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MedNess: bite-size biopharma and medtech news

1st September, 2020
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MedNess This Week
HIGHLIGHTS
Our Sponsors
Onco I-Analyse
FDA approves FoundationOne Liquid CDx, a comprehensive pan-tumour liquid biopsy test
FoundationOne Liquid CDx is an FDA approved in-vitro diagnostic qualitative test based on next-generation sequencing to analyse 324 genes. This test uses samples taken as a simple blood draw (as opposed to the more invasive tumor biopsies) from advanced cancer patients, derives plasma, and isolates circulating cell-free DNA (cfDNA) for use with targeted high throughput hybridisation-based capture technology. The approval was based on analytical and clinical validation studies comprising 7.5K samples & 30K unique variants across from 30 different cancer types. The test demonstrated high precision and specificity and was able to detect even low allele frequencies that are often the case with clinical blood samples.
It is a companion diagnostic to identify BRCA1/2 rearrangements, TMB, MSI instability, and other aberrations like NTRK fusions to help physicians find the best therapeutic options for such patients. FoundationOne Liquid CDx can also identify NSCLC and mCRPC patients who may benefit from treatment with respective targeted therapies (RUBARCA for mCRPC patients with BRCA1, BRCA2 alterations and IRESSA, TAGRISSO & TARCEVA for NSCLC patients with EGFR Exon 19 deletions and EGFR Exon 21 L858R substitution) in accordance with the drug labels.
The use of this diagnostic test does not guarantee that a patient will be matched to a corresponding therapy - the use is limited to the detection of aberrations; however, even the detection part comes with a clause. As per the accompanying FoundationMedicine press release, a negative test does not remove the presence of an alteration. In case of a negative test report, the patients are suggested to get further confirmation by tumor tissue testing and mutation status. Nevertheless, the test remains a significant advancement in the area of biomarker testing as it removes the need of testing for individual biomarkers at one time thus saving crucial time during treatment. 
FoundationOne Liquid CDx is the second comprehensive genomic profiling (CGP) test from this company, which in 2017 launched a tissue-based CGP test called FoundationOne®CDx for patients with solid tumours. 
Collated by : Shilpa Rawal, PhD
Drug Approvals
KEYTRUDA Approved in Japan for Patients With PD-L1+ve chemo-treated ESCC and for a Six-Week Dosing Schedule Across All Adult Indications
“We remain committed to improving outcomes for as many patients with cancer as possible, including those with esophageal squamous cell carcinoma, which is a leading cause of cancer-related death in Japan,” said Dr. Jonathan Cheng, vice president, oncology clinical research, Merck Research Laboratories. “With today’s approvals, specific patients with esophageal cancer can receive a much-needed new treatment option, and adult patients receiving KEYTRUDA will now have the option of a dosing schedule that reduces how often they are at the clinic for treatment.”
Regulatory News
Tepotinib’s NDA filed based on Ph 2 VISION trial in METex14 NSCLC patients; Priority Review granted for evaluation under FDA Real-Time Oncology Review (RTOR) pilot program
“METex14 skipping alterations drive a particularly aggressive form of NSCLC in a patient population that is generally elderly, facing poor clinical prognosis and in urgent need of new therapeutic options,” said Luciano Rossetti, Global Head of Research & Development for the Biopharma business of Merck KGaA, Darmstadt, Germany. “With this acceptance and review under the RTOR program, we look forward to working with FDA and to making this precision medicine available to patients in the U.S. as soon as possible.”
sNDA submitted to FDA for CABOMETYX® (cabozantinib) + Opdivo® (nivolumab) for Advanced RCC based on the Ph 3 pivotal CheckMate -9ER trial
“We are excited to complete our first regulatory submission for CABOMETYX in combination with an immune-checkpoint inhibitor based on the positive results from the CheckMate -9ER phase 3 pivotal trial, which showed a statistically significant and clinically meaningful benefit in the key efficacy measures of progression-free survival, overall survival and objective response rate for patients with previously untreated kidney cancer,” said Gisela Schwab, M.D., President, Product Development and Medical Affairs and Chief Medical Officer, Exelixis. “We expect that, if approved, the combination of CABOMETYX and Opdivo will be an important new first-line treatment regimen for RCC patients who need additional therapeutic options that extend survival. We look forward to continuing to work closely with Bristol Myers Squibb and the FDA through the regulatory review process.”
Fast-Track Designation Granted for Repotrectinib in NTRK-Positive TKI-Pretreated Advanced Solid Tumors
“We believe repotrectinib has the potential to make a meaningful difference in the lives of cancer patients with ROS1- or NTRK-driven tumors and are pleased to receive our third Fast-Track designation that may help expedite its development,” said Athena Countouriotis, M.D., president and chief executive officer. “NTRK-driven cancers are estimated to occur in up to 50,000 patients annually, however there are currently no approved therapies for those patients previously treated with another TRK TKI.”
Melfulfen’s NDA filed based on Ph 2 HORIZON trial in triple-refractory RRMM patients; Priority Review granted; PDUFA: Feb 2021
“This is very exciting news. It is an important milestone for Oncopeptides, and a major step in making melflufen available for patients with multiple myeloma, who desperately need new treatment options”, says Marty J Duvall, CEO of Oncopeptides AB. “I am looking forward to a continuing dialogue with the FDA while we make the product available to RRMM patients in the US through an expanded access program, in an FDA approved trial called sEAPort.”
Trial Results
FAILED TRIAL: Ph 3 IDHENTIFY study of IDHIFA® (enasidenib) did not meet the primary endpoint of OS in R/R AML patients with IDH2 mutation
“While we are disappointed by the outcome of the IDHENTIFY study, we remain confident in IDHIFA’s established role as a treatment option for patients with relapsed or refractory AML with an IDH2 mutation and are grateful to all those who participated in the study,” said Noah Berkowitz, M.D., Ph.D., senior vice president, Global Clinical Development, Hematology, Bristol Myers Squibb. “AML is one of the most difficult-to-treat blood cancers, and we’re committed to furthering our research and improving on the standards of care for patients living with this aggressive disease.”
FAILED TRIAL: Ph 3 INSPIRE Trial of IV rigosertib did not meet primary endpoint of significantly improved survival versus best supportive care in higher-risk MDS
“Onconova would like to thank the MDS community for its participation in the INSPIRE trial. We report these results with great disappointment, and we remain deeply indebted to every patient, physician, and family member involved in the study,” said Steven M. Fruchtman, M.D., President and Chief Executive Officer. “Onconova is fortunate to have built a product pipeline that includes multiple promising agents, including oral rigosertib and ON 123300. Both compounds target meaningful cancer pathways, and we look forward to further efforts with these programs. The Company will review pipeline and in-licensing opportunities both internally and with external advisors.”
Click Here for more on Trial Results
Trial/Program Status
Ph 2 trial to Evaluate the Combination of TAVO + OPDIVO® as Neoadjuvant Therapy for Melanoma initiated
"Patients with locally/regionally advanced melanoma present a major challenge for surgical and medical management," said Dr. Tarhini, who is Director, Cutaneous Clinical & Translational Research and Senior Member in the Departments of Cutaneous Oncology and Immunology at H. Lee Moffitt Cancer Center & Research Institute.  "Following surgical treatment, these patients continue to have a high risk of relapse and death despite the use of standard adjuvant therapy.  Neoadjuvant therapy with an effective immunotherapeutic agent, such as TAVO, combined with the anti-PD-1checkpoint inhibitor nivolumab, has the potential to improve overall outcomes such as operability, pathologic tumor response and long-term disease control.  This, combined with the excellent safety and tolerability profile TAVO has demonstrated with hundreds of patients to-date, leaves me very encouraged and eager to evaluate TAVO-nivolumab combination treatment in the neoadjuvant setting."
First Patient Dosed in Ph 2 IRENE Study of Pelareorep-anti-PD-1 Combination Treatment in TNBC
Principal investigator Mridula George, M.D., Medical Oncologist, Rutgers Cancer Institute of New Jersey and Assistant Professor of Medicine, Rutgers Robert Wood Johnson Medical School, commented, "The paucity of treatment options in metastatic triple-negative breast cancer combined with its aggressive clinical behavior results in a poorer prognosis when compared to other subtypes of breast cancer. This is an exciting study to evaluate the role of immunomodulation in the tumor microenvironment as a treatment option. I'm looking forward to getting this study underway to potentially make an impact in the lives of patients affected with metastatic triple-negative breast cancer."
Click Here for more on Trial Status
Collated by : Richa Tewari, PhD
MedNess Reviews
Abbvie and Harvard Team Up to Find Therapeutics for Emergent Viral Infections
Abbvie and Harvard University recently announced a $30 million collaborative research alliance for the study and development of novel therapies against emergent viral infections. The deal particularly focuses on infections caused by coronaviruses and viruses that lead to hemorrhagic fever. The multi-pronged effort at Harvard Medical School aims to integrate fundamental biology into preclinical and clinical development of new therapies.
Abbvie will provide $30 million over the next three years and additional in-kind support by providing scientific expertise to advance collaborative research and early-stage technology development efforts across five areas namely, immunity and immunopathology, host targeting for antiviral therapies, antibody therapeutics, small molecules and translational development
This collaboration aims to accelerate therapeutic development and be better prepared for future outbreaks.
Researchers Aim to Build Rapid Saliva Test for Detecting Heart Attack
According to preliminary research presented at the ESC Congress 2020, a saliva test could possibly fast track heart attack diagnosis.
Typically in the case of a heart attack, emergency room clinicians scan the chest for signs using either an ultrasound or an electrocardiogram, or send away for a blood test that could take an hour or more. 
Now, the researchers have shown it may be possible to detect potentially severe heart damage in less than 10 minutes using only a saliva sample and are aiming to build a tailor-made test to do it.
The researchers hypothesized that the heart protein troponin, which is released into the bloodstream by the cardiac muscle after suffering from a lack of oxygen due to a blocked artery could also make its way to the saliva.
By filtering out the most common proteins found in saliva and concentrating the remainder, the researchers were able to detect 84% of positive samples, taken from 32 patients hospitalized with a heart injury. Similar samples from healthy volunteers showed no response to the test.
Medness Business
Onco-News

Bayer and Northpond Ventures Lead USD $55 Million Series A Financing Round for Triumvira Immunologics
"As a co-founder of Triumvira, Bloom Burton is thrilled to see a strong syndicate of investors commit to advancing Triumvira’s novel TAC technology," said Brian Bloom, Chairman & Chief Executive Officer of Bloom Burton & Co. "The execution of Triumvira’s Series A funding further demonstrates Bloom Burton’s unique position to invest in life sciences in Canada and beyond our border."
Seattle Genetics to Receive Milestone Payment Under ADC Collaboration with GSK Following EU Approval of BLENREP (belantamab mafodotin)
“This is the second collaborator program utilizing our ADC technology to receive European Commission approval in 2020, and rapidly follows the FDA approval of BLENREP earlier this month, highlighting the potential of these novel therapies in the treatment of cancer patients globally,” said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. “Our ADC collaborator progress, along with the growth of Seattle Genetics’ marketed ADCs, ADCETRIS and PADCEV, and recent positive results of tisotumab vedotin from our ADC pipeline, underscore our leadership in ADCs to treat cancer.”
Collated by : Richa Tewari, PhD
Bio-Pharma and MedTech
Nestle acquires Aimmune Therapeutics for $2.6 billion, bagging first in class peanut allergy drug
On August 31st 2020, Nestle S.A. (Nestle; Vevey, Switzerland) announced its commitment to acquire Aimmune Therapeutics (Aimmune, Brisbane, CA) in a $2.6 billion deal for Aimmune’s peanut allergy drug, PALFORZIA®. PALFORZIA® the first and only approved drug to treat peanut allergy, is a peanut allergen powder and an oral immunotherapy that can mitigate anaphylaxis through dose escalation. It is approved for patients aged 4 to 17.
“Delivering PALFORZIA, the world’s first treatment for food allergy, is a game-changing proposition in the biopharmaceutical industry and is transformative for the lives of millions of people living with potentially life-threatening peanut allergy...This acquisition provides strong value for our shareholders and ensures a level of support for PALFORZIA and our pipeline that will further enhance their potential for patients around the world living with food allergies. Aimmune appreciates the continued strong collaboration with Nestlé Health Science dating back to 2016 through their support as a shareholder and board member, as well as through their consumer/nutrition strength and experience. Their extensive capabilities and global reach, as well as their alignment with our vision of pioneering treatments and solutions for food allergies, are a strong fit for our company.”- Jayson Dallas, MD, President and Chief Executive Officer of Aimmune.
Athira Pharma files $100 million IPO to fuel its neuronal regenerative therapy through Phase III clinical trials in Alzheimer’s
On 28th August 2020, news came in that Seattle-based Athira Pharma (Athira) has filed an IPO of $100 million to  pivotal trials of its neuronal regenerative molecule, ATH-1017, in Alzheimer’s disease. ATH-1017 is a small molecule targeting hepatocyte growth factor (HGF) and its receptor MET towards natural reprogramming of neuronal connections in brain diseases like Alzheime’s and Pakinson’s. Early studies of ATH-1017 in 11 mild-moderate Alzheimer’s patients and 77 healthy individuals demonstrated at P300 latency readouts close to observed values in healthy volunteers. These results led Athira to successfully raise $85 million in series B funding in June this year.
With the cash infux post IPO, Athira plans on Phase III trials of ATH-10i7 in Alzheimer’s patients while also starting Phase II trials in Parkinson’s patients. Athira also plans for Investigational New Drug (IND) studies for neuropsychiatric prospect ATH-1019 and neuropathy treatment ATH-1018.
It is interesting to note that Athira went IPO with no commercial sales from any of its products. In the mired field of Alzheimer’s treatment, Athira presents a novel therapeutic alternative to the well-studied, but failed, Beta amyloid class of drugs; and is banking heavily on the performance of its HGF/MET agonist.
Collated by : Divyaanka Iyer
Click Here for more news and details on mergers, acquisitions and business updates
Editors' Desk
Richa Tewari, PhD
Oncology News
Esha Sehanobish, PhD
MedNess Plus
Arundithi Ananthanarayanan
MedNess Reviews
Tanmoy Samaddar
MedNess Reviews
Divyaanka Iyer
BioPharma News
Debarati Banik
HealthIT
Abhi Dey
Consulting Editor
Shilpa Rawal, PhD
Onco-I-Analyse
Nisha Peter, PhD
Managing Editor
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Content Editors: Richa Tewari , Esha Sehanobish , Divyaanka Iyer, Arundithi Ananthanarayanan, Debarati Banik, Tanmoy Samaddar, Mayur Vadhvani and Abhinav Dey 
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