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MedNess: bite-size biopharma and medtech news

15th December, 2020
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MedNess This Week
HIGHLIGHTS
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Onco-I-Analyse
Turning Point Therapeutics’ Repotrectinib receives Breakthrough Therapy Designation for ROS1+, TKI-Naïve, metastatic NSCLC
On 8th December, the US FDA granted breakthrough therapy designation to repotrectinib as a treatment option for patients with ROS1+, metastatic NSCLC, not treated with a ROS1 tyrosine kinase inhibitor (TKI). The designation is based on initial data from Phase 1 and Phase 2 portions of the Phase 2 TRIDENT-1 registrational study in ROS1+, TKI-naïve NSCLC patients.
Initial data from Phase 1 and 2 portions in ROS1+, TKI-naïve NSCLC patients demonstrated an ORR of 91% and 86%, respectively. Although, currently the data is in fewer patients, the drug shows more potential than crizotinib and entrectinib.
Updated data from the study will be presented at the World Conference on Lung Cancer (WCLC) on January 31, 2021 during a mini-oral presentation. The trial is still currently investigating repotrectinib in potentially registrational cohorts.
FDA had previously granted 3 fast track designations to repotrectinib for ROS1+ NSCLC who are TKI-naïve; ROS1+ NSCLC with one prior platinum chemotherapy and one prior ROS1 TKI; and NTRK+ solid tumors progressing on at least one prior chemotherapy and 1-2 prior TRK TKIs. The drug was shown to demonstrate potential anti-tumor activity and durable responses in kinase inhibitor treatment-naïve and pre-treated patients.
The trial also evaluates additional cohorts – ROS1+ NSCLC patients with 1 prior ROS1-TKI and platinum-based chemotherapy; ROS1+ NSCLC patients with 2 prior ROS1-TKIs and no prior chemotherapy; ROS1+ NSCLC patients with 1 prior ROS1-TKI and no prior chemotherapy; NTRK+, TRK TKI-naïve advanced solid tumors, NTRK+, TRK TKI-pretreated advanced solid tumors.
COVID Special
FDA issues an emergency use authorization for the use of the first vaccine against COVID-19 
FDA is a historic move, announced the EUA for the first-ever vaccine for COVID-19. The authorization was granted to Pfizer and BioNTech. The mRNA vaccine, BNT162b2 will be available for patients 16 years and older. The clinical trial is still underway, as the companies continue to gather information about the safety and efficacy of the vaccine. In the next few months, the companies intend to look into the longer-term safety of the vaccine. They will also determine the efficacy against asymptomatic infection and will also determine the immunogenicity and safety in individuals 12 years to 17 years.
“Pfizer’s purpose is breakthrough that change patient’s lives, and in our 171-year history there has never been a more urgent need for a breakthrough than today with hundreds of thousands of people continuing to suffer from COVID-19, said Albert Bourla, Chairman and CEO, Pfizer. “As a U.S. company, today’s news brings great pride and tremendous joy that Pfizer has risen to the challenge to develop a vaccine that has the potential to help bring an end to this devastation pandemic. We have worked tirelessly to make the impossible possible, steadfast in our belief that science will win.” 
FDA authorizes the first at home sample collection for a diagnostic test that aims to detect both Flu and COVID-19
FDA recently authorized the first diagnostic test to detect both COVID-19 and flu by collecting samples at home. For those with suspected respiratory viral infection with symptoms consistent with COVID-19, the samples can be collected at home if the healthcare provider thinks it to be appropriate.
“Today’s authorization for a COVID-19 plus flu test using samples collected at home is a significant step toward FDA’s nationwide response to COVID-19. With the authorization of this test, the FDA is helping to address the ongoing fight against COVID-19 while in the middle of the flu season, which is important for many, including the most vulnerable of Americans. This is another example of the FDA working with test developers to bring important diagnostics to Americans,” said FDA Commissioner Stephen M. Hahn, M.D.
Click here for more COVID news
Collated by : Esha Sehanobish, PhD
Regulatory News
Sotorasib Granted Breakthrough Therapy Designation For Advanced or mNSCLC Patients With KRAS G12C Mutation
"Breakthrough Therapy designation and Real-Time Oncology Review bring Amgen closer to potentially providing a targeted therapy to patients with a KRAS G12C mutation and establishing sotorasib as the foundational therapy in KRAS G12C-driven cancers," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "We are pleased to receive these regulatory designations and plan to submit a new drug application by end of year as we rapidly work to get sotorasib to the patients who need it."
Meeting highlights from the CHMP Meeting 7-10 December 2020
Positive recommendations for approval to:
  • Conditional marketing authorisation for Enhertu (trastuzumab deruxtecan) in metastatic HER2-positive breast cancer
  • Inrebic (fedratinib) in primary myelofibrosis and of myelofibrosis secondary to polycythaemia vera or essential thrombocythaemia
  • Lumoxiti* (moxetumomab pasudotox) in R/R hairy cell leukaemia
  • Conditional marketing authorisation for Retsevmo (selpercatinib) in RET-fusion positive NSCLC, RET-fusion positive thyroid cancer and RET-mutant medullary-thyroid cancer
  • Tukysa (tucatinib) in HER2-positive locally advanced or metastatic breast cancer
  • extensions of indication for Bavencio and Keytruda
Click here for more Regulatory News
Trial Results
Positive interim data announced from ongoing Ph 1 portion of the TC-210 ( gavocabtagene autoleucel or “gavo-cel”) Ph 1/2 clinical trial for mesothelin-expressing solid tumors
“Although the focus of any Phase 1 trial is safety, the consistency in tumor regression and RECIST responses we have observed with gavo-cel as a single agent supports our belief in the advantages of TRuC-T cells over other cell therapies and the potential for a fundamentally new approach in the treatment of solid tumors,” said Garry Menzel, Ph.D., President and Chief Executive Officer of TCR2 Therapeutics. “The HLA independence of our technology allows us to treat a broad population of patients with mesothelin surface expression while leveraging the full T cell receptor complex to drive enhanced trafficking, on-target killing and persistence in the hostile solid tumor microenvironment. Most important, we are delivering clinical and survival benefit to those patients with heavily pre-treated mesothelioma or ovarian cancer.” 
Exploratory data from the Ph 3 IMvigor010 study in early bladder cancer presents
“Bladder cancer is a complex and often difficult disease to treat, but as we continue to understand its biology, we are gaining greater clarity around new therapeutic avenues,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “By using ctDNA and other biomarkers, we hope to gain insights that enable a more personalised approach to treatment. We are applying these findings to our clinical development programme.”
Trial/Program Status
Fifty Percent Enrollment Milestone Announced in IMerge Ph 3 Clinical Trial in Lower Risk MDS
“Reaching fifty percent enrollment is a key milestone towards the completion of this registration-enabling Phase 3 clinical trial, and we appreciate all of the support from our investigators and the patients who are participating in this study,” said Aleksandra Rizo, M.D., Ph.D., Geron’s Chief Medical Officer. “We believe that the IMerge Phase 3 will confirm the meaningful and durable transfusion independence and the disease-modifying activity of imetelstat observed from the Phase 2, and that imetelstat could become a much-needed treatment alternative for patients with lower risk MDS.”
Opening of IMpactMF Ph 3 Clinical Trial in Refractory Myelofibrosis Announced
“As Geron’s second registration-enabling Phase 3 trial in hematologic myeloid malignancies, the IMpactMF trial represents a milestone for our Company,” said Aleksandra Rizo, M.D., Ph.D., Geron’s Chief Medical Officer. “The IMpactMF trial will evaluate imetelstat in a poor-prognosis refractory MF patient population to confirm the clinical benefits of extended overall survival and symptom improvement observed in our IMbark Phase 2 trial, as well as the reductions in abnormal clones and mutation burden demonstrating disease-modifying activity of imetelstat.”
First Patient Dosed in Ph 2 Trial of CG0070 + KEYTRUDA® (pembrolizumab) for BCG-Unresponsive NMIBC
“We are motivated to advance this crucially important program, despite the challenges presented under the current global pandemic,” said Arthur Kuan, CEO of CG Oncology. “CG0070, an oncolytic immunotherapy which has been administered to over 100 patients for the treatment of NMIBC, may potentially exhibit additional effect when combined with KEYTRUDA, which earlier this year was the first therapy in approximately 20 years approved for this indication.”
Collated by : Richa Tewari, PhD
Medness Plus
FDA approves Xolair (omalizumab) for the add-on maintenance treatment for nasal polyps
FDA recently approved Roche’s supplemental Biologics License Application (sBLA) for Xolair (omalizumab) as an add-on treatment for nasal polyps. It can be used by individuals 18 years and older with inadequate response to nasal corticosteroids. Xolair is an anti-IgE antibody that helps reduce inflammation driven by IgE. It is expected to alleviate some of the symptoms associated with nasal polyps usually characterized by nasal congestion leading to loss of smell along with frequent asthma and allergic attacks. Xolair has already been approved for the treatment of moderate to severe persistent allergic asthma in patients six years and older with inadequately controlled asthma. It has also been approved for the treatment of chronic idiopathic urticaria (CIU) in patients 12 years and older inadequately controlled by H1 antihistamines.
“With today’s approval, people living with nasal polyps now have a treatment option that targets IgE, an underlying driver of various allergic conditions,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We are committed to understanding the full potential of Xolair across the spectrum of allergic diseases and are excited to provide this important treatment for people living with nasal polyps.”
Click here for more MedNess Plus
Collated by : Esha Sehanobish, PhD
Medness Reviews

FDA Authorizes LabCorp’s at-home COVID-19 test without the need for a prescription
LabCorp’s Pixel test for the detection of COVID-19 has secured an FDA nod for a at-home test without a need for a prescription.
The FDA had first authorized the Pixel test in late April. Now, a self- collection kit can be purchased directly through LabCorp’s website by anyone age 18 and older. The kit is priced at $119 when paid -out-of-pocket, though this price can be covered by public and private health insurance.
The self -collection kit enables the collection of the samples by the user by swabbing the inside of the nose. The sealed sample is then shipped overnight in prepaid FedEx envelope for laboratory analysis, with results turned around on an average of one or two days.
LabCorp’s online portal will also connect users who test positive to a healthcare provider, to assist with isolation and treatment. The company also plans to stock the test kit at nationwide retailers.
As the demand of COVID-19 testing see increasing trends, LabCorp aims to help get more people tested and hopefully reduce the spread if the virus.
Conference Coverage - SABCS 2020
ABSTRACTS
  1. Athenex Presents Updated Ph 3 Data on Survival and Tolerability Associated with Oral Paclitaxel and Encequidar in Patients with Metastatic Breast Cancer
  2. AstraZeneca and Daiichi Sankyo present updated results from the DESTINY-Breast01 Ph 2 trial of Enhertu (trastuzumab deruxtecan) in patients with HER2-positive metastatic breast cancer
  3. Gilead presents New Data From Ph 3 ASCENT Trial of Trodelvy® in mTNBC
  4. Novartis Kisqali® demonstrates nearly five years mOS in metastatic breast cancer in MONALEESA-7 trial
  5. Briacell presents Disease control and survival data from the clinical trials of Bria-IMT™ alone or in combination with immune checkpoint inhibitors in advanced breast cancer
  6. CytomX Therapeutics Presented Updates on CX-2009
  7. Evelo Biosciences Presents Additional Interim Data from Ph 1/2 Clinical Trial of EDP1503 in TNBC Patients
  8. G1 Therapeutics reported final OS data from randomized Ph 2 trial of trilaciclib in mTNBC
  9. Immutep Reports Statistically Significant Survival Benefit for Key Patient Groups in the Ongoing Ph 2b AIPAC Study in Metastatic Breast Cancer
  10. Infinity Pharmaceuticals, Inc. announced data from 1L TNBC cohort from ongoing MARIO-3 trial of eganelisib + atezolizumab and nab-paclitaxel mTNBC patients
  11. Odonate presents Positive Results of Ph 3 CONTESSA Study of Tesetaxel in Metastatic Breast Cancer Patients
  12. Olema Oncology presents OP-1250 data
  13. Puma Biotechnology Presents Updated Results from the Ph 2 SUMMIT Trial of Neratinib for HER2-Mutant, HR-Positive Metastatic Breast Cancer
  14. Puma Biotechnology Presents Final OS Analysis from the Ph 3 ExteNET Trial
  15. Puma Biotechnology Presents Efficacy and Safety Outcomes from the Phase III NALA Trial
  16. Seagen Highlights TUKYSA® (tucatinib) Data in Breast Cancer
  17. Sermonix announces data on Ph 2 Study of Lasofoxifene in Combination with Abemaciclib
Medness Business
Onco-News
Taiho Oncology announces establishment of a European headquarters
“The establishment of European headquarters is a significant milestone in Taiho’s development as an emerging global oncology pharmaceutical company,” said Timothy Whitten, President and CEO of Taiho Oncology, Inc., a U.S. subsidiary of Taiho Pharmaceutical Co., Ltd. “As we continue to grow our portfolio, Taiho Oncology has an excellent opportunity to impact the global treatment landscape. We believe that we can contribute a great deal to the future health and well-being of people living with cancer throughout Europe."
Bayer and Tempus Initiate Collaboration to Advance Patient Access to Genomic Testing and Precision Medicine
“Bayer’s strong focus in precision medicine combined with Tempus’ unique testing offering has culminated in this collaboration to bring genomic testing to cancer patients,” said Bhavesh Ashar, Senior Vice President, Head of U.S. Oncology at Bayer. "We are excited for the potential of this initiative to identify patients who may benefit from tailored treatment options.”
Collated by : Richa Tewari, PhD
Editors' Desk
Richa Tewari, PhD
Oncology News
Esha Sehanobish, PhD
MedNess Plus
Arundithi Ananthanarayanan
MedNess Reviews
Divyaanka Iyer
BioPharma News
Shilpa Rawal, PhD
Onco I-Analyse
Debarati Banik
HealthIT
Rinki Saha
BioPharma News
Abhi Dey
Consulting Editor
Nisha Peter, PhD
Managing Editor
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The editors take care to share authentic information.  In case of any discrepancies please write to medness.newsletter@gmail.com
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 , Rinki Saha ,  Shilpa Rawal, PhD ,  Debarati Banik  , Divyaanka Iyer , Arundithi Ananthanarayanan and Abhinav Dey 
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