Category Archives: Stem Cell Therapy

The COVID-19 pandemic has wreaked havoc globally in the last year and a half, and the vaccination drive has come as a relief to the population. India is steadily progressing towards immunising the entire eligible population in a stage-wise manner, considering the huge population of the country.

Currently, India has two major vaccinations approved for emergency use a recombinant viral vector (Covishield, Serum Institute of India/AstraZeneca) and an inactivated virus (Covaxin, Bharat Biotech), with other candidates in the pipeline. The Health Ministry has issued guidelines regarding eligibility for the vaccination providing a broad list of systemic conditions, wherein the patients can safely take the vaccination. In other unlisted conditions, it is advisable that the patients consult with their healthcare provider, who can then advice the vaccination based on the current health status and by modifying medications (if required).

Patients with systemic conditions, especially long-standing cases, are generally considered to be at high risk of contracting the COVID-19 infection and associated mortality, due to the pre-existing disease burden.

Stem cell therapies are indicated for patients with several health conditions, wherein treatments need to target the immune system dysfunction, reduce systemic inflammation, etc., to increase the probability of survival and improve the quality of life.

The Health Ministry has clearly indicated that recipients or those on the wait-list for stem cell therapies can take the vaccination. The rationale for this is that the benefits of vaccination in such high-risk individuals outweigh the potential risks owing to the general immunosuppressive state that can predispose them to additional infections, said Dr Pradeep Mahajan, regenerative medicine researcher, StemRx Bioscience Solutions Pvt. Ltd., Navi Mumbai.

However, for the same reason of being in an immunosuppressive state (especially in the post-transplant period), it is important for patients to stay in contact with their healthcare providers after vaccination to monitor any adverse events, he mentioned.

Furthermore, care should be taken during the interval period between the two doses of the vaccination and for few weeks after the second dose, when the immune system is responding to the vaccination. This period may increase the susceptibility of such patients to opportunistic infections or COVID-19 itself, Dr Mahajan said.

Nonetheless, the manufacturers and the ministry have not issued any serious warning or precautions for such patients, and the vaccinations do not predispose stem cell therapy patients to adverse events or deterioration of their condition, he added.

Thus, there is no need for stem cell therapy patients to fear the after-effects of the vaccination. Close monitoring of overall health along with positive lifestyle and dietary modifications, continuing medications as prescribed, and following the healthcare providers advice will enable such patients to acquire immunity against COVID-19 following vaccination, which should be the priority considering the current situation, he suggested.

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Can stem cell therapy patients take the COVID vaccine? - The Indian Express

Danish pharma company Novo Nordisk has announced a new collaboration and licence agreement with Japans Heartseed to develop the companys investigational cell therapy HS-001 for heart failure.

HS-001, Heartseeds lead asset, is an investigational cell therapy using purified cardiomyocytes derived from induced pluripotent stem cells (iPSC). The therapy is currently being developed as a treatment for heart failure.

Heartseed is already planning to launch a phase 1/2 study of HS-001 in Japan in the second half of 2021, which will evaluate the safety and efficacy of the therapy for the treatment of heart failure caused by ischaemic heart disease.

Under the terms of their agreement, Novo Nordisk will gain exclusive rights to develop, manufacture and commercialise HS-001 globally, excluding Japan where Heartseed will retain the rights to solely develop the therapy.

However, Novo Nordisk has the rights to co-commercialise HS-001 with Heartseed in Japan, with equal profit and cost sharing.

In return, Heartseed is eligible to receive up to a total $598m, with $55m earmarked in upfront and near-term milestone payments.

The Japanese biotech company is also eligible to receive tiered high single-digit to low double-digit royalties of annual net sales on the product outside Japan.

"We are delighted to have a company with the expertise and resources of Novo Nordisk as our partner for development and commercialisation of HS-001, and are also honoured that Novo Nordisk has recognised the innovativeness and high potential of our technology," said Keiichi Fukuda, chief executive officer of Heartseed.

"We believe that the partnership with Novo Nordisk is very valuable as we seek to disseminate our Japan-origin innovation globally as early as possible, he added.

Through this important collaboration with Heartseed, we aim to pioneer novel treatment solutions for people with cardiovascular disease, said Marcus Schindler, chief scientific officer, EVP research and early development at Novo Nordisk.

We [will] gain access to an innovative clinical asset, underlying technology and deep expertise within the field of iPSC biology and cardiac cell transplantation, which can be combined with our knowledge and capabilities in stem cell biology and manufacturing, he added.

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Novo Nordisk partners with Heartseed on heart failure cell therapy - PMLiVE

Feasibility of chimeric antigen receptor (CAR) T-cell therapy targeting C-type lectin-like molecule-1 (CLL-1) for pediatric patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) was validated in a small patient cohort in a phase 1/2 trial (ChiCTR1900027684), results of which were presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting.1

At an interim analysis, 10 of 11 patients completely responded to anti-CLL1based CAR-T cell therapy, with CLL-1positive AML blasts eliminated within 1 month. Six patients achieved complete remission with minimal residual disease (MRD) negativity, added lead investigator Hui Zhang, MD, PhD, an assistant professor at Shanghai Childrens Medical Center and director of Guangzhou Women and Childrens Medical Center at Chinas Guangzhou Medical University.

From all the research shown, we can say that anti-CLL1 based CAR T-cells is a safe therapeutic candidate with manageable CAR T-cellassociated toxicity for children with R/R AML, he said. It is highly effective in targeting CLL1-positive AML cells with superior overall response rate (ORR) relative to conventional/novel targeting compounds.

In this study, 11 pediatric R/R AML patients aged 2 to 16 years were infused between October 2019 and January 2021 with a second-generation CLL1 CAR-T created in Zhangs laboratory. Investigators administered a single dose of CLL1 or CLL1-CD33 dual CAR-T cells (target dose: 0.3-1 x 106/kg) following lymphodepleting conditioning with a cyclophosphamide/fludarabine combination.

Zhang said all 11 patients experienced CAR T-cell expansion in vivo during the first month. Five patients demonstrated persistence of T-cell expansion.

All patients experienced grade 1 to 3 cytokine release syndrome (CRS) but there were no lethal events, Zhang said. All patients experienced myelosuppression, which he said might be due to chemotherapy. Three patients experienced a grade 1/2 hepatic event. No patient experienced cardiac, renal, or gastrointestinal adverse events.

Investigators have suggested that CLL-1 is a promising target because it not expressed on normal hematopoietic stem cells (HSCs), but is expressed on 85% to 92% of AML blasts cells and leukemia stem cells.2 In a humanized mouse model, investigators demonstrated that CAR T-cell therapy specific for CLL-1 exhibit potent cytokine production and cytotoxicity against CLL-1-expressing AML cell lines without disrupting normal HSCs.

Investigators theorized that developing an anti-CLL1 CAR T therapy would help patients avoid the need for HSC transplant.

In 2020, Zhang published a case study of a 10-year-old girl who presented with an elevated peripheral blood blast percentage while undergoing maintenance treatment for a B-cell ALL relapse. Investigators developed a CAR containing a CLL1-specific single-chain variable fragment.3

The patient received lymphodepleting chemotherapy for 4 days before CAR T-cell transfer to enhance in vivo expansion of CAR T-cells. This was followed by a single dose anti-CLL1 CAR-T cells infusion. She experienced Grade 1 to CRS.

After completing CAR T-cell therapy, the patient achieved a complete response and was negative for MRD (<0.1%) on day 29. But the CLL1+ cells were not completely eliminated until 6 months after CAR T-cell therapy. The patient achieved a 10-month response using 1 dose of anti-CLL1 CAR-T monotherapy.

References

1. Zhang H, Bu C, Pen Z, et al. The efficacy and safety of anti-CLL1 based CAR-T cells in children with relapsed or refractory acute myeloid leukemia: A multicenter interim analysis. J Clin Oncol. 2021;39(suppl 15):10000. doi:10.1200/JCO.2021.39.15_suppl.10000

2. Tashiro H, Sauer T, Shum T, et al. Treatment of acute myeloid leukemia with T cells expressing chimeric antigen receptors directed to C-type lectin-like molecule 1. Mol Ther. 2017;25(9):2202-2213. doi:10.1016/j.ymthe.2017.05.024

3. Zhang H, Gan WT, Hao, WG, et al. Successful ant-CLL1 CAR T-cell therapy in secondary acute myeloid leukemia. Front Oncol. 2020;10:685. Doi:10.3389/fonc.2020.00685

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Early Promise of AntiCLL-1 CAR T-Cell Therapy Reported in Pediatric AML - Cancer Network

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 Landscape4.1 Overview4.2 PEST Analysis4.3 Expert Opinion

5. Cell Therapy Bioprocessing Market - Key Market Dynamics5.1 Market Drivers5.1.1 Increasing Investments for Cell and Gene Therapy Manufacturing5.1.2 Growing Approvals for Cell Therapies5.2 Market Restraints5.2.1 Challenges Associated with Cell Therapy Bioprocessing5.3 Market Opportunities5.3.1 Automated Procedures to Produce Cell Therapies5.4 Future Trends5.4.1 Digital Biomanufacturing5.5 Impact Analysis

6. Cell Therapy Bioprocessing Market- Global Analysis6.1 Global Cell Therapy Bioprocessing Market Revenue Forecast and Analysis6.2 Global Cell Therapy Bioprocessing Market, By Geography - Forecast and Analysis6.3 Market Positioning of Key Players

7. Cell Therapy Bioprocessing Market Analysis - By Technology7.1 Overview7.2 Cell Therapy Bioprocessing Market Revenue Share, by Technology (2020 and 2028)7.3 Bioreactor7.4 Lyophilization7.5 Electrospinning7.6 Controlflow Centrifugation7.7 Ultrasonic Lysis7.8 Genome Editing Technology7.9 Cell Immortalization Technology7.10 Viral Vector Technology

8. Cell Therapy Bioprocessing Market Analysis - By Cell Type8.1 Overview8.2 Cell Therapy Bioprocessing Market Revenue Share, by Cell Type (2020 and 2028)8.3 Stem Cell8.4 Immune Cell8.5 Human Embryonic Stem Cell8.6 Pluripotent Stem Cell8.7 Hematopoietic Stem Cell

9. Cell Therapy Bioprocessing Market Analysis - By Indication9.1 Overview9.2 Cell Therapy Bioprocessing Market Revenue Share, by Indication (2020 and 2028)9.3 Cardiovascular Disease (CVD)9.4 Oncology9.5 Wound Healing9.6 Orthopedic

10. Cell Therapy Bioprocessing Market- By End User10.1 Overview10.2 Cell Therapy Bioprocessing Market Revenue Share, by End User (2020 and 2028)10.3 Hospitals and Clinics10.4 Diagnostic Centres10.5 Regenerative Medicine Centres10.6 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

Media Contact:

Research and Markets Laura Wood, Senior Manager [emailprotected]

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

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

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.

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