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 Vincerx Pharma, Inc. (Nasdaq: VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, reported that it will host a virtual investor event reviewing preliminary clinical data from its Phase 1 dose-escalation study of VIP236 and provide an update on pipeline progress on Monday, April 8, 2024, at 2 PM PT (Press release, Vincerx Pharma, APR 1, 2024, View Source [SID1234641661]). This will follow the poster presentation of the VIP236 clinical data at the AACR (Free AACR Whitepaper) Annual Meeting 2024.

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The virtual investor event will include presentations by Ahmed Hamdy, MD, CEO of Vincerx Pharma, along with key opinion leaders, Uma Borate, MD, MBBS, Clinical Associate Professor in the Division of Hematology at The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, and Vivek Subbiah, MD, Chief of Early-Phase Drug Development at Sarah Cannon Research Institute.

To register and view the live webcast, please visit: View Source An archived replay of the webcast will be available on the Vincerx Investor Page website following the conclusion of the live event.

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 Xilio Therapeutics, Inc. (Nasdaq: XLO), a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology therapies for people living with cancer, reported pipeline progress and business updates and reported financial results for the fourth quarter and full year ended December 31, 2023 (Press release, Xilio Therapeutics, APR 1, 2024, View Source [SID1234641662]).

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"With our recently announced partnership with Gilead for XTX301, our tumor-activated IL-12, and additional financing from existing investors, we believe we are well-positioned to continue to advance our differentiated pipeline of tumor-activated I-O therapies and achieve potential near-term clinical milestones and value-drivers," said René Russo, Pharm.D., president and chief executive officer of Xilio. "Looking ahead, we are focused on rapidly advancing clinical development for XTX301 and XTX101, our tumor-activated, Fc-enhanced anti-CTLA-4, with anticipated clinical data for each of these programs later this year, as well as continuing to leverage our novel research platform to design and develop tumor-activated bispecific and immune cell engager molecules."

Pipeline and Business Updates

XTX101: tumor-activated anti-CTLA-4

XTX101 is an investigational tumor-activated, Fc-enhanced, high affinity binding anti-CTLA-4 designed to block CTLA-4 and deplete regulatory T cells when activated (unmasked) in the tumor microenvironment (TME). XTX101 is currently being evaluated in combination with atezolizumab in an ongoing Phase 1 clinical trial in patients with advanced solid tumors.

Xilio today reaffirmed plans to:

● Select a recommended Phase 2 dose for XTX101 in combination with atezolizumab in the second quarter of 2024.
● Subject to the results of the Phase 1 combination dose escalation portion of the trial, initiate the Phase 2 portion of the trial for XTX101 in combination with atezolizumab in patients with microsatellite stable colorectal cancer (MSS CRC) in the third quarter of 2024.
● Report initial Phase 2 data for XTX101 in combination with atezolizumab in approximately 20 patients with MSS CRC in the fourth quarter of 2024 and in approximately 20 additional patients (40 patients total) in the first quarter of 2025.

XTX301: tumor-activated, engineered IL-12

XTX301 is an investigational tumor-activated, engineered IL-12 molecule designed to potently stimulate anti-tumor immunity and reprogram the TME of poorly immunogenic "cold" tumors towards an inflamed, or "hot," state.

In March 2024, Xilio and Gilead Sciences, Inc. (Gilead) announced an exclusive license agreement for Xilio’s tumor-activated IL-12 program, including XTX301. Under the terms of the agreement:

● Xilio is eligible to receive $43.5 million in upfront payments, including a cash payment of $30.0 million and an initial equity investment by Gilead of approximately $13.5 million in Xilio common stock. The initial equity investment closed on March 28, 2024, and the $30.0 million upfront cash payment is payable by Gilead within a specified time period promptly following signing of the license agreement.
● Xilio will be eligible to receive up to $604.0 million in additional contingent payments, including proceeds from up to three additional equity investments by Gilead, a $75.0 million transition fee and specified development, regulatory and sales-based milestones. Xilio will also be eligible to receive tiered royalties ranging from high single digits to mid-teens on annual global net product sales.
● Prior to the potential transition fee, Xilio is eligible to receive up to a total of $29.0 million in additional equity investments and a development milestone payment.
● Xilio will be responsible for conducting clinical development for XTX301 in the ongoing Phase 1 clinical trial through dose expansion. Following the delivery by Xilio of a specified clinical data package for XTX301, Gilead can elect to transition responsibilities for the development and commercialization of XTX301 to Gilead, subject to the terms of the agreement and payment by Gilead of the $75.0 million transition fee. If Gilead elects not to transition responsibilities for development and commercialization of the licensed products and pay the transition fee, then the license agreement will automatically terminate.

For more information, read the press release here.

XTX301 is currently being evaluated in Phase 1 dose escalation in patients with advanced solid tumors.

● In January 2024, Xilio reported encouraging preliminary safety data into the third dose level in the ongoing Phase 1 clinical trial. As of the data cutoff date of January 5, 2024, XTX301 had been administered at doses up to 45 ug/kg, which is nearly 100 times the maximum tolerated dose of recombinant human IL-12, and was generally well-tolerated with no dose-limiting toxicities observed.
● Xilio today reaffirmed plans to report Phase 1 safety, pharmacokinetic and pharmacodynamic data for XTX301 in patients with advanced solid tumors in the fourth quarter of 2024.

XTX202: tumor-activated, engineered IL-2

XTX202 is an investigational tumor-activated, beta-gamma biased IL-2 designed to potently stimulate CD8+ effector T cells and natural killer (NK) cells without concomitant stimulation of regulatory T cells when activated (unmasked) in the tumor microenvironment.

● In March 2024, Xilio announced additional data from its Phase 2 clinical trial evaluating XTX202 in patients with metastatic renal cell carcinoma or unresectable or metastatic melanoma. For more information, read the press release here.
● Together with previously reported data, Xilio believes these additional data further validate the company’s tumor-activated approach and support the broad potential for XTX202 as a combination therapy. Xilio plans to explore strategic opportunities to continue to develop XTX202 in combination with other agents.

Tumor-Activated Bispecific and Immune Cell Engager Programs

In March 2024, Xilio announced plans to focus its research-stage development efforts on tumor-activated bispecifics and immune cell engagers, including tumor-activated cell engagers and tumor-activated effector-enhanced cell engagers.

Preclinical data from the company’s first bispecific program, XTX501, a tumor-activated PD-1/IL-2 bispecific development candidate, will be featured at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2024 in San Diego, California from April 5-10, 2024.

● Presentation title: A tumor-activated PD1/IL2 bispecific molecule, designed to overcome IL-2 receptor-mediated clearance, improve tolerability and stimulate antigen-experienced CD8+ T cells in the tumor microenvironment of murine models
● Session date and time: Sunday, April 7, 2024, at 1:30 pm to 5:00 pm P.T.
● Abstract number: 719
● Poster board number: 5

Corporate Updates

● In March 2024, Xilio announced a private placement equity financing with certain existing accredited investors, including Bain Capital Life Sciences and Rock Springs Capital. Xilio anticipates receiving aggregate gross proceeds from the private placement of approximately $11.3 million, before deducting placement agent fees and expenses payable by the company. The private placement is expected to close on April 2, 2024, subject to the satisfaction of customary closing conditions. Xilio expects to use the proceeds from the private placement to fund working capital and other general corporate purposes.
● In March 2024, Xilio announced plans to implement a strategic portfolio prioritization designed to focus its resources on rapidly advancing clinical development for XTX301 and XTX101 and leveraging the company’s promising research platform to advance differentiated tumor-activated bispecific and immune cell engager molecules. As part of the strategic portfolio reprioritization, Xilio also announced plans to discontinue further investment in XTX202 as a monotherapy and implement an approximately 21% workforce reduction.

Year-End and Fourth Quarter 2023 Financial Results

● Cash Position: Cash and cash equivalents were $44.7 million as of December 31, 2023, compared to $120.4 million as of December 31, 2022.
● Research & Development (R&D) Expenses: R&D expenses were $11.7 million for the quarter ended December 31, 2023, compared to $15.0 million for the quarter ended December 31, 2022. R&D expenses were $52.1 million for the year ended December 31, 2023, compared to $59.2 million for the year ended December 31, 2022. The year-over-year decrease was primarily driven by decreases in manufacturing activities, XTX301 preclinical development activities, XTX101 clinical activities and personnel-related costs. These decreases were partially offset by increases in XTX301 and XTX202 clinical activities.
● General & Administrative (G&A) Expenses: G&A expenses were $6.4 million for the quarter ended December 31, 2023, compared to $8.2 million for the quarter ended December 31, 2022. G&A expenses were $27.0 million for the year ended December 31, 2023, compared to $29.9 million for the year ended December 31, 2022. The year-over-year decrease was primarily driven by decreases in professional and consulting fees, directors’ and officers’ liability insurance and stock-based compensation expenses.

● Net Loss: Net loss was $17.7 million for the quarter ended December 31, 2023, compared to $22.5 million for the quarter ended December 31, 2022. Net loss was $76.4 million for the year ended December 31, 2023, compared to $88.2 million for the year ended December 31, 2022.

Financial Guidance

Based on its current operating plans, Xilio anticipates that its cash and cash equivalents as of December 31, 2023, together with (i) the $30.0 million upfront payment under the license agreement with Gilead, (ii) the approximately $13.5 million in proceeds from the initial private placement with Gilead, which closed on March 28, 2024, and (iii) the approximately $11.3 million in proceeds from the private placement, which is expected to close on April 2, 2024 (subject to customary closing conditions), and after giving effect to (a) one-time costs and anticipated future cost savings associated with Xilio’s strategic portfolio reprioritization and workforce reduction announced in March 2024 and (b) the repayment in the first quarter of 2024 of the outstanding loan balance under Xilio’s loan and security agreement with Pacific Western Bank, will be sufficient to fund its operating expenses and capital expenditure requirements into the second quarter of 2025.

About XTX101 (anti-CTLA-4) and the Phase 1/2 Combination Clinical Trial

XTX101 is an investigational tumor-activated, Fc-enhanced, high affinity binding anti-CTLA-4 monoclonal antibody designed to block CTLA-4 and deplete regulatory T cells when activated (unmasked) in the tumor microenvironment (TME). In the third quarter of 2023, Xilio entered into a co-funded clinical trial collaboration with Roche to evaluate XTX101 in combination with atezolizumab (Tecentriq) in a multi-center, open-label Phase 1/2 clinical trial. Xilio is currently evaluating the safety and tolerability of the combination in patients with advanced solid tumors in the Phase 1 dose escalation portion of the clinical trial. Subject to the results of Phase 1 combination dose escalation, Xilio plans to evaluate the safety and efficacy of the combination in the Phase 2 portion of the clinical trial in patients with microsatellite stable colorectal cancer. Please refer to NCT04896697 on www.clinicaltrials.gov for additional details.

About XTX301 (IL-12) and the Phase 1 Clinical Trial

XTX301 is an investigational tumor-activated IL-12 designed to potently stimulate anti-tumor immunity and reprogram the tumor microenvironment (TME) of poorly immunogenic "cold" tumors towards an inflamed or "hot" state. In March 2024, Xilio entered into an exclusive license agreement with Gilead Sciences, Inc. for Xilio’s tumor-activated IL-12 program, including XTX301. Xilio is currently evaluating the safety and tolerability of XTX301 as a monotherapy in patients with advanced solid tumors in a first-in-human, multi-center, open-label Phase 1 clinical trial. Please refer to NCT05684965 on www.clinicaltrials.gov for additional details.

About XTX202 (IL-2) and the Phase 2 Clinical Trial

XTX202 is an investigational tumor-activated, beta-gamma biased IL-2 designed to potently stimulate CD8+ effector T cells and natural killer (NK) cells without concomitant stimulation of regulatory T cells when activated (unmasked) in the TME. The Phase 2 clinical trial is a multi-center, open-label trial designed to evaluate the safety and efficacy of XTX202 as a monotherapy in patients with unresectable or metastatic melanoma and metastatic renal cell carcinoma who have progressed on standard-of-care treatment. Please refer to NCT05052268 on www.clinicaltrials.gov for additional details.

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.