On January 13, 2025 Novocure (NASDAQ: NVCR) reported preliminary unaudited financial and operational results for the quarter and full year ended December 31, 2024 (Press release, NovoCure, JAN 13, 2025, View Source [SID1234649690]). Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer by developing and commercializing its innovative therapy, Tumor Treating Fields (TTFields).

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"Novocure is at an exciting inflection point as we continue to expand our multi-indication TTFields treatment platform. In 2024, we brought Optune Gio to more than 4,000 glioblastoma patients across the globe, earned FDA approval and launched Optune Lua in non-small cell lung cancer in the U.S., announced two additional successful Phase 3 trial readouts and released our next generation arrays," said Ashley Cordova, Chief Executive Officer. "With two additional indication launches on the horizon, we are well positioned for 2025 and beyond. This progress demonstrates our steadfast commitment to our patient-forward mission: together with our patients, we strive to extend survival in some of the most aggressive forms of cancer."

Financial updates for the year and fourth quarter ended December 31, 2024*:

Total preliminary net revenues for the year were $605.2 million, an increase of 19% compared to the prior year.
2024 growth was primarily driven by our successful launch in France and significantly improved approval rates in the U.S., which are now reflected in our revenue baseline. 2025 net revenue growth is expected to closely reflect growth in Optune Gio active patients.
Total preliminary net revenues for the fourth quarter were $161.3 million, an increase of 21% compared to the same period in 2023.
The U.S., Germany, France and Japan contributed $107.2 million, $17.7 million, $16.0 million and $8.5 million, respectively, with other active markets contributing $9.9 million.
Revenue in Greater China from Novocure’s partnership with Zai Lab totaled $2.0 million.
Improved approval rates in the U.S. resulted in $8.3 million of increased net revenue from prior period claims during the quarter, which we believe should not be considered in our 2025 baseline. This is in addition to the $14.0 million of increased revenue from prior period claims disclosed through the third quarter.
Cash, cash equivalents and short-term investments were $959.9 million as of December 31, 2024.
Operational updates for the fourth quarter ended December 31, 2024:

As of December 31, 2024, there were 4,126 total active patients on TTFields therapy globally.
1,520 Optune Gio prescriptions were received in the quarter, consistent with the same period in 2023. Optune Gio prescriptions from the U.S., Germany, France and Japan contributed 897; 190; 194 and 109 prescriptions, respectively, with the remaining 130 prescriptions received from other active markets.
As of December 31, 2024, there were 4,077 active Optune Gio patients on therapy. Active Optune Gio patients from the U.S., Germany, France and Japan contributed 2,161; 564; 426 and 420 active patients, respectively, with the remaining 506 active patients contributed by other active markets.
On October 15, 2024, Optune Lua was approved by the U.S. Food and Drug Administration (FDA) for the treatment of metastatic non-small cell lung cancer (NSCLC) concurrently with PD-1/PD-L1 inhibitors or docetaxel, in adults who have progressed on or after a platinum-based regimen. As of December 31, 2024, 52 Optune Lua prescriptions were received for NSCLC.
As of December 31, 2024, there were 20 active NSCLC patients on Optune Lua. Additionally, there were 29 active mesothelioma patients on Optune Lua around the globe.
In Q1 2026, Novocure intends to stop reporting new prescriptions and focus on active patients by indication and material market as the key operating statistic.
Fourth quarter and recent updates and achievements:

In October, the FDA granted Breakthrough Device designation for the use of TTFields therapy for brain metastases from non-small cell lung cancer. Breakthrough Device designation provides more frequent, faster and interactive access to the FDA review team and senior management during the review process, priority review of marketing applications upon filing, and expedited review of pre-Premarket Approval Application (PMA) manufacturing and quality systems compliance inspections.
In October, the FDA approved Novocure’s new Head Flexible Electrode (HFE) transducer arrays for use with Optune Gio for the treatment of adult patients with glioblastoma (GBM).
In December, the company announced the Phase 3 PANOVA-3 clinical trial met its primary endpoint, demonstrating a statistically significant improvement in overall survival for patients with unresectable, locally advanced pancreatic cancer. Novocure plans to submit the full data for presentation at an upcoming medical congress.
In December, the FDA granted Breakthrough Device designation for the use of TTFields therapy for the treatment of unresectable, locally advanced pancreatic cancer.
In January 2025, the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) approved Novocure’s new HFE transducer arrays for use with Optune Gio for the treatment of adult patients with GBM.
Anticipated clinical milestones:

Data from Phase 2 PANOVA-4 clinical trial in metastatic pancreatic cancer (2026)
Data from Phase 3 TRIDENT clinical trial in newly diagnosed GBM (2026)
Fourth quarter and full year 2024 financial results conference call:

Novocure will host a conference call and webcast to discuss full year and fourth quarter 2024 financial results at 8:00 a.m. EST on Thursday, February 27, 2025. To access the conference call by phone, use the following conference call registration link and dial-in details will be provided. To access the webcast, use the following webcast registration link.

The webcast, earnings slides presented during the webcast and the corporate presentation can be accessed live from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for at least 14 days following the call. Novocure has used, and intends to continue to use, its investor relations website, as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.

*The unaudited results in this press release are preliminary and subject to the completion of the Company’s annual independent audit and, therefore, are subject to adjustment.

On January 13, 2025 AbCellera (Nasdaq: ABCL) reported that it has expanded its existing collaboration with AbbVie Inc. (NYSE: ABBV) to include the discovery of T-cell engagers (TCE) in oncology (Press release, AbCellera, JAN 13, 2025, View Source [SID1234649689]). The expansion builds upon the successful partnership established in December 2022 and includes access to AbCellera’s TCE platform to develop therapeutic antibodies for tumor targets.

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"We are pleased to broaden our AbbVie collaboration and look forward to using AbCellera’s TCE platform to bring novel cancer immunotherapies to patients in need," said Carl Hansen, Ph.D., founder and CEO of AbCellera.

Under the terms of the agreement, AbCellera will lead discovery activities and AbbVie has the right to develop and commercialize therapeutic antibodies resulting from the collaboration. AbCellera will receive upfront and research payments and is eligible to receive downstream milestone payments as well as tiered royalty payments on net sales.

On January 13, 2025 Scribe Therapeutics Inc., a genetic medicines company unlocking the potential of CRISPR to transform human health, reported the achievement of a success milestone for one of the targets in its research collaboration with Sanofi to develop in vivo CRISPR-based therapeutics (Press release, Scribe Therapeutics, JAN 13, 2025, View Source [SID1234649688]). Scribe is eligible to receive over $1.2 billion across all programs in milestone payments for the achievement of certain research, development, regulatory and commercial milestones, as well as high-single-digit to mid-teen royalties.

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"We are excited about the progress we have made towards creating potentially curative in vivo genetic medicines with a partner like Sanofi," said Benjamin Oakes, Ph.D., co-founder and Chief Executive Officer of Scribe. "The complementary expertise of our teams has enabled the program to move quickly and attain early validation of our CRISPR genome editing technologies. We look forward to further advancement of this program with a direct line of sight towards bringing breakthrough CRISPR-based therapeutics to patients with significant unmet need."

CRISPR by Design is Scribe’s data-driven design and engineering approach for optimizing its CRISPR-based platforms and assets, including X-Editing (XE) technologies, to drive forward a new era of transformative genetic medicines.

"Advancing our in vivo program with Sanofi speaks to the versatility and strength of Scribe’s CRISPR-based platforms," said Svetlana Lucas, Ph.D., Chief Business Officer at Scribe. "We are pleased to reach this important milestone and continue progressing our collaboration to accelerate and expand our patient impact globally."

Scribe announced its initial research collaboration with Sanofi for CRISPR-based cell therapies to address oncology indications in 2022, followed by an expansion in 2023 to advance in vivo medicines for genomic diseases.

On January 13, 2025 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for its highly-sensitive in-situ hybridisation (ISH) test, the VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (Press release, Hoffmann-La Roche, JAN 13, 2025, View Source [SID1234649687]). The test is designed to help pathologists differentiate a B-cell malignancy from a normal, reactive response to an infection, thus facilitating faster access to treatment.4 This announcement follows the assay’s CE Mark approval in June 2024.

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B-cell lymphoma is a type of cancer that typically develops in the lymphatic system. It accounts for approximately 85 percent of non-Hodgkin lymphoma (NHL) cases.3 NHL is one of the most common forms of cancer in the US, accounting for about 4% of all cancer cases,5 and causing more than 80,000 deaths each year.5 In the early stages of NHL, patients may experience symptoms like swelling of the lymph nodes, fever, fatigue, loss of appetite or a red rash.

"Accurately differentiating lymphoma from an infection is critical in ensuring accurate and timely diagnosis, especially as the symptoms can appear similar," said Jill German, Head of Pathology Lab at Roche Diagnostics. "With this new test, clinicians can have confidence in their diagnosis, while the test reduces the need for multiple samples and time consuming follow up tests, giving patients certainty sooner, and enabling faster access to the right treatment."

With increased sensitivity, the new VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail enables assessment across the more than 60 B-cell lymphoma subtypes and plasma cell neoplasms on a single tissue slide. The test can assess small biopsies and formalin-fixed tissue, reducing the need for a fresh tissue sample, which may not be available especially if lymphoma was not originally suspected. These test properties preserve tissue, may result in fewer additional patient biopsies and make interpretation quicker and easier for the pathologist, helping facilitate a faster diagnosis and access to treatment for patients.

This first-of-its-kind assay is a significant addition to Roche’s industry-leading hematopathology portfolio, which includes more than 65 biomarkers.

About the VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail
The VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail Assay is a qualitative assay that is used to detect the expression of kappa and lambda immunoglobulin light chains in formalin-fixed paraffin embedded (FFPE) human hematolymphoid specimens by in situ hybridization (ISH).

The assay is intended as an aid in the diagnosis of mature B-cell lymphomas and plasma cell neoplasms. The VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail is indicated for use when a biopsy of lymph node or bone marrow (core biopsy and clot section) indicates inconclusive results. It enables the assessment of both markers in the context of one another on a single slide as an aid in differentiating between a reactive process or B-cell lymphoma and plasma cell neoplasms.

This is not a standalone test, and results should be evaluated by a qualified pathologist within the context of the patient’s clinical history and other diagnostic tests. This product is intended for in vitro diagnostic (IVD) use.

On January 13, 2025 Ginkgo Bioworks (NYSE: DNA), which is building the leading platform for cell programming and biosecurity, reported a research collaboration with Universal Cells, an Astellas company, to optimize next-generation induced pluripotent stem cell (iPSC)-derived cancer cell therapies (Press release, Ginkgo Bioworks, JAN 13, 2025, View Source [SID1234649686]). This collaboration underscores Ginkgo’s capacity to deploy high-throughput biological approaches to tackle the complex challenge set associated with development of therapies targeting solid tumors.

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iPSC-derived cell therapies have the potential to transform cancer care by offering scalable, ‘off-the-shelf’ treatment options. However, bringing efficacious therapies to patients requires robust design and screening processes to improve persistence in the patient to enable durable clinical responses. By combining Universal Cells’ proprietary iPSC-derived cell technologies with Ginkgo’s expertise in design and screening large CAR libraries and its high throughput, multimodal immune cell engineering platform, the companies aim to accelerate the development of more potent and durable cell therapies while maintaining manufacturability at scale.

Ginkgo’s approach leverages computational tools, deep expertise in library assembly and screening, and rigorous statistical analysis and biological insight to help partners discover and engineer optimal therapeutic designs with greater speed and precision. Ginkgo’s platform capabilities extend across multiple dimensions of cell therapy development, including chimeric antigen receptor (CAR) discovery and optimization, armoring strategies for enhanced cell survival and persistence, and gene editing tools for immune cell engineering. Ginkgo employs high-throughput pooled and arrayed screening methods that enable the simultaneous testing of numerous CAR designs from transcriptome to cell function. This approach facilitates discoveries that aim to improve immune cell persistence and functionality.

"We’re excited to embark on this collaboration, which represents a significant milestone for Ginkgo as we expand our cell therapy portfolio," said Jason Kelly, CEO and co-founder of Ginkgo Bioworks. "Teaming up with Universal Cells, part of Astellas, allows us to bring our comprehensive immune cell engineering capabilities to a highly respected, global pharmaceutical leader. We look forward to working together to optimize iPSC-derived allogeneic cell therapies that have the potential to improve patient outcomes and reshape how we treat solid tumors."

"Cell therapies hold immense promise, but realizing their full potential requires innovation at every step, from design to delivery," said Dr. Narendra Maheshri, VP, Genetic Medicines at Ginkgo Bioworks. "Our platform enables partners to rapidly explore the functional impact of a large number of CAR designs simultaneously, and then iterate to further refine those designs. By applying this approach with Universal Cells, we aim to help accelerate CAR approaches, opening up new possibilities in the fight against cancer."

To learn more about how you can leverage Ginkgo’s capabilities in cell therapy and gene editing – from CAR-T to CRISPR and beyond – please visit our website.