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Nuvation Bio to Collaborate with Thermo Fisher Scientific for U.S.-Based Manufacturing of IBTROZI® for ROS1-Positive Non-Small Cell Lung Cancer

On May 13, 2026 Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, reported the successful completion of process tech transfer and product introduction to Thermo Fisher Scientific, the world leader in serving science, for IBTROZI (taletrectinib) to treat advanced or metastatic ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC). The transition was submitted as a supplement to the IBTROZI New Drug Application held by Nuvation Bio and is now complete.

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"Our commitment to unencumbered access to IBTROZI for appropriate patients with ROS1+ NSCLC starts at the manufacturing stage, where we work to ensure that our collaborators and processes deliver critical medicine with high quality," said David Hung, M.D., Founder, President and Chief Executive Officer of Nuvation Bio. "We are pleased to collaborate with Thermo Fisher, a leading contract manufacturer of pharmaceuticals, to bring IBTROZI manufacturing closer to the patients we serve."

Jennifer Cannon, President, Commercial Operations, Pharma Services at Thermo Fisher added, "We are pleased that Nuvation Bio has selected us for their final drug product manufacturing of IBTROZI in the United States. Our collaboration with Nuvation Bio builds on our commitment to work with both biotech and pharmaceutical companies alike to help ensure the availability and access to innovative treatments that address significant unmet medical needs for patients."

About ROS1+ NSCLC
Each year, more than one million people globally are diagnosed with non-small cell lung cancer (NSCLC), the most common form of lung cancer. It is estimated that approximately 2% of patients with NSCLC have ROS1+ disease. About 35% of patients newly diagnosed with metastatic ROS1+ NSCLC have tumors that have spread to their brain. The brain is also the most common site of disease progression, with about 50% of previously treated patients developing central nervous system (CNS) metastases.

About IBTROZI
IBTROZI is an oral, potent, CNS-active, selective, next-generation ROS1 inhibitor therapy. On June 11, 2025, following Priority Review and Breakthrough Therapy designations for both TKI-naive and TKI-pretreated disease, the U.S. Food and Drug Administration (FDA) approved IBTROZI for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC. Learn more at IBTROZI.com. 

Indication
IBTROZI is indicated for the treatment of adult patients with locally advanced or metastatic ROS1+ non-small cell lung cancer (NSCLC).

IMPORTANT SAFETY INFORMATION FOR IBTROZI (taletrectinib)

WARNINGS AND PRECAUTIONS

Hepatotoxicity: Hepatotoxicity, including drug-induced liver injury and fatal adverse reactions, can occur. 88% of patients experienced increased AST, including 10% Grade 3/4. 85% of patients experienced increased ALT, including 13% Grade 3/4. Fatal liver events occurred in 0.6% of patients. Median time to first onset of AST or ALT elevation was 15 days (range: 3 days to 20.8 months).

Increased AST or ALT each led to dose interruption in 7% of patients and dose reduction in 5% and 9% of patients, respectively. Permanent discontinuation was caused by increased AST, ALT, or bilirubin each in 0.3% and by hepatotoxicity in 0.6% of patients.

Concurrent elevations in AST or ALT ≥3 times the ULN and total bilirubin ≥2 times the ULN, with normal alkaline phosphatase, occurred in 0.6% of patients.

Interstitial Lung Disease (ILD)/Pneumonitis: Severe, life-threatening, or fatal ILD or pneumonitis can occur. ILD/pneumonitis occurred in 2.3% of patients, including 1.1% Grade 3/4. One fatal ILD case occurred at the 400 mg daily dose. Median time to first onset of ILD/pneumonitis was 3.8 months (range: 12 days to 11.8 months).

ILD/pneumonitis led to dose interruption in 1.1% of patients, dose reduction in 0.6% of patients, and permanent discontinuation in 0.6% of patients.

QTc Interval Prolongation: QTc interval prolongation can occur, which can increase the risk for ventricular tachyarrhythmias (e.g., torsades de pointes) or sudden death. IBTROZI prolongs the QTc interval in a concentration-dependent manner.

In patients who received IBTROZI and underwent at least one post baseline ECG, QTcF increase of >60 msec compared to baseline and QTcF >500 msec occurred in 13% and 2.6% of patients, respectively. 3.4% of patients experienced Grade ≥3. Median time from first dose of IBTROZI to onset of ECG QT prolongation was 22 days (range: 1 day to 38.7 months). Dose interruption and dose reduction each occurred in 2.8% of patients.

Significant QTc interval prolongation may occur when IBTROZI is taken with food, strong and moderate CYP3A inhibitors, and/or drugs with a known potential to prolong QTc. Administer IBTROZI on an empty stomach. Avoid concomitant use with strong and moderate CYP3A inhibitors and/or drugs with a known potential to prolong QTc.

Hyperuricemia: Hyperuricemia can occur and was reported in 14% of patients, with 16% of these requiring urate-lowering medication without pre-existing gout or hyperuricemia. 0.3% of patients experienced Grade ≥3. Median time to first onset was 2.1 months (range: 7 days to 35.8 months). Dose interruption occurred in 0.3% of patients.

Myalgia with Creatine Phosphokinase (CPK) Elevation: Myalgia with or without CPK elevation can occur. Myalgia occurred in 10% of patients. Median time to first onset was 11 days (range: 2 days to 10 months).

Concurrent myalgia with increased CPK within a 7-day time period occurred in 0.9% of patients. Dose interruption occurred in 0.3% of patients with myalgia and concurrent CPK elevation.

Skeletal Fractures: IBTROZI can increase the risk of fractures. ROS1 inhibitors as a class have been associated with skeletal fractures. 3.4% of patients experienced fractures, including 1.4% Grade 3. Some fractures occurred in the setting of a fall or other predisposing factors. Median time to first onset of fracture was 10.7 months (range: 26 days to 29.1 months). Dose interruption occurred in 0.3% of patients.

Embryo-Fetal Toxicity: Based on literature, animal studies, and its mechanism of action, IBTROZI can cause fetal harm when administered to a pregnant woman.

ADVERSE REACTIONS
Among patients who received IBTROZI, the most frequently reported adverse reactions (≥20%) were diarrhea (64%), nausea (47%), vomiting (43%), dizziness (22%), rash (22%), constipation (21%), and fatigue (20%).

The most frequently reported Grade 3/4 laboratory abnormalities (≥5%) were increased ALT (13%), increased AST (10%), decreased neutrophils (5%), and increased creatine phosphokinase (5%).

DRUG INTERACTIONS

Strong and Moderate CYP3A Inhibitors/CYP3A Inducers and Drugs that Prolong the QTc Interval: Avoid concomitant use.
Gastric Acid Reducing Agents: Avoid concomitant use with PPIs and H2 receptor antagonists. If an acid-reducing agent cannot be avoided, administer locally acting antacids at least 2 hours before or 2 hours after taking IBTROZI.
OTHER CONSIDERATIONS

Pregnancy: Please see important information in Warnings and Precautions under Embryo-Fetal Toxicity.
Lactation: Advise women not to breastfeed during treatment and for 3 weeks after the last dose.
Effect on Fertility: Based on findings in animals, IBTROZI may impair fertility in males and females. The effects on animal fertility were reversible.
Pediatric Use: The safety and effectiveness of IBTROZI in pediatric patients has not been established.
Photosensitivity: IBTROZI can cause photosensitivity. Advise patients to minimize sun exposure and to use sun protection, including broad-spectrum sunscreen, during treatment and for at least 5 days after discontinuation.
Please see accompanying full Prescribing Information.

(Press release, Nuvation Bio, MAY 13, 2026, View Source [SID1234665648])

Lantern Pharma Inc. Announces up to $9.25 Million Registered Direct Offering with Existing Holders and a Single Institutional Investor

On May 13, 2026 Lantern Pharma Inc. (NASDAQ: LTRN) ("Lantern" or the "Company"), a clinical-stage AI-driven precision oncology company developing targeted and transformative cancer therapies using its proprietary AI and machine learning platforms with multiple clinical stage drug programs, reported that it has entered into a definitive agreement for the purchase and sale of an aggregate of 2,135,923 shares of its common stock (or pre-funded warrants in lieu thereof) at a purchase price of $2.06 per share (or pre-funded warrant in lieu thereof) in a registered direct offering. In addition, in a concurrent private placement, the Company will issue unregistered warrants to purchase up to 2,135,923 shares of common stock. The warrants will have an exercise price of $2.27 per share, will be exercisable six months following the initial issuance date, and will expire five years following the initial exercise date. The closing of the offering is expected to occur on or about May 14, 2026, subject to the satisfaction of customary closing conditions.

The Company has also communicated plans to create an independent business entity composed of the AI platform, withZeta.ai, and related technologies and personnel under the leadership of CEO Mr. Panna Sharma. The Company intends to separate its public facing clinically trained AI agent into an independent business entity in order to access dedicated funding sources and potentially realize valuation multiples separate from its drug development operations, which such entity the Company anticipates will become a newly listed company on a national stock exchange or market. Ryan Lane, from Empery Asset Management, whose funds led the financing round, commented: "We started using the AI platform shortly after its public release and have found the prompt results exceptionally useful for our in-house compound viability analysis versus generic LLM models. We believe with additional funding, withZeta will become a leading AI co-scientist for investors and biotech executives."

The Company plans on hosting a separate investor webinar and meeting to provide additional details in the coming month.

Rodman & Renshaw LLC is acting as the exclusive placement agent for the offering.

The aggregate gross proceeds to the Company from the offering are expected to be approximately $4.4 million, before deducting the placement agent fees and other offering expenses payable by the Company. The potential additional gross proceeds from the unregistered warrants, if fully exercised on a cash basis, will be approximately $4.85 million. No assurance can be given that any of the warrants will be exercised. The Company currently intends to use the net proceeds from the offering for working capital and other general corporate purposes.

The shares of common stock (or pre-funded warrants in lieu thereof) (but not the warrants issued in the private placement or the shares of common stock underlying such warrants) are being offered by the Company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-279718) filed with the Securities and Exchange Commission ("SEC") on May 24, 2024, and became effective on June 10, 2024. The registered direct offering of the shares of common stock (or pre-funded warrants in lieu thereof) is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. The prospectus supplement and the accompanying prospectus relating to the shares of common stock (or pre-funded warrants in lieu thereof) being offered in the registered direct offering will be filed with the SEC and be available at the SEC’s website at www.sec.gov. Electronic copies of the prospectus supplement and the accompanying prospectus relating to the registered direct offering may also be obtained, when available, by contacting Rodman & Renshaw LLC at 600 Lexington Avenue, 32nd Floor, New York, NY 10022, by telephone at (212) 540‑4414, or by email at [email protected].

The warrants described above are being issued in a concurrent private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or the 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 the registration or qualification under the securities laws of any such state or jurisdiction.

(Press release, Lantern Pharma, MAY 13, 2026, View Source;Announces-up-to-9-25-Million-Registered-Direct-Offering-with-Existing-Holders-and-a-Single-Institutional-Investor/default.aspx [SID1234665647])

Candel Therapeutics to Present at Upcoming Investor Conferences

On May 13, 2026 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal immunotherapies to improve outcomes for patients with cancer, reported that Paul Peter Tak, M.D., Ph.D., FMedSci, Candel’s President and Chief Executive Officer, will present and participate in one-on-one meetings with investors at upcoming investor conferences.

Stifel 2026 Virtual Targeted Oncology Forum
Date/ Time: Wednesday, May 20, 2026, at 10 AM ET
Webcast Link: Stifel / Candel Presentation

2026 Jefferies Global Healthcare Conference (New York, NY)
Date/Time: Wednesday, June 3, 2026, at 5:30 PM ET
Webcast Link: Jefferies / Candel Presentation

Live webcasts of the presentations will be available by selecting Events and Presentations under the News & Events tab in the Investors section on www.candeltx.com. A replay of the webcasts will be archived for up to 90 days following the session date.

(Press release, Candel Therapeutics, MAY 13, 2026, View Source [SID1234665646])

Aptevo Therapeutics Provides a 1Q26 Business Update; RAINIER on Track for 2026 Completion and Phase 2 Dose Selection

On May 13, 2026 Aptevo Therapeutics Inc. (Nasdaq:APVO), a clinical-stage biotechnology company focused on developing novel immune-oncology therapeutics based on its proprietary ADAPTIR and ADAPTIR-FLEX platform technologies, reported a business update.

"Aptevo is entering a defining period as a company, supported by growing clinical momentum, a committed leadership team, and a pipeline with the potential to create significant long-term value," said Jeff Lamothe, President and Chief Executive Officer of Aptevo. "Mipletamig continues to generate compelling frontline AML data, combining strong remission activity with a differentiated safety profile with the potential as an important addition to standard-of-care therapy. At the same time, we are continuing to advance our next generation of multispecific immunotherapy programs, including our emerging trispecific candidates, which are designed to address complex solid tumors through differentiated mechanisms and targeted immune modulation. We believe our ADAPTIR and ADAPTIR-FLEX platforms position Aptevo to expand into multiple high-value areas of oncology innovation. With meaningful clinical and strategic milestones ahead, financial flexibility to support execution, and increasing validation of multispecific approaches throughout the industry, we believe we are building from an increasingly strong foundation for future growth and value creation."

RAINIER trial on track for completion and Phase 2 dose selection by year end.

Mipletamig continues to generate strong data in frontline acute myeloid leukemia (AML) in combination with venetoclax + azacitidine. Across 31 evaluable patients (includes data through RAINIER Cohort 5, plus 4 patients from the previously completed dose expansion trial), the data has demonstrated continued efficacy, including:

87% clinical benefit rate* that demonstrates broad anti-leukemia activity and blast reduction across response categories

81% CR or CRi (remission), compared to 66.4% in the Phase 3 VIALE-A trial**

65% achieved CR (complete remission), compared to 37% in the Phase 3 VIALE-A trial**

No cytokine release syndrome (CRS), a common and often dose-limiting toxicity associated with similar therapies, has been observed in frontline patients to date

The data also show that 52% of patients who achieved CR/CRi had blast reductions that reached the important measurable residual disease-negative level, a result that is typically associated with stronger, more durable responses.

As the dataset continues to expand, efficacy and safety outcomes continue to deliver favorable results, further supporting mipletamig’s potential in the frontline setting.

*Clinical benefit rate: complete remission (CR), complete remission with incomplete hematologic recovery (CRi), and partial remission (PR)

**Phase 3 VIALE-A trial evaluating venetoclax plus azacitidine in frontline intent-to-treat AML patients who were ineligible for intensive induction chemotherapy, the reported composite CR/CRi rate was 66.4%, and the CR rate was 37% (DiNardo et al., New England Journal of Medicine, 2020).

Completed Leadership Transitions; Company Poised for a Defining Year

Aptevo entered 2026 with purposeful momentum, highlighted by a planned executive leadership transition designed to support the company’s next phase of growth. Jeff Lamothe was appointed President and Chief Executive Officer, while Marvin White transitioned to Executive Chair. The move reflects continuity in strategy while positioning the organization for focused execution across clinical development, capital strategy, and long-term value creation.

Q1 2026 Cash Position

Aptevo had cash and cash equivalents totaling $14.5 million as of March 31, 2026. During the first quarter of 2026, the company raised $0.9 million, net, under the company’s Standby Equity Purchase Agreements (SEPAs) with Yorkville. For additional APVO financial information and complete access to the company’s filings, click here.

Enhanced Financial Flexibility Supports Upcoming Catalysts

During the quarter, Aptevo secured a $60 million SEPA, providing meaningful access to capital and extending financial flexibility as the company advances toward planned milestones. Management believes the facility better positions Aptevo to execute strategically, support ongoing development programs, and approach future opportunities from a position of greater strength.

(Press release, Aptevo Therapeutics, MAY 13, 2026, View Source [SID1234665645])

Sapu Nano Announces First Patient Dosed in Phase 1b Trial of Sapu003, an Intravenous Deciparticle™ Formulation of Everolimus

On May 13, 2026 Sapu Nano and Oncotelic (OTCQB: OTLC) reported that the first patient has been dosed in the Phase 1b clinical trial of Sapu003, the Company’s investigational intravenous Deciparticle formulation of everolimus.

The trial: SP-03-B101- Sapu003 in Patients with Advanced mTOR-sensitive Solid Tumors, (NCT07369505), is a Phase 1b, open-label, dose-escalation trial designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of Sapu003 in patients with advanced mTOR-sensitive solid tumors. The investigational product is administered intravenously over 30 minutes once weekly in 4-week cycles.

The study includes two cohort patients. Cohort A enrolls patients with HR-positive/HER2-negative breast cancer, receiving Sapu003 in combination with aromatase inhibitor and Cohort B enrolls patients with renal cell carcinoma, neuroendocrine tumors, TSC-associated tumors, or hepatocellular carcinoma, receiving Sapu003 as monotherapy. Dose escalation follows a Bayesian Optimal Interval design, with planned dose levels of 5 mg/m², 7.5 mg/m², and 10 mg/m², and an optional lower dose cohort of 3.5 mg/m² if required for safety.

"This first-patient-dosed milestone represents an important step in advancing Sapu003 from clinical readiness into active patient treatment," said Dr. Vuong Trieu, Chief Executive Officer. "Everolimus is a validated mTOR inhibitor with established activity across multiple cancers, but oral delivery has limitations including variable absorption and dose-limiting toxicity. Sapu003 was designed to re-engineer everolimus, as a weekly IV Deciparticle formulation, with the goal of improving exposure control and expanding the therapeutic potential of mTOR inhibition."

The Sapu003 program has also been featured at the 2025 San Antonio Breast Cancer Symposium, held December 9-12, 2025. The Sapu003 program is being developed in collaboration with Southern Oncology Clinical Research Unit, iNGENū CRO, and Shanghai Medicilon, supporting the clinical, translational, pharmacokinetic, and manufacturing development of Sapu003.

(Press release, Sapu Bioscience, MAY 13, 2026, View Source [SID1234665644])