technical expertise, production capacity, and large-scale facilities have attracted strong attention from international pharmaceutical companies. The increased utilization of EirGenix’s two commercial production lines in Zhubei further demonstrates its rapid progress. EirGenix is poised to become a key development and manufacturing partner in the global biosimilar landscape and continue its strong growth trajectory.

(Press release, EirGenix, NOV 11, 2025, View Source [SID1234659763])

On November 11, 2025 Salarius Pharmaceuticals, Inc. ("Salarius" or the "Company") (NASDAQ: SLRX) reported the pricing of an underwritten public offering for gross proceeds of approximately $7 million before deducting underwriting discounts and commissions and other offering expenses.

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The offering is comprised of 2,514,335 shares of its common stock ("Common Stock") and pre-funded warrants to purchase 2,152,331 shares of Common Stock, in each case with accompanying Series A Warrants to purchase up to an aggregate of 4,666,666 shares of Common Stock and Series B Warrants to purchase up to an aggregate of 4,666,666 shares of Common Stock. The combined public offering price per share of Common Stock and accompanying warrants is $1.50 per share and accompanying warrants, and the combined public offering price per pre-funded warrant and accompanying warrants is $1.4999 per pre-funded warrant and accompanying warrants. The warrants issued in this offering are fixed priced and do not contain any variable pricing features or alternative exercise provisions. All of the securities are being sold by Salarius.

Ladenburg Thalmann & Co. Inc. is acting as sole book-running manager in connection with the offering.

The closing of the offering is expected to occur on or about November 12, 2025, subject to the satisfaction of closing conditions, including consummation of the Company’s proposed business combination transaction with Decoy Therapeutics Inc. ("Decoy"). In addition, Salarius has granted the underwriter an option for a period of 45 days to purchase up to an additional 699,999 shares of Common Stock, and/or 699,999 Series A Warrants, and/or 699,999 Series B Warrants at their respective public offering prices, less underwriting discounts and commissions.

Salarius expects to use the net proceeds from the offering (i) to advance the clinical development of Salarius’ and Decoy’s research and development programs; (ii) to pay off certain of Decoy’s outstanding promissory notes as required thereby; and (iii) for other general corporate purposes, including working capital, research and development, and capital expenditures.

Each pre-funded warrant has an exercise price of $0.0001 per pre-funded warrant, and is immediately exercisable until such pre-funded warrant is exercised in full. Each of the Series A Warrants and Series B Warrants has an exercise price of $1.50. The Series A Warrants will be exercisable for a period of five years from the date of issuance. The Series B Warrants will be exercisable for a period of one year from the date of issuance.

The securities described above are being offered pursuant to a registration statement on Form S-1 (File No. 333- 284368) that became effective in accordance with Section 8(a) of the Securities and Exchange Act of 1933, as amended, on November 10, 2025.

The securities are being offered by means of a prospectus relating to the offering that form a part of the registration statement. A preliminary prospectus relating to the offering was filed with the Securities and Exchange Commission (the "SEC") on October 21, 2025, and is available on the SEC’s website at www.sec.gov. The final prospectus relating to and describing the terms of the offering will be filed with the SEC and also will be available on the SEC’s website at www.sec.gov. Before investing in the offering, you should read prospectus relating to the offering in their entirety as well as the other documents that Salarius has filed with the SEC that are incorporated by reference in the prospectus relating to the offering, which provide more information about Salarius and the offering. Electronic copies of the final prospectus may be obtained, when available, on the SEC’s website at View Source or by contacting Ladenburg Thalmann & Co. Inc., Prospectus Department, 640 Fifth Avenue, 4th Floor, New York, New York 10019 or by email at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.

(Press release, Salarius Pharmaceuticals, NOV 11, 2025, View Source [SID1234659764])

On November 11, 2025 iLeukon Therapeutics, Inc., a San Diego-based clinical-stage biotechnology company developing next-generation mRNA-based immunotherapies, reported new clinical results from the ongoing first-in-human Phase I trial (NCT05978102) of ILKN421H, presented during a Late-Breaking Clinical Oral Session at the 2025 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in National Harbor, MD.

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The study evaluates ILKN421H, a lipid-nanoparticle (LNP)-formulated mRNA encoding a non-α HSA–IL-2 variant (IL-2v), as monotherapy and in combination with pembrolizumab in patients with advanced solid tumors, including first-line non-small cell lung cancer (NSCLC). The presentation highlighted ILKN421H’s unique scientific design and distinct pharmacologic advantages that enable potent immune activation with a favorable safety profile.

Key Advantages of ILKN421H in Preclinical Research:

Stem-like CD8+ T Cell Amplification: ILKN421H selectively expands PD1- stem-like CD8⁺ T cells, a subset capable of self-renewal and durable antitumor immunity.
Lymphoid Specific Expression and Reduced Systemic Exposure: ILKN421H mRNA is predominantly expressed in lymphoid organs, such as the spleen and lymph nodes, with <5% expressed in liver and other organs. This targeted biodistribution reduces the systemic exposure of IL–2v while enhancing its immune activity.
Overcoming the Cytokine-Sink Effect and a Remarkable Amplification of CD8+ T and NK cells: Unlike protein-based IL-2 therapies that are rapidly internalized by the targeting cells which terminates the IL-2 signaling towards T cell proliferation, ILKN421H’s sustained mRNA–mediated production bypasses the cytokine-sink effect. This enables robust CD8+ T/NK cell proliferation with 1/100 of systemic IL-2v exposure compared with other protein based counterparts like PEG-IL-2v.
Favorable Safety and Tolerability
Across 45 patients with advanced solid tumors, ILKN421H was well tolerated with no dose-limiting toxicities (DLTs) and the maximum tolerated dose (MTD) was not reached. There were no Grade 4 adverse events (AEs), no treatment-related deaths, and no serious adverse events (SAEs) occurring in more than one patient. The Grade 3 AEs observed in more than one patient included anemia, decreased neutrophil count, decreased platelet count, fever, and hypokalemia. The safety profile of ILKN421H in combination with pembrolizumab is generally similar to that of pembrolizumab alone. No vascular leak syndrome (VLS) or hypotension were observed. These findings highlight ILKN421H’s favorable safety and tolerability relative to earlier-generation IL-2 therapeutics.

Reliable and Robust PK/PD
Pharmacokinetic data from the Phase I study demonstrated prolonged IL-2v expression with a half-life of approximately 20 hours. Pharmacodynamic study showed marked increase of peripheral CD8⁺ T cells and NK cells, up to 10-fold and 25-fold respectively. No ADA was detected, and no sign of reduced IL-2v expression or pharmacological effect was observed after repeated administration up to 30 cycles (Q3W per cycle).

Clinical Efficacy
In patients with first-line (1L) non-small cell lung cancer (NSCLC) regardless of PD-L1 expression levels (n=20), ILKN421H in combination with pembrolizumab demonstrated promising efficacy, with a confirmed objective response rate (ORR) of 80% (16/20 patients). When analyzed by PD-L1 status, ORR was 87% in PD-L1–positive patients and 60% in PD-L1–negative patients. Median progression-free survival (PFS) has not yet been reached and is projected to exceed 12 months. In the post–immunotherapy (post-IO) NSCLC cohort (n=3), ILKN421H combined with pembrolizumab achieved an ORR of 33.3% (1/3 patients), including one partial response (PR) and one patient with durable stable disease (SD) lasting more than 14 months. Together, these results highlight the clinical promise of ILKN421H in both first-line and post-IO NSCLC, supporting its continued development across treatment settings.

Advancement to Phase II Development
Based on these favorable Phase I results, the FDA has cleared iLeukon’s IND application and Phase II protocol to evaluate ILKN421H in combination with pembrolizumab for both 1L and post-IO treatment of NSCLC. "These Phase I results validate the novel design of ILKN421H and demonstrate its potential to deliver meaningful clinical benefit for patients with cancer," said Haining Huang, Ph.D., Chief Executive Officer of iLeukon Therapeutics. "ILKN421H defines the next evolution of IL-2 therapy by combining mRNA technology with selective immune activation to deliver durable efficacy and a favorable safety profile. We look forward to advancing this program into Phase II evaluation."

(Press release, iLeukon Therapeutics, NOV 11, 2025, View Source [SID1234659765])