Category Archives: Regenerative Medicine

AVITA Medical

Funds will support completion of the ongoing pivotal clinical trial

VALENCIA, Calif. and MELBOURNE, Australia, March 21, 2022 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a regenerative medicine company that is developing and commercializing a technology platform that enables point-of-care autologous skin restoration for multiple unmet needs, announced today that the Biomedical Advanced Research and Development Authority (BARDA) has modified its existing contract with the Company to support AVITA Medicals clinical trial in soft tissue reconstruction. BARDA is a part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS).

We are extremely pleased that BARDA is supporting advanced treatment options for soft tissue reconstruction, said Dr. Mike Perry, Chief Executive Officer of AVITA Medical. The RECELL System has already proven itself as a safe and effective tool for those with burns, and we are committed to expanding its use to include all acute wounds. We are pleased BARDA recognizes the potential it holds for a broader group of patients experiencing trauma. BARDA has been an outstanding partner, and we are excited to continue our work to expand the indication for the RECELL System with their support.

Soft tissue reconstruction is of particular concern to BARDA and AVITA Medical, as skin grafting, the current standard of care for soft tissue reconstruction, requires the harvesting of donor skin which can result in an additional wound to the patient. Significant pain, delayed healing, risk of infection, the need for multiple procedures, discoloration and scarring are associated with donor site wounds. While skin grafting is commonly associated with burn treatment, in 2017, approximately 80% of acute wounds that required skin grafting were non-burn related injuries accounting for more than 200,000 procedures in the U.S.i

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AVITA Medical is currently completing a pivotal trial for the use of the RECELL System for soft tissue reconstruction. Currently, the RECELL System is indicated in the U.S. for treatment of acute thermal burns. The clinical trial will compare the clinical performance of conventional autografting to that of widely meshed autografting with the RECELL System on acute non-burn full-thickness skin defects, with the goal of demonstrating that less donor skin is needed without compromising healing outcomes. Topline data from the trial will be shared later this year.

AVITA Medical has had a long-term positive relationship with BARDA since September 2015 and was of fundamental importance to the Company being able to achieve premarket approval for the RECELL System in late 2018.

This project has been funded in whole or in part with Federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201500028C

ABOUT AVITA MEDICAL, INC.AVITA Medical is a regenerative medicine company with a technology platform positioned to address unmet medical needs in burns, chronic wounds, and aesthetics indications. AVITA Medicals patented and proprietary collection and application technology provides innovative treatment solutions derived from the regenerative properties of a patients own skin. The medical devices work by preparing a RES REGENERATIVE EPIDERMAL SUSPENSION, an autologous suspension comprised of the patients skin cells necessary to regenerate natural healthy epidermis. This autologous suspension is then sprayed onto the areas of the patient requiring treatment.

AVITA Medicals first U.S. product, the RECELL System, was approved by the U.S. Food and Drug Administration (FDA) in September 2018 and a new ease-of-use design was approved in 2022. The RECELL System is indicated for use in the treatment of acute thermal burns. The RECELL System is used to prepare Spray-On Skin Cells using a small amount of a patients own skin, providing a new way to treat severe burns, while significantly reducing the amount of donor skin required. The RECELL System is designed to be used at the point of care alone or in combination with autografts depending on the depth of the burn injury. Compelling data from randomized, controlled clinical trials conducted at major U.S. burn centers and real-world use in more than 10,000 patients globally reinforce that the RECELL System is a significant advancement over the current standard of care for burn patients and offers benefits in clinical outcomes and cost savings. Healthcare professionals should read the INSTRUCTIONS FOR USE - RECELL Autologous Cell Harvesting Device (https://recellsystem.com/) for a full description of indications for use and important safety information including contraindications, warnings, and precautions.

In international markets, our products are marketed under the RECELL System brand to promote skin healing in a wide range of applications including burns, chronic wounds, and aesthetics. The RECELL System is TGA-registered in Australia and received CE-mark approval in Europe. To learn more, visit http://www.avitamedical.com.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This press release includes forward-looking statements. These forward-looking statements generally can be identified by the use of words such as anticipate, expect, intend, could, may, will, believe, estimate, look forward, forecast, goal, target, project, continue, outlook, guidance, future, other words of similar meaning and the use of future dates. Forward-looking statements in this press release include, but are not limited to, statements concerning, among other things, our ongoing clinical trials and product development activities, regulatory approval of our products, the potential for future growth in our business, and our ability to achieve our key strategic, operational and financial goal. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Each forward-looking statement contained in this press release is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others, the timing of regulatory approvals of our products; physician acceptance, endorsement, and use of our products; failure to achieve the anticipated benefits from approval of our products; the effect of regulatory actions; product liability claims; risks associated with international operations and expansion; and other business effects, including the effects of industry, economic or political conditions outside of the companys control. Investors should not place considerable reliance on the forward-looking statements contained in this press release. Investors are encouraged to read our publicly available filings for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this release, and we undertake no obligation to update or revise any of these statements.

This press release was authorized by the review committee of AVITA Medical, Inc.

FOR FURTHER INFORMATION:

i 2017 Procedural Data. 2019 DR/Decision Resources, LLC

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AVITA Medical Announces Modification of BARDA Contract to Advance Development of RECELL System in Soft Tissue Reconstruction - Yahoo Finance

TheGlobal Cell Therapy Marketwas worth USD7.8 billion in 2021, according to a new analysis released by Maximize Market Research, and is expected to rise to USD 20.2 billion by 2027, with a CAGR of 14.5% percent over the forecast period. From the markets perspective, its ever-changing trends, industrial environment, existing market features, and the current short-term and long-term influence on the market

the research will aid decision-makers in developing the outline and strategies for organisations by region.

The implantation of a human cell to replace or repair damaged tissue or cells is known as cellular therapy. Therapy typically consists of live cells that are safely injected, implanted, or grafted into the patients body to have a therapeutic effect. T-cell and stem cell treatment are two types of cell therapy that are used to combat cancer via cell mediated immunity or to repair damaged tissues. For patients with long-term ailments, cell therapy has become a popular treatment option.

Cell Therapy Market Scope and Dynamics:

The Maximize Market Research report contains a detailed study of factors that will drive and restrain the growth of the Cell Therapy Market Globally. Significant advances in cell therapy, a growing emphasis on regenerative medicine, increased R&D activities in the life sciences sector to develop advanced cellular therapies, and the rising prevalence of cancer, musculoskeletal disorders, cardiovascular diseases, autoimmune disorders, and neurological diseases are all driving the global cell therapy market revenue growth.

Other significant factors driving global market revenue growth include increased awareness and commercialization of stem cell therapies, an increase in the number of clinical trials of new cell therapies, an increase in the use of human cells in cell therapy research and development, and an increase in cellular therapy manufacturing under Good Manufacturing Practices (GMP) supervision. Increased government investments in the healthcare industry, as well as increased collaborations between pharmaceutical and biotechnology behemoths and leading research institutes for the development of advanced cellular therapies for cancer, cardiovascular disease, and other severe chronic diseases, are expected to boost global cell therapy market revenue growth in the coming years.

The Impact of COVID-19 on the Cell Therapy Market:

The COVID-19 pandemic has impacted the majority of biopharmaceutical companies, but several cellular treatment development companies have seen a significant negative impact, which can be related to logistical issues as well as the manufacturing models used in this field. Furthermore, large and reliable funding is required to ensure successful commercial translation of cell-based medicines, a factor that was negatively impacted in 2020, affecting market growth even more.

Request For Free Sample @https://www.maximizemarketresearch.com/request-sample/126471

Cell Therapy Market Region Insights:

Regional analysis is another highly comprehensive part of the research and analysis study of the global Cell Therapy Market presented in the report. The global cell treatment market is dominated by North America. In 2020, North America held a total market share of 14.5%percent, as new institutions and institutes invest in R&D to propel cell therapy forward. Institute for Stem Cell Biology and Regenerative Medicine, Stanford University, Harvard Stem Cell Institute, and Yale Steam Cell Center are among the main universities in the United States that are involved in new research in cell regenerative technologies. During the forecasted period, Asia Pacific is expected to increase at a significant rate of 14.5%percent. China, South Korea, and Japan are spending extensively in regenerative medicine and stem cell therapies. Certain government-funded institutes are devoted to R&D with the goal of pushing the market forward.

What does the report include?

The study on the Global Cell Therapy Market includes qualitative characteristics such as drivers, constraints, and opportunities.The research looks at the current and future rivals in the Global Cell Therapy Market, as well as their product development strategies.The study examines the market in both qualitative and quantitative terms, and it is separated into three segments: component, deployment type, organisation size, and industry. Furthermore, the report provides comparable statistics for the key regions.For each of the above-mentioned segments, actual market sizes and predictions have been presented.

Cell Therapy Market Segmentation:

Global Cell Therapy Market, by Therapy Type:

AutologousAllogeneic

Global Cell Therapy Market, by Cell Type:

T-CellStem Cell

Global Cell Therapy Market, by Application:

MalignanciesMusculoskeletal DisorderAutoimmune DisorderDermatologyOthers

Global Cell Therapy Market, by End User:

Hospitals and clinicsAcademics and Research Institutes

By Region:

North AmericaEuropeAsia PacificSouth AmericaMiddle East and Africa

Key Players in Cell Therapy Market:

Kolon TissueGene Inc.Anterogen Co. Ltd.JCR Pharmaceuticals Co., Ltd.Castle Creek Biosciences, Inc.The Future of Biotechnology, MEDIPOSTOsiris Therapeutics, Inc.PHARMICELL Co., LtdTameika Cell Technologies, Inc.Cells for CellsNuVasive, Inc.Vericel CorporationCelgene CorporationThermo Fisher Scientific Inc.Merck KGaADanaher CorporationBecton, Dickinson, and CompanyLonza GroupSartorius AGTerumo BCTFresenius Medical Care AG & Co. KGaA

To Get a Detailed Report Summary and Research Scope of Cell Therapy MarketClick here @https://www.maximizemarketresearch.com/market-report/cell-therapy-market/126471/

About Maximize Market Research:

Maximize Market Research, a global market study firm with a dedicated team of specialists and data, has conducted thorough research on the Cell Therapy Market. Maximize Market Research is well-positioned to assess and predict market size while also taking into account the competitive landscape of the various industries. Maximize Market Research has a strong unified team of industry professionals and analysts across sectors to guarantee that the whole industry ecosystem, as well as current developments, new trends, and futuristic the technology effect of uniquely particular industries is taken into consideration.

Contact Maximize Market Research:

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Pune Banglore Highway, Narhe,

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Cell Therapy Market is Expected to Grow by USD 20.2 Billion Progressing at a CAGR of 14.5% By Forecast 2027 - Digital Journal

Visiongain Ltd

Visiongain has published a new report on Viral Vectors and Plasmid DNA Manufacturing Market 2021-2031. Forecasts by Vector Type (Adenovirus, Retrovirus, Plasmid DNA, AAV, Lentivirus, Others), Application (Antisense & RNAi, Gene Therapy, Cell Therapy, Vaccinology), Disease (Oncology, Genetic Disorders, Infectious Diseases, Others), End-Use (Pharma and Biopharma Companies, Research Institutes), Region (North America, Europe, Asia Pacific, Latin America, Middle East, and Africa), PLUS COVID-19 Recovery Scenarios

Global viral vectors and plasmid DNA manufacturing market size is estimated to be valued at US$420.7million in 2020 and is anticipated to reach US$2,381.5 million in 2031 while growing at a CAGR of17.4% during the forecast period from 2021 to 2031.

Download Exclusive Sample of Report @ https://www.visiongain.com/report/viral-vectors-manufacturing-market-2021/#download_sampe_div

COVID-19 Impact on the Viral Vectors and Plasmid DNA Manufacturing Market

Due to increases in the therapies in progress, the dosages provided, & the patient populations targeted, viral vector production capacity has become increasingly reduced in recent years. The condition is aggravated by COVID-19. The number of companies developing innovative medicines such as cell, gene, & tissue-based therapies surpassed 1,000 in the first half of 2020, according to the ARM (Alliance for Regenerative Medicine). Since 2015, that represents an upsurge of almost 50%. Increases in clinical trial activity have corresponded to the emergence of successful advanced therapy companies.

Market Drivers

A Robust Pipeline for Gene Therapy and Viral Vectors

Almost 400 Embryonic cell and gene therapies address a broad variety of diseases. The overlapping areas of biomedical science with common therapeutic targets that target DNA or RNA within or outside the body are cell and gene therapy. To optimize functioning or tackle the disease, all techniques aim to alter genetic material. Specifically, gene therapy uses genetic material, or DNA, to cure an inherited or acquired disorder by modifying a patient's cells. The injection or transplantation of whole cells into a recipient for the treatment of an inherited or acquired disorder is cell therapy.

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Increasing Capacities by Manufacturers Owing to Rising Demand

There is a growing need for realistic production methods for viral vectors that can be quickly standardized and scaled since cell and gene therapies have the ability to progress rapidly from clinical trials through commercialization. Brammer Bio and Pall Biotech are both designing and applying state-of-the-art solutions designed to speed up process growth and scale-up for the manufacture of viral vectors through ongoing efforts. While biological drug substances with lower molecular weight are often generated through fermentation, larger recombinant proteins, and monoclonal antibodies (mAbs) are usually manufactured using well-established platform processes, accounting for the largest fraction of biologics on the market today. Consequently, manufacturing equipment has been built for the production ofmAbs, and this room is well serviced by suppliers of equipment.

Market Opportunities

The rise in the Development of Allogeneic and Autologous Cell Therapy

The more commercially appealing development of allogeneic cell therapy currently dominates over the production of autologous cell therapy, while clinical research in support of patient-specific therapy is convincing. There are opportunities for both autologous and allogeneic cell therapies to be developed, which differ greatly in their production requirements, patient administration paths, and cost structures.

In an autologous transplant, the patient's own stem cells are used for transplantation purposes for the treatment of many diseases such as cancer. The stem cells are obtained from either bone marrow or blood and are then frozen for harvest purposes. High doses of chemo or radiation therapy damage different cells of the body. Thus, after these therapies during cancer treatment, the thawed stem cells are reintroduced into the patient's body to restore the damaged cells. As the patient's own cells are used during autologous stem cell transplantation, there would be no risk of transplant rejection. This type of transplant is mainly utilized for the treatment of types of leukemia, lymphomas, and multiple myeloma. It is occasionally used to treat cancers in children and follicular lymphoma.

Competitive Landscape

Some of the major companies operating in the global Viral Vectors and Plasmid DNA Manufacturing market are Merck KGaA, Lonza, FUJIFILM Diosynth Biotechnologies U.S.A., Inc., Cobra Biologics Ltd., Brammer Bio, Waisman Biomanufacturing, Genezen, YPOSKESI, Advanced BioScience Laboratories, Inc. (ABL, Inc.), Novasep Holding S.A.S, ATVIO Biotech Ltd, Vigene Biosciences, Inc., Cytiva, CEVEC Pharmaceuticals GmbH, Batavia Biosciences B.V, Biovian Oy, Wuxi AppTec Co., Ltd., VGXI, Inc., Paragon Bioservices, Inc., MiltenyiBiotec GmbH, SIRION Biotech GmbH, Virovek Incorporation, BioNTech IMFS GmbH, VIVEbiotech S.L., Creative Biogene, Vibalogics GmbH, Cell and Gene Therapy Catapult, BlueBird Bio, Addgene, Inc., Aldevron, L.L.C., Audentes Therapeutics, and BioMarin Pharmaceutical.

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Global Viral Vectors and Plasmid DNA Manufacturing Market is anticipated to reach US$2,381.5 Million in 2031: Visiongain Research Inc - Yahoo Finance

Exhibit features live presentations and interactive content highlighting innovative allograft biologics for bone healing and joint reconstruction

CHICAGO, March 22, 2022 /PRNewswire/ -- LifeNet Health, the world leader in allograft biologics, is showcasing its comprehensive portfolio of advanced biomaterials for fractures, fusions, and joint repair and reconstruction at the 2022 AAOS Annual Meeting (Booth #3445) March 23-25 in Chicago.

Its featured solutions include:

"Having the right biologics can be critical to ensuring patients heal successfully," said Daniel Osborne, LifeNet Health Vice President of Global Marketing and Commercial Strategy. "Our combination of proprietary technologies and clinical insight allows us to offer better biologics, and we look forward to sharing data at AAOS that illustrates how our solutions provide efficiency in the OR and efficacy for patients."

LifeNet Health's presence at AAOS will highlight the robust clinical and technical data behind its solutions, such as recent studies that show ViviGen supports outcomes equivalent to autograft1,2 and superior to mesenchymal stem cell (MSC)-based grafts in even high-risk foot and ankle procedures.

Live Presentations In-Person or OnlineIn addition to its exhibit hall and digital presence, LifeNet Health's Medical Science Liaison Elena Gianulis, PhD, will lead live, in-booth presentations on two of the most-advanced osteobiologics solutions available, ViviGen and PliaFX Prime.

The first presentation explores the growing body of evidence showing ViviGen supports healing in trauma, extremity and spine procedures. The second session will focus on how the unique technology of PliaFX Prime 100% bone moldable, demineralized fibers supports effective outcomes while providing exceptional value to hospitals. Dr. Gianulis' talks will take place March 23 and 24 at 10:10 a.m. and 3:10 p.m. CST. They also will be streamed live to LifeNet Health's online showcase.

Learn more about LifeNet Health's activities at AAOS, as well as its portfolio of solutions for sports medicine, trauma, extremity and spine procedures, at http://www.LifeNetHealth.org/AAOS2021.

About LifeNet HealthLifeNet Health helps save lives, restore health, and give hope to thousands each year. It is the world's most trusted provider of transplant solutions from organ procurement to bio-implants and cellular therapies and a leader in regenerative medicine, while always honoring the donors and healthcare professionals who enable healing. For more information about LifeNet Health, go to http://www.lifenethealth.org.

SOURCE LifeNet Health

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LifeNet Health features best-in-class orthobiologic solutions at AAOS Annual Meeting - PR Newswire

By Dr. Greg Pursley ~ PC Wellness Centers

Thursday, January 20, 2022

If your joints and spine function properly, do they hurt? No. Pain occurs from damage. If there is no damage, there is no pain.

Heres how it works. Pain develops from damage. Damage comes from improper function. Improper function comes from imbalance in the joint and muscle. When the joint or spine stops functioning properly, either from a one-time injury that didnt heal correctly, or a repetitive trauma, it starts to get damaged which leads to inflammation, called arthritis, and if not corrected will lead to degenerative arthritis.

Arthritis stands for joint (Arth) and inflammation (Itis). Inflammation occurs in the body for two reasons. It causes irritation in the tissue, so you stay off it and floods the area with healing properties. Degenerative Arthritis occurs due to three factors: 1) How bad is it working? (Function) 2) How much you are using it? (Pressure) 3) How long it has been happening? (Time)

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Simply put, if there is a joint in your body that is not working properly, you are using it a lot, and if it has been happening for a long time it will turn into degenerative arthritis. If you restore the proper function of that joint the degenerative arthritis will stop.

This leads to two treatment options. The first option is focusing on improving the function by healing the tissue and improving joint mobility and muscle balance with therapy. This option should be used if you would like to return to doing the things that the pain has stopped you from doing.

The other option is symptom reduction through medications, steroid injections and surgery. This option should be used for pain relief but does not offer any functional improvements or restoring proper use.

The clinicians at PC Medical Centers are experts in helping the body restore the function and eliminate the need for meds or surgery in the future by using regenerative medicine, joint mobility, and therapy at the same time.

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Can regenerative medicine help prevent joint and spine surgery? - Southeast Missourian

NOW IS THE TIME TO SUPPORT REGENERATIVE MEDICINE

TORONTO, Jan. 19, 2022 /CNW/ - As The Government of Ontario prepares its 2022 Spring Budget, OIRM is raising awareness of the massive losses expected if critically important sector funding is not continued.

At OIRM, we understand the unprecedented financial challenges facing Ontario, particularly in the healthcare sector, and this makes it even more vital that we take full advantage of the vast potential of Ontario's newly established Regenerative Medicine ecosystem to address Finance Minister Bethlenfalvy's key priorities:

Ontario's innovative stem cell scientists are already saving lives, including state-of-the-art treatments for COVID recovery, as Sharon Charlebois can attest. After being admitted into ICU with COVID-19 at The Ottawa Hospital, Sharon attributes her survival to the stem cell treatment she received. Read Sharon's fully story here.

Stem cell science originated in Toronto 50 years ago with the ground-breaking discovery by Doctors James Till and Ernest McCulloch; a remarkable contribution to our provincial, and national, legacy.

At a time when the unprecedented commercial value of stem cell technologies are just beginning to be realized, Ontario's stem cell innovators are now at a crossroads. Without ongoing funding, Ontario stands to lose it competitive advantage and the opportunity to benefit from the burgeoning Regenerative Medicine commercial sector.

Catalyzed by an initial $25M investment from the provincial government in 2015, OIRM has since generated $174.5M (6.9-fold ROI) in leveraged funding and invested in cutting-edge technologies that generated an additional $332M (13-fold ROI) in Series A investment. OIRM support was a key factor in the path leading to the creation of BlueRock Therapeutics, one of the greatest Canadian biotech success stories, which was acquired by Bayer in 2019 for $1B (40-fold ROI) and is now a leading engineered cell therapy company.

"BlueRock invested in the Ontario ecosystem because of work that OIRM had supported from Dr. Michael Laflamme (UHN). It was really the strength of the science under OIRM's guidance, in my view, that led to our decision to launch and build BlueRock Therapeutics in the Toronto-area. OIRM's support was critical to getting a small biotech launched. I would like to see that funding envelope increased to give the Institute the ability to bring these programs to a later phase of value creationsomething that would have the added benefit of creating more confidence in potential investors."- Dr. Bob Deans, Chief Technical Officer, BlueRock Therapeutics 2017-2020

It is reasonable to expect more opportunities like BlueRock to develop if Ontario continues to nurture stem cell research and innovation. Ontario is staring at a $1B economic opportunity by funding Regenerative Medicine advancements. But in 2020, while the California Institute for Regenerative Medicine was refunded at $5.5B USD, here at home the funding for OIRM was removed as part of a cost-cutting exercise, and unfortunately before a glowing reportfrom a blue-ribbon international review panel that recommended renewed funding for OIRM.

OIRM is imploring government to reconsider its position and continue funding stem cell advancements in Ontario. An investment of $25M over 5 years will yield massive returns for Ontario.

At no point in history have public health and economic recovery been simultaneously prioritized by the provincial government as urgently as right now. Medical treatments are evolving rapidly, and if made-in-Ontario stem cell research remains a priority for The Government of Ontario, there is good reason to feel hopeful about the future.

OIRM is a passionate champion for healthcare providers and their patients as we build a healthier future for Ontario, Canada, and the world.

SOURCE Ontario Institute for Regenerative Medicine

For further information: For media inquiries, please contact: Sandra Donaldson, Vice President and Chief Operating Officer, Ontario Institute for Regenerative Medicine, E: [emailprotected], T: 647-926-1228

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Ontario Institute for Regenerative Medicine (OIRM) - Urgent Appeal to The Government of Ontario - Canada NewsWire

C-CAR039 showed positive efficacy and safety data in patients with relapsed or refractory B-cell non-Hodgkin lymphoma.

Officials with the FDA have granted both Regenerative Medicine Advanced Therapy (RMAT) Designation and Fast Track Designation to C-CAR039, a novel autologous bi-specific chimeric antigen receptor (CAR) T-cell therapy, for the treatment of patients with relapsed or refractory (r/r) diffuse large B cell lymphoma (DLBCL).

C-CAR039 targets both the CD19 and CD20 antigens, and early results from an investigator-led trial demonstrate positive efficacy and safety data in patients with r/r B-cell non-Hodgkin lymphoma. As of April 20, 2021, 34 patients received the therapy, 28 of whom were eligible for safety analyses and 27 of whom were evaluable for efficacy analyses. Patients median age was 55.5 years and 75% had cancer of Ann Arbor stage 3/4. Participants had a median of 3 prior lines of therapy and bridging therapy had been given to 17.9% of patients.

According to a press release, the best overall response rate was 92.6%, with a complete response rate of 85.2%. Patients had a median time to response of 1 month and at a median follow-up of 7 months, 74.1% of patients were still in complete remission. Furthermore, the 6-month estimated progression-free survival rate was 83.2%.

This is great news for CBMG that the FDA has granted C-CAR039 both RMAT and fast track designations based on its potential to increase objective and complete response rate in r/r DLBCL, said Tony Liu, chairman and CEO of Cellular Biomedicine Group, in the press release. The clinical data based on our clinical trials in China continue to support the hypothesis that C-CAR039 is the best-in-class CAR T asset for patients in this indication.

Cytokine release syndrome (CRS) was reported in 96% of patients, 92% of which was grade 1/2. Only 1 patient had grade 3 CRS. Immune effector cell-associated neurotoxicity syndrome occurred at grade 1 in 2 patients and no grade 2 or higher neurologic events were reported, according to the press release. The researchers will continue to evaluate patients with longer follow-up.

Separately, the FDA Office of Orphan Products Development granted an Orphan Drug Designation to C-CAR039 for the treatment of follicular lymphoma in June 2021. The Investigational New Drug application was cleared by the FDA on December 10, 2021.

We are working toward initiating 1b/2 trials for C-CAR039 in the US soon, Liu said in the press release. And we will work closely with the FDA to seek the best path forward to deliver the drug to patients in the US and EU.

REFERENCE

CBMG Receives FDA Regenerative Medicine Advanced Therapy and Fast Track Designations. News release. CBMG; January 12, 2022. Accessed January 13, 2022. https://www.cellbiomedgroup.com/newsroom/fda-rmat?lang=en

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FDA Grants Regenerative Medicine Advanced Therapy, Fast Track Designations to Novel CAR T-Cell Therapy for Relapsed, Refractory B-cell Non-Hodgkin...

Jan. 13, 2022

Health and innovative thinking was the focus of this years Founders Day Convocation at Illinois Wesleyan University.

A recording of the virtual Convocation may be viewed here.

Illinois Wesleyan President S. Georgia Nugent spoke of the motives that led to the founding of the University in 1850 and their relevance today, as well as the annual intellectual theme of Health, Healing and Humanity.

A theme that obviously could not be more relevant today, as we see these three inextricably intertwined in the context of the Coronavirus pandemic, she said.

Biomedical researcher William Murphy, a 1998 IWU Physics and math graduate, gave the keynote address titled Mimicking Nature to Create New Technology.

Murphy spoke about how his experience as a Titan helped shape his future career in biotechnology. He shared examples of his research efforts to create regenerative medicine based on materials already found in nature.

You are fortunate to be enrolled at a yes, and institution, said Murphy. You dont have to choose to become only a physicist, or only a chemist, or only a business student. You can also be a baseball player or a musician. One can engage in all of these opportunities at once to build what will become the foundation for your lifes journey.

He reminded students that every course of study can make an impact on the world.

I hope Ive convinced you today that there is so much more to discover and leverage in nature and that all disciplines can contribute to the future of biotechnology, he said. Your IWU education is preparing you wonderfully to make breakthrough discoveries and turn them into real-world products.

By Julia Perez

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Founders' Day Speaker: Breakthrough Discoveries Lead to Real World Applications - Illinois Wesleyan University

SUWANEE, GA, Jan. 18, 2022 (GLOBE NEWSWIRE) viaNewMediaWire SANUWAVE Health, Inc. (SNWV), a leading provider of next-generation wound care products, announced it will hold a conference call on Wednesday, January 19, 2022, at 9:00 am ET to discuss its recent business activity, provide an update on SEC filings and detail strategic initiatives.

Telephone access to the live call will be available by dialing the following numbers:

Toll Free: 1-877-407-0784

International: 1-201-689-8560

A replay of the call can be accessed through February 2, 2022, at:

Toll Free: 1-844-512-2921

International: 1-412-317-6671

Replay Passcode: 13726404

About SANUWAVE Health

SANUWAVE Health (SNWV) is focused on the research, development, and commercialization of its patented,Energy Firstnon-invasive and biological response-activating medical systems for the repair and regeneration of skin, musculoskeletal tissue, and vascular structures.

SANUWAVEs end-to-end wound care portfolio of regenerative medicine products and product candidates help restore the bodys normal healing processes. SANUWAVE applies and researches its patented energy transfer technologies in wound healing, orthopedic/spine, plastic/cosmetic, and cardiac/endovascular conditions. For more information, please visit.www.SANUWAVE.com.

Investor Relations ContactSANUWAVE Health, Inc.Kevin Richardson IIChairman and Chief Executive Officer978-922-2447investorrelations@SANUWAVE.com

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By Deborah Borfitz

January 19, 2021 | Eight years ago, an international team of researchers proposed that the term proteoform be adopted to describe the vast number of forms of protein products from our genesincluding changes due to genetic variations, alternative RNA splicing, and post-translational modificationsto reduce the semantic-related ambiguity in the study of proteins. Since these proteoforms can be turned on or off, understanding them with absolute molecular precision is required to demystify the world of how proteins function and unlock the future of human biology, says Neil Kelleher, professor of molecular biosciences, chemistry, and medicine at Northwestern University and faculty director of Northwestern Proteomics, as well as a world-renowned proteomics pioneer.

To that end, the nonprofit Consortium for Top-Down Proteomics recently proposed the Human Proteoform Project to generate a definitive reference set of the proteoforms produced from the genome. This will become a seminal moment in science, Kelleher says, and the initiative is the next obvious step now that the Human Genome Project has provided the blueprint for how proteins get made.

Details of the proposal were recently published in Science Advances (DOI: 10.1126/sciadv.abk0734). The end goal is creation of a Human Proteoform Atlas, a high-resolution reference proteome that will be public and available to all, including the many proteomics companies recently advancing in the private sector. It is possible to accomplish this ambitious project over the next decade, Kelleher says.

Mapping of the open frontier of our proteome would have wide-ranging implications, he adds. The impacts would improve and elevate the return on investment in clinical proteomics, chemical proteomics and drug development, regenerative medicine, and next-generation proteomics like single-molecule protein sequencing.

Most people have more than a passing interest in proteins whether they are aware of it or not, says Kelleher, because proteins are involved in all human diseases. The Human Proteoform Project would enable earlier and more precise detection of those diseases.

That could help explain the rush of money from venture capitalists, institutional investors, and Wall Streetby some accounting, roughly $3 billion in the past 18 months aloneinto proteomics, says Kelleher. The recipients include biotechnology companies focused on promising technologies such as single-cell proteomics techniques, single-molecule proteoform analysis, and single molecule protein sequencing.

In some sense, they are vying to become the Illumina of proteomics, he says, replicating the success of one of the biggest next-generation companies made possible by the Human Genome Project. In the few years afterward, that publicly funded initiative stimulated the creation of about 300,000 new jobs as the price of sequencing genomes plummeted.

Proteomics is on a path to become equal to genomics in terms of economics and benefits for the future of human health, says Kelleher. With government support, the proteomics ecosystem could grow tenfold. A pre-competitive proteomics initiative launched now could therefore have accelerated impact relative to the Human Genome Project because of work already underway in the private sector.

Life Of Their Own

Northwestern Proteomics, the leader in top-down proteomics, is certainly interested in advancing the Human Proteoform Project. The 60-scientist group maintains the proteoform informatics platform that will serve as initial versions of Human Proteoform Atlas, Kelleher shares. Details about creation of the web-based repository just published in Nucleic Acids Research (DOI: 10.1093/nar/gkab1086).

The field has long been dominated by bottom-up proteomics, based on mass spectrometry, which generates about $5 billion per year in economic activity. Northwestern Proteomics, and the Consortium for Top-Down Proteomicswhere Kelleher serves as president of the board of directorsis concerned with systematic discovery of intact proteoforms with all their molecular parts.

Even today, proteoform is probably a familiar term to a minority of scientists, he says. Structural biologists may have concluded that study of the proteome has reached its pinnacle now companies like AlphaFold (developed by Googles sister company DeepMind) have figured out how to fold proteins via computer.

But the proteoforms, what Kelleher describes as all the decorations that occur in life, remain largely unknown. As an example, he points to the eyeballs, which yellow and get diseased with age because certain protein molecules dont get repopulated.

Its the same scenario across all major disease areas, he says, including cardiology, oncology, and, most especially, neurology and neurodegeneration. Clinicians even call them proteinopathies, or diseases of proteins in your brain.

By mapping out what proteins are created from the bodys 20,300 human genes, the Human Proteoform Project will elevate the whole ecosystem for biomedical research and for clinical practice, says Kelleher. There is a proteoform family for every human gene, and proteoforms have a life of their own. They can be activated or repressed after they are produced, and their diversity varies widely in our different cell types in unknown ways.

Millions of unique proteoforms are created across the genome due to genetic variation, modification, or alternative splicing, making it an almost unfathomably large undertaking. All of this is radically open science, Kelleher says, from which all humankind stands to benefit.

Top-Down Strategy

The Consortium for Top-Down Proteomics launched in 2012. It now has 400 members from around the world advocating for a government role in funding the Human Proteoform Project, says Kelleher.

The proposed approach is different from mainstream proteomics, which captures about 10% of the human proteome, he continues. He likens the bottom-up strategy to stamp collecting where proteoforms are a collection of stamps that get shredded into about 50 pieces each, all about the same size, which then get blown about. Scientists must get down on the floor to collect all the little pieces and try to put the stamps (proteoforms) back together.

In contrast, a top-down strategy determines the precise weight of each stamp (proteoform), all of which are slightly different, says Kelleher. The stamps would also have distinct structural attributes. Scientists then controllably break the stamps into pieces to achieve 100% molecular precision for each one.

The board of directors of the Consortium for Top-Down Proteomics is now forming an advisory board to broaden the advocacy base for the Human Proteoform Project, Kelleher reports. It will include current supporters of the consortium as well as scientific leaders.

The consortium has members from academic institutions, corporations, and government agencies worldwide, and its work is supported by sponsorships from Thermo Fisher Scientific, Bruker, SCIEX, Pfizer, and Agilent.

Players in the proteomics space include big players (e.g., Thermo Fisher Scientific, Bruker, Agilent, Waters, and Sciex), numerous small- to mid-size companies providing tools and services, and a growing assortment of small biotech companies attracting venture capital, says Kelleher. Additionally, many biopharmaceutical companies are already using top-down proteomics every day. Half of the whole pipeline of new drugs are proteins, so that means proteoforms.

Scaling The Atlas

The existing proteoform atlas, residing on the consortiums website, contains a couple hundred thousand proteoforms. Northwestern Proteomics also has 50,000 unique human proteoforms from five human tissues, Kelleher says.

As envisioned, technology development over the first three to four years of the project will focus on advancing mass spectrometrya linear extension of the current state of play in top-down proteomics, says Kelleher. After that, the crystal ball as to what disruptive platforms could emerge gets a little hazy which is why were excited by all those biotech proteomic entrepreneurial companies.

The community will need to expand its team of proteoform informaticians to perhaps 40 or 50 software engineers, he adds. The Consortium for Top-Down Proteomics also has a working group of about 40 computer geeks around the world currently being funded by an assortment of small grants.

But the project cant realistically happen on the scale proposed without major financial support from federal governments or foundations, Kelleher notes. The initial ask, now that the framework for the project has been outlined, is on the order of $100 million a year in support. For perspective, the Human Genome Project required approximately $4 billion in public investment over about a decade.

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Human Proteoform Project Could Be Biology's Next Moonshot - Bio-IT World