On July 7, 2025 Sona Nanotech Inc. (CSE: SONA) (OTCQB: SNANF) (the "Company", "Sona") an oncology-focused life sciences company developing innovative therapies based on its uniquely biocompatible gold nanorod technology, reported that a first dosing has been achieved in the previously announced early feasibility study of its Targeted Hyperthermia Therapy ("THT") cancer treatment (Press release, Sona Nanotech, JUL 7, 2025, View Source [SID1234654262]).

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Dr. Carman Giacomantonio, Sona’s CMO, commented, "Our unique therapy aims to modify tumors making them more visible to the immune system with a view to enabling an elimination of the cancer. As with any new technology, we are required to demonstrate that we can safely and feasibly deliver the treatment in the clinical setting. We have smartly designed this inaugural study to also provide us with some key, first ever reported, insights into its effect in human cancer. Success in this study will enable us to proceed to our next planned study that will more critically evaluate the biological effects and clinical outcomes of this exciting technology."

David Regan, CEO, commented, "Getting to this first dosing of a patient with our Targeted Hyperthermia Therapy is a milestone achieved through the culmination of years of research, toil and many preclinical studies. We plan to follow this critical first clinical step quickly with a second, more expansive human trial following further engagement with regulators, as well as a peer-reviewed article in a leading scientific journal detailing our findings. We also expect the learnings from this study to help inform on THT’s potential for complementing the treatment of other cancer types."

About the Study
The study is designed to assess THT’s safety, tolerability, and preliminary efficacy as measured by tumor growth inhibition and the extent to which it causes immune system engagement with the cancer. The study includes two treatments of Sona’s THT, one week apart, for patients with advanced melanoma who are, or have been on, standard of care immunotherapy protocols but have failed to respond or progressed during treatment. The study is anticipated to generate an initial read out of results this summer, with final results expected in the fall.

Technology will be evaluated for:

Ease of setting up and preparation for the treatment
Ease of administration of GNR’s in a variety of different tumors
Reproducibility in the clinical setting, i.e. the ability to train others to use the technology
Resource requirements, i.e. what additional resources are required in the clinical setting
Time required to administer the treatment in the clinical setting
Participants will be evaluated for:

Tolerability to the treatment itself
Adverse events during and following treatment
Clinical response, i.e. did the tumor change in any way after treatment
Pathological immune response, i.e. histological evidence of immune activation in the tumor that is directly relatable to the treatment itself.
Sona Nanotech believes that its THT cancer treatment may provide benefits over current standard of care immunotherapy treatments alone which have shown limited response rates and can have undesirable side effects.

On July 7, 2025 Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted protein degradation medicines, reported that the European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) to bexobrutideg (NX-5948) for the treatment of lymphoplasmacytic lymphoma (Press release, Nurix Therapeutics, JUL 7, 2025, View Source [SID1234654261]). Bexobrutideg is an orally bioavailable, brain penetrant degrader of Bruton’s tyrosine kinase (BTK) which is being evaluated in an ongoing Phase 1a/b clinical trial in adults with relapsed or refractory B-cell malignancies, including lymphoplasmacytic lymphoma, also known as Waldenström macroglobulinemia (WM).

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The EMA’s Orphan Drug Designation program grants orphan status to therapies intended for the treatment, diagnosis, or prevention of rare diseases that affect fewer than 5 in 10,000 people in the European Union. This designation provides several incentives to encourage the development of treatments for rare conditions, including 10 years of market exclusivity in the EU upon approval, access to protocol assistance, eligibility for centralized marketing authorization, and significant reductions in regulatory fees.

"The EMA’s Orphan Drug Designation for bexobrutideg represents an important milestone in our regulatory strategy and underscores the significant unmet medical need for improved treatments for Waldenström macroglobulinemia," said Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix. "Granting of the designation highlights bexobrutideg’s potential to provide patients with WM a promising new therapeutic option."

Waldenström macroglobulinemia is a rare type of blood cancer that affects B lymphocytes, a form of white blood cell. In this disease, B cells grow and survive abnormally, leading to their accumulation in the bone marrow, lymph nodes, and spleen. Early symptoms often include fatigue and weakness. It is characterized by the overproduction of IgM paraprotein—a blood protein that can cause the blood to thicken and lead to complications such as vision issues, heart problems, hemolytic anemia, and neurological symptoms.

Bexobrutideg previously received the U.S. Food and Drug Administration’s Fast Track designation in December 2024 for the treatment of WM and Fast Track designation in January 2024 for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) after at least two lines of therapy, including a BTK inhibitor and a B-cell lymphoma 2 (BCL2) inhibitor. In November 2024, the EMA granted PRIME designation to bexobrutideg for the treatment of adult patients with relapsed or refractory CLL/SLL after treatment with at least a BTK inhibitor and a BCL2 inhibitor.

About Bexobrutideg (NX-5948)

Bexobrutideg is an investigational, orally bioavailable, brain penetrant, small molecule degrader of BTK currently being evaluated in a Phase 1 clinical trial in patients with relapsed or refractory B cell malignancies. Nurix previously has reported encouraging safety and efficacy data in patients with WM treated in the ongoing Phase 1a/b clinical trial of bexobrutideg, demonstrating early promise of clinical benefit with potential for durable outcomes. Nurix continues to enroll patients with WM in an ongoing Phase 1b expansion cohort and anticipates sharing additional clinical data in 2025. Additional information on the ongoing clinical trial can be accessed at clinicaltrials.gov (NCT05131022). Nurix is also developing bexobrutideg for the potential treatment of inflammatory diseases.

On July 7, 2025 Inventiva (Euronext Paris and Nasdaq: IVA) ("Inventiva" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of oral therapies for the treatment of metabolic dysfunction-associated steatohepatitis ("MASH"), reported the receipt of a $10 million milestone payment from Chia Tai-Tianqing Pharmaceutical Group Co., Ltd ("CTTQ"), a subsidiary of Sino Biopharm (Press release, Inventiva Pharma, JUL 7, 2025, View Source [SID1234654260]).

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This milestone payment follows the successful settlement of the second tranche of €115.6 million1 in gross proceeds (net proceeds of €108.5 million) of the previously announced structured financing of up to €348 million2 (the "Structured Financing").

In September 2022, Inventiva entered into a licensing and collaboration agreement with CTTQ (as amended on October 11, 2024, the "CTTQ License Agreement") to develop and commercialize lanifibranor, Inventiva’s proprietary compound, for the treatment of MASH and potentially other metabolic diseases in Mainland China, Hong Kong Special Administrative Region, Macau Special Administrative Region and Taiwan. Under the CTTQ License Agreement, Inventiva is eligible to receive up to an additional $265 million of clinical, regulatory and commercial milestone payments, as well as royalties in the low single digits on annual net sales of lanifibranor, if approved.

Based on the results from the Phase 2b NATIVE clinical trial, lanifibranor was granted Breakthrough Therapy Designation for MASH by the U.S. Food and Drug Administration in October 2020 and by the Chinese National Medical Products Administration (NMPA) in December 2023. This designation could potentially accelerate the development and regulatory review of drug candidates for serious or life-threatening conditions. CTTQ joined Inventiva’s ongoing NATiV3 pivotal Phase 3 clinical trial, which includes over 60 sites across mainland China. Furthermore, CTTQ has completed a Phase I bridging study and confirmed no significant ethnic differences, thereby paving the way to seek regulatory approval in China based on the results of the NATiV3 trial.

On July 7, 2025 ImmunityBio, Inc. (NASDAQ: IBRX) reported that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for ANKTIVA (nogapendekin alfa inbakicept-pmln) in combination with Bacillus Calmette-Guérin (BCG) for the treatment of certain bladder cancer patients (Press release, ImmunityBio, JUL 7, 2025, View Source [SID1234654259]). This is the first marketing approval outside the U.S. for this novel lymphocyte-stimulating agent.

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"With the MHRA’s authorization of ANKTIVA plus BCG, we can now offer our immunotherapy outside the U.S. to help patients with a disease that, if not effectively treated, can lead to bladder removal," said Dr. Patrick Soon-Shiong, Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. "This immune-boosting, lymphocyte-stimulating agent, the first of its kind, is central to our Cancer BioShield platform, which is designed to restore immune function and support long-term disease control."

"ImmunityBio is honored to have received this important authorization from the UK MHRA. In light of the United States Most-Favored-Nation Prescription Drug Pricing policy implemented on May 12, 2025, we are actively evaluating our go-to-market strategy for the UK," said Richard Adcock, CEO and President of ImmunityBio.

ANKTIVA is a first-in-class IL-15 agonist that activates and proliferates natural killer (NK) cells and CD4+ and CD8+ T cells. It is designed to restore immune competence by reversing lymphopenia—a condition in which cancer and conventional therapies, such as chemotherapy, radiation and checkpoint inhibitors, reduce the number and function of immune cells. Restoring immune function is essential for immunosurveillance, immunogenic cell death, and sustained tumor control. The BioShield platform’s effectiveness can be monitored using a routine complete blood count (CBC).

ANKTIVA was designated a Breakthrough Therapy by the FDA and received approval from both the FDA and MHRA based on its safety and efficacy outcomes of complete response (CR) and duration of response (DOR). In a single-arm, multicenter trial, 77 evaluable patients received ANKTIVA with BCG for up to 37 months.

As of the November 2023 data cutoff, the duration of complete response for some patients exceeded 47 months and remains ongoing. These extended duration of complete responses beyond 24 months with ANKTIVA and BCG surpasses the benchmark for meaningful clinical results set by experts from the International Bladder Cancer Group.

ImmunityBio has also submitted regulatory applications to the European Medicines Agency (EMA) to expand availability of ANKTIVA across the 27 European Union (EU) member states, as well as Iceland, Norway and Liechtenstein.

About NMIBC CIS

Bladder cancer is the 10th most commonly-diagnosed cancer globally,2 and in the UK, the Action Bladder Cancer UK estimates approximately 23,000 patients are diagnosed annually.1 At the time of diagnosis, about 80% of cases are non-muscle invasive bladder cancer (NMIBC), wherein the cancer is found only on the inner layer of the bladder wall.3 The standard therapy for NMIBC is intravesical instillation (delivery to the bladder via a catheter) of bacillus Calmette-Guerin (BCG).4,5 BCG is a benign bacteria that induces an immune response in the bladder in proximity to the cancer cells, leading to clearance of the cancer in many patients. In ~30-40% of patients, however, BCG will fail, and in ~50% that initially respond, cancer will recur.6

About ANKTIVA

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.

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 drives the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones. The proliferation of the trifecta of these immune killing cells and the activation of trained immune memory results in immunogenic cell death, inducing a state of equilibrium with durable complete responses. ANKTIVA has improved pharmacokinetic properties, longer persistence in lymphoid tissues, and enhanced anti-tumor activity compared to native, non-complexed IL-15 in-vivo.

ANKTIVA was approved by the FDA in 2024 for BCG-unresponsive non-muscle invasive bladder cancer CIS with or without papillary tumors. For more information, visit Anktiva.com.

Indication and Important Safety Information from the FDA Label

INDICATION AND USAGE: ANKTIVA is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Guerin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

WARNINGS AND PRECAUTIONS: Risk of Metastatic Bladder Cancer with Delayed Cystectomy. Delaying cystectomy can lead to the development of muscle invasive or metastatic bladder cancer, which can be lethal. If patient with CIS do not have a complete response to treatment after a second induction course of ANKTIVA with BCG, reconsider cystectomy.

DOSAGE AND ADMINISTRATION: For lntravesical Use Only. Do not administer by subcutaneous or intravenous routes. Instill intravesically only after dilution. Total time from vial puncture to the completion of the intravesical instillation should not exceed 2 hours.

USE IN SPECIFIC POPULATIONS: Pregnancy: May cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.

ADVERSE REACTIONS: The most common (≥15%) adverse reactions, including laboratory test abnormalities, are increased creatinine, dysuria, hematuria, urinary frequency, micturition urgency, urinary tract infection, increased potassium, musculoskeletal pain, chills and pyrexia.

For more information about ANKTIVA, please see the Full Prescribing Information at www.anktiva.com.

You are encouraged to report negative side effects of prescription drugs to FDA.

Visit www.FDA.gov/medwatch or call 1-800-332-1088. You may also contact lmmunityBio at 1-877-ANKTIVA (1-877-265-8482)

On July 7, 2025 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519, hereafter "Chugai"), and Gero PTE. LTD. (hereafter "Gero"), a Singapore-based biotechnology company, reported that they have entered into a joint research and license agreement to develop novel therapies for age-related diseases (Press release, Chugai, JUL 7, 2025, View Source [SID1234654258]).

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In this collaboration, Chugai will create novel antibody drug candidates using its proprietary antibody engineering technologies for new drug targets discovered by Gero through analysis of human datasets using their unique AI target discovery platform. Under this agreement, Gero grants Chugai exclusive worldwide rights for the creation, research, development, manufacturing, and commercialization of antibodies for the identified targets. In addition to an upfront payment, Chugai will potentially pay up to approximately 250 million USD in total if predetermined development or sales milestones are achieved. If Chugai successfully launches a product, it will also pay royalties on sales to Gero.

"We believe that open innovation with external partners, including leading global players, is extremely important for achieving global first-class drug discovery outlined in our growth strategy toward 2030, TOP I 2030. By combining Gero’s target discovery technology with Chugai’s drug discovery technologies, we will accelerate the creation of innovation," said Chugai’s President and CEO, Dr. Osamu Okuda.

"Our AI platform is built to identify therapeutic targets that drive multiple age-related diseases and potentially aging itself," said Peter Fedichev, CEO of Gero. "In this collaboration, we aim to translate those insights into therapeutics that can help restore the lost function. This partnership with Chugai is an important step toward achieving Gero’s mission: to meaningfully target the biological processes of human aging."

"We are excited to partner with Chugai, a leading pharmaceutical company, to unlock the synergy between human data-driven target discovery and cutting-edge therapeutic design technology platforms. Together, we aim to develop first-in-class therapeutics to address unmet needs of increasing number of patients suffering from age-related diseases," said Alex Kadet, CBO of Gero.