On December 12, 2024 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a clinical-stage biotechnology company developing novel LAG-3 immunotherapiesfor cancer and autoimmune disease, reported positive clinical resultsfrom Cohort B of the TACTI-003 (KEYNOTEC34) Phase IIb trial (Press release, Immutep, DEC 11, 2024, View Source [SID1234649054]). This study evaluates eftilagimod alpha (efti) in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA (pembrolizumab) in first line recurrent/metastatic head and neck squamous cell carcinoma (1L HNSCC) patients with negative PD-L1 expression.

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The new promising data presented by Martin Forster, M.D., Ph.D., at the ESMO (Free ESMO Whitepaper) Immuno-Oncology (IO) Annual Congress 2024 includes strong overall survival, progression-free survival, and durability. This adds to the high response rates and favourable safety data previously reported on 12 July 2024.

Prof. Martin Forster of the UCL Cancer Institute and University College London Hospital NHS Foundation Trust, London, UK, and TACTI-003 Investigator, stated, "The new survival and durability data, coupled with increasing complete responses, build on the strong response rates already established with this novel IO combination in head and neck squamous cell cancers with PD-L1 CPS <1. This difficult-to-treat disease places a high burden on patients who unfortunately have very limited treatment options that all include chemotherapy. Collectively, these impressive results build on the potential promise of efti to improve patient outcomes and expand populations that respond to anti-PD-1."

Results

Data as of the 31 October 2024 cut-off date in evaluable 1L HNSCC patients (N=31) whose tumours express PD-L1 below 1 (Combined Positive Score [CPS] <1) and who typically do not respond well to anti-PD-1 therapy alone shows:
• Positively, median overall survival (OS) has not yet been reached and the 12-month OS rate is 67%
• Promising progression-free survival (PFS) of 5.8 months
• Strong durability with interim median duration of response (DOR) of 9.3 months
• High 35.5% objective response rate (ORR) and 58.1% disease control rate (DCR), as reported on 12 July
• Complete response rate increases to 12.9% and 16.1%, according to RECIST 1.1 and iRECIST, respectively1
• Efti in combination with pembrolizumab continues to be well-tolerated with no new safety signals This data compares favourably to historical results from anti-PD-1 therapy alone in 1L HNSCC patients with PD-L1 CPS <1 including a 7.9-month median OS, 12-month OS rate of 39%, 2.1-month median PFS, 2.6-month median DOR, 5.4% ORR and 32.4% DCR with no complete responses

On December 11, 2024 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, reported results from a multicenter phase 3 clinical trial evaluating CAN-2409 viral immunotherapy in localized prostate cancer patients (Press release, Candel Therapeutics, DEC 11, 2024, View Source [SID1234649040]).

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In the United States alone, over 100,000 men are diagnosed with localized prostate cancer every year, and over 50,000 men currently receive radiotherapy. Prostate cancer continues to be the second leading cause of cancer death among men in the United States and there has not been any new treatment or significant change in the standard of care of localized, non-metastatic prostate cancer for over 20 years. The localized prostate cancer addressable market for CAN2409 is potentially worth over $10 billion in the U.S. alone.

The phase 3 clinical trial of CAN-2409 in intermediate-to-high-risk, localized prostate cancer met its primary endpoint, by demonstrating statistically significant improvement in disease-free survival in patients who received CAN-2409 plus prodrug (valacyclovir) combined with standard of care compared to standard of care alone.

The 2:1 randomized, double-blind, placebo-controlled, multicenter clinical trial enrolled 745 patients (intent to treat population, ITT) to evaluate the effectiveness and safety of CAN-2409 plus prodrug (valacyclovir) viral immunotherapy in combination with standard of care external beam radiation therapy to improve disease-free survival (DFS) in patients with intermediate-to-high risk, localized prostate cancer. Patients were randomized and stratified for the use of short-term (< 6 months) androgen deprivation therapy (ADT).

CAN-2409 is an investigational, off-the-shelf, replication-defective adenovirus that delivers the herpes simplex virus thymidine kinase (HSV-tk) gene to tumor cells. CAN-2409, when administered with valacyclovir, is designed to induce immunogenic cell death of tumor cells with exposure of tumor antigens in the context of an activated tumor microenvironment. Together, this regimen is designed to induce an individualized and specific CD8+ T cell-mediated response against the tumor, based on in situ vaccination against a variety of tumor antigens. Preclinical and clinical evidence suggests that CAN-2409 can be synergistic with local radiotherapy, providing further support for the design of the current phase 3 clinical trial.

"The improvement observed in disease-free survival in this phase 3 clinical trial is clinically meaningful. We have not seen significant advances in this indication in decades. CAN-2409 has demonstrated the potential to significantly improve long-term outcomes without adding substantial toxicity to standard of care radiation," said Glen Gejerman, M.D., MBA, Co-Director of Urologic Oncology at Hackensack Meridian Health, and one of the principal investigators of the study. "If approved, this approach has the potential to transform the treatment paradigm in prostate cancer, offering patients with localized disease an effective treatment option that may reduce the risk of disease recurrence."

Phase 3 Trial Results in Intermediate-High Risk Disease

The study met its primary endpoint, demonstrating a statistically significant improvement in disease-free survival compared to the control arm.

Key topline results include:

•
Statistically significant improvement in DFS for CAN-2409 plus radiation therapy (n=496) vs. radiation therapy alone (n=249) (p=0.0155; HR 0.7) in the intent to treat population

•
We observed a 14.5% relative improvement in DFS at 54 months for the CAN-2409 treatment arm compared to the placebo control arm

•
DFS improvement was observed both in patients receiving short term ADT and in patients not receiving ADT

•
In an analysis that focused on prostate-specific outcomes (e.g., censored mortality due to other causes), CAN-2409 showed a highly significant effect (p=0.0046; HR 0.6) on prostate cancer-free survival

•
Significant increase in the proportion of patients achieving a prostate-specific antigen (PSA) nadir (<0.2 ng/ml) was observed in the treatment arm compared to the placebo control arm (67.1% vs. 58.6%, respectively; p<0.0164)

•
CAN-2409 induced 80.4% pathological complete responses (pCRs) in the 2-year post-treatment biopsies compared to 63.6% observed in the control arm (p=0.0015)

The median follow-up time for the recruited population was 50.3 months. The primary outcome measure included the evaluation of post-treatment biopsies, performed at two years from the end of radiation, for the presence of tumor recurrence. Local or systemic recurrence and death from any cause were also part of the DFS endpoint. 

The safety profile of CAN-2409 was generally consistent with previous studies, with no new safety signals identified. The most common CAN-2409-related adverse events were flu-like symptoms, fever and chills, which were generally mild to moderate in severity and self-limited.

The company also reported today that the phase 2 clinical trial of monotherapy CAN-2409 in 190 patients with low-to-intermediate risk localized prostate cancer undergoing active surveillance showed numerical improvement in time to radical treatment and the percentage of patients achieving negative (prostate cancer-free) biopsies at 1-year post-treatment. However, these differences did not reach statistical significance. The safety profile of CAN-2409 was generally consistent with that reported in the phase 3 clinical trial.

"We are thrilled to report the phase 3 results for CAN-2409 in intermediate-to-high risk, localized prostate cancer," said Paul Peter Tak, M.D., Ph.D., FMedSci, President and Chief Executive Officer of Candel. "This study validates previous observations of CAN-2409 activity seen in difficult-to-treat solid tumors, often resistant to immunotherapy, and confirms our previous observation of synergies with radiation therapy in models of prostate cancer. Importantly, this study was conducted under a Special Protocol Assessment (SPA) agreed with the U.S. Food and Drug Administration (FDA), on key aspects of study design, meaning that safety and efficacy data generated from the study could be sufficient for the Company to seek regulatory approval for CAN-2409 in this indication. We look forward to working with the FDA, as a next step, to seek approval to bring CAN-2409 to patients in the U.S., and advance our broad viral immunotherapy pipeline across other large oncology indications of high unmet need."

Based on these results, Candel intends to initiate discussions with the FDA regarding the regulatory pathway for CAN-2409 in intermediate-to-high-risk localized prostate cancer. The Company will present the totality of the data for both studies at upcoming medical conferences.

Conference Call and Webcast

Candel will host a webcast and conference call today, at 8:30 a.m. EDT. The webcast can be accessed (Here) and also on the Candel website at www.candeltx.com under News & Events, in the IR section,of the website. An archived webcast will be available on Candel’s website for 30 days following the presentation. Participants may register for the conference call (Here) to receive the dial-in numbers and unique PIN to access the call seamlessly. It is recommended that you join 10 minutes prior to start of the event (although you may register and dial in at any time during the call).

About CAN-2409

CAN-2409, Candel’s most advanced multimodal biological immunotherapy candidate, is an investigational, off-the-shelf, replication-defective adenovirus designed to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene to a patient’s specific tumor and induce an individualized, systemic immune response against the tumor. HSV-tk is an enzyme that locally converts orally administered valacyclovir into a toxic metabolite that kills nearby cancer cells. Together, this regimen is designed to induce an individualized and specific CD8+ T cell-mediated response against the injected tumor and uninjected distant metastases for broad anti-tumor activity, based on in situ vaccination against a variety of tumor antigens. Because of its versatility, CAN-2409 has the potential to treat a broad range of solid tumors. Encouraging monotherapy activity as well as combination activity with standard of care radiotherapy, surgery, chemotherapy, and immune checkpoint inhibitors have previously been shown in several preclinical and clinical settings. More than 1,000 patients have been dosed with CAN-2409 with a favorable tolerability profile to date, supporting the potential for combination with other therapeutic strategies without inordinate concern of overlapping adverse events.

Currently, Candel is evaluating CAN-2409 in non-small cell lung cancer (NSCLC), borderline resectable pancreatic ductal adenocarcinoma (PDAC), and localized, non-metastatic prostate cancer in ongoing clinical trials. CAN-2409 plus prodrug (valacyclovir) has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of PDAC, stage III/IV NSCLC in patients who are resistant to first line PD-(L)1 inhibitor therapy and who do not have activating molecular driver mutations or have progressed on directed molecular therapy, and localized primary prostate cancer. Candel’s pivotal phase 3 clinical trial in prostate cancer has been conducted under a Special Protocol Assessment agreed with the FDA. The FDA has also granted Orphan Drug Designation to CAN-2409 for the treatment of PDAC.

On December 11, 2024 A2A Pharmaceuticals, Inc. ("A2A or "the company"), a clinical-stage pioneering biopharmaceutical company focused on developing innovative cancer therapies, reported significant progress in its clinical studies exploring TACC3 (Transforming Acidic Coiled-Coil 3) inhibition in patients with ovarian cancer, triple-negative breast cancer (TNBC), and endometrial cancer, as well as other malignancies (Press release, A2A Pharmaceuticals, DEC 11, 2024, View Source [SID1234649055]).

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A2A Pharmaceuticals has progressed into cohort 4, an important inflection point in its Phase 1 clinical trial to assess the safety and efficacy of its lead TACC3 inhibitor, A0-252. Early results have shown strong safety and efficacy profiles with the potential for a wide therapeutic index in these patient populations.

"We are excited about the advancements in our TACC3 program and its potential for patients with challenging cancer diagnoses. The company is continually exploring collaborations and partnerships to accelerate development timelines and enhance patient access to cutting-edge treatments," said Sotirios Stergiopoulos, M.D. President, CEO and Founder, A2A Pharmaceuticals, Inc. "Our focus on understanding the biology of cancer and leveraging innovative targeted therapies underscores our commitment to transforming cancer care and improving outcomes for patients."

"While our current focus with AO-252 is on addressing the unmet needs in ovarian, TNBC, and endometrial cancers, we are equally excited about its potential to benefit patients in other indications in the future," said Robbin Frnka, vice president of Clinical Operations. "This is just the beginning of our journey, and we look forward to exploring broader applications of this promising treatment option to make an even greater impact across multiple indications of need."

"This trial represents a promising step forward in delivering therapies that could impact the standard of care for patients," said Alex Spira, Principal Investigator of Next Oncology Virginia. "A2A Pharmaceuticals is committed to supporting the cancer community by advancing novel therapies that target the underlying biology of tumors."

Key Highlights of the TACC3 Program:

The selected cancers are characterized by limited treatment options and high rates of recurrence in patients. A2A’s TACC3 inhibitor is designed to disrupt critical cellular mechanisms involved in cancer cell proliferation, providing a much-needed new avenue of treatment for patients battling these aggressive malignancies.

Beyond these indications, pre-clinical studies suggest A2A’s TACC3 PPI inhibitor may also show efficacy in other solid tumors, including gastric and prostate cancers, sarcomas and certain hematologic malignancies. Ongoing research efforts are focused on expanding the indication spectrum and optimizing treatment regimens for diverse cancer types.

On December 11, 2024 Champions Oncology, Inc. (Nasdaq: CSBR), a global preclinical and clinical research services provider that offers end-to-end oncology solutions, reported its financial results for its second quarter of fiscal 2025, ended October 31, 2024 (Press release, Champions Oncology, DEC 11, 2024, View Source [SID1234649041]).

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Second Quarter and Recent Highlights:

•Total revenue increased 17% to $13.5 million
•Gross profit of $6.1 million; margin of 45%
•Net income of approximately $730,000
•Adjusted EBITDA of $1.1 million
•Development of new data revenue stream

First Half 2025 Highlights:

•Total revenue increased 14% to $27.6 million
•Gross profit of $13.1 million; margin of 47%
•Net income of $2.1 million
•Adjusted EBITDA of $3.2 million

Ronnie Morris, CEO of Champions, commented, "Our second quarter’s performance solidified our confidence in the Company’s turnaround that we’ve been discussing the last several quarters. We remain cautiously optimistic that the pharma and biotech environment is improving which will continue to contribute to our long-term growth." Morris added, "In addition to our core business, we made significant strides in monetizing our data platform, establishing an additional revenue stream that can be transformative for the Company."

David Miller, CFO of Champions, added, "We continued to deliver strong financial results in our second quarter as revenue increased 17% to $13.5M while we reduced total costs by $771,000. As a result, we recorded adjusted EBITDA of $1.1 million." Miller added, "With the renewed underlying strength in our core business coupled with the expected revenue contribution from our data platform, we’re projecting revenue growth for the year of at least 10% – 15%."

Second Fiscal Quarter Financial Results

Total revenue for the second quarter of fiscal 2025 was $13.5 million compared to $11.6 million for the same period last year, an increase of 17%. The combination of operational improvements and efficiencies implemented, which led to an increase in our revenue conversion percentage, and the acceleration in our bookings, generated an increase in revenue for both the three months and six months ended October 31, 2024. Total costs and operating expenses for the second quarter of fiscal 2025 were $12.8 million compared to $13.5 million for the second quarter of fiscal 2024, a decrease of $771,000 or 5.7%.

For the second quarter of fiscal 2025, Champions reported income from operations of $732,000, including $9,000 in stock-based compensation and $399,000 in depreciation and amortization expenses, compared to a loss from operations of $2.0 million, inclusive of $53,000 in stock-based compensation and $484,000 in depreciation and amortization expenses, in the second quarter of fiscal 2024. Excluding stock-based compensation, depreciation and amortization expenses, Champions reported adjusted EBITDA of $1.1 million for the second quarter of fiscal 2025 compared to an adjusted EBITDA loss of $1.4 million in the second quarter of fiscal 2024.

Cost of oncology services was $7.4 million for the three-months ended October 31, 2024, an increase of $810,000, or 12.2% compared to $6.6 million for the three-months ended October 31, 2023. The increase in cost of oncology services was primarily from an increase in mice and lab costs to support revenue growth. For the three-months ended October 31, 2024, total margin was 45% compared to 43% for the three-months ended October 31, 2023. The improved margin resulted primarily from an increase in revenue and a lower cost base due to operational efficiencies implemented, but was under some specific pressure due to the cost of humanized mice.

Research and development expense for the three-months ended October 31, 2024 was $1.7 million, a decrease of $826,000 or 32.8%, compared to $2.5 million for the three-months ended October 31, 2023. The decrease was primarily due to reduced investment in research and development, including our target discovery program. Sales and marketing expense for the three-months ended October 31, 2024 was $1.8 million, a slight decrease of $44,000, or 2.5%, compared to $1.8 million for the three-months ended October 31, 2023. General and administrative expense for the three-months ended October 31, 2024 was $1.9 million, a decrease of $711,000, or 27.3%, compared to $2.6 million for the three-months ended October 31, 2023. The decrease was primarily from a decline in compensation and recruitment expenses and a one-time reduction in our credit loss reserve.

Net cash used in operating activities was approximately $283,000 for the three-months ended October 31, 2024 and was primarily due to an increase in accounts receivable and a decrease in accounts payable offset by net income for the quarter. Net changes in our working capital accounts were in the ordinary course of business. Net cash used in investing activities for the three-months ended October 31, 2024 was approximately $94,000 and was for lab and computer equipment. Net cash provided by financing activities for the three-months ended October 31, 2024 was approximately $239,000 resulting primarily from proceeds from options exercise.

The Company ended the quarter with cash on hand of approximately $2.8 million. The Company has no debt.

Year-to-Date Financial Results

Total revenue for the first half of fiscal 2025 was $27.6 million compared to $24.1 million for the same period last year, an increase of 14.2%. Total costs and operating expenses for the first half of fiscal 2025 were $25.5 million compared to $28.6 million for the first half of fiscal 2024, a decrease of $3.2 million or 11.0%.

For the first half of fiscal 2025, Champions reported income from operations of $2.1 million, including $267,000 in stock-based compensation and $848,000 in depreciation and amortization expenses, compared to a loss from operations of $4.5 million, inclusive of $476,000 in stock-based compensation and $929,000 in depreciation and amortization expenses, in the first half of fiscal 2024. Excluding stock-based compensation, depreciation and amortization expenses, Champions reported adjusted EBITDA of $3.2 million for the first half of fiscal 2025 compared to an adjusted EBITDA loss of $3.1 million in the first half of fiscal 2024.

Cost of oncology services was $14.5 million for the six-months ended October 31, 2024, an increase of
$198,000, or 1.4% compared to $14.3 million for the six-months ended October 31, 2023. The increase in cost of oncology services was primarily from an increase in mice costs. For the six-months ended October 31, 2024, total margin was 47% compared to 41% for the six-months ended October 31, 2023. The improved margin resulted primarily from a combination of an increase in revenue while minimizing cost increases due to operational efficiencies implemented and other cost reduction initiatives.

Research and development expense for the six-months ended October 31, 2024 was $3.1 million, a decrease of $2.2 million or 40.8%, compared to $5.3 million for the six-months ended October 31, 2023. The decrease was primarily due to reduced investment in research and development in non-essential services, including our target discovery program. Sales and marketing expense for the six-months ended October 31, 2024 was $3.4 million, a slight decrease of $61,000, or 1.7%, compared to $3.5 million for the six-months ended October 31, 2023. General and administrative expense for the six-months ended October 31, 2024 was $4.4 million, a decrease of $1.1 million, or 20.3%, compared to $5.5 million for the six-months ended October 31, 2023. The decrease was primarily from a reduction in compensation, recruitment, and stock-based compensation expenses.

Conference Call Information:
The Company will host a conference call today at 4:30 p.m. EST (1:30 p.m. PST) to discuss its second quarter financial results. To participate in the call, please call 888-506-0062 (Domestic) or 973-528-0011 (International) and enter the access code 710610, or provide the verbal reference "Champions Oncology".
Full details of the Company’s financial results will be available by or before December 16, 2024 in the Company’s Form 10-Q at www.championsoncology.com.

On December 11, 2024 Florida Cancer Specialists & Research Institute, LLC (FCS) medical oncologists and hematologists reported groundbreaking breast cancer research studies being presented this week at the San Antonio Breast Cancer Symposium (Press release, Florida Cancer Specialists & Research Institute, DEC 11, 2024, View Source;research-institute-advancing-breast-cancer-research-302328323.html [SID1234649056]). Abstracts that detail first in-human Phase 1 and Phase 2 clinical trials conducted with FCS participation were selected to be highlighted at the prestigious international symposium attended by oncology experts from 100 countries.

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FCS Assistant Managing Physician David Wenk, MD said, "It is gratifying to share significant findings that are transforming and expanding treatment options for patients around the world diagnosed with breast cancer and other breast diseases." In the U.S., breast cancer is the most common cancer among women, after melanoma skin cancer. It affects men as well. Survival rates have increased dramatically in recent years thanks to ongoing advances in clinical research.

The following FCS medical oncologists and hematologists are co-authors of five abstracts that include first-in-human Phase 1 and Phase 2 clinical trials and will be presented in poster and/or oral presentations:

Lowell Hart, MD, FACP, as first author, and Stacey Garofalo, RN: P4-09-20: Extended Endocrine Adjuvant therapy for Early HR+ Breast Cancer, Comparisons Between Molecular Expression Profiles (Abstract SESS-1965)
Manish Patel, MD, FCS director of drug development, — P4-10-28: Efficacy, safety and biomarker results of AC699, a chimeric estrogen receptor degrader, in patients with advanced or metastatic breast cancer. (Abstract SESS-1394)
Alexander Philipovskiy, MD, PhD: P4-08-20: Trial in progress: A first-in-human phase 1a/b, dose escalation/expansion study of BG-68501/ETX-197 (CDK2 inhibitor) as monotherapy or in combination with fulvestrant for patients with HR+/HER2- breast cancer and other advanced solid tumors; and P2-10-27: An Open Label Study of BTX-A51 in Patients with ER+/HER2- GATA3 Mutant and Wild Type Metastatic Breast Cancer. (Abstract SESS-1333)
Judy Wang, MD, FCS associate director of drug development: P2-10-27: An Open Label Study of BTX-A51 in Patients with ER+/HER2- GATA3 Mutant and Wild Type Metastatic Breast Cancer. (Abstract SESS-1333) and P4-08-24: AKTive-001: A Phase 1/1b Multiple Cohort Trial of ALTA2618 in Patients with Advanced Solid Tumors with AKT1 E17K Mutation (Trial in Progress) (Abstract SESS-614)
Dr. Manish Patel oversees the statewide practice’s three drug development units, which, at any given time, are providing patients with the most advanced treatment options with access to over 130 clinical trials. He said, "Clinical trials lay the foundation for the future of cancer care, showcasing groundbreaking advancements in targeted therapies and innovative treatment strategies."