On April 1, 2024 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) partner Bristol Myers Squibb (NYSE: BMY) reported the pivotal Phase 3 KRYSTAL-12 study, evaluating KRAZATI (adagrasib) as a monotherapy in patients with pretreated locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring a KRASG12C mutation, met the primary endpoint of progression-free survival (PFS) and the key secondary endpoint of overall response rate (ORR) as assessed by Blinded Independent Central Review (BICR) at final analysis for these endpoints (Press release, Zai Laboratory, APR 1, 2024, View Source; [SID1234641684]). The study remains ongoing to assess the additional key secondary endpoint of overall survival. Results of the confirmatory trial showed that KRAZATI demonstrated a statistically significant and clinically meaningful benefit in PFS and ORR compared to standard-of-care chemotherapy as a second-line or later treatment for these patients. KRAZATI had no new safety signals and the safety data was consistent with the known safety profile.

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"We are delighted to see these data underscoring the potential of adagrasib as a therapy for patients with KRASG12C mutated NSCLC in second or later line treatment," said Rafael G. Amado, M.D., President, Head of Global Oncology Research and Development, Zai Lab. "Lung cancer is the most common cancer in China, and adagrasib is one of several important products in Zai Lab’s growing lung cancer pipeline. We are proud to have contributed to the KRYSTAL-12 study and are looking forward to bringing adagrasib to patients in need in China."

Bristol Myers Squibb will complete a full evaluation of the available data and will share the results with the scientific community at an upcoming medical conference as well as discuss the results with health authorities.

Zai Lab expects to submit the New Drug Application (NDA) for adagrasib to the National Medical Products Association (NMPA) for KRASG12C mutated NSCLC in second or later line treatment in China this year.

In addition to KRASG12C-mutated NSCLC, KRAZATI and KRAZATI-based combinations have shown encouraging meaningful benefit in Phase 2 clinical trials across several tumors, including advanced colorectal cancer, pancreatic cancer and other solid tumors. In February, the U.S. FDA accepted for priority review the supplemental new drug application (sNDA) for KRAZATI in combination with cetuximab for the treatment of patients with previously treated KRASG12C-mutated locally advanced or metastatic colorectal cancer (CRC). The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 21, 2024.

Zai Lab thanks the patients and investigators involved in the KRYSTAL-12 clinical trial.

About NSCLC in China
According to the World Health Organization, the incidence of lung cancer in China in 2020 was 815,563 cases, with 714,699 deaths. Lung cancer consists of NSCLC in approximately 85% of cases and small cell lung cancer (SCLC) in approximately 15% of cases. KRASG12C is the most common KRAS mutation in NSCLC. The mutation is a biomarker of poor prognosis in Chinese patients with NSCLC.

ABOUT KRAZATI (adagrasib)
KRAZATI (adagrasib) is highly selective and potent oral small-molecule inhibitor of KRASG12C that is optimized to sustain target inhibition, an attribute that could be important to treat KRASG12C-mutated cancers, as the KRAS protein regenerates every 24-48 hours. In China, it is estimated that there are around 42,000 patients each year with KRASG12C-mutated NSCLC and colorectal cancer indications alone.

In 2022, KRAZATI was granted accelerated approval for treatment of adult patients with KRASG12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy. This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of a clinical benefit in a confirmatory trial(s).

In 2023, Medicines and Healthcare products Regulatory Agency (MHRA) granted conditional marketing authorization for KRAZATI as a targeted treatment option for adult patients with KRASG12C-mutated advanced non-small cell lung cancer and disease progression after at least one prior systemic therapy followed by the European Commission (EC) in 2024.

KRAZATI continues to be evaluated as monotherapy and in combination with other anti-cancer therapies in patients with advanced KRASG12C-mutated solid tumors, including non-small cell lung cancer and colorectal cancer.

In 2022, the FDA granted breakthrough therapy designation for KRAZATI in combination with cetuximab in patients with KRASG12C-mutated advanced colorectal cancer whose cancer has progressed following prior treatment with chemotherapy and an anti-VEGF therapy.

For U.S. Prescribing Information, visit KRAZATI.

About KRYSTAL-12
KRYSTAL-12 is an open-label, multicenter, randomized Phase 3 study evaluating KRAZATI compared to standard-of-care chemotherapy alone, in patients with KRASG12C-mutated non-small cell lung cancer. The primary endpoint of the study is PFS as assessed by BICR. Secondary endpoints included overall survival (OS), overall response rate (ORR), duration of response (DOR), and safety.

On April 1, 2024 GeneCentric Therapeutics, a company making precision medicine more precise through RNA-based diagnostics, reported upcoming presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2024 being held in San Diego, California from April 5-10 (Press release, GeneCentric Therapeutics, APR 1, 2024, View Source [SID1234641683]). Presentations will include a poster describing a new colorectal cancer predictive response signature (MSS-PRS) that selects tumors not identified with conventional MSI testing but have molecular characteristics consistent with microsatellite instability, making them a potential target for immune checkpoint inhibition. A second poster presentation describes ongoing clinical validation for PurISTSM, a novel RNA-expression test developed in collaboration with Tempus. PurIST identifies patients with the classical subtype of pancreatic ductal adenocarcinoma (PDAC) that are likely to experience longer overall survival with standard of care FOLFIRINOX than patients with the basal subtype of PDAC.

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Details of the AACR (Free AACR Whitepaper) presentations are as follows:

Title: Development of a novel RNA-based microsatellite stable predictive response signature (MSS-PRS) to identify MSS colorectal cancer (CRC) patients with a microsatellite instability-high (MSI-H) molecular phenotype
Session: PO.CL01.01 – Diagnostic Biomarkers 1, Section 42
Date: April 7, 2024, 1:30pm – 5:00pm PT
Abstract/Poster Number: 040 / 20

Title: Real-world validation of the PurIST classifier demonstrates enhanced therapy selection for pancreatic ductal adenocarcinoma (PDAC) patients
Session: PO.CL10.01 – Real-World Biomarkers, Section 45
Date: April 8, 2024, 9:00am – 12:30pm PT
Abstract/Poster Number: 2542 / 2

The posters will be accessible under the News & Events section of the Company’s website following the conference.

On April 1, 2024 Xcell Biosciences Inc. (Xcellbio), an instrumentation company focused on cell and gene therapy applications, reported it has added new elements to its research collaboration agreement with Labcorp, a global leader of innovative and comprehensive laboratory services (Press release, Xcell Biosciences, APR 1, 2024, View Source [SID1234641682]). Through the expanded collaboration, Labcorp will participate in the beta program for Xcellbio’s clinical manufacturing line of AVATAR instruments and has been given an observer seat on the company’s board of directors. In exchange, Labcorp has increased its strategic investment in Xcellbio. Financial details of the investment were not disclosed. The companies will be jointly presenting results from their existing cell and gene therapy collaboration at the upcoming annual meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper).

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Xcellbio has developed the AVATAR incubator system for cell therapy research and development. Its latest platform, the AVATAR Foundry system, is a cGMP cell therapy manufacturing platform that delivers novel capabilities for improving the potency of cell therapies. These capabilities are especially important for cell therapies targeting solid tumors, which are frequently met with challenges in overcoming the harsh immunosuppressive tumor microenvironment (TME) to achieve durable potency at the target tumor site. The AVATAR and AVATAR Foundry systems offer small-scale research and process development as well as scale-up manufacturing platforms for metabolically reprogramming therapeutic cells to improve their potency and persistence in the TME.

"We have worked closely with the Xcellbio team for years and have been continually impressed by their dedication to improving the development and manufacture of cell and gene therapies," said Maryland Franklin, Ph.D., vice president and enterprise head of cell and gene therapy at Labcorp, who has now joined Xcellbio’s board of directors as an observer. "Incorporating AVATAR technology into Labcorp’s robust cell and gene therapy development program will allow us to deliver decision-enabling results to our clients around the world and, ultimately, will help us drive precision healthcare for a broad range of patients."

Through the expanded collaboration, Labcorp’s preclinical oncology site in Ann Arbor, Mich., will become a beta site for the AVATAR Foundry system. More information about the beta access program is available at View Source

"We are proud to be a trusted partner for Labcorp, who recognizes that key partnerships will help unlock what’s possible in the development of cell and gene therapies," said Brian Feth, co-founder and CEO at Xcellbio. "We look forward to deepening our ties as we continue on our shared mission of developing safer, more effective treatments for more patients and a wide array of diseases."

Poster Presentations at AACR (Free AACR Whitepaper)

Along with scientific collaborators at Labcorp, Xcell team members will be presenting two posters at the upcoming AACR (Free AACR Whitepaper) annual meeting, taking place April 5-10 in San Diego.

Poster #3908: Generation of new oncology cell models through long-term acclimation under hypoxic and hyperbaric culture conditions
Presenter: Yewei Xing, Labcorp
Summary: In this poster, scientists will show that long-term acclimation of conventional tumor cell lines to conditions reflective of the TME alters their phenotype and gene expression profiles.

Poster #6334: Metabolic reprogramming enhances expansion and potency of CAR-T cells
Presenter: Candy Garcia and James Lim, Xcellbio
Summary: This presentation will illustrate how manufacturing CD19 CAR T cells in optimized environmental conditions can enhance their expansion potential and potency, as measured with an in vitro tumor killing assay.

On April 1, 2024 TriSalus Life Sciences Inc., (Nasdaq: TLSI), reported its financial results for the fourth quarter and full year ended December 31, 2023, and provided a business update (Press release, TriSalus Life Sciences, APR 1, 2024, View Source [SID1234641681]).

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"2023 was a critical year for TriSalus, underscored by significant growth in TriNav revenue, a landmark achievement of permanent reimbursement, and disciplined progress within our technology and clinical pipelines," said Mary Szela, Chief Executive Officer and President of TriSalus.

"The release of compelling real-world evidence demonstrating the impactful benefits of the TriNav method for complex patients, along with the exploration of nelitolimod in conjunction with the TriNav system through selected phase 1 clinical studies, reinforces our commitment to improving care options for oncology patients. As an example, the phase 1 clinical trial for locally advanced pancreatic patients utilizes our novel pancreatic infusion device in combination with nelitolimod with a goal to demonstrate improved outcomes for pancreatic patients.

Furthermore, receiving 510k clearance of a larger vessel size of the TriNav system, and successfully accessing the public markets underscore our dedication to advancing our company for sustained growth and success. As we reflect on the achievement of the past year, we recognize not only the milestones achieved but also acknowledge the solid foundation for continued future progress across the business, and we remain fully focused and committed to delivering benefit to patients."

Fourth Quarter 2023 and Subsequent Highlights

CMS Reimbursement for the TriNav Infusion System via Assignment of a New Technology Healthcare Common Procedure Coding System (HCPCS) Code

In December, TriSalus announced that the Centers for Medicare & Medicaid Services (CMS) had created a New Technology Healthcare Common Procedure Coding System (HCPCS) code for procedures involving the TriNav Infusion System. This new code, HCPCS 9797, has been assigned to the Ambulatory Payment Classification (APC) 5194 – Level 4 Endovascular Procedures. The new code became effective on January 1, 2024, and may be reported by hospital outpatient departments (HOPDs) and ambulatory surgical centers (ASCs).

Real-World Data Demonstrates Ability of TriNav to Successfully Treat Patients with Higher Disease Burden and to Improve Delivery of Therapeutics to Liver Tumors

In February, the Company announced the publication in Current Medical Research and Opinion of a manuscript detailing a real-world study of the use of the Pressure-Enabled Drug Delivery (PEDD) method with the TriNav device for trans-arterial chemoembolization (TACE) and trans-arterial radioembolization (TARE) in patients with hepatocellular carcinoma (HCC) and liver metastases. The data presented in the study captured real-world safety and clinical outcomes data for the TriNav system utilizing a large, 300 million patient dataset covering 98% of U.S. payers.

The study data demonstrates that the TriNav method is preferentially selected to treat patients with a higher burden of disease than patients treated with standard catheters, yet these patients show similar results post-treatment compared to patients with a lower disease burden. TriNav patients showed impressive trends toward better outcomes in matched cohort comparisons, including an increased rate of liver transplants.

Completed Enrollment in Multiple Phase 1 Clinical Trials (100 Patients) in Uveal Melanoma Liver Metastases, Hepatocellular Cancer, and Intrahepatic Cholangiocarcinoma in Leading Academic Oncology Centers Across the U.S. to Determine Which Indication to Progress; Full Data Set Will be Analyzed in the Second Half of 2024 to Facilitate the Final Decision

TriSalus presented phase 1 data for the PERIO-01 program, nelitolimod administered via the PEDD method for uveal melanoma liver metastases, at a late-breaking oral session by our lead investigator from The University of Texas MD Anderson Cancer Center at the Society for Immunotherapy for Cancer meeting in November 2023.

Data presented included the following:

Safety data on 56 uveal melanoma patients with liver metastases, of whom 65% had failed prior therapy.
Grade 3 or greater treatment related serious adverse event rate was 11% across all doses and cohorts.
Pharmacokinetic data from the PERIO-01 trial indicate the TriNav system is able to achieve high drug levels in the liver, and systemic exposure is limited with drug undetectable by four hours in more than 95% of patients.
Amongst patients with available data ctDNA clearance was 59%, with 86% showing reduction in ctDNA.
Disease control rate (DCR) was 58% across all dose levels, and at the presumed optimal biologic dose (2mg, N=7), there was a DCR of 81%, median progression free survival (PFS) of 11.7 months and 1-year overall survival rate (OS) of 86%.
The optimal biologic dose assessment was made based on PFS, OS, and immune signals, including MDSC elimination from liver metastases. There was also evidence of systemic immune activation, as measured by serum cytokines and peripheral immune cell activation.
Initiated Phase 1 Study with Nelitolimod via our Novel Pancreatic Infusion Device

The Pancreatic Infusion System with SmartValve technology is an FDA-cleared device for delivery of therapeutics to the peripheral vasculature. This device is being studied for the delivery of nelitolimod into unresectable pancreatic tumors.

Retrograde venous delivery to the pancreas involves the placement of a PEDD device into the veins draining the pancreas to enable targeted delivery of therapeutics using standard interventional radiology procedures. Unlike the liver, small vessels and extensive collateralization in the pancreas make the arterial route challenging for targeted delivery. Retrograde pancreatic venous infusion provides a potentially more feasible and reliable strategy for targeted delivery of therapeutics through direct venous access.

In November of 2023, TriSalus released study data on three patients receiving nelitolimod via its novel pancreatic infusion device demonstrating immune signals consistent with previous reported data for liver metastases. The Company expects to complete enrollment and report the phase 1 data in the second half of 2024.

Received 510k Clearance for TriNav Large and TriGuide

This year, TriSalus received 510k clearance for a larger vessel size of the TriNav system, TriNav Large, and its dedicated guide catheter, TriGuide. Currently, the Company is in market evaluation for both devices and intends to launch in the second half of 2024. The launch of this TriNav system provides a significant market expansion since the larger vessel size can access an incremental 25% of the embolization market.

Unaudited Financial Results for Q4 and Full Year 2023

Notification of Late Filing

The Company will file a Form 12b-25, Notification of Late Filing, with the SEC related to the Company’s Annual Report on Form 10-K for fiscal year 2023. The Company’s need to request a 15-day extension is primarily due to errors identified in determining the Company’s stock-based compensation expense for 2023 due in part to the Company’s transition to a new service provider in 2023 and the use of incorrect assumptions. The Company is working diligently to evaluate the materiality of the errors to determine whether any corrections for the third quarter financial results are required and to complete the Company’s year-end 2023 financial statements. As a result, the results below and elsewhere in this press release are unaudited and subject to change pending the completion of the Company’s financial statements as of and for the year ended December 31, 2023.

Revenue and Gross Margin

Revenue, all of which is from the sale of the TriNav system, was $5.7 million and $18.5 million, respectively, in the three months and full year ended December 31, 2023. These amounts represent growth vs. prior year of 77% in the fourth quarter and 49% for the full year, primarily due to increased selling resources and continued market share increases.

Gross margins were 90% in the fourth quarter and 86% for the full year ended December 31, 2023, versus 75% and 82%, respectively, in the fourth quarter and full year in 2022. The improvement is due to increased factory volumes and improved operations efficiency.

Operating Results

Operating losses were $14.1 million and $54.2 million, respectively, for the fourth quarter and full year ended December 31, 2023. These amounts include non-recurring professional service fee costs of $7.9 million year to date, primarily related to the completion of the deSPAC process in August 2023. These amounts compare to prior year losses of $11.8 million and $36.4 million, respectively. The Company increased investments in 2023 in R&D to support clinical program progress and in sales and marketing, primarily to expand its sales force to continue to increase market penetration.

Net Results and Earnings per Share

Net losses available to common stockholders were $35.5 million and $59.0 million, respectively, for the fourth quarter and full year ended December 31, 2023. These amounts compare to prior year losses of $22.5 million and $47.2 million, respectively. Net losses include the impact of non-cash related gains/(losses) on revaluation of contingent earnout liabilities of ($9.6) million in the fourth quarter and $10.3 million for the full year period of 2023. In addition, 2023 net losses include the impact of non-cash related losses associated with revaluation of tranche and warrant liabilities of $11.5 million and $10.9 million, respectively, for the fourth quarter and full year ended December 31, 2023. These amounts compare to prior year losses of $2.2 million in the fourth quarter and full year. The fourth quarter and full year ended December 31, 2023, also includes a non-cash related loss on equity issuance of $0.2 million and $4.4 million, respectively. These amounts compare to prior year losses of $8.3 million in the fourth quarter and full year.

Basic and diluted loss per share for the fourth quarter and full year ended December 31, 2023, was $1.56 and $6.73 respectively, compared to a basic and diluted loss per share of $75.01 and $161.55 for the fourth quarter and full year ended December 31, 2022, respectively.

Conference Call

The event will be webcast live on the investor relations section of TriSalus’ website at View Source Following the conclusion of the event, a webcast replay will be available on the website for approximately 90 days. Interested parties participating by phone will need to register using this online form. After registering for the webcast, dial-in details will be provided in an auto-generated e-mail containing a link to the conference phone number along with a personal pin.

On April 1, 2024 Charles River Laboratories International, Inc. (NYSE: CRL) reported that its industry-leading team of oncology experts will attend the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (Press release, Charles River Laboratories, APR 1, 2024, View Source [SID1234641679]). Charles River will present technology-driven capabilities and highlight the latest advancements in immuno-oncology, in vitro assays, and more. The meeting is taking place from April 5-10, 2024, at the San Diego Convention Center in San Diego, California.

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"In the dynamic landscape of oncology research, the pursuit of innovative solutions for predictive screening is imperative. Cypre’s proprietary 3D tumor microenvironment models platform expands Charles River’s oncology portfolio and offers our clients seamless, high-content analysis screening for their cancer immunotherapy and targeted therapy."

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Charles River Launches New Tools & Services to Support Oncology Research
Charles River is showcasing an expanding portfolio of end-to-end cancer research tools and services, including:

The Apollo Price Estimator, a new application that enables seamless generation of oncology study design, simplifies preclinical drug development by allowing clients to quickly generate price estimates.
The Cancer Model Database, a tool that unlocks the ability to access different assays and comprehensive, well-characterized models for oncology drug development.
Charles River is also expanding its cell sourcing offering to include same-day delivery of fresh leukopaks from its collection centers into the Cambridge and Greater Boston area as well as the San Diego biohub.
During the AACR (Free AACR Whitepaper) Annual Meeting, the Charles River team will host a spotlight session and present over 20 scientific posters, including:

Spotlight Session: PDX: Predictive Tumor Models to Accelerate your Preclinical Research In Vivo, In Vitro and In Silico
Sunday, April 7, 1:30-2:30 p.m., Sails Pavilion Theater B

Charles River, Cypre Inc., and Aitia will come together to discuss the use of breakthrough technologies, such as PDX 3D tumor models and Digital Twins, in the process of identifying optimal drug candidates. The session will also cover the use of PDX-based in vitro 3D platforms in the context of the FDA Modernization Act and different in vivo screening formats. Featured speakers include:

Julia Schueler, Therapeutic Area Lead, Charles River
Isabelle Caffry, Senior Director of Strategy and Corporate Development, Aitia
Kolin Hribar, CEO, Cypre
Poster #2714: Developing an mRNA Encoded Therapeutic Antibody Platform to Simplify Manufacturing and Reduce Time to Clinic
Monday, April 8, 1:30-5:00 p.m., Section 6

The production of therapeutic antibodies entails costly manufacturing processes, intricate purification methods, and extensive stability optimization, which contribute to elevated treatment expenses. Charles River’s poster will discuss the use of mRNA-based approaches to produce therapeutic antibodies in vivo, offering a promising strategy for solid tumor treatment, potentially reducing costs and improving biologic development.

Poster #4186: Development of an Orthotopic A549 Lung Carcinoma Model in CD34+ Humanized NCG Mice and Response to Treatment with Paclitaxel and Pembrolizumab
Tuesday, April 9, 9:00-12:30 p.m., Section 9

Translational in vivo models are critical to expediting the discovery of new treatments for lung cancer. In response to the growing demand for humanized models that can generate translatable outcomes, Charles River demonstrates the use of an orthotopic lung carcinoma model in humanized mice (HuCD34 NCG) to evaluate the activity of paclitaxel and pembrolizumab as single and combination agents.

To learn more about Charles River’s research tools and services portfolio, visit booth #1121 at the AACR (Free AACR Whitepaper) Annual Meeting 2024. A full schedule of Charles River’s activities and reprints of each poster will be available online, and more content exploring topics discussed at the meeting will be shared on the Eureka Blog.

Approved Quotes

"Our expert team of oncology researchers here at Charles River is committed to supporting clients across the R&D continuum, from basic research to IND and every stage in between. We look forward to showcasing innovative technology and digitally driven approaches to cancer research at the AACR (Free AACR Whitepaper) Annual Meeting." – Aidan Synnott, Corporate Vice President, Global Discovery Services, Charles River
"In the dynamic landscape of oncology research, the pursuit of innovative solutions for predictive screening is imperative. Cypre’s proprietary 3D tumor microenvironment models platform expands Charles River’s oncology portfolio and offers our clients seamless, high-content analysis screening for their cancer immunotherapy and targeted therapy." – Kolin Hribar, PhD, CEO & Founder, Cypre Inc.
"Aitia and Charles River’s joint effort to pioneer PDX Digital Twins stands at the forefront of a transformative shift in oncology research, aligning with the industry’s commitment to reduce reliance on traditional animal models. By integrating breakthrough technologies like PDX-based in vitro 3D platforms and Digital Twins, our collaborative efforts represent a significant leap towards advancing next-generation, in vivo oncology research across multiple cancer types." – Isabelle Caffry, Senior Director of Strategy and Corporate Development, Aitia