On June 30, 2026 Orion Pharma ("Orion") and Shilpa Biologicals Private Limited, a fully-owned subsidiary of Shilpa Medicare Limited ("Shilpa"), reported to have entered into an agreement to commercialise intravenous (iv) nivolumab biosimilar in Europe. Nivolumab is an immune checkpoint inhibitor which is used to treat various cancers. Shilpa’s nivolumab biosimilar is currently under development by the company.

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Under the terms of the agreement, Orion will gain exclusive right to distribute, market and sell Shilpa’s iv nivolumab biosimilar in Europe. Shilpa will supply the product to Orion, and is entitled to receive from Orion certain development and regulatory milestone payments.

"We are pleased to add yet another product to our strategic partnership with Shilpa," said Satu Ahomäki, EVP Generics and Consumer Health, Orion Pharma. "This agreement is a step forward in our efforts to expand and strenghten our operations in hospital segment in Continental Europe, and an indication of the progress of the implementation of our division’s strategy which aims to create everybody an access to affordable quality medicines."

"Extending our partnership with Orion into immuno-oncology is a defining moment for Shilpa Biologicals," added Vishnukant Bhutada, Managing Director, Shilpa Medicare. "It reflects the trust our partners place in our quality, our science and our ability to deliver complex biologics at scale – and it moves us closer to our mission of making advanced medicines affordable and accessible worldwide."

(Press release, Orion, JUN 30, 2026, View Source [SID1234669027])

On June 30, 2026 Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical-stage company developing next-generation therapeutics for difficult-to-treat cancers, reported that it has entered into definitive securities purchase agreements for a private placement expected to result in gross proceeds of approximately $50 million, before deducting placement agent fees and offering expenses, and an additional approximately $64 million of gross proceeds if the accompanying warrants are exercised in full for cash.

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The financing was led by BVF Partners L.P. with participation from GordonMD Global Investments, RTW Investments, and Coastlands Capital. The upfront proceeds are expected to extend the Company’s cash runway into the second quarter of 2027 and support the continued advancement of its lead clinical program, MICVO (micvotabart pelidotin), through key clinical milestones.

"We are pleased to have the support of a high-quality group of new and existing healthcare investors, whose participation reflects confidence in MICVO and our strategy to advance the program," said Tom Civik, Interim Chief Executive Officer and Director of Pyxis Oncology. "This financing strengthens our balance sheet, provides the flexibility to extend patient follow-up in our expansion trial following completion of enrollment in the first quarter, and enables us to generate additional clinical evidence for MICVO. We look forward to an exciting second half of 2026 as we continue advancing MICVO for patients with head and neck cancer."

The Company has elected to incorporate additional patient follow-up and planned analyses into its next clinical update and now expects to report updated data from the ongoing Phase 1 monotherapy study in second-line and beyond recurrent/metastatic head and neck squamous cell carcinoma (2L+ R/M HNSCC) in Fall 2026. The update is expected to include patients treated at 5.4 mg/kg IV Q3W with a dose equivalent to or below a dose cap, along with detailed analyses of the dose cap impact on safety, tolerability and efficacy.

The Company also expects to report updated data from the ongoing Phase 1/2 dose-escalation study evaluating MICVO in combination with pembrolizumab for first-line (1L) R/M HNSCC in the fourth quarter of 2026.

Under the terms of the financing, Pyxis Oncology has agreed to sell 19,600,153 shares of its common stock at a price of $2.551 per share and warrants to purchase an equal number of shares of common stock. The common stock warrants have an exercise price of $3.289 per share and are exercisable in accordance with their terms (including via cashless exercise). The private placement is expected to close on or about July 2, 2026, subject to the satisfaction of customary closing conditions.

Wells Fargo Securities acted as sole placement agent for the private placement.

The securities described above have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or applicable state securities laws and may not be offered or sold in the United States absent registration or an applicable exemption from such registration requirements. Pyxis Oncology has agreed to file a registration statement with the U.S. Securities and Exchange Commission covering the resale of the shares of common stock issued in the private placement and the shares issuable upon exercise of the warrants.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful.

(Press release, Pyxis Oncology, JUN 30, 2026, View Source [SID1234669026])

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])