Regenerative medicine: moving next-gen treatments from lab to clinic – Pharmaceutical Technology

The investment in bolstering defences in virtual space also remains a top priority, as the pharmaceutical industry is extremely susceptible to cyber-attacks due to the involvement of sensitive and valuable data.

Several pharmaceutical companies and research institutes including Hammersmith Medicines Research in the UK, the University of California, San Francisco (UCSF), and US-based clinical services company eResearch Technology (ERT) remained targets for cyberattacks due to their involvement in the development of COVID-19 vaccines.

GlobalData conducted to survey to assess to extent to which emerging technologies such as cybersecurity will help a company survive through the Covid-19 pandemic.

Analysis of the results found that 54% of the respondents opined that cybersecurity would play a significant role in helping companies to pull through the crisis created by the pandemic.

Cybersecuritys Role During COVID-19 Crisis

Another 33% of the surveyed companies expect cybersecurity to play a minor role during the COVID-19 crisis.

Further, 10% of the companies stated that cybersecurity will play no role during the pandemic, while 3% of the respondents were unaware of the impact of cybersecurity.

The analysis is based on responses received in GlobalData, Emerging Technologies Survey 2020 fielded between 29 May and 09 July 2020.

Customised Viral Vectors for Cell Modelling, Gene Therapy, and Vaccination Research and Development

28 Aug 2020

Pharmaceutical-Grade Water Purification Systems for the Pharmaceutical and Biopharma Markets

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Global $30+ Billion Cell Therapy Bioprocessing Market to 2028: Market Opportunities in Automated Procedures to Produce Cell Therapies – PRNewswire

DUBLIN, June 4, 2021 /PRNewswire/ -- The "Cell Therapy Bioprocessing Market Forecast to 2028 - COVID-19 Impact and Global Analysis By Technology, Cell Type, End User, and Geography" report has been added to ResearchAndMarkets.com's offering.

The global cell therapy bioprocessing market is expected to reach US$ 30,052.61 million in 2028 from US$ 11,192.50 million in 2020. The market is estimated to grow with a CAGR of 13.14% from 2020 to 2028.

Cell therapy bioprocessing is a subfield of bioprocess engineering that bridges cell therapy and bioprocessing (i.e., biopharmaceutical manufacturing). Cell therapy is one of the fastest-growing areas of the life sciences. It entails delivering entire living cells to a patient to treat chronic and rare diseases.

Cell and gene therapy is still in an early stage of development in the biotechnology sector. Despite of being niche domain of the biotechnology sector, cell and gene therapy have paved the investments by the contract development and manufacturing organizations (CDMO)/contract manufacturing organizations (CMO).

Companies are investing to enhance their manufacturing capabilities and offer world-class therapies to treat chronic conditions. Companies are adopting inorganic and organic strategies such as acquisitions and expansion to broaden their cell and gene therapy segment.

Recently, there have been a few instances of companies investing a huge amount to enter in the cell and gene therapy segment. For instance, in February 2020, Catalent, Inc. and MaSTherCell Global, Inc. have signed an agreement, in which Catalent, Inc. has agreed to acquire MaSTherCell Global, Inc. for an amount of US$ 135 million. It is stated that Catalent, Inc. is in a good state to merge with MaSTherCell Global, Inc.'s capabilities and R&D resources to build its own development and commercial manufacturing facilities.

Similarly, in February 2021, Rentschler Biopharma, a German-based CDMO has expanded its manufacturing capabilities at Cell and Gene Therapy (CGT) Catapult in the UK. Rentschler Biopharma is looking forward to entering the regenerative medicine segment and initiate the production of adeno-associated virus (AAV) vector for cell and gene therapies. Rentschler Biopharma is likely to invest an undisclosed amount over the five years and will share its expertise and capabilities with CGT Catapult.

Such instances of investments are expected to boost the sector and enhance the cell therapy bioprocessing in the coming future. Additionally, in the last few years, there has been significant investments done by the biopharmaceutical companies in the cell and gene therapy segment.

According to the Alliance for Regenerative Medicine (ARM), investments in the cell and gene therapy has doubled in 2020 compared to 2019 and considerably higher than 2018. Companies across the world have invested US$ 19.9 billion in 2020, whereas the investments were accounted for US$ 13.5 billion in 2018 and US$ 9.8 billion in 2019. Thus, owing to the heavy investments, the market is expected to be flourishing in the coming years.

Report Highlights

Key Topics Covered:

1. Introduction

2. Cell Therapy Bioprocessing Market- Key Takeaways

3. Research Methodology

4. Cell Therapy Bioprocessing Market- Market Landscape 4.1 Overview 4.2 PEST Analysis 4.3 Expert Opinion

5. Cell Therapy Bioprocessing Market - Key Market Dynamics 5.1 Market Drivers 5.1.1 Increasing Investments for Cell and Gene Therapy Manufacturing 5.1.2 Growing Approvals for Cell Therapies 5.2 Market Restraints 5.2.1 Challenges Associated with Cell Therapy Bioprocessing 5.3 Market Opportunities 5.3.1 Automated Procedures to Produce Cell Therapies 5.4 Future Trends 5.4.1 Digital Biomanufacturing 5.5 Impact Analysis

6. Cell Therapy Bioprocessing Market- Global Analysis 6.1 Global Cell Therapy Bioprocessing Market Revenue Forecast and Analysis 6.2 Global Cell Therapy Bioprocessing Market, By Geography - Forecast and Analysis 6.3 Market Positioning of Key Players

7. Cell Therapy Bioprocessing Market Analysis - By Technology 7.1 Overview 7.2 Cell Therapy Bioprocessing Market Revenue Share, by Technology (2020 and 2028) 7.3 Bioreactor 7.4 Lyophilization 7.5 Electrospinning 7.6 Controlflow Centrifugation 7.7 Ultrasonic Lysis 7.8 Genome Editing Technology 7.9 Cell Immortalization Technology 7.10 Viral Vector Technology

8. Cell Therapy Bioprocessing Market Analysis - By Cell Type 8.1 Overview 8.2 Cell Therapy Bioprocessing Market Revenue Share, by Cell Type (2020 and 2028) 8.3 Stem Cell 8.4 Immune Cell 8.5 Human Embryonic Stem Cell 8.6 Pluripotent Stem Cell 8.7 Hematopoietic Stem Cell

9. Cell Therapy Bioprocessing Market Analysis - By Indication 9.1 Overview 9.2 Cell Therapy Bioprocessing Market Revenue Share, by Indication (2020 and 2028) 9.3 Cardiovascular Disease (CVD) 9.4 Oncology 9.5 Wound Healing 9.6 Orthopedic

10. Cell Therapy Bioprocessing Market- By End User 10.1 Overview 10.2 Cell Therapy Bioprocessing Market Revenue Share, by End User (2020 and 2028) 10.3 Hospitals and Clinics 10.4 Diagnostic Centres 10.5 Regenerative Medicine Centres 10.6 Academic and Research Institute

11. Cell Therapy Bioprocessing Market - Geographical Analysis

Company Profiles

For more information about this report visit https://www.researchandmarkets.com/r/e1ig4d

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Global $30+ Billion Cell Therapy Bioprocessing Market to 2028: Market Opportunities in Automated Procedures to Produce Cell Therapies - PRNewswire

Global Stem Cell & Regenerative Medicine Market Report Forecast to 2027 3M Group Novartis AG Integra Gene Therapies The Manomet Current – The…

Stem Cell & Regenerative Medicine Market Report, History and Forecast 2016-2027, Breakdown Data by Companies, Key Regions, Types and Application

The worldwide Stem Cell & Regenerative Medicine market has the planned climate to do a development worth USD xx million with developing CAGR at a pace of xx% during the figure time frame, that is from 2021 to 2027.

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The Key players operating in the Stem Cell & Regenerative Medicine market are @ 3M Group Novartis AG Integra Gene Therapies; Progenitor &Stem CellTherapies

The main goal for the dissemination of this information is to give a descriptive analysis of how the trends could potentially affect the upcoming future of Stem Cell & Regenerative Medicine market during the forecast period. This markets competitive manufactures and the upcoming manufactures are studied with their detailed research. Revenue, production, price, market share of these players is mentioned with precise information.

Global Stem Cell & Regenerative Medicine Market: Regional Segment Analysis

This report provides pinpoint analysis for changing competitive dynamics. It offers a forward-looking perspective on different factors driving or limiting market growth. It provides a five-year forecast assessed on the basis of how they Stem Cell & Regenerative Medicine Market is predicted to grow. It helps in understanding the key product segments and their future and helps in making informed business decisions by having complete insights of market and by making in-depth analysis of market segments.

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What will the market size and the growth rate be in 2026?

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What are the challenges to market growth?

Who are the key vendors in the Global Stem Cell & Regenerative Medicine Market?

What are the market opportunities and threats faced by the vendors in the Global Stem Cell & Regenerative Medicine Market?

Trending factors influencing the market shares of the Americas, APAC, Europe, and MEA.

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5.) Market entry and investment feasibility;

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All the research report is made by using two techniques that are Primary and secondary research. There are various dynamic features of the business, like client need and feedback from the customers. Before (company name) curate any report, it has studied in-depth from all dynamic aspects such as industrial structure, application, classification, and definition.

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It helps in making informed business decisions by having complete insights of market and by making in-depth analysis of market segments

TABLE OF CONTENT:

1 Report Overview

2 Global Growth Trends

3 Market Share by Key Players

4 Breakdown Data by Type and Application

5 United States

6 Europe

7 China

8 Japan

9 Southeast Asia

10 India

11 Central & South America

12 International Players Profiles

13 Market Forecast 2019-2025

14 Analysts Viewpoints/Conclusions

15 Appendix

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Novel CAR-T Cell Therapy Produces Early and Deep Responses in Certain Patients with Multiple Myeloma – Curetoday.com

Treatment with a single infusion of the novel CAR-T cell therapy ciltacabtagene autoleucel (cilta-cel) induced early and deep responses in a group of patients with relapsed/refractory multiple myeloma, according to results of a phase 2 study.

The findings, which were presented during the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, demonstrated that a single-infusion of the CAR-T cell therapy resulted in an overall response rate (which includes a partial response or better) of 95% with a stringent complete response rate of 75%, and a very good partial response rate or better of 85%.

Cilta-cel, formerly JNJ-68284528, is a second-generation CAR-T cell therapy with two BCMA-targeting, single-domain antibodies designed to confer avidity. Previous data that were published from the phase 1b/2 CARTITUDE-1 trial demonstrated that single infusion of cilta-cel was associated with deep and durable response among heavily pretreated patients with relapsed/refractory disease.

Measuring minimal residual disease negativity, or the small number of cancer cells in the body after cancer treatment, was the main goal of the study. Other goals included assessing overall response rate, duration of response, as well as time and duration of minimal residual disease negativity and incidence and severity of side effects.

The study comprised 20 patients (median age, 60 years; 65% men) who were either refractory to treatment with the chemotherapy lenalidomide or relapsed after one to three prior lines of treatment. One of the patients was treated in an outpatient setting.

Twelve of the patients had received fewer than three lines of prior therapy, and the remaining individuals received three prior lines of therapy.

All the patients had been previously treated with a proteasome inhibitor, an immunomodulatory drug and the steroid dexamethasone. Almost all (95%) of the patients were exposed to alkylating agents, and 65% received treatment with Darzalex (daratumumab).

As of the data cutoff of January 2021, four evaluable patients achieved minimal residual disease negativity.

Blood-related side effects that occurred in 20% or more of the patients included neutropenia (95%), thrombocytopenia (80%), anemia (65%), lymphopenia (60%) and leukopenia (55%). Moreover, cytokine release syndrome (which involves the cytokines overstimulating the immune system so that it attacks healthy organs) occurred in 85% of patients, of which 10% were considered serious or severe.

The safety profile was manageable, including in the one patient that was treated in the outpatient setting, said study author Dr. Mounzer E. Agha, director of the Mario Lemieux Center for Blood Cancers and clinical director of Hematopoietic Stem Cell Transplantation at the UPMC Hillman Cancer Center in Pittsburgh, during a recorded presentation of the data. There were no cases of movement and neurocognitive adverse effects.

Agha noted that one death occurred 100 days after the infusion of cilta-cel due to COVID-19 infection and was assessed as treatment-related by the investigators.

Early and deep responses were observed with a single infusion of cilta-cel in lenalidomide refractory patients with multiple myeloma, who received one-to three prior lines of therapy, he concluded.

The CAR-T cell therapy is being evaluated in other cohorts of the CARTITUDE-2 in earlier line settings, as well as in the phase 3 CARTITUDE-4 study in patients with one to three prior lines of therapy.

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Novel CAR-T Cell Therapy Produces Early and Deep Responses in Certain Patients with Multiple Myeloma - Curetoday.com

BioRestorative Therapies to Present at the Emerging Growth Conference on June 9, 2021 – StreetInsider.com

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BioRestorative Therapies invites individual and institutional investors, as well as advisors and analysts, to attend its real-time, interactive presentation at the online Emerging Growth Conference.

MELVILLE, N.Y., June 07, 2021 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (the Company or BioRestorative) (OTC: BRTX), a life sciences company focused on stem cell-based therapies, is pleased to announce that it is has been invited to present at the online Emerging Growth Conference on June 9, 2021.

The Emerging Growth Conference will be held on June 9, 2021. This live, interactive online event will give existing shareholders and the investment community the opportunity to interact with the Companys CEO, Lance Alstodt, and Vice President of Research and Development, Francisco Silva, in real time.

Mr. Alstodt will make a presentation and answer questions. Please ask your questions during the event and Mr. Alstodt will try to respond to as many as possible.

BioRestorative Therapies will be presenting at 10:45 AM Eastern time for 45 minutes.

Please register here to ensure you are able to attend the conference and receive any updates that are released:

https://goto.webcasts.com/starthere.jsp?ei=1469230&tp_key=f8b5116237&sti=brtx

If attendees are unable to join the event live on the day of the conference, an archived webcast will also be made available on EmergingGrowth.com, and the Company will also release a link to that site after the event.

About the Emerging Growth Conference

The Emerging Growth Conference is an effective way for public companies to present and communicate their new products, services and other major announcements to the investment community from the convenience of their office, in a time efficient manner.

The Conferences focus and coverage includes companies in a wide range of growth sectors, with strong management teams, innovative products and services, focused strategy, execution, and the overall potential for long term growth. Its audience includes potentially tens of thousands of individuals and institutional investors, as well as investment advisors and analysts.

All sessions will be conducted through video webcasts and will take place in the Eastern time zone.

About BioRestorative Therapies, Inc.

BioRestorative Therapies, Inc. (www.biorestorative.com) develops therapeutic products using cell and tissue protocols, primarily involving adult stem cells. Our two core programs, as described below, relate to the treatment of disc/spine disease and metabolic disorders:

Disc/Spine Program (brtxDISC): Our lead cell therapy candidate, BRTX-100, is a product formulated from autologous (or a persons own) cultured mesenchymal stem cells collected from the patients bone marrow. We intend that the product will be used for the non-surgical treatment of painful lumbosacral disc disorders or as a complementary therapeutic to a surgical procedure. The BRTX-100 production process utilizes proprietary technology and involves collecting a patients bone marrow, isolating and culturing stem cells from the bone marrow and cryopreserving the cells. In an outpatient procedure, BRTX-100 is to be injected by a physician into the patients damaged disc. The treatment is intended for patients whose pain has not been alleviated by non-invasive procedures and who potentially face the prospect of surgery. We have received authorization from the Food and Drug Administration to commence a Phase 2 clinical trial using BRTX-100 to treat chronic lower back pain arising from degenerative disc disease.

Metabolic Program (ThermoStem): We are developing a cell-based therapy candidate to target obesity and metabolic disorders using brown adipose (fat) derived stem cells to generate brown adipose tissue (BAT). BAT is intended to mimic naturally occurring brown adipose depots that regulate metabolic homeostasis in humans. Initial preclinical research indicates that increased amounts of brown fat in animals may be responsible for additional caloric burning as well as reduced glucose and lipid levels. Researchers have found that people with higher levels of brown fat may have a reduced risk for obesity and diabetes.

Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events or results to differ materially from those projected in the forward-looking statements as a result of various factors and other risks, including, without limitation, those set forth in the Company's latest Form 10-K filed with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. Any forward-looking statements in this release are made as of the date hereof and the Company undertakes no obligation to update such statements.

CONTACT: Email: ir@biorestorative.com

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Innovent Biologics and IASO Biotherapeutics to Present Updated Data from its Anti-BCMA CAR-T Therapy in Relapsed/Refractory Multiple Myeloma at…

SAN FRANCISCO and SUZHOU, China, June 7, 2021 /PRNewswire/ -- Innovent Biologics Inc. ("Innovent", HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, together with IASO Biotherapeutics (IASO Bio), jointly announced to deliver an oral presentation on updated data from the Phase I study of IBI326 in patients with relapsed/refractory multiple myeloma (R/R MM) at the European Hematology Association (EHA) Congress, June 9-17, 2021. The presentation will further demonstrate the safety, efficacy, and increased persistence of IBI326.

IBI326 is a fully-human B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T-cell therapy co-developed by IASO Bio and Innovent (Innovent: IBI326, IASO Bio: CT103A), and it is currently under the pivotal Phase II clinical trial. In February 2021, IBI326 was granted the Breakthrough Therapy Designation (BTD) by China regulatory authority, National Medical Production Administration (NMPA) for the treatment of relapsed/refractory multiple myeloma.

In the oral presentation, Professor Chunrui Li with Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology (HUST) in China will report the clinical data on 35 patients with R/R MM, who received 1.0, 3.0, or 6.0 106/kg IBI326 treatment respectively in the dose-escalation phase and dose-expansion cohort. The 1.0 106/kg dose was determined as Recommended Phase II Dose (RP2D). The median age of the 35 patients was 54 (27, 72). Among them, eight patients had extramedullary multiple myeloma (EMM) and one patient had complication with plasma cell leukemia. The median number of prior treatment regimens was four (3, 12). Ten patients previously received autologous hematopoietic stem cell transplantation (AHSCT), and 10 patients received murine BCMA CAR-T treatment. As of May 1, 2021, the median follow-up of the 35 patients was 291 days (21, 954).

The clinical data of the study in patients with R/R MM presented at the 61st American Society of Hematology (ASH) Annual Meeting in 2019 highlighted the impressive safety profile, efficacy, and durability of response of IBI326. The study also included four patients who had relapsed after prior murine BCMA CAR T-cell treatment. The overall response of these four patients demonstrated that IBI326 can also be an effective treatment option for patients who have relapsed from a prior CAR-T therapy.

In June 2021, the results were published in Blood, a peer-reviewed journal specializing in hematology, in an article titled "A phase 1 Study of a Novel Fully Human BCMA-targeting CAR (IBI326) in Patients with Relapsed/Refractory Multiple Myeloma." The editors of Blood were impressed by the unique persistence of IBI326 and the authors' exposition on the re-treatment prospects of the disease during the study. Therefore, they invited experts from University College London Cancer Institute to write a review titled "BCMA CARs in multiple myeloma: room for more?" (DOI 10.1182/blood.2021010833).

Dr. Hui Zhou, Senior Vice President of Medical Development, Innovent Biologics, said, "We are glad to see that the excellent clinical data of IBI326 (IASO: CT103aA) has been highly recognized by the EHA congress. In particular, it still shows good clinical benefits to the patients who received prior murine BACM CAR-T treatment, and provides better treatment options for patients with relapsed/refractory multiple myeloma. We look forward to the launch of this cell therapy to benefit patients in the future. "

Maxwell Wang, Chief Executive Officer of IASO Bio, said, "We are very glad that our high-quality clinical data are presented at the European Hematology Association Congress, one of the top global academic conferences. It's also the only oral presentation on a China-developed BCMA CAR-T treatment at this year's EHA Congress. The updated data reinforce the advantages and uniqueness of CT103A in the treatment of patients with relapsed/refractory multiple myeloma. Particularly, we enrolled 8 patients with extramedullary multiple myeloma and 10 patients receiving prior murine BCMA CAR-T treatment. All patients have obtained clinical benefits. IASO Biotherapeutics will continue to leverage its innovative clinical development strategy to further prove the advantages of CT103A. We also look forward to the oral presentation by Professor Chunrui Li with Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology (HUST) at the EHA Congress."

Presentation details:

Abstract: S194 AN UPDATED PHASE 1 STUDY OF A NOVEL FULLY HUMAN BCMA-TARGETING CAR-T CELLS (CT103A) IN PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA

Type: Oral Presentation

Session title: T cell re-directing therapies in relapsed/refractory multiple myeloma

About Multiple Myeloma

Multiple Myeloma is a deadly blood cancer that often infiltrates the bone marrow causing anemia, kidney failure, immune problems, and bone fractures. For multiple myeloma patients, common first-line drug treatments include proteasome inhibitors, immunomodulatory drugs, and alkylating agents. While treatment may result in remission, most patients will inevitably enter the relapsed or refractory stage as there's currently no cure. As a result, there is a significant unmet need for patients with relapsed/refractory multiple myeloma.

About IBI326 (BCMA CAR-T)

IBI326 is an innovative therapy co-developed by Innovent and IASO Bio. Previous studies indicate subjects with relapsed/refractory multiple myeloma (R/R MM) who received high-dose BCMA-targeting CAR-T cells may achieve better remission but have worse adverse events. Moreover, once the disease progresses again, the re-infusion of CAR-T cells will not be effective. To solve this dilemma, IBI326 has been developed, a lentiviral vector containing a CAR structure with a fully human scFv, CD8a hinger and transmembrane, 4-1BB co-stimulatory and CD3 activation domains. Based on strict selection and screening, utilizing a proprietary in-house optimization platform, the construct of the BCMA CAR-T is potent and persistent. In February 2021, IBI326 was granted breakthrough therapy designation by the NMPA for the treatment of relapsed/refractory multiple myeloma.

About Innovent

Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to develop, manufacture and commercialize high-quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high quality innovative medicines for the treatment of cancer, autoimmune, metabolic diseases, and other major therapeutic areas. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK.

Since its inception, Innovent has developed a fully integrated multi-functional platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. By leveraging this platform, the company has built a robust pipeline of 24 valuable assets in major therapeutic areas, with 4 products officially approved for marketing in China - TYVYT (sintilimab injection), BYVASDA (bevacizumab biosimilar injection), SULINNO (adalimumab biosimilar injection) and HALPRYZA (rituximab biosimilar injection), one Biologics License Application (BLA)submission for sintilimab accepted by the U.S. FDA, six assets in Phase 3 or pivotal clinical trials, and 14 more molecules in clinical trials. TYVYT (sintilimab injection) was included in the National Reimbursement Drug List (NRDL) in 2019 as the historically first PD-1 inhibitor entering in NRDL and the only PD-1 included in the list in that year.

Innovent has built an international team of advanced talented professionals in high-end biopharmaceutical development and commercialization, including many overseas experts. The company has also entered into strategic collaborations with Eli Lilly and Company, Adimab, Incyte, MD Anderson Cancer Center, Hanmi and other international partners. Innovent strives to work with all relevant parties to help advance China's biopharmaceutical industry, improve drug availability to ordinary people and enhance the quality of the patients' lives. For more information, please visit: http://www.innoventbio.com.

About IASO Bio

IASO Bio is a clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and autoimmune diseases. Leveraging its proprietary fully human antibody discovery platform (IMARS), high-throughput CAR-T drug priority platform, and proprietary manufacturing processes, IASO Bio is developing a rich clinical-stage pipeline of multiple autologous and allogeneic CAR-T and biologics product candidates. Currently, the company is developing a diversified portfolio of over 10 novel pipeline products, IASO's leading asset, IBI326, an innovative anti-BCMA CAR-T cell therapy under pivotal study for relapsed/refractory (R/R) multiple myeloma (RRMM), was granted Breakthrough Therapeutic Designation by China's National Medical Products Administration (NMPA) in February 2021. For more information on IASO, please visit http://www.iasobio.com.

Forward-Looking Statements

This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to the Company, are intended to identify certain of such forward-looking statements. The Company does not intend to update these forward-looking statements regularly.

These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of the Company with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond the Company's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, the Company's competitive environment and political, economic, legal and social conditions.

The Company, the Directors and the employees of the Company assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialise or turn out to be incorrect.

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Innovent Biologics and IASO Biotherapeutics to Present Updated Data from its Anti-BCMA CAR-T Therapy in Relapsed/Refractory Multiple Myeloma at...

High Rate of Response Noted in MCL and CLL With Cirmtuzumab Plus Ibrutinib – Cancer Network

Patients with mantle cell lymphoma (MCL) or chronic lymphocytic leukemia (CLL) who were treated with cirmtuzumab and ibrutinib (Imbruvica) in a phase 1/2 trial showed promising responses with and tolerability of therapy, according to data presented at the American Society of Clinical Oncology (ASCO) Annual Meeting.

The majority of the patients demonstrated a significant reduction in tumor sizes, lead study author Hun Ju Lee, MD, assistant professor of medicine in the Department of Lymphoma & Myeloma at The University of Texas MD Anderson Cancer Center said during the presentation.

ORR for patients with MCL was 83.3% and was 91.1% for patients with CLL. The complete response rates were 38.9% and 14.7% for the MCL and CLL arms, respectively. Ultimately, 94.4% of patients with MCL and 100% of patients with CLL elicited a clinical benefit from the cirtuzumab/ibrutinib regimen.

The median progression-free survival in both cancers was not reached.

Because MCL and CLL are considered incurable, the study aimed to test the efficacy and safety profile of cirmtuzumab, which inhibits tumor promoting activity of onco-embryonic tyrosine kinase receptor ROR1 found in many solid and hematologic cancers, plus ibrutinib in patients with relapsed/refractory MCL or treatment nave or relapsed/refractory CLL.

The study was performed in 3 parts with separate arms. Part 1, for dose escalation; part 2, for dose expansion; and part 3, comparing cirmtuzumab plus ibrutinib with ibrutinib alone in CLL.

Overall, 26 patients with refractory MCL (median age 66.5, 15.4% women) and 34 patients with treatment nave or RR CLL (median age 68, 23.5% women) were enrolled in the study.

For part 1, 12 patients with MCL were enrolled, and 5 into part 2. The median number of prior regimens was 2, including patients relapsing after ibrutinib (n=4), autologous stem-cell transplantation (n=3), autologous stem cell transplantation/allogenic stem cell transplantation (1) and autologous stem cell transplantation /CAR-T (1). For patients with CLL, at least 74% were high risk, as determined by unmutated IGHV, del17p and/or del11q, in parts 1 and 2.

In part 1, cirmtuzumab was given intravenously 5 times every 2 weeks, and then every 4 weeks, at 2 to 16 mg. Three-hundred or 600 mg doses were also examined. Researchers assessed the safety profile of cirmtuzumab during the first 28 days, which was then followed by ibrutinib at approved doses for each indication. A treatment regimen of cirmtuzumab (600 mg) given intravenously 3 times every 2 weeks, and then every 4 weeks, in combination with ibrutinib starting day 0, was chosen as the recommended dosing for parts 2 and 3.

In summary, cirmtuzumab plus ibrutinib is a very well tolerated regimen, Lee noted.

Adverse events with 20% or greater incidence were recorded, including fatigue (n=11), diarrhea (n = 9), contusion (n = 7), dizziness (n = 7) and nausea (n = 7). The efficacy is robust in many of these pre-treated patients, [including] high response, rate durable response [and] encouraging PFS, demonstrating clinical benefit, he concluded.

Of note, the phase 2 study for CLL is completed, and is awaiting a long-term follow-up. Phase 2 for MCL is currently enrolling.

Reference

Lee HJ, Choi M, Siddiqi T, et al. Phase 1/2 study of cirmtuzumab and ibrutinib in mantle cell lymphoma (MCL) or chronic lymphocytic leukemia (CLL).J Clin Oncol. 2021;39(suppl 15; abstr 7556).

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High Rate of Response Noted in MCL and CLL With Cirmtuzumab Plus Ibrutinib - Cancer Network

Triplet Combo of Polatuzumab Vedotin, Rituximab and Lenalidomide Safe, Effective to Treat Relapsed/Refractory DLBCL – Cancer Network

The novel triplet combination with polatuzumab vedotin (Polivy), rituximab, and lenalidomide was safe while improving overall and complete responses for patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), according to data presented at the 2021 ASCO Annual Meeting.

In this first report of a triplet combination of polatuzumab, rituximab and lenalidomide, the triplet combination showed notable efficacy in a challenging-to-treat relapsed and refractory diffuse large B-cell lymphoma population, said Catherine S.M. Diefenbach, MD, associate professor of medicine, translational director of hematology and director of clinical lymphoma at Perlmutter Cancer Center at NYU Langone Health, during the virtual presentation.

In this phase 1b/2 trial, researchers analyzed the safety of this combination in 57 patients (median age, 71 years; 67% men) with relapsed/refractory diffuse large B-cell lymphoma, were ineligible for or failed prior autologous stem cell transplantation and were treated with at least one prior anti-CD20-containing chemo-immunotherapy regimen. Efficacy of the treatment was assessed in 49 patients (median age, 72 years; 63% men).

The median age was 71, as is typical for this lymphoma, but the age range was from between 28 and 92 years, Diefenbach said.

Most patients in the safety and efficacy groups (86% and 84%, respectively) had stage 3 to 4 disease, nearly a quarter had two lines of therapy (28% and 27%) and nearly a third had three or more lines of therapy (33% and 31%). In addition, some patients underwent previous CAR T-cell therapy (5% and 6%, respectively) or prior bone marrow transplant (11% and 12%).

At induction, all patients received induction during 6 28-day cycles with 1.8 mg/kg of intravenous polatuzumab vedotin, 375 mg/m2 of intravenous rituximab and either a dose escalation of oral lenalidomide (between 10 mg and 20 mg) or the recommended daily dose of the drug on days 1 through 21. Patients who responded to the treatment at the end of induction received 6 months consolidation of 10 mg of lenalidomide (days 1 through 21, monthly) and 375 mg/m2 of rituximab (day 1 every 2 months).

Primary endpoints for this trial included the safety and tolerability of this triplet combination, in addition to complete response rates at the end of induction as assessed by positron emission tomography (PET) scans. Follow-up was conducted for a median of 9.7 months in the safety population and for 9.5 months in the efficacy population.

In the safety population, 75% of patients experienced grade 3 to 4 adverse events, with the most common including neutropenia (58%), thrombocytopenia (14%) and infections (14%). Adverse events led to 26% of patients undergoing a lenalidomide dose reduction and 67% had treatment interruption. One grade 5 adverse event related to the treatment neutropenic sepsis was reported.

The additional (adverse events) were not considered related to study drug, Diefenbach said. For example, a patient who had a fatal gastric hemorrhage who had been enrolled but not yet treated, and a patient with COVID-19 who contracted this disease 167 days after his last dose of the study therapy.

In the efficacy population, the overall response rate was 39% with a complete response rate of 29%. Ten percent of patients had a partial response. Median progression-free survival for the entire population was 6.3 months (95% CI, 4.5-9.7) with a median duration of remission of 8.1 months (95% CI, 4.7-not evaluated) and a median overall survival of 10.9 months (95% CI, 10.9-not evaluated).

However, for the patients who obtained a (complete response) this is 13 patients who were evaluable, the median progression-free survival at 9 months had not been reached, nor has the median overall survival, Diefenbach said. Nearly all patients remain in complete remission.

Additional follow-up is needed to assess the impact of consolidation therapy on the duration of long-term response, Diefenbach said. In summary, the triplet combination of polatuzumab, rituximab and lenalidomide represents a potential novel regimen for patients with transplant-ineligible relapsed and refractory diffuse large B-cell lymphoma and is worthy of further study.

Reference

Magid Diefenbach CS, Abrisqueta P, Gonzalez-Barca E, et al. Polatuzumab vedotin (Pola) + rituximab (R) + lenalidomide (Len) in patients (pts) with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL): Primary analysis of a phase 1b/2 trial. J Clin Oncol. 2021;39(suppl 15):Abstract 7512.

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Triplet Combo of Polatuzumab Vedotin, Rituximab and Lenalidomide Safe, Effective to Treat Relapsed/Refractory DLBCL - Cancer Network

Dr. Ghosh on the Role of Off-the-Shelf CAR T-Cell Therapy in Myeloma June – OncLive

Monalisa Ghosh, MD, discusses the role of off-the-shelf CAR T-cell therapy in patients with multiple myeloma.

Monalisa Ghosh, MD, a clinical assistant professor at the University of Michigan, discusses the role of off-the-shelf CAR T-cell therapy in patients with multiple myeloma.

These products are promising in many ways and provide several advantages, including a decreased manufacturing time, Ghosh says. Experts in the field can request and receive off-the-shelf CAR T-cell products from a bank, she explains.This eliminates the need to wait for patient cell collection, which puts the patient at some degree of risk, and decreases the manufacturing time that ordinarily takes several weeks. The decreased treatment timeline can also be beneficial to patients with rapidly progressive disease, Ghosh notes.

However, challenges exist with this therapy, as allogenic cells may cause certain adverse effects, such as a graft-versus-host reaction that is similar to reactions observed with stem cell transplantation, Ghosh says. Currently, certain methods of T-cell receptor engineering may be able to mitigate this risk, she adds.Additionally, some hosts may reject the cells, a possibility that has been observed in early studies, wherein cells have not demonstrated long-term persistence.It may be possible to overcome this through multiple cell infusions, Ghosh notes.

Overall, the accessibility of off-the-shelf CAR T-cell products to a large group of patients with multiple myeloma appears promising, Ghosh concludes.

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Dr. Ghosh on the Role of Off-the-Shelf CAR T-Cell Therapy in Myeloma June - OncLive

Income, Education Affect Treatment and Survival in MDS – DocWire News

There may be a correlation between income and education and treatment and survival among patients with myelodysplastic syndromes (MDS), according to a study. The results were published in the European Journal of Haematology.

Using the Swedish MDS Register, the researchers identified 2,945 patients diagnosed with MDS between 2009 and 2018. They evaluated relative mortality using Cox regression and treatment differences using Poisson regression. Mortality comparisons were made using a matched group from the general population.

Patients in the lowest income category, compared to the highest, had 50% higher mortality; similarly, those with mandatory school education had 40% higher mortality than those with college or university education. There were also correlations observed between treatment with hypomethylating agents and allogeneic stem cell transplantation (SCT), and investigation with cytogenetic diagnostics, and income and education. Differences in risk class or comorbidity at the time of diagnosis did not account for these differences in mortality and treatment.

In this large, population-based study, we demonstrate that Swedish MDS patients with lower income or shorter education have shorter survival. They are further less likely to be investigated with cytogenetic diagnostics, and less likely to receive treatment with hypomethylating agents, or an allogeneic SCTthe only existing curative treatment for MDS today, the researchers wrote in their conclusion.

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Income, Education Affect Treatment and Survival in MDS - DocWire News