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MedNess: bite-size biopharma and medtech news

2nd February, 2022
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MedNess This Week
HIGHLIGHTS
 
  Drug Approvals

FDA approves KIMMTRAK® (tebentafusp-tebn) for the treatment of unresectable or metastatic uveal melanoma
Bahija Jallal, Chief Executive Officer of Immunocore, said: “Today’s approval of KIMMTRAK is a historic milestone and the culmination of years of dedication by the Immunocore team, patients, and our healthcare partners. Every year in the United States, hundreds of people are diagnosed with metastatic uveal melanoma who, until now, had no approved treatment options. KIMMTRAK is the first therapy to demonstrate a survival benefit to patients with this disease and we are focused on making KIMMTRAK available as quickly as possible.

European Commission Approves KEYTRUDA® as Monotherapy for Adults With RCC at Increased Risk of Recurrence Following Nephrectomy, or Following Nephrectomy and Resection of Metastatic Lesions
“KEYTRUDA addresses a critical unmet need for treatment options that help patients reduce their risk of cancer returning following surgery,” said Dr. Thomas Powles, professor of Genitourinary Oncology and director of Barts Cancer Centre at St. Bartholomew’s Hospital. “The European Commission’s approval of KEYTRUDA brings certain patients with renal cell carcinoma a long-awaited therapy that has demonstrated a statistically significant reduction in the risk of disease recurrence or death by almost a third.”
Regulatory News

NDA for parsaclisib for the treatment of patients with R/R FL, MZL and MCL to be withdrawn

  • Incyte is withdrawing the New Drug Application (NDA) for parsaclisib for the treatment of patients with relapsed or refractory follicular lymphoma (FL), marginal zone lymphoma (MZL) and mantle cell lymphoma (MCL).
  • The decision to withdraw the NDA follows discussions with U.S. Food and Drug Administration (FDA) regarding confirmatory studies to support an accelerated approval, which Incyte determined cannot be completed within a time period that would support the investment.
  • The withdrawal of the NDA is a business decision and is not related to any changes in either the efficacy or safety of parsaclisib. The decision impacts only the FL, MZL and MCL indications in the U.S., and does not affect other ongoing clinical trials in the U.S. or other countries.
  • Additionally, as part of its ongoing portfolio prioritization and capital allocation review, Incyte has decided to opt-out of the continued development of MCLA-145. Incyte will continue to collaborate with Merus and leverage their platform to develop a pipeline of novel agents.

"The safety and well-being of people enrolled in our studies is our top priority. We will share more information with the medical and patient community as soon as we can,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “Considering the high unmet need for new medicines in myelodysplastic syndrome and acute myeloid leukemia, we will work closely with regulatory authorities worldwide to continue the magrolimab development program appropriately. We remain confident in the potential of magrolimab across a broad range of tumors, including the other, ongoing magrolimab studies. We are grateful to those participating in our studies, their families, and the investigators for their continued contributions to the clinical program for magrolimab.”
Click here for more Regulatory News
Trial Results
Two Complete Responses reported in First Three Patients Enrolled in the Phase 1b/2 KEYNOTE-B84 Study of Pepinemab + KEYTRUDA in Patients with Recurrent or Metastatic Head and Neck Cancer
Maurice Zauderer, Ph.D., President and Chief Executive Officer of Vaccinex, remarked, “We believe there is a strong rationale for continued development of pepinemab in combination with KEYTRUDA in HNSCC because these tumors are known to express high levels of SEMA4D and preclinical studies by Vaccinex and others have indicated that SEMA4D induces increased numbers and activity of myeloid suppressor cells that inhibit immune responses. Notably, pepinemab in combination with KEYTRUDA does not include administration of chemotherapy. The KEYNOTE-B84 study is accruing patients in the now open expansion phase which will enroll up to an additional 62 patients in approximately equal groups of patients with CPS <20 and CPS ≥20 across 18 U.S. trial sites. We look forward to sharing further results at a medical conference as the study progresses, with interim analysis around the midpoint of enrollment (2H 2022).”
Positive Findings from Ph 3 Trial of Tislelizumab in Combination with Chemotherapy in First-Line Gastric or Gastroesophageal Junction Cancer Announced
“The addition of tislelizumab to chemotherapy significantly extended the overall survival for previously untreated patients with advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumor expressed PD-L1. We will continue to follow up to determine OS benefits across the patient population in the trial,” commented Yong (Ben) Ben, M.D., Chief Medical Officer, Solid Tumors at BeiGene.
Click here for more Trial Results
Trial/Program Status
Update Provided on Precision Promise Trial of SM-88 in Metastatic Pancreatic Cancer
“Given pancreatic cancer’s high mortality rate, we wanted to make a difference in the lives of these patients. Our team understood that many efforts before us have failed, but based on SM-88's prior activity and safety profile, we were hopeful we could provide an effective new option for those fighting against this devastating disease,” said Richie Cunningham, Chief Executive Officer of TYME. “I want to express my sincerest appreciation to the patients, their loved ones, the researchers, and the principal investigators involved in this trial, as well as thank PanCAN and Precision Promise for their passionate dedication to exploring new treatment options for pancreatic cancer patients.”
Click here for more Trial/Program Statuses
Collated by: Richa Tewari, PhD 
Genes and Therapy
Bicistronic gene therapy shows positive initial biomarker data
Taysha Gene Therapies’ bicistronic gene therapy is designed to target two genes, HEXA and HEXB, mutations in which cause Tay-Sachs disease and Sandhoff disease, respectively. Positive results were observed for a patient treated for Sandhoff disease with 90% and 288% increase in HexA enzyme after one and three months of treatment. This patient however died, possibly due to COVID-19. A 25% increase in HexA enzyme was observed for Tay-Sachs patient after one month from therapy. TSHA-101 is administered intrathecally and is currently being evaluated in a single arm, open-label Phase 1/2 clinical trial for the treatment of infants with GM2 gangliosidosis sponsored by Queen’s University. Additional clinical safety and efficacy data are expected by the end of 2022.
The U.S. FDA issues hold on IND application for XSCID lentiviral gene therapy
The U.S. FDA issues hold on Mustang Bio’s IND application for MB-207. The IND is to initiate a pivotal Phase 2 multicenter study to assess the safety, tolerability, and efficacy of MB-207, Mustang’s lentiviral gene therapy for the treatment of patients with X-linked severe combined immunodeficiency (XSCID), also known as bubble boy disease, who have been previously treated with a hematopoietic stem cell transplantation (HSCT) and for whom re-treatment is indicated.
CONFERENCE COVERAGE: 2022 American Society for Clinical Oncology (ASCO) Gastrointestinal (GI) Cancers Symposium

  1. AVEO Oncology Presents Three Posters for Tivozanib/Immunotherapy Combinations

  2. Basilea reports updated interim results for iCCA patients with FGFR2 mutations and amplifications from phase 2 study FIDES-01

  3. Deciphera Pharmaceuticals Presents Results from the INTRIGUE Phase 3 Clinical Study

  4. ERYTECH Announces Presentation of Results of Two Clinical Trials of Eryaspase in Pancreatic Cancer

  5. Panbela Presents Clinical Data on Phase 1b Clinical Trial of SBP-101 in Combination with Gemcitabine and Nab-Paclitaxel in Patients with Metastatic PDA

  6. PCI Biotech announced the decision to stop the RELEASE study and focus drug development efforts on the fimaVacc and fimaNAc assets
Collated by: Richa Tewari, PhD 
MedNess Business
Onco-News
AstraZeneca and Scorpion Therapeutics enter agreement to discover, develop and commercialise novel cancer treatments against ‘undruggable’ targets
Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “Unlocking potentially transformative biology is pivotal for delivering the next wave of cancer treatments. Scorpion’s innovative platform is a strong strategic fit as we explore a range of new modalities across our broad drug discovery toolbox with promise to disrupt the activity of these highly-validated cancer targets.”
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

 
Rinki Saha
BioPharma News
Managing 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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