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MedNess: bite-size biopharma and medtech news

19th August, 2020
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HIGHLIGHTS
Our Sponsors
Onco I-Analyse
Umbralisib’s NDA for MZL/FL has been accepted by the US FDA with a Priority Review for MZL and Standard Review for FL
On 13th August, TG Therapeutics announced that the FDA has accepted an NDA for Umbralisib, a dual PI3K-delta and CK1-epsilon inhibitor, for previously treated MZL/ FL patients. Given the Breakthrough Therapy Designation granted by the FDA to umbralisib in January 2019, the review application for MZL has been granted priority review with PDUFA date of February 15, 2021. The FL indication, on the other hand, will undergo standard review with PDUFA date of June 15, 2021.
The NDA was based on data from umbralisib monotherapy MZL and FL cohorts of the phase 2b UNITY-NHL trial. The trial evaluated MZL patients with at least one prior anti-CD20 based regimen and FL patients with at least two prior systemic therapies, including an anti-CD20 regimen and an alkylating agent. In 2019, both cohorts had met the primary endpoint of ORR, meeting the Company’s target guidance of 40-50% ORR. Data from the cohorts will be presented at ASH 2020 medical conference.
In June 2020, TG Therapeutics completed rolling submission of the NDA requesting accelerated approval for Umbralisib in R/R MZL and FL. The FDA also notified the Company that it is not currently planning to hold an advisory committee meeting to discuss this application, which is regarded as a positive signal from the agency.
A commercial launch for the MZL and FL indications could come in 1Q21 and 3Q21, respectively with an expanding pool of ~23k new and ~6-10k R/R patients.
Collated by : Shilpa Rawal, PhD
Drug Approvals
TUKYSA® (tucatinib) Approved Within Months for All Countries Participating in FDA’s Project Orbis Initiative
“The rapid approval of concurrent global reviews under FDA’s Project Orbis for TUKYSA will allow for accelerated market entry of this new best-in-class treatment to HER2-positive breast cancer patients in need,” said Clay Siegall, Ph.D., Chief Executive Officer at Seattle Genetics. “As our company continues to expand globally, we look forward to bringing TUKYSA to patients around the world.”
Regulatory News
FDA grants Fast Track Designation for XMT-1536 for the Treatment of Patients with Platinum-resistant Ovarian Cancer
“We are very encouraged by the FDA’s decision to grant us Fast Track Designation for our lead program XMT-1536, which has shown very encouraging activity and tolerability in our Phase 1 study in ovarian cancer to date. We believe this recognition underscores the high unmet medical need for a treatment for patients with platinum-resistant ovarian cancer,” said Anna Protopapas, President and Chief Executive Officer of Mersana Therapeutics. “With this designation in hand, we plan to be able to quickly advance through the administrative steps of XMT-1536’s development and bring forth a therapy for these patients as soon as possible.”
Trial Results
RWE confirms sequential Gilotrif® followed by osimertinib provided a mOS of nearly four years in U.S.-treated patients with EGFR mutation-positive NSCLC
“Developing resistance to EGFR TKIs is, unfortunately, an expected outcome for many people with this specific lung cancer, and strategies for sequencing treatments continue to evolve with the use of TKIs in clinical practice,” said Balazs Halmos, M.D., Chief of Thoracic/Head and Neck Oncology at Montefiore Medical Center. “These real-world data provide further insight into the overall survival associated with afatinib and subsequent osimertinib treatment and reinforce that previous findings may have application in the U.S. treatment setting for patients with T790M acquired resistance.”
Ph 3 CheckMate-577 trial of Adjuvant Opdivo in Resected Esophageal or GEJ Cancer Meets Primary Endpoint of DFS improvement
“Approximately 50% of patients with esophageal or gastroesophageal junction cancer who undergo neoadjuvant chemoradiation therapy followed by tumor resection will have disease recurrence within four years, and among those who do not respond completely to neoadjuvant treatment, recurrence will occur sooner,” said Ronan J. Kelly M.D., MBA, Director of the Charles A. Sammons Cancer Center at Baylor University Medical Center. “Medical oncologists have had limited to no treatment options to offer esophageal cancer patients who undergo neoadjuvant chemoradiation therapy followed by surgery and fail to demonstrate a complete pathological response. For the first time, we have a potential therapeutic option with nivolumab in the adjuvant setting for these patients.”
Ph 3 CheckMate-649 Trial of Opdivo + Chemo vs. Chemo Meets Primary Endpoints Demonstrating Superior OS/PFS in 1L Treatment of Gastric and Esophageal Cancers
“There is an urgent need to improve therapeutic options for patients with esophageal and stomach cancer. Responses to the current standard chemotherapy in patients are short lived, and less than 6% of patients with metastatic disease survive beyond five years,” said Yelena Y. Janjigian, M.D., Principal Investigator, Chief, Gastrointestinal Oncology, Memorial Sloan Kettering Cancer Center. “Immunotherapy helped transform how we care for our patients across different tumor types, and the encouraging results from CheckMate -649 represent a new opportunity to improve survival for patients beyond standard chemotherapy.”
Click Here for more on Trial Results
Trial/Program Status
DSMC completes second interim analysis in ongoing Ph 3 OVAL trial of ofranergene obadenovec (VB-111) in platinum-resistant ovarian cancer patients; recommends continuation
"We are pleased by the DSMC recommendation to continue the OVAL trial as planned," said Dror Harats, MD, Chief Executive Officer of VBL Therapeutics. "This is the second successful analysis in the OVAL study, which reviewed unblinded overall survival data comparing VB-111 to placebo. The OVAL study continues to show strong recruitment despite the COVID-19 pandemic, and we are very encouraged by the high response rate of over 50% of the trial participants, which has been maintained. This latest DSMC recommendation, together with the remarkable response rate observed in our first interim efficacy analysis and the survival benefit seen in the Phase 2 trial of VB-111 in patients with platinum-resistant ovarian cancer, support the confidence we have in OVAL. We are excited to advance VB-111 for the potential benefit of ovarian cancer patients."
First Patient Dosed in Ph 1/2a trial of VB10.NEO + Bempegaldesleukin (NKTR-214) in SCCHN Patients
"We're pleased to advance our collaboration with Vaccibody to evaluate the potential of bempeg given with a personalized vaccine, VB10.NEO, in patients with advanced head and neck cancer," said Jonathan Zalevsky, Ph.D., Chief Research & Development Officer at Nektar. "The rationale for this clinical study is supported by our promising preclinical data which demonstrated how a personalized cancer vaccine and a T cell proliferator can work synergistically to induce maximal expansion of vaccine-induced T cell clones, provide deep and durable responses and, at the same time, offer specific anti-tumor immunity."
First Patient Dosed in Amended Stage 2 of the Ph 2 Trial of Prexigebersen in AML patients
“Despite recent advances in the field, AML continues to be a challenging malignancy with unmet medical need as most patients unfortunately eventually succumb to their disease. The potential for prexigebersen in combination with new standard of care treatments seems particularly promising. We look forward to the execution of this trial and, hopefully, to bringing another tool to bear in the fight against this deadly disease,” said Jorge Cortes, M.D., Director of the Georgia Cancer Center and Chairman of the Bio-Path Scientific Advisory Board.
Collated by : Richa Tewari, PhD
MedNess Reviews
FDA approves rapid, inexpensive saliva test for coronavirus
In a big push to rapid, easy, and inexpensive testing of the COVID-19 testing, FDA issued an emergency use authorization (EUA) to Yale School of Public Health for its SalivaDirect COVID-19 diagnostic test, which uses a new method of processing saliva samples for COVID-19 infection testing.
The test was developed by a team led by Nathan Grubaugh and Anne Wyllie of Yale School of Public Health in partnering with the National Basketball Association and National Basketball Players Association.
Instead of relying on nasopharyngeal specimens, SalivaDirect does not require any special type of swab or collection device rather any sterile container can be used to collect a saliva sample. The test requires no separate nucleic acid extraction step. This is of importance because in the extraction kits used for this step in other tests have been prone to shortages in the past and hence limit the number of tests that can be performed. Besides, the SalivaDirect methodology has been validated and authorized for use with different combinations of commonly used reagents and instruments thus enabling most high-complexity labs to perform the test.
“Official data shows 88-94% [sensitivity]. If you assume 90% sensitivity, this is the best accuracy (sensitivity) of any saliva test,” Andy Slavitt, a former acting administrator of the Centers for Medicare and Medicaid Services in the Obama administration tweeted.
Yale intends to provide the SalivaDirect protocol as an “open source” protocol to all interested laboratories, provided they comply with the conditions of authorization in the EUA. Since the test does not depend on any proprietary equipment from Yale and can use a variety of commercially available testing components, it can be assembled and used in high-complexity labs throughout the country.
In the eight months of the pandemic, U.S. and other countries have struggled to test large number of people quickly and efficiently using a reliable test that is also inexpensive. The FDA emergency use authorisation has therefore been welcomed by public health experts.
Collated by : Tanmoy Samaddar
Medness Business
Onco-News

Bristol-Myers Squibb licensed its fourth TriNKET™ immunotherapy drug candidate from Dragonfly Therapeutics
"We are impressed with the quality of candidates developed using Dragonfly's TriNKET™ technology," said Rupert Vessey, FRCP, DPhil, President of Research and Early Development, Bristol Myers Squibb. "In just three years, Dragonfly delivered four drug candidates to BMS, a remarkable pace of development.  During that time, we have assessed Dragonfly's TriNKET™ drug candidates in both cancer and autoimmune indications, and have built three collaborations together. We continue to be encouraged by the potential treatment options for patients offered by harnessing the power of NK cells."
Pieris Pharmaceuticals and Eli Lilly and Company to evaluate the safety and efficacy of PRS-343 + ramucirumab and paclitaxel for 2L HER2-positive gastric cancer in a Ph 2 study
"We have seen impressive single-agent activity in the phase 1 trial of PRS-343, including a complete response and many patients experiencing a clinical benefit, and believe there is a compelling biology and clinical rationale to adding PRS-343 to the current standard of care regimen for advanced or metastatic gastric cancer in the second line, ramucirumab and paclitaxel," said Stephen S. Yoder, President and Chief Executive Officer of Pieris. "Today's announcement further supports exploring this clinical rationale while managing costs efficiently."
Collated by : Richa Tewari, PhD
Bio-Pharma and MedTech
CureVac, the mRNA-based COVID-19 vaccine maker, plans an IPO of $216 million
On 10th August 2020, CureVac B.V. (CureVac; Tubingen, Germany) announced an initial public offering of 13,333,333 shares at an average price $15/share, with BofA Securities, Jefferies and Credit Suisse acting as underwriters for 1,999,999 shares at the same price. CureVac is a clinical stage biopharmaceutical company, which is currently in the front running for an mRNA-based SARS-CoV2 vaccine.
CureVac will use the monetary proceeds towards propelling its coronavirus vaccine through Phase 3 clinical trials, while also funding its mRNA-based Rabies vaccine (CV7202, RABV-G glycoprotein complexed with LNP) through Phase 2. The money will also be used for expanding manufacturing abilities, development of CureVac’s oncology program- CV8102 (TLR7/8/RIG-1 agonist single stranded RNA)- through Phase 2 and advancing its proprietary mRNA technology platform in other disease areas.
CureVac’s proprietary technology assembles stable mRNA sequences with customized 5’ and 3’ UTRs, and open reading frames that ensure optimal protein production, once targeted to cells in various disease indications. The platform uses Arcturus’s lipid nanoparticle technology (LNP) or CureVac’s in house developed CureVac carrier molecule (CVCM) as delivery vehicles.
CureVac’s pipeline across prophylactic vaccines, RNA-based cancer immunotherapies and protein-based therapies can be accessed here.
Sanofi plans acquisition of Principia Biopharma at $3.68 billion, taking control of Principia’s BTK inhibitor pipeline
Sanofi (Paris, France) announced the acquisition of Principia Biopharma (Principia; South San Francisco, CA) for $3.68 billion on 17th August 2020.
Principia has a strong treatment pipeline based on its proprietary Tailored Covalency® platform, that generates reversible and irreversible, covalent, small molecule inhibitors to Bruton tyrosine kinases (BTKs). This includes the brain penetrating BTK inhibitor, SAR442168, which is in phase 2 trials for multiple sclerosis (MS); the oral BTK inhibitor, Rilzabrutinib, in Phase 3 program for immune thrombocytopenia and the topical BTK inhibitor, PRN473 Topical, for immune related skin conditions. The pipeline enhances Sanofi’s core interest in autoimmune and allergic diseases.
“The addition of multiple BTK inhibitors to our pipeline demonstrates our commitment to strategic product acquisitions in our priority therapeutic areas. Full ownership of our brain-penetrant BTK inhibitor ‘168 removes complexities for this priority development program and simplifies future commercialization”- Paul Hudson, Sanofi Chief Executive Officer
“...The benefit of developing several BTK inhibitors will allow us to target specific organ systems for optimal patient benefit. The merger will provide global resources to get these novel therapies to patients faster”- Martin Babler, President and CEO at Principia Biopharma.
 
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
Ananda Ghosh, PhD
Founder
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The sponsors do not have any influence on the nature or kind of the news/analysis reported in MedNess. The views and opinions expressed in this article are those of the authors and do not necessarily reflect the official policy or position of Medness. Examples of analysis performed within this article are only examples. They should not be utilized in real-world analytic products as they are based only on very limited and dated open source information. Assumptions made within the analysis are not reflective of the position of anyone volunteering or working for Medness. This blog is strictly for news and information. It does not provide medical advice, diagnosis or treatment nor investment suggestions. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or another qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.
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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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