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Orca Bio expands manufacturing capabilities to take cell therapies through to commercialization – BioPharma-Reporter.com

Posted: September 16, 2022 at 2:12 am

This facility will support the late-stage clinical development and commercialization of Orca Bios precision cell therapies, including Orca-T, which is currently being evaluated in a Phase 3 registrational trial.

The new facility is located in Sacramento's newly developed Metro Air Park next to the Sacramento International Airport, enabling direct shipping access to transplant centers across the US. It is also in close proximity to Orca Bio's existing clinical manufacturing building.

The facility is uniquely tailored to manufacture precision cell therapies designed to replace cancerous blood and immune systems with healthy ones. It will include modular production suites, which are adjustable for future growth, quality control laboratories, warehouse space and offices.

The site will have the capacity to manufacture around 3,000 cell therapy products a year: thus allowing the company to scale to meet future demand and providing the critical infrastructure to enable Orca Bio to expand its pipeline.

Construction has already begun and is scheduled to be completed later this year, with the facility set to be fully validated and operational in the first half of 2023.

Orca Bio uses precision cell selection technology to identify the less than 1% of the 100 billion donor cells that potentially contain therapeutic benefits for patients. These cells are then manufactured into potentially curative cell therapies designed to maximize efficacy of treatment and significantly limit treatment-related risks.

Orca-T is an investigational high-precision allogeneic cellular therapy consisting of infusions containing regulatory T-cells, conventional T-cells and CD34+ stem cells derived from peripheral blood from either related or unrelated matched donors. Orca-T has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration and is being studied to treat multiple hematologic malignancies.

At the head of its pipeline is Orca-T: which recently entered a Phase 3 study for the treatment of acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL) and high-risk myelodysplastic syndromes (MDS).

Throughout the clinical development of our products, we have demonstrated the ability to reliably manufacture and deliver high-precision cell therapies with rapid turnaround times, regardless of donor and patient location, said Ivan Dimov, Ph.D., co-founder and chief executive officer of Orca Bio.

This new facility will further enhance our capabilities to deliver our therapies urgently and seamlessly to patients at scale, while meeting the highest quality and regulatory standards.

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BioRestorative Therapies : BRTX Presentation September 2022 – Marketscreener.com

Posted: September 16, 2022 at 2:12 am

FORWARD LOOKING STATEMENT

STATEMENTS IN THIS PRESENTATION, INCLUDING THE INFORMATION SET FORTH AS TO THE FUTURE FINANCIAL OR OPERATING PERFORMANCE OF BIORESTORATIVE THERAPIES, INC. (THE "COMPANY") THAT ARE NOT CURRENT OR HISTORICAL FACTUAL STATEMENTS MAY CONSTITUTE "FORWARD LOOKING" INFORMATION WITHIN THE MEANING OF THE U.S. FEDERAL AND STATE SECURITIES LAWS. WHEN USED IN THIS PRESENTATION, SUCH STATEMENTS MAY INCLUDE, AMONG OTHER TERMS, SUCH WORDS AS "MAY," "WILL," "EXPECT," "BELIEVE," "PLAN," "ANTICIPATE," "INTEND," "ESTIMATE," "PROJECT," "TARGET" AND OTHER SIMILAR TERMINOLOGY. THESE STATEMENTS REFLECT CURRENT EXPECTATIONS, ESTIMATES AND PROJECTIONS REGARDING FUTURE EVENTS AND OPERATING PERFORMANCE AND SPEAK ONLY AS TO THE DATE OF THIS PRESENTATION. READERS SHOULD NOT PLACE UNDUE IMPORTANCE ON FORWARD LOOKING STATEMENTS AND SHOULD NOT RELY UPON THIS INFORMATION AS OF ANY OTHER DATE.

FORWARD LOOKING STATEMENTS INVOLVE KNOWN AND UNKNOWN RISKS, UNCERTAINTIES AND OTHER IMPORTANT FACTORS THAT COULD CAUSE OUR ACTUAL RESULTS, PERFORMANCE OR ACHIEVEMENTS, BUSINESS PLAN OR INDUSTRY RESULTS, TO DIFFER MATERIALLY FROM OUR EXPECTATIONS OF FUTURE RESULTS, PERFORMANCE OR ACHIEVEMENTS EXPRESSED OR IMPLIED BY THESE FORWARD LOOKING STATEMENTS. THESE FORWARD LOOKING STATEMENTS MAY NOT BE REALIZED DUE TO A VARIETY OF FACTORS, INCLUDING WITHOUT LIMITATION: (I) OUR LIMITED OPERATING HISTORY, LACK OF SIGNIFICANT REVENUES, AND SUBSTANTIAL LOSSES SINCE INCEPTION;(II) OUR ABILITY TO OBTAIN SUFFICIENT FINANCING TO INITIATE AND COMPLETE OUR CLINICAL TRIALS AND FUND OUR OPERATIONS; (III) OUR ABILITY TO TIMELY AND SUCCESSFULLY DEVELOP AND COMMERCIALIZE BRTX-100, OUR LEAD PRODUCT CANDIDATE FOR THE TREATMENT OF CHRONIC LUMBAR DISC DISEASE; (IV) DELAYS IN ENROLLING PATIENTS IN OUR CLINICAL TRIALS; (V) DISRUPTION TO OUR ACCESS TO THE MEDIA (INCLUDING CELL CULTURE MEDIA) AND REAGENTS THE COMPANY IS USING IN THE CLINICAL DEVELOPMENT OF OUR CELL THERAPY PRODUCT CANDIDATES; (VI) FAILURE OF OUR CLINICAL TRIALS TO DEMONSTRATE ADEQUATELY THE SAFETY AND EFFICACY OF OUR PRODUCT CANDIDATES; (VII) OUR LACK OF MANUFACTURING CAPABILITIES TO PRODUCE OUR PRODUCT CANDIDATES AT COMMERCIAL SCALE QUANTITIES AND LACK OF AN ALTERNATIVE MANUFACTURING SUPPLY; (VIII) A LOSS OF OUR EXCLUSIVE LICENSE RIGHTS WITH REGARD TO OUR DISC/SPINE TECHNOLOGY; (IX) SAFETY PROBLEMS ENCOUNTERED BY US OR OTHERS DEVELOPING NEW STEM CELL- BASED THERAPIES; (X) ETHICAL AND OTHER CONCERNS SURROUNDING THE USE OF STEM CELL THERAPY WHICH NEGATIVELY IMPACT THE PUBLIC PERCEPTION OF OUR STEM CELL PRODUCTS AND/OR SERVICES; (XI) OUR LIMITED EXPERIENCE IN THE DEVELOPMENT AND MARKETING OF CELL THERAPIES; (XII) OUR RELIANCE ON NOVEL TECHNOLOGIES THAT ARE INHERENTLY EXPENSIVE AND RISKY; (XIII) SIGNIFICANT PRODUCT LIABILITY CLAIMS AND LITIGATION TO WHICH THE COMPANY MAY BE SUBJECT, INCLUDING POTENTIAL EXPOSURE FROM THE USE OF OUR PRODUCT CANDIDATES IN HUMAN SUBJECTS; (XIV) OUR INABILITY TO OBTAIN REIMBURSEMENT FOR OUR PRODUCTS AND SERVICES FROM PRIVATE AND GOVERNMENTAL INSURERS; (XV) OUR INABILITY TO PROTECT OUR PROPRIETARY RIGHTS; AND (XVI) COMPLIANCE WITH APPLICABLE FEDERAL, STATE, LOCAL, AND INTERNATIONAL REQUIREMENTS. SEE ALSO "MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS - FACTORS THAT MAY AFFECT FUTURE RESULTS AND FINANCIAL CONDITION" SET FORTH IN THE

COMPANY'S MOST RECENT ANNUAL REPORT FILED WITH THE SEC.

MANY OF THESE ISSUES CAN AFFECT THE COMPANY'S ACTUAL RESULTS AND COULD CAUSE THE ACTUAL RESULTS TO DIFFER MATERIALLY FROM THOSE EXPRESSED OR IMPLIED IN ANY FORWARD LOOKING STATEMENTS MADE BY, OR ON BEHALF OF, THE COMPANY. YOU ARE CAUTIONED THAT FORWARD LOOKING STATEMENTS ARE NOT GUARANTEES OF FUTURE PERFORMANCE, AND YOU SHOULD NOT PLACE RELIANCE ON THEM. IN FORMULATING THE FORWARD LOOKING STATEMENTS CONTAINED IN THIS PRESENTATION, IT HAS BEEN ASSUMED THAT BUSINESS AND ECONOMIC CONDITIONS AFFECTING THE COMPANY AND THE ECONOMY GENERALLY WILL CONTINUE SUBSTANTIALLY IN THE ORDINARY COURSE. THESE ASSUMPTIONS, ALTHOUGH CONSIDERED REASONABLE AT THE TIME OF PREPARATION, MAY PROVE TO BE INCORRECT.

THE DESCRIPTION OF THE COMPANY AND ITS BUSINESS IN THIS PRESENTATION DOES NOT PURPORT TO BE COMPLETE AND IS SUBJECT TO THE MORE DETAILED DESCRIPTION OF THE

COMPANY AND ITS BUSINESS IN THE COMPANY'S ANNUAL, QUARTERLY AND CURRENT REPORTS FILED WITH THE SEC.

2

LANCE ALSTODT

Chairman & CEO

Lance leads BRTX's mission to improve the lives of patients through the use of Regenerative Medicine

Lance spent over 30 years leading, advising and operating companies within the Healthcare sector. He is the founder of MedVest Capital, a Healthcare fund created in 2013 and prior to that led the Medical Technology Investment banking group at Bank of America Merrill Lynch and Leerink Partners.

ROBERT KRISTAL

Chief Financial Officer

Robert has a versatile background of over 25 years on Bay Street and Wall Street

Robert most recently was the DOR for a Healthcare focused Investment Bank. His career has spanned Trading, Sales, Investment Banking and Research.

FRANCISCO SILVA

Vice President of R&D

Francisco has over 20 years of experience in the development of cell based and off the shelf therapeutics.

Francisco has obtained a number of issued patents in cell therapy, and has manuscripts published with regard to translational stem cell research.

3

Disruptive Platform Technologies in Cellular Therapy

Strong Preliminary Data Indicative of Positive Trial Outcomes

Active Phase 2 Trial in Spine

Addressing Multi-Billion Dollar Markets with Unmet Needs

Opportunity for Key Strategic Partnerships

Multiple Near-Term Value Enhancing Inflection Points

Strong Intellectual Property Protection

Experienced Management Team & Scientific Advisory Board

4

Preclinical

Phase 1

Phase 2

Phase 3

Spine

Lumbar

Cervical

Thoracic

Musculoskeletal System

Hips/Knees

Extremities

Avascular Zones

Metabolic

Type 2 Diabetes

Obesity

PCOS

Brown Adipose Stem Cells

ARDS

Long Hauler Covid

Gene Modification

BRTX 200 Polymer/Crispr

Disclaimer

BioRestorative Therapies Inc. published this content on 13 September 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 14 September 2022 18:59:06 UTC.

Publicnow 2022

Income Statement Evolution

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Advanced cellular therapy brings hope to KSA cancer patients – Omnia Health Insights

Posted: September 16, 2022 at 2:12 am

Cancer remains a major public health and economic burden on patients, families, and healthcare systems. But breakthrough advances in cancer biology in the last two decades have dramatically changed our understanding of its pathogenesis and, consequently, our strategies to beat it.

The progress in managing blood cancers, specifically lymphoma, has raised optimism in the medical community. Lymphomas are a diverse group of cancers that affect the lymphatic system and are one of the most common malignancies worldwide and in Saudi Arabia. They are histologically categorized into Hodgkin's lymphoma and non- Hodgkin's lymphoma (NHL), where each category has many subtypes.

Related: Pregnancy-associated breast cancer: How common is it?

Until the late 1990s, all we had in our battle against cancer were conventional treatment methods with surgery, radiation, and chemotherapy. With the more advanced medical tools at our disposal, drug development and discovery have shifted toward personalised cancer treatment with molecular and immunological targeted agents.

A good example is chimeric antigen receptor T-cell (CAR T-cell) therapy, a revolutionary approach for treating different haematologic malignancies, including NHL, acute lymphoblastic leukemia, and multiple myeloma. The currently available CAR T-cell therapies are genetically engineered autologous T lymphocytes with an enhanced immune response against a specific tumour antigen, CD19 in the case of NHL.

Related: HIPEC increases cancer survival rates but lacks regional awareness

The introduction of anti-CD19 CAR T-cell therapies to the market has given new hope to patients with refractory and relapsed aggressive B-cell lymphomas who progressed despite multiple prior treatments. This represents a paradigm shift in NHL treatment, where it induced an impressive response rate of 82 per cent in ZUMA-1 study with a five-year overall survival rate of 43 per cent and a 63.1-month median follow up. This encouraged the medical community to explore other ways to optimise the clinical impact of CAR-T cell therapy by studying how to integrate it with allogeneic hematopoietic stem cell transplantation or checkpoint blockade in the future.

More promising new innovative cellular therapeutics are on the future horizon for cancer patients, such as "off-the-shelf" or allogeneic CAR-T cell and CAR natural killer cell-based immunotherapy. This type of treatment may eventually replace conventional chemotherapy, which is the standard of care for patients with advanced stage Diffuse Large B Cell Lymphoma (DLBCL) for the past 20 years. While the addition of rituximab to CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) in 2010 has shown significant benefit over CHOP in all categories of older patients, only about two-thirds of patients are typically cured with R-CHOP in the first-line setting. Many clinical trials over the past years have evaluated different ways to improve R-CHOP outcomes with no luck.

Furthermore, there is a huge unmet need for effective treatment options in refractory and relapsed DLBCL. The prognosis of these patients is generally poor, where only 30 per cent to 40 per cent of patients will respond to chemotherapy.

Additionally, the safety of intense chemotherapy regimens for the treatment of NHL is a significant concern, especially in older, frail patients with other comorbidities. This becomes a challenge, as we know that survival of lymphoma patients is correlated with achievement of complete remission; hence, dose reductions could compromise the treatment outcomes. A recent challenge we have been facing regionally and globally is the shortage of essential conventional chemotherapy agents. This has led to treatment delays or treating urgent cases with suboptimal alternative chemotherapy regimens.

Any progress in diagnosing and treating lymphoma is welcome news in Saudi Arabia, where NHL is ranked as the second most common cancer type in Saudi men and fifth among Saudi women (Source: Saudi Cancer Registry, 2016). The median age of diagnosis is 50 years in males compared to 57 years in females, which is remarkably younger than the reported median age of diagnosis in the U.S.

Diffuse Large B Cell Lymphoma is the most common subtype of NHL, where it accounts for half of NHL cases in both genders among the Saudi population. More than 40 per cent of DLBCL cases present with an advanced-disease stage, which is associated with a lower survival rate. This delay in seeking medical attention could be explained by the lack of public awareness about the disease, especially since the clinical presentation includes unspecific symptoms, in addition to the absence of effective screening methods for early detection.

An important note to consider is that the local literature reporting lymphoma in Saudi Arabia is limited, as the reported data may not represent lymphoma epidemiology in the Kingdom. More data are needed, especially from peripheral hospitals.

Cancer management is complex, and various medical professionals play a critical role in the overall patient journey. As pharmacists, our responsibilities in CAR-T cell therapy programmes include policy development, clinical assessment of bridging and lymphodepleting chemotherapy, toxicity management, and patient and staff education. Pharmacists with an experience in cellular therapy are highly needed in clinical practice, as this treatment modality continues to evolve to effectively treat incurable haematologic malignancies and potentially even solid tumours.

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IN8bio Partners with the Dunbar CAR T-Cell Program at the University of Louisville as the Manufacturing Center for INB-400 – BioSpace

Posted: September 16, 2022 at 2:12 am

NEW YORK and LOUISVILLE, Ky, Sept. 15, 2022 (GLOBE NEWSWIRE) -- IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company discovering and developing innovative gamma-delta T cell therapies that utilize its DeltEx platform, today announced it has selected the UofL Health - Brown Cancer Center GMP Manufacturing Facility at the University of Louisville, home of the Dunbar CAR T-Cell Program, as its manufacturing partner for INB-400. The collaboration provides IN8bio exclusive access to a state-of-the-art GMP manufacturing facility and is structured to support the Companys anticipated INB-400 Phase 2 clinical program in glioblastoma.

We are proud to be partnering with the University of Louisville (UofL), the UofL Health - Brown Cancer Center and the Dunbar CAR T-Cell Program who have been at the forefront of clinical development and patient access to novel cellular immunotherapies. One of the biggest challenges facing cell therapy companies is efficient access to high-quality manufacturing facilities with the experience and capacity required to support multicenter clinical trials and commercial manufacturing, said Kate Rochlin, Ph.D., Chief Operating Officer of IN8bio. The Dunbar CAR T-Cell Program has a superb facility designed specifically to advance the development of promising T-cell therapies. We are excited to progress our INB-400 program towards a Company sponsored investigational new drug (IND) application that will advance this program into Phase 2.

Since their inception, the UofL Health Brown Cancer Center GMP Manufacturing Facility and the Dunbar CAR T-Cell Program at the University of Louisville have been committed to bringing these lifesaving immunotherapies to adult and pediatric cancer patients throughout Kentucky and the region. This manufacturing agreement with IN8bio will allow our facility to provide these groundbreaking immunotherapies for patients throughout the United States, said James Cripps, Ph.D., manager of the Brown Cancer Center GMP Manufacturing Facility.

It is with the greatest excitement for the Evan Dunbar Foundation CAR T-cell program that we announce that IN8bio has joined us in this world-changing research, said Thomas E. Dunbar. Along with the amazing work at the University of Louisville, I believe that IN8bio can join with us in achieving the goals of the Evan Dunbar Foundation CAR T-cell program. These three organizations working together will create trials that will impact hundreds, if not thousands of patients.

I am so honored and pleased to see our vision of cancer research come closer to trial and real-time treatment of patients. This has been my lifelong dream and is the most fulfilling way to honor my son, Evan Dunbar, my wife, Dr. Stephanie Altobellis, my father, Wallace and the rest of my family.

The Dunbar CAR T-Cell Program was created in 2019 thanks to a $1-million pledge from Dunbar, a Louisville resident. It is a state-of-the-art manufacturing facility custom built to collaborate with the biotech industry to advance cutting-edge cell and gene therapies. T-cell therapies utilize immune cells that are genetically modified to fight cancer. The modified cells are infused into the patient with the goal of fighting the cancer and creating long-term immunity to delay or prevent recurrence. The facility is led by and staffed with experts in cell therapy manufacturing who will work closely with the IN8bio team to produce the DeltEx DRI cells for INB-400.

Facility team in the of the UofL Health - Brown Cancer Center GMP Manufacturing Facility at the University of Louisville.

About INB-400INB-400 is IN8bios DeltEx Allogeneic DRI. INB-400 expands the application of DRI gamma-delta T cells into other solid tumor types through the development of allogeneic or off-the-shelf DeltEx DRI therapies. INB-400 will be a genetically modified DeltEx allogeneic candidate in both newly diagnosed and relapsed refractory glioblastoma.

About IN8bioIN8bio is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing gamma-delta T cell product candidates for solid and liquid tumors. Gamma-delta T cells are a specialized population of T cells that possess unique properties, including the ability to differentiate between healthy and diseased tissue. IN8bios DeltEx platform employs allogeneic, autologous, iPSC, and genetically modified approaches to develop cell therapies that synergize with chemotherapy to effectively identify and eradicate tumor cells.

IN8bio is currently conducting two investigator-initiated Phase 1 clinical trials for its lead gamma-delta T cell product candidates: INB-200 for the treatment of newly diagnosed glioblastoma and INB-100 for the treatment of patients with leukemia undergoing hematopoietic stem cell transplantation. IN8bio also has a broad portfolio of preclinical programs focused on addressing other solid tumor types. For more information about IN8bio and its programs, please visitwww.IN8bio.com.

Forward Looking StatementsThis press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as aims, anticipates, believes, could, estimates, expects, forecasts, goal, intends, may, plans, possible, potential, seeks, will and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding the success of IN8bios partnership with UofL Health - Brown Cancer Center GMP Manufacturing Facility at the University of Louisville; the timing of initiation, progress and scope of clinical trials for IN8bios product candidates; the potential of IN8bios DeltEx platform to discover and develop innovative product candidates, including iPSC-derived cell therapies; and IN8bios ability to achieve planned milestones, including data readouts from its trials and plans to file an IND application. IN8bio may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: risks to site initiation, clinical trial commencement, patient enrollment and follow-up, as well as IN8bios ability to meet anticipated deadlines and milestones, presented by the ongoing COVID-19 pandemic; uncertainties inherent in the initiation and completion of preclinical studies and clinical trials and clinical development of IN8bios product candidates; the risk that IN8bio may not realize the intended benefits of its DeltEx platform; availability and timing of results from preclinical studies and clinical trials; whether the outcomes of preclinical studies will be predictive of clinical trial results; whether initial or interim results from a clinical trial will be predictive of the final results of the trial or the results of future trials; the risk that trials and studies may be delayed and may not have satisfactory outcomes; potential adverse effects arising from the testing or use of IN8bios product candidates; expectations for regulatory approvals to conduct trials or to market products; IN8bios reliance on third parties, including licensors and clinical research organizations; and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, are described in greater detail in the section entitled Risk Factors in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 12, 2022, as well as in other filings IN8bio may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and IN8bio expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

About the University of Louisville:Founded in 1798 as one of the nations first city-owned, public universities, the University of Louisville (UofL) is a vital ecosystem that creates thriving futures for students, our community and society. As one of only 79 universities in the United States to earn recognition by the Carnegie Foundation as both a Research 1 and a Community Engaged university, we impact lives in areas of student success and research and innovation, while our dynamic connection with our local and global communities provides unparalleled opportunities for students and citizens both. The university serves as an engine that powers Metro Louisville and the commonwealth and as a classroom for UofLs more than 23,000 students, who benefit from partnerships with top employers and a wide range of community service opportunities.

Get more news from UofL delivered straight to your inbox every Thursday evening by signing up for our UofL News Weekly Roundup here: uoflalumni.org/uoflnews-signup.

About UofL Health:UofL Health is a fully integrated regional academic health system with seven hospitals, four medical centers, Brown Cancer Center, Eye Institute, nearly 200 physician practice locations, and more than 800 providers in Louisville and the surrounding counties, including southern Indiana. Additional access to UofL Health is provided through a partnership with Carroll County Memorial Hospital.

With more than 12,000 team members physicians, surgeons, nurses, pharmacists and other highly-skilled health care professionals, UofL Health is focused on one mission: to transform the health of communities we serve through compassionate, innovative, patient-centered care.

Company Contact:IN8bio, Inc.Patrick McCall+ 1 646.600.6GDT (6438)info@IN8bio.com

Investors & Media Contact: Argot PartnersIN8bio@argotpartners.com

University of Louisville Contact:Jill Scoggins+1 502.650.2624Jill.scoggins@louisville.edu

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/5340530f-9020-4612-aeb7-ef243b175770

Facility team in the of the UofL Health - Brown Cancer Center GMP Manufacturing Facility at the University of Louisville.

Facility team in the of the UofL Health - Brown Cancer Center GMP Manufacturing Facility at the University of Louisville.

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IN8bio Partners with the Dunbar CAR T-Cell Program at the University of Louisville as the Manufacturing Center for INB-400 - BioSpace

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The five hottest private biotech companies in India – Labiotech.eu

Posted: September 16, 2022 at 2:12 am

India is brimming with biotech companies and a young and skilled workforce. Heres a quick glance at the private healthcare biotechs in India that captured investors imaginations in the last couple of years.

India has historically been known for its large IT, pharmaceutical and vaccine manufacturing sectors, but is also a force to be reckoned with in the global biotechnology market. The nation boasts around 5,000 biotech companies, with more than 4,000 being startups. This startup count is expected to reach 10,000 by 2024.

With a huge population of young and skilled workers, India has many ingredients for expanding the number of its biotech companies in the coming years. Add to this a large patient pool for lifestyle-related diseases such as type 2 diabetes, and there is a large potential for generating innovations in healthcare.

Weve assembled a shortlist of the hottest private biotech companies in India by checking whos raised impressive cash in the last few years. These companies are carrying out innovative healthcare research and are primarily based in Mumbai and Bengaluru.

Founded: 2014

Headquarters: Bengaluru, India and Saratoga, U.S.

Bugworks has multiple sites in the U.S. and Australia with a research and development base in India. The firm specializes in the development of antibiotics that could address the growing crisis of antimicrobial resistance.

Bugworks lead candidate antibiotic blocks the replication machinery in invading bacteria. In addition, the drug is designed to bypass normal resistance mechanisms in bacteria, which could make it harder for strains to become resistant to the treatment.

The company is testing its antibiotic in phase 1 trials for the treatment of multi-drug resistant infections in collaboration with the nonprofit initiatives CARB-X and the Global Antibiotic Research and Development Partnership (GARDP).

Bugworks is financing its antibiotics research with a $18 million Series B1 round closed in February 2022. In addition, Bugworks will use the proceeds to fund the preclinical development of a dual-acting drug to treat cancer.

Founded: 2012

Headquarters: Mumbai

Epigeneres Biotech hit the headlines in January 2022 with a $6 million Series B funding round. The Indian biotech company is using the cash to develop a wide range of different technologies in its arsenal, including cancer tests, nanotechnology-based medicines and nutraceuticals.

Cancer detection is Epigeneres most recent pursuit. In 2021, the firm teamed up with the Singaporean company Tzar Labs to develop cancer diagnostics that screen for telltale RNA molecules from tumors at early stages of disease. Epigeneres is poised to launch a screening service in India based on the technology.

Epigeneres also has nucleic acid drugs in development for the treatment of conditions ranging from infertility to renal failure to autoimmune diseases. The firm uses a form of nanotechnology to boost the delivery of the drugs to the target cells.

In addition, Epigeneres is working on small molecule drugs that can increase the population of stem cells in the body in a regenerative medicine setting.

Founded: 2016

Headquarters: Bengaluru

In August 2022, Eyestem caught the eye of investors in a $6.4 million Series A round. The Indian biotech startup is working on cell therapies for eye disorders, with a flagship therapy in the pipeline for the treatment of dry age-related macular degeneration (dry AMD).

There is currently no treatment for dry AMD. In patients with the condition, the eye accumulates cellular debris, which causes destructive inflammation in the retina. This leads to a loss of retinal pigment epithelium, the layer of cells that support the photosensitive cells we need to see.

Eyestem is developing an off-the-shelf stem cell therapy to replace lost retinal pigment epithelium. The biotech has earmarked money from its recent Series A round for preparing its cell therapy for early-stage clinical testing.

Founded: 2019

Headquarters: Bengaluru

Immuneel Therapeutics is making waves in the field of autologous CAR-T cell therapy, where a patients immune T cells are removed, engineered in the lab to kill blood cancer cells, and reinfused into the patient. There are CAR-T therapies already available, but these complex, expensive therapies are currently limited to only the wealthiest countries.

Immuneels mission is to develop CAR-T therapies that are accessible and affordable in India. To support this push, the company raised $15 million in June 2022 in a Series A round.

The therapies in Immuneels pipeline are targeted to various types of blood cancer in children and adult patients. As the Indian biotech closed its Series A round, Immuneel kicked off a phase 2 trial of a CAR-T therapy in what it claims is the first industry-sponsored CAR-T trial in India.

Founded: 2013

Headquarters: Bengaluru and Wilmington, U.S.

MedGenome has sites around the globe, with a large part of its operations and genetic testing situated in, and targeted to, India.

The company carries out genomics-focused research and diagnostics services for biopharma clients that can help in the development of drugs tackling cancer, diabetes, eye conditions and cardiovascular diseases. To provide a rich dataset, the company works with more than 500 hospitals in India.

MedGenome raised one of the Asia-Pacific regions biggest biotech investments in August 2022 a $50 million round led by Novo Holdings. The funds will be used to increase access to genetic testing in emerging markets, which have lagged behind the wealthier parts of the world.

MedGenome also aims to collect genetic data from a wide range of populations in Asia, which could provide a treasure trove of clinical insights for genes related to disease. In keeping with this aim, the company is a founding member of the initiative GenomeAsia 100K, which will analyze the genomes of 100,000 people from a range of Asian populations to speed up the development of precision medicine in this part of the world.

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Be The Match and William G. Pomeroy Foundation Announce $500k Gift and Matching Campaign – PR Newswire

Posted: September 16, 2022 at 2:12 am

The Foundation's donation and fundraising efforts will help diversify the Be The Match Registry

MINNEAPOLIS, Sept. 13, 2022 /PRNewswire/ -- In support of enhanced accessibility to life-saving stem cell transplants through the Be The Match Registry, the William G. Pomeroy Foundation has made a $500,000 grant to Be The Match that will further the organization's partnerships at historically Black colleges and universities (HBCUs).

"Patients are most likely to match a donor of their own ethnic background," said Bill Pomeroy

The $500,000 gift will enable Be The Match to grow its partnerships at HBCUs with focused recruitment efforts, education, awareness and internship opportunities for students; all in pursuit of increased stem cell transplant accessibility for Black and African American patients. Six new campus partnerships have already been established as a result of this gift.

"This generous gift from the Pomeroy Foundation is going to have a lasting impact on our ability to reach Black and African American communities and will make a difference for diverse patients in need of a donor," said Amy Ronneberg, Chief Executive Officer of Be The Match.

In addition, the Pomeroy Foundation donation sponsors a gift matching campaign that will help to diversify the donor registry. The matching opportunity coincides with this year's observance of World Marrow Donor Day on Saturday, Sept. 17. Donations to Be The Match throughout the month of September will be matched dollar for dollar, up to $500,000. Visit this link to donate and have your gift matched. The doubled donation will give patients a greater chance of finding a match and a second chance at life.

"Patients are most likely to match a donor of their own ethnic background," said Bill Pomeroy, Founder and Trustee of the Pomeroy Foundation. "Improving the ethnic diversity of the registry improves all patients' odds of finding a life-saving match."

Currently, the chance of having a matched, available donor on the registry ranges from 29-79%, with people of color less likely to find a match because fewer potential donors with diverse backgrounds are registered.

In 2004, Bill Pomeroy was diagnosed with an aggressive form of leukemia. He received a life-saving transplant from a fully matched donor found on the Be The Match Registry in 2005. Bill's transplant experience served as a catalyst for the creation of the Pomeroy Foundation, which works closely with Be The Match to expand recruitment efforts, especially for ethnically diverse donors. Bill is Trustee Emeritus for the Be The Match Foundation.

To double your donation to Be The Match during this month's matching gift campaign and to learn more about diversifying the Be The Match Registry, visit: bethematch.org.

About Be The Match:

Be The Match is the leading global partner working to save lives through cellular therapy. With more than 30 years of experience managing the most diverse registry of potential unrelated blood stem cell donors and cord blood units in the world, Be The Match is a proven partner in providing cures to patients with life-threatening blood and marrow cancers and diseases. Through their global network, they connect centers and patients to their best cell therapy options, from blood stem cell transplant to next-generation therapy, and collaborate with cell and gene therapy companies to support therapy development and delivery through Be The Match BioTherapies. Learn more at bethematch.org.

About the Pomeroy Foundation

The William G. Pomeroy Foundationis committed to supporting the celebration and preservation of community history; and working to improve the probability of finding appropriate donor matches or other life-saving treatments for blood cancer patients. Established by Trustee Bill Pomeroy in 2005 to bring together his two greatest passions, the Pomeroy Foundation is a private, philanthropic organization located in Syracuse, N.Y. As the nation's leading funder of historic roadside markers, the Pomeroy Foundation has awarded nearly 2,000 grants for markers and bronze plaques in 46 states and Washington, D.C. To learn more about the Pomeroy Foundation, visit wgpfoundation.org.

Media Contact: Erica SevillaPhone Number: 763-406-8758Email: [emailprotected]Website: bethematch.org

Media Contact: Steve BodnarCommunications ConsultantWilliam G. Pomeroy Foundation[emailprotected]315-913-4068

SOURCE Be The Match; William G. Pomeroy Foundation

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Leo Hohmann: Biden’s Executive Order Designed to Release Transhumanist …

Posted: September 16, 2022 at 2:11 am

If anyone needed proof that the powers pushing the levers behind the mindless moron who sits in the Oval Office are fully on board with the World Economic Forum/United Nations agenda of biomedical tyranny and transhumanism, look no further than theexecutive order that Joe Biden signed on Monday, September 12.

By quietly getting Bidens signature on this document, his handlers may have given us the most ominous sign yet that we stand on the threshold of a technocratic one-world beast system. Prepare to make your stand because its about to get much more intense.

This documents Orwellian title,Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy, will assure that its significance will fly right over the heads of 99 percent of the media, even the conservative media.

They will read it and yawn. I plead with everyone reading this article to please not make that same mistake.

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Because of the arcane scientific language in which this document is written, even most of those who take the time to read and study it (I assure you Biden did not) will not fully grasp what is being ordered by the White House.

Thats where we strive to help.

Karen Kingston, a former Pfizer employee and current analyst for the pharmaceutical and medical-device industries, helps us decipher whats going on in this executive order.

Kingston stated in a Twitter post:

Let me read between the lines for the America. Bidens Sept. 12, 2022, executive order declares that Americans must surrender all human rights that stand in the way of transhumanism. Clinical trial safety standards and informed consent will be eradicated as they stand in the way of universally unleashing gene-editing technologies needed to merge humans with A.I. In order to achieve the societal goals of the New World Order, crimes against humanity are not only legal, but mandatory.

Were ed.https://t.co/qjuf8MUXIO pic.twitter.com/3irdwjuEnx

NEWSNANCY (@NewsNancy9) September 13, 2022

Patrick Wood, an economist and author of several books on technocracy, has been following the transhumanist and global technocracy movements for four decades. He told me that Kingston is not overstating the issue.

He said this E.O. is proof that the executive branch is now owned lock, stock and barrel by the biomedical/pharmaceutical industry. It will be Katy bar the door from here on out.

The transhumanists within Big Pharma have completely taken over government policy and taxpayer funds to promote their own anti-human agenda of hacking the software of life, Wood told me. It also clearly demonstrates who has the power, and who sets the policies in America.

The mRNA injections that have already gone into the bodies of at least 70 percent of adults in the U.S. mark the gateway to transhumanism. We have been told this by Kingston as well as by the late Dr. Zev Zelenko and Dr. Robert Malone, a co-inventor of the mRNA platform.

LeoHohmann.com was one of the first sites to blow the whistle on Modernas former chief medical officer, Tal Zaks, who told the world straight up in December 2017 that We have hacked the software of life, and that this mRNA gene-editing biotechnology would be incorporated into vaccines to treat and prevent all manner of illnesses. Weve seen how well they work, with millions getting sick and even dying after getting two or more doses of the Covid injections offered up by Moderna and Pfizer. With the FDA and CDC now totally on board, this mRNA technology is being included in scores of other vaccines, including flu shots.

The September 12 executive order was no doubt put in place as back up for the continued experimentation on the human population, and I expect the vaccine industry will exploit it to the max. Soon we will see the return of vax mandates, this time more ferociously policed and enforced than before.

This E.O. may also have been timed at least partly in anticipation of the new pandemic treaty that the Biden administration is hoping to get passed through the United Nations World Health Organization next year. This treaty will transfer sovereignty over matters of health emergencies from the national level to the WHO.

Wood said the E.O.s intended consequences is to push the frontier of genetic modification of all living things and especially humans. He believes this will ultimately spark the biggest public backlash in modern history.

Biden pledges not only funding but an all-of-government transformation to support this anti-human scheme from top to bottom, Wood writes. It also automatically blocks any agency or department from dissent.

Below are just a few of the highlights quoted directly from the document:

What this means is that human beings will be data mined for their most personal possession, their DNA and genomic properties, and the government will offer no protection.

It will actually be encouraged and seen as a green light for biomedical practitioners worldwide. It is the goal of the technocratic proprietors of Agenda 2030 to catalogue, map out, and monitor every living thing on earth.

This was spelled out in the early 2000s by the late researcher Rosa Koire and put into book form in 2011 with Behind the Green Mask: U.N. Agenda 21. Koire was a Democrat, but she understood that the takedown of America and indeed every nation of the formerly free world, would not be accomplished by the left or the right but by supranational globalists with an allegiance to no nation. In fact, these globalists detest the nation-state model that has dominated the world for thousands of years. Their goal is a global governance and they say it out loud in their own documents.

Have no fear.

Do not be intimidated.

Truth will not be defeated.

Humanity will prevail against these anti-human eugenicist monsters because we have living souls and are created in the image of a Holy God with individual free wills.

Because of that, we humans are capable of having a personal relationship with Jesus Christ and the one and only triune God of the Bible. Those who take the bait of the globalists and submit to the world system will in essence be handing over their humanity in exchange for empty promises of safety and security. They will become transhumans, thus foregoing, at some point, their ability to connect with God. Thats a very big step and a decision that will face every human being sooner or later as this technology ramps up. Your very soul will depend on the choice you make. Will you follow God or will you follow man?

Above all, this is a spiritual battle.

Expose the sinister transhumanist agenda that these globalist predators did their best to keep hidden within a scientific vernacular that they know will wow and mystify the average person. We have decoded it for you in this article from two of the best Christian experts on the topic available in the world today Karen Kingston and Patrick Wood.

Share this article far and wide.

LeoHohmann.com is 100 percent reader supported. We survive on contributions from you, no matter how small, and do not accept any of the hush money offered by corporate America or Big Pharma. You may send donations c/o Leo Hohmann, PO Box 291, Newnan, GA 30264, or via credit card below.

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Purrsonalised health: The startups and VCs betting on pet genetics – Sifted

Posted: September 16, 2022 at 2:09 am

Direct-to-consumer home genetic kits allowed startups like 23andMe to offer health and ancestry insights at an affordable cost. Now, similar tech is coming to pets.

Itll help vets, breeders and pet parents to verify parentage and breed, diagnose diseases and plan for future health risks.

Everything we have seen happening in humans, in terms of predictive and personalised medicine and genetics-based diagnostics, has migrated into the pet space, says Sergey Jakimov, founding partner of LongeVC, a European VC fund that focuses on early-stage biotech and longevity. This is super exciting because pets, as living beings, have equalised themselves in importance in terms of how much money and attention is spent on their longevity, and in disease diagnostics and prevention.

Its not the first time human health innovation has come to the animal world US-based Signal Pet, for example, provides artificial intelligence-based radiology but animal genetics could be big business.

Animal genetics market revenue is predicted to exceed $6.4bn by 2027, up from $99m in 2020. Sifted dug into the sector and found the startups to watch and the VCs watching them.

Feragen, an Austria-based pet genetics startup, sees the vet sector as a growth engine for its business. It wants to move from diagnostics, where such tools are common, into disease prevention.

Puppies are more like family members

We want to push the prevention angle. What can we learn from genetics to create a life plan for a dog? says Anja Geretschlger, founder and CEO. Pet parents are becoming more interested in understanding the risk of diseases that might come when the pet is five or six, so they are more prepared when the symptoms show up.

Michael Geretschlger, Anjas husband and collaborator, says preventive health is getting more [attention] as puppies are more like family members. Anja Geretschlger adds that genetic insights are valuable for breeders in the era of designer dogs.

This is because cross-breeding can lead to health complications, such as labradoodles developing skin problems due to different fur structures between labradors and poodles.

Another European player is Germany-based Generatio, which provides genetic testing for animal owners, vets and breeders.

Theres also UK-based AffinityDNA, acquired in May by Australian diagnostics company Genetic Technologies, which provides animal testing for allergies and intolerances, paternity testing and direct-to-consumer (DTC) genetic tests from companies like Embark, Wisdom Panel and BasePaws.

Genetic Technologies portfolio includes General Genetics Corporation and associated brand EasyDNA, which offers UK pet owners breed composition tests, disease susceptibility tests for dogs, and feline and equine offerings.

European VCs are also interested in startups across the pond. Garri Zmudze, a Latvian biotech angel investor and founder of Switzerland-based LongeVC, investedin Basepaws, the American cat genetics company recently acquired by Zoetis, an animal medicines and vaccinations company.

Basepaws plans to expand into the veterinary portfolio of genetic, oral and microbiome screening tools for disease risk, screening 64 feline health markers and over 210 canine health markers.

For some, the pet genetics space is not just a play on the pet market but could inform human health and longevity science. Some diseases are rare in humans but are common in certain breeds of pets, who are useful for studies into genetic disease origins.

There is a tight connection between humans and animals and we can learn from both, says Anja Geretschlger.

Zmudzes investment in Basepaws, for instance, was not a pet consumer market bet at all. Instead it was aligned with his interest in human longevity, given the genetic overlaps between animals and humans in diseases like cancer and some neurodegenerative conditions.

There is a tight connection between humans and animals and we can learn from both

These overlaps are the reason we have animal models in clinical trials, because the metabolic processes are translatable, says Jakimov. There are tonnes of matches.

Matt Kaeberlein, professor of laboratory medicine and pathology at the University of Washington School of Medicine and head of the dog ageing project, a world-leading biological study of ageing in dogs, sits on the LongeVC advisory board, alongside executives from European pharmaceutical giants Roche and Novartis. And Zmudze was also an investor in Insilico Medicine, an AI drug discovery unicorn.

As home to many of the worlds top pharmaceutical companies, Europe could be a major player in longevity research. Switzerland is developing a Longevity Valley initiative, Bristol Myers Squibb and Merck are major investors in cancer immunotherapies and the pharma industry is investing in early stage longevity companies like senescent cells companies, through initiatives like Mercks early stage venture arm.

Pharmaceutical companies live in the future, they live in 10 to 20 year cycles, says Jakimov. They are super focused on the longevity sector.

This article first appeared in our monthly Unleashed pet tech newsletter, a collaboration with Purina Accelerator Lab. All content is editorially independent.Sign upto our newsletter here to keep up to date with the latest goings on in the European pet tech industry.

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Uncovering the genetic basis of mental illness requires data and tools that aren’t just based on white people – Down To Earth Magazine

Posted: September 16, 2022 at 2:09 am

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Mental illness is a growing public health problem. In 2019, an estimated 1 in 8 people around the world were affected by mental disorders like depression, schizophrenia or bipolar disorder.

While scientists have long known that many of these disorders run in families, their genetic basis isnt entirely clear. One reason why is that the majority of existing genetic data used in research is overwhelmingly from white people.

In 2003, the Human Genome Project generated the first reference genome of human DNA from a combination of samples donated by upstate New Yorkers, all of whom were of European ancestry.

Researchers across many biomedical fields still use this reference genome in their work. But it doesnt provide a complete picture of human genetics. Someone with a different genetic ancestry will have a number of variations in their DNA that arent captured by the reference sequence.

When most of the worlds ancestries are not represented in genomic data sets, studies wont be able to provide a true representation of how diseases manifest across all of humanity.

Despite this, ancestral diversity in genetic analyses hasnt improved in the two decades since the Human Genome Project announced its first results. As of June 2021, over 80 per centof genetic studies have been conducted on people of European descent. Less than two per cent have included people of African descent, even though these individuals have the most genetic variation of all human populations.

To uncover the genetic factors driving mental illness, I, Sinad Chapman and our colleagues at the Broad Institute of MIT and Harvard have partnered with collaborators around the world to launch Stanley Global, an initiative that seeks to collect a more diverse range of genetic samples from beyond the US and Northern Europe and train the next generation of researchers around the world.

Not only does the genetic data lack diversity, but so do the tools and techniques scientists use to sequence and analyse human genomes. So we are implementing a new sequencing technology that addresses the inadequacies of previous approaches that dont account for the genetic diversity of global populations.

To study the genetics of psychiatric conditions, researchers use data from genome-wide association studies that compare the genetic variations between people with and without a particular disease.

However, these data sets are mostly based on people of European ancestry, largely because research infrastructure and funding for large-scale genetics studies, and the scientists conducting these studies, have historically been concentrated in Europe and the United States.

One way to close this gap is to sequence genetic data from diverse populations. My colleagues and I are working in close partnership with geneticists, statisticians and epidemiologists in 14 countries across four continents to study the DNA of tens of thousands of people of African, Asian and Latino ancestries who are affected by mental illness.

We work together to recruit participants and collect DNA samples that are sequenced at the Broad Institute in Massachusetts and shared with all partners for analysis.

Prioritising the voices and priorities of local communities and scientists is foundational to our work. All partners have joint ownership of the project, including decision-making and sample and data ownership and control.

To do this, we build relationships and trust with the local communities we are studying and the local university leaders and scientists with whom we are partnering. We work to understand local cultures and practices, and adapt our collection methods to ensure study participants are comfortable.

For example, because there are different cultural sensitivities around providing saliva and blood samples, we have adapted our practices by location to ensure study participants are comfortable.

We also freely share knowledge and materials with our partners. There is a two-way exchange of information between the Broad Institute and local teams on study progress and results, enabling continual learning, teaching and unity between teams.

We strive to meet each other where we are by exchanging practices and training scientists to support the development of locally grown and locally led research programmes.

Our collaboration with African research groups provides a prime example of our model. For example, our African research colleagues are co-leaders on the grants that fund the lab equipment, scientists and other staff for projects based at their study sites. And we help to support the next generation of African geneticists and bioinformaticians through a dedicated training programme.

Analysing variation

Collecting samples from more diverse populations is only half of the challenge.

Existing genomic sequencing and analysis technologies do not adequately capture genetic variation across populations from around the world. Thats because these technologies were designed to detect genetic variations based on reference DNA from people of European ancestry, and they reduce accuracy when analysing sequences that arent derived from the reference genome.

When these tools are applied to genetic data from other populations, they fail to detect much of the rich variation in their genomes. This can lead researchers to miss out on important biomedical discoveries.

To address this issue, we developed an approach to genome sequencing that can detect more genetic variation from populations around the world. It works by sequencing the exome the less thantwo per cent of the genome that codes for proteins in high detail, as well as sequencing the 98 per cent of the genome that does not code for proteins in less detail.

This combined approach reduces the trade-offs geneticists often have to make in sequencing projects. High-depth whole genome sequencing, which reads through the entire genome multiple times to get detailed data, is too costly to do on a large number of DNA samples.

While low-coverage sequencing reduces costs by reading smaller segments of the genome, it may miss some important genetic variation. With our new technology, geneticists can get the best of both worlds: sequencing the exome in depth maximises the likelihood of pinpointing specific genes that play a role in mental illness, while sequencing the whole genome less in depth allows researchers to process large numbers of whole genomes more cost-effectively.

Personalising medicine

Our hope is that this new technology will allow researchers to sequence large sample sizes from a diverse range of ancestries to capture the full breadth of genetic variation. With a better understanding of the genetics of mental illness, clinicians and researchers will be better equipped to develop new treatments that work for everyone.

Genomic sequencing opened a new era of personalised medicine, which promises to deliver treatments tailored to each individual person. This can be done only if the genetic variations of all ancestries are represented in the data sets that researchers use to make new discoveries about disease and develop treatments.

Hailiang Huang, Assistant Professor of Medicine, Harvard University

This article is republished from The Conversation under a Creative Commons license. Read the original article.

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Solving medical mysteries with genetics: The Penn Neurogenetics Therapy Center | Penn Today – Penn Today

Posted: September 16, 2022 at 2:09 am

At 44, Janet Waterhouse should have been the picture of health; a former Division I soccer player, she taught yoga, enjoyed running, and didnt drink alcohol. Despite her healthy and active lifestyle, over a span of decades she experienced a number of unexplained symptoms.

Her symptoms continued to worsen into her 20s when she began to sporadically lose function of her hands and experience severe bouts of vertigo. Most doctors attributed her symptoms to stress and anxiety. During this time, Waterhouse was seeing a pain management specialist, who was concerned enough about her worsening symptoms to run a blood test, where he found irregularly shaped blood cells, called acanthocytes.

A series of serendipitous referrals led Waterhouse to Ali Hamedani, an assistant professor of neurology and ophthalmology in the Perelman School of Medicine. Based on her symptoms and exam, he suspected a genetic condition called chronic progressive external ophthalmoplegia (CPEO) and referred her to Laynie Dratch, a certified genetic counselor in the Penn Neurogenetics Therapy Center, for genetic testing.

In May of 2022, Dratch gave Waterhouse what she had been chasing for decades: a diagnosis. When the genetic counselor told me they found the genetic mutation they were looking for, I cried for a solid five minutes out of relief, Waterhouse says.

Waterhouses case of CPEO was found to be caused by a variation on her RRM2B gene, which affects the mitochondria in her cells. While the condition is very rare and can sometimes take years to locate and diagnose, Hamedanis hunch about the gene mutation led them right to it.

Because little is known about CPEO, treatment options are limited. Most people would be discouraged by the uncertainty, she says, but it thrills me to get to be the blueprint. I get to show people how to live with this.

Launched in March 2020, the Penn Neurogenetics Therapy Center has a team of clinicians, nurses, genetic counselors, and clinical research staff who are devoted to the care of patients with inherited neurological disorders and to participating in clinical trials of novel gene and molecular therapies.

The programs mission is twofold: first, they utilize the expertise of clinicians and researchers throughout the department of Neurology and across Penn Medicine to achieve a genetic diagnosis for as many patients like Waterhouse as possible, creating a database of eligible patients for new treatments and clinical trials. Second, they work to establish clinical trials using novel gene and molecular therapies for patients with genetically-based neurological disorders.

Our genetics counselors are some of the best in the country, and are incredibly effective at diagnosing patients and matching them with effective treatments and clinical trials, says Steven Scherer, a professor of neurology and director of the Neurogenetics Therapy Center. Now we can utilize this expertise to design tomorrows therapies.

Read more at Penn Medicine News.

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