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MedNess: bite-size biopharma and medtech news

28th April, 2021

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MedNess This Week
HIGHLIGHTS
Onco-I-Analyse
The US FDA grants Breakthrough Therapy Designation to bemarituzumab for FGFR2b+ gastric cancer
On 19th April, Amgen announced that the US FDA has granted breakthrough therapy designation to bemarituzumab (anti-FGFR2b) as a frontline treatment option in combination with mFOLFOX6 for HER2neg, fibroblast growth factor receptor 2b (FGFR2b) overexpressing metastatic and locally advanced gastric and gastroesophageal (GEJ) adenocarcinoma. The designation is based on results from the Phase 2 FIGHT study.
Background: Gastric cancer (GC) is an aggressive cancer, with particularly high incidence rates in East Asian countries and a 5-year survival rate of only 5.5% for metastatic GC. It is the third most common cause of deaths by cancer worldwide.
As many as 30% patients with HER2neg GC express FGFR2b which has been shown to play a prominent in driving gastric tumorigenesis. It is a poor pathological and prognostic marker for GC associated with worse survival outcomes and no approved treatment options.
Details: BTD was granted for FGFR2b overexpression in at least 10% of tumor cells as demonstrated by an FDA approved companion diagnostic assay.
The FIGHT study investigated bemarituzumab + mFOLFOX6 vs. mFOLFOX6 in 155 patients with previously untreated advanced, HER2neg GC/GEJ cancer with FGFR2b overexpression. The trial showed clinically meaningful improvement in primary endpoint of PFS (9.5 vs. 7.4 months; HR: 0.68, p=0.0727) and key secondary endpoints of OS (NR vs. 12.9 months; HR: 0.58, p=0.0268) and ORR (47% vs. 33%) for bemarituzumab + mFOLFOX6 vs. mFOLFOX6, respectively. Median duration of response was 12.2 vs. 7.1 months. Patients with higher expression showed better survival outcomes with mPFS in patients with IHC 2+/3+ at ≥10% of sample being 14.1 vs. 7.3 months (HR: 0.44).
Implications: Amgen acquired bemarituzumab from Five Prime Therapeutics in a $1.9B acquisition, completed on 16th April. Results from the FIGHT study will support a pivotal Phase III study in GC/GEJ cancer patients. Bemarituzumab has the potential to become first-in-class therapy for the treatment of GC patients with FGFR2b overexpression, thereby addressing the high unmet need for this patient segment.
Collated by : Shilpa Rawal, PhD
Drug Approvals
FDA approves JEMPERLI (dostarlimab-gxly) for dMMR endometrial cancer
“The approval of JEMPERLI is a transformative milestone for AnaptysBio. This event provides important validation for our proprietary SHM antibody discovery platform and provides significant potential future milestone and royalty revenue to support AnaptysBio’s growth,” said Hamza Suria, president and chief executive officer of AnaptysBio. “While AnaptysBio has partnered certain pipeline assets, our primary value-creation strategy remains focused on advancing wholly-owned, first-in-class therapeutic antibodies from discovery through development, and we look forward to multiple upcoming clinical data readouts from our product pipeline through 2021 and 2022.”
FDA approves ZYNLONTA™ (loncastuximab tesirine-lpyl) in R/R DLBCL
“There is a significant unmet need for treatment options for patients with r/r DLBCL, including those who have been heavily pretreated and have difficult-to-treat disease,” said Paolo F. Caimi, MD, University Hospitals Cleveland Medical Center and Case Comprehensive Cancer Center, Case Western Reserve University. “Single-agent ZYNLONTA demonstrated clinically important outcomes in the pivotal LOTIS-2 study across several disease subtypes. Notably, this included transplant eligible and ineligible patients and patients who previously received stem cell transplant or CAR-T cell therapy.”
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Regulatory News

Pre-BLA Meeting Requested with the FDA to Discuss Path to Eryaspase’s Approval in ALL

  • Results from the NOPHO-sponsored Ph 2 clinical trial demonstrated that eryaspase + chemotherapy combination, administered every two weeks, provides a sustained asparaginase enzyme activity level, and is generally well tolerated with few hypersentivity reactions. 
  • The trial results were presented at the 62nd ASH Annual Meeting held in December 2020. 
  • The investigators positioned eryaspase as a potential attractive treatment option for patients who developed hypersensitivities to PEG-asparaginase. 
  • ERYTECH initiated a dialogue with the US FDA in 2020 to evaluate the potential of eryaspase to be approved for the treatment of hypersensitive ALL patients based on the NOPHO-sponsored Phase 2 clinical trial.
  • The FDA confirmed the unmet medical need and, following the review of a comprehensive data package submitted by ERYTECH, invited the Company to request a pre-BLA meeting to discuss the potential for the NOPHO-sponsored Phase 2 clinical trial to support marketing approval in the United States.  
  • ERYTECH has requested a pre-BLA meeting and subject to the feedback received in that meeting, the Company plans to submit a Biologics License Application (BLA) in the second half of 2021 for its lead product candidate eryaspase for the treatment of hypersensitive ALL patients.
US FDA Requests Additional Information for CER-T technology-based FSHR-targeting CAR-T Therapy
Dr. Amit Kumar, President and CEO of Anixa Biosciences, stated, "We are eagerly awaiting guidance from the FDA with details about the specific information requested to clear the IND, enabling initiation of clinical trials."
Click here for more Regulatory News
Trial Results
  • IDMC of the JUPITER-06 clinical trial has determined that toripalimab + paclitaxel/cisplatin as first-line treatment for patients with advanced ESCC has achieved the pre-specified primary endpoints of PFS and OS at the interim analysis.
  • JUPITER-06 is a randomized, double-blind, placebo-controlled, multi-center, Ph 3 clinical trial initiated in 2019 with 514 patients enrolled.
  • The interim analysis showed that toripalimab + paclitaxel/cisplatin combination significantly prolonged the PFS and OS of patients with advanced ESCC, compared with paclitaxel/cisplatin chemotherapy alone.
  • Data from the study are expected later this year.
“Safety results from ACIS were consistent with prior studies of ERLEADA and ZYTIGA plus prednisone, with no new safety signals observed. The study also generated valuable scientific outcomes and insights in subgroups of patients with luminal type in PAM50 test and tumors with average or high androgen receptor activity (molecular signatures of hormone sensitivity), which warrant further investigation,” said Kiran Patel, M.D., Vice President, Clinical Development, Solid Tumors, Janssen Research & Development, LLC. “These data will be important in informing future programs in our pipeline, as we look to build upon our leadership and commitment in bringing transformational therapies to patients diagnosed with prostate cancer.”
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Trial/Program Status
ULTRA-V Ph 3 Trial Evaluating the Triple Combination of UKONIQ™ (umbralisib), Ublituximab, and Venetoclax launched
Richard R. Furman, MD, Director of CLL Research Center at Weill Cornell Medicine and Study Chair for the ULTRA-V Phase 2 and Phase 3 trials stated, “We are excited to launch this pivotal Phase 3 study based on the promising Phase 1 clinical results reported to date on the triplet combination of UKONIQ, ublituximab and venetoclax in patients with CLL. While recent approvals provide excellent treatment options for patients, disease progression and treatment tolerability still remain problematic for many patients. Our belief is that time-limited treatment regimens, such as U2 plus venetoclax, have the potential to produce meaningful responses without the need to expose patients to continuous therapy and related toxicities. We look forward to presenting the results of the Phase 2 portion of this study at a future medical meeting. I want to thank my colleagues for their strong support of the Phase 2 ULTRA-V trial and look forward to continuing and expanding our efforts now in Phase 3.”
First Patient Dosed in Ph 3 inMIND Study Evaluating the Addition of Tafasitamab to Lenalidomide and Rituximab in R/R FL & MZL
“Despite improvements in treatment for patients with relapsed or refractory FL and MZL, there continues to be a significant medical need for additional therapies with improved outcomes,” said Peter Langmuir, M.D., Group Vice President, Oncology Targeted Therapeutics, Incyte. “We are pleased to have initiated the inMIND study as we seek meaningful, new options for patients with relapsed or refractory FL or MZL.”
Click here for more Trial Statuses
Genes and Therapy
Vertex and Obsidian Therapeutics enter collaboration to discover novel regulatory gene editing therapies for serious diseases
On 22nd April 2021, Vertex Pharmaceuticals and Obsidian Therapeutics entered into a multi-year strategic research collaboration and licensing agreement focused on the discovery of novel therapies that regulate gene editing for the treatment of serious diseases. This leverages Obsidian’s proprietary cytoDRiVE® platform to discover gene-editing medicines whose therapeutic activity can be precisely controlled using small molecules and Vertex’s scientific and clinical capabilities in small molecule, cell and genetic therapies.
CARISMA Therapeutics collaborates with Bruce Blazar to develop allogeneic CAR-Macrophages
CARISMA Therapeutics has established a multi-year scientific collaboration on 26th April 2021 with Bruce Blazar, MD, Regents Professor of Pediatrics, Division of Blood and Marrow Transplantation and Cellular Therapy at the University of Minnesota to investigate and develop allogeneic macrophage therapies. This collaboration is undertaken with an intention to expand CARISMA's CAR-Macrophage (CAR-M) platform beyond oncology and into other diseases with unmet clinical needs.  
Click here for more on Genes and Therapy
MedNess Business
BioPharma News

Biofacturing company Zymergen goes IPO at $ 500 million, with a pipeline of bio-materials based solutions for electronics, agriculture and consumer products
On 22nd April 2021, Zymergen Inc. (Zymergen; Emeryville, CA), a biofacturing company aiming to provide naturally occurring biopolymers-based solutions, went IPO at $500 million. Zymergen’s hyaline-based optical film can be used as flexible screens in electronic goods. The company aims to deliver natural compounds or biochemicals as solutions for agriculture (ex, pest management, biofertilizers), electronics (ex. Films, adhesives and coatings) and consumer care (ex. insect repellents, personal care). Together, these industries comprise a potential market of $1 trillion. 
The IPO values Zymergen at $2.96 billion. The company sold 16.13 million shares, priced at $31 per share. JP Morgan and Goldman Sachs are the lead book running managers, with Lazard acting as the co-manager.
Zymergen uses artificial intelligence and machine learning platforms to screen bio-libraries identifying molecules with suitable properties. These molecules are then synthesized by microbes expressing optimized genetic codes. Robotic genomics matches microbial strains with genetic codes, achieving end-protein products or enzymes that can produce other biochemicals.
More information on their biofacturing platform and pipeline can be accessed here.

Onco-News
Samsung Biologics and TG Therapeutics Expand Collaboration for the Large-Scale Manufacture of Ublituximab
Michael S. Weiss, Executive Chairman and CEO of TG Therapeutics, stated, “Samsung is the global leader in biologics manufacturing and we are happy to have them as our partner as we look forward to the potential commercialization of ublituximab across both oncology and autoimmune indications. With the recent positive ULTIMATE I and II MS Phase 3 studies, we re-evaluated our supply needs and were very pleased we were able to secure the long-term capacity we believe we will need to meet the potential global demand for ublituximab. This is an important next step in our long-standing relationship with Samsung.”
Click here for more on mergers, acquisition and business news
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
Managing Editor
Shalini Roy Choudhury
Genes and Therapy
Managing Editor
Nisha Peter, PhD
Managing Editor
Abhi Dey
Consulting Editor
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Content Editors: Richa Tewari , Esha SehanobishRinki Saha ,  Shilpa Rawal, PhD ,  Debarati Banik  , Divyaanka Iyer , Arundithi Ananthanarayanan and Abhinav Dey 
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