On Janaury 11, 2023 Guardant Health reported 5 Myths Associated with Blood-Based Cancer Screening (Press release, Guardant Health, JAN 11, 2023, View Source [SID1234626195]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On a recent flight, I had the most interesting conversation with a fellow passenger which led me to write this article. We were having a casual conversation, and, of course, she asked me what I do for a living. I told her that I work in the blood-based cancer screening space. As someone with a family history of cancer and having gone through some genetic testing herself, she had several follow-up questions for me. This opened my eyes to the fact that when you say "blood-based screening", that can ring different bells for different people, and here I will go through some common misconceptions that people have about blood-based screening.

Myth #1: Blood-based cancer screening is the same as hereditary cancer testing.

Cancer screening tests are very different from hereditary cancer tests. To understand this clearly, we first need to understand the difference between a screening test and a diagnostic test. A screening test is usually done to detect diseases in individuals who do not have any symptoms. The main purpose of a screening test is to be able to detect diseases early as this is when treatment is often more effective. Today, technology has evolved such that there are blood-based screening tests available to screen for certain cancers.

A diagnostic test, on the other hand, is done to establish or confirm the presence or absence of disease among individuals who display symptoms or asymptomatic individuals with an abnormal screening test. The purpose of a diagnostic test is to provide a definite diagnosis of a disease. Hereditary cancer testing or what we refer to as "genetic testing" is a diagnostic test that looks for specific inherited changes in a person’s genes that put a person at an increased risk for developing cancer. This may be performed due to a personal or family history of cancer, rare cancers in the family or the presence of birth defects that may be associated with cancer. If there is a concern of there being an inherited cancer syndrome in the family, genetic counseling and testing are usually recommended.

Myth #2: My ob/gyn did some blood tests when I was pregnant. I should be good.

Women undergo prenatal testing when pregnant. Noninvasive prenatal tests (NIPTs) can screen women’s blood to determine if the baby is more or less likely to have certain birth defects, many of which are genetic disorders. These may be done in the first or second trimesters, and if positive, they may be followed up with diagnostic testing and/or ultrasound. If there is a family history of cancer, the clinician may order confirmatory genetic testing, which again, is not the same as blood-based cancer screening.

Myth #3: I had a normal or negative result the last time I got screened, so I don’t ever need to get screened again.

Screening is to be done in certain intervals depending on what you are getting screened for and what technique is being used for screening. It also depends on the risk factors and the healthcare provider’s recommendations. For example, if someone with no family or personal history of cancer was screened for colorectal cancer via colonoscopy and received a negative result, their next screening will likely be after 10 years. However, if the same person was screened via a stool-based test such as a fecal immunochemical test (FIT) and received a negative result, they will need to get screened again the following year1. Similarly, if you undergo blood-based cancer screening, you will need to rescreen based on your healthcare provider’s recommendation.

Myth #4: Drawing multiple tubes of blood will harm my health.

Until I learned that this was a concern for my fellow passenger, I didn’t realize that this was a common concern for patients. Most healthy adults can tolerate losing up to 14% of their blood without any physical effect2. However, blood draws in healthy adults should not exceed 3% of the total blood volume3. For instance, a normal adult weighing 70 kgs (155 pounds) has approximately 5.5 liters (5500 ml) of blood. It is safe to draw up to 165 ml of blood from this person. Most tubes of blood carry about 10 ml of blood. Drawing 10 tubes of blood would mean drawing 100 ml. Hence, drawing a few tubes of blood is harmless in most cases.

Myth #5: I had an abnormal or positive test result. There must be something wrong with me.

Screening tests, blood or otherwise, are usually never 100% sensitive or specific, and there is room for false positives and false negatives. A positive screening result must always be followed by a diagnostic test for confirmation.

Blood-based screening is the screening option that patients prefer today4 because it fits right into patients’ schedules and breaks through barriers of screening since it does not require any special preparation, and people don’t have to take another day off work. In the long run, this will help increase adherence and improve compliance to screening, which is a major goal of the US Department of Health and Human Services’ Healthy People 2030.

I am glad that I had this conversation with my fellow passenger in the airplane, as this opened my eyes to what misconceptions people may have when it comes to blood-based screening.

On January 11, 2023 MPC Therapeutics (MPC Tx), a Swiss biotechnology company focused on metabolism and rejuvenation, reported the closing of its CHF 1.5 million seed-funding round (Press release, MPC Therapeutics, JAN 11, 2023, View Source [SID1234626193]). Funds will serve to advance MPC Tx’s proprietary small molecule towards clinical trials and open new therapeutic applications. The funding round was led by Plutus Investment Group, a London-based family office, and received additional funding from business angels.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

MPC Therapeutics spun-off from University of Geneva (UNIGE) in 2018 to develop molecules able to modulate mitochondrial function and trigger cellular re-programming to fight cancer and degenerative diseases. Based on the pioneering work of Prof. Jean-Claude Martinou, the company was able to screen, optimize and patent small molecule compounds which specifically inhibit the Mitochondrial Pyruvate Carrier (MPC).

Improving cell immunotherapies against cancer

The MPC Tx’s lead program aims to improve the performance and durability of CAR-T cell therapy. Preparation of CAR-T cells in the presence of the MPC Therapeutics’ compound have been shown in different preclinical cancer models to dramatically improve survival compared to standard CAR-T cells.

Raphaël Martinou, CEO and co-founder of MPC Therapeutics said: "CAR-T cell therapies give hope to patients that failed to respond to earlier cancer treatments, yet too often these patients still relapse one year after CAR-T cell therapy. Reprogramming T-cells by modulating their metabolism could really transform sub-optimal treatments into highly performing life-saving ones."

Towards a 2024 clinical trial and diversification in alopecia

The seed investment funding will enable MPC Tx to advance its T-cell therapy adjuvant programme into the clinic by 2024. In addition, as modulating mitochondrial function has been shown to promote stem cell proliferation, the team plans to position its proprietary molecules as novel treatments for alopecia.

Mohammed Jamal, CEO and founder of Plutus Investment Group, said "We are happy to have invested in MPC Therapeutics, this expands our reach into life sciences. MPC Therapeutics have world-class expertise and can become a leading biotech in the rapidly-growing cell therapies and cell rejuvenation markets."

On January 11, 2023 Takeda (TSE:4502/NYSE:TAK) reported that EXKIVITY (mobocertinib) has been approved by the National Medical Products Administration (NMPA) of China for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) Exon20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy (Press release, Takeda, JAN 11, 2023, View Source [SID1234626192]). EXKIVITY has shown clinically meaningful and durable responses in patients with locally advanced or metastatic EGFR Exon20 insertion+ NSCLC and is now the first and only treatment available for this patient population in China. EXKIVITY, an oral tyrosine kinase inhibitor designed to target Exon20 insertions, was reviewed as part of the NMPA’s Breakthrough Therapy program. Full approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The approval of EXKIVITY in China for patients with locally advanced or metastatic EGFR Exon20 insertion+ NSCLC was only possible through dedicated collaboration and support from the NMPA and the Chinese government," said Awny Farajallah, Head, Global Medical Affairs Oncology, Takeda. "Lung cancer is a devastating disease, and we know the discovery and delivery of precision medicines like EXKIVITY to target cancer types that are hard-to-treat have the potential to improve patient outcomes. We are thrilled to introduce EXKIVITY in China as the second lung cancer therapy from Takeda and remain committed to research and development to meet the needs of this patient community."

Lung cancer is the most commonly diagnosed cancer in China, and NSCLC accounts for approximately 85% of all lung cancer cases in the country.1 Of those patients diagnosed with EGFR-mutated NSCLC in China, up to 10% harbor Exon20 insertions.2-7 Despite this prevalence, patients in China have lacked a targeted treatment option designed to address cancers driven by these mutations.

"Since the discovery of EGFR mutations nearly twenty years ago, patients with Exon20 insertions have been waiting for a targeted therapy to treat their disease," said Sean Shan, President of Takeda China. "The approval of EXKIVITY in China is a remarkable breakthrough, demonstrating the strong commitment of the Chinese government to encourage and accelerate the introduction of innovative therapies. EXKIVITY offers a targeted, oral therapy to a population that has been historically underserved, and this approval brings us one step closer to defeating this complex and heterogeneous disease for patients in this region."

This approval is based on the results from the platinum-pretreated population in the Phase 1/2 trial of EXKIVITY, which consisted of 114 patients with EGFR Exon20 insertion+ NSCLC who received prior platinum-based therapy and were treated at the 160 mg dose. Results demonstrated a confirmed ORR of 28% per IRC as well as a median DoR of 15.8 months per IRC, a median overall survival (OS) of 20.2 months and a median progression-free survival (PFS) of 7.3 months per IRC. The most common treatment-related adverse reactions (TRAEs) were diarrhea (92%), rash (46%), paronychia (38%) and decreased appetite (37%).

About EXKIVITY (mobocertinib)

EXKIVITY is a first-in-class, oral tyrosine kinase inhibitor (TKI) specifically designed to selectively target epidermal growth factor receptor (EGFR) Exon20 insertion mutations.

EXKIVITY is currently approved in the United States, Great Britain, Switzerland, South Korea, Australia and China for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR Exon20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy.

For more information about EXKIVITY, visit View Source For the Prescribing Information, including the Boxed Warning, please visit View Source

About EGFR Exon20 Insertion+ NSCLC

Non-small cell lung cancer (NSCLC) is the most common form of lung cancer, accounting for approximately 85% of the estimated 2.2 million new cases of lung cancer diagnosed each year worldwide, according to the World Health Organization.9, 10 Patients with epidermal growth factor receptor (EGFR) Exon20 insertion+ NSCLC make up approximately 1-2% of patients with NSCLC, and the disease is more common in Asian populations compared to Western populations.2-6 This disease carries a worse prognosis than other EGFR mutations, as EGFR TKIs – which do not specifically target EGFR Exon20 insertions – and chemotherapy provide limited benefit for these patients.

Takeda is committed to continuing research and development to meet the needs of the lung cancer community through the discovery and delivery of transformative medicines.

EXKIVITY IMPORTANT SAFETY INFORMATION

QTc Interval Prolongation

Heart rate-corrected QT (QTc) interval prolongation, including resultant life-threatening arrhythmias, such as Torsades de Pointes, occurred in patients treated with mobocertinib.

A concentration-dependent QTc interval prolongation of approximately 12.7 msec (90% CI: 8.69, 16.8) was observed at the steady-state Cmax following 160 mg daily doses based on an analysis of data from 194 patients with advanced solid malignances.

Clinical trials of mobocertinib did not enroll patients with baseline QTc greater than 470 msec. Assess QTc and electrolytes at baseline and correct abnormalities in sodium, potassium, calcium, and magnesium prior to initiating mobocertinib. Monitor QTc and electrolytes periodically during treatment. Increase monitoring frequency in patients with risk factors for QTc prolongation, such as in patients with congenital long QTc syndrome, heart disease, electrolyte abnormalities, or those who are taking medicinal products known to prolong the QTc interval. Avoid concomitant use of medicinal products which are known to prolong the QTc interval. Avoid concomitant use of strong or moderate CYP3A inhibitors with mobocertinib, which may further prolong the QTc interval. Permanently discontinue mobocertinib in patients who develop QTc interval prolongation with signs or symptoms of life-threatening arrhythmia.

Interstitial Lung Disease/Pneumonitis

Severe, life-threatening, and fatal interstitial lung disease (ILD)/pneumonitis have occurred in patients treated with mobocertinib.

Withhold mobocertinib for acute onset of new or progressive unexplained pulmonary symptoms such as dyspnea, cough, and fever pending diagnostic evaluation and diagnosis confirmation. Permanently discontinue mobocertinib if ILD/pneumonitis is confirmed.

Cardiac Toxicity

Cardiac failure (including congestive cardiac failure, decreased ejection fraction, and cardiomyopathy) has occurred in patients treated with mobocertinib.

Mobocertinib can cause QTc prolongation resulting in Torsades de Pointes.

Atrial fibrillation (1.3%), ventricular tachycardia (0.3%), first degree atrioventricular block (0.7%), second degree atrioventricular block (0.3%), left bundle branch block (0.3%), supraventricular extrasystoles (0.3%) and ventricular extrasystoles (0.3%) also occurred in patients receiving mobocertinib. The causality of these events to mobocertinib has not been established.

Conduct cardiac monitoring, including assessment of left ventricular ejection fraction at baseline and during treatment. Patients who develop signs and symptoms consistent with cardiac failure should be treated as clinically indicated. Withhold, reduce the dose, or permanently discontinue mobocertinib based on the severity.

Diarrhea

In clinical studies, most patients experienced mild to moderate diarrhea. Diarrhea can be severe or life threatening. The median time to first onset of diarrhea was five days but could occur as soon as 24 hours after administration of mobocertinib. Diarrhea is usually transient and had a median time to resolution of three days. Prolonged diarrhea may lead to dehydration or electrolyte imbalance, with or without renal impairment.

Early and compliant diarrhea management such as prescribed anti-diarrheal medicinal products (e.g., loperamide), diet, adequate fluid intake (~2L clear liquids per day), and patient education is recommended. Instruct patients to have anti-diarrheal medicinal products (e.g., loperamide) readily available. Begin anti-diarrheal treatment at the first episode of poorly formed or loose stools or the earliest onset of bowel movements more frequent than normal. In mobocertinib clinical trials where loperamide was used as the antidiarrheal, the dosage regimen for loperamide was 4 mg at the first bout of diarrhea and then 2 mg every 2 hours until the patient is diarrhea-free for at least 12 hours; daily dose of loperamide did not exceed 16 mg. If using loperamide as the antidiarrheal treatment, refer to loperamide product labeling for additional information.

If diarrhea does not improve or additional signs or symptoms are reported, standard medical practice intervention, including other anti-diarrheal medications, are recommended. Antidiarrheal prophylaxis may be considered as needed. Monitor electrolytes and instruct patients to increase fluid and electrolyte intake as needed. No dose modification is necessary unless the patient does not tolerate mobocertinib or the symptoms recur, or the diarrhea doesn’t resolve with medical intervention. Interrupt mobocertinib and reduce subsequent doses if severe diarrhea occurs.

Embryo-Fetal Toxicity

Based on its mechanism of action and data from animal studies, mobocertinib can cause fetal harm when administered to pregnant women.

Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective non-hormonal contraception during treatment with mobocertinib and for one month following the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with mobocertinib and for one week following the final dose of mobocertinib.

On January 11, 2023 Paige reported a collaboration with Microsoft to apply the power of artificial intelligence (AI) to digital pathology images to develop and deliver a new generation of clinical applications and computational biomarkers to transform cancer diagnosis and patient care (Press release, Paige AI, JAN 11, 2023, View Source [SID1234626191]). Microsoft will also make a strategic investment in Paige to accelerate the development and deployment of life-saving AI diagnostics.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Through the collaboration, Paige and Microsoft will scale Paige’s technology globally and accelerate the adoption of AI in digital pathology.

Paige will use Microsoft Azure as its cloud provider for the Paige Platform, a comprehensive solution to power a lab’s digital pathology workflow that consists of data management, cloud storage options and FullFocus, an FDA-cleared whole-slide image viewer. As part of this collaboration, Paige will become a Microsoft Cloud for Healthcare partner and enable Microsoft to enhance its own offerings for healthcare customers.

Clinical AI applications have the potential to help pathologists diagnose cancer more confidently and efficiently, with the ultimate goal of improving patient care. Paige, a global leader in end-to-end digital pathology solutions and clinical AI applications, is currently the only company to have received FDA approval for an AI algorithm in pathology. Paige puts the power of AI into the hands of pathologists by developing novel AI applications on a powerful platform, making it easy to deploy AI in laboratories globally.

Paige will work with other entities, including Microsoft Research on developing large scale machine learning models to push the boundaries of research in oncology and pathology. Paige is also working with Nuance, a Microsoft company, on integrating their offering with Nuance’s Precision Imaging Network.

"We are thrilled to partner with Microsoft to make AI cancer diagnostics accessible to countless laboratories and hospitals around the world as part of the digital transformation of pathology," said Andy Moye, Ph.D., Chief Executive Officer at Paige. "We believe that Microsoft’s world-class AI resources, cloud infrastructure, global reach and scale, combined with our deep expertise in developing AI cancer diagnostics, will drive a new era of diagnostics and precision treatment to improve the lives of patients."

"The application of technology to help clinicians and researchers further enhance patient care and, in many cases, provide life-saving treatment is a core tenet for Microsoft in health and life sciences," said Tom McGuinness, corporate vice president, Global Healthcare & Life Sciences, Microsoft. "We look forward to further collaborating with Paige and giving Microsoft Cloud for Healthcare customers the ability to harness the power and promise of AI in digital pathology."

Paige technology will be offered as a partner solution in Microsoft Cloud for Healthcare, expanding access to cutting-edge digital cancer diagnostic tools. Microsoft Cloud for Healthcare connects customers with trusted partner solutions that make it easier to create personalized patient experiences, give clinicians connected tools, and adopt data standards important to healthcare. Together with Nuance, healthcare organizations can access the broadest and deepest set of trusted AI solutions to address the biggest challenges in the industry. Paige becoming a Microsoft Cloud for Healthcare partner extends the solution’s robust capabilities and helps Paige reach new customers.

On January 11, 2023 Oncopeptides AB (publ.) (Nasdaq Stockholm: ONCO), a biotech company focused on research and development of therapies for difficult-to-treat hematological diseases, reported that the Company has appointed Holger Lembrer as Chief Financial Officer, CFO. Prior to joining Oncopeptides Holger Lembrer was Business Unit CFO at Assa Abloy, and before that Investor Relations Officer, and Financial Controller (Press release, Oncopeptides, JAN 11, 2023, View Source [SID1234626190]). He has also been a Senior Auditor at Ernst & Young. Holger Lembrer will assume his new position before the end of February 2023 and will replace Annika Muskantor who has been interim CFO since November 1, 2021.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"I am very pleased that Holger Lembrer has decided to join Oncopeptides, and really look forward to working together with him," says Monica Shaw, CEO of Oncopeptides. "His combined expertise from leading financial roles, in a highly recognized, publicly traded, international Company, will be a great asset for Oncopeptides and its Leadership Team."