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MedNess: bite-size biopharma and medtech news

30th March, 2022
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MedNess This Week
HIGHLIGHTS
 
  Drug Approvals
FDA Approves LAG-3-Blocking Antibody Combination, Opdualag™ (nivolumab and relatlimab-rmbw), as Treatment for Patients with Unresectable or Metastatic Melanoma
“While we have made great progress in the treatment of advanced melanoma over the past decade, we are committed to expanding dual immunotherapy treatment options for these patients,” said Samit Hirawat, chief medical officer, global drug development, Bristol Myers Squibb.3 “Inhibiting LAG-3 with relatlimab, in a fixed-dose combination with nivolumab, represents a new treatment approach that builds on our legacy of bringing innovative immunotherapy options to patients. The approval of a new medicine that includes our third distinct checkpoint inhibitor marks an important step forward in giving patients more options beyond monotherapy treatment.”
 FDA Approves KEYTRUDA® for Patients With MSI‑H/dMMR Advanced Endometrial Carcinoma, Who Have Disease Progression Following Prior Systemic Therapy in Any Setting and Are Not Candidates for Curative Surgery or Radiation 
“New data from the KEYNOTE-158 trial showed an objective response rate of 46% for certain patients with advanced endometrial carcinoma that is MSI-H or dMMR treated with KEYTRUDA,” said Dr. David O’Malley, Division of Gynecologic Oncology, The Ohio State University Wexner Medical Center and The James Comprehensive Cancer Center. “The objective response rate and duration of response observed in this trial solidify the role of KEYTRUDA as a treatment option for these patients.”
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  Regulatory News

Complete Response Letter for Sintilimab + Pemetrexed and Platinum Chemotherapy for the First-Line Treatment of People with Nonsquamous NSCLC

  • FDA issued a complete response letter (CRL) for the Biologics License Application (BLA) for the investigational medicine sintilimab injection in combination with pemetrexed and platinum chemotherapy for the first-line treatment of people with nonsquamous NSCLC.
  • The letter indicates that the review cycle is complete but the FDA is unable to approve the application in its current form, consistent with the outcome of the Oncologic Drugs Advisory Committee Meeting in February.
  • The CRL includes a recommendation for an additional clinical study, specifically a multiregional clinical trial comparing standard of care therapy for first line metastatic NSCLC to sintilimab with chemotherapy utilizing a non-inferiority design with an overall survival endpoint.
  • Along with Innovent, Lilly is assessing next steps for the sintilimab program in the U.S.

Pivotal Ph 3 Trial Design for Gedatolisib in the Treatment of Advanced Breast Cancer announced
"We are excited to finalize the trial design for our pivotal Phase 3 study following productive meetings with the FDA," said Brian Sullivan, CEO and co-founder of Celcuity. "This design, we believe, provides us with an opportunity to generate data that could support the future submission to the FDA of a New Drug Application for gedatolisib to treat a broad patient population."
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Trial Results
FAILED TRIAL: CALLA Ph 3 trial of Imfinzi and chemoradiotherapy in locally advanced cervical cancer failed to meet primary endpoint of PFS improvement
Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “CALLA tested a novel immunotherapy approach in locally advanced cervical cancer, a devastating and complex disease where many patients progress following available treatments. While the results were not what we hoped for, insights from the trial will advance our understanding and application of immunotherapy across our broad clinical development programme, exploring the benefits of Imfinzi in many tumour types.”
Updated 2-THE-TOP Data Suggest Improvements in PFS, OS Compared to Matched-Control Patients from EF-14 Trial
“We are very encouraged by the data from Dr. Tran’s 2-THE-TOP study, and by the mechanistic insights published by his research group in JCI,” said William Doyle, Novocure’s Executive Chairman. “We plan to continue exploring the potential of using Tumor Treating Fields with immunotherapies, which could shift the treatment paradigm for patients with this aggressive disease.”
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Trial/Program Status
First Patient Enrolled in EMERGE-201 Ph 2 Basket Trial Evaluating Zepzelca® (lurbinectedin) in Patients with Select Advanced/Metastatic Solid Tumors
"Even with the rapid advancements in medical technology and care delivery across many tumor types over the last decade, there still remain many patients who continue to face unmet needs and experience a high burden of morbidity and mortality," said Arielle Heeke, M.D., breast medical oncologist at the Levine Cancer Institute and a primary investigator in the EMERGE-201 trial. "With the EMERGE-201 trial now underway, we look forward to seeing the potential clinical impact of Zepzelca on advanced solid tumor cancers, including HRD cancers, that have limited approved treatment options other than traditional chemotherapy. The trial will evaluate if this treatment can elicit tumor response based upon the underlying biology of these cancers and Zepzelca's novel method of action."
First Patient dosed in ADVANCED-1 Ph 1 Study of TARA-002 in Non-Muscle Invasive Bladder Cancer
“NMIBC is one of the most recurrent and difficult to treat cancers with very limited treatment options,” said Jesse Shefferman, Chief Executive Officer of Protara Therapeutics. “We are thrilled to have dosed the first patient in our Phase 1 study in NMIBC and look forward to exploring TARA-002’s full potential in this pressing area of high unmet need.”
Collated by: Richa Tewari, PhD 
Genes and Therapy
Positive initial clinical trial data for gene therapy against dystrophic epidermolysis bullosa 
Krystal Biotech’s positive results from the Phase 1 and 2 study of topical beremagene geperpavec (B-VEC) for the treatment of dystrophic epidermolysis bullosa (DEB) was published in Nature Medicine. The trial shows that repeat topical applications of B-VEC were associated with durable wound closure, full-length cutaneous type VII collagen (COL7) expression, and anchoring fibril assembly with minimal reported adverse events. B-VEC is an investigational non-invasive, topical, redosable gene therapy designed to deliver two copies of the COL7A1 gene when applied directly to DEB wounds. B-VEC was designed to treat DEB at the molecular level by providing the patient’s skin cells the template to make normal COL7 protein, thereby addressing the fundamental disease-causing mechanism.
Taysha Gene Therapies initiates development of gene therapy for Rett Syndrome
Taysha Gene Therapies has initiated the development of TSHA-102, which utilizes novel miRARE platform to regulate transgene expression genotypically on a cell-by-cell basis, and is the only gene therapy in clinical development for Rett syndrome. TSHA-102 has yielded positive preclinical data in non-primate and primate models. Clinical Trial Application (CTA) for the gene therapy has been approved by Health Canada in March 2022.
MedNess Business
Onco News
Transcenta and BMS to Evaluate TST001 in Combination with Opdivo® in Patients with Locally Advanced or Metastatic Gastric/Gastroesophageal Junction Cancer
"TST001 is a high affinity humanized monoclonal antibody targeting Claudin18.2. It has shown to be safe in ongoing trials as monotherapy or in combination with chemotherapy and displayed encouraging anti-tumor activity signals in gastric cancer and other solid tumor patients expressing Claudin18.2. TST001 works through NK cell mediated antibody dependent cellular cytotoxicity to exert its anti-tumor activity, and the addition of PD-1 inhibitor and chemotherapy have resulted in synergistic effects in preclinical models. We are excited to test the combination of TST001 with Opdivo for the treatment of metastatic gastric / gastroesophageal junction cancer as a new potential treatment option for these patients." said Dr. Michael Shi, EVP, Head of Global R&D and CMO of Transcenta.
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 
Concept and Design: Ananda Ghosh and Nisha Peter
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