On March 14, 2025 iOncologi, Inc., a clinical-stage biopharmaceutical company focused on advancing immunotherapy platform technologies, reported the acquisition of TargImmune Therapeutics, a biotechnology company specializing in novel tumor targeted immunotherapies (Press release, iOncologi, MAR 14, 2025, View Source [SID1234651154]). This strategic acquisition significantly enhances iOncologi’s capabilities in developing cutting-edge immunotherapies for solid tumors.

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As part of the transaction, iOncologi, Inc. and TargImmune Therapeutics executed a share purchase agreement, resulting in iOncologi acquiring at least 99% of TargImmune’s shares, warrants, and options. Following the acquisition, TargImmune will continue to operate in Basel, Switzerland, as a wholly owned subsidiary of iOncologi, Inc. This structure ensures the seamless continuation of TargImmune’s research into novel tumor-targeted RNA therapies while benefiting from iOncologi’s expanded resources and strategic vision.

"This acquisition represents a pivotal moment for iOncologi as we continue to push the boundaries of immunotherapy for solid tumors," said Dr. Edgardo Rodriguez-Lebron, iOncologi’s recently appointed CEO. "TargImmune’s pioneering approaches perfectly align with our mission to develop transformative cancer therapies. By integrating two incredibly talented and highly experienced drug development teams, we are well-positioned to accelerate innovation and bring novel treatments to patients with limited therapeutic options."

The acquisition aligns with iOncologi’s broader strategy to expand its therapeutic pipeline, leverage next-generation RNA-based immunotherapies, and drive innovation in oncology.

On March 14, 2025 Photocure ASA (OSE: PHO), the Bladder Cancer Company, reported the publication of the study "Oncologic Outcomes of Blue Light Cystoscopy in an Equal Access Setting: Results of the BRAVO study" in JU Open Plus this week (Press release, PhotoCure, MAR 14, 2025, View Source [SID1234651155]). The research objective was to assess if blue light cystoscopy (BLC) aided TURBT has an impact on the clinical outcomes of patients with NMIBC*. Results of the real-world evidence study show that BLC was associated with a statistically significant 38% reduction in risk of recurrence compared to white light cystoscopy (WLC) use alone in a predominantly high-risk NMIBC patient cohort. These results are in line with prior results from multiple randomized controlled clinical trials.

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The BRAVO study (Bladder Cancer Recurrence Analysis in Veterans and Outcomes) is a propensity score matched, retrospective analysis evaluating clinical outcomes following BLC compared to WLC alone in patients from the Veterans Affairs Healthcare System.

626 patients were included in this study, 313 in each study arm (WLC versus BLC). Outcomes data for BRAVO was measured at a 3-year time point in a predominately high-risk patient population. Median age at diagnosis was 71 years. Median follow-up was 3.7 years.

Study results include:

Risk of recurrence at 3-years was significantly reduced following BLC vs. WLC (HR, 0.62; 95% CI, 0.45-0.86; p<0.01). The 38% reduction in the risk of recurrence is in line with prior results from multiple randomized controlled clinical trials. A positive trend for reduction in risk of progression was also observed (HR=0.71; 95% CI, 0.37-1.38; p=0.32) at 3-years although not statistically significant due to a low number of patients progressing on the study.
The study indicates that use of BLC can drive treatment decisions that lead to improved outcomes. Specifically highlighted in the study was that BLC patients were significantly more likely to receive intravesical BCG therapy (61% vs 43%; p<0.01) or intravesical chemotherapy (48% vs 27%, p<0.01). This data supports reasoning that using BLC enhances a clinician’s ability to decide on the appropriate bladder cancer therapy based on precision risk stratification and a more complete TURBT.
The Veterans’ Affairs (VA) Healthcare system accepts all U.S. Veterans, regardless of financial background, and retains its patients, allowing for high-quality data capture over a long-term follow-up period, therefore serving as a robust real-world model for equal access.

"Bladder cancer detection plays an important role in preventing cancer recurrence and optimizing appropriate treatment pathways, as previous research has shown that WLC alone may not comprehensively detect all NMIBCs. In this propensity-score matched cohort study, we found that the use of BLC vs. WLC alone was associated with significantly decreased 38% risk of recurrence. Our results are in line with the recent Cochrane review of nearly 3,000 patients across 15 randomized trials, where the authors found that that BLC may reduce the risk of bladder cancer recurrence by 34%. These data support current AUA/SUO guidelines recommending BLC usage in patients with NMIBC to increase detection and decrease recurrence", said Dr. Steven Williams, Professor and Chief of the Division of Urology, at the University of Texas-Medical Branch, and one of the study authors.

"The exciting long-term real-world results from the BRAVO study complement and confirm the generalizability of prior recurrence outcomes with BLC beyond the randomized controlled trial setting, reflecting a routine clinical practice patient population", said Anders Neijber, Chief Medical Officer of Photocure.

Read the full publication here: View Source

An editorial to the publication can be found here: View Source

*NMIBC: Non muscle-invasive bladder cancer

Note to editors:

All trademarks mentioned in this release are protected by law and are registered trademarks of Photocure ASA.
This press release may contain product details and information which are not valid, or a product is not accessible, in your country. Please be aware that Photocure does not take any responsibility for accessing such information which may not comply with any legal process, regulation, registration or usage in the country of your origin.

About Bladder Cancer
Bladder cancer ranks as the 8th most common cancer worldwide – the 5th most common in men – with 1 949 000 prevalent cases (5-year prevalence rate)1a, 614 000 new cases and more than 220 000 deaths in 2022.1b
Approx. 75% of all bladder cancer cases occur in men.1 It has a high recurrence rate with up to 61% in year one and up to 78% over five years.2 Bladder cancer has the highest lifetime treatment costs per patient of all cancers.3
Bladder cancer is a costly, potentially progressive disease for which patients have to undergo multiple cystoscopies due to the high risk of recurrence. There is an urgent need to improve both the diagnosis and the management of bladder cancer for the benefit of patients and healthcare systems alike.
Bladder cancer is classified into two types, non-muscle invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC), depending on the depth of invasion in the bladder wall. NMIBC remains in the inner layer of cells lining the bladder. These cancers are the most common (75%) of all BC cases and include the subtypes Ta, carcinoma in situ (CIS) and T1 lesions. In MIBC the cancer has grown into deeper layers of the bladder wall. These cancers, including subtypes T2, T3 and T4, are more likely to spread and are harder to treat.

About Hexvix/Cysview (hexaminolevulinate HCl)
Hexvix/Cysview is a drug that preferentially accumulates in cancer cells in the bladder, making them glow bright pink during Blue Light Cystoscopy (BLC). BLC with Hexvix/Cysview, compared to standard white light cystoscopy alone, improves the detection of tumors and leads to more complete resection, fewer residual tumors, and better management decisions.
Cysview is the tradename in the U.S. and Canada, Hexvix is the tradename in all other markets. Photocure is commercializing Cysview/Hexvix directly in the U.S. and Europe and has strategic partnerships for the commercialization of Hexvix/Cysview in China, Chile, Australia, New Zealand and Israel. Please refer to View Source for further information on our commercial partners.
The following safety information is solely included to comply with U.S. regulatory requirements: Important Risk & Safety Information for Cysview (hexaminolevulinate HCl)

On March 13, 2025 Medigene AG (Medigene, FSE: MDG1, Prime Standard), an oncology platform company focused on the research and development of T cell receptor (TCR)-guided therapies for the treatment of cancer, reported the submission of a patent for a novel natural killer (NK) cell-specific TCR construct to the European Patent Office. With that, Medigene is advancing its TCR-guided strategy by expanding the application of its proprietary 3S (sensitive, specific, and safe) TCRs into NK cells (Press release, MediGene, MAR 13, 2025, View Source [SID1234651135]). This patent application marks a major expansion of Medigene’s intellectual property portfolio, broadening its therapeutic reach and reinforcing its commitment to developing innovative, off-the-shelf immunotherapies for cancer treatment.

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To enable this innovation, Medigene combined TCR-guided precision targeting with innate NK cell killing. The Company has developed a proprietary universal scaffold that allows its 3S TCRs to function in NK cells without requiring CD3 co-expression. This novel NK-TCR system enhances NK cell production and therapeutic potential by facilitating the efficient transfer of all 3S TCRs into NK cells, streamlining the manufacturing process for future allogeneic TCR-NK therapies. By eliminating CD3 dependency, this approach overcomes a critical limitation in TCR-based NK cell therapy development, delivering a scalable, clinically viable solution that accelerates therapeutic timelines and reduces costs.

"This innovative approach supports our strategy to apply Medigene’s 3S TCRs into new TCR-guided modalities, such as TCR-TCEs and now TCR-NKs, to create additional value for both patients and our shareholders," said Selwyn Ho, CEO of Medigene. "Expanding our TCR-guided therapies to include NK cells aligns with our commitment to developing off-the-shelf, highly specific, and effective immunotherapies for cancer treatment."

The global NK cell therapeutics market is rapidly expanding, driven by rising cancer prevalence, an aging population, and demand for innovative immunotherapies. Valued at ~$0.55B in 2024, it is projected to reach $2.13B by 2033 (Source:Business Research Insights). Medigene’s proprietary TCR-NK technology is well-positioned to drive this growth with highly specific, scalable NK cell-based therapies.

Medigene continues to strengthen its intellectual property portfolio through the generation of new 3S TCRs, development of advanced technologies, and strategic expansion of existing patents across additional geographies. With over 29 unique patent families worldwide, Medigene safeguards its proprietary TCR and End-to-End Platform technologies, ensuring a strong competitive position in the immunotherapy space.

On March 13, 2025 Enliven Therapeutics, Inc. (Enliven or the Company) (Nasdaq: ELVN), a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics, reported financial results for the fourth quarter and full year ended December 31, 2024, and provided a business update, including highlights of pipeline progress (Press release, Enliven Therapeutics, MAR 13, 2025, View Source [SID1234651136]).

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"We are very pleased with the ongoing progress we are making as a Company. We continue to hear significant enthusiasm and excitement from investigators on both of our programs. The momentum of ELVN-001 has accelerated since the data presentation at the ESH-iCMLf conference," said Sam Kintz, Co-founder and Chief Executive Officer of Enliven. "2025 is a big year for Enliven and we are excited for the upcoming program updates. We are focused on continued clinical execution and preparing for the potential start of a pivotal trial for ELVN-001 in 2026."

Recent Research and Development Highlights and Upcoming Milestones

ELVN-001 is a potent, highly selective, small molecule kinase inhibitor designed to specifically target the BCR::ABL gene fusion

In 2024, the Company announced positive initial data from the ongoing Phase 1 clinical trial that compared favorably to the precedent Phase 1 trials for the approved BCR::ABL1 tyrosine kinase inhibitors (TKIs).
The U.S. Food and Drug Administration (FDA) granted orphan drug designation to ELVN-001 for the treatment of chronic myeloid leukemia (CML).
The first patient was dosed in the Phase 1 trial evaluating ELVN-001 in Japanese patients with CML (NCT06787144).
The Company plans to report additional data from the ongoing Phase 1a/b trial in the middle of 2025.
ELVN-002 is a potent, highly selective, central nervous system (CNS) penetrant and irreversible HER2 inhibitor with activity against wild type HER2 and various HER2 mutations

Enliven continued to enroll patients in its Phase 1 trial evaluating ELVN-002 as a monotherapy agent in patients with HER2+ and HER2 mutant tumors and its exploratory cohort in combination with Kadcyla (an approved HER2 antibody drug conjugate) in patients with HER2+ metastatic breast cancer (MBC) (NCT05650879).
Additionally, the Company continued to enroll patients in its Phase 1 trial evaluating ELVN-002 in combination with trastuzumab +/- chemotherapeutic agents in patients with HER2+ MBC and colorectal cancer (CRC) and began dosing patients in the Phase 1b trial specifically evaluating patients with CRC (NCT06328738).
Enliven plans to report data from the ongoing Phase 1 trials in the second half of 2025.
Fourth Quarter and Full Year 2024 Financial Results

Cash Position: As of December 31, 2024, the Company had cash, cash equivalents and marketable securities totaling $313.4 million, which is expected to provide cash runway into mid-2027.
Research and development (R&D) expenses: R&D expenses were $20.7 million for the fourth quarter of 2024, compared to $17.9 million for the fourth quarter of 2023. R&D expenses were $80.8 million for the full year 2024, compared to $64.6 million for the full year 2023.
General and administrative (G&A) expenses: G&A expenses for the fourth quarter of 2024 were $6.2 million, compared to $4.8 million for the fourth quarter of 2023. G&A expenses were $23.8 million for the full year 2024, compared to $19.0 million for the full year 2023.
Net Loss: Enliven reported a net loss of $23.2 million for the fourth quarter of 2024, compared to a net loss of $19.4 million for the fourth quarter of 2023. Total net loss for the full year 2024 was $89.0 million, compared to $71.6 million for the full year 2023.

On March 13, 2025 Immorta Bio Inc., a scientific longevity company focused on "Treating Diseases of Aging and Treating Aging as Disease," reported that its Chairman and CEO, Dr. Boris Reznik, presented the latest findings from its SenoVax Program at the LSX Investival Showcase on March 11th at the Miami Beach Convention Centre (Press release, Immorta Bio, MAR 13, 2025, View Source [SID1234651137]).

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The presentation disclosed advancements in the Company’s oncology pipeline, highlighting animal studies showing the regression of brain, lung, skin, pancreas, and breast cancers by SenoVax, the Company’s lead product. Additionally, cellular mechanisms by which this "longevity therapeutic" targets a broad range of cancers were discussed.

"It has been widely demonstrated that senescent cells play a critical role in initiating, promoting and protecting cancer," said Dr. Thomas Ichim, President and Chief Scientific Officer of the Company. "By amplifying the body’s natural immunological activities to kill senescent cells, SenoVax induces regression of tumors."

The Company, together with the University of California San Diego, George Washington University, Calidi Biosciences, and Cedars Sinai, demonstrated in a peer-reviewed publication that SenoVax kills cancer in part by inducing antibody and T cell responses that eliminate senescent cells¹.

"We are developing multiple programs focused on radical extension of human healthspan including our senolytic immunotherapy platform," said Dr. Boris Reznik, Chairman and CEO of Immorta Bio. "Our development strategy is to apply longevity-associated technologies to address unmet medical needs that can provide answers in months not decades."