On June 30, 2026 Imviva Biotech, a clinical-stage biotechnology company developing next-generation allogeneic CAR-T cell therapies, reported that the U.S. Food and Drug Administration (FDA) has granted authorization for its Investigational Device Exemption (IDE) application for the use of Adaptive Biotechnologies’ clonoSEQ assay in the TENACITY-01 clinical trial (NCT07070219). The TENACITY-01 trial evaluates CTD402, Imviva’s investigational allogeneic anti-CD7 CAR-T cell therapy, for the treatment of relapsed/refractory (R/R) T-cell acute lymphoblastic leukemia/lymphoblastic lymphoma (T-ALL/LBL) and patients with T-ALL/LBL in first or second complete remission with minimal (or measurable) residual disease (MRD-positive).

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Next-generation sequencing-based clonoSEQ provides highly sensitive, reliable detection of MRD—small amounts of cancer that remain after treatment but are often missed by standard methods and can lead to relapse. The relationship between MRD status and relapse risk is well-established, and a threshold of 0.01% (10-4) is widely used as a clinically actionable cutoff to define high-risk disease and guide treatment escalation in ALL (National Comprehensive Cancer Network). The use of clonoSEQ will serve a dual purpose in the TENACITY-01 trial—identifying patients with MRD levels of 0.1% or higher for enrollment eligibility and detecting and quantifying MRD in post-treatment bone marrow samples to support exploratory analyses.

IDE authorization signals that an assay is capable of being used in a highly regulated clinical development program where test results may be used for patient management. This IDE authorization enables the use of highly sensitive MRD assessment in the TENACITY-01 trial to identify eligible patients for enrollment and precisely evaluate treatment response.

Despite improvements in remission rates for newly diagnosed T-ALL/LBL, particularly in pediatric populations, high relapse rates remain a significant challenge. MRD status is one of the strongest independent predictors of relapse and survival in ALL, with studies showing 10-year event-free survival rates of approximately 77% versus 32% for MRD-negative versus MRD-positive pediatric patients (Berry et al., 2017).

"FDA authorization of our IDE is a significant step forward as we advance the TENACITY-01 clinical trial," said Jan Davidson-Moncada, MD, PhD, Imviva Biotech Chief Medical Officer. "Integrating clonoSEQ will allow us to more accurately monitor MRD and evaluate the durability of CTD402. These insights can accelerate clinical decision-making and ultimately support improved patient outcomes by enabling earlier intervention and more personalized treatment strategies."

"As the field moves increasingly toward MRD-guided treatment strategies, interventional clinical trials require MRD technologies that can deliver highly sensitive, standardized results across diverse clinical settings," said Mary Pat Lancelotta, Senior Vice President, MRD Biopharma at Adaptive Biotechnologies. "With its extensive clinical validation and broad use in hematologic malignancies, clonoSEQ is uniquely positioned to support these next-generation trial designs and help advance MRD-guided care for patients with T-ALL/LBL."

The ongoing global, single-arm, open-label TENACITY-01 trial is enrolling adolescents and adults (≥12 years) to evaluate the safety, efficacy, and cellular pharmacokinetics of CTD402. The current study will enroll up to 120 patients, divided between R/R and MRD-positive cohorts. All participants will receive a standard dose lymphodepletion (fludarabine/cyclophosphamide) and a flat dose of 400×10⁶ CTD402 CAR-T cells.

For more information, visit www.imvivabio.com.

About CTD402

CTD402 is an investigational ‘ready-at-point of care’ allogeneic anti-CD7 CAR-T cell therapy designed for T-cell mediated disease. The product candidate incorporates T-cell receptor (TCR) and HLA class II knockout, along with Imviva’s proprietary ANSWER inhibitory ligands to enhance resistance to host immune rejection. The robustness of CTD402’s manufacturing process, showing product consistency across multiple donors and production lots, promises to deliver an ‘off-the-shelf’ allogeneic platform with the critical advantage of immediate availability, eliminating manufacturing delays that can be life-threatening for patients with rapidly progressive disease.

A global Phase 1b/2 clinical trial (TENACITY-01) evaluating CTD402 for the treatment of relapsed/refractory T-ALL/LBL patients is enrolling patients (NCT07070219). The U.S. Food and Drug Administration has granted Rare Pediatric Disease Designation (RPDD), and Regenerative Medicine Advanced Therapy (RMAT) designation to CTD402 for the treatment of relapsed or refractory T-cell acute lymphoblastic leukemia (T-ALL).

(Press release, Imviva Biotech, JUN 30, 2026, View Source [SID1234669025])

On June 30, 2026 Liminatus Pharma, Inc. (Nasdaq: LIMN) ("Liminatus" or the "Company"), a biotechnology company developing innovative cancer therapies, reported that it has amended and restated the previously announced definitive merger agreement with InnocsAI LLC ("InnocsAI"), an oncology biotechnology company focused on next-generation cell therapy technologies.

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The transaction has been re-structured to allow closing prior to obtaining stockholder approval, with closing now expected to occur on July 2, 2026, subject to the satisfaction or waiver of customary closing conditions.

Under the amended terms of the merger agreement, the equity holders of InnocsAI will receive merger consideration consisting of a combination of Liminatus common stock and newly designated non-voting convertible preferred stock, at an issue price of $0.20 per common share, representing an aggregate implied transaction value of approximately $320 million, together with contingent value rights representing the right to receive 20% of future net proceeds from certain strategic transactions involving the acquired assets.

Upon closing of the merger:

The InnocsAI equity holders will receive shares of Liminatus common stock representing up to the maximum amount issuable without prior stockholder approval under applicable Nasdaq listing rules (or an estimated 19.99% of the Company’s outstanding common stock immediately prior to the closing); and
The balance of the merger consideration will consist of shares of newly designated non-voting convertible preferred stock.
The non-voting convertible preferred stock will not be convertible into common stock unless and until the Company has obtained stockholder approval for the issuance of the underlying common shares to the extent required under applicable Nasdaq listing rules.

The merger consideration is expected to be issued following the closing in accordance with the amended terms of the merger agreement and related transaction documents.

"This merger represents a transformational step in Liminatus’ strategy to build a diversified oncology biotechnology company," said Chris Kim, Chief Executive Officer of Liminatus Pharma. "InnocsAI’s innovative cell therapy platform complements our existing immuno-oncology programs and significantly broadens our development pipeline while providing multiple opportunities to create long-term shareholder value."

Strategic Benefits

The combined company is expected to benefit from:

An expanded oncology pipeline spanning cell therapy and immunotherapy.
Multiple preclinical product candidates.
Proprietary intellectual property supporting future oncology development.
Increased opportunities for strategic partnerships and licensing.
A diversified platform targeting both hematologic malignancies and solid tumors.
Following closing, Liminatus intends to pursue integration activities, file a registration statement on Form S-1 relating to the merger consideration, seek the required stockholder approvals, and continue advancing the combined oncology pipeline.

Additional information regarding the amended and restated merger agreement will be included in a Current Report on Form 8-K to be filed by the Company with the U.S. Securities and Exchange Commission (the "SEC").

(Press release, Liminatus Pharma, JUN 30, 2026, View Source [SID1234669024])

On June 30, 2026 Novocure (NASDAQ: NVCR) reported that Optune Pax has received CE (Conformité Européenne) Mark for the treatment of adult patients with locally advanced pancreatic cancer of exocrine origin, concomitant with gemcitabine and nab-paclitaxel (gem/nab-pac) in accordance with guideline recommendations.

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"Pancreatic cancer is often diagnosed in late stages when tumors are more difficult to treat. As a result, treatment options have limited effect and survival rates have remained low for decades. However, in the Phase 3 PANOVA-3 trial for Optune Pax, a statistically significant improvement in overall survival was observed in patients who were at an advanced stage of disease," said Teresa Macarulla, MD, PhD, Head of the Department of Medical Oncology at Hospital Clínic Barcelona. "In addition, Optune Pax was also shown to delay pain progression, a debilitating symptom of pancreatic cancer. This is a promising treatment for patients who have an urgent need for new options."

Optune Pax is a portable medical device that delivers Tumor Treating Fields (TTFields) non-invasively through wearable arrays. TTFields are alternating electric fields that disrupt processes critical for cancer cell division and survival, resulting in cancer cell death without significantly affecting healthy cells.

The CE Mark for Optune Pax for locally advanced pancreatic cancer is supported by data from the Phase 3 PANOVA-3 clinical trial, which met its primary endpoint by demonstrating a statistically significant improvement in median overall survival (mOS) for patients treated with Optune Pax and gem/nab-pac, compared to those patients who received gem/nab-pac alone, while also significantly extending time to pain progression, a key secondary endpoint. Because the use of gemcitabine and nab-paclitaxel may vary by market, the approved CE Mark intended purpose for Optune Pax includes a reference to guideline recommendations to account for these local differences.

"The CE Mark designation is a critical milestone in our efforts to bring Optune Pax to people living with locally advanced pancreatic cancer, a disease in need of new treatment options," said Anne Calixte de Lembeye, Senior Vice President, EMEA and Canada, Novocure. "We are proud of this achievement and are committed to working with national agencies to secure access to Optune Pax for patients with pancreatic cancer who may benefit from treatment."

Data Supporting the CE Mark of Optune Pax in Locally Advanced Pancreatic Cancer

PANOVA-3 was an international, prospective, randomized, open-label, controlled Phase 3 clinical trial designed to evaluate the use of Optune Pax concomitant with gem/nab-pac as a first-line treatment for locally advanced pancreatic cancer compared to gem/nab-pac alone.

The trial enrolled 571 patients who were randomized 1:1 and followed for a minimum of 18 months. The trial met its primary endpoint, demonstrating a statistically significant improvement in mOS for patients treated with Optune Pax.

In the intent-to-treat population (ITT), patients treated with Optune Pax concomitantly with gem/nab-pac (n=285) had an mOS of 16.2 months [95% confidence interval (CI) 15.0–18.0] compared to 14.2 months (95% CI 12.8–15.4) for patients treated with gem/nab-pac alone (n=286), a statistically significant 2.0-month improvement [hazard ratio (HR) 0.82; (95% CI 0.68–0.99) p=0.039].
In the modified intent-to-treat (mITT) population, defined as patients who received at least 28 days of Optune Pax therapy concomitant with gem/nab-pac or at least one complete cycle of gem/nab-pac, patients treated with Optune Pax concomitantly with gem/nab-pac (n=198) had an mOS of 18.3 months (95% CI 16.1–20.0) compared to 15.1 months (95% CI 13.4–17.0) in those treated with gem/nab-pac alone (n=207), a statistically significant 3.2-month improvement [HR 0.77; (95% CI 0.62–0.97) p=0.023].
Optune Pax concomitant with gem/nab-pac demonstrated improvement in several secondary endpoints, including the one-year survival rate.

The one-year survival rate in the ITT population showed a significant improvement in the Optune Pax concomitant with gem/nab-pac treated group with 68.1% [95% CI 62.0–73.5] compared to those who received gem/nab-pac alone, 60.2% [95% CI 54.2–65.7].
In the mITT population, the one-year survival rate showed a significant improvement in the Optune Pax concomitant with gem/nab-pac treated group with 75.2% (95% CI 68.5–80.7) compared to 65.9% (95% CI 59.0–72.0) in patients who received gem/nab-pac alone.
Pancreatic cancer can cause significant pain as the disease progresses and managing pain is a key clinical challenge. In PANOVA-3, time to pain progression was defined as the time from baseline until an increase of 20 or more points was reported by patients on a visual analogue scale for pain or until death.

Patients treated with Optune Pax concomitant with gem/nab-pac had a median time to pain progression of 15.2 months (95% CI 10.3–22.8) compared to a median 9.1 months in the group treated with gem/nab-pac alone (95% CI 7.4–12.7). This is a significant 6.1-month extension in time to pain progression [HR 0.74; (95% CI 0.56–0.97) p=0.027].
Quality of life (QoL) was a secondary endpoint measured at baseline and every 8 weeks. Analyses were performed for all patients using the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) with the pancreatic cancer-specific PAN26 addendum. Treatment with Optune Pax concomitant with gem/nab-pac resulted in longer deterioration-free survival (DFS) in global health status, pain, pancreatic pain and most of the digestive problems. Similar trends were observed for emotional function and fatigue/lack of energy.

There was no significant difference in additional secondary outcome measures of progression-free survival, local progression-free survival, objective response rate, puncture-free survival or tumor resectability rate between the Optune Pax concomitant with gem/nab-pac and the gem/nab-pac alone arms.

Optune Pax was well-tolerated and did not exacerbate gem/nab-pac -related systemic toxicity, no new safety signals were observed, and serious adverse events (SAEs) were comparable between study arms. Most Optune Pax-treated patients experienced the expected device-related skin adverse events (AEs) under the arrays (76.3% of the Optune Pax-treated participants). The majority of these events were mild to moderate (Grade 1-2), with 21 (7.7%) experiencing a Grade ≥3 event. The most common device-related AE not related to skin AEs was fatigue, reported in 14 participants (5.1%). There was one Grade 4 AE suspected to be related to the device by the investigator, which was a non-serious event of neutrophil count decrease. There were no device-related AEs that led to death, and no unanticipated device-related safety issues during the study.

The results from the Phase 3 PANOVA-3 trial were published in the Journal of Clinical Oncology, available online at View Source

Optune Pax was approved by the U.S. Food and Drug Administration in February 2026.

Novocure plans to launch Optune Pax in Germany in the coming weeks.

About Pancreatic Cancer

According to the World Health Organization (WHO), pancreatic cancer is one of the most lethal cancers and is the fifth most frequent cause of death from cancer in Europe.1 While overall cancer incidence and death rates are remaining stable or declining, the incidence and death rates for pancreatic cancer are increasing.2 It is estimated that in Europe approximately 146,000 patients are diagnosed with pancreatic cancer each year.3 Pancreatic cancer has a five-year relative survival rate of just 13%.4

Physicians use different combinations of surgery, radiation, and pharmacological therapies to treat pancreatic cancer, depending on the stage of the disease. Unfortunately, most locally advanced pancreatic cancer cases are diagnosed when the cancer is no longer operable, meaning encasement of blood vessels, but no extra-pancreatic disease, leaving few treatment options. The standard of care for locally advanced pancreatic cancer is chemotherapy with or without radiation, and surgery if it is possible.

About Tumor Treating Fields

Tumor Treating Fields (TTFields) are electric fields that exert physical forces to kill cancer cells via a variety of mechanisms. TTFields do not significantly affect healthy cells because they have different properties (including division rate, morphology, and electrical properties) than cancer cells. These multiple, distinct mechanisms work together to target and kill cancer cells. Due to these multi-mechanistic actions, TTFields therapy can be added to cancer treatment modalities in approved indications and it demonstrated enhanced effects across solid tumor types when used with chemotherapy, radiotherapy, immune checkpoint inhibition, or targeted therapies in preclinical models. TTFields therapy provides clinical versatility that has the potential to help address treatment challenges across a range of solid tumors.

To learn more about TTFields therapy and its multifaceted effect on cancer cells, visit novocure.com/ttfields.

(Press release, NovoCure, JUN 30, 2026, View Source [SID1234669023])

On June 30, 2026 ADC Therapeutics SA (NYSE: ADCT), a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs), reported the completion of enrollment in the LOTIS-7 Phase 1b open-label clinical trial evaluating the safety and efficacy of ZYNLONTA (loncastuximab tesirine-lpyl) in combination with the bispecific antibody glofitamab (COLUMVI) in patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (r/r DLBCL).

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LOTIS-7 trial enrollment is now complete with 100 r/r DLBCL patients dosed at the selected 150 µg/kg dose of ZYNLONTA plus glofitamab. Enrollment occurred in 30 total sites with 70% of patients in the US and 30% in the EU. The study enrolled patients with baseline characteristics similar to other bispecific combination studies in this space and included 46% relapsed and 54% primary refractory patients with a median age of 66 years.

Primary endpoints of the study include safety and tolerability. Secondary endpoints include overall response rate, duration of response, complete response, relapse free survival, progression-free survival, and overall survival, as well as pharmacokinetics and immunogenicity. As part of the study protocol, anti-infective prophylaxis, intravenous immunoglobulin (in patients experiencing B-cell loss with an increased risk of infection) and vaccination are strongly recommended.

"We are excited by the previously reported data from this study which demonstrated an 89.8% ORR and 77.6% CR and a manageable safety profile across the 49 efficacy-evaluable patients with a minimum of 6 months of follow-up," said Mohamed Zaki, MD, PhD, Chief Medical Officer of ADC Therapeutics. "We continue to believe this ZYNLONTA combination has the potential to be the best-in-class bispecific antibody-based combination in 2L+ DLBCL. With enrollment now complete, we look forward to sharing more comprehensive results from LOTIS-7 later this year."

Further to the previously reported results from LOTIS-7 demonstrating promising clinical activity for the combination of ZYNLONTA plus glofitamab in patients with r/r DLBCL, the Company plans to share full data from LOTIS-7 at a medical meeting and submit the results for publication by the end of 2026. In addition, the Company plans to assess potential regulatory and compendia pathways for the combination.

About LOTIS-7

LOTIS-7 is a Phase 1b global multicenter, multi-arm study in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL) including Part 1 (dose escalation) and Part 2 (dose expansion). The three dosing arms include ZYNLONTA plus polatuzumab vedotin, ZYNLONTA plus glofitamab, and ZYNLONTA plus mosunetuzumab T-cell-engaging bispecific monoclonal antibodies (BsAbs). Enrollment in LOTIS-7 includes Part 1 of the study with a 3+3 dose escalation in 3L+ heavily pre-treated patients with ZYNLONTA doses starting at 90 µg/kg and then proceeding to 120 µg/kg and 150 µg/kg. Part 2 includes dose expansion in 2L+ large B-cell lymphoma in the ZYNLONTA plus glofitamab arm at dose levels determined from Part 1 (120 µg/kg and 150 µg/kg of ZYNLONTA plus the approved dosing of glofitamab).

For more information about the LOTIS-7 trial, visit clinicaltrials.gov (NCT04970901).

About ZYNLONTA

ZYNLONTA is a CD19-directed antibody drug conjugate (ADC). Once bound to a CD19-expressing cell, ZYNLONTA is internalized by the cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload. The potent payload binds to DNA minor groove with little distortion, remaining less visible to DNA repair mechanisms. This ultimately results in cell cycle arrest and tumor cell death.

The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have approved ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma. The trial included a broad spectrum of heavily pre-treated patients (median three prior lines of therapy) with difficult-to-treat disease, including patients who did not respond to first-line therapy, patients refractory to all prior lines of therapy, patients with double/triple hit genetics and patients who had stem cell transplant and CAR-T therapy prior to their treatment with ZYNLONTA. This indication is approved by the FDA under accelerated approval and in the European Union under conditional approval based on overall response rate and continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Please see full prescribing information including important safety information about ZYNLONTA at www.ZYNLONTA.com.

ZYNLONTA is also being evaluated as a therapeutic option in combination studies in other B-cell malignancies and earlier lines of therapy.

(Press release, ADC Therapeutics, JUN 30, 2026, View Source [SID1234669022])

On June 30, 2026 FibroBiologics, Inc. (Nasdaq: FBLG) ("FibroBiologics"), a clinical-stage biotechnology company with 270+ patents issued and pending with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, reported that Founder and Chief Executive Officer, Pete O’Heeron, and Chief Scientific Officer, Hamid Khoja, Ph.D., will participate in a fireside chat at the H.C. Wainwright 4th Annual Cell Therapy Virtual Conference taking place June 30 – July 1, 2026.

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The fireside chat is scheduled for 1:00 p.m. ET on June 30, 2026, and will be moderated by Matthew Caufield, Senior Research Healthcare Analyst at H.C. Wainwright & Co. FibroBiologics will be available for one-on-one meetings throughout the event.

For more information, please visit FibroBiologics’ website, email FibroBiologics at [email protected] or follow FibroBiologics on LinkedIn, YouTube, Facebook or X.

(Press release, FibroBiologics, JUN 30, 2026, View Source [SID1234669021])