Author Archives: admin


The Next Berlin Patient: Another Man Cured of HIV After Stem Cell Transplant – POZ

[Editors note: This case was presented at a July 18 press briefing in advance of the International AIDS Conference next week. POZ will update this report, if needed, after the full data are presented on July 24.]

A seventh person appears to be cured of HIV after a stem cell transplant for cancer treatment, according to a case study to be presented at the International AIDS Conference (#AIDS2024) next week in Munich. The man and his donor both have only a single copy of a rare mutation that prevents HIV from entering cells, raising questions about the keys to a functional cure.

The anonymous man was diagnosed with HIV in 2009 and receiveda transplant to treat acute myeloid leukemia inOctober 2015. He stopped antiretroviral therapy in September 2018 and still has sustained HIV remission nearly six years later, Christian Gaebler, MD, of Charite University of Medicine in Berlin told reporters.

The apparent success of this procedure suggests that the stem cell donor pool could be expanded, giving more HIV-positive cancer patients a chance to be cured of HIV. The procedure is too risky for people who dont have life-threatening malignancies, but each case offers new clues.

All these cases are important scientificallywith every case, you learn more about whats possible, and therefore what could be mimicked in an intervention, said International AIDS Society president and conference cochair Sharon Lewin, MD, PhD, of the Peter Doherty Institute at the University of Melbourne. While these cases are very rare, they are inspirational to both people living with HIV and scientists, she added. We need to give people hope but make it realistic.

A Handful of Curesand Some Failures

Antiretroviral therapy can keep HIV suppressed indefinitely, but the virus inserts its genetic blueprints into host cells and establishes a long-lasting reservoir that is nearly impossible to eradicate.

To date, only a small number of people have been cured of HIV after stem cell transplants. The first, Timothy Ray Brownthe original Berlin Patientreceived two transplants to treat acute myeloid leukemia in 2006. In the hope of curing both cancer and HIV, his oncologist, Gero Htter, MD, from the same medical center in Berlin, had the idea to use stem cells from a donor with two matching copiesknown as homozygousof a mutation dubbed CCR5-delta32 that disables a receptor most strains of HIV use to enter cells.

Brown underwent intensive chemotherapy and whole-body radiation to prepare for the transplant. In effect, the conditioning regimen kills off existing malignant immune cells to make room for healthy new ones from the donor. Afterward, he developed near-fatal graft-versus-host disease, which occurs when donor immune cells attack the recipient. As first reported in 2008, he stopped antiretrovirals at the time of his initial transplant, but his viral load did not rebound. Over the years, researchers extensively tested his blood, gut and other tissues, finding no evidence of intact HIV anywhere in his body. At the time of his death in September 2020, he had been free of HIV for more than 13 years.

Three other peopleAdam Castillejo (the London Patient), Marc Franke (the Dsseldorf Patient) and Paul Edmonds (the City of Hope Patient)were also cured after receiving stem cell transplants to treat leukemia or lymphoma from donors with a double CCR5-delta32 mutation. They received less harsh conditioning chemotherapy and experienced milder graft-versus-host disease. All three remain off antiretroviral therapy without viral rebound, their cancer is still in remission and they will appear together at next weeks conference.

Initially, experts assumed Browns cure was attributable to the use of homozygous donor cells with a double CCR5-delta32 mutation. More than a decade ago, Timothy Henrich, MD, now at the University of California San Francisco, described two HIV-positive men in Boston who received transplants of stem cells without the mutation, known as wild-type. These cases generated much excitement as the patients appeared to control HIV after stopping antiretrovirals, but they ultimately experienced viral rebound three months and eight months after treatment interruption.

But Henrichs team later performed a mathematicalmodelinganalysis that predicted a small number of transplant recipients would achieve a cure without CCR5-delta32 stem cells, he told POZ.

In early 2022, researchers described the New York Patient, a middle-aged, mixed-race woman with leukemia who received a combination of umbilical cord blood cells with the CCR5-delta32 mutation and partially matched adult stem cells from a relative without the mutation. Prior to the transplant, she received intensive chemotherapy and whole-body radiation, but she did not develop graft-versus-host disease. The CCR5-delta32 variation is most often found in people of Northern European descent, so this approach could potentially open up the procedure to more people of color. The woman stopped antiretrovirals three years after her transplant and at last report was still free of HIV.

The mystery deepened last year when researchers at the International AIDS Society Conference on HIV Science presented the case of a man known as the Geneva Patient, who appears to have been cured after a wild-type stem cell transplant from a donor with no copies of the CCR5-delta32 mutation. This man received whole-body radiation and chemotherapy and experienced moderately severe graft-versus-host disease. He also used ruxolitinib (Jakafi), an immune-modulating drug that may help shrink the viral reservoir.

Another Berlin Patient

This brings us to the latest casethe new Berlin Patienta man with a single copy of the CCR5-delta32 mutation, known as heterozygous. His doctors were unable to find a suitable donor with two copies of the mutation but found a heterozygous match with one copy. CCR5-delta32 heterozygous individuals can acquire HIV, but the disease generally progresses more slowly. About 16% of Northern Europeans have a single copy of the mutation, while only about 1% have two copies, Gaebler noted.

Prior to the transplant, the man received whole-body radiation and intensive chemotherapy, and he developed mild graft-versus host disease. He achieved full chimerism, meaning all his immune cells eventually originated from the donor, and his leukemia went into remission.

The man discontinued antiretroviral treatment in 2018. Since then, his plasma viral load has remained suppressed, he has no detectable HIV DNA in peripheral blood cells, and duodenal and ileum gut biopsies tested negative. The researchers could not induce virus production from his CD4 cells in the lab. No HIV-specific T cell responses were detected, and his HIV antibodies are decreasing, suggesting there may be no remaining virus to trigger an immune response.

The fact that the man receivedpartiallysusceptible donor cells makes Gaebler more hesitant to declare that hes cured, but if he was going to experience viral rebound, it likely would have happened sooner than six years.

Researchers are still trying to figure out why these seven people were cured with stem cell transplants while other attempts have failed, but there does not seem to be a single decisive factor common to all cases.

Four of the men received transplants from CCR5-delta32 homozygous donors, one received cells from a heterozygous donor, one received wild-type stem cells and the woman received a mix of CCR5-delta32 homozygous and wild-type cells. Four patients underwent intensive conditioning therapy, while three received gentler regimens. Brown and the Geneva Patient experienced severe graft-versus host disease, but the other did not.

Taken together, the seven cases suggest that its not all about CCR-delta32, Lewin said. Its likely that multiple factors play a role in remission, and these may differ from patient to patient. People who receive stem cells from CCR-delta32 wild-type donors have the most susceptible T cells for the virus to target, people who receive stem cells from a heterozygous donoror who are heterozygous themselveshave fewer vulnerable T cells and those with a homozygous donor have few or no susceptible cells. The size of the viral reservoir, the severity of graft-versus host disease and individual immune response are also important.

We believe there was depletion of the replication-competent HIV reservoir, which cannot lead now to viral rebound, Gaebler said. He thinks allogeneic immunity, or the immune response of the donor stem cells, might be key. Having one or two copies of the CCR5-delta32 mutation provides an additional safety layer to give us protection with a resistant immune system, but based on the new case and that of the Geneva Patient, it is possible to cure HIV even when functional receptors for the virus are present. Maybe we do not fully need to achieve complete depletion.

Henrich suggested that the conditioning regimen and graft-versus-host response may be key,while using CCR5-delta32 heterozygous donor cells leaves the virus with fewer targets. This case demonstrates that by dramatically reducing the pretransplant HIV reservoir and maintaining this reduction over time with beneficial graft-versus-host effects, long-term remission remains a possibility for a small number of people even without CCR5-delta32 homozygous donor cells, he told POZ.

Stem cell transplantation is an arduous procedure limited to people with advanced cancer, and it is far from a feasible solution for the vast majority of people living with HIV worldwide. But each new case provides clues that could lead to a more widely applicable functional cure. Some researchers, for example, are exploring whether gene editing approaches such as CRISPR could be used to delete or disable CCR5 receptors to make an individuals own immune cells resistant to HIV.

The next Berlin Patients experience suggests that we can broaden the donor pool for these kinds of cases, although stem cell transplantation is only used in people who have another illness, such as leukemia, Lewin said. This is also promising for future HIV cure strategies based on gene therapy, because it suggests that we dont have to eliminate every single piece of CCR5 to achieve remission.

[This report has been updated to include comments from Timothy Henrich]

Click here formore reports from AIDS 2024.

Click herefor more news about HIV cure research.

See the original post:
The Next Berlin Patient: Another Man Cured of HIV After Stem Cell Transplant - POZ

Cell BioEngines Raises Additional $2M in Funding – FinSMEs

Cell BioEngines, a NYC-based company researching stem cells in order to develop new cell therapies, raised additional $2M in funding.

The round consisted of $1.75M from SOSV and the Partnership Fund, and $0.25M from Empire State Developments NY Ventures, the states venture capital arm through the Pre-Seed and Seed Matching Fund Program.

The company intends to use the funds to expand operations and its R&D sector.

Led by CEO Dr. Ajay Vishwakarma, Cell BioEngines is a clinical-stage biotech company focused on developing allogeneic off-the-shelf stem cell-derived therapies as drugs for human disease treatment. It leverages its proprietary platform technology using universal non-gene-modified donor blood stem cells obtained from umbilical cord to produce clinical grade cells at scale.

Commenting on the news, Ajay Vishwakarma said: The funds will support our first multicenter clinical trial, aimed at hematological cancer patients unable to find a donor and seeking an alternative to HLA-haploidentical blood stem cell transplants. CBE-101 represents a novel approach with expanded cord blood-derived hematopoietic cell therapy, aligned with Cell BioEngines vision to deliver off-the-shelf cell-based therapies to patients.

FinSMEs

22/07/2024

Here is the original post:
Cell BioEngines Raises Additional $2M in Funding - FinSMEs

Latest HIV Cure Case Is the Most Encouraging One Yet – Gizmodo

Doctors have apparently cured another person of HIV using a bone marrow transplant. Unlike previous cases, however, the patient was cured without needing donated stem cells from someone genetically immune to HIV. This development could change our understanding of how best to treat similar patients in the future, though these transplants still arent a practical solution for most people living with the virus.

The success story is a 60-year-old man from Germany who was diagnosed with HIV in 2009. In 2015, he also became diagnosed with acute myeloid leukemia (AML), a form of blood cancer. Doctors eventually advised that he undergo a bone marrow transplant for his AML, a radical treatment that functionally tries to replace a persons immune system with one belonging to a healthy donor.

Doctors at Charit Universitatsmedizin Berlin performed the mans transplant. Years earlier, in 2007, a team there performed the first bone marrow transplant for cancer that resulted in an HIV cure. At the time, the patient decided to stay anonymous and was nicknamed the Berlin Patient. He later revealed himself as Timothy Ray Brown and remained an HIV/AIDS advocate until his death in 2020 from a recurrence of his leukemia. This latest case has also chosen to go anonymous and has been dubbed the next Berlin Patient.

Brown and most others like him in the years since have received bone marrow from donors with two copies of a particular mutation in their CCR5 gene, which regulates the CCR5 receptor found on white blood cells. The mutation, called CCR5-delta 32, makes immune cells naturally resistant to infection from strains of HIV-1 (the more common type of HIV). By transplanting stem cells containing the mutation to HIV patients, the hope is that you can transfer over that resistance as well, allowing their bodies to permanently eliminate the virus.

Just a small percentage of people carry two copies of the CCR5-delta 32 mutation, however, and Charit doctors were only able to find a compatible donor for their patient who carried one copy. But to everyones surprise, the switch still worked. The patient chose to stop taking his HIV medication in 2018 and tests have continued to show no traces of the virus in his system (he also remains cancer-free). The man is now believed to be the seventh person cured of HIV using stem cells, but the first without needing both copies of the CCR5-delta 32 mutation.

The mans case was presented this week at AIDS 2024, the 25th International AIDS Conference.

A healthy person has many wishes, a sick person only one, said the next Berlin Patient in astatement released by the International AIDS Society, which hosts the conference.

At this point, its not clear exactly how the next Berlin Patient was able to clear his HIV completely. People with only one copy of the CCR5-delta 32 mutation can still get infected by HIV, though it does seem to reduce the odds of catching it. So its possible that even one copy is enough to help eliminate its presence in someone already infected. But its also possible that simply flushing away an HIV-infected persons immune system and replacing it with a new one, regardless of whether the CCR5-delta 32 mutation is around, can do the same. That said, other HIV patients who have received stem cell transplants from non-CCR5-delta 32 donors have seen their infections rebound within months, so other factors might be important to a cure, such as how quickly the donated immune system takes over.

Stem cell transplants are a last resort treatment for conditions like leukemia, due to their risky, even potentially life-threatening side effects. And these days most people with HIV can keep the virus in check with antiretrovirals, to the point of no longer being contagious to others. So these transplants will never become a widely used cure for HIV. But the lessons learned from these patients could help scientists develop more practical cures for HIV or help patients who need stem cell transplants for other reasons.

The next Berlin Patients experience suggests that we can broaden the donor pool for these kinds of cases, although stem cell transplantation is only used in people who have another illness, such as leukemia, said Sharon Lewin, president of the International AIDS Society, in a statement. This is also promising for future HIV cure strategies based on gene therapy because it suggests that we dont have to eliminate every single piece of CCR5 to achieve remission.

Visit link:
Latest HIV Cure Case Is the Most Encouraging One Yet - Gizmodo

Abeona Therapeutics and Beacon Therapeutics Announce Non-Exclusive Agreement for Beacon to Evaluate Therapeutic Potential of Abeona’s Patented AAV204…

CLEVELAND and LONDON, July 11, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a cell and gene therapy company with proprietary adeno-associated virus (AAV)-based capsids, and Beacon Therapeutics, an ophthalmic gene therapy company and Syncona portfolio company, today announced an agreement by which Beacon will evaluate Abeona's patented AAV204 capsid for the development and commercialization of potential gene therapies for select ophthalmology indications.

Follow this link:
Abeona Therapeutics and Beacon Therapeutics Announce Non-Exclusive Agreement for Beacon to Evaluate Therapeutic Potential of Abeona's Patented AAV204...

Rentschler Biopharma Announces New State-of-the-Art Production Line in Massachusetts is Fully Operational

LAUPHEIM, Germany and MILFORD, Mass., July 11, 2024 (GLOBE NEWSWIRE) -- Rentschler Biopharma SE, a leading global contract development and manufacturing organization (CDMO) for biopharmaceuticals, including advanced therapy medicinal products (ATMPs), today announced that the company’s new state-of-the-art production line, formerly known as the Rentschler Biopharma Manufacturing Center (RBMC), in Milford, MA in the U.S. is now fully operational. The company has a major project underway at the new line, with several additional projects in the pipeline, and continues to welcome new projects and clients.

See more here:
Rentschler Biopharma Announces New State-of-the-Art Production Line in Massachusetts is Fully Operational

Entero Therapeutics Announces Exercise of Warrants and Issuance of New Warrants in a Private Placement for $1.9 Million Gross Proceeds

BOCA RATON, Fla., July 11, 2024 (GLOBE NEWSWIRE) -- Entero Therapeutics, Inc. (“Entero” or the “Company”) (NASDAQ: ENTO), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced it has entered into agreements with certain holders of its existing warrants exercisable for 1,762,674 shares of its common stock, in the aggregate, to exercise their warrants at a reduced exercise price of $1.09 per share, in exchange for new warrants as described below. The aggregate gross proceeds from the exercise of the existing warrants is expected to total approximately $1,921,315, before deducting financial advisory fees. The reduction in the exercise price of the existing warrants and the issuance of the new warrants was structured as an at-market transaction under Nasdaq rules.

Read more:
Entero Therapeutics Announces Exercise of Warrants and Issuance of New Warrants in a Private Placement for $1.9 Million Gross Proceeds

Acumen Pharmaceuticals to Present Patient Experience and Biomarker Insights from Phase 1 INTERCEPT-AD Study at the Alzheimer’s Association…

NEWTON, Mass., July 11, 2024 (GLOBE NEWSWIRE) -- Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS), a clinical-stage biopharmaceutical company developing a novel therapeutic that targets toxic soluble amyloid beta oligomers (A?Os) for the treatment of Alzheimer’s disease (AD), today announced that the Company will present patient experience and biomarker data from its Phase 1 INTERCEPT-AD study of sabirnetug (ACU193) at the Alzheimer’s Association International Conference (AAIC®) 2024 taking place in Philadelphia and online from July 28 – Aug. 1, 2024. The posters expand upon biomarker data associated with sabirnetug, methods for detecting levels of sabirnetug in cerebrospinal fluid (CSF), and provide insights on patients’ experiences in the INTERCEPT-AD study to inform future clinical trial considerations for sabirnetug.

Read more here:
Acumen Pharmaceuticals to Present Patient Experience and Biomarker Insights from Phase 1 INTERCEPT-AD Study at the Alzheimer’s Association...

Lexeo Therapeutics Announces Investor Webcast to Report Interim Phase 1/2 Clinical Data of LX2006 for the Treatment of Friedreich Ataxia…

NEW YORK, July 11, 2024 (GLOBE NEWSWIRE) -- Lexeo Therapeutics, Inc. (Nasdaq: LXEO), a clinical stage genetic medicine company dedicated to pioneering treatments for genetically defined cardiovascular diseases and APOE4-associated Alzheimer’s disease, today announced that the company will conduct an investor webcast on Monday, July 15, 2024, at 8:00 AM ET to provide an interim clinical data update on LX2006, an AAVrh10.hFXN gene therapy for the treatment of Friedreich ataxia (FA) cardiomyopathy. The presentation will include an overview of the natural history of FA cardiomyopathy and summary of clinically meaningful endpoints, interim data from Lexeo’s ongoing SUNRISE-FA Phase 1/2 clinical trial (NCT05445323) and the ongoing Weill Cornell Medicine investigator-initiated trial (NCT05302271), as well as an overview of program next steps.

Here is the original post:
Lexeo Therapeutics Announces Investor Webcast to Report Interim Phase 1/2 Clinical Data of LX2006 for the Treatment of Friedreich Ataxia...