For many patients with multiple myeloma, a new generation of drugs and drug combinations is producing better outcomes and fewer side effects. In recent months, several novel therapies studied and tested by Dana-Farber scientists have gained approval from the U.S. Food and Drug Administration (FDA) or taken a step toward approval after posting solid results in clinical trials.
The drugs are the fruit of years of research into improving treatment for multiple myeloma, a cancer of white blood cells known as plasma cells in the bone marrow. Many of the new agents are biologically derived made from substances such as proteins and antibodies found in living things and target biological mechanisms in a very specific, targeted fashion. Dana-Farber researchers have played a key role in these efforts.
These are each powerful examples of how next-generation novel therapies translated here at Dana-Farber from bench to bedside are further improving outcomes for our patients, and at a remarkable pace, says Paul G. Richardson, MD, clinical program leader and director of clinical research at the Jerome Lipper Multiple Myeloma Center at Dana-Farber.
Following a Dana-Farber-led clinical trial, the FDA recently approved the novel drug isatuximab in combination with pomalidomide and dexamethasone for adults with relapsed or refractory (non-responsive) myeloma who have received at least two prior therapies, including lenalidomide and drugs known as proteasome inhibitors. The drug went into trials after laboratory work by Dana-Farbers Yu-Tzu Tai, PhD, and Kenneth Anderson, MD, showed it was active against myeloma cells. In the clinical trial, the three-drug combination lowered the risk that the disease would progress by 40%, compared to pomalidome and dexamethasone alone.
Dana-Farber investigators conducted laboratory research and led the first clinical trial of the drug melflufen plus dexamethasone in patients with relapsed or refractory myeloma. Melflufen is a peptide conjugate drug made of a stub of protein, or peptide, joined to a chemotherapy agent and delivers a toxic payload directly to myeloma cells in a selective, time-sparing approach.
Results from an early-phase clinical trial published in Lancet Oncology showed the drug is active in patients with myeloma and is safe at recommended doses. Unlike the previously used standard drug melphalan, it doesnt cause mucositis inflammation of membranes within the digestive tract or hair loss. The results prompted investigators to launch two larger trials, some of whose results are being processed and are due to be published soon.
In a major study published in Blood, Dana-Farber researchers and their associates found that in patients newly diagnosed with myeloma who are eligible for a stem cell transplant, adding the drug daratumumab to the standard three-drug regimen produced more responses, and deeper responses, than in patients receiving the three-drug therapy alone.
Dana-Farber researchers were involved in the development and initial testing of the drug belantamab mafodotin, which has shown considerable promise in clinical trials and has been granted priority review for approval by the FDA.
An antibody conjugate drug consisting of an antibody that specifically targets myeloma cells and an agent that disrupts cell division, its use was informed by a preclinical trial at Dana-Farber involving Yu-Tzu Tai, PhD, and Kenneth Anderson, MD. Balantamab mafodotin was tested in studies led by Paul Richardson, MD, in patients with relapsed or refractory multiple myeloma whose disease continued to worsen after a stem cell transplant, chemotherapy, or other treatment. In the DREAMM-1 and -2 trials, the drug showed strong anti-myeloma activity with manageable side effects.
After certification in Internal Medicine, Hematology and Medical Oncology, as well as working in Cancer Pharmacology from 1994 onwards at Dana-Farber Cancer Institute (DFCI), Dr. Paul Richardson joined the Jerome Lipper Myeloma Center in 1999, was appointed Clinical Director in 2001, and led the development of several first-generation novel drugs including bortezomib, lenalidomide and pomalidomide for the treatment of multiple myeloma. Subsequent studies have focused on next-generation novel drugs including panobinostat and second-generation proteasome inhibitors including ixazomib. More recently, his clinical innovations have been in the development of the breakthrough monoclonal antibodies elotuzumab and daratumumab for the treatment of both untreated and relapsed myeloma, as well as isatuximab and more broadly, antibody drug conjugates including belantamab mafodotin, as well as other immunotherapeutic strategies. In addition to these agents, he is leading the development of melflufen, a targeted cytotoxic and an first-in-class small molecule inhibitor selinexor, which inhibits XPO-1, a key nuclear export protein, as well as first-in-human studies of cereblon E3 ligase modulators (so called CELMoDs) for the treatment of relapsed and refractory myeloma.
Over the last decade, his major effort has been focused on the development of lenalidomide, bortezomib and dexamethasone (so-called RVD), and its incorporation as part of the Intergroup Francophone Myelome (IFM)/DFCI clinical trial in newly diagnosed patients eligible for stem cell transplant treated with RVD. This regimen has generated an unprecedented response rate, leading to its adoption in this international study, as well as others in the United States and elsewhere. This particular trial incorporates genomic and proteomic evaluation to establish a future platform for tailored therapy and the optimal positioning of stem cell transplant, with results anticipated in 2021-22. Furthermore, RVD has been established as a backbone to which next-generation agents are being added, including elotuzumab, daratumumab and isatuximab, as well as panobinostat.
He has published extensively, having authored or co-authored over 400 original articles and 330 reviews, chapters, and editorials in peer-reviewed journals. In addition to holding positions on the Editorial Boards of leading journals, he is prior Chairman of the Multiple Myeloma Research Consortium (MMRC), Clinical Trials Core, a position held for 5 years as part of a rotating tenure, and for which he continues as a member of the Steering and Project Review Committee. He was also a member of ASCO Hematologic Malignancies Subcommittee for the required one-year term, and then for one year on the ASCO Internet Cancer Information Committee during 2017. He was appointed Chair of the Alliance Myeloma Committee in 2011 and continues in this role.
Honors include the George Canellos Award for Excellence in Clinical Research and Patient Care, and The Tisch Outstanding Achievement Award for Clinical Research, as well as an honorary Fellowship of the Royal College of Physicians (UK), given in recognition for international contributions in multiple Myeloma and stem cell transplantation. He was a co-recipient of the prestigious Warren Alpert Foundation Prize in recognition of the successful therapeutic targeting of the ubiquitin-proteasome pathway in 2012. He was also a co-recipient of the Accelerator Award for contributions to clinical research and patient enrollment in MMRC studies, as well as for the Research Center of the Year Award in 2009, followed by the second award for Center of the Year in 2017. He was ranked by Thomson Reuters Science Watch amongst the top 19 investigators at DFCI for the most highly cited research in 2016. He was the co-recipient of the ASH Ernest Beutler Prize for clinical science and translational research in the development of proteasome inhibition as an effective treatment strategy for multiple myeloma in 2015; the COMY Award for MM research (Paris, France) in 2016, and the prestigious IMF Robert A. Kyle Lifetime Achievement Award in 2017, and the Morse Research Award in 2019.
- Global Animal Stem Cell Therapy Market Research Report by Size, Data, Developments, Global Demand, In-Depth Analysis and Forecast 2020 to 2025 |... - November 27th, 2020
- Stem Cell Therapy Market Size, Growth, Demand, Opportunities & Forecast To 2025 - Cheshire Media - November 27th, 2020
- Celularity Announces Dosing of First Patient in Phase I Study of Human Placental Hematopoietic Stem Cell-Derived Natural Killer Cells (CYNK-001) in... - November 27th, 2020
- Scientists Reveal a New Drug That Directs Stem Cells To Desired Sites - Science Times - November 27th, 2020
- Global Stem Cells Market is estimated to account for US$ 18289.9 Mn by end of 2027, Says Coherent Market Insights (CMI) - Business Wire - November 27th, 2020
- Stem Cell Therapy Market To Observe Exponential Growth By 2020-2027 | Reports Globe - Cheshire Media - November 27th, 2020
- Ash 2020 cell therapy preview the battle for recognition - Vantage - November 27th, 2020
- Animal Stem Cell Therapy Market 2020 to Flourish with an Impressive CAGR of XX% in the year 2026, Market Size & Growth with Complete Business... - November 27th, 2020
- Adipose Tissue-derived Stem Cell Therapy Market: Worldwide Industry to Boost in the Period of 2020-2025 - Express Journal - October 19th, 2020
- Global Stem Cell Therapy Market 2020: Trends, and Opportunity Analysis, Top Manufacturers And Forecast to 2027 - PRnews Leader - October 19th, 2020
- Stem Cell Therapy Market Research Report Forecast to 2029 (Includes Business Impact of COVID-19) - Eurowire - October 19th, 2020
- Global Adipose Tissue-derived Stem Cell Therapy Market 2020 Demand, Business Growing Strategies, Industry Segmentation and Forecast 2025 -... - October 19th, 2020
- Stem Cell Therapy Market Trends, Opportunities, New Technologies and Developments, Competitor analysis and Market Sizing from 2020 to 2026 - PRnews... - October 19th, 2020
- Global Adipose Derived Stem Cell Therapy Market 2020 Demand, Business Growing Strategies, Industry Segmentation and Forecast 2025 - TechnoWeekly - October 19th, 2020
- Notch Therapeutics Strengthens Leadership Team with Appointment of Kamran Alam as CFO and Gregory Block as SVP, Corporate Development - PRNewswire - October 19th, 2020
- Stem Cell Therapy Market To Observe Exponential Growth By 2020-2027 | Verified Market Research - Stock Market Vista - October 19th, 2020
- Stem Cell Therapy Market 2020 growth factors, latest trend and regional analysis of leading players by 2025 - News by Decresearch - October 19th, 2020
- Cell Therapy Market Size, Share, Market Research and Industry Forecast Report, 2020-2027 (Includes Business Impact of COVID-19) - Eurowire - October 19th, 2020
- Autologous Cell Therapy Market is Anticipated to Expand at a CAGR of 18.1% from 2019 to 2027 - Eurowire - October 19th, 2020
- Cell Therapy Market Trend,COVID-19 Impact,Current Industry Figures With Demand By Countries And Future Growth - PRnews Leader - October 19th, 2020
- Gamida Cell and Be The Match BioTherapies Expand Strategic Collaboration - BioSpace - October 19th, 2020
- Cell Therapy Manufacturing Market to be Worth USD 8 billion by 2030, predicts Roots Analysis - The Think Curiouser - October 19th, 2020
- Novellus Therapeutics Exclusively Licenses Induced Mesenchymal Stem Cells (iMSCs) to NoveCite for COVID-19 Related Acute Respiratory Distress Syndrome... - October 19th, 2020
- UofL-born company secures an additional $115 million to advance cell therapy - uoflnews.com - October 19th, 2020
- Global and United States Cancer Stem Cell Therapy Market Leading Players Expected to Witness the Highest Growth 2025 | AVIVA BioSciences, AdnaGen,... - October 19th, 2020
- Can Stem Cell Therapy Repair Damaged Knees? - September 2nd, 2020
- Vor Biopharma and Metagenomi to Collaborate on Engineered Hematopoietic Stem-Cell Therapies - Business Wire - September 2nd, 2020
- COVID-19 cell therapy drives Mesoblast to seek manufacturing muscle - BioPharma-Reporter.com - September 2nd, 2020
- New Report Begins a New Era of Stem Cell Science and Medicine: Stem Cell Biotechnology Company Asymmetrex Tells How It Counts Therapeutic Tissue Stem... - September 2nd, 2020
- Optimized Freezing Solutions for Clinical Application of Cell Therapy Products - Technology Networks - September 2nd, 2020
- Global Cord Blood Banking Market 2020 with Analysis of 44 Industry Players - PRNewswire - September 2nd, 2020
- Cartesian Therapeutics Initiates Clinical Trial of First RNA-Engineered Cell Therapy for Acute Respiratory Distress Syndrome and COVID-19 - PRNewswire - September 2nd, 2020
- New Comprehensive Report on Stem Cell Therapy Market to Witness an Outstanding Growth during 2020 2025 with Top Players Like Chiesi Pharmaceuticals,... - September 2nd, 2020
- CAR T-Cell Optimization Starts in Production, Extends to Therapy - Genetic Engineering & Biotechnology News - September 2nd, 2020
- Ruxolitinib May Be Another Option for Children With Steroid Refractory aGVHD - AJMC.com Managed Markets Network - September 2nd, 2020
- Growing Focus on R&D Likely to Accelerate the Growth of the Stem Cell Therapy Market - The News Brok - September 2nd, 2020
- Oldest male polar bear on record humanely euthanized at Point Defiance Zoo - MyNorthwest.com - September 2nd, 2020
- FDA Approves First Maintenance Therapy for AML - Medscape - September 2nd, 2020
- Elixirgen Therapeutics planning to begin Phase I/II Clinical Trials of its COVID-19 Vaccine Candidate EXG-5003 at Fujita Health University -... - September 2nd, 2020
- Hill Highlights the Potential of Selinexor as a Less Intensive Option for DLBCL - OncLive - September 2nd, 2020
- Global Rheumatoid Arthritis Stem Cell Therapy Market Dynamics, Forecast, Analysis and Supply Demand 2018 to 2028 - Scientect - September 2nd, 2020
- Growing at an annualized rate of over 20%, the cell therapy manufacturing market is estimated to reach close to USD 10 Billion by 2030, claims Roots... - September 2nd, 2020
- Strategic Analysis to Understand the Competitive Outlook of Cell Therapy Manufacturing Market - The News Brok - September 2nd, 2020
- In Depth Analysis and Survey of COVID-19 Pandemic Impact on Global Canine Stem Cell Therapy Coronavirus Impact Editon of Key Players VETSTEM... - August 10th, 2020
- Tevogen Bio Announces Partnership With Preeminent Scientist Professor Neal Flomenberg, MD, to Investigate Proprietary T-Cell Therapy for Treatment of... - August 10th, 2020
- Marker Therapeutics Reports Second Quarter 2020 Operating and Financial Results - PRNewswire - August 10th, 2020
- University of Minnesota expands clinical investigation of engineered iPSC-derived natural killer cells, opening U.S. clinical trial for the treatment... - August 10th, 2020
- Clinical study using mesenchymal stem cells for the treatment of patients with severe COVID-19 - DocWire News - August 10th, 2020
- UPDATED: After a 4-year sojourn, struggling microbiome pioneer Seres claims a breakout PhIII comeback. And shares respond in frenzied spike -... - August 10th, 2020
- New Report: Regenerative Medicine & Advanced Therapies Sector Thriving Despite COVID-19 - PharmiWeb.com - August 10th, 2020
- Covid-19 roundup: CureVac beefs up its unicorn IPO dreams as billionaire owner takes this Covid-19 mRNA player on a forced march to Nasdaq; Kodak's... - August 10th, 2020
- Coronavirus Drug and Treatment Tracker - The New York Times - August 10th, 2020
- Nearly 70K donated so far towards Wistaston boy's 120K lifesaving treatment - Cheshire Live - August 10th, 2020
- Avacta extends partnership with Daewoong Pharmaceutical and AffyXell Therapeutics for Covid-19 stem cell treatments - Cambridge Independent - August 9th, 2020
- Three Years After Stem Cell Trial for Heart Failure was Abandoned New Evidence Shows it Works - Diagnostic and Interventional Cardiology - August 9th, 2020
- Stem Cell And Platelet Rich Plasma (PRP) Alopecia Therapies Market 2020 Size by Product Analysis, Application, End-Users, Regional Outlook,... - August 9th, 2020
- IMAC Holdings Receives FDA Authorization to Initiate Clinical Study of Its Umbilical Cord-Derived Allogenic Mesenchymal Stem Cells for the Treatment... - August 9th, 2020
- Strathmore man with MS calls for more Canadian treatment alternatives - CTV Toronto - August 9th, 2020
- Adipose Derived Stem Cell Therapy Market: Technological Advancement & Growth Analysis with Forecast to 2026 - Chelanpress - August 9th, 2020
- ASCO Expert on the Possible Benchmark Analysis of Autologous Transplantation in B-Cell Lymphomas - Cancer Network - August 9th, 2020
- Cell Therapy Market: Study Navigating the Future Growth Outlook | Osiris Therapeutics, NuVasive, Vericel Corporation - Chelanpress - August 9th, 2020
- Global Stem Cell Therapy Market 2020: Growth, Demand, Service, Types, Applications, Key Players and Industry Forecast till 2025 - Chelanpress - August 9th, 2020
- Personalized Cell Therapies Market to Show Incredible Growth by 2025 - Owned - August 9th, 2020
- Nerve Repair and Regeneration Market worth $9.7 billion by 2025 - Exclusive Report by MarketsandMarkets - PRNewswire - August 9th, 2020
- High-throughput 3D screening for differentiation of hPSC-derived cell therapy candidates - Science Advances - August 9th, 2020
- Immatics Extends Cell Therapy Manufacturing Collaboration with UTHealth - GlobeNewswire - August 9th, 2020
- Contract Manufacturing Services market for stem cells is expected to be worth over USD 2.5 billion by 2030, claims Roots Analysis - Market Research... - August 9th, 2020
- In Depth Analysis and Survey of COVID-19 Pandemic Impact on Global Cancer Stem Cell Market Report 2020 Key Players Thermo Fisher Scientific Inc.,... - August 9th, 2020
- Tafasitamab Combination Approved for Adults With R/R DLBCL - AJMC.com Managed Markets Network - August 8th, 2020
- Celularity announces the activation of first California Clinical Trial Site following CIRM Grant Award to Advance Treatments for COVID-19 - PRNewswire - August 8th, 2020
- Trending News on Targeted Oncology, Week of August 7, 2020 - Targeted Oncology - August 8th, 2020
- Find Out Why Bioreactor Market is thriving worldwide by top key players like mergency Response USA, Buddi US, LLC, Connect America - Owned - August 8th, 2020
- BCLI: Phase 3 ALS Data Expected by the End of November 2020 - Zacks Small Cap Research - August 8th, 2020
- New Report: Regenerative Medicine & Advanced Therapies Sector Thriving Despite COVID-19 - GlobeNewswire - August 8th, 2020
- Immatics Extends Cell Therapy Manufacturing Collaboration with UTHealth - marketscreener.com - August 8th, 2020
- Impact of COVID-19 Outbreak on Canine Stem Cell Therapy Market Expected to Secure Notable Revenue Share During 2020-2026 - Research Newspaper - August 8th, 2020
- Calidi Biotherapeutics in San Diego receives FDA Approval for COVID-19 Treatment clinical trial - - KUSI - August 7th, 2020
- Edited Transcript of BLCM.OQ earnings conference call or presentation 6-Aug-20 9:00pm GMT - Yahoo Finance - August 7th, 2020
- NICE Amends Guidance on Haematopoietic Stem Cell Transplantation During the Pandemic - Medscape - August 6th, 2020
- AlloVir raises $276M IPO to run broad cell therapy program - FierceBiotech - August 6th, 2020