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MedNess: bite-size biopharma and medtech news

16th March, 2022
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HIGHLIGHTS
 
  Drug Approvals
FDA Approves LYNPARZA® as Adjuvant Treatment for Patients With gBRCAm, HER2-Nege High-Risk Early Breast Cancer Who Have Been Treated With Neoadjuvant or Adjuvant Chemotherapy
Dave Fredrickson, executive vice president, oncology business unit, AstraZeneca, said, “This important approval gives early-stage high-risk breast cancer patients in the U.S. with a germline BRCA mutation a new targeted therapy option in the adjuvant setting starting today. LYNPARZAreduced the risk of disease recurrence in these patients, and now new data confirm it also significantly extended patients’ lives versus placebo. These data underline the importance of germline BRCA testing as soon as possible after diagnosis to help identify patients who may be eligible for LYNPARZA.”
FDA Approves Opdivo® with Chemotherapy as Neoadjuvant Treatment for Certain Adult Patients with Resectable Non-Small Cell Lung Cancer
“Given the rates of disease recurrence in patients with resectable NSCLC, additional treatment options are needed that can be given before surgery to help improve the chance of successful surgical treatment and support the goal of reducing the risk of cancer returning,” said Mark Awad, MD, PhD, CheckMate -816 study investigator and clinical director of the Lowe Center for Thoracic Oncology at Dana-Farber Cancer Institute.2,3 “The approval of nivolumab with platinum-doublet chemotherapy marks a turning point in how we treat resectable NSCLC and it enables us to use immunotherapy and chemotherapy as neoadjuvant treatment for patients before surgery. Today’s announcement reinforces the need to increase the rates of NSCLC screening and early detection, and for patients to discuss treatment options with their providers.”
  
  Regulatory News

MHRA Approves Ph 1/2 Clinical Trial of IN3BIO Vaccine to Improve Outcomes for Colorectal Cancer Patients
Erik D'Hondt, CEO of IN3BIO, said, "This clinical trial is aimed to establish a new standard in treating CRC patients. IN3BIO confidently launches this trial following promising data in a combination clinical trial in NSCLC patients. Based upon this encouraging data, more clinical trials are planned in 2022 with IN3BIO proprietary molecules; combination trials aiming to augment the efficacy of current TKIs and SMIs. Notably, IN3BIO’s proprietary molecule appears to enhance existing targeted treatments significantly, while appearing to be well tolerated. We are excited to progress to these clinical trials with the aim of improving patient outcomes and their treatment experience."

FDA Partial Clinical Hold on NEON-2 Trial of Davoceticept (ALPN-202) in Combination with Pembrolizumab
“Patient safety remains, as always, our top priority,” said Mitchell H. Gold, Executive Chairman and Chief Executive Officer of Alpine. “We appreciate the dialogue with FDA and look forward to working diligently with FDA, Merck, the study Safety Monitoring Committee, and the study investigators to further understand this unfortunate event. Given the strong scientific rationale for the combination of davoceticept and pembrolizumab to benefit treatment-refractory patients, we are hopeful that the study will soon be resumed after appropriate safety review, and with appropriate safety precautions in place.”
Click here for more Regulatory News
Trial Results
KEYTRUDA® Demonstrated Significant Improvement in DMFS vs placebo as Adjuvant Therapy for Patients With Resected Stage IIB/IIC Melanoma in Ph 3 KEYNOTE-716 Trial
“Patients with melanoma that has spread to distant sites have a significantly worse prognosis and the goal of adjuvant therapy is to delay disease recurrence, especially distant metastases,” said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. “In KEYNOTE-716, adjuvant treatment with KEYTRUDA first showed a significant improvement in recurrence-free survival and has now demonstrated a significant improvement in the time until the first diagnosis of a distant metastasis compared to placebo. The distant metastasis-free survival data from KEYNOTE-716 reinforce the evidence for KEYTRUDA as adjuvant therapy in stage IIB and IIC melanoma.”
Ph 3 TROPiCS-02 Study Met the Primary Endpoint of Progression-Free Survival in Late-Line HR+/HER2- Metastatic Breast Cancer
“Trodelvy demonstrated consistent activity in this difficult-to-treat patient population,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “We are evaluating the data and will explore potential pathways with regulatory authorities to bring Trodelvy to this group of patients. As we work to expand the patient benefit of Trodelvy beyond its current indications for second-line metastatic triple-negative breast cancer and accelerated approval in second-line metastatic bladder cancer, we are pursuing studies across multiple tumor types and earlier lines of therapy.”
Click here for more Trial Results
Trial/Program Status
Completion of Enrollment in OVAL Ph 3 Trial of Ofra-Vec in Ovarian Cancer and Unanimous Recommendation by IDMC to Continue Study as Planned
“We would like to take this opportunity to thank the participating physicians and patients in the Phase 3 OVAL trial,” said Prof. Dror Harats, M.D., chief executive officer of VBL Therapeutics. “We are very pleased to have completed enrollment in OVAL and see this as a significant milestone in the ofra-vec clinical program. I would also like to thank the DSMC members for their work and guidance. Their analysis was particularly important, as the committee provided its recommendation following the review of unblinded data from patients representing over 90% of the targeted enrollment. We look forward to the readout of the PFS primary endpoint in the second half of this year. With positive results, we intend to submit a BLA to the FDA.”
Collated by: Richa Tewari, PhD 
Genes and Therapy
Novartis and Voyager Therapeutics collaborate over next generation gene therapy vectors for neurological disorders
Novartis entered into a license option agreement with Voyager Therapeutics, for three capsids to use in potential gene therapies for neurological diseases, with options to access capsids for two other targets. This agreement will allow access to capsids from Voyager’s TRACER platform may help deliver therapies to previously intractable regions of the brain, potentially overcoming barriers that have hindered the development of gene therapies for neurological diseases to date.
Positive results from spinal muscular atrophy gene therapy clinical trial
Positive results from Novartis’ Zolgensma clinical trial suggest its ability as an essential one-time treatment for spinal muscular dystrophy (SMA). The completed Phase 3 SPR1NT study demonstrated that children with three copies of the SMN2 back-up gene who were treated presymptomatically achieved age-appropriate motor milestones, including standing and walking. Zolgensma® (onasemnogene abeparvovec) is the only approved gene therapy for the treatment of SMA and the only SMA treatment designed to directly address the genetic root cause of the disease by replacing the function of the missing or non-working SMN1 gene to halt disease progression through sustained SMN protein expression with a single, one-time IV infusion. 
MedNess Business
Onco News
Targovax ASA and Agenus announce collaboration on mutant KRAS cancer vaccine adjuvanted with QS-21 STIMULON™
Dr. Garo H. Armen, Chief Executive Officer of Agenus Inc., said: “We look forward to collaborating with Targovax to extend the benefit of QS-21 STIMULON to new patient populations such as those harboring KRAS-mutated cancers. It highlights the broad applicability of our QS-21 STIMULON technology and could unlock a sizeable commercial opportunity in KRAS-mutated cancers.”
BioNTech and Regeneron Expand Strategic Collaboration to Advance Clinical Development of FixVac and Libtayo® (cemiplimab) Combination in NSCLC
“Advancing the sixth FixVac product candidate based on uridine mRNA into clinical development underlines the versatility and potential of this platform. Advanced NSCLC still has a five-year survival rate of only 25% leaving patients with very limited treatment options. We believe that a potent vaccine that induces strong T cell responses against shared tumor associated antigens combined with PD-1 blockade that further enables the activated T cell repertoire will help to address the high unmet medical need in this indication,” said Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. “We look forward to further building on our successful collaboration with Regeneron to accelerate the clinical development of BNT116 in our growing mRNA oncology pipeline.”
Click here for more on mergers, acquisitions, and business news
Collated by: Richa Tewari, PhD 
Editors' Desk
Richa Tewari, PhD
Oncology News
Debarati Banik
HealthIT
Sohini Dutta
BioPharma News
MedNess Plus
Manoj Mishra
Neuroimmunology and immunotherapies
Darpan Chakraborty
Social Media Manager
IP & BioPharma News
 
Nisha Peter, PhD
Consulting Editor

 
Shalini Roy Choudhury
Genes and Therapy
Managing Editor
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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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