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Chugai Obtains Approval for FoundationOne CDx Cancer Genomic Profile as a Companion Diagnostic of Alecensa for ALK Fusion Gene-Positive Solid Tumors

On May 18, 2026 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it has obtained approval from the Ministry of Health, Labour and Welfare (MHLW) on March 9, 2026 for FoundationOneCDx Cancer Genomic Profile to be used as a companion diagnostic for Alecensa (generic name: alectinib), an anti-cancer agent/ALK inhibitor for ALK fusion gene-positive solid tumors.

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This approval enables the detection of ALK fusion gene using the FoundationOne CDx Cancer Genomic Profile to guide the decision to use Alecensa for ALK fusion gene-positive solid tumors. The efficacy and safety of Alecensa for advanced or recurrent ALK fusion gene-positive solid tumors were evaluated in an investigator initiated Japanese Phase II clinical study (TACKLE study), and an approval for a partial change to the marketing authorization was obtained on May 18, 2026.

FoundationOne CDx Cancer Genomic Profile has continuously expanded its tumor-agnostic companion diagnostic capabilities, enabling a single comprehensive genomic profiling test to support treatment plans for multiple medicines. With the addition of Alecensa as a companion diagnostic for ALK fusion gene-positive solid tumors, beyond its already approved use in non-small cell lung cancer, the potential treatment options for patients with solid tumors are expected to expand. As a leading company in oncology, Chugai is committed to realizing more advanced personalized healthcare in the oncology field and contributing to patients through the wider adoption of comprehensive genomic profiling.

Approval information The underlined and bolded part has been newly added.

Intended uses or indications

The product is used for comprehensive genomic profiling of tumor tissues in patients with solid cancers.
The product is used for detecting gene mutations and other alterations to support the assessment of drug indications listed in the table below.
Alterations Cancer type Relevant drugs
Activated EGFR alterations Non-small cell lung cancer (NSCLC) afatinib, erlotinib, gefitinib, osimertinib, dacomitinib
EGFR exon 20 T790M alterations osimertinib
ALK fusion genes alectinib, crizotinib, ceritinib, brigatinib
ROS1 fusion genes entrectinib
MET exon 14 skipping alterations capmatinib
BRAF V600E and V600K alterations Malignant melanoma dabrafenib, trametinib, vemurafenib, encorafenib, binimetinib
ERBB2 copy number alterations (HER2 gene amplification positive) Breast cancer trastuzumab
AKT1 alterations capivasertib
PIK3CA alterations
PTEN alterations
KRAS/NRAS wild-type Colorectal cancer cetuximab, panitumumab
Microsatellite instability high nivolumab
Microsatellite instability high Solid tumors pembrolizumab
Tumor mutational burden high pembrolizumab
NTRK1/2/3 fusion genes entrectinib, larotrectinib, repotrectinib
RET fusion genes selpercatinib
ALK fusion genes alectinib
BRCA1/2 alterations Ovarian cancer olaparib
BRCA1/2 alterations Prostate cancer olaparib, talazoparib
FGFR2 fusion genes Biliary tract cancer pemigatinib

(Press release, Chugai, MAY 18, 2026, View Source [SID1234665819])

Certara to Participate in Upcoming Investor Conferences

On May 18, 2026 Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, reported that Company management will participate in the following investor conferences:

RBC CM Global Healthcare Conference
Date and Time: Tuesday, May 19 at 9:30 a.m. ET

William Blair’s 46th Annual Growth Stock Conference
Date: Tuesday, June 2

Jefferies Global Healthcare Conference
Date: Wednesday, June 3 at 1:20 p.m. ET

Live webcasts for the RBC and Jefferies conferences will be available on Certara’s investor relations website at View Source and will be available for replay for at least 90 days thereafter.

(Press release, Certara, MAY 18, 2026, View Source [SID1234665818])

AKIR001 advances to cohort 3 in Phase I trial

On May 18, 2026 Akiram Therapeutics, a Swedish biotech company specializing in targeted radiotherapy, reported that cohort 2b in the ongoing Phase I clinical trial evaluating the drug candidate 177Lu-AKIR001 has been completed. Following the safety review, the study has advanced to cohort 3. The results continue to support a favorable safety profile, enabling further dose escalation and evaluation of higher activity levels according to the study protocol.

The trial is conducted at Karolinska University Hospital, which also serves as the study sponsor, and is designed to evaluate the safety, tolerability, and pharmacokinetic profile of the drug candidate.

In cohort 2b, the protein dose was evaluated while maintaining the same activity level as in the previous cohort. Following review of the cohort 2b data, the Safety Review Committee approved continued dose escalation, allowing the study to proceed to cohort 3.

Across the cohorts evaluated to date, no dose-limiting toxicities have been observed, and imaging data have demonstrated selective tumor uptake and accumulation in tumor tissue in treated patients. Several patients have also received repeat treatment based on medical assessment, further supporting the tolerability, manageability, and feasibility of repeated administration. Taken together, the findings support continued clinical evaluation in the ongoing trial.

Akiram’s drug candidate 177Lu-AKIR001 is a targeted radiopharmaceutical that combines an antibody directed against CD44v6 — a cancer marker associated with several aggressive tumor types — with the therapeutic radioisotope lutetium-177. Through this mechanism, radiation can be delivered selectively to tumor cells while minimizing exposure to healthy tissue.

"Advancing to cohort 3 marks an important step in our clinical development program. The results support further evaluation of dose levels, and the next stage will be central to further defining dosing parameters and treatment characteristics ahead of future stages of development," says Marika Nestor, CEO of Akiram Therapeutics.

"The decision to proceed to cohort 3 follows a thorough safety evaluation. We look forward to continuing the study and collecting additional clinical data," says Dr. Luigi De Petris, Principal Investigator at Karolinska University Hospital.

The trial enrolls patients with CD44v6-positive solid tumors who currently lack available treatment options.

The project is the result of a successful national collaboration between leading clinical and academic institutions in precision oncology and has been supported by the Swedish Cancer Society, the Sjöberg Foundation, the Erling-Persson Foundation, the Swedish Research Council, and Vinnova, Sweden’s Innovation Agency.

The trial is registered at ClinicalTrials.gov: NCT06639191.

(Press release, Akiram Therapeutics, MAY 18, 2026, View Source [SID1234665817])

ImPact Biotech Presents Updated Data from Phase 3 ENLIGHTED Trial of Padeliporfin VTP in LG-UTUC at AUA 2026

On May 17, 2026 ImPact Biotech, a clinical-stage biotechnology company focused on developing Padeliporfin Vascular Targeted Photodynamic therapy (VTP) to treat a range of solid tumors, reported updated results from ENLIGHTED, the Company’s ongoing Phase 3 study of Padeliporfin VTP treatment in patients with low-grade upper tract urothelial carcinoma (UTUC). These data will be shared during a podium presentation and in an interactive poster at the American Urological Association (AUA) Annual Meeting taking place May 15-18, 2026, in Washington, D.C.

"These updated efficacy and durability results from the Phase 3 ENLIGHTED trial continue to reinforce Padeliporfin VTP’s potential to become an attractive alternative, minimally invasive ureteroscopic treatment option for patients with low-grade UTUC," said Eyal Morag, M.D., Chief Medical Officer of ImPact Biotech. "The promising complete response rate and encouraging durability observed to date, alongside a well-established safety profile, further support the opportunity to provide a meaningful organ-sparing treatment for patients with limited options in UTUC and additional solid tumor indications. We look forward to sharing topline data from ENLIGHTED later this year and preparing for regulatory submission in 2027, while exploring strategic opportunities to commercialize the program and maximize Padeliporfin VTP’s impact for UTUC patients facing great unmet need."

Key updated results from the ongoing Phase 3 ENLIGHTED study of Padeliporfin VTP:

As of April 20, 2026, the data cut-off for the poster presentation at AUA 2026, 82 patients had begun treatment, of which 72 had completed PRE and were evaluable for efficacy.

Efficacy Profile:

Overall response rate: 88%
50 of the 72 (70%) response-evaluable patients achieved a CR at the end of PRE.
13 of the 72 (18%) response-evaluable patients achieved a partial response (PR) at the end of PRE.

Durability Profile:

18 of the 21 (85.7%) response-evaluable patients who completed the Maintenance Treatment Phase (MTP) sustained CRs in the treated area for at least 12 months as of the data cutoff date, with additional patients ongoing the MTP that have yet to complete the 12-month evaluation period. Padeliporfin VTP treatment has demonstrated evidence of efficacy and durability.
The current median duration of response (DoR) in the treated area for evaluable patients is 23.9 months based on available follow-up, with ongoing responses still being observed.

Safety and Tolerability Profile:

Padeliporfin VTP was well-tolerated with a safety profile consistent with the previous data obtained from the Phase 1 study and previously announced preliminary Phase 3 results. Padeliporfin VTP treatment has demonstrated a consistent and acceptable safety profile.
Adverse events (AEs): the majority of treatment-emergent adverse events (TEAEs) were mild or moderate, primarily related to the ureteroscopic procedure, and resolved within a few days. Two patients had Grade 3 serious adverse events related to VTP treatment which resolved within two days. No TEAEs of special interest were reported and no TEAE led to discontinuation of the study treatment.

While the Company is pursuing strategic partnering opportunities to support the commercialization of its low-grade UTUC program, ImPact recently presented initial data supporting the advancement of Padeliporfin VTP in locally advanced pancreatic ductal adenocarcinoma (LA-PDAC) at the Society of Interventional Radiology (SIR) 2026 Annual Meeting, which demonstrated a consistent tolerability profile alongside early signs of clinical efficacy, showing potential to convert patients with unresectable stage III LA tumors to surgically resectable candidates.

Additional updates from both programs will be presented at the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 29 – June 2, 2026, in Chicago, IL.

AUA Presentation Details:

Interactive Poster Title: The ENLIGHTED Phase 3 Trial: Advancing Treatment of Low-Grade Upper Tract Urothelial Carcinoma (LG UTUC) with Padeliporfin Vascular-Targeted Photodynamic Therapy (VTP)
Presenter: Vitaly Margulis, M.D., Professor of Urologic Oncology, University of Texas Southwestern Medical Center
Poster Number: IP30-04
Session Title: Bladder Cancer: Upper Tract Transitional Cell Carcinoma I
Session Date & Time: Saturday, May 16, 2026 at 7:00 AM ET

Podium Presentation Title: ENLIGHTED Phase 3 Trial of Non-Thermal, Drug-Activated Padeliporfin Vascular-Targeted Photodynamic Therapy (VTP) for Low-Grade Upper Tract Urothelial Carcinoma (LG UTUC)
Presenter: Jonathan Coleman, M.D., Urologic Surgeon, Memorial Sloan Kettering Cancer Center
Session Title: Clinical Trials in Progress: Bladder Cancer
Session Date & Time: Sunday, May 17, 2026 at 9:16 AM ET

About ENLIGHTED
The Phase 3 ENLIGHTED study is a single arm, non-randomized, open-label, pivotal trial evaluating Padeliporfin VTP for the treatment of low-grade UTUC. Across 29 clinical sites globally, ImPact is targeting enrollment of up to 100 patients with new or recurrent low-grade, non-invasive UTUC of
the kidney or ureter. The study consists of two parts – an Induction Treatment Phase (ITP) and Maintenance Treatment Phase (MTP) – across which Padeliporfin, a photosensitizing drug, is administered intravenously and VTP therapy is performed, via an ureteroscopy which applies a laser fiber illumination for 10 minutes in the proximity of the tumor, leading to local activation of Padeliporfin in the tumor. ITP consists of one-to-three treatments with VTP therapy at four-week intervals or until a complete response (CR) is achieved; MTP follows with standard-of-care treatment alongside VTP therapy administered every three months for up to 12 months. The study’s primary objective is to assess the response rate to Padeliporfin VTP treatment at the end of ITP, with secondary objectives evaluating safety, tolerability and duration of response.

(Press release, ImPact Biotech, MAY 17, 2026, View Source [SID1234665816])

Nanobiotix Announces Presentation of Part 1 Data From a Randomized Phase 2 Clinical Trial Evaluating JNJ-1900 (NBTXR3) in Stage 3 Inoperable Lung Cancer

On May 17, 2026 NANOBIOTIX (Euronext: NANO – NASDAQ: NBTX – the "Company"), a late-clinical stage biotechnology company pioneering nanotherapeutic approaches to expand treatment possibilities for patients with cancer and other major diseases, reported the presentation of Part 1 data from the CONVERGE study, a Johnson & Johnson-sponsored randomized Phase 2 clinical trial evaluating potential first-in-class Nanoradioenhancer JNJ-1900 (NBTXR3) for patients with stage 3 inoperable non-small cell lung cancer ("NSCLC"), at the 2026 European Society for Radiotherapy and Oncology Annual Meeting (ESTRO 2026).

PRESENTATION #116: Radiographic Response in Patients with Stage III Unresectable Non-Small Cell Lung Cancer Treated with an Intratumoral Radioenhancer (JNJ-90301900)

Jeffrey Bradley,1 Benjamin T. Cooper,2 Sushma Patel,3 David DiBardino,4 Michael Pritchett,5 Kevin C. Ma,4 Isaac Laniado,6 Melina E. Marmarelis,7 Matthew Scarlotta,8 Joshua K. Sabari,9 Yi -Wen Ma,10 Tori Stromp,10 Yina Kuang,10 Balaji Laxmanan,10 Kiran Devisetty,10 Steven Feigenberg1

Study Conclusions

Early results suggest that intratumoral/intranodal injection of JNJ-1900 (NBTXR3) is feasible and can be performed safely in patients with stage III unresectable NSCLC
Initial efficacy responses observed in 7 patients following the full treatment regimen of concurrent chemoradiotherapy, JNJ-1900 (NBTXR3), and consolidation with durvalumab are promising:
Overall response rate ("ORR") = 85.7% (6/7 patients)
Complete response rate ("CRR") = 57.1% (4/7 patients)
With the current standard of care, concurrent chemoradiation therapy (cCRT) ± durvalumab, depth of response remains limited in Stage 3 Inoperable NSCLC with very low rates of complete response (<5%) *
Disease control rate ("DCR") = 100.0% (7/7 patients)
Absence of progressive disease and deepening response over time suggests potential for long-term durability
1Radiation Oncology, University of Pennsylvania, Philadelphia, USA; 2Radiation Oncology, NYU Langone Health, New York, USA; 3Radiation Oncology, FirstHealth of the Carolinas, Pinehurst, USA; 4University of Pennsylvania, Philadelphia, USA; 5Interventional Pulmonology, FirstHealth of the Carolinas, Pinehurst, USA; 6Interventional Pulmonology, NYU Langone Health, New York, USA; 7Medical Oncology, University of Pennsylvania, Philadelphia, USA; 8Medical Oncology, FirstHealth of the Carolinas, Pinehurst, USA; 9Medical Oncology, NYU Langone Health, New York, USA; 10Johnson & Johnson, New Brunswick, NJ, USA

* Antonia SJ, et al. N Engl J Med. 2017.

About JNJ-1900 (NBTXR3)

JNJ-1900 (NBTXR3) is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. Its proof-of-concept was achieved in soft tissue sarcomas through a successful randomized Phase 2/3 study in 2018. The product candidate’s mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the physical MoA, Nanobiotix believes that JNJ-1900 (NBTXR3) could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly immune checkpoint inhibitors.

Radiotherapy-activated JNJ-1900 (NBTXR3) is being evaluated across multiple solid tumor indications as a single agent or combination therapy. The program is led by NANORAY-312—a global, randomized Phase 3 study in locally advanced head and neck squamous cell cancers. In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of JNJ-1900 (NBTXR3) activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy—the same population being evaluated in the Phase 3 study.

Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a collaboration strategy to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several Phase 1 and Phase 2 studies evaluating JNJ-1900 (NBTXR3) across tumor types and therapeutic combinations. In 2023, Nanobiotix announced a license agreement for the global co-development and commercialization of JNJ-1900 (NBTXR3) with Janssen Pharmaceutica NV, a Johnson & Johnson company.

(Press release, Nanobiotix, MAY 17, 2026, View Source [SID1234665815])