On June 12, 2026 Roche (SIX: RO, ROP; OTCQX: RHHBY) reported that the VENTANAⓇ PTEN (SP218) RxDx Assay is the first immunohistochemistry (IHC) companion diagnostic test to receive U.S. Food and Drug Administration (FDA) approval for determining PTEN protein loss, also known as PTEN deficiency, in tumours of patients with prostate adenocarcinoma. These patients may now be eligible for treatment with AstraZeneca’s targeted therapy TRUQAPⓇ (capivasertib).

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"Prostate cancer is one of the leading cancer diagnoses for men in the United States," said Matt Sause, CEO of Roche Diagnostics. "The FDA approval of our new companion diagnostic will provide clinicians with a vital tool to identify patients with PTEN loss and potentially provide new therapeutic options."

PTEN is a tumour suppressor protein and loss of PTEN is commonly observed in a variety of cancers.2 Roche’s test enables patients with PTEN-deficient prostate cancer to potentially benefit from a combination treatment with TRUQAP. TRUQAP provides a new, first-line treatment option for patients with PTEN-deficient metastatic androgen pathway modulation-naïve or sensitive (mAPMN/S) prostate cancer, previously referred to as metastatic hormone-sensitive prostate cancer (mHSPC).3

Metastatic hormone-sensitive prostate cancer is an aggressive form of prostate cancer and treatments specifically targeting the PTEN protein loss biology were previously not available. The average length of survival after new, metastatic prostate cancer diagnosis is about 5 to 6 years.4 About 25% of patients with metastatic hormone-sensitive prostate cancer have PTEN-deficient tumors as evaluated by immunohistochemistry (IHC).1

Foundation Medicine, an independent affiliate of the Roche Group, is one laboratory using the VENTANA PTEN (SP218) RxDx Assay companion diagnostic kit to help healthcare providers identify patients with PTEN protein loss.

About the VENTANA PTEN (SP218) RxDx Assay
The VENTANA PTEN (SP218) RxDx Assay is a qualitative immunohistochemical assay intended to be used in the assessment of PTEN protein in prostate adenocarcinoma. The OptiView DAB IHC Detection Kit is used for staining on a BenchMark ULTRA instrument. The assay is indicated as an aid in identifying patients with prostate adenocarcinoma who may be eligible for treatment with TRUQAP in combination with abiraterone acetate in accordance with the approved therapeutic product labeling.

The approval of the VENTANA PTEN (SP218) RxDx Assay is based on the results of the CAPItello-281 clinical study where it was used as the enrollment assay to identify patients whose tumours exhibited PTEN deficiency. The clinical cutoff for PTEN protein loss status is ≥ 90% of viable malignant cells with no specific cytoplasmic staining. PTEN protein loss status is based on the pathologist’s observation of an absence or presence of PTEN expression within prostate adenocarcinoma.5 Patients who received combination therapy with TRUQAP experienced a statistically significant and clinically meaningful reduction in disease progression.

(Press release, Hoffmann-La Roche, JUN 12, 2026, https://www.globenewswire.com/news-release/2026/06/12/3311289/0/en/roche-receives-fda-approval-for-the-first-companion-diagnostic-to-assess-pten-protein-in-people-living-with-prostate-cancer.html [SID1234666614])

On June 12, 2026 Lyell Immunopharma, Inc. (Nasdaq: LYEL), a late-stage clinical company advancing a pipeline of next-generation chimeric antigen receptor (CAR) T-cell therapies for patients with cancer, reported new safety data from the ongoing Phase 1/2 clinical trial of rondecabtagene autoleucel (ronde-cel) in patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) in the second-line (2L) and third- and later-line (3L+) settings and new translational data for ronde-cel. The new data will be presented today in two poster presentations at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress in Stockholm, Sweden.

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"The clinical data presented today reinforce the differentiated profile of ronde-cel in more than 100 patients with relapsed or refractory large B-cell lymphoma," said Lynn Seely, M.D., President and Chief Executive Officer of Lyell. "The updated safety profile, with no Grade 3 or higher CRS and low rates of Grade 3 or higher ICANS, supports outpatient administration. The translational data extend our understanding of ronde-cel’s durable clinical responses. Our data indicate they are achieved through next-generation dual-antigen targeting and production of CD62L-enriched CAR T-cells with enhanced memory phenotype."

Low-Grade CRS and ICANS with Rondecabtagene Autoleucel, a Dual-Targeting CD19/CD20 CAR T-Cell Product Candidate, in Patients with Large B-Cell Lymphoma: Updated Safety Analysis (Poster: PF962)

A total of 108 patients with R/R LBCL (43 2L and 65 3L+) were treated with ronde-cel in the ongoing Phase 1/2 trial as of the data cutoff date of May 5, 2026. The population reflected high-risk disease: median age 64 years (range, 20 to 87), 67% (72/108) with primary refractory disease, and 28% (30/108) had an International Prognostic Index score of 3 or 4. Of the patients treated, 59% (64/108) received dexamethasone prophylaxis, 10 mg daily for three days at the time of CAR T-cell administration.

Key Safety Findings:

Cytokine Release Syndrome (CRS): There were no reports of Grade ≥ 3 events in patients treated with or without dexamethasone prophylaxis. Grade 1 CRS events were reported in 56% (36/64) and Grade 2 in 13% (8/64) of patients receiving prophylaxis, compared with cases of Grade 1 CRS reported in 30% (13/44) or Grade 2 in 39% (17/44) of patients who did not receive prophylaxis.
Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS): Grade ≥ 3 events of ICANS occurred in 8% (5/64) of patients receiving prophylaxis vs. 16% (7/44) of patients who did not receive prophylaxis. Grade 1 events were reported in 6% (4/64) and Grade 2 in 2% (1/64) of patients receiving prophylaxis vs. 11% (5/44) or 5% (2/44) who did not receive prophylaxis.
With over 100 patients treated, ronde-cel continues to show a consistent and manageable safety profile, supporting the potential for outpatient administration. Notably, dexamethasone prophylaxis did not change ronde-cel cell expansion and pharmacokinetics. Manufacturing has also proven reliable to date, with a 97% success rate across these patients.

Durable Responses with Rondecabtagene Autoleucel (Dual-Targeting CD19/CD20 CAR
T-Cells) Are Associated with Higher Proportion of Cytotoxic T Cells with Memory Potential in Infusion Products (Poster: PF1097)

The purpose of this study was to explore the roles of CD62L+ enrichment and CD19/CD20
dual-targeting in ronde-cel infusion products on clinical response observed in patients with R/R LBCL.

Single-cell RNA sequencing was conducted on ronde-cel infusion products to assess memory potential of cytotoxic effector cells compared to FDA-approved CD19 CAR T-cell therapies. Cluster analysis identified a population of cytotoxic effector cells (defined by high GZMB, IFNG, CCL4, CCL5, KLRD1 gene expression) that had higher expression of memory-associated genes (CD62L, IL7R, LEF1) compared to an analogous cytotoxic cluster from FDA-approved CD19 CAR T-cell therapies. These cells co-expressing cytotoxic genes and memory-associated genes are referred to as Cytotoxic T cells with Memory Potential (Tcmp) in this study.

Key Translational Findings:

Tcmp cells were more abundant in the ronde-cel products of patients with durable responses (>12 months) than in patients with progressive disease
Ronde-cel drug product Tcmp cells have a stronger memory potential compared to
axicabtagene ciloleucel’s cytotoxic effector cells
Ronde-cel Tcmp cells following CD62L enrichment also had higher survival and expansion in vitro compared to cytotoxic effector cells with CD4/CD8 enrichment.
Ronde-cel CAR+ T cells collected from patients two months after infusion sustained the capacity to proliferate, kill tumor cells, and secrete cytokines
Durable complete responses > 12 months observed in patients with LBCL with low CD19 or CD20 antigen expression on tumor biopsies at baseline
Collectively, these data offer a potential biological rationale for the benefits of CD62L+ enrichment during manufacturing and CD19/CD20 dual-targeting, which are thought to underpin the high rates of durable complete responses previously reported with ronde-cel.

Ronde-cel is currently being evaluated for the treatment of R/R LBCL across two pivotal clinical trials. In the 3L+ setting, the ongoing single-arm PiNACLE trial is expected to report updated data in the second half of 2026 and pivotal data by mid-2027, setting up a subsequent Biologics License Application (BLA) submission in the second half of 2027. In the 2L setting, the Phase 3 randomized PiNACLE-H2H trial is evaluating ronde-cel against investigator’s choice of axicabtagene ciloleucel or lisocabtagene maraleucel.

(Press release, Lyell Immunopharma, JUN 12, 2026, View Source [SID1234666615])

On June 11, 2026 Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted protein degradation medicines, reported updated clinical data from the Company’s ongoing NX-5948-301 Phase 1a/b clinical trial evaluating bexobrutideg (NX-5948), an investigational oral CNS-penetrant BTK degrader, in patients with chronic lymphocytic leukemia (CLL). The data will be presented during an oral presentation at the 2026 EHA (Free EHA Whitepaper) Congress taking place June 11–14, 2026, in Stockholm, Sweden.

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"These updated data continue to demonstrate the differentiated profile of bexobrutideg, including durable responses in heavily pretreated patients and encouraging activity in patients earlier in their treatment journey," said Talha Munir, M.B. Ch.B., Ph.D., consultant hematologist at Leeds Teaching Hospitals NHS Trust and deputy chair of the United Kingdom National Cancer Research Institute CLL Study Group. "Importantly, responses were observed across patients with difficult-to-treat disease characteristics, including BTK inhibitor resistance mutations, high-risk molecular features and CNS involvement, while maintaining a favorable tolerability profile."

"With longer follow-up in relapsed/refractory CLL and expansion into earlier-line treatment settings, we continue to see a consistent efficacy and safety profile for bexobrutideg," said Paula O’Connor, M.D., chief medical officer of Nurix. "The durability of responses observed in heavily pretreated patients together with the promising activity seen in BCL2i-naïve and BTKi-naïve patients further support the broad potential of BTK degradation across all lines of therapy in CLL."

"These latest findings continue to reinforce our belief that bexobrutideg has the potential to redefine BTK-directed therapy and emerge as a potentially best-in-class treatment for CLL," said Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix Therapeutics. "The updated data to be presented at EHA (Free EHA Whitepaper) across Phase 1 cohorts continue to support the launch of a broad Phase 3 monotherapy program and strengthen the rationale for exploring the use of combination regimens in first- and second-line patients. We look forward to advancing these programs through our recently announced collaboration with Roche."

Growing Safety Cohort Continues to Support Differentiated Profile
Across all Phase 1a/b CLL patients (n=142), bexobrutideg was well tolerated, consistent with prior disclosures, with safety findings generally comparable between patients treated at the 600 mg RP2D and the broader study population.

As of the January 1, 2026, data cutoff:
•No dose-limiting toxicities were observed
•No treatment-related Grade 5 adverse events were reported
•Treatment discontinuations due to adverse events occurred in only 5.6% of patients
•The most common treatment-emergent adverse events included purpura/contusion, neutropenia, petechiae, diarrhea, and fatigue.

Updated Phase 1a Data in Relapsed/Refractory CLL Continue to Support Durable Responses
The Phase 1a dose escalation study enrolled 48 patients with relapsed/refractory CLL/SLL treated with bexobrutideg at doses ranging from 50 mg to 600 mg once daily. Patients were heavily pretreated, having received a median of four prior lines of therapy (range 2–12), including prior BTK inhibitors (97.9%), prior BCL2 inhibitors (83.3%), and prior non-covalent BTK inhibitors (27.1%). Baseline high-risk features included BTK inhibitor resistance mutations (38.3%), TP53 mutations (44.7%), PLCG2 mutations (14.9%), and central nervous system (CNS) involvement (10.4%).

As of the January 1, 2026, data cutoff:
•Median follow-up was 22.4 months
•Median progression-free survival (PFS) was 22.1 months (95% CI: 14.0–NR)
•Objective response rate (ORR) was 83.0% (95% CI: 69.2–92.4)
•Responses included two complete responses, one nodal partial response, and 36 partial responses.
•Responses were observed across patients with BTK inhibitor resistance mutations, high-risk molecular features, and CNS involvement

Phase 1b Data Supports High ORR in Earlier-Line Cohorts
Nurix also presented new data from two of the Phase 1b cohorts evaluating bexobrutideg in earlier lines of treatment, including patients who had received prior BTKi treatment but were BCL2i-naïve (Cohort 5) and patients who were BTKi-naïve, including treatment-naïve patients (Cohort 15).

In Cohort 5 (n=19), patients had received prior BTK inhibitor therapy but no prior BCL2 inhibitor:
•ORR was 92.9% (95% CI: 66.1–99.8) among evaluable patients (n=14)
•18 of 19 patients remained on treatment at data cutoff
•Median follow-up was 5.2 months
•Five patients have not yet reached their first scan but remain on treatment

In Cohort 15 (n=20), which included BTKi-naïve and treatment-naïve patients:
•ORR was 84.2% (95% CI: 60.4–96.6) among evaluable patients (n=19)
•19 of 20 patients remained on treatment at data cutoff
•Median follow-up was 4.9 months
•Three patients with stable disease remain on treatment

About Bexobrutideg
Bexobrutideg (NX-5948) is an investigational, orally bioavailable, brain-penetrant, highly selective small-molecule degrader of Bruton’s tyrosine kinase (BTK) being developed by Nurix and Roche as a potential best-in-class therapy across oncology, immunology and neurology.

Bexobrutideg is currently being evaluated in the DAYBreak CLL-201 clinical trial (NCT07221500), a pivotal single-arm Phase 2 study in patients with relapsed or refractory chronic lymphocytic leukemia (CLL), and in the NX-5948-301 Phase 1a/1b clinical trial (NCT05131022) in patients with relapsed or refractory B-cell malignancies. A new tablet formulation of bexobrutideg is also being evaluated in a first-in-human single-ascending-dose and multiple-ascending-dose study in healthy volunteers (NCT06717269) to support future development in immunology and neurology indications. Additional information about ongoing clinical trials can be found at clinicaltrials.gov.

(Press release, Nurix Therapeutics, JUN 11, 2026, View Source [SID1234666567])

On Jiune 11, 2026 Compugen Ltd. (NASDAQ: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in predictive computational drug target discovery powered by AI/ML, reported that it will present a trial-in-progress poster on the MAIA-ovarian Phase 1 study of COM701, a potential first-in-class anti-PVRIG antibody, at the ESMO (Free ESMO Whitepaper) Gynaecological Cancers Congress 2026, taking place from June 17 to June 19, 2026, in Copenhagen, Denmark.

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Poster details:

Title: MAIA-ovarian (NCT06888921) Adaptive Platform Clinical Trial to Evaluate Safety and Efficacy of COM701 Maintenance Treatment in Relapsed Platinum Sensitive Ovarian Cancer (PSOC)

Speaker: Dr. Oladapo Yeku, Massachusetts General Hospital, Boston, MA, U.S.

Poster presentation number: 170

Date and time of poster presentation: June 18, 2026, 12:45 – 13:30 CEST

Following the presentation, the poster will be available in the publications section of Compugen’s website, www.cgen.com

(Press release, Compugen, JUN 11, 2026, View Source [SID1234666583])

On June 11, 2026 Medicenna Therapeutics Corp. ("Medicenna" or the "Company") (TSX: MDNA, OTCQX: MDNAF), a clinical-stage immunotherapy company developing Superkines for targeting cancer and autoimmune disease, reported the issuance of two new U.S. patents and the allowance of an additional U.S. patent application covering its proprietary IL-4 and IL-13 Superkine platforms, including bizaxofusp (formerly MDNA55), the Company’s IL-4 Empowered Superkine in clinical development for recurrent glioblastoma (rGBM).

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The newly issued U.S. patents, together with parallel patents recently granted in Australia and Canada within the same patent families, further reinforce Medicenna’s intellectual property position across the cytokine biology underlying its lead clinical programs: bizaxofusp, MDNA11 (IL-2 Superkine) and MDNA113 (anti–PD-1 × IL-2 bifunctional Superkine).

"These newly issued and allowed U.S. patents underscore the depth and breadth of the Superkine science Medicenna has built and the strength of the IP estate now protecting the platforms behind bizaxofusp, MDNA11 and MDNA113," said Dr. Fahar Merchant, President and Chief Executive Officer of Medicenna. "Our cytokine engineering work spans three distinct receptor systems, including IL-2, IL-4 and IL-13 and these grants extend protection into important new applications, including cellular immunotherapy and combination treatment of CNS tumors. With more than 100 active granted patents and applications worldwide, Medicenna has assembled what we believe is one of the most comprehensive patent estates in Superkine-based immunotherapy."

U.S. Patents Recently Issued

U.S. Patent No. 12,503,496: "Interleukin-4 Receptor-Binding Fusion Proteins and Uses Thereof" (Medicenna and the U.S. National Institutes of Health, co-owners). The issued patent covers the application of Medicenna’s proprietary IL-4 Superkine fusion proteins to enhancing cellular immunotherapy. With this grant, the family now includes three issued U.S. patents, and additional granted patents in Europe and India.
U.S. Patent No. 12,590,133: "IL-13/IL-4 Superkines: Immune Cell Targeting Constructs and Methods of Use Thereof" (in-licensed by Medicenna from Stanford University). The issued patent is directed to IL-13 Superkine immune cell targeting constructs, vectors, and engineered cells. The family is now granted in the United States and China, with pending applications in Canada and Europe.
U.S. Patent Recently Allowed

U.S. Patent Application No. 18/248,601: "Combination Therapy of MDNA55 and a Vascular Endothelial Growth Factor a (VEGF-A)" (Medicenna-owned). Once issued, the patent will cover combinatorial treatment of CNS tumors with bizaxofusp, including with VEGF-A-directed agents. The family also has pending applications in Canada, China, Europe, India, Japan and Korea.
Additional Recent Patent Grants Outside the United States

In parallel with these U.S. milestones, Medicenna recently received patent grants in two additional jurisdictions that extend the geographic reach of its core Superkine families:

Australian Patent No. 2018347796, "IL-4 Fusion Formulations for Treatment of Central Nervous System (CNS) Tumors," directed to Medicenna’s proprietary bizaxofusp formulation and its application to the treatment of CNS tumors. This family is now granted in Australia, Europe and the United States, with pending applications in Canada, China and India.
Canadian Patent No. 3,067,909, "Uses and Methods for IL-2 Superagonists, Agonists, and Fusions Thereof," directed to the combination of Medicenna’s IL-2 Super Agonist and checkpoint inhibitors for the treatment of cancer. This family is now granted in Australia, Canada, Japan and the United States, with additional pending applications in China, Europe and India, as well as further applications in Australia, Japan and the United States.
Medicenna continues to develop a robust global patent portfolio across its R&D platforms and clinical programs, with over 100 active granted patents and applications.

(Press release, Medicenna Therapeutics, JUN 11, 2026, View Source [SID1234666599])