On June 22, 2022 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported new data demonstrating the clinical value of the Company’s tests for skin cancer in guiding more informed disease management decisions (Press release, Castle Biosciences, JUN 22, 2022, View Source [SID1234616188]). Data on each of Castle’s skin cancer tests, as outlined below, was shared during the recent Society of Dermatology Physician Assistants (SDPA) Annual Summer Dermatology Conference 2022 .

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DecisionDx-Melanoma

While patients with thin cutaneous melanoma (CM) tumors (T1, ≤1mm) are typically deemed low risk by traditional staging alone, studies have shown that up to 15%1-3 of these patients will go on to experience disease recurrence. As such, there is an opportunity to use DecisionDx-Melanoma to identify which patients with thin CM tumors may have aggressive tumor biology and thus could benefit from increased surveillance through advanced imaging or adjuvant therapy.

"The data in this study reinforced what we find in clinical practice: some patients initially thought to be low risk by traditional, clinicopathologic staging methods can have more aggressive tumor biology, and their melanoma may come back, even after their primary tumor has been removed," said lead study author Abel Jarell, M.D., dermatologist and dermatopathologist at Northeast Dermatology Associates in Portsmouth, New Hampshire. "DecisionDx-Melanoma can help identify these high-risk patients who may warrant a need for more intense treatment and surveillance to reduce their likelihood of recurrence and potentially improve the overall outcome of their disease."

Patients with T1 CM (classified according to the American Joint Committee on Cancer Eighth Edition (AJCC8) staging framework) from three previously published studies were combined for analysis (N=979). The results of the analysis was shared in a poster titled, "The 31-gene expression profile test stratifies the risk of recurrence in patients with T1 cutaneous melanoma: Results of a pooled analysis of 979 patients." The poster, which is available here, highlights the ability of DecisionDx-Melanoma to stratify patients with thin CM tumors according to their risk of recurrence.

Study highlights:

In the study, patients with thin tumors who received a DecisionDx-Melanoma high-risk Class 2B result had lower 3-year recurrence-free survival than patients with a low-risk Class 1A result (75.9% vs. 97.7%) and an 8-fold higher recurrence rate (22.5% vs. 2.7%, p<0.001).
Moreover, nearly one in four patients in the cohort who received a DecisionDx-Melanoma high-risk Class 2B result experienced melanoma recurrence, with a median 11-month time to recurrence.
A high-risk Class 2B test result was a significant predictor of disease recurrence (HR=4.49, p=0.001), similar to a positive sentinel lymph node (SLN) (HR=4.46, p<0.001). As a positive SLN is evidence that a patient’s melanoma has spread, these patients are candidates for advanced imaging and potentially, adjuvant therapies. These data suggest that patients receiving a DecisionDx-Melanoma Class 2B result could benefit from similar, more intense treatment aligned to their elevated risk of recurrence.
DecisionDx-SCC

The rise of squamous cell carcinoma (SCC) diagnoses is an emerging problem in the U.S. that is complicated by broad clinicopathological staging criteria and treatment guidelines for the disease. Castle’s DecisionDx-SCC test was designed to address this unmet medical need for patients with SCC and one or more high-risk factors. The test provides clinically actionable information about a patient’s biologic risk of metastasis, independent of clinicopathologic factors and traditional staging systems, which can help guide more informed and risk-appropriate treatment decisions within established guidelines.

The poster, titled "Study of 400 dermatologic clinicians corroborates the clinical impact of the prognostic 40-gene expression profile (40-GEP) test in patients with high-risk cutaneous squamous cell carcinoma (SCC)," shares the impact of DecisionDx-SCC test results on clinicians’ management of invasive SCC. The poster is available here.

"The study showed that many clinicians would consider de-escalating treatment plan decisions and potentially forgoing interventions for some patients if their DecisionDx-SCC test results indicated a low biological risk of metastasis," said Robert Cook, Ph.D., senior vice president of research and development at Castle Biosciences. "DecisionDx-SCC test results, when considered on their own and in the context of other clinicopathologic staging systems, can lead to risk-aligned treatment plan changes, either de-intensified or intensified, based on a patient’s individual metastatic risk. We were pleased that the survey responses supported this."

Study highlights:

The majority of clinicians (approximately 80%) indicated they would recommend ordering DecisionDx-SCC for patients with SCC lesions on high-risk locations when also considering the size of the lesion.
Previous studies4,5 have found that DecisionDx-SCC test results (low, moderate or high biological risk results) led to risk-aligned decreases or increases in clinician-directed treatment plans.
The survey results supported this, with the majority of clinicians who recommend the use of interventions for patients with high-risk SCC indicating they would consider forgoing certain treatments (64% for radiologic nodal imaging, 68% for SLN biopsy and 66% for adjuvant radiation therapy) for at least some patients who received a DecisionDx-SCC Class 1 test result (low biologic risk of metastasis).
Intention to further reduce recommendations for radiologic nodal imaging or SLN biopsy with a Class 1 test result was seen in those clinicians who were already using DecisionDx-SCC in their clinical practice (72% and 75%, respectively), accentuating the impact of the test among users.
MyPath Melanoma and DecisionDx DiffDx-Melanoma

MyPath Melanoma and DecisionDx DiffDx-Melanoma are Castle’s diagnostic tests designed to provide objective, highly accurate results to aid in the diagnosis of suspicious melanocytic lesions with ambiguous histopathology. The tests can provide clinically actionable information to help guide and potentially increase confidence in a diagnosis, if any uncertainty or discordance exists, to help clinicians deliver more informed patient management plans and provide their patients with more appropriate and individualized care.

The poster, titled "The current 23- and 35-gene expression profile (GEP) ancillary diagnostic testing workflow for difficult-to-diagnose melanocytic lesions increases the rate of actionable results to 99%," highlights how the current laboratory workflow for Castle’s two diagnostic tests can leverage the strengths of both individual tests to report accurate and clinically actionable results. The poster can be viewed here.

Study highlights:

In the current laboratory workflow, clinical samples are processed first through MyPath Melanoma, and if a technical failure or intermediate result is received, processed next through DecisionDx DiffDx-Melanoma.
In the study, the test workflow demonstrated a high rate of accuracy in the performance cohort, with 96.0% sensitivity and 87.8% specificity.
Based on the analysis of Castle test results reported over a six-month period (June 3-Dec. 3, 2021), the current workflow substantially improved the reporting of clinically actionable results from a historic rate of ~77% with MyPath Melanoma alone to over 99% when both tests were run in a combined workflow.
About DecisionDx-Melanoma

DecisionDx-Melanoma is a gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma (CM) metastasis or recurrence, as well as the risk of sentinel lymph node positivity, independent of traditional staging factors, and has been studied in more than 6,300 patient samples. Using tissue from the primary melanoma, the test measures the expression of 31 genes. Additionally, Castle has an ongoing collaboration with the National Cancer Institute (NCI) to link DecisionDx-Melanoma testing data with data from the Surveillance, Epidemiology and End Results (SEER) Program’s registries on CM cases. This collaboration has resulted in Castle’s analysis of 5,226 samples (clinically tested through December 31, 2018) in a study to evaluate melanoma-specific survival and overall survival; in this study, patients tested with DecisionDx-Melanoma had better survival rates than untested patients, and the data suggested that DecisionDx-Melanoma can accurately risk-stratify for disease progression to aid in risk-aligned treatment plans for improved patient outcomes and survival. The test has been validated in four archival risk of recurrence studies of 901 patients and six prospective risk of recurrence studies including more than 1,600 patients. Additionally, impact on patient management plans for one of every two patients tested has been shown in five multi-center/single-center studies including more than 800 patients. The consistent performance and accuracy demonstrated in these studies provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results. To predict risk of recurrence and likelihood of sentinel lymph node positivity, the Company utilizes its proprietary algorithms, i31-ROR and i31-SLNB, to produce an Integrated Test Result. Through March 31, 2022, DecisionDx-Melanoma has been ordered 97,288 times for patients with cutaneous melanoma.

About DecisionDx-SCC

DecisionDx-SCC is a 40-gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous squamous cell carcinoma metastasis for patients with one or more risk factors. The test result, in which patients are stratified into a Class 1 (low), 2A (moderate) or 2B (high) risk category, predicts individual metastatic risk to inform risk-appropriate management.

Peer-reviewed publications have demonstrated that DecisionDx-SCC is an independent predictor of metastatic risk and that integrating DecisionDx-SCC with current prognostic methods can add positive predictive value to clinician decisions regarding staging and management.

About MyPath Melanoma and DecisionDx DiffDx-Melanoma

MyPath Melanoma and DecisionDx DiffDx-Melanoma are two gene expression profile tests designed to provide a highly accurate, objective result to aid dermatopathologists and dermatologists in characterizing difficult-to-diagnose melanocytic lesions. Of the approximately two million suspicious pigmented lesions biopsied annually in the U.S., Castle estimates that approximately 300,000 of those cannot be confidently classified as either benign or malignant through traditional histopathology methods. For these cases, the treatment plan can also be uncertain. Obtaining highly accurate, objective ancillary testing can mean the difference between a path of overtreatment or the risk of undertreatment. Interpreted in the context of other clinical, laboratory and histopathologic information, MyPath Melanoma and DecisionDx DiffDx-Melanoma are designed to reduce uncertainty and provide confidence for dermatopathologists and help dermatologists deliver more informed patient management plans.

On June 22, 2022 Echosens, a high-technology company offering liver diagnostic solutions, and Novo Nordisk A/S, a leading global healthcare company, reported a partnership to advance early diagnosis of non-alcoholic steatohepatitis (NASH) and increase awareness of the disease among patients, healthcare providers and other stakeholders (Press release, Novo Nordisk, JUN 22, 2022, View Source [SID1234616187]).

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NASH is a chronic metabolic liver disease that affects more than 115 million people worldwide1. The condition is caused by build-up of fat and inflammation in the liver. This causes progressive damage to the liver and can lead to end-stage liver disease and death.

NASH is a ‘silent’ disease due to lack of symptoms in the early stages and, as a result, it is estimated that nine out of 10 people living with NASH go undiagnosed2. To significantly increase early diagnosis, broadly accepted non-invasive tests for diagnosing people living with NASH are needed, as confirmatory diagnosis currently relies on an invasive procedure known as a liver biopsy.

Echosens and Novo Nordisk will collaborate to support additional clinical validation, generation of real-world evidence and adoption of non-invasive diagnostic tests for NASH and work together to increase awareness of the disease and the importance of early diagnosis and management. The companies have a shared ambition of doubling diagnostic rates for people living with advanced to severe NASH by 2025.

"NASH is the more severe form of non-alcoholic fatty liver disease (NAFLD). It has few non-specific or no symptoms in its early stage, leading to inappropriate referrals to secondary care and patients often remaining undiagnosed until irreversible complications occur," said Dominique Legros, CEO at Echosens. "There is a pressing need for a broader adoption of our non-invasive liver tests to improve the diagnosis of people living with NASH, and we are proud to partner with Novo Nordisk to combine our strengths and shared mission to empower medical professionals with improved ways to assess, diagnose and manage the condition."

NASH is more common in people living with obesity (82% of people with NASH are living with obesity) and conditions related to obesity, such as type 2 diabetes (44% of people with NASH are living with type 2 diabetes)3. The low diagnosis rate for NASH is partly caused by a lack of awareness of the condition and associated risk factors among at-risk patients, healthcare providers, payers and policymakers.

"At Novo Nordisk we are committed to driving change in NASH, to develop new treatment options and advance care for this serious, chronic disease. An important step towards realizing that ambition is to ensure that we can identify the people in need of care," said Camilla Sylvest, executive vice president for Commercial Strategy & Corporate Affairs at Novo Nordisk. "But we cannot solve this challenge alone and through our partnership with Echosens, we hope to leverage our complementary skills to meet the needs of patients, healthcare providers and other stakeholders striving to address this ‘silent’ epidemic."

About NASH

Non-alcoholic steatohepatitis (NASH) is the most severe form of non-alcoholic fatty liver disease (NAFLD). It is a progressive metabolic liver disease characterised by fat accumulation and inflammation in the liver, which can lead to scarring, or fibrosis, and eventually end-stage liver disease and death. The risk of progression to advanced liver disease, including liver cancer, is higher in people with NASH than in the general population, and NASH is predicted to be the leading cause of liver transplantation by 2030. Moreover, NASH increases the risk of developing cardiovascular disease. Currently, no treatment is globally approved for the treatment of NASH, and people with NASH are left with very few management options.

On June 22, 2022 Daiichi Sankyo (TSE: 4568) reported that the European Medicines Agency (EMA) has validated the Type II Variation application for trastuzumab deruxtecan as monotherapy for the treatment of adult patients with unresectable or metastatic HER2 low (immunohistochemistry (IHC) 1+ or IHC 2+/in-situ hybridization (ISH)-negative) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy (Press release, Daiichi Sankyo, JUN 22, 2022, View Source [SID1234616186]). Patients with hormone receptor (HR) positive breast cancer must additionally have received or be ineligible for endocrine therapy.

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Trastuzumab deruxtecan is a specifically engineered HER2 directed antibody drug conjugate (ADC) being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/Nasdaq: AZN).

Validation confirms that the application is complete and commences the scientific review process by the EMA’s Committee for Medicinal Products for Human Use (CHMP). This application is based on data from the DESTINY-Breast04 phase 3 trial recently presented at the plenary session of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (#ASCO22) Annual Meeting and simultaneously published in The New England Journal of Medicine.

"Trastuzumab deruxtecan is the first HER2 directed therapy to demonstrate a survival benefit in patients with HER2 low metastatic breast cancer. We now have the potential to redefine how we classify and treat approximately half of all metastatic breast cancers," said Gilles Gallant, BPharm, PhD, FOPQ, Senior Vice President, Global Head, Oncology Clinical Development, Oncology R&D, Daiichi Sankyo. "In addition to the ongoing review of two other applications for the treatment of patients with HER2 positive metastatic breast cancer or gastric cancer in Europe, we are pleased to have received this third validation for HER2 low metastatic breast cancer with the goal of bringing trastuzumab deruxtecan to as many eligible patients with HER2 targetable cancers as possible."

In DESTINY-Breast04, trastuzumab deruxtecan demonstrated superior and clinically meaningful efficacy in progression-free survival (PFS) and overall survival (OS) in previously treated patients with HER2 low unresectable and/or metastatic breast cancer with HR positive or HR negative disease versus standard of care physician’s choice of chemotherapy. The safety profile of trastuzumab deruxtecan was consistent with previous clinical trials with no new safety concerns identified. Interstitial lung disease (ILD) or pneumonitis rates were consistent with that observed in late-line HER2 positive breast cancer trials of trastuzumab deruxtecan with a lower rate of grade 5 ILD observed, as determined by an independent adjudication committee.

About DESTINY-Breast04

DESTINY-Breast04 is a global, randomized, open-label, pivotal phase 3 trial evaluating the efficacy and safety of trastuzumab deruxtecan (5.4 mg/kg) versus physician’s choice of chemotherapy (capecitabine, eribulin, gemcitabine, paclitaxel or nab-paclitaxel) in patients with HR positive or HR negative, unresectable and/or metastatic breast cancer with low HER2 expression previously treated with one or two prior lines of chemotherapy. Patients were randomized 2:1 to receive either trastuzumab deruxtecan or chemotherapy.

The primary endpoint of DESTINY-Breast04 is PFS in patients with HR positive disease based on blinded independent central review (BICR). Key secondary endpoints include PFS based on BICR in all randomized patients (HR positive and HR negative disease), OS in patients with HR positive disease and OS in all randomized patients (HR positive and HR negative disease). Other secondary endpoints include PFS based on investigator assessment, objective response rate based on BICR and on investigator assessment, duration of response based on BICR and safety. DESTINY-Breast04 enrolled 557 patients at multiple sites in Asia, Europe and North America. For more information about the trial, visit ClinicalTrials.gov.

About Breast Cancer and HER2 Expression

Breast cancer is the most common cancer and is one of the leading causes of cancer-related deaths worldwide.1 More than two million cases of breast cancer were diagnosed in 2020 resulting in nearly 685,000 deaths globally.1 In Europe, approximately 531,000 cases of breast cancer are diagnosed annually.2

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors including breast, gastric, lung and colorectal cancers, and is one of many biomarkers expressed in breast cancer tumors.3

HER2 expression is currently defined as either positive or negative, and is determined by an IHC test which estimates the amount of HER2 protein on a cancer cell, and/or an ISH test, which counts the copies of the HER2 gene in cancer cells.3,4 HER2 positive cancers are defined as IHC 3+, IHC 2+/ISH+.3 HER2 negative cancers are currently defined as IHC 0, IHC 1+ or IHC 2+/ISH-.3 Approximately half of all patients with breast cancer have tumors with a HER2 IHC score of 1+, or a HER2 IHC score of 2+ in combination with a negative ISH test, an expression level not currently eligible for HER2 targeted therapy.5,6,7,8 Low HER2 expression occurs in both HR positive and HR negative disease.9

HER2 testing is routinely used to determine appropriate treatment options for patients with metastatic breast cancer. Targeting the lower range of expression in the HER2 spectrum may offer another approach to delay disease progression and extend survival in patients with metastatic breast cancer.10 Currently, patients with low HER2 expression with HR positive tumors have limited treatment options following progression on endocrine (hormone) therapy.11 Few targeted options are available for those who are HR negative.12

About Trastuzumab Deruxtecan

Trastuzumab deruxtecan (fam-trastuzumab deruxtecan-nxki in the U.S. only) is a HER2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, trastuzumab deruxtecan is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced program in AstraZeneca’s ADC scientific platform. Trastuzumab deruxtecan consists of a HER2 monoclonal antibody attached to a topoisomerase I inhibitor payload, an exatecan derivative, via a stable tetrapeptide-based cleavable linker.

Trastuzumab deruxtecan (5.4 mg/kg) is approved in Canada, Israel and the U.S. for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting, or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy, based on results from the DESTINY-Breast03 trial. Trastuzumab deruxtecan also is approved in approximately 40 countries for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti-HER2-based regimens based on the results from the DESTINY-Breast01 trial.

Trastuzumab deruxtecan (6.4 mg/kg) is approved in several countries for the treatment of adult patients with locally advanced or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01 trial.

About the Trastuzumab Deruxtecan Clinical Development Program

A comprehensive global development program is underway evaluating the efficacy and safety of trastuzumab deruxtecan monotherapy across multiple HER2 targetable cancers including breast, gastric, lung and colorectal cancers. Trials in combination with other anticancer treatments, such as immunotherapy, also are underway.

Regulatory applications for trastuzumab deruxtecan are currently under review in China, Europe, Japan and several other countries for the treatment of adult patients with HER2 positive unresectable or metastatic breast cancer who have received a prior anti-HER2-based regimen based on the results from the DESTINY-Breast03 trial.

Trastuzumab deruxtecan also is currently under review in the U.S. for the treatment of adult patients with unresectable or metastatic NSCLC whose tumors have a HER2 (ERBB2) mutation and who have received a prior systemic therapy based on the results from the DESTINY-Lung01 trial, and in Europe for the treatment of adult patients with locally advanced or metastatic HER2 positive gastric or GEJ adenocarcinoma who have received a prior anti-HER2-based regimen based on the DESTINY-Gastric01 and DESTINY-Gastric02 trials.

Trastuzumab deruxtecan was granted Breakthrough Therapy Designation in the U.S. for the treatment of adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-negative) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results of the DESTINY-Breast04 trial. Patients with HR positive breast cancer should additionally have received or be ineligible for endocrine therapy.

About the Daiichi Sankyo and AstraZeneca Collaboration

Daiichi Sankyo Company, Limited (referred to as Daiichi Sankyo) and AstraZeneca entered into a global collaboration to jointly develop and commercialize trastuzumab deruxtecan in March 2019 and datopotamab deruxtecan (Dato-DXd) in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi Sankyo is responsible for the manufacturing and supply of trastuzumab deruxtecan and datopotamab deruxtecan.

On June 22, 2022 Biogen (NASDAQ:BIIB) and Happify Health (www.HappifyHealth.com), the Intelligent Healing Company, reported a collaboration to provide a digital solution for patient education and engagement, powered by artificial intelligence (AI), to support people living with multiple sclerosis (MS) (Press release, Biogen, JUN 22, 2022, View Source [SID1234616185]). Through this collaboration, Biogen and Happify Health will help people with MS manage their care journey, improve their wellbeing, learn about treatment options, consult with experts, and connect with other people in the MS community for support.

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More than 2.3 million people live with MS globally, including over 1 million people in the United States, according to the National MS Society. Women are two to three times more likely to develop MS than men1.

"This collaboration is one of many ways we are focused on supporting patients by meeting them where they are. The combination of Biogen’s expertise in neuroscience and our commitment to digital health, along with Happify Health’s AI and digital therapeutic capabilities will help drive a connected and comprehensive experience that allows patients to feel supported throughout their journey," said Jason Hawbecker, Head of Strategic Partnerships & Collaborations at Biogen. "We are excited about the potential of this partnership to provide overall support for the MS community."

The Happify Health solution, which brings together a digital tool configured for MS and a care community (Kopa), offers holistic health and wellness support, with access to neurology providers (doctors, nurse practitioners, physicians assistants and nurses) as well as mental health specialists, dietitians, and rehabilitation professionals. The online community that recently launched provides a place for those living with MS to ask experts questions and discuss the physical and mental challenges they are facing with patients in similar stages. Happify Health uses its proprietary AI technology to personalize content to patients’ life stages, symptoms and interests.

"It can be challenging for people living with MS to stay up-to-date with the latest treatments, interpret new symptoms, or investigate changes in their health that may or may not be related to MS," said Ofer Leidner, President of Happify Health. "We are providing the MS community with a solution configured to accommodate their specific needs, as well as opportunities to engage with experts, receive curated content, and discuss disease management with other community members. We are very excited to partner with Biogen on this opportunity given their leadership in the MS space."

Biogen, a global leader in developing treatments for people living with serious neurological and neurodegenerative diseases, will provide support for the MS platform, including educational content and resources for the patient care journey. The company is a global leader in treating MS with a portfolio of medicines to treat relapsing forms of MS, characterized by periods where symptoms subside, with full or partial recovery, and there is no disease progression between attacks.

In addition to psoriasis and maternal health, MS is the third therapeutic area to be addressed through Happify Health’s unique SequenceTM approach. Sequences are configured to support specific medical conditions and weave together components like evidence-based digital therapeutics, online communities, and coaching in one unified platform, with recommendations tailored for each individual.

On June 22, 2022 Propanc Biopharma, Inc. (OTCQB: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company developing novel cancer treatments for patients suffering from recurring and metastatic cancer, reported that the results from a small trial of just 18 rectal cancer patients in complete remission using an immunotherapy called dostarlimab are "impressive," whilst acknowledging there’s more work to be done (Press release, Propanc, JUN 22, 2022, View Source [SID1234616184]). Chief Scientific Officer and Co-Founder, Dr Julian Kenyon MD, MB, ChB, believes that the field’s biggest challenge remains that immunotherapies work inconsistently across cancers. Oncologists estimate a response rate of 20% across cancer types, according to the Wall Street Journal ("WSJ"). The drugs can wipe out cancers from some people, but fail to work for others. It is also uncertain whether the cancer may eventually return once a patient is in remission, even after a prolonged period of time.

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Immunotherapies like dostarlimab, known as a checkpoint inhibitor, seek to inhibit key regulators of the immune system that when stimulated, reduces the body’s immune response to fight cancer. Given that immunotherapies target specific gene sequences, it often means they can encounter resistance, due to mutations that occur and genetic variation even within the primary tumor of a patient. As a result, Dr Cercek, from Memorial Sloan Kettering, who conducted the study for dostarlimab, estimates only 10% of rectal cancer patients and about 4% of all cancers will respond to treatment, according to the WSJ.

"For many cancers, multiple factors can drive growth, making it hard to effectively match one biomarker, or a particular gene sequence, to a single drug. On the other hand, a therapeutic approach like our lead product candidate, PRP, which alters the characteristics of the cancer cell, by enforcing it to express proteins it normally wouldn’t, means the treatment is less likely to encounter resistance through mutations, which is what we have observed in the lab as well as in clinical practice," said Dr Julian Kenyon.

In addition to specifically selecting the 18 rectal cancer patients according to their genetic biomarker, the trial included patients that were pre-metastatic, where tumors were locally advanced in one area, but not spread to other organs. This means patients identified with metastatic cancer were excluded from the trial. Therefore, the treatment and prevention of metastatic cancer, the main cause of patient death for sufferers, still remains the unsolved, final frontier. Cancer stem cells, which are the cells responsible for spreading to other parts of the body, remains a key focus for Dr Kenyon.

Dr Kenyon said, "PRP is a proenzyme treatment that targets and eradicates cancer stem cells by altering multiple pathways of a cancerous cell rather than a single genetic sequence. We’ve observed that once they are treated with PRP, the effects are irreversible and are more easily recognizable by the immune system, therefore potentially improving the response rates of standard approaches like immunotherapy, to overcome advanced cancers. We look forward to testing the utility of PRP with these approaches as we further advance into the clinic."

PRP is a mixture of two proenzymes, trypsinogen and chymotrypsinogen from bovine pancreas administered by intravenous injection. A synergistic ratio of 1:6 inhibits growth of most tumor cells. Examples include kidney, ovarian, breast, brain, prostate, colorectal, lung, liver, uterine and skin cancers.