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MedNess: bite-size biopharma and medtech news

21st April 2021
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MedNess This Week
HIGHLIGHTS
     Onco-I-Analyse

GSK discontinues clinical trials of feladilimab in SCCHN
On 14th April, GSK announced that it has halted two Phase II/III clinical trials of feladilimab, an ICOS agonist, investigating the drug as frontline treatment in recurrent locally advanced or metastatic head and neck squamous cell carcinoma (SCCHN).
Background: Head and neck squamous cell carcinoma is the 7th leading cancer in the world with a 5-year survival rate of ~40% in patients with distant metastasis. Pembrolizumab, in combination with -FU-platinum chemotherapy, is the preferred SoC for frontline treatment with mOS of 13 months while pembrolizumab monotherapy is recommended for patients with PD-L1+ tumors. ICOS agonists are expected to enhance the activity of checkpoint inhibitors.
Details: Following a recommendation by the Independent Data Monitoring Committee (IDMC), GSK decided to stop enrolment and simultaneously suspend treatment of patients in Phase II/III INDUCE-3 and INDUCE-4 trials.
Both trials were investigating feladilimab combination therapy as first line treatment for recurrent or metastatic SCCHN. While INDUCE-3 was evaluating feladilimab + pembrolizumab versus pembrolizumab monotherapy in PD-L1+ patients, INDUCE-4 was investigating feladilimab + pembrolizumab + 5-FU-platinum chemotherapy versus pembrolizumab + 5-FU-platinum chemotherapy in patients with known PD-L1 status.
Earlier, GSK evaluated the safety and tolerability of feladilimab combination therapy in the Phase I INDUCE-1 trial. Interim analysis demonstrated that the combination had manageable safety profile with mostly Grade 1-2 AEs.
Implications: Although the company has not yet disclosed the reason behind discontinuation of studies, it is likely that feladilimab combination therapy did not provide the desired clinical benefits. GSK will now evaluate the totality of data to assess overall clinical development of feladilimab in oncology.
In Nov 2020, Jounce Therapeutics terminated clinical trial of its ICOS agonist, vopratelimab, in combination with ipilimumab (CTLA-4i) after an interim analysis.
Collated by : Shilpa Rawal, PhD
    Drug Approvals
EU Approves for Opdivo® + Cabometyx® (cabozantinib) as 1L Treatment for advanced RCC Patients
“With this approval, we can now offer patients two different Opdivo-based combinations that have demonstrated significant survival benefits versus sunitinib,” said Dana Walker, M.D., M.S.C.E., vice president, development program lead, genitourinary cancers, Bristol Myers Squibb. “Today’s milestone builds on our heritage of developing and delivering novel treatments for patients with advanced renal cell carcinoma, first with the only dual immunotherapy option, Opdivo plus Yervoy, and now with a new immunotherapy and tyrosine kinase inhibitor regimen. We look forward to working with a broad range of European stakeholders to bring Opdivo in combination with Cabometyx to patients who may benefit from this treatment.”
 
U.S. FDA Grants Accelerated Approval to Trodelvy® for the Treatment of Metastatic Urothelial Cancer
“Only a fraction of patients derives long-term benefit from previously approved cytotoxic therapy or immunotherapy, leaving a great unmet need for treatment options for patients with advanced urothelial cancer who have progressed on first- and second-line therapies,” said Scott T. Tagawa, MD, MS, FACP, Professor of Medicine and Urology at Weill Cornell Medicine, an oncologist at New York-Presbyterian/Weill Cornell Medical Center and principal investigator of the TROPHY study. “The response rate and tolerability seen with sacituzumab govitecan-hziy may provide physicians an effective new treatment option for patients whose cancer continues to progress even after multiple therapies.”
Click here for more Drug Approvals
Regulatory News
U.S. FDA Filing Acceptance for Priority Review of Tisotumab Vedotin BLA for Patients with Recurrent or Metastatic Cervical Cancer
“The FDA’s filing of the tisotumab vedotin BLA with Priority Review marks an important step forward for this ADC as a potential treatment for patients with recurrent or metastatic cervical cancer,” said Roger Dansey, M.D., Chief Medical Officer at Seagen. “We are collaborating closely with the FDA throughout the review process to make this important therapy available to patients.”
Trial Results
Safety of Tegavivint Confirmed Following Completion of Enrollment in Ph 1/2a Expansion Study in Patients with Desmoid Tumors
"We have seen very good tolerability with no dose-limiting toxicities and no significant adverse events in escalating clinical doses," said Casey Cunningham, Chief Medical Officer of Iterion. "We are seeing a very strong safety signal in patients who have been on Tegavivint for over a year and are also observing tumor activity in patients. We continue to follow the patients that are still receiving treatment and look forward to sharing efficacy results at an upcoming medical conference." 
Darovasertib (IDE196) Monotherapy Overall Survival Data Reported and Early Partial Responses Observed in Binimetinib Combination in Metastatic Uveal Melanoma
"The darovasertib single-agent one-year survival data in MUM is encouraging and compares favorably to historical survival rates in this indication, where a therapy has yet to be approved," said Meredith McKean, MD, MPH, Associate Director, Melanoma and Skin Cancer Research,  Sarah Cannon Research Institute at Tennessee Oncology, Nashville, TN. "The early partial responses observed in the darovasertib and binimetinib combination in MUM are exciting where historical response rates have been from zero to low to mid-single-digit percent, and we look forward to seeing the data set mature," said Richard Carvajal, MD, Co-Leader, Precision Oncology and Systems Biology Program, Director of Experimental Therapeutics and Director of the Melanoma Service, Columbia University Irving Medical Center.
Trial/Program Status
Update Announced on Ph 3 Pivotal LUNAR Trial of Tumor Treating Fields in NSCLC
“We are very pleased with the DMC recommendations, which we believe support the potential for TTFields to make a significant difference in treatment outcomes for patients with non-small cell lung cancer, whether used together with immune checkpoint inhibitors or docetaxel,” said William Doyle, Novocure’s Executive Chairman. “The accelerated interim analysis with an encouraging outcome adds to the accumulating evidence of Tumor Treating Fields’ broad potential across a range of hard-to-treat cancers.”
Partial Clinical Hold Lifted on Ph I SBP-101 Study in Pancreatic Cancer
  • U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on the Ph 1 first-line study of SBP-101 when used in combination with standard of care agents gemcitabine and nab-paclitaxel for treatment of patients with metastatic pancreatic ductal adenocarcinoma (PDA).
  • SBP-101 is a polyamine metabolic inhibitor.
Panbela Therapeutics has agreed to include in the design of all future studies the exclusion of patients with a history of retinopathy or at risk of retinal detachment and scheduled ophthalmologic monitoring for all patients.
Click here for more Trial Statuses
Conference Coverage: AACR 2021
  1. Advaxis Presents Translational Biomarker Data from Ongoing ADXS-503 Ph 1/2 Lung Cancer Trial
  2. Affimed Announces Initial Data from Ph 1 Study of Cord Blood-derived NK Cells Pre-complexed with Innate Cell Engager AFM13
  3. Arcus Biosciences Presents Updated Data for Etrumadenant in 3L mCRC and New Data on its HIF-2α Program
  4. AstraZeneca accelerates early oncology pipeline across key strategic scientific platforms
  5. BeiGene Presents Interim Analysis Results of RATIONALE 303 Trial of Tislelizumab in 2L/3L NSCLC patients
  6. BioLineRx to present analysis of results by liver metastases from the COMBAT/KEYNOTE-202 triple combination study of motixafortide in metastatic pancreatic cancer
  7. Codiak Presents Data Demonstrating Potential of Engineered Exosomes to Enhance the Therapeutic Index of Well-Validated Cancer Immunotherapy Pathways
  8. Clovis Oncology Highlights Rubraca® (Rucaparib) Clinical Data
  9. Copanlisib-Rituximab Combination Cuts Lymphoma Progression or Death by Nearly Half in CHRONOS-3 Trial
  10. Greenwich LifeSciences Presents Immune Response Ph 2b Poster, Showing Peak Immunity after 6 Months of GP2 Treatment, Resulting in 100% DFS from Recurring Breast Cancer
  11. GT Biopharma announced additional interim results from its GTB-3550 TriKE™ first-in-human Ph 1/2 clinical trial for the treatment of high-risk MDS and R/R AML
  12. HOOKIPA announces positive preliminary Ph 1 immunogenicity data for its immunotherapy candidates to treat advanced HPV16+ cancers
  13. Interim late-breaking clinical data validate not-alpha profile of THOR-707 (SAR444245), Sanofi’s novel investigational IL-2
  14. Investigational Combination of Aliqopa® (copanlisib) and rituximab Significantly Increases PFS in Patients with Relapsed iNHL
  15. Iovance Biotherapeutics Announces Clinical Data Updates for Lifileucel in Advanced Melanoma
  16. iTeos Therapeutics Announces New Preliminary Data Indicating Clinical Activity with its Anti-TIGIT Antibody, EOS-448
  17. Kintara Presents Updates on Two Ph 2 Clinical Trials
  18. Lilly Presents New Data on Retevmo® (selpercatinib) in Advanced RET Fusion-Positive Gastrointestinal and Other Cancers
  19. New Clinical Responses for AGEN1181 Presented
  20. Neoadjuvant Opdivo + Chemotherapy Significantly Improves pCR in Patients with NSCLC in Ph 3 CheckMate-816 Trial
  21. Oncocyte presents new data demonstrating potential for pan-cancer utility of Determaio™
  22. Rubius Therapeutics Presents Initial Clinical Results from the Ongoing Ph 1/2 Clinical Trial of RTX-240 in Advanced Solid Tumors
  23. Seagen to Highlight Data from Novel Targeted Therapies
  24. Spectrum Pharmaceuticals Presents Additional Twice Daily Dosing Data for Poziotinib
  25. Taiho Oncology announced efficacy and safety results from the Ph 2 FOENIX-CCA2 trial oh futibatinib (TAS-120) in patients with intrahepatic cholangiocarcinoma (iCCA) harboring FGFR2 gene rearrangements including gene fusions who have failed at least one line of therapy
  26. Transgene presents initial Ph 1 data of TG6002, highlighting the potential of the intravenous administration of its oncolytic viruses
  27. Ultimovacs Presents the INITIUM Study Design as a Trial-in-Progress Poster
  28. Zentalis Pharmaceuticals announced initial efficacy and safety data from the Ph 1 dose-escalation portion of ongoing Ph 1/2 clinical trial of ZN-c3 in patients with advanced solid tumors
Collated by : Richa Tewari, PhD
MedNess @ HealthIT
 

NIH coming to the aid of opioid research through collaborations and data management platforms
Helping to End Addiction Long-term (HEAL), a program led by NIH is leveraging data management and stewardship expertise to advance research on opioid crisis. NIH has allocated a sum of $21.4 million funding to be distributed over five years to the Renaissance Computing Institute (RENCI) at the University of North Carolina at Chapel Hill and RTI International to prepare and sustain data from 500+ studies. The project will utilize a cloud-based solution to break down silos of data storage, and exchange information securely amongst researchers and policy makers. According to Rebecca G. Baker, PhD, director of the NIH HEAL Initiative Baker, “To be maximally useful, data must be findable to support new research and secondary analyses, as well as to guide education and policy about pain and addiction.” The data for the HEAL project will be sourced but not limited to imaging and microscopy, behavior, genomics, and pharmacokinetics. According to tan Ahalt, director of RENCI: “Given the urgency of HEAL's mission, we are thankful to be able to provide expertise that can facilitate discovery of important elements hidden within the data.”
Microsoft’s acquiring of Nuance may open new horizon in AI-empowered healthcare delivery
A recent acquisition of Nuance by Microsoft via a $20 billion deal may position AI on the verge of breaking into front-end care delivery, in the form of voice recognition and virtual assistant technologies. Nuance is a leading provider of conversational AI and cloud-based intelligence for healthcare, leveraging speech-recognition technologies. According to Microsoft CEO Satya Nadella, this merger is about empowering healthcare and reducing costs: “It’s now very clear that healthcare organizations that accelerate their digital investments can improve patient outcomes and reduce cost at scale.” According to Girish Venkatachaliah, former vice president of athena.Intelligence, athenahealth, AI can be an incredibly useful tool in performing grunt work and reduce administrative burden/friction within the system, and this is where their needs are. At this era, voice recognition technology in clinical care has become relatively common, and the involvement of tech giants such as Microsoft is an indication that the pandemic has ramped up the motivation for them to explore the healthcare sector. Another example of such an initiative is the announcement of Suki, a provider of voice AI technology for healthcare, to join the American Association of Orthopaedic Surgeons’ (AAOS) Member Advantage Program. Suki aims to offer its AI-powered, voice-enabled digital assistant to AAOS’ 39,000 orthopaedic surgeons for creating clinical notes and perform administrative tasks, with considerably more accuracy and speed than ever before.
MedNess Reviews

Sanofi Acquires Tidal Therapeutics in a $470m deal
Sanofi has acquired a preclinical biotech company Tidal Therapeutics to add an advanced mRNA-based research platform with applications in various disease areas to its portfolio. The deal totals approximately $470 with an upfront payment of $160 million.
Tidal Therapeutics, a Fred Hutchinson Cancer Research Center spin-off has been attracting much attention despite keeping a low profile. The company’s technology is an m-RNA based approach for in vivo reprogramming of immune cells that could enable patients to make their own CAR-T cells, eliminating the complex cell therapy supply chain while improving safety and dosing.
Tidal’s proprietary nanoparticles deliver mRNA to reprogram immune cells in the body, Tidal Therapeutics’ technology provides mRNA cargos selectively to certain types of cells in the body, with initial applications targeting special types of immune cells.
The in vivo approach could potentially offer similar efficacy to existing ex vivo approaches where immune cells are genetically modified to boost their therapeutic properties, thereby possibly enhancing safety, outpatient dosing and repeat dosing.
At present, Tidal Therapeutics is progressing pre-clinical programmes, including in vivo reprogramming of T cells or other immune cell types for cancer indications.
MedNess Business
BridgeBio Pharma And UCSD, UCD, Roswell Park, Oregon Health & Science University, Gylconet, and Lundquist Institute Announce Collaboration To Advance Treatments For Genetically Driven Conditions
“UC San Diego is a leading research institution with a top pharmacology department and a strong profile in neurology and oncology. By leveraging their expertise through our collaboration partnership, we hope to advance discoveries into potential treatments as quickly and safely as possible,” said BridgeBio founder and CEO Neil Kumar, Ph.D.
TILT Biotherapeutics and MSD to collaborate on clinical trial of adenoviral cancer immunotherapeutic TILT-123 in combination with KEYTRUDA® (pembrolizumab) for ovarian cancer
TILT Biotherapeutics’ CEO, Akseli Hemminki, a biotech entrepreneur and cancer clinician who has personally treated almost 300 patients with ten different oncolytic viruses, said, “There is a pressing need for a therapy to address platinum refractory ovarian cancer. The heart of our approach revolves around the use of oncolytic adenoviruses armed with cytokines to boost the patient’s immune response towards the tumor, enabling it to find and destroy cancer cells. We are delighted to be working with MSD to progress our lead candidate, TILT-123, towards the clinic in combination with its breakthrough immunotherapy KEYTRUDA.”
Click here for more on mergers, acquisition and business news 
Collated by : Richa Tewari, PhD
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
Managing Editor
Shalini Roy Choudhury
Managing Editor
Nisha Peter, PhD
Consulting Editor
Abhi Dey
Consulting 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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