On November 13, 2024 Daiichi Sankyo (TSE: 4568) reported that it will highlight new clinical research and real-world data from seven abstracts for TURALIO (pexidartinib) at the Connective Tissue Oncology Society (#CTOS2024) 2024 Annual Meeting (Press release, Daiichi Sankyo, NOV 13, 2024, https://www.businesswire.com/news/home/20241113520939/en/Daiichi-Sankyo-to-Showcase-TURALIO%C2%AE-Research-in-Patients-with-Tenosynovial-Giant-Cell-Tumor-at-CTOS [SID1234648313]).

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TURALIO is the first and only oral systemic therapy approved in the U.S. for adult patients with tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery. TGCT is a rare and typically non-malignant tumor that affects small and large joints.1,2,3

Data at CTOS will highlight ongoing TURALIO research, including two analyses from the ENLIVEN phase 3 trial. One analysis evaluates the efficacy of TURALIO according to surgical history and the feasibility of surgery following treatment with TURALIO. The other is an exploratory analysis examining the dose of TURALIO at the time of objective response and the first timepoint response of progressive disease in relation to adverse events.

"These latest data being presented at CTOS continue to support the role of TURALIO as a treatment option for certain patients with tenosynovial giant cell tumor," said Dan Switzer, Head of U.S. Oncology Business, Daiichi Sankyo, Inc. "As a leader in TGCT research and development, Daiichi Sankyo has made significant progress in transforming the treatment landscape for patients with this rare, debilitating tumor and we remain committed to educating the medical community on identifying appropriate patients who may be eligible for treatment with TURALIO."

Additional TURALIO data at CTOS include health-related quality of life (HRQOL) outcomes from a phase 4 trial evaluating the discontinuation and re-treatment in patients with TGCT previously treated with TURALIO and a trial-in-progress of a phase 4 trial evaluating the risk of idiosyncratic cholestatic hepatoxicity associated with TURALIO treatment.

Other clinical research includes interim results from an investigator-initiated phase 1 trial evaluating the safety and tolerability of TURALIO in pediatric patients and young adults with TGCT, a case study reporting the use of TURALIO as an upfront treatment strategy for TCGT and results of a real-world assessment evaluating symptom change in patients with TGCT receiving TURALIO.

An overview of TURALIO data to be presented at CTOS includes:

Presentation Title

Author

Presentation (PST)

Pexidartinib use in patients with tenosynovial giant cell tumor: an analysis of the phase 3 randomized ENLIVEN clinical trial according to surgical history

J. Healey

Oral Presentation
Saturday, November 16
3:30 – 4:30 pm

Tumor response and regrowth in relation to clinical events among pexidartinib-treated subjects in the phase 3 ENLIVEN trial

J. Desai

Poster Session
Thursday, November 14
5:45 – 6:45 pm

Health-related quality of life from a phase 4 study to evaluate discontinuation and rechallenge of pexidartinib in patients with tenosynovial giant cell tumor previously treated with pexidartinib

J. Desai

Poster Session
Thursday, November 14
5:45 – 6:45 pm

A long-term phase 4 study to evaluate the risk of hepatotoxicity associated with pexidartinib treatment

A. Singh

Poster Session
Thursday, November 14
5:45 – 6:45 pm

Tenosynovial giant cell tumor in children: interim results from a phase 1 study of TURALIO

J. Lake

Poster Session
Thursday, November 14
5:45 – 6:45 pm

Pexidartinib upfront in a case of tenosynovial giant cell tumor: proof of concept for a treatment paradigm shift

E. Palmerini

Poster Session
Thursday, November 14
5:45 – 6:45 pm

Real-world experience of patients newly initiated on pexidartinib for tenosynovial giant cell tumor

D. Dai

Poster Session
Thursday, November 14
5:45 – 6:45 pm

About TGCT (PVNS/GCT-TS)
TGCT, also referred to as pigmented villonodular synovitis (PVNS) or giant cell tumor of the tendon sheath (GCT-TS), is a rare, typically non-malignant tumor that can be locally aggressive. TGCT affects the synovium-lined joints, bursae and tendon sheaths, resulting in reduced mobility in the affected joint or limb.1,2,3

While the exact incidence of TGCT is not known, it is estimated that the worldwide incidence of TGCT is 43 patients per million person-years.4,5,6 TGCT is subcategorized into two types: localized, which is more common and accounts for 80% to 90% of cases, and diffuse, which accounts for 10% to 20% of cases.5,6 The current standard of care for TGCT is surgical resection.1,7 However, in patients with recurrent, difficult-to-treat, or the diffuse form of TGCT, the tumor may wrap around bone, tendons, ligaments and other parts of the joint. In these cases, the tumor may be difficult to remove and/or may not be amenable to improvement with surgery. Multiple surgeries for more severe cases can lead to significant joint damage, debilitating functional impairments and reduced quality of life, and amputation may be considered.7,8,9

Recurrence rates for localized TGCT are estimated to be up to 15% following complete resection.3,6,10,11,12 Diffuse TGCT recurrence rates are estimated to be up to 55% following complete resection.3,6,10,13 TGCT affects all age groups with the diffuse type on average occurring most often in people below the age of 40, and the localized type typically occurring in people between 30 and 50 years old.1,4,5,6

About TURALIO
TURALIO (pexidartinib) is an oral small molecule that targets colony stimulating factor 1 receptor (CSF1R), KIT proto-oncogene receptor tyrosine kinase (KIT), and FMS-like tyrosine kinase 3 (FLT3) harboring an internal tandem duplication (ITD) mutation. Overexpression of the CSF1R ligand promotes cell proliferation and accumulation in the synovium.

TURALIO is approved in the U.S. for the treatment of adult patients with symptomatic TGCT associated with severe morbidity or functional limitations and not amenable to improvement with surgery based on the results of the ENLIVEN trial.

Important Safety Information

Indication
TURALIOⓇ (pexidartinib) is indicated for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery.

WARNING: HEPATOTOXICITY

TURALIO can cause serious and potentially fatal liver injury. Monitor liver tests prior to initiation of TURALIO and at specified intervals during treatment. Withhold and dose reduce or permanently discontinue TURALIO based on severity of hepatotoxicity. TURALIO is available only through a restricted program called the TURALIO Risk Evaluation and Mitigation Strategy (REMS) Program.

Contraindications
None

Warnings and Precautions
Hepatotoxicity

Hepatotoxicity with ductopenia and cholestasis occurred in patients treated with TURALIO. Across 768 patients who received TURALIO in clinical trials, there were two irreversible cases of cholestatic liver injury. One patient with advanced cancer and ongoing liver toxicity died and one patient required a liver transplant.
The mechanism of cholestatic hepatotoxicity is unknown and its occurrence cannot be predicted. It is unknown whether liver injury occurs in the absence of increased transaminases.
In ENLIVEN, 3 of 61 (5%) patients who received TURALIO developed signs of serious liver injury, defined as alanine aminotransferase (ALT) or alanine aminotransferase (AST) ≥3 × upper limit of normal (ULN) with total bilirubin ≥2 × ULN. In these patients, peak ALT ranged from 6 to 9 × ULN, peak total bilirubin ranged from 2.5 to 15 × ULN, and alkaline phosphatase (ALP) was ≥2 × ULN. ALT, AST and total bilirubin improved to <2 × ULN in these patients 1 to 7 months after discontinuing TURALIO.
Avoid TURALIO in patients with preexisting increased serum transaminases, total bilirubin, or direct bilirubin (>ULN); or active liver or biliary tract disease, including increased ALP.
Monitor liver tests, including AST, ALT, total bilirubin, direct bilirubin, ALP, and gamma-glutamyl transferase (GGT), prior to initiation of TURALIO, weekly for the first 8 weeks, every 2 weeks for the next month and every 3 months thereafter.
Withhold and dose reduce, or permanently discontinue TURALIO based on the severity of the hepatotoxicity. Rechallenge with a reduced dose of TURALIO may result in a recurrence of increased serum transaminases, bilirubin, or ALP. Monitor liver tests weekly for the first month after rechallenge.
TURALIO REMS

Requirements include: 1) prescribers must be certified by enrolling and completing training, 2) patients must complete and sign an enrollment form for inclusion in a patient registry, and 3) pharmacies must be certified and must dispense only to patients who are authorized (enrolled in the REMS patient registry).
Further information is available at www.TURALIOREMS.com or 1-833-887-2546.
Embryo-fetal toxicity

TURALIO may cause fetal harm when administered to a pregnant woman. Advise patients of reproductive potential of the potential risk to a fetus. Verify pregnancy status in females of reproductive potential prior to the initiation of TURALIO.
Advise females of reproductive potential to use an effective nonhormonal method of contraception. TURALIO can render hormonal contraceptives ineffective during treatment with TURALIO and for 1 month after the final dose.
Advise males with female partners of reproductive potential to use effective contraception during treatment with TURALIO and for 1 week after the final dose.
Potential Risks Associated with a High-Fat Meal

Taking TURALIO with a high-fat meal increases pexidartinib concentrations, which may increase the incidence and severity of adverse reactions, including hepatotoxicity.
Instruct patients to take TURALIO with a low-fat meal (approximately 11 to 14 grams of total fat) and to avoid taking TURALIO with a high-fat meal (approximately 55 to 65 grams of total fat).
Adverse Reactions

The most common adverse reactions (>20%) were increased lactate dehydrogenase (92%), increased AST (88%), hair color changes (67%), fatigue (64%), increased ALT (64%), decreased neutrophils (44%), increased cholesterol (44%), increased ALP (39%), decreased lymphocytes (38%), eye edema (30%), decreased hemoglobin (30%), rash (28%), dysgeusia (26%), and decreased phosphate (25%).
Drug Interactions

Hepatotoxic products: Avoid coadministration in patients with increased serum transaminases, total bilirubin, or direct bilirubin (>ULN) or active liver or biliary tract disease.
Moderate or strong CYP3A inhibitors and UGT inhibitors: Concomitant use may increase pexidartinib concentrations. Reduce TURALIO dosage if concomitant use cannot be avoided.
Strong CYP3A inducers: Avoid concomitant use due to decreased pexidartinib concentrations.
Acid-reducing agents: Avoid concomitant use of proton pump inhibitors due to decreased pexidartinib concentrations. Use histamine-2 receptor antagonists or antacids if needed.
CYP3A substrates: Avoid concomitant use where minimal concentration changes may lead to serious therapeutic failure (e.g., hormonal contraceptives) due to decreased concentrations of CYP3A substrates.
Use in Specific Populations

Lactation: Advise not to breastfeed and for at least 1 week after the final dose.
Renal impairment: Reduce the dosage for patients with mild to severe renal impairment.
Hepatic impairment: Reduce the dosage for patients with moderate hepatic impairment. TURALIO has not been studied in patients with severe hepatic impairment.
To report SUSPECTED ADVERSE REACTIONS, contact Daiichi Sankyo, Inc, at 1-877-437-7763 or FDA at 1-800-FDA-1088 or fda.gov/medwatch.

Please see accompanying full Prescribing Information, including Boxed WARNING, and Medication Guide.

On November 13, 2024 Viracta Therapeutics, Inc. (Nasdaq: VIRX), a clinical-stage precision oncology company focused on the treatment and prevention of virus-associated cancers that impact patients worldwide, reported financial results for the third quarter of 2024 and provided a business update (Press release, Viracta Therapeutics, NOV 13, 2024, View Source [SID1234648290]).

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"Last quarter, based on productive feedback from FDA, we announced a sharpened focus on the second-line EBV-positive PTCL subpopulation in the NAVAL-1 trial’s expansion phase, which is ongoing," said Mark Rothera, President and Chief Executive Officer of Viracta. "To optimally support both the NAVAL-1 trial as well as a randomized controlled trial that we are planning for the second half of next year and reduce cash burn, we recently announced a reprioritization of resources intended to right-size our organization and further reduce our operating expenses. With a clearly defined regulatory path forward for Nana-val, we believe this will allow us to be efficient while we work toward the possible submission of a New Drug Application in 2026 and seek to introduce the first EBV-targeted therapy for lymphoma patients, subject to obtaining requisite funding."

"We are pleased to have determined a recommended Phase 2 dose for Nana-val in patients with advanced EBV-positive solid tumors," said Darrel P. Cohen, M.D., Ph.D., Chief Medical Officer of Viracta.

"Although the EBV-positive solid tumor program has been paused, clinical development in this patient population is ready for Phase 2, with additional financing or with a partner, using nanatinostat and valganciclovir doses that were well tolerated with evidence of antitumor activity."

Clinical Trial Updates and Anticipated Milestones

Phase 1b/2 trial of Nana-val (nanatinostat in combination with valganciclovir) in patients with recurrent/metastatic (R/M) Epstein-Barr virus-positive (EBV+) nasopharyngeal carcinoma (NPC) and other advanced EBV+ solid tumors (Study 301)

Clinical Trial Update:

In October, determined the recommended Phase 2 dose in patients with advanced EBV+ solid tumors.
Phase 2 NAVAL-1 trial of Nana-val (nanatinostat in combination with valganciclovir) in patients with relapsed or refractory (R/R) Epstein-Barr virus-positive (EBV+) lymphoma

Clinical Trial Updates:

In August, announced positive combined Stage 1 and Stage 2 data (n=21) in the R/R EBV+ PTCL cohort of patients treated with nanatinostat (20 mg orally once daily, 4 days/week) in combination with valganciclovir (900 mg orally once daily, 7 days/week) across the first two stages of the study.
Combined data from Stages 1 and 2 demonstrated Nana-val’s substantial antitumor activity and generally well-tolerated safety profile with a median duration of response (DOR) that has not yet been reached.
In August, announced that a productive FDA meeting was held to align on a potential regulatory path forward for Nana-val in patients with R/R EBV+ PTCL.
Based on feedback from the FDA and the particularly robust response rates observed in the second-line treatment setting, and to target its resources, Viracta will focus the primary analysis on the second-line EBV+ PTCL subpopulation in the ongoing NAVAL-1 trial’s expansion phase.
The Company plans to begin a randomized controlled trial (RCT) of Nana-val in the second-line treatment of EBV+ PTCL patients in the second half of 2025, subject to obtaining financing.
Anticipated Milestones

Viracta plans to deliver on the following milestones, subject to obtaining financing:

Meet with the FDA to finalize the proposed RCT design in the second-line treatment of patients with EBV+ PTCL in the first half of 2025.
Initiate the RCT in the second half of 2025.
Report preliminary data from the expansion phase of the NAVAL-1 trial in second-line EBV+ PTCL patients in the first half of 2025.
Report Stage 1 data from patients with R/R EBV+ diffuse large B-cell lymphoma (DLBCL) in the first half of 2025.
Present interim analysis outcomes from the NAVAL-1 trial’s expansion phase in second-line EBV+ PTCL patients in 2026.
File NDA for accelerated approval in 2026 based on interim analysis of the NAVAL-1 trial’s expansion cohort.
Business Updates

Announced on November 6th a reprioritization of resources intended to enhance focus on the Company’s lead program, reduce cash burn, and drive shareholder value:
Included a reduction in force affecting approximately 42% of the Company’s employees.
Also reduced the size of its Board of Directors from 10 to 6 seats following voluntary resignations from 4 directors.
Third Quarter 2024 Financial Results

Cash position – Cash, cash equivalents, and short-term investments totaled approximately $21.1 million as of September 30, 2024, which Viracta expects will be sufficient to fund operations late into the first quarter of 2025.
Research and development expenses – Research and development expenses were approximately $7.2 million and $23.7 million for the three and nine months ended September 30, 2024, respectively, compared to approximately $8.2 million and $24.0 million for the same periods in 2023. The decrease in research and development expenses for the three months ended September 30, 2024 compared to the same period in 2023, was driven by decreases in costs incurred to support the advancement and expansion of our clinical development programs, including incremental costs to support NAVAL-1, our Phase 2 trial of Nana-val in patients with R/R EBV+ lymphomas and personnel-related costs. The decrease in research and development expenses for the nine months ended September 30, 2024 compared to the same period in 2023, was largely due to decreases in costs incurred related to our clinical development programs and personnel-related costs, partially offset by a non-cash adjustment for insurance costs related to the February 2021 reverse merger with Sunesis Pharmaceuticals of $1.8 million.
General and administrative expenses – General and administrative expenses were approximately $3.0 million and $10.0 million for the three and nine months ended September 30, 2024, respectively, compared to $4.3 million and $13.2 million for the same periods in 2023. The decrease in general and administrative expenses was largely due to decreases in personnel-related costs, corporate liability insurance premiums and consulting and legal costs.
Net loss – Net loss was approximately $10.6 million, or $0.27 per share (basic and diluted), for the quarter ended September 30, 2024, compared to a net loss of $12.6 million, or $0.33 per share (basic and diluted), for the same period in 2023. This change was primarily the result of decreases in research and development expenses and personnel-related costs. Net loss was approximately $29.5 million, or $0.75 per share, (basic and diluted) for the nine months ended September 30, 2024, compared to a net loss of $37.3 million, or $0.97 per share, (basic and diluted) for the same period in 2023. This change was primarily the result of $5.0 million of other income received related to the monetization of a pre-commercialization, event-based milestone from Day One Biopharmaceuticals, Inc. in March 2024, and decreases in costs related to our clinical development programs and personnel-related costs, partially offset by the non-cash adjustment for insurance costs related to the February 2021 merger of $1.8 million.
About the NAVAL-1 Trial
NAVAL-1 (NCT05011058) is a global, multicenter, clinical trial of Nana-val in patients with relapsed or refractory (R/R) Epstein-Barr virus-positive (EBV+) lymphoma. This trial employs a Simon two-stage design where, in Stage 1, participants are enrolled into one of three indication cohorts based on EBV+ lymphoma subtype. If two objective responses are achieved within a lymphoma subtype in Stage 1 (n=10), then additional patients will be enrolled in Stage 2 for a total of 21 patients. EBV+ lymphoma subtypes demonstrating promising antitumor activity in Stage 2 may be further expanded following discussion with regulators to potentially support registration.

About Nana-val (Nanatinostat and Valganciclovir)
Nanatinostat is an orally available histone deacetylase (HDAC) inhibitor being developed by Viracta. Nanatinostat is selective for specific isoforms of Class I HDACs, which are key to inducing viral genes that are epigenetically silenced in Epstein-Barr virus (EBV)-associated malignancies. Nanatinostat is currently being investigated in combination with the antiviral agent valganciclovir as an all-oral combination therapy, Nana-val, in various subtypes of EBV-associated malignancies. Ongoing trials include a potentially registrational, global, multicenter, open-label Phase 2 basket trial in multiple subtypes of relapsed or refractory (R/R) EBV+ lymphoma (NAVAL-1) as well as a multinational Phase 1b/2 clinical trial in patients with recurrent or metastatic (R/M) EBV+ NPC and other advanced EBV+ solid tumors.

About Peripheral T-Cell Lymphoma
T-cell lymphomas comprise a heterogeneous group of rare and aggressive malignancies, including peripheral T-cell lymphoma not otherwise specified (PTCL-NOS) and angioimmunoblastic T-cell lymphoma (AITL). There are approximately 5,600 newly diagnosed T-cell lymphoma patients and approximately 2,600 newly diagnosed PTCL-NOS and AITL patients in the U.S. annually. Approximately 70% of these patients are either refractory to first-line therapy, or eventually experience relapse of their disease. Clinical trials are currently recommended for all lines of PTCL therapy, and most patients with R/R PTCL have poor outcomes, with median progression-free survival and median overall survival times reported to be 3.7 and 6.5 months, respectively. Approximately 40% to 65% of PTCL is associated with EBV, the incidence of EBV+ PTCL varies by geography, and reported outcomes for patients with EBV+ PTCL are inferior to those whose disease is EBV-negative. There is no approved targeted treatment specific for EBV+ PTCL, and therefore this represents a high unmet medical need.

About EBV-Associated Cancers
Approximately 90% of the world’s adult population is infected with EBV. Infections are commonly asymptomatic or associated with mononucleosis. Following infection, the virus remains latent in a small subset of cells for the duration of the patient’s life. Cells containing latent virus are increasingly susceptible to malignant transformation. Patients who are immunocompromised are at an increased risk of developing EBV-positive (EBV+) lymphomas. EBV is estimated to be associated with approximately 2% of the global cancer burden including lymphoma, nasopharyngeal carcinoma (NPC), and gastric cancer.

On November 13, 2024 Reverb Therapeutics, a leader harnessing the body’s immune system and cytokine signaling to treat life-threatening diseases, reported it has launched a collaboration with Royalmount Laboratories, based in Montreal, as Reverb works towards lead selection and pre-IND enabling work on its first drug candidate (Press release, Royalmount Laboratories, NOV 13, 2024, View Source [SID1234648314]).

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Royalmount Laboratories is one of Canada’s premier CRO organizations, supporting biopharma and pharma companies with their bioanalytical needs to advance their discovery, preclinical and clinical programs. It is rapidly becoming the leading niche small and large molecule bioanalytical CRO in Canada.

"As we move towards the start of clinical trials in about 18 months’ time, we needed a scientific partner that could assist with toxicity studies, scale-up of manufacturing, and a variety of CMC tasks to ensure that our drug candidate moves swiftly from the lab to the clinic," said David de Graaf, Ph.D., CEO of Reverb Therapeutics. "We are impressed with Royalmount Laboratories’ capabilities and the quality of their staff."

Adrien Musuku, Senior Director of biopharmaceutics for Royalmount Laboratories, said, "At Royalmount Laboratories, we provide both small and large molecule bioanalytical support needed to bring life-changing therapies to those in need. Our proven track record of strong science, unmatched quality and consistent on-time delivery facilitates quick advancement in the development of new therapeutic entities. We are proud to support companies like Reverb Therapeutics, an early-stage firm with novel science and a unique approach to harnessing the power of cytokines to treat disease. Reverb Therapeutics is a perfect example of the kind of dynamic company we want to help advance to the clinic and beyond."

Terms of the collaboration were not disclosed. Development work for Reverb begins immediately.

Reverb’s novel Amplify•R platform combines bispecific antibody engineering with data-driven modelling of antibody-tissue interaction to amplify endogenous cytokines and redirect them to tissues of interest. This approach avoids the hurdles that have blocked other attempts to enlist cytokines to treat disease, which include systemic toxicity, immunogenicity, and manufacturing issues. Reverb Therapeutics is developing its precision medicine for the immune system with a focus on the treatment of cancer and auto-immune diseases.

The Amplify•R platform is designed to expand the therapeutic window of cytokines by harnessing the body’s own endogenous cytokines and amplifying their activity in a tissue-specific manner, leading to profound disease-modifying effects. The Amplify•R platform is a modular, plug-and-play, IgG-based platform, enabling rapid pre-clinical testing and ease of manufacturing for scale-up and clinical utility.

On November 13, 2024 Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, reported that it will present three abstracts highlighting significant advancements in the development of a multi-cancer early detection (MCED) test (Press release, Exact Sciences, NOV 13, 2024, View Source [SID1234648275]). The results of a study evaluating a new multi-biomarker class approach showed improved sensitivity for early-stage and overall cancer detection. In addition, new modeling data estimate that adding MCED testing to recommended screening may reduce the incidence of stage IV cancer and, subsequently, cancer mortality over 10 years. Another new analysis from the DETECT-A study suggests that adding MCED testing complements guideline-recommended lung cancer screening without affecting adherence to current standard of care. These findings will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Special Conference in Cancer Research: Liquid Biopsy from November 13-16, 2024, in San Diego, Calif.

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"Cancer is on pace to be the leading cause of death in the U.S. by 2030 1 . Currently, only an estimated 14% of all cancers in the U.S. are diagnosed through screening, 2 revealing a glaring gap in patient care," said Tom Beer, M.D., chief medical officer and vice president, multi-cancer early detection, Exact Sciences. "We believe MCED testing is our single biggest opportunity to combat these stark statistics, and the Exact Sciences team is committed to taking a rigorous, comprehensive approach to multi-cancer screening. The new data answer key questions about the impact we can anticipate with MCED testing if integrated into clinical practice."

A new study demonstrates the ability of a multi-biomarker class MCED test to improve early-stage sensitivity by incorporating a DNA mutation reflex approach to methylation and protein (MP) test results. When excluding breast and prostate cancer and at a 98.5% specificity, sensitivity increased by 28% for stage I cancers and 12.5% for early-stage cancers (stages I and II) in a case-control study, underscoring the potential of a three-biomarker class (DNA methylation, protein, DNA mutation reflex, or MP-r) test to improve the detection of cancer in earlier stages.

Cancer stage

MP-r sensitivity

MP sensitivity

% improvement

Stage I

22.1%

17.2%

28.0%

Stage II

54.7%

51.9%

5.5%

Stage I/II

35.9%

31.9%

12.5%

Overall

62.3%

59.3%

5.0%

This new research will help inform the final design of Exact Sciences’ Cancerguard test, which is currently in development and intends to harness the additive sensitivity of multiple biomarker classes to detect more cancers in earlier stages.

The abstracts featured at the AACR (Free AACR Whitepaper) Special Conference: Liquid Biopsy 2024 are as follows:

Title: Performance of multi-biomarker class reflex testing in a prospectively-collected cohort
Poster session: Thursday, November 14, 5:15 – 7:15 p.m. PT (Session A)
Poster number: A056
Key findings: A new analysis from a case-control study demonstrated the ability of a three-biomarker class (DNA methylation, protein, DNA mutation reflex, or MP-r) MCED test approach to increase sensitivity for early-stage detection. When excluding breast and prostate cancer, stage I sensitivity increased by 28%, and stage I/II increased by 12.5%.

Title: The potential of multi-cancer early detection screening for reducing cancer mortality
Oral presentation: Friday, November 15, 9:35 a.m. PT (Plenary Session 4: Early Detection of Primary Cancer and Relapse)
Presenter: Tyson, C
Poster number: PR006, A073
Key findings: New modeling points to the potential to reduce the burden of cancer by demonstrating an estimated 42% reduction in stage IV cancer incidence and a 17% estimated 10-year reduction in cancer mortality with the addition of MCED testing to usual care.

Title: Lung cancer screening adherence among participants in DETECT-A, the first prospective interventional trial of a multi-cancer early detection (MCED) blood test
Poster session: Thursday, November 14, 5:15 – 7:15 p.m. PT (Session A)
Poster number: A064
Key findings: Analysis from the prospective, interventional DETECT-A study showed lung cancer screening adherence was not reduced in participants who received an MCED test compared to controls.

About the DETECT-A study

The DETECT-A (Detecting cancers Early Through Elective mutation-based blood Collection and Testing) study was the first-ever large, prospective, interventional study to use a blood test to detect multiple types of cancer in a real-world setting. The DETECT-A study enrolled more than 10,000 women with no history of cancer to determine if a blood test in combination with standard-of-care screenings could detect cancers before signs and symptoms appeared. The CancerSEEK test, the MCED test studied in DETECT-A, was the forerunner to the Cancerguard test, the MCED test currently in development at Exact Sciences.

About the Cancerguard test

The Cancerguard test, currently in development, is designed to detect multiple cancers in their earliest stages from a single blood draw. Building upon decades of research, Exact Sciences intends to harness the additive sensitivity of multiple biomarker classes to detect more cancers in earlier stages. The Cancerguard test will utilize a streamlined and standardized imaging-based diagnostic pathway, which may result in fewer follow-up procedures. The test is being developed to provide high specificity to help minimize false positives while detecting multiple cancers, including those with the biggest toll on human health. These features describe current development goals. The Cancerguard test has not been cleared or approved by the U.S. Food and Drug Administration or any other national regulatory authority. To learn more, visit View Source

On November 13, 2024 Helix BioPharma Corp. (TSX: "HBP", OTC PINK: "HBPCD", FRANKFURT: "HBP020241113_Laevoroc LOI_Final") ("Helix" or the "Company), a clinical-stage biopharmaceutical company developing novel and unique therapies in the field of immuno-oncology, based on its proprietary technological CEACAM6 platform, DOS47, reported that the Company has entered into a non-binding letter of intent (LOI) to acquire a 100% interest in the oncology assets of Laevoroc Chemotherapy AG and Laevoroc Immunology AG, both privately-held, Swiss oncology companies (Press release, Helix BioPharma, NOV 13, 2024, View Source [SID1234648246]).

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HELIX BIOPHARMA CORP. ENTERS INTO NON-BINDING LOI TO ACQUIRE LAEVOROC GROUP’S ONCOLOGY ASSETS