On February 20, 2026 Partner Therapeutics, Inc. (PTx) reported findings from a post hoc analysis of the eNRGy trial (NCT02912949) evaluating treatment beyond progression with zenocutuzumab in patients with advanced neuregulin 1 fusion-positive (NRG1+) non-small cell lung cancer (NSCLC). Results were presented at the 2026 International Association for the Study of Lung Cancer (IASLC) Targeted Therapies of Lung Cancer (TTLC) meeting. NRG1+ NSCLC is associated with low response rates and poor outcomes with non-targeted therapies, underscoring the need for effective targeted treatment options such as zenocutuzumab and potential use beyond progression.

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"Patients with advanced NRG1 fusion-positive non-small cell lung cancer often have limited treatment options after progression," said Dr. Misako Nagasaka, MD, PhD of the University of California Irvine and senior author. "In this analysis, continued zenocutuzumab treatment beyond RECIST progression provided meaningful, sometimes long-lasting, clinical benefit while maintaining a favorable tolerability profile."

The analysis included 27 patients with NRG1+ NSCLC who received at least three doses of zenocutuzumab after radiographic progression. Oligoprogression occurred in 81% of patients, while 19% experienced diffuse progression. Median total zenocutuzumab exposure increased to nearly 10 months, compared with approximately 7 months before progression. Eight patients continued treatment for more than six months beyond progression, including one patient remaining on zenocutuzumab for more than 23 months after progression, with treatment still ongoing as of December 2025. Another patient remained on zenocutuzumab for nearly four years in total. Additionally, 22% of patients were able to continue zenocutuzumab following local management of progressing lesions including radiotherapy, gamma knife surgery, and surgical resection. Treatment was generally well tolerated, and no patients discontinued therapy due to adverse events.

"These data underscore the potential heterogeneity of disease at progression and provide evidence that continued use of a targeted therapy, like zenocutuzumab, may offer meaningful clinical benefit without introducing new safety concerns," said Pritesh J. Gandhi, Chief Development Officer at Partner Therapeutics. "We continue to work with physicians to generate more information on the use of zenocutuzumab beyond progression."

In December 2024, zenocutuzumab-zbco (BIZENGRI) received U.S. Food and Drug Administration accelerated approval for the treatment of adults with advanced unresectable or metastatic non-small cell lung cancer (NSCLC) and pancreatic adenocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy. The indications were approved under accelerated approval based on ORR and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). NRG1 gene fusions and other gene fusions are best detected using the combination of tissue-based DNA and RNA next-generation sequencing.

For more information on the eNRGy trial and zenocutuzumab-zbco, please visit www.partnertx.com.

About NRG1 Gene Fusions

NRG1 fusions are unique cancer drivers that create oncogenic chimeric ligands rather than the more widely described chimeric receptors (NTRK, RET, ROS1, ALK, and FGFR fusions). The chimeric ligands bind to HER3, triggering HER2/HER3 heterodimerization and activate downstream signaling pathways that cause cancer cells to grow and proliferate. Zenocutuzumab-zbco is a bispecific antibody that blocks HER2/HER3 dimerization and NRG1 fusion interactions with HER3, resulting in the suppression of these pathways. Comprehensive molecular testing, notably the combination of tissue-based DNA and RNA next generation sequencing, is essential to identify rare and actionable gene fusions like NRG1.

About BIZENGRI (zenocutuzumab-zbco)

INDICATIONS

BIZENGRI is indicated for the treatment of adults with advanced unresectable or metastatic non-small cell lung cancer (NSCLC) harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy.

BIZENGRI is indicated for the treatment of adults with advanced unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy.

These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Important Safety Information

BOXED WARNING: EMBRYO-FETAL TOXICITY

Embryo-Fetal Toxicity: Exposure to BIZENGRI during pregnancy can cause embryo-fetal harm. Advise patients of this risk and the need for effective contraception.

WARNINGS AND PRECUATIONS

Infusion-Related Reactions/Hypersensitivity/Anaphylactic Reactions

BIZENGRI can cause serious and life-threatening infusion-related reactions (IRRs), hypersensitivity and anaphylactic reactions. Signs and symptoms of IRR may include chills, nausea, fever, and cough.

In the eNRGy study, 13% of patients experienced IRRs, all were Grade 1 or 2; 91% occurred during the first infusion.

Administer BIZENGRI in a setting with emergency resuscitation equipment and staff who are trained to monitor for IRRs and to administer emergency medications. Monitor patients closely for signs and symptoms of infusion reactions during infusion and for at least 1 hour following completion of first BIZENGRI infusion and as clinically indicated. Interrupt BIZENGRI infusion in patients with ≤ Grade 3 IRRs and administer symptomatic treatment as needed. Resume infusion at a reduced rate after resolution of symptoms. Immediately stop the infusion and permanently discontinue BIZENGRI for Grade 4 or life-threatening IRR or hypersensitivity/anaphylaxis reactions.

Interstitial Lung Disease/Pneumonitis

BIZENGRI can cause serious and life-threatening interstitial lung disease (ILD)/pneumonitis.

In the eNRGy study, ILD/pneumonitis occurred in 2 (1.1%) patients treated with BIZENGRI. Grade 2 ILD/pneumonitis (Grade 2) resulting in permanent discontinuation of BIZENGRI occurred in 1 (0.6%) patient. Monitor for new or worsening pulmonary symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, fever). Immediately withhold BIZENGRI in patients with suspected ILD/pneumonitis and administer corticosteroids as clinically indicated.

Permanently discontinue BIZENGRI if ILD/pneumonitis ≥ Grade 2 is confirmed.

Left Ventricular Dysfunction

BIZENGRI can cause left ventricular dysfunction.

Left ventricular ejection fraction (LVEF) decrease has been observed with anti-HER2 therapies, including BIZENGRI. Treatment with BIZENGRI has not been studied in patients with a history of clinically significant cardiac disease or LVEF less than 50% prior to initiation of treatment.

In the eNRGy study, Grade 2 LVEF decrease (40%-50%; 10 – 19% drop from baseline) occurred in 2% of evaluable patients. Cardiac failure without LVEF decrease occurred in 1.7% of patients, including 1 (0.6%) fatal event.

Before initiating BIZENGRI, evaluate LVEF and monitor at regular intervals during treatment as clinically indicated. For LVEF of less than 45% or less than 50% with absolute decrease from baseline of 10% or greater which is confirmed, or in patients with symptomatic congestive heart failure (CHF), permanently discontinue BIZENGRI.

Embryo-Fetal Toxicity

Based on its mechanism of action, BIZENGRI can cause fetal harm when administered to a pregnant woman. No animal reproduction studies were conducted with BIZENGRI. In post marketing reports, use of a HER2-directed antibody during pregnancy resulted in cases of oligohydramnios manifesting as fatal pulmonary hypoplasia, skeletal abnormalities, and neonatal death. In animal models, studies have demonstrated that inhibition of HER2 and/or HER3 results in impaired embryo-fetal development, including effects on cardiac, vascular and neuronal development, and embryolethality. Advise patients of the potential risk to a fetus. Verify the pregnancy status of females of reproductive potential prior to the initiation of BIZENGRI. Advise females of reproductive potential to use effective contraception during treatment with BIZENGRI and for 2 months after the last dose.

ADVERSE REACTIONS

NRG1 Gene Fusion Positive Unresectable or Metastatic NSCLC

Serious adverse reactions occurred in 25% of patients with NRG1 gene fusion positive NSCLC who received BIZENGRI. Serious adverse reactions in ≥ 2% of patients included pneumonia (n=4) dyspnea and fatigue (n=2 each). Fatal adverse reactions occurred in 3 (3%) patients and included respiratory failure (n=2), and cardiac failure (n=1). Permanent discontinuation of BIZENGRI due to an adverse reaction occurred in 3% of patients. Adverse reactions resulting in permanent discontinuation of BIZENGRI included dyspnea, pneumonitis and sepsis (n=1 each).

In patients with NRG1 gene fusion positive NSCLC who received BIZENGRI, the most common (>20%) adverse reactions, including laboratory abnormalities, were decreased hemoglobin (35%), increased alanine aminotransferase (30%), decreased magnesium (28%), increased alkaline phosphatase (27), decreased phosphate (26%), diarrhea (25%), musculoskeletal pain (23%), increased gamma-glutamyl transpeptidase (23%), increased aspartate aminotransferase (22%), and decreased potassium (21%).

NRG1 Gene Fusion Positive Unresectable or Metastatic Pancreatic Adenocarcinoma

Serious adverse reactions occurred in 23% of patients with NRG1 gene fusion positive pancreatic adenocarcinoma who received BIZENGRI.

There were 2 fatal adverse reactions, one due to COVID-19 and one due to respiratory failure.

In patients with NRG1 gene fusion positive pancreatic adenocarcinoma who received BIZENGRI the most common (≥20%) adverse reactions, including laboratory abnormalities, were increased alanine aminotransferase (51%), diarrhea (36%), increased aspartate aminotransferase (31%), increased bilirubin (31%), decreased phosphate (31%), increased alkaline phosphatase (28%), decreased sodium (28%), musculoskeletal pain (28%), decreased albumin (26%), decreased potassium (26%), decreased platelets (26%), decreased magnesium (24%), increased gamma-glutamyl transpeptidase (23%), decreased hemoglobin (23%), vomiting (23%), nausea (23%), decreased leukocytes (21%), and fatigue (21%).

(Press release, Partner Therapeutics, FEB 20, 2026, View Source [SID1234662823])

On February 20, 2026 Oncotelic Therapeutics Inc. (OTCQB: OTLC) reported its placement in an editorial published by BioMedWire (BMW), one of 75+ brands within the Dynamic Brand Portfolio@IBN (InvestorBrandNetwork), a specialized communications platform with a focus on financial news and content distribution for private and public companies and the investment community.

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To view the full publication, "Drug-Delivery Breakthroughs, Cross-Indication Research Accelerate New Momentum in CNS and Oncology Development," please visit: View Source

Biotechnology mergers and acquisitions ("M&As") are increasingly shaped by a clear strategic evolution. Pharmaceutical companies are prioritizing clinical-stage and late-stage programs supported by human data rather than early discovery platforms with uncertain timelines. Following a period where capital heavily favored preclinical innovation, investors and acquirers are now focusing on assets that demonstrate safety signals, efficacy data and clearer pathways toward commercialization.

Within this shifting landscape, companies holding diversified clinical-stage portfolios across oncology and central nervous system ("CNS") indications are drawing renewed attention. One such example is Oncotelic Therapeutics Inc., which recently announced expanded international intellectual property coverage for OT-101, its proprietary TGF-β antisense therapeutic platform. The development strengthens protection across neurology, oncology and CNS drug-delivery technologies aimed at crossing the blood-brain barrier.

(Press release, Oncotelic, FEB 20, 2026, View Source [SID1234662822])

On February 20, 2026 PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, reported the adoption of a protocol amendment to its Phase 3 VERSATILE-003 clinical trial. The amendment includes PFS as an interim primary endpoint to support a potential accelerated approval pathway for PDS0101 in HPV16-positive recurrent and/or metastatic head and neck cancer. Median overall survival (mOS) remains the trial’s primary endpoint for full approval, consistent with the Company’s prior regulatory dialogue and post-meeting communication following its Type C meeting with the U.S. Food and Drug Administration ("FDA"). Following the FDA’s standard 30-day wait period since filing of the amended protocol to the Investigational New Drug (IND) Application, without objection, the Company is proceeding with the amended protocol.

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"Including PFS as an interim primary endpoint provides a potential pathway to shorten the duration of VERSATILE-003 and accelerate the timeline to regulatory submission, as well as making the trial more cost efficient," said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. "Survival and safety will continue to anchor full approval, and we remain confident in the path we’ve outlined and in our commitment to advancing a promising targeted immunotherapy for the rapidly growing population of patients with HPV16-positive recurrent and/or metastatic head and neck cancer."

(Press release, PDS Biotechnology, FEB 20, 2026, View Source [SID1234662820])

On February 20, 2026 Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a specialty pharmaceutical company, reported new real world data supporting potential use of PEDMARK (sodium thiosulfate injection) in adults with head and neck cancers were presented as a digital poster at the 2026 Multidisciplinary Head and Neck Cancers Symposium (MHNCS) in Palm Desert, CA from February 19 – 21, 2026.

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Findings from a multi-institutional retrospective review of 15 adults with head and neck cancers (HNC) showed that PEDMARK could be safely given ≥six hours after cisplatin dosing and was easy to incorporate into the real-world care plan for adults with HNC. This strict post-cisplatin timing is a validated approach intended to preserve cisplatin antitumor activity and no disruption to curative-intent cisplatin-based treatment delivery was observed as part of the study review.

"Head and neck cancer is one of the most common cancers globally,i underscoring why these results are encouraging for clinicians. Importantly, the data support the potential of the drug to address cisplatin-induced hearing loss – a major and often overlooked survivorship challenge – without compromising cisplatin’s proven antitumor activity," said Maria A. Velez, M.D., M.S., coauthor of the study and clinical instructor in the Division of Hematology/Oncology at UCLA Health.

"Cisplatin-induced hearing loss remains one of the most underrecognized yet deeply consequential toxicities associated with cancer treatment," said Leslie Worona, FNP-BC, OCN, coauthor of the study and oncology nurse practitioner at Mount Sinai Hospital. "The findings that most patients – even those with high rates of pre-existing hearing impairment – who received PEDMARK experienced no measurable hearing loss during or after treatment supports further exploration of PEDMARK use in additional patient populations and tumor types such as HNC."

PEDMARK was shown to be well tolerated, with only isolated, self-limited infusion events and no grade 3 or 4 toxicities.

"These new findings are critical to demonstrating the feasibility, scalability and long-term value of PEDMARK beyond those studied in our pivotal clinical program," said Pierre S. Sayad, PhD, M.S., chief medical officer of Fennec Pharmaceuticals. "Additionally, these data may help to strengthen the case for broader clinical adoption in a sizable patient population at high risk for permanent hearing loss."

The study’s primary endpoint evaluated feasibility, defined by timing adherence (≥6 hours) and operational metrics, including administration setting (home vs. clinic infusion) and chair time for infusion-center dosing. Secondary endpoints included infusion-related events, need for antiemetic escalation, and completion of on-treatment and post-treatment audiology assessments.

PEDMARK is currently approved for pediatric patients one month of age and older with localized, non-metastatic solid tumors, and is also recognized by the National Comprehensive Cancer Network with a 2A recommendation for use in adolescent and young adult patients.

About Cisplatin-Induced Ototoxicity

Cisplatin and other platinum-based chemotherapies are widely used to treat solid tumors and have been vital in improving survival rates. Unfortunately, these life-saving treatments often result in permanent, irreversible hearing loss, also known as ototoxicity.ii

Hearing loss from cisplatin treatment is not rare. Studies show that between 60-90% of patients treated with cisplatin may develop hearing loss, depending upon the dose and duration of chemotherapyiii. Many of those treated with cisplatin will require lifelong hearing aids or cochlear implants, which can be helpful for some, but do not reverse the hearing loss and can be costly over time.iv Treatment-induced hearing loss can reduce quality of survivorship as it impacts many aspects of life, such as speech and language skills, academic performance, social-emotional development, career potential and the ability to live independently.v,vi While audiologic monitoring is recommended to help manage ototoxicity, it is currently underutilized in certain cancer patient populations.

PEDMARK (sodium thiosulfate injection)

PEDMARK is the first and only U.S. Food and Drug Administration (FDA) approved therapy indicated to reduce the risk of ototoxicity associated with cisplatin treatment in pediatric patients 1 month of age and older with localized, non-metastatic, solid tumors. It is a unique formulation of sodium thiosulfate in single-dose, ready-to-use vials for intravenous use in pediatric patients. PEDMARK is also the first and only therapeutic agent with proven efficacy and safety data with an established dosing regimen, across two open-label, randomized Phase 3 clinical studies, the Children’s Oncology Group (COG) Protocol ACCL0431 and SIOPEL 6.

Additionally, PEDMARK is recommended for the adolescent and young adult (AYA) population by the National Comprehensive Cancer Network, or NCCN, with a 2A endorsement.

Approximately 500,000 patients in the U.S. are diagnosed annually with cancers that could be treated with a platinum-based chemotherapy.vii,viii The incidence of ototoxicity depends upon the dose and duration of chemotherapy, and many of those treated will require lifelong hearing aids. Until the FDA approval of PEDMARK, there were no preventative agents for this hearing loss. Patients with hearing loss resulting from cancer treatment have a statistically significant worse quality of life compared with peers who have no hearing loss.ixx

PEDMARK has been studied by co-operative groups in two Phase 3 clinical studies of survival and reduction of ototoxicity, COG ACCL0431 and SIOPEL 6. Both studies have been completed. The COG ACCL0431 protocol enrolled childhood cancers typically treated with intensive cisplatin therapy for localized and disseminated disease, including newly diagnosed hepatoblastoma, germ cell tumor, osteosarcoma, neuroblastoma, medulloblastoma, and other solid tumors. SIOPEL 6 enrolled only hepatoblastoma patients with localized tumors.

Indications and Usage

PEDMARK (sodium thiosulfate injection) is indicated to reduce the risk of ototoxicity associated with cisplatin in pediatric patients 1 month of age and older with localized, non-metastatic solid tumors.

Limitations of Use

The safety and efficacy of PEDMARK have not been established when administered following cisplatin infusions longer than 6 hours. PEDMARK may not reduce the risk of ototoxicity when administered following longer cisplatin infusions, because irreversible ototoxicity may have already occurred.

Important Safety Information

PEDMARK is contraindicated in patients with history of a severe hypersensitivity to sodium thiosulfate or any of its components.

Hypersensitivity reactions occurred in 8% to 13% of patients in clinical trials. Monitor patients for hypersensitivity reactions. Immediately discontinue PEDMARK and institute appropriate care if a hypersensitivity reaction occurs. Administer antihistamines or glucocorticoids (if appropriate) before each subsequent administration of PEDMARK. PEDMARK may contain sodium sulfite; patients with sulfite sensitivity may have hypersensitivity reactions, including anaphylactic symptoms and life-threatening or severe asthma episodes. Sulfite sensitivity is seen more frequently in people with asthma.

PEDMARK is not indicated for use in pediatric patients less than 1 month of age due to the increased risk of hypernatremia or in pediatric patients with metastatic cancers.

Hypernatremia occurred in 12% to 26% of patients in clinical trials, including a single Grade 3 case. Hypokalemia occurred in 15% to 27% of patients in clinical trials, with Grade 3 or 4 occurring in 9% to 27% of patients. Monitor serum sodium and potassium levels at baseline and as clinically indicated. Withhold PEDMARK in patients with baseline serum sodium greater than 145 mmol/L.

Monitor for signs and symptoms of hypernatremia and hypokalemia more closely if the glomerular filtration rate (GFR) falls below 60 mL/min/1.73m2.

Administer antiemetics prior to each PEDMARK administration. Provide additional antiemetics and supportive care as appropriate.

The most common adverse reactions (≥25% with difference between arms of >5% compared to cisplatin alone) in SIOPEL 6 were vomiting, nausea, decreased hemoglobin, and hypernatremia. The most common adverse reaction (≥25% with difference between arms of >5% compared to cisplatin alone) in COG ACCL0431 was hypokalemia.

Please see full Prescribing Information for PEDMARK at: www.PEDMARK.com.

(Press release, Fennec Pharmaceuticals, FEB 20, 2026, View Source [SID1234662818])

On February 20, 2026 Exact Sciences Corporation (NASDAQ: EXAS) ("Exact Sciences"), a leading provider of cancer screening and diagnostic tests, reported that its stockholders voted to approve the proposed acquisition of Exact Sciences by Abbott (NYSE: ABT) at the special meeting of stockholders held earlier today.

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At the special meeting, preliminary results showed that more than 99% of the votes cast, representing approximately 67% of the total outstanding shares of Exact Sciences common stock as of the January 9, 2026 record date for the special meeting, were voted in favor of the transaction. Final voting results from the special meeting will be reported by Exact Sciences in a Current Report on Form 8‑K filed with the U.S. Securities and Exchange Commission (the "SEC").

Subject to the satisfaction or waiver of the remaining conditions to closing, the transaction is expected to close before the end of the second calendar quarter of 2026. Under the terms of the definitive agreement with Abbott, upon completion of the transaction, Exact Sciences’ stockholders will be entitled to receive $105.00 in cash, without interest and subject to any applicable withholding taxes, for each share of Exact Sciences common stock they owned as of immediately before the completion of the transaction.

(Press release, Exact Sciences, FEB 20, 2026, View Source [SID1234662817])