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MedNess: bite-size biopharma and medtech news

25th November, 2020
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HIGHLIGHTS
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Onco I-Analyse
ADC Therapeutics’ Lonca has been accepted for Priority Review by the US FDA
On 20th November, the US FDA accepted the BLA for Loncastuximab Tesirine (Lonca; ADCT-402), CD19-targeting ADC, being developed by ADC Therapeutics, for priority review in relapsed or refractory Diffuse Large B-cell Lymphoma (R/R DLBCL) patients with ≥2 prior lines of treatment. The PDUFA action date has been set for May 21, 2021.
The company had submitted the BLA on 21st September based on the pivotal, single-arm Ph 2 LOTIS 2 study evaluating Lonca in R/R DLBCL. Results in 145 patients (data cut-off date - April 6, 2020) with median of 3 prior therapies, demonstrated an ORR of 48.3% and CR of 24.1%. Lonca had a manageable safety and tolerability profile with following grade ≥3 treatment-emergent adverse events (TEAEs) in ≥10% patients - neutropenia (25.5%), thrombocytopenia (17.9%), GGT increased (16.6%) and anaemia (10.3%). Further subgroup analysis data will be presented at ASH Annual Meeting.
ADC Therapeutics is preparing for commercial launch of Lonca in the US in mid-2021. In this regard, it is building its sales force and claims to cover 90% of DLBCL treating haematologists/oncologists.  
Additionally, in September, a Phase 3 LOTIS 5 confirmatory trial was initiated in combination with rituximab in patients with ≥1 prior therapy and ineligible for ASCT. This will be an LCM strategy to bring Lonca forward in the treatment architecture of DLBCL. Another pivotal, Phase 1/2 LOTIS 3 trial in combination with ibrutinib in R/R DLBCL or MCL is enrolling patients. A Phase 2 trial will be initiated in R/R follicular lymphoma in H1 2021 to further explore opportunities in other NHL indications.
Lonca will be competing against two CAR-T therapies – Yescarta (Kite Pharma/ Gilead) and Kymriah (Novartis) also approved in 3L+ DLBCL. BMS’ Lisocabtagene Maraleucel is also under review by the FDA for 3L+ DLBCL. However, given the complexity of treatment and associated AEs with CAR-Ts, treatment with ADCs might present certain advantages despite lower response rates.
Furthermore Lonca will need to carve out a market share against 2 other combination therapies – Monjuvi (MorphoSys-Incyte; CD19-targeting mAb) and Polivy (Roche; CD79b targeting ADC) were granted approvals in 2L (accelerated approval) and 3L DLBCL, respectively.
Collated by :Shilpa Rawal, PhD
Drug Approval
Imfinzi approved in the US for less-frequent, fixed-dose use
Victoria M. Villaflor, MD, Clinical Professor in the Department of Medical Oncology and Therapeutics Research at City of Hope Cancer Center, Los Angeles, California, said: “This new four-week dosing option gives doctors the choice to cut the number of visits for critical cancer treatment in half and offers a regimen that is more convenient for patients. Additionally, it limits potential exposure to infection in the healthcare environment for a population that is especially vulnerable to complications from COVID-19.”
Regulatory News
FDA’s review of BLA for lisocabtagene maraleucel (liso-cel) in R/R large B-cell lymphoma not to be completed by PDUFA action date of November 16, 2020
“Bristol Myers Squibb continues to work closely with the FDA to support the ongoing review of the BLA for liso-cel,” said Samit Hirawat, M.D., executive vice president, chief medical officer, global drug development, Bristol Myers Squibb. “We are committed to bringing liso-cel to patients with relapsed or refractory large B-cell lymphoma who still have significant unmet need.”
FDA Lifts Clinical Hold on MELANI-01 Study Evaluating UCARTCS1 in Multiple Myeloma
“We remain confident in the potential clinical benefit of UCARTCS1 product candidate for patients with relapsed/refractory multiple myeloma, a widely unmet medical need that Cellectis will continue to address. The safety of patients enrolled in our clinical trials remains our priority, and we are committed to resuming the clinical development of this promising program,” said Carrie Brownstein, MD, Chief Medical Officer, Cellectis.
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Trial Results
Complete and Durable Responses Observed in OPTIMA II Ph 2b Final Results for UGN-102 in Patients with Low-Grade Intermediate Risk NMIBC
“The current approach to treating patients diagnosed with low-grade intermediate risk non-muscle invasive bladder cancer is surgery. In most cases, the cancer comes back and repetitive surgical intervention is required. This puts a tremendous burden on patients and their families and can even be life-threatening,” said Andrea Maddox-Smith, Chief Executive Officer, Bladder Cancer Advocacy Network. “Being able to provide patients with an alternative, non-surgical treatment option that is effective, well-tolerated and durable, would greatly benefit those in the patient community.”
RATIONALE 303 Trial of Tislelizumab in NSCLC Met the Primary Endpoint of OS at Interim Analysis
“The RATIONALE 303 trial is the third Phase 3 trial of tislelizumab in NSCLC that has achieved a positive outcome at interim analysis, and more importantly, marks the first global pivotal trial with a positive outcome in the tislelizumab clinical program, demonstrating BeiGene’s capabilities in global clinical development. We look forward to sharing the full results at an upcoming medical conference and providing additional updates on our lung cancer program in the future,” commented Yong (Ben) Ben, M.D., Chief Medical Officer, Immuno-Oncology at BeiGene. “As we continue to advance tislelizumab in its broad clinical program, which targets a wide range of prevalent cancer types, we expect to see a growing body of clinical evidence that we believe will help further evaluate this potentially differentiated checkpoint inhibitor and support potential regulatory filings in China and globally.”
SNO 2020: Interim data from Ph 1/2 trial of INO-5401 + INO-9012 + Libtayo® (cemiplimab) in 1L GBM patients presented
Dr. David Reardon, Clinical Director of the Center for Neuro-Oncology at the Dana-Farber Cancer Institute and coordinating principal investigator of GBM-001 said, "This is a landmark combination trial in which a novel DNA vaccine is combined with a checkpoint inhibitor and radiation and chemotherapy. We look forward to continuing to review these data, with an eye towards those patients who are most likely to benefit from this innovative approach and to see whether, over time, there is an extension of survival in these very hard-to-treat patients. Coupling immune response with clinical outcome may prove insightful."
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Collated by : Richa Tewari, PhD
Medness Business
Onco-News

Olema Oncology and Pfizer to Evaluate OP-1250 + Palbociclib (IBRANCE®) Combination in Advanced Metastatic Breast Cancer
"This agreement with Pfizer represents continued momentum toward our goal of advancing the clinical development of OP-1250," said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "We look forward to learning more about the potential of OP-1250 in combination with palbociclib in patients living with breast cancer."
Zymeworks and ALX Oncology to evaluate Zanidatamab + ALX148 in Patients with Advanced HER2‑Expressing Breast Cancer
“In addition to broad anti-tumor activity, zanidatamab’s safety profile supports combination approaches with other therapeutics,” said Diana Hausman, M.D., Chief Medical Officer at Zymeworks. “Our collaboration with ALX Oncology and their CD47 blocker, ALX148, has the potential to further expand the opportunity for zanidatamab to provide benefit to a broader population of patients, including those with advanced HER2‑expressing breast cancer.”
MD Anderson and Obsidian Therapeutics to accelerate advancement of novel engineered tumor infiltrating lymphocyte therapy (cytoTIL™) for solid tumors
“TIL therapy has emerged as a promising option for treating patients with solid tumors, though its widespread use today is limited by safety and efficacy challenges,” said Rodabe Amaria, M.D., associate professor of Melanoma Medical Oncology at MD Anderson. “We are pleased to work with Obsidian to advance their novel cytoTIL program, which has the potential to drive more durable treatment responses and expand TIL therapy to a broader group of our patients.” 
BioPharma and MedTech
Precision Bioscience cuts a research collaboration and licensing deal with Eli Lilly for its gene-editing platform ARCUS®
20th November 2020: Precision Biosciences (North Carolina) announced a research collaboration and exclusive license agreement with Eli Lilly worth up to $555M. Precision Bioscience has developed a versatile genome editing technology ARCUS®, derived from a highly specific natural genome-editing enzyme called I-CreI. Under the terms of this license agreement Precision will receive $100M upfront. Eli Lilly will also invest $35M in Precision stock. Future payments up to $420 million would include milestones and royalties on developed products.
"We look forward to working with Lilly to leverage our deep understanding of in vivo gene editing and experience with ARCUS to develop new therapies, including a potentially transformative treatment for Duchenne muscular dystrophy," said Derek Jantz, chief scientific officer and co-founder of Precision BioSciences.
Novartis forges $1.35B deal with Mesoblast over Remestemcel-L for acute respiratory distress syndrome (ARDS), including COVID-19
On 20th November 2020, Mesoblast announced a license and collaboration agreement with Novartis to advance their ARDS therapeutic product remestemcel-L. Remestemcel-L is a Phase 3 mesenchymal stromal cell (MSC) product of Mesoblast which is believed to control the cytokine storm associated with COVID-19 and other inflammatory conditions. Currently, the drug is being tested in a Phase 3 study for Covid-19-related ARDS in 300 patients, and the initial data will be available in early 2021. Under the agreement deal, Mesoblast will receive a $50M upfront payment including $25 million in equity, while Novartis will acquire an exclusive worldwide right to develop, commercialize and manufacture remestemcel-L for ARDS. Besides, Mesoblast will gain additional pre-commercialization milestone payments that could total $505 million and post-commercialization milestones up to $750 million.
“Our collaboration with Novartis will help ensure that remestemcel-L could become available to the many patients suffering from ARDS, the principal cause of mortality in COVID-19 infection. This agreement is in line with our corporate strategy to collaborate and partner with world-leading major pharma companies to maximize market access for our innovative cellular medicines.” - Silviu Itescu, CEO, Mesoblast.
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Collated by : Richa Tewari, PhD and Rinki Saha 
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
BioPharma News
Abhi Dey
Consulting Editor
Nisha Peter, PhD
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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