On April 29, 2025 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation for the VENTANA TROP2 (EPR20043) RxDx Device (Press release, Hoffmann-La Roche, APR 29, 2025, View Source [SID1234652307]). This is the first Breakthrough Device Designation to be granted for a computational pathology companion diagnostic (CDx) device.

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"This FDA Breakthrough Device Designation is another example of our commitment to deliver innovation that enables more precise diagnosis in oncology," said Matt Sause, CEO of Roche Diagnostics. "This solution, which leverages our industry-leading expertise in companion diagnostics development, uses artificial intelligence for a greater depth of sample analysis, helping to deliver truly personalised treatment."

The VENTANA TROP2 (EPR20043) RxDx Device is a computational pathology device, consisting of the TROP2 algorithm, navify Digital Pathology Image Management System, Roche Digital Pathology scanners (DP 200, DP 600) and the VENTANA TROP2 (EPR20043) RxDx Assay used with OptiView DAB Detection Kit for staining on a BenchMark ULTRA IHC/ISH staining instrument. The VENTANA TROP2 (EPR20043) RxDx Device analyses whole slide images of non-small cell lung cancer (NSCLC) tissue stained with TROP2 to compute a quantitative TROP2 score.

The algorithm incorporates AstraZeneca’s proprietary computational pathology platform, Quantitative Continuous Scoring (QCS), which enables a level of diagnostic precision not possible with traditional manual scoring methods.

"This FDA Breakthrough Device Designation underscores the potential of our computational pathology platform to enable more personalised treatment decisions for people with cancer," said Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca.

The FDA granting Breakthrough Device Designation has the potential to make a TROP2 CDx AI-driven system available sooner, which could aid in identifying patients with NSCLC most likely to benefit from treatment with Daiichi Sankyo and AstraZeneca’s DATROWAY (datopotamab deruxtecan-dlnk). DATROWAY is a specifically engineered TROP2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed by AstraZeneca and Daiichi Sankyo.

About the VENTANA TROP2 (EPR20043) RxDx Device
The VENTANA TROP2 (EPR20043) RxDx Device is indicated as an aid in identifying patients with previously treated advanced or metastatic non-squamous NSCLC without actionable genomic alteration (AGA) most likely to benefit from treatment with Daiichi Sanko and AstraZeneca’s DATROWAY (datopotamab deruxtecan-dlnk). A qualified pathologist is responsible for reviewing staining and image quality, as well as ensuring adequate tumor detection sensitivity and precision, in conjunction with histological examination, relevant clinical information, and proper controls.

Following the pathologist assessment, the nDP TROP2 algorithm independently detects tumor cells and generates associated measures of TROP2 IHC staining intensity in both membrane and cytoplasm to compute the Normalised Membrane Ratio (NMR) score. The algorithm then classifies the TROP2 status as positive or negative based upon the pre-defined NMR cutoff.

On April 29, 2025 Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in generic and biosimilar medicines, reported that it has signed a global collaboration agreement with Shanghai Henlius Biotech, Inc. (Henlius, HKEX:02696) to commercialize a biosimilar of leading oncology therapy, ipilimumab (Press release, Shanghai Henlius Biotech, APR 29, 2025, View Source [SID1234652328]). The agreement is milestone-based for a total consideration of up to USD 301 million, including an upfront payment of USD 31 million, and will target net reference-medicine sales of USD 2.5 billion[1].

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Under the terms of the agreement, Sandoz has exclusive commercial rights for a biosimilar of ipilimumab in Australia, Canada, Europe, Japan and the US. The core sequence patent for ipilimumab expired in March 2025 in the US and will expire no later than February 2026 in the EU.

Richard Saynor, CEO of Sandoz, said: "The global burden of cancer continues to grow and the potential to address unmet patient needs has never been greater.[3] This agreement offers us the chance to reach many more millions of patients, while helping to drive the long-term sustainability of healthcare systems."

The reference medicine, ipilimumab, is a monoclonal (CTLA-4) antibody-blocking medication, which is used alone or with other medicines to treat certain types of colorectal cancer, esophageal cancer, hepatocellular carcinoma (a type of liver cancer), malignant pleural mesothelioma, melanoma, non-small cell lung cancer, and renal cell carcinoma (a type of kidney cancer).[4,5,6]

Henlius is developing its own proposed biosimilar of ipilimumab in an integrated Phase I/III trial in the unresectable hepatocellular carcinoma setting, targeting 656 patients to be enrolled (NCT06841185).

Sandoz is developing its own proposed biosimilar of nivolumab in an integrated Phase I/III trial in the advanced melanoma setting, targeting 720 patients to be enrolled (NCT06587451). The reference medicine, nivolumab, (Opdivo**) is a monoclonal (PD-1) antibody-blocking medication, which is used alone or with other medicines to treat more than 10 different cancer types. In combination with ipilimumab, nivolumab is indicated for the treatment of melanoma, malignant pleural mesothelioma, renal cell carcinoma, certain types of colorectal cancer, esophageal cancer, non-small cell lung cancer and hepatocellular carcinoma.[7,8]

Sandoz is the leading biosimilar provider globally and has recently moved up to third position in the US, with a strategic ambition to occupy the leading position in that market.[9] The Company’s industry-leading biosimilars pipeline comprises 28 molecules, complemented by around 450 generic pipeline medicines to support its goal of sustainable and broadly-based long-term growth. The marketed biosimilar oncology portfolio includes Rixathon, Zarzio, Ziextenzo, and Binocrit. This year, Sandoz expects to launch its biosimilars Wyost/Jubbonti (denosumab) in the US in the second quarter and in Europe in the fourth quarter.

On April 29, 2025 AbCellera (Nasdaq: ABCL) reported new data on its PSMA x CD3 T-cell engagers (TCEs), presented as a poster at the American Association for Cancer Research (AACR) (Free AACR Whitepaper)Ⓡ (AACR) (Free AACR Whitepaper) 116th Annual Meeting at the McCormick Place Convention Center in Chicago, Illinois, taking place April 25 to 30, 2025 (Press release, AbCellera, APR 29, 2025, View Source [SID1234652344]).

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Targeting prostate-specific membrane antigen (PSMA) with a CD3 TCE could provide an effective treatment option for metastatic castration-resistant prostate cancer (mCRPC). In its poster presentation at AACR (Free AACR Whitepaper), AbCellera demonstrated that its PSMA x CD3 TCEs show promising preclinical activity, including:

Potent in vitro tumor-cell killing, with one molecule showing ~10x higher EC50 than benchmark
Sustained in vitro activity across four rounds of serial T-cell killing
Preclinical in vivo efficacy, with significant tumor growth inhibition in a xenograft mouse model
Potential for enhanced potency when combined with costimulatory PSMA x CD28 bispecifics
"The preclinical data package presented at AACR (Free AACR Whitepaper) is the first demonstration that our novel CD3-binders can be used to generate molecules with potent anti-tumor efficacy in vivo," said Adam Clarke, Ph.D., SVP, Discovery at AbCellera. "The poster underscores the strength of our TCE platform strategy, which is to combine diverse CD3- and tumor-binding antibodies and use empirical testing to engineer optimized therapeutic candidates. In addition, the data strongly support the use of costimulation to further increase anti-tumor activity."

On April 28, 2025 Alpha Tau Medical Ltd. ("Alpha Tau", or the "Company") (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported that it has successfully closed a registered direct offering (the "offering") whereby an affiliate of Oramed Pharmaceuticals Inc. ("Oramed") (Nasdaq: ORMP) (TASE: ORMP) purchased 14,110,121 of Alpha Tau’s ordinary shares, no par value, at a purchase price of $2.612 per ordinary share (Press release, Alpha Tau Medical, APR 28, 2025, View Source [SID1234652216]). The offering closed on April 28, 2025.

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The total gross proceeds of the offering were approximately $36.9 million, before deducting estimated offering expenses payable by Alpha Tau. Alpha Tau intends to use the net proceeds from the offering for general corporate purposes, including research and development-related purposes in connection with its product candidates, for expansion of its manufacturing capabilities and for potential commercialization of its product candidates.

In addition, the parties have entered into an agreement whereby an affiliate of Oramed will provide Alpha Tau with certain strategic services (investor relations and public relations) over the next three years in exchange for payments from Alpha Tau as well warrants to purchase additional Alpha Tau shares.

Alpha Tau CEO Uzi Sofer commented, "We are delighted to welcome Oramed as a strategic partner and to leverage their extensive expertise in navigating diverse capital markets channels. This investment comes at the perfect time for Alpha Tau given the rapid expansion of our business activities, including four parallel trial approvals in the U.S., expansion into trials in multiple internal organs, and continued expansion of our manufacturing capacity and pre-commercial preparations. We look forward to a long and fruitful relationship with Oramed."

Oramed CEO Nadav Kidron added, "We are incredibly excited about this alliance with Alpha Tau. We have tremendous conviction in the strength of the Alpha DaRT technology and the Alpha Tau management team. We anticipate significant advancements and milestone achievements as they execute their clinical and commercial roadmap."

A registration statement on Form F-3 relating to the securities to be sold in the registered direct offering has been filed with the U.S. Securities and Exchange Commission (the "SEC") and was declared effective on April 13, 2023. This registered direct offering was made only by means of a prospectus. A copy of the prospectus supplement and the accompanying prospectus relating to this offering was filed with the SEC and may be obtained for free by visiting EDGAR on the SEC’s website at www.sec.gov

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

On April 28, 2025 SOPHiA GENETICS (Nasdaq: SOPH), a cloud-native healthcare technology company and global leader in data-driven medicine, reported the expansion of its ongoing collaboration with AstraZeneca (LSE/STO/Nasdaq: AZN) to accelerate the deployment of MSK-ACCESS powered with SOPHiA DDM globally (Press release, AstraZeneca, APR 28, 2025, View Source [SID1234652267]). Building on the initial collaboration announced in October 2024, this new phase will extend the test’s reach to a total of 30 clinical institutions worldwide in 2025.

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Developed in collaboration with Memorial Sloan Kettering Cancer Center, MSK-ACCESS powered with SOPHiA DDM is an innovative liquid biopsy testing application designed to detect actionable genomic alterations from a single blood draw using proprietary, state-of-the-art algorithms which analyze circulating tumor DNA (ctDNA). The application supports real-time cancer monitoring and treatment selection when traditional tissue biopsies are not feasible due to cost, turnaround time, insufficient tissue, or the invasiveness of the procedure.

The expanded rollout will continue to contribute to AstraZeneca’s global real-world evidence initiatives and help further validate the clinical impact of decentralized liquid biopsy testing across diverse healthcare systems. By increasing the availability of MSK-ACCESS powered with SOPHiA DDM, SOPHiA GENETICS and AstraZeneca aim to understand further how liquid biopsy testing can complement solid tissue testing and, in some cases, provide greater benefit for labs and patients.

The announcement coincides with SOPHiA GENETICS’s presentation at AACR (Free AACR Whitepaper), in which the company presented data demonstrating the robust transferability of the decentralized MSK-ACCESS powered with SOPHiA DDMTM solution. Historically, site-to-site discordance has been a major barrier to the widespread adoption of liquid biopsy testing. SOPHiA GENETICS presented real-world data highlighting the consistent accuracy and precision of MSK-ACCESS powered with SOPHiA DDMTM across various laboratory settings. Interim results from the multi-center study demonstrated the high analytical performance of the decentralized test in line with the original single-site test at Memorial Sloan Kettering Cancer Center in New York.

"Our collaboration with AstraZeneca represents a significant step toward scaling next-generation oncology diagnostics globally," said Ross Muken, President, SOPHiA GENETICS. "This expanded deployment reflects the growing momentum behind liquid biopsy and our shared ambition to make these technologies more accessible and impactful worldwide."

Visit SOPHiA GENETICS at the American Association for Cancer Research (AACR) (Free AACR Whitepaper)’s Annual Meeting in Chicago, Illinois from April 25th–30th to learn more about how SOPHiA GENETICS is collaborating with AstraZeneca to transform patient care with data-driven medicine.