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MedNess: bite-size biopharma and medtech news

9th December, 2020
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HIGHLIGHTS
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Onco-I-Analyse
Jazz Pharma’s and PharmaMar’s Lurbinectedin failed to meet primary endpoint in confirmatory SCLC trial
On 3rd December, Jazz Pharmaceuticals and PharmaMar announced that Zepzelca (lurbinectedin) in combination with doxorubicin failed to meet the primary endpoint of overall survival (OS) in SCLC patients with disease progressed following one prior platinum-containing therapy in the Phase 3 ATLANTIS study.
Background: SCLC is an aggressive tumor with high unmet need and chemotherapy as the backbone treatment option. Approval of lurbinectedin monotherapy earlier this year had raised hopes of an alternative and promising treatment option for second-line SCLC patients.
Details: The multicenter, randomized trial evaluated lurbinectedin + doxorubicin against physician's choice chemotherapy - topotecan or cyclophosphamide/doxorubicin/vincristine (CAV), in limited or extensive stage SCLC patients with failure on one prior platinum-containing regimen and a chemotherapy-free interval ≥ 30 days. The trial failed to show statistically significant improvement in OS in the ITT population. However, no adverse impact on OS was observed in the lurbinectedin arm.
Although, secondary endpoints and subgroup analyses favoured the investigational arm, no additional hypotheses were formally tested in the trial. The safety was consistent with the known safety profile of lurbinectedin monotherapy with no new adverse events. Detailed results will be presented at an upcoming medical conference.
Earlier in June 2020, lurbinectedin monotherapy had received an accelerated approval by the US FDA based on ORR and DoR data from the Phase 2 basket trial in similar settings. Following which, Jazz had launched lurbinectedin in the US in July and saw promising drug uptake. The approved dose of monotherapy was 3.2mg/m2, but the ATLANTIS trial tested lurbinectedin dose of 2.0mg/m2 in the experimental arm.
Implications: Due to lack of second-line treatment options, this failure is not very likely to affect the accelerated approval and lurbinectedin monotherapy uptake. Despite the ATLANTIS trial failure, investigators still see the potential of lurbinectedin in treating SCLC and will continue the development of monotherapy and combination therapy in various tumors. The company will discuss the ATLANTIS data with the FDA to assess the confirmatory data required for full approval.
Collated by : Shilpa Rawal, PhD
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Drug Approvals
FDA Approves GAVRETO™ (pralsetinib) for the Treatment of Patients with Advanced or Metastatic RET-Mutant and RET Fusion-Positive Thyroid Cancer
"With this approval, Blueprint Medicines has achieved four marketing authorizations this year across our lead programs, making real our vision to bring transformative precision therapies to patients globally," said Jeff Albers, Chief Executive Officer of Blueprint Medicines. "Today's approval also builds further momentum toward bringing GAVRETO to a wide range of patients with RET-altered cancers. Now, as we work with our partner Genentech to rapidly deliver GAVRETO to patients with RET-altered non-small cell lung cancer and thyroid cancers, we continue to explore the potential of GAVRETO to address additional tumor types and treatment settings."
Regulatory News
BLA Submitted to FDA Seeking Approval of Amivantamab for the Treatment of mNSCLC Patients with EGFR Exon 20 Insertion Mutations
“This submission marks an important step forward in our drive toward evolving the treatment landscape for patients with NSCLC who have EGFR exon 20 insertion mutations and for whom there are no FDA-approved targeted treatment options,” said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC. “We are committed to the development of therapies like amivantamab that progress precision medicine and target specific pathways, and to providing access through expanded access programs.”
FDA Fast Track designation for irinotecan liposome injection (ONIVYDE®) as a 2L monotherapy treatment of SCLC
“The Fast Track designation of ONIVYDE® as a potential treatment for people living with small cell lung cancer is an extension of Ipsen’s focus and contribution to the treatment landscape in oncology,” said Howard Mayer, M.D., Executive Vice President, Head of Research and Development at Ipsen. “With this aggressive and often late-stage diagnosed form of lung cancer, we are proud to be one step closer to making another treatment option available to patients.”
Click here for more Regulatory News
Trial Results
Survivin-Targeted T Cell Therapy Shows Durable Clinical Benefits in Phase 2 Study in Patients with Hard-to-Treat Advanced Recurrent Ovarian Cancer
“IMV’s targeted T cell therapy continues to elicit a rapid and robust immune response with a demonstration that survivin-specific CD8+ T cells can infiltrate solid cancerous tumors. This could prove to be of significant interest considering that the narrowly focused action of cytotoxic CD8+ T cells allows them to kill single infected cells in tissue without creating widespread tissue damage,” declared Fred Ors, President and Chief Executive Officer of IMV.
Encouraging Interim Data on STRO-002 Ph 1 Dose-Escalation Study for Ovarian Cancer Patients Announced
“We are encouraged to see meaningful clinical benefit from STRO-002 for patients with advanced platinum-resistant and refractory ovarian cancer. The women on the study are heavily pretreated and have limited treatment options as many have received experimental agents and participated in other clinical trials,” said Dr. Lainie P. Martin, Leader of Gynecology/Oncology Program at Hospital of the University of Pennsylvania and an investigator on the STRO-002 study. “The deepening of responses in patients as well as disease control over time demonstrates STRO-002 to be an important potential treatment option for patients with ovarian cancer.”
Trial/Program Status
Ph 2 Trial of Bomedemstat (IMG-7289) for the Treatment of Myelofibrosis Expanded into Hong Kong
“Patients with myelofibrosis around the world are still in need of new treatment options,” said Hugh Young Rienhoff, Jr. M.D., Chief Executive Officer, Imago BioSciences. “We are progressing well with enrollment and are pleased to continue expanding our global Phase 2 study into new geographies like Hong Kong. We are encouraged by the signs of clinical activity and safety of bomedemstat as a treatment alternative for patients who do not benefit from the current standards of care.”
First Patient Dosed in Ph 2 LUMINOS-101 Trial of PVSRIPO + Pembrolizumab for rGBM Patients
“The initiation of this Phase 2 trial represents a significant milestone in the advancement of PVSRIPO and our quest to treat this formidable opponent,” said Matt Stober, President and Chief Executive Officer at Istari Oncology. “Currently the treatment options for patients with rGBM are limited and outcomes are grim, so following the encouraging results of our Phase 1 trial, we are eager to see the effectiveness of PVSRIPO in combination with pembrolizumab.”
Click here for more Trial Status
Collated by : Richa Tewari, PhD
Medness Reviews

FDA authorizes approval for Quest Diagnostics Self-Collection Kit for COVID-19 and Flu
With growing number of daily COVID-19 cases and the flu season around the corner, FDA approved self-collection kit for COVID-19 and Flu available from Quest Diagnostics. With this approval Americans above 18 years of age with a respiratory symptom can reliably send their nasal swab sample via mail to the company to check if they have COVID-19 or seasonal Flu. This home sample collection kit is only available after a prescription and this allows people to stay at home while waiting for the test result. Adolescents and children can also be swabbed with adult supervision.
“With just one swab or sample, combination tests that are authorized for use with home-collected samples can be used to get answers to Americans faster, in the comfort and relative safety of their home, which allows patients to continue to quarantine while awaiting results. This efficiency can go a long way to providing timely information for those sick with an unknown respiratory ailment.”- Stephen M. Hahn, M.D, FDA Commissioner.
Collated by : Rinki Saha 
Conference Coverage - ASH 2020 
 
Abstracts
  1. AbbVie shows Combined Data from Multiple Ph 3 Studies of IMBRUVICA® Showing Efficacy & Safety in High-Risk, Previously Untreated CLL and Real-World Data Indicating Low Biomarker Testing Rates for These Patients
  2. Actinium Announces Positive Interim Results from Iomab-B Pivotal Ph 3 SIERRA Trial at 75% of Total Patient Enrollment
  3. Autolus Therapeutics presents additional data on AUTO3 in DLBCL
  4. Curis Announces Updated Preliminary Data from Ph 1 Study of CA-4948 Showing Durable and Dose-Dependent Reductions in Tumor Burden in R/R NHL Patients
  5. Gilead presents Magrolimab’s Clinical Responses in Ph 1b Trial of 1L AML Patients
  6. Janssen presents Updated Results from Ph 1 Study of the BCMAxCD3 Bispecific Teclistamab Showing Preliminary Efficacy in Heavily Pretreated RRMM Patients
  7. Kura Oncology Presents First Clinical Data for Menin Inhibitor KO-539
  8. Precigen Presents New Data Supporting the Safety, Clinical Activity, Expansion and Persistence of PRGN-3006 UltraCAR-T®
  9. Roche announces new data reinforcing the long-term benefit of Venclexta/Venclyxto-based combination for R/R CLL patients
  10. Sierra Oncology Presents Long-term OS and Sustained Efficacy Outcomes Data for Momelotinib
Click here for more ASH 2020 abstracts
Collated by : Richa Tewari, PhD
Medness Business
Onco-News
Merck and Artios Pharma Announce a Global Strategic Collaboration on Novel DNA Damage Response Targets in Oncology
“Our platform has the potential to revolutionize targeted treatment in cancer and deliver on the promise of precision medicine. This collaboration will leverage the potential of our unique discovery platform of novel DNA repair nuclease inhibitors and targets that we have been developing. The partnership puts us in an exceptional position to focus internal efforts on our leading portfolio of assets which includes a small-molecule ATR inhibitor and a Polθ programme, both in candidate IND evaluation,” said Niall Martin, Chief Executive Officer at Artios Pharma.
Bayer and Atara Biotherapeutics Enter Strategic Collaboration for Mesothelin-Targeted CAR T-cell Therapies for Solid Tumors
“This exciting collaboration between Atara and Bayer will accelerate the development of mesothelin-targeted CAR T-cell therapies for multiple solid tumors and helps us advance the power of our allogeneic cell therapy platform to patients as quickly as possible,” said Pascal Touchon, President and CEO Atara. “Bayer’s proven track record in oncology global development and commercialization, and growing presence in cell and gene therapy, enhances Atara’s capabilities and complements our leading allogeneic T-cell platform.”
BioPharma and MedTech
Aligos Therapeutics signs a license and research collaboration agreement with Merck
On 7th December 2020, Aligos Therapeutics entered an Exclusive License and Research Collaboration Agreement with Merck. Under this agreement, Merck and Aligos will simultaneously utilize Aligos’ oligonucleotide platform technology to discover, research, optimize, and develop oligonucleotides directed against a non-alcoholic steatohepatitis (NASH) target. This deal also confirms that both companies can develop up to one additional target of interest in cardiometabolic/fibrosis therapeutics. Aligos holds extensive expertise and resources necessary to develop oligonucleotide candidates for liver diseases, including STOPS™ molecules as well as an antisense oligonucleotide (ASO) and small interfering RNA (siRNA) candidates in development for Aligos’ program in chronic hepatitis B and NASH.
“We have assembled a team of scientists and medical professionals with significant experience in oligonucleotide-based drug discovery and we have developed a proprietary oligonucleotide chemistry platform that has broad applicability across diverse therapeutic areas,” “Given the imperative to find new innovative treatments for NASH, a chronic liver disease that can progress to fibrosis, cirrhosis, end-stage liver disease, and hepatocellular carcinoma, we are pleased to collaborate with Merck to advance the development of potentially effective therapeutic regimens.” - Lawrence Blatt, Ph.D., MBA, CEO, Aligos.
BioCryst bags $325 M funding to develop small molecule therapeutics for rare diseases like hereditary angioedema (HAE)
On 7th December 2020, New York-based BioCryst has secured $325 M from Royalty Pharma plc and Athyrium Capital Management. $250 M from this newly acquired fund is allocated for the launch of ORLADEYO™ for hereditary angioedema (HAE) attack and the development of its oral Factor D inhibitor, BCX9930. Right before this funding round on 6th December 2020, BioCryst announced that ORLADEYO™ has got the FDA approval.
With this newly acquired fund BioCryst plans to launch ORLADEYO™ across the US and Europe. Additionally, they will focus on the clinical trial of the Factor D inhibitor, BCX9930. BioCryst will receive $125 M upfront cash from Royalty Pharma and gain royalties of annual net sales of ORLADEYO up to $350 million. The rest of the fund will be provided by Athyrium Capital Management as a credit facility.
“We believe ORLADEYO will be a transformative medicine and we are excited to partner with BioCryst to bring this oral, once-daily medicine to HAE patients. Based on the encouraging proof of concept data in paroxysmal nocturnal hemoglobinuria with BCX9930, we also believe this oral Factor D inhibitor offers substantial opportunities across multiple complement-mediated diseases,”- Pablo Legorreta, CEO, Royalty Pharma.
Click here for more on mergers, acquisitions and business news
Collated by : Richa Tewari, PhD and Rinki Saha 
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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