CAR NK-Cell Therapy Is Quickly Growing in Immunotherapy – Targeted Oncology

The introduction of CAR engineering to adoptive cell therapy has led to immune effector cell treatments with improved cytotoxicity.

In hematologic oncology, advancements in chimeric antigen receptors (CARs) for T-cell therapy have led to new investigations and an emerging role for CAR-natural killer (NK) cell therapy. Here we review why CAR-NK cell therapy is an area of interest, how it differentiates from CAR T-cell therapy, its potential challenges, and the current stage of development of this form of treatment.

The introduction of CAR engineering to adoptive cell therapy has led to immune effector cell treatments with improved cytotoxicity. This has been a major advancement in treatment for many patients with relapsed or refractory hematologic malignancies.1

Autologous CAR T cells were used in pioneering therapies, and their efficacy has led to FDA approvals in hematologic malignancies.1 For example, tisagenlecleucel (Kymriah), a CAR T-cell therapy, was approved for patients with relapsed/refractory acute lymphoblastic leukemia based on trial results showing an overall response rate of 81%, with 60% of patients achieving complete remission.2,3

However, despite their clinical efficacy, CAR T cells have limitations.4 Not all patients are candidates for CAR T-cell therapy. For example, heavily pretreated patients may not have sufficient autologous T cells to achieve clinically relevant doses of CAR T cells.1,4 Also, generating individualized autologous CAR T-cell products for each patient can take weeks, which can lead to unacceptable treatment delays in patients with rapidly progressive disease. Furthermore, patients receiving CAR T cells are at risk of developing graft-vs-host disease (GVHD) even if human leukocyte antigen (HLA) matching between donor and recipient is performed.

This form of therapy has also yet to make significant headway in treating patients with solid tumors. Few patients with solid malignancies have achieved complete responses to date, potentially due to limited expansion or persistence of CAR T cells and the inability of these cells to penetrate solid tumors.5

Moreover, long-term persistence of CAR T cells may cause cytokine release syndrome (CRS) and immune effector cellassociated neurotoxicity syndrome (ICANS), which can be life threatening.1,4,6 Lastly, target antigen loss after therapy can render CAR T immune cells ineffective due to their dependence on antigens for efficacy.

However, interest in CAR NK-cell therapy has resulted in ongoing research.1,7

Peter Riedell, MD, assistant professor of medicine, Section of Hematology/Oncology, University of Chicago Medicine, provided his insights in an interview with Targeted Therapies in OncologyTM.

CAR T-cell therapies take time, and this can be problematic for patients [who] have more rapidly progressive disease and need therapy urgently, said Riedell in an interview comparing CAR T-cell therapy to CAR-NK cell therapy. Having a cellular therapy product which is off-the-shelf is very attractive as it means we may be able to treat patients sooner rather than later with this therapy, he added.

NK cells, which were discovered almost 50 years ago, can defend against tumors in most tissues without requiring detection of specific tumor antigens.7 Potent innate anti-tumor activity and favorable safety profile features have promoted interest in CAR-NK cell immunotherapy.

NK toxicity against tumor cells involves both innate and adaptive immunity.7,8 For example, unlike T cells, NK cells can kill tumor cells without expression of major histocompatibility complex (MHC) molecules. As a result, CAR-expressing NK cells can eradicate heterogeneous malignancies that CAR T cells cannot, due to CAR T-cell dependence on MHC expression.8 Furthermore, NK cells are able to perform CD16-mediated anti- body-dependent cell-mediated cytotoxicity, giving them an added killing mechanism.8,9

CAR-NK cells also differ from CAR T cells by having a shorter lifespan in the blood-stream. Less potential for long-term off-tumor toxicities in CAR-NK cells is theorized as a result.9 Healthy cells express CD19 as well as malignant cells. While having CAR T cells remain in the body for longer periods may be associated with continued clinical benefit in maintaining remissions, when CAR T cells remain in the body for prolonged periods, this may also lead to B-cell aplasia and hypogammaglobulinemia, explained Riedell.

Additionally, preclinical and phase 1/2 trials have shown that allogeneic CAR-NK- cell infusions decrease the risk of GVHD.1,9,10 This allows the expansion of NK-cell production beyond autologous cells or only 1 cell line source. Persistence of allogeneic CAR NK cells has been observed in patients for at least 1 year despite HLA mismatching.11,12

Furthermore, NK cells can be administered without a requirement for full HLA matching.10 This allows for the use of allogeneic sources for CAR NK cells, including healthy donors, umbilical cord blood units, or induced pluripotent stem cells, Riedell noted. Importantly, manufacturing failures and out-of-specification products can also be avoided with off-the-shelf therapy.10

This allows for the use of allogeneic sources for CAR NK cells, including healthy donors, umbilical cord blood units, or induced pluripotent stem cells. Products are able to come off the shelf without the need to navigate collection of patients T cells and await their engineering and manufacture, which can take weeks, Riedell noted. Importantly, manufacturing failures and out-of-specification products can also be avoided with off-the-shelf therapy.10

CAR-NK cell therapy may be associated with a lower incidence and severity of CRS and neurologic toxicity, which is another reason this therapy is being explored, explained Riedell. These less severe adverse events may be due to the release of milder cytokines such as granulocyte-macrophage colony-stimulating factor and interferon-.9 CAR T cells induce the release of more cytotoxic cytokines, such as interleukin-1 (IL-1) and IL-6, that are associated with CRS.

Despite the safety and promising clinical efficacy of unmodified allogeneic NK cells, several challenges to using CAR-NK cells have emerged from clinical trials.

While CAR-NK cell therapy has been shown to be technically feasible, there is overall limited data in regard to the efficacy and safety of this treatment approach. Given that these cellular therapy products are allogeneic, there is a concern for emergence of graft-vs-host disease, Riedell said. There are many current clinical trials being conducted that evaluate CAR-NK cell therapy and we eagerly await the results of these trials to better understand the impact of this treatment approach, he added.

Furthermore, NK cells have a short lifespan of only 1 to 2 weeks, and without cytokine support, infused cells do not persist in the donor, which restricts efficacy.13

It is unknown if responses seen with this treatment may be durable and associated with continued remissions or if this therapy may be better utilized to induce responses and remissions in patients and then consolidate those remissions with an allogeneic stem cell transplant, explained Riedell.

Techniques to enhance the stability of CAR-NK cells include incorporation of transgenes encoding exogenous cytokines, such as IL-15.11 However, exogenous cytokines have undesirable adverse effects and can promote the activation of other immune sub- sets, such as regulatory T cells, which may suppress the effector functions of NK cells.14

Another challenge with CAR-NK cells is that NK cells are limited in number and often require ex vivo expansion and actiation. NK cells represent a minor fraction of peripheral blood leukocytes, and thus the generation of sufficient numbers of NK cells remains a major challenge for adoptive immunotherapy.

NK-92 is an established NK cell line that can be used as a source of cells for CAR- NK therapies, representing an alternative to patient- or donor-derived NK cells. An advantage of this process is easier manufacture of off-the-shelf CAR-NK products; however, a drawback is that NK-92 cells are from a tumor cell line and have a potential tumorigenicity risk.15

Lastly, CAR NK approaches are limited by approaches to gene transfer in NK cells. Gene transduction may lead to random intergration of DNA into the target cell genome, and can encourage off-target effects, including the silencing of essential genes or expression of tumor suppressor genes.9

Viral transduction results in low levels of transgene expression in NK cells and adversely impacts their survival. Nonviral vectors have been explored and are considered safe alternatives, but their relative overall benefits remain unclear.11

Several phase 1 and 2 trials for CAR-NK therapy are ongoing, with some published results.

In a phase 1/2 study (NCT03056339), patients with B-cell lymphoid malignancies were administered cord bloodderived, HLA-mismatched, anti-CD19 CAR-NK cells.12 The cells were transduced with a retroviral vector that expressed genes encoding anti- CD19 CAR, IL-15, and inducible caspase 9 (safety switch).

Of 11 heavily pretreated patients with CD19-positive lymphoma or chronic lymphocytic leukemia (CLL), 8 had an objective response (73%) and 7 had complete remission (64%) without major toxic effects. There were no recorded events of CRS, neurotoxicity, hemophagocytic lymphohistiocy- tosis, or GVHD.

Myelotoxicity was observed, which the investigators attributed to the lymphodeplet-ing chemotherapy prior to infusion. Many responses were seen within 30 days of infusion. Also, the CAR-NK cells expanded and persisted for at least 12 months.

A second study, a phase 1 trial (NCT04245722), evaluated the safety and efficacy of FT596, a multi-antigentargeted, pluripotent stem cellderived, off-the-shelf, anti-CD19 CAR-NK cell therapy. In the study, 20 heavily pretreated patients with relapsed/ refractory B-cell lymphoma or CLL were treated with FT596, either alone or in combination with rituximab (Rituxan).

Responses were seen in 8 of 11 efficacy-evaluable patients, 7 of which were complete respons- es. No GVHD or ICANS was observed in any of the 20 treated patients, and only 2 cases of CRS were reported.16

Several other clinical trials of interest are ongoing. A phase 1 study (NCT05247957) evaluating NKG2D, a cord bloodderived CAR-NK therapy, in patients with relapsed/refractory acute myeloid leukemia is expected to conclude at the end of 2022.

Another phase 1 study (NCT04887012) of HLA haploidentical anti-CD19 CAR-NK cells in relapsed/refractory B-cell non-Hodgkin lymphoma is ongoing. Finally, an early phase 1 study (NCT05215015) of CAR-NK cells targeting CD33 in patients with acute myeloid leukemia is ongoing.

CAR-NK cell therapy will likely become much more common and an area of increasing research focus should we be able to gain a better understanding that this treatment approach is safe and efficacious, Riedell noted. Additional studies are needed in order to understand optimal CAR-NK cell constructs, the best antigens to target, and strategies to bolster CAR-NK cell manufacturing, storage, and delivery, he added.

REFERENCES:

1. Basar R, Daher M, Rezvani K. Next-generation cell therapies: the emerging role of CAR-NK cells. Blood Adv. 2020;4(22):5868-5876. doi: 10.1182/bloodadvances.2020002547

2. FDA approves tisagenlecleucel for B-cell ALL and tocilizumab for cytokine release syndrome. FDA. September 7, 2017. Accessed March 23, 2022. https://bit.ly/38mmisI

3. Maude SL, Laetsch TW, Buechner J, et al. Tisagenlecleucel in children and young adults with B-cell lymphoblastic leukemia. N Engl J Med. 2018;378(5):439-448. doi:10.1056/NEJMoa1709866

4. Sterner RC, Sterner RM. CAR-T cell therapy: current limitations and potential strategies. Blood Cancer J. 2021;11(4):69. doi:10.1038/s41408-021-00459-7

5. Wagner J, Wickman E, DeRenzo C, Gottschalk S. CAR T cell therapy for solid tumors: bright future or dark reality? Mol Ther. 2020;28(11):2320-2339. doi:10.1016/j.ymthe.2020.09.015

6. Morris EC, Neelapu SS, Giavridis T, Sadelain M. Cytokine release syndrome and associated neurotoxicity in cancer immunotherapy. Nat Rev Immunol. 2022;22(2):85-96. doi:10.1038/s41577-021-00547-6

7. Marofi F, Saleh MM, Rahman HS. CAR-engineered NK cells; a promising therapeutic option for treatment of hematological malignancies. Stem Cell Res Ther. 2021;12(1):374. doi:10.1186/s13287-021-02462-y

8. Farag SS, Caligiuri MA. Human natural killer cell development and biology. BloodRev. 2006;20(3):123-137.doi:10.1016/j.blre.2005.10.001

9. Xie G, Dong H, Liang Y, Ham JD, Rizwan R, Chen J. CAR-NK cells: A promising cellular immunotherapy for cancer. EBioMedicine. 2020;59:102975. doi:10.1016/j.ebiom.2020.102975

10. Lupo KB, MatosevicS. Natural killer cells as allogeneic effectors in adoptive cancer immunotherapy. Cancers. 2019;11(6):769.doi:10.3390/cancers11060769

11. Gong Y, Klein Wolterink RGJ, Wang J, Bos GMJ, GermeraadWTV. Chimeric antigen receptor natural killer (CAR-NK) cell design and engineering for cancer therapy. J Hematol Oncol. 2021;14(1):73. doi:10.1186/s13045-021-01083

12. Liu E, Marin D, Banerjee P. Use of CAR-transduced natural killer cells in CD19-positive lymphoid tumors. N Engl J Med. 2020;382(6):545-553. doi:10.1056/NEJMoa1910607

13. Malmberg KJ, Carlsten M, Bjrklund A, Sohlberg E, Bryceson YT, Ljunggren HG. Natural killer cell-mediated immunosurveillance of human cancer. Semin Immunol. 2017;31:20-29. doi:10.1016/j.smim.2017.08.002

14. Pedroza-Pacheco I, Madrigal A, Saudemont A,et al. Interaction between natural killer cells and regulatory T cells: perspectives for immunotherapy. Cell Mol Immunol. 2013;10(3):222-229.doi:10.1038/cmi.2013.2

15. Zhang C, Oberoi P, Oelsner S, et al. Chimeric antigen receptor-engineered NK-92 cells: an off-the-shelf cellular therapeutic for targeted elimination of cancer cells and induction of protective antitumor immunity. Front Immunol. 2017;8:533.doi:10.3389/fimmu.2017.00533

16. Bachanova V, Ghobadi A, Patel K, et al. Safety and efficacy of FT596, a first-in-class, multi-antigen targeted, off-the-shelf, iPSC-derived CD19 CAR NK cell therapy in relapsed/refractory b-cell lymphoma. Blood. 2021;138(suppl 1):823. doi:10.1182/blood-2021-151185

Excerpt from:
CAR NK-Cell Therapy Is Quickly Growing in Immunotherapy - Targeted Oncology

The Tendonitis Market to Exhibit Growth at a CAGR of 2.9% In The 7MM During The Study Period (2018-30), Assesses DelveInsight – PR Newswire

The tendonitis market is expected to grow significantly owing to an increase in the targeted patient pool and novel treatment approaches by the leading companies such as R3 Stem Cell, TRB Chemedica, InGeneron, MiMedx Group, among others.

LAS VEGAS, April 14, 2022 /PRNewswire/ -- DelveInsight's Tendonitis Market Insightsreport includes a comprehensive understanding of current treatment practices, Tendonitis emerging drugs, market share of individual therapies, and current and forecasted market size from 2018 to 2030, segmented into 7MM (the United States, the EU5 (the United Kingdom, Italy, Spain, France, and Germany), and Japan.

Key Takeaways from the Tendonitis Market

Discover more about therapies set to grab major Tendonitis market share @Tendonitis Market Landscape

Tendonitis Overview

Tendonitis is an inflammation of a tendon, which is a thick, flexible cord of tissue that connects muscles to bone and helps the bone or structure move. Tendonitis most frequently affects the shoulder, bicep, elbow, hand, wrist, thumb, calf, knee, or ankle. The most common types of tendonitis include Tennis elbow tendonitis, golfer's elbow tendonitis, patellar tendonitis, Achilles tendonitis, supraspinatus tendonitis, trigger finger, or trigger thumb, wrist tendonitis, peroneal tendonitis, and posterior tibial tendonitis.

Tendonitis causes inflammation, soreness, and discomfort in the tendons, ligaments, and muscles around a joint. Different types of tendonitis might strike quickly and continue for days or weeks. The discomfort is exacerbated by movement and normally improves with rest or medication. Tendonitis symptoms might reoccur in the same body part.

Tendonitis symptoms often include discomfort and are commonly characterized as a dull aching (particularly while moving the afflicted limb or joint), soreness, and minor swelling at the place where a tendon joins to a bone.

Tendonitis can be diagnosed if there is discomfort at a specific place in the tendon. If the patient does not react to therapy, the doctor may order various testing. An x-ray can reveal calcium deposits surrounding the tendon, which can aid in Tendonitis diagnosis. Other imaging procedures for Tendonitis diagnosis, such as ultrasound or MRI, may indicate tendon sheath edema.

Tendonitis Epidemiology Segmentation

As per DelveInsight, the total Tendonitis incident caseswere found to be more than 11 million in the 7MM in 2020.

The total Tendonitis treated cases was more than 5 million in the 7MM in 2020.

The Tendonitis Market Reportproffers epidemiological analysis for the study period 2019-2032 in the 7MM segmented into:

Download the report to understand which factors are driving Tendonitis epidemiology trends @ Tendonitis Epidemiological Insights

Tendonitis Treatment Market

Tendonitis may go away over time. If this is not the case, the doctor will offer therapies to minimize pain and inflammation while preserving mobility. Severe symptoms of tendonitis may necessitate the services of a rheumatologist, orthopedic surgeon, or physical therapist. Most tendonitis symptoms, when properly treated, do not result in lasting joint damage or disability. RICE (Rest, Ice, Compression, Elevation) therapy; physical or occupational therapy; splints, braces, or slings these assistive Tendonitis devices allow the affected area to rest until the pain subsides; over-the-counter (OTC) and prescription medications; and corticosteroids injections are all Tendonitis treatment options.

Treatment for Tendonitis aims to alleviate pain and minimize inflammation. Failure to rest will almost certainly prolong the symptoms. If the problem is in a hip, leg, or foot, they may need to refrain from strenuous weight-bearing activities for a brief period of time. This allows the irritation to subside. Ice may aid in the reduction of inflammation and discomfort. Once or twice a day, freeze the affected region for 1015 minutes. If the pain persists, patients may require nonsteroidal anti-inflammatory drugs (NSAIDs) such as aspirin, ibuprofen, or naproxen. Topical NSAIDs are now available and may relieve pain and inflammation without causing stomach problems. In addition, acetaminophen (Tylenol) can help with pain relief.

Discover more about therapy set to grab substantial Tendonitis market share @ TendonitisTreatment

TendonitisPipeline Therapies and Key Players

To know about more new drugs for Tendonitis treatment available in the tendonitis market visit @ Best Anti-inflammatory Drugs forTendonitis Treatment

Tendonitis Market Dynamics

Tendinopathy is becoming more common in the developed world as a result of greater engagement in leisure activities and an older population. As a result, the Tendonitis market is anticipated to increase significantly owing to an increase in the targeted patient pool. Moreover, the anticipated launch of upcoming targeted therapy options and novel treatment approaches by leading companies such as, TRB Chemedica, CollPlant, MiMedx Group, among others for tendonitis treatment would provide hope to patients and have a beneficial impact on the Tendonitis market.

Nevertheless, there are certain limitations associated with the current Tendonitis treatment which are impeding the Tendonitis market growth. The lack of awareness of the biology and clinical importance of the condition may limit the right diagnosis, perhaps leading to a delayed diagnosis and misdiagnosis, the greatest problem of tendonitis treatment and thus limiting the growth of the Tendonitis market. Furthermore, one of the key causes of poor patient care is a breakdown in communication between doctors and patients. It may stifle the expansion of the Tendonitis market and access to treatments. In addition, despite several clinical advancements in the treatment for Tendonitis, there is still an unmet need for effective therapeutic options to supplement intrinsic and surgical healing. These above-mentioned factors are acting as a barrier to Tendonitis market growth.

Scope of the TendonitisMarket Report

Discover more about the future Tendonitis market share of treatment therapies @Drugs forTendonitis Treatment

Table of Contents

1.

Tendonitis Market Key Insights

2.

Tendonitis Market Report Introduction

3.

Tendonitis Market Overview at a Glance

4.

Tendonitis Market Executive Summary

5.

Disease Background and Overview

6.

Treatment and Management

7.

Epidemiology and Patient Population

8.

Patient Journey

9.

Tendonitis Marketed Therapies

10.

Tendonitis Emerging Drugs

11.

7 Major TendonitisMarket Analysis

12.

Tendonitis Market Outlook

13.

Potential of Current and Emerging Therapies

14.

KOL Views

15.

Tendonitis Market Drivers

16

Tendonitis Market Barriers

17.

Unmet Needs

18.

SWOT Analysis

19.

Appendix

20.

DelveInsight Capabilities

21.

Disclaimer

22.

About DelveInsight

Get in touch with our Business executive @Healthcare Due Diligence Services

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The Tendonitis Market to Exhibit Growth at a CAGR of 2.9% In The 7MM During The Study Period (2018-30), Assesses DelveInsight - PR Newswire

O-Shot Therapy Raises Hope of Enhanced Sexual Experience in Genitally Mutilated Females – THISDAY Newspapers

Mary Nnah

There is hope for full conjugal experience with their partners for over 20 million Nigerian girls and women who have undergone female genital mutilation (FGM) with O-Shot therapy.

O-Shot, a regenerative medicine procedure that is done through Adult Stem Cell Therapy (non-invasive) or Platelet Rich Plasma (PRP) therapy (non-invasive) is a cosmetic procedure to enhance female sexual wellness.

According to Dr. David Ikudayisi, Medical Director of Glory Wellness and Regenerative Centre, Lekki, Lagos, O-Shot (aka orgasm shot) treatment, Involves injecting the Clitoris, Labia and G-spot with Platelets-substances in your blood that contains healing proteins called growth factor-extracted from your own blood.

Speaking during a recent webinar titled: Female Genital Mutilation (FGM): How to Enhance Your Sexual Experience Through Adult Stem Cell as part of the activities to mark the International Women Day, 2022, Dr. Ikudayisi explained: We use Platelet Rich Plasma (PRP) from your own blood, in addition to the use of Adult Stem Cells (such as Umbilical Blood Stem Cells, Fat-derived Stem Cells, Bone Marrow Stem Cells, Stem Cells Exosomes) and Shockwave Therapy to enhance female sexual wellness.

Ikudayisi, who is United States of America Board Certified Internist and Regenerative Medicine Specialist, said the application of PRP around the genital organ promotes blood flow and cell growth which leads to regeneration within the Clitoris. The result is new, healthy tissues (clitoris) that is permanent, he added.

Dr. Ikudayisi decried the high prevalence of female genital mutilation in Nigeria and in many African countries saying that apart from denying women the opportunity of enjoying sex it has huge health implications.

These include abscesses, cysts, excessive scar tissue, painful sex and menstruation, Hepatitis and other blood-borne diseases, urinary tract infections, infertility, and increased risk of bleeding during childbirth.

Ikudayisi said a survey on February 1, 2022, by Statista Research Department, shows that as of 2018, 20 per cent surveyed women in Nigeria had undergone female genital mutilation. Compared to 2013, this figure decreased by five percentage points (25 per cent)..

According to him, Nigeria ranks the third-highest globally in the prevalence of FGM, accounting for 10 per cent of the global total.

Ikudayisi identified age-long cultural and religious practices as the factors promoting FGM in Nigeria.

He said several civil society organisations and international non-governmental organisations are involved in strong advocacy against FGM while those females who have come under the knife can get their genital area, especially the clitoris back, and hence have full sexual experience through the O-Shot therapy.

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O-Shot Therapy Raises Hope of Enhanced Sexual Experience in Genitally Mutilated Females - THISDAY Newspapers

Europe Autologous Stem Cell and Non-Stem Cell Based Therapies Market: Demand Growth, Geographic Segmentation, Key Players Analysis To 2028 Political…

Europe Autologous Stem Cell and Non-Stem Cell Based Therapies Market market research report is always useful to business or organization in many subjects of trade for taking better decisions, solving the toughest business questions, and minimizing the risk of failure. The studies of this market report carefully analyzes the market status, growth rate, future trends, market drivers, opportunities, challenges, risks, entry barriers, sales channels, and distributors. The most advanced tools and techniques including SWOT analysis and Porters Five Forces Analysis have been applied to structure this business report. Moreover, diverse segments of the market are taken into consideration in Europe Autologous Stem Cell and Non-Stem Cell Based Therapies Market market report which gives better market insights and extend reach to the success.

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What Does The Report Include? The report includes a variety of topics significant for the market players to understand such as financial structure of the market, market size, market threats, constraints, total production, annual sales, yearly revenue, growth prospects, and more about the Europe Autologous Stem Cell and Non-Stem Cell Based Therapies Market. The report includes forecast from the year 2021 and 2028, demand, and expected revenue in US dollars. Macroeconomic indicators influencing theEurope Autologous Stem Cell and Non-Stem Cell Based Therapies Market are provided in the report. Sector-wise analysis of the factors identified in demand side, supply side, external factors, and principal forces that are affecting the Europe Autologous Stem Cell and Non-Stem Cell Based Therapies Market. The total demand of the market segmented by business, consumer, and government is given in the report.

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Europe Autologous Stem Cell and Non-Stem Cell Based Therapies Market: Demand Growth, Geographic Segmentation, Key Players Analysis To 2028 Political...

Eggschain CEO to Speak on Blockchain Applications in Fertility Treatment at 2022 College of Reproductive Biology Symposium – Business Wire

AUSTIN, Texas--(BUSINESS WIRE)--Eggschain, the first biotech company on the bitcoin blockchain and the first patented blockchain-integrated chain of custody and end-to-end lab management solution for all biospecimens, is pleased to share that company founder and CEO Wei Escala will be speaking at the 2022 College of Reproductive Biology (CRB) Symposium. The event will take place May 12 May 14 in Austin, Texas, at the AT&T Hotel and Conference Center.

Details of Ms. Escalas discussion are below: Title: Blockchain and Information Technology Applications in Fertility Treatment Date: Saturday, May 14, 2022 Time: 10:15 a.m. - 11:15 a.m. CT

The CRB Symposium presents an excellent opportunity to educate the scientific community on how our platform can bring professional grade information and data to individuals undergoing fertility treatments in a secure, transparent and universally trackable format, as well as how our platform can apply to other biospecimen procedures, said Wei Escala, founder and CEO of Eggschain. Biospecimens include but are not limited to sperm, eggs, embryos, DNA, RNA, tissues, organs, genome, blood and stem cells, illustrating the broad application of Eggschains patented capabilities."

The College of Reproductive Biology (CRB), a not-for-profit special interest group of the American Association of Bioanalysts (AAB), provides a focused forum for andrologists and embryologists to communicate with each other, share ideas and knowledge, and foster closer collaborations. CRBs educational programs have been well received within the field of assisted reproductive technology by clinic staff and laboratory personnel. The CRB Symposium educational program features a variety of topics covering the newest science and technology and is approved for continuing education credit. Symposium attendees are reproductive biologists and include laboratory directors, technical supervisors, clinical consultants, and andrology and embryology laboratory scientists.

About Eggschain, INC. Eggschain is a healthcare technology company and thought leader in the fertility, health tech, family-building and cryogenic preservation industries. Patent-granted and cloud-based, Eggschain is the first blockchain-integrated inventory management and chain of custody technology for tracking bio specimens, including sperm, eggs, embryos, genome, stem cell, tissues and organs, and other genetic material. In partnership with several of the worlds leading experts in reproductive biology, endocrinology and high complexity labs, Eggschain delivers medical grade information and data to individuals undergoing IVF in a secure, transparent and universally trackable format and also provides the means for clinics to monitor their inventory, either personal, such as oocytes and sperm, or lab-related, including equipment inventory and maintenance scheduling. At its core, Eggschain strives to enable better decision-making, preserving the hope of life and helping to advance humanity.

About AAB The American Association of Bioanalysts (AAB) is a professional association representing bioanalysts (clinical laboratory directors, owners, managers, and supervisors), medical technologists, medical laboratory technicians, and physician office laboratory technicians. AABs specialized membership sections include the College of Reproductive Biology (CRB), AAB Associate Member Section (AMS), Environmental Biology and Public Health (EBPH) Section, and the National Independent Laboratory Association (NILA).

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Eggschain CEO to Speak on Blockchain Applications in Fertility Treatment at 2022 College of Reproductive Biology Symposium - Business Wire

Drug Price Watchdog Calls Bluebird Bio’s $2.1 Million Gene Therapy Cost-Effective – BioSpace

Courtesy of Pavlo Gonchar/SOPA Images/LightRocket via Getty Images

Drug pricing watchdog ICER, the Institute for Clinical and Economic Review, issued a draft report on bluebird bios gene therapy betibeglogene autotemcel for beta-thalassemia. Despite the proposed price tag of $2.1 million, ICERs not-yet-finalized report supports the therapys cost-effectiveness. This is good news for the recently beleaguered company.

Gene therapies are typically designed to cure a disease by replacing or fixing a damaged gene. Bluebirds therapy, which is listed under the brand name Zynteglo, had been approved in Europe and the UK, where its price is around $1.7 million (U.S.). However, the company pulled the therapy off the market in Europe over what it called a hostile pricing and reimbursement environment.

On April 5, bluebird bio announced it was beginning a comprehensive restructuring in hopes of cutting $160 million in costs over the next two years. It planned to re-focus on near-term catalysts, which include Zynteglo in the U.S., gene therapy for cerebral adrenoleukodystrophy (eli-cel) and a potential biologics license application (BLA) for lovotibeglogene autotemcel (lovo-cel) gene therapy for sickle cell disease. The BLA application is planned for 2023, while the U.S. regulatory decisions are expected this year. The PDUFA date for Zynteglo is Aug.19, 2022, and Sept. 16, 2022, for eli-cel.

As part of the restructuring, the company is cutting its workforce by about 30%.

ICER recommendations arent binding, but they have influence. If ICER says a drug is overpriced, it provides ammunition for payers, such as Medicare and insurers, to push back against proposed prices.

Gene therapies are very expensive. For example,Novartis Zolgensma, the one-time gene therapy onasemnogene abeparvovec for spinal muscular atrophy (SMA), is generally viewed as the most expensive drug with a price tag of $2.1 million. On the other hand, as an apparent cure for a disease that kills children by the age of two, it is very rare. The argument for these therapies, aside from their curative potential for otherwise incurable diseases, is that over the life of the patient, they are cost-effective.

Novartis and Spark Therapeuticss gene therapy Luxturna (voretigene neparvovec) runs about $850,000 per patient in the U.S. The therapy is for inherited retinal dystrophy with RPE65 mutations. It is typically diagnosed in childhood and eventually causes almost total blindness, and the therapy is essentially a cure.

Beta thalassemia is a genetic disease that impairs the ability of red blood cells to manufacture hemoglobin, the molecule in the body that carries oxygen. There are about 40,000 newly diagnosed cases in children each year around the world. People with the most severe form of it develop life-threatening anemia around four to six months of age and have to receive monthly blood transfusions and other treatments, such as iron-chelating drugs. The only other potential cure is hematopoietic stem cell transplantation (HSCT) but requires a donor with a matching human leukocyte antigen (HLA) profile within the appropriate age range.

Bluebirds Zynteglo appears to be another option for a cure, although how long the therapys effects last is something of an open question. The ICER report noted the uncertainties, but concluded that the evidence suggests that beti-cel provides net health benefits to patients with TDT.

The ICER report indicated, per Managed Healthcare Executive, that "patients could be treated without reaching the potential budget impact threshold at three prices (about $1.85 million, $2.11 million and $2.38 million per course of treatment). This analysis was done at several prices to document the percentage of patients who could be treated without crossing a potential budget impact threshold that is aligned with the overall growth in the U.S. economy.

In Phase III trials, 89% of patients who received the therapy became transfusion independent, and in Phase I/II and III trials, those patients remained transfusion-free for at least 42 months. In general, side effects were mild and no deaths were reported. In December 2021, bluebird presented data at the American Society of Hematology meeting from a long-term study (LTF-303) that showed adult and pediatric patients with beta-thalassemia who required regular red blood cell transfusions can produce normal or near-normal levels of total hemoglobin and remain transfusion-free with stable iron markers up to seven years after receiving beti-cel.

A 2017 study published in Blood found that on average, beta-thalassemia patients required 17 transfusions per year, 23 days apart. Mean total healthcare costs for the patients were $128,062, plus or minus $62,260 per year. Total costs were primarily driven by chelation and transfusion costs.

Although the severity of the disease varies, a 2009 study found that people with beta-thalassemia major often die from cardiac complications of iron overload by 30 years of age," making bluebird's new therapy, if it is successful, vital for these patients.

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Drug Price Watchdog Calls Bluebird Bio's $2.1 Million Gene Therapy Cost-Effective - BioSpace