On May 7, 2026 Nykode Therapeutics ASA (OSE: NYKD), a clinical stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, reported the dosing of the first patient in Abili-T, a randomised Phase II clinical trial evaluating abi-suva (formerly VB10.16) in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD1 therapy, KEYTRUDA (pembrolizumab) versus pembrolizumab alone as first-line treatment for patients with HPV16-positive, PD-L1-positive recurrent or metastatic head and neck squamous cell carcinoma (1L r/m HNSCC).

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The initiation of Abili-T marks a pivotal milestone in Nykode’s clinical development programme and reinforces the Company’s strategy to advance abi-suva as a targeted immunotherapy for the significant unmet medical need that exists in HPV16-driven cancers.

"Initiating the first patient in the Abili-T trial is an important step forward for Nykode and most importantly for patients with first-line recurrent/metastatic head and neck squamous cell carcinoma who continue to have significant unmet medical needs," said Michael Engsig, Chief Executive Officer at Nykode Therapeutics. "Abi-suva is designed to generate strong and durable HPV16-specific immune responses and we look forward to generating data in a randomized setting. We are grateful to the clinical investigators and patients participating in this study."

"There is a significant unmet need for patients with HPV16-driven head and neck cancer, particularly in the first-line setting," said Åse Bratland, Coordinating Investigator of the Abili-T trial, The Norwegian Radium Hospital, Oslo University Hospital. "Abi-suva is designed to generate a targeted and durable immune response and combining it with pembrolizumab may offer a meaningful new approach for these patients. We are hopeful that this study will provide important insights and, ultimately, lead to improved outcomes."

Abili-T is a randomised, open-label, multicentre Phase II trial evaluating abi-suva in combination with pembrolizumab versus pembrolizumab alone as first-line treatment in patients with HPV16-positive, PD-L1-positive recurrent or metastatic head and neck squamous cell carcinoma (1L r/m HNSCC).

The trial will enroll approximately 100 patients across 40 sites in Europe and Canada. Patients will be randomised to receive either abi-suva in combination with pembrolizumab or pembrolizumab alone. The primary endpoints are progression-free survival (PFS) and objective response rate (ORR). Secondary endpoints include duration of response (DOR), disease control rate (DCR), and overall survival (OS).

The Abili-T trial follows the successful completion of three prior clinical studies with abi-suva, VB-C-01, VB-C-02 and VB-C-03, which established the safety and tolerability of abi-suva as monotherapy and in combination with checkpoint inhibitors and demonstrated a strong and durable clinical effect in patients with advanced HPV16-driven cancers.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. KEYTRUDA has been supplied by MSD for the Abili-T trial according to the clinical trial collaboration and supply agreement between Nykode and MSD.

Disease Background and Market Opportunity

The combined incidence of HPV16-positive HNSCC in the EU and US is approximately 63,000 new cases annually and the incidence of HPV16-driven HNSCC is rising.

Despite recent advances in immuno-oncology, patients with recurrent or metastatic HNSCC continue to face a significant unmet medical need. Current standard of care achieves an objective response rate of 19% and a median overall survival of 12.3 months. The majority of treatments currently in development for HNSCC are focused on HPV-negative disease, leaving the HPV16-positive patient population particularly underserved.

Beyond HNSCC, abi-suva has the potential to address a broader HPV16-driven cancer population including cervical, anal, vulvar and penile cancers with an annual incidence of approximately 134,000 patients annually in Europe and the US. This broader opportunity is supported by the clinical data generated in the VB-C-02 trial, which demonstrated strong and durable clinical effects in advanced cervical cancer patients, and in the VB-C-01 demonstrating a promising efficacy and favorable safety profile and confirmed the induction of robust HPV16-specific T-cell responses in pre-cancerous lesions (CIN).

(Press release, Nykode Therapeutics, MAY 7, 2026, View Source [SID1234665339])

On May 7, 2026 MEDSIR, an international company and a leader in oncology research, reported the results of the PHERGain and PHERGain-2 studies at the ESMO (Free ESMO Whitepaper) Breast 2026 scientific congress. Both studies evaluate de-escalation strategies based on targeted therapies in HER2-positive early breast cancer, with the aim of identifying which patients could safely avoid standard chemotherapy without compromising therapeutic benefit. Taken together, these studies reinforce a more personalized approach focused on reducing treatment-related toxicity while better preserving patients’ quality of life.

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PHERGain is an international, multicenter, phase II clinical trial in which 356 patients were enrolled across 45 hospitals in seven European countries, including Spain. Following publication of the primary results in leading scientific journals such as The Lancet, MEDSIR has now presented the five-year survival outcomes at ESMO (Free ESMO Whitepaper) Breast 2026. The objective of the study was to further validate a therapeutic de-escalation strategy in patients with HER2-positive early breast cancer, based on PET imaging and adapted to pathological complete response (pCR), allowing chemotherapy to be omitted without compromising disease control or survival.

The study demonstrated the efficacy of the combination of trastuzumab and pertuzumab within this adaptive strategy, showing that approximately 30% of patients with localized HER2-positive early breast cancer could avoid chemotherapy. The results presented at the congress confirm the robustness of this approach, with close to 90% of patients remaining recurrence-free five years after surgery. These findings support the validity of this adaptive therapeutic strategy as a safe and durable alternative over time, prioritizing patient well-being by avoiding conventional chemotherapy and its associated toxicities.

In addition, the company presented a translational analysis of the PHERGain study showing that circulating tumor DNA detected through liquid biopsy represents a precise, rapid, and non-invasive tool with the potential to identify patients who will remain disease-free in the long term.

As highlighted during the congress by Dr. Javier Cortés, principal investigator of the study and Director of the International Breast Cancer Center in Madrid and Barcelona: "In addition to the clinical outcomes, with nearly 90% of patients free from relapse five years after surgery, we see that the analysis of circulating tumor DNA in blood is emerging as a key tool to enable early identification of patients with a better prognosis and those who may benefit from more intensive treatment."

PHERGain-2: De-escalation with a focus on quality of life

PHERGain-2, presented at ESMO (Free ESMO Whitepaper) Breast 2026 and published simultaneously in Annals of Oncology, is an international, multicenter, phase II trial that enrolled 396 patients across 47 centers in Spain, Italy, Denmark, Hungary, Poland, and Bulgaria. The study aims to demonstrate the efficacy of a de-escalation strategy in HER2-positive early breast cancer in selected low-risk patients. Specifically, it focuses on patients with tumors measuring between 5 and 30 mm, with no nodal involvement at diagnosis and high HER2 protein expression.

The trial explores a chemotherapy-free, pCR-guided strategy based on the targeted therapies trastuzumab and pertuzumab, incorporating T-DM1 within the treatment regimen. In addition, quality of life is established as the primary safety objective, placing patient-reported outcomes at the center of treatment evaluation. The results presented suggest that more than half of the patients maintain a satisfactory quality of life throughout the first year of treatment, reinforcing the notion that avoiding chemotherapy contributes to a reduction in long-term adverse effects.

With regard to efficacy, the primary endpoint is still pending. Nevertheless, the observed pCR rate of 60% is encouraging, particularly considering that treatment is initiated without chemotherapy. These findings support the clinical potential of this strategy in this patient population.

As stated by Dr. Antonio Llombart-Cussac, principal investigator of the study and Head of the Medical Oncology Department at Hospital Arnau de Vilanova in Valencia: "The results of PHERGain-2 reinforce the idea that it is possible to offer patients a therapeutic alternative that prioritizes quality of life by avoiding side effects that negatively impact physical and emotional well-being, such as fatigue, hair loss, or other health problems associated with chemotherapy."

(Press release, MedSIR, MAY 7, 2026, View Source [SID1234665357])

On May 7, 2026 AN2 Therapeutics, Inc. (Nasdaq: ANTX), a biopharmaceutical company advancing novel small molecule therapeutics derived from its boron chemistry platform, reported that Eric Easom, Co-Founder, Chairman, President and CEO will participate in a fireside chat at the 2026 Stifel Virtual Targeted Oncology Forum on May 19, 2026 at 4:00 PM ET, and members of management will be available for 1×1 meetings.

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A webcast can be accessed on the Investors section of the AN2 Therapeutics website at www.an2therapeutics.com. An archived replay will be available for at least 30 days following the presentation.

(Press release, AN2 Therapeutics, MAY 7, 2026, View Source [SID1234665308])

On May 7, 2026 Roche (SIX: RO, ROP; OTCQX: RHHBY) reported that it has entered into a definitive merger agreement to acquire PathAI, a US-based company in digital pathology and AI-powered technology for pathology laboratories and the biopharma industry. This acquisition builds on the successful partnership between Roche and PathAI, established in 2021 and scaled up in 2024 to include the development of AI-enabled companion diagnostic algorithms. Subject to the closing of the transaction, which is expected in the second half of the year, the acquired entity will become part of the Diagnostics division.

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This acquisition strengthens Roche’s position in Digital Pathology, which is transforming extensive manual workflows into fully automated, AI-driven processes and insights. Digital pathology enables the creation of high-resolution digital images from physical tissue on slides, allowing pathologists to use AI tools to facilitate diagnostic workflows and provide patients with faster results.

"Digital pathology has the potential to improve precision diagnosis of cancer and enable physicians to offer better tailored treatment regimens," said Matt Sause, CEO of Roche Diagnostics. "Bringing PathAI into Roche Diagnostics will allow us to combine their best-in-class digital pathology tools with our leading oncology diagnosis platforms to deliver better insights for physicians and potentially better outcomes for patients worldwide."

Andy Beck, CEO and Co-Founder of PathAI, adds: "Joining forces with Roche marks a new era for PathAI, enabling us to realise our mission of improving patient outcomes through AI-powered pathology at unprecedented scale and speed. Roche’s global infrastructure and expertise will bring our digital diagnostics technology to patients worldwide."

PathAI’s AISight IMS software interface is efficient and user-friendly, seamlessly integrating advanced analysis and workflow capabilities within the digital pathology laboratory. In the rapidly growing pathology market, Roche intends to scale this solution globally.

In addition, the expanded capabilities strengthen Roche’s competitiveness in precision medicine by enhancing its biopharma services. PathAI’s strength in AI-driven solutions, including clinical trial support and translational research, will complement Roche’s deep expertise in companion diagnostics. Combining these capabilities will foster the discovery of new biomarkers, potential drug targets and novel diagnostic tools, increasing the value Roche can bring to biopharma companies.

Terms of the merger agreement
The closing of the transaction is subject to customary closing conditions, including antitrust and regulatory approvals and is currently expected in the second half of the year.

Under the terms of the agreement, Roche will pay a purchase price of USD 750 million upfront and additional milestone payments of up to USD 300 million.

(Press release, Hoffmann-La Roche, MAY 7, 2026, View Source [SID1234665324])

On May 7, 2026 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported financial and operational results for the first quarter ended March 31, 2026, highlighted recent business accomplishments, and reaffirmed financial guidance for the full year 2026.

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First Quarter and Recent Strategic and Operational Highlights

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Secured Milestone Medicare Coverage for Lung Cancer: Received Medicare coverage approval in the first quarter for the surveillance of cancer recurrence in lung cancer patients for Stage I to III non-small cell lung cancer (NSCLC). This marks the Company’s second major coverage decision in six months, alongside breast cancer.
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Announced Early Access Launch of Real-Time Variant Tracker: Launched a pioneering new feature for NeXT Personal that empowers clinicians to longitudinally track resistance and therapeutically targetable mutations during routine disease monitoring, and potentially optimize treatment.
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Published Neoadjuvant Treatment Monitoring Results in Breast Cancer: Featured data in the Journal of Clinical Oncology from the PREDICT-DNA prospective study for Triple-Negative (TNBC) and HER2+ breast cancer patients that showed NeXT Personal can outperform current standard approaches for predicting patient outcomes following neoadjuvant therapy (NAT).

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Presented Compelling Data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting:
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Colorectal Cancer (CRC) Podium Presentation: Highlighted the ultrasensitive ctDNA detection by NeXT Personal for predicting and tracking response to neoadjuvant immunotherapy in CRC patients, demonstrating a remarkable 100% negative predictive value and 100% specificity for disease relapse following surgery.
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Lung Cancer Poster Presentation: Demonstrated that ultrasensitive ctDNA monitoring with NeXT Personal successfully predicts the early response of immunotherapy in recurrent metastatic NSCLC patients.
First Quarter 2026 Financial Results Compared with First Quarter 2025

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Quarterly Revenue: $15.5 million compared with $20.6 million; reflecting the planned decline in non-core revenue as the company focuses on growing revenue from its strategic MRD offering.
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Clinical Revenue: Clinical test revenue of $1.4 million, compared with $0.3 million; delivered 7,815 clinical tests compared with 2,184, representing a 258% increase.

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Core Revenue Streams: Pharma testing services and all other customers contributed $11.2 million. Revenue from enterprise sales (Natera) and population sequencing (the VA MVP) totaled approximately $2.9 million.
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Strong Cash Position: Ended the quarter with approximately $233.2 million in cash, cash equivalents, and short-term investments. This includes approximately $21.0 million in net proceeds from the Company’s At-The-Market (ATM) sales program, executed at a weighted-average price of $10.00 per share.
CEO Commentary

"Our accomplishments in the first quarter demonstrated that our ‘Win-in-MRD’ strategy is working to establish NeXT Personal as the new standard for how cancer is detected and monitored," said Chris Hall, Chief Executive Officer of Personalis. " Delivering 26% sequential and 258% year-over-year clinical volume growth—especially during what is traditionally the industry’s toughest seasonal quarter reflects the strong market demand for our ultrasensitive NeXT Personal test. With new Medicare coverage for lung cancer joining our existing breast cancer win, Personalis now has a reimbursement success in two of the largest oncology indications. We are transforming our ultrasensitive MRD technology from a clinical leader into a potential commercial powerhouse and we remain firmly on track to grow our clinical revenue five-fold this year."

Full Year 2026 Outlook

Personalis reaffirmed the following guidance for the full year of 2026:

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Total company revenue in the range of $78.0 to $80.0 million.
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Clinical test volume scaling rapidly to a range of 43,000 to 45,000 tests, reflecting 171% growth year-over-year at the midpoint.
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Clinical revenue of $10.0 to $11.0 million, representing roughly a five-fold growth year-over-year, driven by Medicare reimbursement from breast and lung cancer surveillance.
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Revenue from pharma testing services and all other customers in the range of $55.0 to $56.0 million.
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Revenue from population sequencing and enterprise sales of approximately $13.0 million.
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Gross margin in the range of 15% to 20%, reflecting the strategic decision to accelerate clinical volume adoption ahead of full reimbursement coverage to establish market share.
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Net loss of approximately $105.0 million.
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Cash usage of approximately $100.0 million, driven by commercial investments to support projected clinical test volume growth and expansion.

(Press release, Personalis, MAY 7, 2026, View Source [SID1234665340])