On January 14, 2026 ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, reported that the Saudi Food and Drug Authority (SFDA) has granted accelerated approval of ANKTIVA (nogapendekin alfa inbakicept) for use in combination with immune checkpoint inhibitors for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose disease has progressed following standard-of-care therapy. This marks the first approval of the Company’s innovative treatment for this indication anywhere in the world, and the first approval for subcutaneous administration.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"This approval represents a significant step forward for lung cancer patients in the Kingdom of Saudi Arabia and a meaningful milestone that we hope will pave the way toward additional approvals across a region where lung cancer claims far too many lives each year," said Patrick Soon-Shiong, M.D., ImmunityBio’s Founder, Executive Chairman, and Global Chief Scientific and Medical Officer. "This combination of ANKTIVA plus a checkpoint inhibitor serves as a foundational backbone to immunotherapy 2.0, enabling activation of the complex immune system through subcutaneous outpatient therapy."

Dr. Soon-Shiong added, "We are pleased that the Saudi FDA recognized the significance of ANKTIVA in restoring and maintaining immune competence and achieving prolonged survival in patients with lung cancer who have exhausted all standards of care. Clinical studies are ongoing to build on this ANKTIVA plus CPI backbone, as well as to evaluate CAR-NK cell therapy plus this combination in other indications. The goal of this combination immunotherapy approach is to orchestrate the immune system as a paradigm shift in the treatment of cancer across all tumor types. The NANT Cancer Vaccine (Patent #11,071,774) describes this vision of a next-generation immunotherapy designed to achieve durable remission and improved quality of life for patients with cancer."

In the Kingdom of Saudi Arabia, lung cancer is one of the most prevalent cancer types overall, according to the Saudi Ministry of Health, and is the third most common cancer among males over 45 years of age, as discussed at the Inaugural Summit: USA-Saudi Biotech Alliance meeting.1

ImmunityBio plans to open a regional office in the Kingdom of Saudi Arabia to support physicians and health systems across the Middle East and North Africa. The company will collaborate with Biopharma Cigalah as its commercial and distribution partner in the region. Founded in 2007, BioPharma Cigalah provides the commercial infrastructure and capabilities needed to support therapies for serious diseases and expand patient access throughout the Middle East and North Africa.

"The incidence of lung and other cancers in the Middle East and North Africa is large and growing, demonstrating a significant unmet need for the kind of innovative treatments ImmunityBio is developing," added Richard Adcock, President and CEO of ImmunityBio. "We are pursuing approvals across the region to fill that need, as well as investing in a regional office in Saudi Arabia in order to support our expansion into these growing markets."

The accelerated approval for NSCLC is based on an observed increase in absolute lymphocyte count (ALC) associated with overall survival in single-arm clinical study (QUILT 3.055) together with the randomized trial QUILT 2.023 demonstrating the biological activity of ANKTIVA in restoring and maintaining lymphocyte count (see related announcement here). An ongoing confirmatory randomized trial in NSCLC is actively recruiting patients who have failed chemoradiation and checkpoint inhibitors (ResQ 201A).

The combination of ANKTIVA plus checkpoint inhibitor therapy is protected by multiple issued patents, including U.S. Patent Nos. 9,925,247 and 11,071,774, with patent terms extending into 2032–2039.

About ANKTIVA (nogapendekin alfa inbakicept)

The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells. By activating NK cells, ANKTIVA overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response. A key component in the Company’s BioShield platform, ANKTIVA is a first-in-class IL-15 agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 by dendritic cells and driving the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones.

(Press release, ImmunityBio, JAN 14, 2026, View Source [SID1234662041])

On January 14, 2026 Rapt therapeutics presented its corporate presentation.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

(Presentation, RAPT Therapeutics, JAN 14, 2026, View Source [SID1234662043])

On January 14, 2026 Sana Biotechnology presented its corporate presentation.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

(Presentation, Sana Biotechnology, JAN 14, 2026, View Source [SID1234662044])

On January 14, 2026 Beyond Air, Inc. (NASDAQ: XAIR) ("Beyond Air" or the "Company"), a commercial stage medical device and biopharmaceutical company focused on harnessing the power of nitric oxide to improve the lives of patients, reported that it entered into a securities purchase agreement with an institutional investor to issue and sell, in a private placement priced at-the-market under Nasdaq rules, 3,930,818 shares of common stock (or pre-funded warrants in lieu thereof), and warrants to purchase up to an aggregate of 3,930,818 shares of common stock, at a combined purchase price of $1.272 per share of common stock (or pre-funded warrant in lieu thereof, less the nominal exercise price of $0.0001 per share) and associated warrant, for expected gross proceeds of approximately $5.0 million, before deducting placement agent fees and other offering expenses payable by the Company. The warrants will have an exercise price of $1.147 per share of common stock and will be exercisable immediately upon issuance with a term of five years following the date of issuance.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Rodman & Renshaw LLC is acting as the exclusive placement agent for the private placement. Roth Capital Partners and D. Boral Capital are acting as financial advisors to the Company for the private placement.

The closing of the private placement is expected to occur on or about January 16, 2026, subject to the satisfaction of customary closing conditions. The Company intends to use the net proceeds from the private placement for working capital and for general corporate purposes.

The offer and sale of the foregoing securities are being made in a transaction not involving a public offering and the securities have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or applicable state securities laws. Accordingly, the securities 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. Under an agreement with the investor, the Company agreed to file one or more registration statements with the Securities and Exchange Commission covering the resale of the shares of common stock to be issued to the investors, including the shares of common stock issuable upon the exercise of the warrants.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other 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 other jurisdiction.

(Press release, Beyond Air, JAN 14, 2026, View Source [SID1234662045])

On January 14, 2026 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS’’ or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported that it has entered into an agreement with IMPACT-AML, a European collaborative initiative dedicated to advancing innovative treatments for patients with acute myeloid leukemia (AML). Under the agreement, the IMPACT-AML network will conduct a clinical study evaluating SLS009, a highly selective CDK9 inhibitor, enabling access to multiple European clinical sites and patients.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

IMPACT-AML is a pan-European project and builds an inclusive clinical network (STREAM platform) that connects patients, clinicians, and researchers to test novel AML therapies and improve patient outcomes (View Source). It is part of the prestigious EU Mission Cancer program and a top-tier scientific cluster. The IMPACT-AML project is led by a consortium of major research and clinical institutions in Europe, including IRST (IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori"), the University of Bologna, IIS LA FE (Health Research Institute Hospital La Fe), several European AML collaborative groups, and supranational organizations under the umbrella of the European Leukemia Net (ELN), as well as various university hospitals across Europe. By leveraging IMPACT-AML’s existing infrastructure and expertise, SELLAS expects to expand European patient access to SLS009 in a highly cost-efficient manner while supporting broader participation across the clinical program.

"This is a highly meaningful milestone for SELLAS and for the SLS009 program," said Angelos Stergiou, M.D., Sc.D., President and Chief Executive Officer of SELLAS. "Gaining access to the IMPACT-AML framework represents strong external validation of SLS009 and reflects the growing recognition of SLS009’s potential in addressing critical unmet needs in AML. Importantly, this collaboration allows us to efficiently expand our clinical program into Europe by leveraging an established infrastructure, significantly improving capital efficiency while supporting broader and faster patient enrollment as we advance the program into frontline AML."

The collaboration is expected to support the continued execution of the SLS009 clinical program as SELLAS advances into frontline AML. The study in Europe is planned to enroll approximately 40 patients to evaluate SLS009 in combination with azacitidine and venetoclax (AZA/VEN) in patients with newly diagnosed AML with high-risk features. Enrollment in the first part of the trial for newly diagnosed patients is expected to begin at U.S. sites in Q1 2026, followed by initiation at European sites in Q2 2026, subject to regulatory and site readiness.

"IMPACT-AML is committed to accelerating access to promising new therapeutic approaches for patients with AML who face limited treatment options," said IMPACT-AML Scientific Coordinator, Dr. Giovanni Martinelli. "We are pleased to collaborate with SELLAS and support the evaluation of SLS009 within our European network, consistent with our mission to facilitate efficient, high-quality clinical research in AML."

(Press release, Sellas Life Sciences, JAN 14, 2026, View Source [SID1234662046])