On March 26, 2026 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, reported a 30-minute oral presentation on TG4050, the Company’s Individualized Neoantigen Therapeutic Vaccine (INTV) at the World Vaccine Congress (WVC), taking place from March 31 to April 2, 2026, in Washington, D.C., USA. The presentation will be held on April 1st.

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The presentation will highlight findings of the Phase 1 part of the ongoing Phase 1/2 trial in head and neck cancer. Transgene will also discuss the potential of INTVs to reshape early-stage cancer treatment.

"We are delighted to share our positive data on our lead asset TG4050 with the scientific community", said Katell Bidet Huang, PhD, Head of Translational Medicine at Transgene.
"TG4050 is a highly innovative, AI-powered, immunotherapy designed individually for each patient, based on its tumor characteristics. In our Phase 1 trial, we were able to show that patients with resected head and neck cancer treated with our vaccine had developed new immune responses targeting preselected neoantigens present in the tumor cells, and TG4050-treated patients were all tumor-free 2 years after the start of their immune treatment. The comprehensive translational data generated to date supports our proposed mechanism of action and the ongoing Phase 2 trial. This technology could be applied across multiple solid tumors where significant unmet medical need remains.
With the myvac platform, Transgene will continue generating clinical data in patients with head and neck cancer and in an additional indication with the aim of preventing cancer relapse for patients at risk."

About the Oral Presentation:

Title: TG4050, an Individualized Neoantigen Therapeutic Vaccine in early-stage cancer treatment
Speaker: Dr Katell Bidet Huang, PhD, Head of Translational Medicine, Transgene
Session: Cancer & Immunotherapy Vaccines Conference – Early Development/Target selection & discovery
Date: April 1st, 2026, at 12:10 PM

(Press release, Transgene, MAR 26, 2026, View Source [SID1234663945])

On March 26, 2026 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported its business update and consolidated financial results for the year ending December 31, 2025. The consolidated financial statements are attached to this press release.

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"2025 has been a year of strong execution across our portfolio. With the TELLOMAK-3 design finalized and FDA clearance in hand, lacutamab is planned for confirmatory Phase 3 initiation in H2 2026, dependent on current negotiations with pharma partners and royalty structures. IPH4502, our Nectin-4 exatecan ADC, is progressing rapidly, with early signs of anti-tumor activity in heavily pre-treated patients, including in urothelial cancer post-enfortumab vedotin, where we aim to validate our preclinical hypothesis supporting a differentiated profile versus MMAE-based approaches. We continue to enrich cohorts at pharmacologically active dose levels, and explore activity in tumors with low to moderate Nectin-4 expression, where we believe IPH4502 has best-in-class potential among Topo I-based Nectin-4 ADCs. We look forward to the PACIFIC-9 readout in H2 2026, which remains a key catalyst for Innate Pharma," said Jonathan Dickinson, Chief Executive Officer of Innate Pharma.

Pipeline highlights:

Lacutamab (anti-KIR3DL2 antibody):

Cutaneous T Cell Lymphoma

The planned confirmatory Phase 3 TELLOMAK-3 trial is an open-label, multi-center, randomized, comparative study evaluating lacutamab in patients with Sézary syndrome and mycosis fungoides, who have failed at least one prior systemic therapy.
TELLOMAK-3 includes two cohorts: a confirmatory cohort in Sézary syndrome, intended to support a potential Accelerated Approval based on existing TELLOMAK Phase 2 data, and a registrational cohort in mycosis fungoides, intended to support full approval. The primary endpoint of the study for both cohorts is progression-free survival (PFS) evaluated by blinded central review.
Following the U.S. Food and Drug Administration (FDA) review of the Phase 3 protocol, with no further comments in November 2025, the trial is planned for initiation in H2 2026.
The FDA provided encouraging feedback on the TELLOMAK Phase 2 results and the proposed regulatory pathway, which may support an Accelerated Approval in Sézary syndrome once the Phase 3 trial is underway. In February 2025, the FDA granted Breakthrough Therapy Designation to lacutamab for relapsed or refractory Sézary syndrome.
The TELLOMAK Phase 2 trial is completed, and patients who were receiving treatment will continue to receive lacutamab through a Post Trial Access program.
Peripheral T Cell Lymphoma (PTCL)

KILT (anti-KIR in T-Cell Lymphoma) Phase 2 trial, an investigator-sponsored, randomized study led by the Lymphoma Study Association (LYSA) evaluating lacutamab in combination with GEMOX (gemcitabine and oxaliplatin) versus GEMOX alone in patients with KIR3DL2-expressing relapsed/refractory PTCL, is ongoing.
IPH4502 (Nectin-4 exatecan ADC):

The IPH4502-101 Phase 1 study (NCT06781983), recruiting in France and in the United States, is evaluating the safety, tolerability, and preliminary anti-tumor activity of IPH4502 in advanced solid tumors known to express Nectin-4, including but not limited to urothelial carcinoma, non-small cell lung, breast, ovarian, gastric, esophageal, and colorectal cancers.
The first patient was dosed in January 2025. The maximum tolerated dose (MTD) is currently being explored, with cohort enrichment ongoing at pharmacologically active dose levels, including in patients with urothelial cancer relapsed or refractory to enfortumab vedotin, as well as selected additional tumor types. Preliminary anti-tumor activity was observed in heavily pre-treated patients with advanced solid tumors with a favorable safety profile to date.
Monalizumab (anti-NKG2A antibody), partnered with AstraZeneca:

The PACIFIC-9 Phase 3 trial run by AstraZeneca evaluating durvalumab (anti-PD‑L1) in combination with monalizumab or AstraZeneca’s oleclumab (anti-CD73) in patients with unresectable, Stage III non-small cell lung cancer (NSCLC) who have not progressed following definitive platinum-based concurrent chemoradiation therapy (CRT) is ongoing. Enrollment in the trial is complete, and data readout is expected in H2 2026.
Other Clinical stage assets

IPH5201 (anti-CD39 antibody, partnered with AstraZeneca): The MATISSE Phase 2 trial, evaluating IPH5201 in combination with durvalumab and platinum-based chemotherapy in the neoadjuvant lung cancer setting, is ongoing and continues recruitment, following a pre-planned interim analysis performed for efficacy on 40 patients. These interim results have been selected for an oral presentation in a Clinical Trials Plenary Session at the AACR (Free AACR Whitepaper) Annual Meeting 2026 (April 17–22, 2026, San Diego).

IPH5301 (anti-CD73, proprietary): The investigator-sponsored CHANCES Phase 1 trial of IPH5301 with Institut Paoli-Calmettes is ongoing.

IPH6101 (ANKET anti-CD123, proprietary): Innate regained the rights to SAR’579/IPH6101 in July 2025. Innate has initiated a research collaboration to further assess next steps of development.

IPH6501 (ANKET anti-CD20 with IL-2V, proprietary): The Phase 1/2 study has evaluated IPH6501 in patients with B-cell non-Hodgkin’s lymphoma (B-NHL). Following completion of dose escalation, the study has been discontinued as part of the Company’s strategic prioritization of its pipeline. Clinical data are expected to be presented in 2026.

IPH6401/SAR’514 (ANKET anti-BCMA, partnered with Sanofi): In a recent corporate update, Sanofi announced deprioritization of SAR’514, a trifunctional anti-BCMA NK-cell engager. Sanofi retains exclusive development and commercialization rights, and the license terms remain unchanged.

Corporate Update:

As previously announced, in line with its strategic focus, the Company has streamlined its organization. Planned layoffs are being implemented through a redundancy plan and should be completed in H1 2026. A collective majority agreement supporting the redundancy plan was endorsed by the French authorities (Dreets) in December 2025.
The ATM program, pursuant to which Innate may, from time to time, offer and sell to eligible investors a total gross amount of up to $75 million of American Depositary Shares ("ADS") is still in place. As of December 31, 2025, no sales have been made under the program. As of December 31, 2025, the balance available under our April 2023 sales agreement under the At-The-Market program remains at $75 million.
Financial highlights for 2025:

The key elements of Innate’s financial position and financial results as of and for the year ended December 31, 2025 are as follows:

Cash, cash equivalents, short-term investments and financial assets amounting to €44.8 million as of December 31, 2025 (€91.1m as of December 31, 2024), including €10.5m in non-current financial instruments (€10.3m as of December 31, 2024).
As of December 31, 2025, financial liabilities amount to €22.6m (€31.0m as of December 31, 2024). This change is mainly due to loan repayments.
Revenue and other income amounted to €9.0m in 2025 (2024: €20.1m, -55.2%). It mainly comprises revenue from collaboration and licensing agreements (€2.8m in 2025 vs €12.6m in 2024, -77.9%), and research tax credit (€6.2m in 2025 vs €7.5m in 2024, -17.1%):
Revenue from collaboration and licensing agreements mainly resulted from the partial or entire recognition of the proceeds received pursuant to the agreements with AstraZeneca and Sanofi. They are recognized when the entity’s performance obligation is met. Their accounting is made at a point in time or spread over time according to the percentage of completion of the work that the Company is committed to carry out under these agreements:
(i) Revenue from collaboration and licensing agreements for monalizumab decreased by €4.2m to €0.2m in 2025 ( €4.4m in 2024). As of December 31, 2025, the revenue from this agreement has been fully recognized, and accordingly, no "Current contract liabilities" related to these studies remains.
(ii) Revenue related to the research collaboration and licensing agreement signed with Sanofi in 2022 amounted €0.4m as of December 31, 2025 (€2.1m as of December 31, 2024). After Sanofi’s announcement in October 2024 that it was returning the rights related to its second option, terminating the research collaboration, the €1.7 million in revenue allocated to the research work to be conducted by the company was recognized in full in the income statement as of December 31, 2024. Revenue related to research work on the first license amounted to €401,000 during fiscal year 2025, as it did during fiscal year 2024.
(iii) Revenue related to the license and collaboration agreement signed with Sanofi in 2016 decreased by €4.0m and are nil for year ended December 31, 2025. Innate regained the right to SAR’579/IPH6101 in July 2025.
The research tax credit (CIR) of €6.2m of as December 31, 2025 (€7.5m for year ended December 31, 2024). The 17% decrease resulted from the eligible costs decrease.
Operating expenses amounted to €63.0m in 2025 (2024: €71.7m, -12.1%):
General and administrative (G&A) expenses amounted to €19.4m in 2025 (2024: €19.7m, -1.6%). These expenses represented 27% and 31% of net operating expenses for the years ended December 31, 2024 and 2025 respectively. G&A expenses mainly comprise personnel costs not allocated to research and development, as well as costs of services relating to the management of the Company. The decrease between 2024 and 2025 results from the combined effect of (i) lower non‑scientific consulting fees and (ii) reduced insurance expenses. Personnel expenses remained stable despite €0.6 million in restructuring charges resulting from the implementation of the Workforce Restructuring Plan (Plan de Sauvergarde de Sauvegarde de l’Emploi).
Research and development (R&D) expenses from continuing activities amounted to €43.6m in 2025 (2024: €52.0m, -16.1%). R&D expenses from continuing operations amounted to €43.6 million and €52.0 million for the years ended December 31, 2025 and 2024, respectively. These expenses represented 73% and 69% of net operating expenses from continuing operations for the years ended December 31, 2024 and 2025, respectively. The decrease between 2024 and 2025 mainly reflects lower direct research and development costs related to clinical programs. Indirect research and development expenses decreased primarily due to lower personnel costs (excluding restructuring charges of €2.3 million), reduced scientific consulting fees, lower depreciation and amortization, and a decrease in intellectual property expenses, partially offset by restructuring charges associated with the implementation of the Workforce Restructuring Plan (Plan de Sauvegarde de l’Emploi).
A net financial income of €4.8m in 2025 (2024: €2.1m gain). The financial income has been increased due to favorable foreign exchange impact.
A net loss of €49.2m in 2025 (2024: net loss of €49.5m).
The table below summarizes the IFRS consolidated financial statements as of and for the year ended December 31, 2025, including 2024 comparative information.

In thousands of euros, except for data per share

December 31, 2025

December 31, 2024

Revenue and other income

9,005

20,121

Research and development

(43,620)

(51,980)

Selling, general and administrative

(19,394)

(19,716)

Total operating expenses

(63,013)

(71,696)

Operating income (loss) before impairment

(54,008)

(51,575)

Impairment of intangible asset

—

—

Operating income (loss) after impairment

(54,008)

(51,575)

Net financial income (loss)

4,831

2,104

Income tax expense

—

—

Net income (loss) from continuing operations

(49,177)

(49,471)

Net income (loss) from discontinued operations

—

—

Net income (loss)

(49,177)

(49,471)

Weighted average number of shares outstanding (in thousands)

89,591

81,052

Basic income (loss) per share

(0.55)

(0.61)

Diluted income (loss) per share

(0.55)

(0.61)

Basic income (loss) per share from continuing operations

(0.55)

(0.61)

Diluted income (loss) per share from continuing operations

(0.55)

(0.61)

Basic income (loss) per share from discontinued operations

—

—

Diluted income (loss) per share from discontinued operations

—

—

December 31, 2025

December 31, 2024

Cash, cash equivalents and financial asset

44,765

91,051

Total assets

62,719

111,059

Shareholders’ equity

-21,704

8,834

Total financial debt

22,573

30,995

(Press release, Innate Pharma, MAR 26, 2026, View Source [SID1234663944])

On March 26, 2026 Inhibikase Therapeutics, Inc. (Nasdaq: IKT) ("Inhibikase" or "Company"), a clinical-stage pharmaceutical company developing therapeutics to modify the course of cardiopulmonary diseases namely, Pulmonary Arterial Hypertension ("PAH"), reported financial results for the year ended December 31, 2025 and highlighted recent developments.

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"The fourth quarter of 2025 was a transformational quarter for the Company as we transitioned to a global pivotal Phase 3 clinical study in Pulmonary Arterial Hypertension following receipt of a Written Response from a Type C interaction from the United States Food and Drug Administration," said Mark Iwicki, Chief Executive Officer of Inhibikase. "With regulatory submissions in over 20 countries already filed and our first sites initiated, we are well-placed to advance enrollment in our global pivotal study, called IMPROVE-PAH, in PAH."

Recent Developments:

The Company is advancing IKT-001 into a global pivotal Phase 3 study in PAH:
The Phase 3 study, named IMPROVE-PAH (IKT-001 for Measuring Pulmonary Vascular Resistance and Outcome Variables in a Phase 3 Evaluation of PAH; NCT07365332), has been initiated with regulatory approval and the recent activation of our first clinical sites in the United States.
Following receipt from the United States Food and Drug Administration (the "FDA") of the Written Response from the Company’s Type C meeting interaction with the agency, the Company is initiating a two-part adaptive Phase 3 study.
Part A of IMPROVE-PAH is a double blind, placebo-controlled study in approximately 140 patients with a primary endpoint of Pulmonary Vascular Resistance ("PVR") at Week 24.
Part B of IMPROVE-PAH, which shall immediately commence enrollment following enrollment of the last patient in Part A, adopts an identical format to Part A, except the primary endpoint will be 6-minute walk distance ("6MWD") at Week 24 in approximately 346 patients.
The Company believes this adaptive Phase 3 study design has important advantages including: (1) permitting a 12-week dose-titration phase designed to get patients to the highest tolerable dose of IKT-001; (2) uninterrupted enrollment between Part A and Part B; and (3) the ability to, if necessary, undertake a sample size re-estimation for Part B based on Part A findings.
IMPROVE-PAH is expected to be conducted in up to approximately 180 sites around the world.
The Company is progressing regulatory approvals with submissions in over 20 countries together with receiving confirmation of acceptance under "Facilitating and Accelerating Strategic Trials in the European Union", called FAST-EU, which is a pilot initiative that commenced on January 30, 2026 to accelerate the approval of multinational clinical trials. FAST-EU offers a potential maximum 10-week (70-day) timeline for authorization, integrating Ethics Committee opinions and improving efficiency within the European Union Clinical Trials Information System.
Inhibikase successfully completed various required pre-clinical studies that are necessary to support an application to the FDA for Orphan Drug Designation for delivery of IKT-001 for PAH. Various information from these studies is expected to be presented at the American Thoracic Society International Conference to be held in Orlando, Florida on May 17th and 20th, 2026.
In November 2025, the Company completed a $115 million underwritten public offering of its common stock and pre-funded warrants.
Aggregate gross proceeds from this offering were approximately $115 million, before deducting underwriting discounts and commissions and other offering expenses, excluding the exercise of any pre-funded warrants.
Financial Results

Cash Position: As of December 31, 2025, cash, cash equivalents and marketable securities were $178.8 million as compared to $97.5 million as of December 31, 2024.

Net Loss: Net loss for the year ended December 31, 2025, was $48.3 million, or $0.49 per share, compared to a net loss of $27.5 million, or $1.16 per share in the year ended December 31, 2024.

R&D Expenses: Research and development expenses were $29.8 million for the year ended December 31, 2025, which includes a non-cash write-off of in-process research and development of $7.4 million and $2.5 million of stock-based compensation expense, both associated with the Company’s acquisition of CorHepta in February 2025, compared to $17.2 million for the year ended December 31, 2024.

SG&A Expenses: Selling, general and administrative expenses for the year ended December 31, 2025 were $23.6 million, which includes $1.0 million of severance expenses resulting from the transition of senior executives in the Company during the year, compared to $11.4 million for the year ended December 31, 2024.

(Press release, Inhibikase Therapeutics, MAR 26, 2026, View Source [SID1234663943])

On March 26, 2026 ImmunityBio, Inc. (NASDAQ: IBRX), a vertically integrated, commercial-stage immunotherapy company, reported that based on the Independent Data Monitoring Committee (IDMC) review of the interim data, the committee recommended that the study is adequately powered to detect the pre-specified clinically meaningful difference in complete response (CR) rate between the experimental arm (ANKTIVA + BCG) and the control arm (BCG alone) at the protocol-specified power, in the randomized QUILT-2.005 (NCT02138734) study. The QUILT-2.005 study was designed to detect the pre-specified difference in CR rate between ANKTIVA (nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG) and BCG alone in patients with BCG-naïve non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary disease, based on its review of the planned interim analysis.

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On February 26, 2026, ImmunityBio announced enrollment was complete in the pivotal randomized trial. By March 2026, 50% of enrolled patients were evaluable (N=183) for the primary efficacy endpoint. Upon reaching this pre-specified 50% evaluable threshold, a planned interim analysis by an IDMC was initiated per protocol to verify that the 366 patients enrolled to date provides sufficient statistical power to detect the pre-specified clinically meaningful difference in CR rate between the two arms.

Based on the IDMC review of the interim data, the committee recommended that no additional enrollment beyond N=366 is required and that the study is adequately powered to detect the pre-specified clinically meaningful difference in CR rate at the protocol-specified power.

"Over the past decade, our scientific thesis has been that activating natural killer cells and CD8+ cytotoxic T cells through IL-15 receptor agonism would generate durable immunological memory against bladder cancer. The NCI identified IL-15 as the number one ranked immunostimulatory cytokine nearly two decades ago, and this program has been the clinical validation of that thesis. The IDMC’s confirmation that QUILT-2.005 is adequately powered to detect clinically meaningful differences when ANKTIVA is combined with BCG. Among participants from the QUILT 2.005 Phase 1b study which began in 2014, those patients who enrolled in long-term follow-up (6 of 9 evaluable), all (6 out of 6, 100%) demonstrated a prolonged duration of complete remission with a median survival of 8.8 years with ongoing bladder preservation to date. In addition, the initial interim analysis of QUILT-2.005 performed in the first 43 patients in 2023, further demonstrated a difference in durable complete response when ANKTIVA is combined with BCG in the BCG-naïve setting. The consistency of durable response from the first 9 patients in 2014, to the next 43 patients in 2023 is encouraging and I am pleased that statistical power of the randomized trial requires no further enrollment," said Patrick Soon-Shiong, M.D., Founder, Executive Chairman and Global Chief Medical and Scientific Officer of ImmunityBio. "The combination of ANKTIVA with BCG is approved for adult patients with BCG-unresponsive NMIBC with CIS with or without papillary disease, and the enrollment of QUILT-2.005 is now complete. ImmunityBio is on track to submit a supplemental Biologics License Application based on the final data analysis in 2026."

"The regulatory and commercial development of ANKTIVA in urologic oncology and across solid tumor indications continues to advance. We are grateful to the patients who participated in this trial and to the ImmunityBio team whose work made this milestone possible," said Richard Adcock, President and CEO of ImmunityBio. "With ANKTIVA approved with BCG for adult patients with BCG-unresponsive NMIBC CIS with or without papillary disease in 34 countries and territories, the opportunity to extend its use earlier in the disease course in the BCG-naïve setting represents a substantial expansion of the addressable patient population."

About QUILT-2.005

QUILT-2.005 (NCT02138734) is a randomized, controlled Phase 2b clinical trial evaluating ANKTIVA (nogapendekin alfa inbakicept-pmln) in combination with Bacillus Calmette-Guérin (BCG) versus BCG alone in patients with BCG-naïve non-muscle invasive bladder cancer (NMIBC). BCG-naïve patients are those receiving BCG-based therapy for the first time, representing an earlier stage of treatment than the BCG-unresponsive population for whom ANKTIVA is currently FDA approved. The trial is designed to assess whether the addition of ANKTIVA to standard induction BCG improves the complete response (CR) rate in patients with carcinoma in situ (CIS) with or without papillary disease. QUILT-2.005 completed enrollment in February 2026. In March 2026, the Independent Data Monitoring Committee determined that the study was adequately powered to detect a clinically meaningful difference between the control and experimental arms. Supplemental BLA submission is anticipated Q4 2026.

About ANKTIVA (nogapendekin alfa inbakicept-pmln)

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 receptor 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 dendritic cell membrane-bound IL-15 receptor alpha 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.

IMPORTANT SAFETY INFORMATION

INDICATION AND USAGE: ANKTIVA is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Guérin (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 patients 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 Intravesical Use Only. Do not administer by subcutaneous or intravenous routes.

Please see the complete Indication and Important Safety Information and Prescribing Information for ANKTIVA at Anktiva.com.

(Press release, ImmunityBio, MAR 26, 2026, View Source [SID1234663942])

On March 26, 2026 HOOKIPA Pharma Inc. (OTCID: HOOK, "HOOKIPA", the "Company") reported the completion of the sale of its immuno-oncology related assets, consisting primarily of the HB-200 (eseba-vec) and HB-700 development programs, to NeoTrail Therapeutics, Inc. ("NeoTrail"). The purchase price remains undisclosed. The asset purchase agreement was signed on January 28, 2026, and the closing of the transaction occurred on March 20, 2026.

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About HB-200
Eseba-vec (also known as HB-200) is an investigational immunotherapeutic agent being evaluated for HPV16 positive cancers. HB-200 alternates the administration of both HB-201 (LCMV) and HB-202 (PICV), collectively referred to as "HB-200," attenuated viral vectors, which on their own are replicating-based therapeutics expressing a non-oncogenic, but highly immunogenic, E7E6 fusion protein from HPV16. Positive preliminary data from a Phase 2 trial (NCT04180215) of HB-200 in combination with pembrolizumab in patients with recurrent/metastatic HPV16 positive head and neck cancers in the first line setting was presented in November 2024 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Conference. Trial close out activities were completed before the end of 2025. HB-200 received Fast Track Designation from the U.S. Food and Drug Administration and PRIME designation from the European Medicines Agency. HB-200 was developed using HOOKIPA’s proprietary arenavirus platform.

About HB-700
HB-700 is an investigational arenaviral immunotherapy designed to treat KRAS-mutated lung, colorectal, pancreatic and other cancers. HB-700 is a replicating 2-vector therapy that targets the most prevalent KRAS mutations (G12D, G12V, G12R, G12C and G13D) and has the potential to benefit more patients than single mutation inhibitors. HB-700 received Investigational New Drug application clearance from the Food and Drug Administration in April 2024 and is Phase 1 ready, with clinical trial material manufacturing completed.

(Press release, Hookipa Pharma, MAR 26, 2026, View Source [SID1234663941])