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MedNess: bite-size biopharma and medtech news

16th June, 2021
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MedNess This Week
HIGHLIGHTS
Onco-I-Analyse
BMS’ Breyanzi beats chemotherapy + HSCT in 2nd line R/R Large B-cell Lymphoma
On 10th June, BMS announced that Breyanzi (lisocabtagene maraleucel/liso-cel/JCAR017) met the primary endpoint of event-free survival (EFS) in a Phase 3 TRANSFORM trial against the standard of care high dose chemotherapy (HDCT) followed by hematopoietic stem cell transplant (HSCT) in high-risk patients with relapsed or refractory (R/R) large B-cell lymphoma . 
Background: HDCT followed by SCT is considered the gold standard for patients with LBCL. However, the therapy is very intense with considerable side-effects. Thus, there is a significant unmet need for newer, better therapies for patients with R/R LBCL. ​
Details: The trial evaluated Breyanzi as second line therapy, against SoC (salvage therapy including R-DHAP/R-ICE/R-GDP à HDCT à HSCT), in transplant-eligible patients with either primary refractory LBCL or had relapsed within 12 months of frontline therapy.
A pre-specified interim analysis by independent review committee (IRC) demonstrated that Breyanzi showed a clinically meaningful and ‘highly’ statistically significant benefit in EFS. Although, the OS data was still immature, the trial exhibited meaningful improvements in other key secondary endpoints of CR rate and PFS. The toxicity profile was compared to safety results from the TRANSCEND-NHL-001 trial.
The company will present detailed results at an upcoming medical meeting and will also submit the data to regulatory agencies.
In February 2021, Breyanzi was approved by the US FDA as a 3L+ treatment for R/R LBCL based on Phase 1 TRANSCEND-NHL-001 trial.
Implications: Usually, CAR-Ts are considered later in the treatment algorithm, but Breyanzi is the first CD19 CAR-T to show improvements over the gold standard and demonstrate promise as 2nd line therapy for this patient segment, as per the company.
Although BMS’ Breyanzi was the third approved CAR-T in 3rd L LBCL after Novartis’ Kymriah and Gilead’s Yescarta, these results put BMS ahead of its competitors in second line. Gilead and Novartis are also evaluating their CAR-T therapies in 2L DLBCL in Phase 3 trials.
If approved, Breyanzi will move up in the earlier treatment lines for LBCL and as per analysts could generate sales of USD 1+ billion.
Collated by : Shilpa Rawal, PhD
Trial Results
Positive Topline Results of Pivotal Ph III TULIP® Study announced in Patients with HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer
“There is considerable unmet medical need in patients with HER2-positive metastatic breast cancer and [vic-]trastuzumab duocarmazine represents a promising potential clinical advance,” said Byondis Chief Medical Officer Jan Schellens, M.D., Ph.D. “We are excited by the topline results of TULIP and indebted to all patients who participated in the clinical studies.”
Calquence demonstrated fewer incidences of atrial fibrillation versus ibrutinib in previously treated patients with CLL and sustained patient benefit at four years in the front-line setting
Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: “Tolerability is a critical factor in treating patients with chronic lymphocytic leukaemia who often remain on medicines for many years and experience multiple comorbidities. The totality of the Calquence data at ASCO confirm our confidence in the favourable benefit-risk profile of this medicine, with over 40 months of follow up in each of these two trials. Together, the results provide strong evidence that Calquence is a preferred option for people living with this chronic and devastating disease.”
Click here for more Trial Results
Trial/Program Status
First Patient with MZL Dosed in Expanded Global Ph 2 TIDAL Study of Zandelisib
"Relapsed and refractory marginal zone lymphoma is an incurable disease for which there are limited available therapeutic options for patients who may not have responded to conventional therapies," said Pier Luigi Zinzani, M.D., Ph.D. Professor, Institute of Hematology Seràgnoli University of Bologna, Bologna, Italy, and co-chair of the global TIDAL study. "Given the positive and encouraging results to date with zandelisib, we are eager to further evaluate the potential benefit zandelisib may offer patients with marginal zone lymphoma."
First patient dosed in Ph 2 KICKSTART clinical trial of tomivosertib in combination with KEYTRUDA® in NSCLC patients
“We observed in our Phase 2a trial of tomivosertib in combination with checkpoint inhibitors that following disease progression, the addition of tomivosertib was correlated with a noted change in tumor trajectory, as well as durable treatment benefit, demonstrating our product candidate’s potential to reverse resistance to checkpoint inhibitors. Furthermore, a retrospective analysis of the Phase 2a data showed that PD-L1 positivity correlated with duration of benefit, supporting use of PD-L1 >50% as a biomarker for patient selection in KICKSTART,” said Steve Worland, Ph.D., President and CEO of eFFECTOR. “Based on those encouraging results that substantially extended patient benefit from immunotherapy, we are launching KICKSTART to be focused in both the frontline and frontline-extension settings in combination with pembrolizumab. We designed tomivosertib to down-regulate multiple factors that suppress an immune response and to reprogram T cells to enhance immune response and fight tumors, and ultimately hope to bring a novel and improved treatment option for patients with cancer.”
Click here for more Trial Statuses
CONFERENCE COVERAGE: Highlights from European Hematology Association (EHA) 2021 Virtual Congress 
1.    BeiGene Presents ALPINE Results at Demonstrating Both Efficacy and Safety Advantages of BRUKINSA® (Zanubrutinib) in Head-to-Head Comparison to Ibrutinib in CLL
2.    BeiGene Presents Long-Term Efficacy and Safety Results from Three Pivotal Trials of BRUKINSA® (Zanubrutinib) and Tislelizumab
3.    BerGenBio presents encouraging preliminary updated data from Ph 2 study in rAML patients
4.    CAPTIVATE Study Shows an IMBRUVICA® + VENCLEXTA® Chemotherapy-Free Combination Has Potential to Provide Remission After Fixed-Duration Treatment for CLL
5.    IMBRUVICA® + VENCLEXTA® Combination Shows Superior PFS Compared to Chlorambucil + Obinutuzumab in 1L CLL Ph 3 GLOW Study
6.    Innovent Biologics and IASO Biotherapeutics to Present Updated Data from  Anti-BCMA CAR-T Therapy in Relapsed/Refractory Multiple Myeloma
7.    Karyopharm Announces XPOVIO® (selinexor) Data to be Presented 
8.    Mustang Bio Announces Updated Interim Ph 1/2 Data for MB-106 CD20-Targeted CAR T in Patients with R/R B-cell NHL and CLL
9.    New Data Shows VENCLYXTO® Fixed Duration Combination Demonstrates Sustained PFS in CLL Patients after Three Years off Treatment
10.    Roche announces data reinforcing efficacy of Venclexta/Venclyxto combinations in CLL & AML
Collated by : Richa Tewari, PhD 
       MedNess @ HealthIT
Eye health is about to get a facelift via clinical decision tool from Bausch + Lomb
Bausch + Lomb, a company well-known in the world of eye health is collaborating with the software company Lochan to form the next generation of clinical decision support software, named as eyeTELLIGENCE. The analytic cloud-based software was originally launched in 2018, intended for ophthalmologists to streamline complex surgery processes and facilitate treatment/care. Through this partnership, Bausch + Lomb anticipates bringing in artificial intelligence and analytics expertise of Lochan to their portfolio of clinical support tools. The tool is designed to bridge the gaps in data management and digital systems for ophthalmologists, still struggling for a streamlined system requiring to manually transfer vast amounts of data. According to Mark Lobanoff, MD, founder of Lochan and director of refractive surgery at the North Suburban Eye Specialists, "As a practicing surgeon, I have experienced first-hand the disconnect that exists between the different phases of the surgical planning process and the lack of interconnectivity between technologies that we use."
In this era of physician burnout and shortage, which is even aggravated by the COVID-situation, an improvement in digital tools for clinical decision support integrated with the EHR system, is imperative to reduce burden on physicians. Development of this tool for the ophthalmologists shows hope for increased physician retention and decreased administrative burdens due to vast amounts of data that providers need to deal with on a regular basis.
Colonoscopy screening gets a new aid through AI
By implementing an FDA approved computer-aided polyp detection (CADe) tool, The Ohio State Wexner Medical Center and the Ohio State Comprehensive Cancer Center (OSUCCC) in Ohio state University becomes the first academic medical center to take advantage of this AI powered tool to detect early state colorectal cancer. The equipment in use is GI Genius, a medical device approved by FDA in April 2021. It leverages AI to generate markers and superimpose them on the video screen for the gastroenterologists to detect lesion. The AI algorithm highlights portions of the colon where there may be a potential lesion, including polyps or suspected tumors, in real time during a colonoscopy.
According to Darwin L. Conwell, MD, director of the Division of Gastroenterology, Hepatology and Nutrition at the Ohio State College of Medicine, “This is truly a game-changer for early detection of colorectal cancer because it pairs the expertise of a highly trained physician with the power of artificial intelligence to identify potential high-risk lesions that may have gone undetected with the human eye alone.” CDC has declared colon cancer as the second leading cause of cancer deaths in the nation, and the third most common cancer for both men and women. Polyps are the precancerous growths in colon that needs to be identified and addressed for the diagnosis of pancreatic cancer. Racial disparity and social determinants of health play large roles in the development and diagnosis of the disease. According to CDC, 21.7 million adults between the ages of 50 and 75 have never been screened for colon cancer. GI Genius, in combination of the expert eyes of gastroenterologists, brings us closer to a more accurate level of diagnosis at an early stage, promising to save many more lives.
Collated by: Debarati Banik, PhD
MedNess Reviews
Nucleome Therapeutics Plans to Use Novel 3D Genome Mapping Method for Drug Discovery
Nucleome Therapeutics, a University of Oxford spinout aims to unlock the non-coding part of the genome for drug target discovery and development. The company is working on novel method for 3D analysis of the genome known as micro-capture-C, or MCC. The method was invented at the University of Oxford and maps the 3D genome structure at unprecedented single base-pair resolution.
In the recent study published in Nature, the University of Oxford researchers reported that MCC could spot the physical interactions between gene-regulating proteins and the DNA code itself at base-pair resolution even though one targeted string may be controlled by genes located tens of thousands to millions of base pairs further along the chain. Such high-resolution 3D genome mapping improves the accuracy and confidence of linking disease-relevant genetic changes to genes.
Nucleome Therapeutics plans to use its technique to identify the genes at play behind severe COVID as well as find new drug targets for diseases such as rheumatoid arthritis and multiple sclerosis. The company has exclusively licensed the technology from the University of Oxford.
MedNess Business
Onco-News
ALX Oncology to Collaborate with Lilly to Evaluate ALX148 + CYRAMZA® (Ramucirumab), Trastuzumab, and Paclitaxel in Patients with Gastric or GEJ Cancer
“We are thrilled to enter this collaboration with Lilly that aims to provide a CD47-targeted combination regimen for gastric or gastroesophageal junction cancer patients in need of novel effective treatment options,” said Jaume Pons, Ph.D., Founder, President and Chief Executive Officer of ALX Oncology. “Our team has worked tirelessly to advance the clinical development of ALX148 in the fight against cancer, and we believe that ALX148 has the potential to be best-in-class as a new foundational immunotherapy in both hematologic and solid tumors.”
Shoreline Biosciences and BeiGene Announce Strategic Worldwide Collaboration to Develop and Commercialize Genetically Modified NK Cell Therapies
“BeiGene is a globally recognized biotechnology leader, and we are thrilled to announce our collaboration today,” said Kleanthis G. Xanthopoulos, Ph.D., Shoreline Chairman & CEO. “We look forward to combining our iPSC NK cells with BeiGene’s discovery and clinical development expertise as the parties work to accelerate the development of the next generation of cell therapies for patients around the world.”
Collated by: Richa Tewari, PhD 
Editors' Desk
Richa Tewari, PhD
Oncology News
Shilpa Rawal, PhD
Onco I-Analyse
Arundithi Ananthanarayanan
MedNess Reviews
Divyaanka Iyer
BioPharma News
Debarati Banik
HealthIT
Darpan Chakraborty
Social Media Manager
Nisha Peter, PhD
Consulting Editor
Abhi Dey
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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