Cellular Cancer Immunotherapy Development and Manufacturing in … – Cancer Discovery

As the seven FDA approved CAR T cell products continue to prove therapeutically and commercially viable, the development and scalability of CAR manufacturing platforms within academic cell production facilities will be critical to keeping pace with industry partners and ensuring academic workflows can be transferred to commercial production. CAR manufacturing must be further streamlined, standardized, and economized. To this end, closed and automated manufacturing systems offer a means of reducing labor costs, alleviating GMP manufacturing environmental requirements, and minimizing the risk associated with contamination or product variability. The CliniMACs Prodigy, a combination of a cell washer, magnetic cell separation system, and cell cultivation device is likely the most feasible means of achieving this goal, as it is one of the systems available that can enrich cell products within a closed environment (53). The Prodigy has already demonstrated the ability to select and expand T cells from preselected populations or whole apheresis, enabling the scalable production of CAR T cells in a controlled, GMP-compliant manner with no advanced manufacturing training necessary (8183). Closed-system continuous perfusion bioreactors offer varying degrees of automatic T-cell selection, expansion, vector transfection or transduction, cell washing, concentration, harvesting, cell product formulation, and in-process control testing. A number of manufacturing studies conducted at academic institutions have demonstrated that closed-system bioreactors, including the Prodigy, limit microbial contamination and are capable of generating CAR T cells with tumor-specificity, functionality, and phenotypic expression similar to immunotherapies generated by other methods (28, 8486). Although cell products did meet release criteria for expansion, cytotoxicity, and sterility, issues did arise with variability in cell growth, vector copy number, and myc overexpression (86). Transduction efficiency and cell yield are sufficient for clinical application in the manufacturing of CAR T-cell and DC therapies (85, 87, 88). Importantly, the use of an automated, closed-loop manufacturing system has already proven successful in the treatment of relapsed and refractory B-cell malignancies in trials conducted at academic medical centers (82, 89).

Refining transduction techniques beyond -retroviral and lentiviral vectors will also give academic manufacturing programs more flexibility in developing future CAR T-cell therapies. The use of SB, CRISPR Cas9, and mRNA gene transfer systems would circumvent the need for costly release testing and viral vector production. Concerns related to transduction efficacy, cell viability, duration of culture, and the duration of expression in the case of mRNA can only be dispelled through expanded clinical trials. Likewise, production variability in relation to treatment outcomes must be closely monitored before these modalities can be more widely adopted in academic manufacturing protocols.

The CAR transgene itself can also be updated through continued exploration of costimulatory molecules, suicide genes, and expanded CAR T-cell targets. CD20, CD22, CD30, CD33, CD138, CD171, CEA, EGFR, EFGRvIII, ErbB, FAP, GD2, Glypican 3, Her 2, Mesothelin, and NKG2D are all tumor associated proteins currently being targeted by academic programs designing CAR T cells (90). Targeting novel surface receptors is proving to be a key component of successful CAR T-cell products for the treatment of solid neoplasms. Tumor heterogeneity and antigen loss as a means of therapeutic escape reinforce that creating CAR T-cell therapies that target multiple surface markers through a pooled product may further improve clinical responses and prevent disease relapse.

Given the commercial success of multiple CAR T-cell products, collaboration with industry partners will further improve these manufacturing tools. When leveraged with the resources and finances available to the biopharma industry, the extensive experience academic programs have in the CAR T-cell arena can facilitate needed technological advancement, accelerate workflow development, and promote the expansion of CAR T-cell therapies to a greater patient population. The T-Charge platform, developed by Novartis, could be a particularly apt example of the benefit collaboration could pose for academic manufacturing centers; although only abstract data are currently available, the platform has demonstrated the ability to retain T-cell stemness and rapidly produce CAR T-cell products in less than 2 days.

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Cellular Cancer Immunotherapy Development and Manufacturing in ... - Cancer Discovery

VetStem Shares the Success Story of Sherlock who was Treated with VetStem Cell Therapy for Arthritis and Knee – EIN News

Sherlock, a large mixed-breed dog, was successfully treated with VetStem Cell Therapy for arthritis and cruciate ligament injuries.

Sherlock's Owner

Sherlocks veterinarian recommended surgical repair in addition to VetStem Cell Therapy. To begin the VetStem process, Sherlocks veterinarian collected fat from his abdomen while he was anesthetized for his cruciate ligament surgery. The fat was aseptically packaged and shipped to the VetStem processing laboratory in Poway, California. Lab technicians processed the fat to extract and concentrate the stem and regenerative cells contained therein. Four injectable doses of Sherlocks cells were shipped to his veterinarian for treatment and all the remaining cells were put into cryostorage for potential future treatment. Approximately 48 hours after the initial fat collection procedure, Sherlock received one injection of his own stem cells into each knee and each elbow.

Sherlocks owner reported that he responded well to his initial stem cell treatment but that shortly after, he injured the cruciate ligament in his left knee. This time, his veterinarian was able to request doses from his stored stem cells, which she administered during the surgery on his left knee. Sherlock once again received an injection of his own stem cells into each knee and each elbow.

After treatment, his owner said that his recovery went from six weeks to three-and-a-half weeks. She stated, He healed so quickly that it surprised everyone. He was 12 years old by this time and a full recovery seemed almost too hopeful to wish for, but instead we not only got a full recovery but a faster recovery than before. She went on to state, Sherlock is now 13 years old and we do not run and chase balls anymore, but we enjoy walks on the beach and lots of snuggles and I am so grateful that he is still here feeling good and enjoying life with me. Stem cell therapy made an immense difference in his ability to live a high quality life in his older years.

Unfortunately, cruciate ligament rupture is one of the most common reasons for hind limb lameness, pain, and subsequent knee arthritis in dogs. Additionally, according to the American College of Veterinary Surgeons, 40-60% of dogs who injure one cruciate ligament will go on to injure the other cruciate ligament in the future. Because of this, many veterinarians choose to treat both knees with stem cells, even when there is only one injured knee. While there are multiple treatment options available, both surgical and non-surgical, treatment with stem cells may accelerate and improve healing within the joint. Stem cells are regenerative cells that can differentiate into many tissue types, reduce pain and inflammation, help to restore range of motion, and stimulate regeneration of tendon, ligament, and joint tissues. According to surveys answered by owners and veterinarians, greater than 80% of dogs showed an improved quality of life after receiving VetStem Cell Therapy for orthopedic conditions.

About VetStem, Inc. VetStem is a veterinarian-led Company that was formed in 2002 to bring regenerative medicine to the profession. This privately held biopharmaceutical enterprise, based near San Diego, California, currently offers veterinarians an autologous stem cell processing service (from patients own fat tissue) among other regenerative modalities. With a unique expertise acquired over the past 15 years and thousands of treatments by veterinarians for joint, tendon and ligament issues, VetStem has made regenerative medicine applications a therapeutic reality. The VetStem team is focused on developing new clinically practical and affordable veterinary solutions that leverage the natural restorative abilities present in all living creatures. In addition to its own portfolio of patents, VetStem holds exclusive global veterinary licenses to a large portfolio of issued patents in the field of regenerative medicine.

Kristi Hauta, Director of Commercial OperationsVetStem, Inc.+1 858-748-2004email us here

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VetStem Shares the Success Story of Sherlock who was Treated with VetStem Cell Therapy for Arthritis and Knee - EIN News

SARS-CoV-2-reactive antibody waning, booster effect and … – Nature.com

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SARS-CoV-2-reactive antibody waning, booster effect and ... - Nature.com

Targeted Therapies and Immunotherapy Play Greater Role in … – Targeted Oncology

Neeta Somaiah, MD, an associate professor and deputy department chair in the department of sarcoma medical oncology, division of cancer medicine at The University of Texas MD Anderson Cancer Center, discusses new and upcoming targeted therapies for sarcomas at the Inaugural Miami Cancer Institute Precision Medicine Oncology Symposium.

Due to the variety of sarcomas, different targets are under investigation. According to Somaiah, liposarcomas and desmoid sarcomas are subtypes where targeted therapies have shown efficacy, including CDK4 inhibitors and MDM2 inhibitors. Gamma secretase inhibitors have been employed in Kaposi sarcoma. Additionally, FGFR and IDH mutations have shown potential as targets in some soft tissue sarcomas and bone sarcomas.

Somaiah says that immunotherapy is an important area of investigation for her, though there is a challenge in finding the right subtype that will respond to immunotherapy. Combination immunotherapies are under investigation in patients with soft tissue and bone sarcoma, but the same combinations used in other cancers may not be effective in sarcomas. Currently the only sarcoma with an approved immunotherapy is alveolar soft part sarcoma, where pembrolizumab (Keytruda) alone or in combination with axitinib (Inlyta) are preferred regimens.

TRANSCRIPTION:

0:08 | We have targets within the liposarcoma space, we have CDK4 inhibitors, MDM2 inhibitors that are of interest. In the desmoid space, there are newer gamma secretase inhibitors that are being looked at, similarly there are specific mutations in FGFR or IDH, etc, that are being targeted across certain soft tissue sarcomas and bone sarcomas.

I personally am very interested in advancing immunotherapy in the sarcoma space. The challenge there is finding the right subtypes that will respond and also finding the right type of immunotherapy combinations that will be helpful for these [patients with sarcoma] that are different than some of the carcinomas that we see. I think there are some combination trials that we'll be seeing in the future that we hope can bring the immunotherapy into the soft tissue and bone sarcoma spaces as well. Right now, [immunotherapy] is only approved for a small subtype called alveolar soft part sarcomas.

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Targeted Therapies and Immunotherapy Play Greater Role in ... - Targeted Oncology

iTolerance, Inc. Completes Pre-IND Meeting with U.S. FDA for … – AccessWire

MIAMI, FL / ACCESSWIRE / March 1, 2023 / iTolerance, Inc. ("iTolerance" or the "Company"), an early-stage regenerative medicine company developing technologies to enable tissue, organoid or cell therapy without the need for life-long immunosuppression, today announced it has completed a Pre-Investigational New Drug Application ("pre-IND") meeting with the U.S. Food and Drug Administration ("FDA") to discuss the development of the Company's iTOL-100 immunomodulatory technology. A pre-IND meeting provides an opportunity for a drug development company and the FDA to discuss the drug's development plan and to obtain the agency's guidance for clinical studies of the company's new drug candidate.

iTolerance's iTOL-100 immunomodulatory technology is a biotechnology-derived Strepavidin-FasL fusion protein, a synthetic form of the naturally occurring protein FasL, mixed with a biotin-PEG microgel (SA-FasL microgel) that potentially allows convenient and effective co-administration with implanted cells or organoids to induce local immune tolerance without the need for life-long immunosuppression. Utilizing its iTOL-100 immunomodulatory technology, the Company is developing iTOL-102 as a potential cure for Type 1 Diabetes without the need for life-long immunosuppression. iTOL-100, which acts to generate localized immune tolerance is combined with insulin producing stem cell-derived pancreatic islets to be implanted in the body. These stem cell-derived pancreatic islets are potentially capable of secreting insulin in response to sugar intake, similar to how native pancreatic islet cells behave. Additionally, the use of stem cell-derived pancreatic islets provides a potentially inexhaustible supply of insulin-producing cells.

"It's critical to have open dialogue with regulatory bodies as we continue the development of our lead program, iTOL-102. The meeting and subsequent feedback provided valuable insight and clarity for iTolerance as we advance our iTOL-100 immunomodulatory technology," commented Dr. Anthony Japour, Chief Executive Officer of iTolerance. "We are grateful for the guidance from the FDA and are pleased that it was in line with our team's expectations. Importantly, the Agency's guidance allows the company to maintain its current timeline for the iTOL-102 development program. Moving forward, our focus remains on the advancement of iTOL-102 towards an IND submission."

About iTolerance, Inc.iTolerance is an early-stage privately held regenerative medicine company developing technologies to enable tissue, organoid or cell therapy without the need for life-long immunosuppression. Leveraging its proprietary biotechnology-derived Strepavidin-FasL fusion protein/biotin-PEG microgel (SA-FasL microgel) platform technology, iTOL-100, iTolerance is advancing a pipeline of programs using both allogenic pancreatic islets and stem cells that have the potential to cure diseases. The Company's lead program, iTOL-102, leverages significant advancements in stem cells to derive pancreatic islets which allows an inexhaustible supply of insulin-producing cells. Utilizing iTOL-100 to induce local immune tolerance, iTOL-102 has the potential to be a cure for Type 1 Diabetes without the need for life-long immunosuppression. Additionally, the Company is developing iTOL-201 for the treatment of liver failure by utilizing hepatocytes and iTOL-401 as a nanoparticle formulation for large organ transplants without the need for life-long immunosuppression. For more information, please visit itolerance.com.

Forward-Looking StatementsThis press release contains "forward-looking statements" within the meaning of the "safe-harbor" provisions of the Private Securities Litigation Reform Act of 1995. When used herein, words such as "anticipate", "being", "will", "plan", "may", "continue", and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking.

All forward-looking statements are based upon the Company's current expectations and various assumptions. The Company believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. The Company may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, anticipated levels of revenues, future national or regional economic and competitive conditions, and difficulties in developing the Company's platform technology. Consequently, forward-looking statements should be regarded solely as the Company's current plans, estimates and beliefs. Investors should not place undue reliance on forward-looking statements. The Company cannot guarantee future results, events, levels of activity, performance or achievements. The Company does not undertake and specifically declines any obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by law.

Investor ContactJenene ThomasChief Executive OfficerJTC Team, LLCT: 833.475.8247[emailprotected]

Media ContactSusan RobertsT: 202.779.0929[emailprotected]

SOURCE: iTolerance, Inc.

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iTolerance, Inc. Completes Pre-IND Meeting with U.S. FDA for ... - AccessWire

You could be the stem cell donor who saves Murray Foltyn’s life – Jewish News

The Sue Harris Campaign is behind an urgent search for a stem cell donor to save the life of a married father of two.

Murray Foltyn aged 41, formerly of Hampstead, now lives in Sydney, Australia and urgently needs an unrelated stem cell donor to help save his life.

Married to Claudia and with two young children Jamie (3 years old) and Georgia (just 9 months old), Murrays potential lifesaver is likely to share his Ashkenazi background and have Czech or Russian ancestors. Indeed, he can trace his family back to the village of Trnava (today part of Slovakia) or Morava Ostrava (today close to the border of Poland).

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He has a rare blood cancer, for which his only chance of successful treatment is with a stem cell transplant from someone with a matching tissue type. Because Murray is Jewish, a matching donor is far more likely to be Jewish too.

HERE IS HOW YOU CAN HELP:

If you are a young Jewish person aged between 16 and 30 years old, the Sue Harris Campaign is running recruitment drives on the evening of Monday 6th March at Purim events at several sites in London and also at Jewish societies across the country.

Here are the places you can get swabbed this Purim:

Monday 6 March, eveningAish UK Central London Purim EventChabad, Hampstead Garden SuburbNer Yisrael SynagogueSouth Hampstead SynagogueSt Johns Wood SynagogueThe Jewish Learning ExchangeLondon JSoc Purim PartyLeeds JSocOxford JSocNottingham JSoc

Tuesday 7 March, eveningHampstead Garden Suburb Synagogue

Thursday 9 March, eveningMoishe House Camden

If you are unable to attend any of the above, you can still potentially save a life by requesting a swab kit be sent to you by clicking here.

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You could be the stem cell donor who saves Murray Foltyn's life - Jewish News