TCR-CAR+ iPSC-derived CD8 T Cells Induced Complete and Durable Responses In Vivo in Systemic Leukemia Model

Cell-surface Markers, Gene Transcription Profile, and In Vivo Anti-tumor Activity of TCR-CAR+ iPSC-derived CD8 T Cells Compared Favorably with Healthy-donor Peripheral Blood CAR T Cells

Phase 1 Study Ongoing of First-ever iPSC-derived T-cell Product Candidate FT819 for Off-the-shelf Treatment of Patients with Relapsed / Refractory B-cell Malignancies

SAN DIEGO, Aug. 09, 2022 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. ( FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for patients with cancer, today announced the publication of preclinical study results demonstrating the successful generation, durable anti-tumor response, and functional persistence of TCR-CAR+ iPSC-derived CD8 T cells from induced pluripotent stem cells (iPSCs). The CD8 T cells were derived from a single engineered iPSC integrating a novel chimeric antigen receptor (CAR) transgene into the T-cell receptor alpha constant (TRAC) locus, ensuring complete bi-allelic disruption of T-cell receptor (TCR) expression and promoting uniform CAR expression. The discoveries were made under a multi-year research collaboration between the Company and Memorial Sloan Kettering Cancer Center (MSK) led by Michel Sadelain, M.D., Ph.D., Director, Center for Cell Engineering and Head, Gene Expression and Gene Transfer Laboratory, and were published this week in Nature Biomedical Engineering.

Scientists have previously differentiated induced pluripotent stem cells to form CAR T cells, however, it was observed that premature TCR or constitutive CAR expression resulted in the derivation of innate-like T cells that do not acquire the phenotype nor exhibit the function of conventional CD8 T cells, said Dr. Sadelain. Our published findings are the first to show the generation of iPSC-derived CD8 CAR T cells lacking a TCR, where timed and calibrated expression of the CAR in place of the TCR successfully drove T-cell maturation and promoted the acquisition of a transcriptional and functional profile more closely resembling that of natural CD8 T cells.

The mass production of TCR-CAR+ CD8 T cells from master engineered iPSC lines is a promising approach for development of off-the-shelf, cell-based cancer immunotherapies. Through a systematic assessment of factors that affect T-cell lineage commitment and induce adaptive T-cell formation, the researchers discovered that integrating the CAR construct into the TRAC locus delayed its expression and drove T-cell lineage commitment, and that regulation of CAR signaling strength promoted the generation of CD4+CD8+ double-positive cells mimicking thymic development in the absence of a TCR. Subsequent stimulation of the CAR matured the double-positive population into single-positive CD8 T cells with a phenotype highly correlated with peripheral blood CD8 effector T cells and distinct from T cells and natural killer cells. Preclinical studies showed that iPSC-derived TCR-CAR+ CD8 T cells were able to repeatedly lyse tumor cells in vitro and durably control leukemia in vivo, with persistence in the bone marrow, spleen, and blood, in a systemic NALM6 leukemia model.

These published findings continue to support our unique ability to generate TCR-CAR+ CD8 T cells from master engineered iPSC lines that exhibit a phenotypic profile and anti-tumor activity comparable to healthy donor-derived peripheral blood CAR T cells in preclinical model systems, said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. We believe our off-the-shelf, iPSC-derived CAR T cell programs overcome the numerous challenges associated with the manufacture, consistency, and reach of autologous and allogeneic CAR T cells, and we look forward to sharing initial clinical data from our landmark Phase 1 study of FT819 later this year.

The Company is conducting a multicenter Phase 1 study of FT819, the first T-cell therapy manufactured from a clonal master iPSC line to undergo clinical investigation. The product candidates clonal engineered master iPSC line is created from a single iPSC that has a novel CD19-targeted 1XX CAR construct integrated into the TRAC locus, ensuring complete bi-allelic disruption of TCR expression to prevent graft-versus-host disease and promoting uniform CAR expression for enhanced anti-tumor activity. Dose escalation is currently ongoing in single-dose and multi-dose escalation cohorts for relapsed / refractory B-cell malignancies.

Pursuant to a license agreement with MSK, Fate Therapeutics has an exclusive license for all human therapeutic use to U.S. Patent No. 10,370,452, which covers compositions and uses of effector T cells expressing a CAR, where such T cells are derived from a pluripotent stem cell including an iPSC. In addition to the patent rights licensed from MSK, the Company owns an extensive intellectual property portfolio that broadly covers compositions and methods for the genome editing of iPSCs using CRISPR and other nucleases, including the use of CRISPR to insert a CAR in the TRAC locus for endogenous transcriptional control.

Fate Therapeutics has licensed intellectual property from MSK on which Dr. Sadelain is an inventor. As a result of the licensing arrangement, MSK has financial interests related to Fate Therapeutics.

About Fate Therapeutics iPSC Product PlatformThe Companys proprietary induced pluripotent stem cell (iPSC) product platform enables mass production of off-the-shelf, engineered, homogeneous cell products that are designed to be administered with multiple doses to deliver more effective pharmacologic activity, including in combination with other cancer treatments. Human iPSCs possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Companys first-of-kind approach involves engineering human iPSCs in a one-time genetic modification event and selecting a single engineered iPSC for maintenance as a clonal master iPSC line. Analogous to master cell lines used to manufacture biopharmaceutical drug products such as monoclonal antibodies, clonal master iPSC lines are a renewable source for manufacturing cell therapy products which are well-defined and uniform in composition, can be mass produced at significant scale in a cost-effective manner, and can be delivered off-the-shelf for patient treatment. As a result, the Companys platform is uniquely designed to overcome numerous limitations associated with the production of cell therapies using patient- or donor-sourced cells, which is logistically complex and expensive and is subject to batch-to-batch and cell-to-cell variability that can affect clinical safety and efficacy. Fate Therapeutics iPSC product platform is supported by an intellectual property portfolio of over 350 issued patents and 150 pending patent applications.

About FT819FT819 is an investigational, universal, off-the-shelf, T-cell receptor (TCR)-less CD19 chimeric antigen receptor (CAR) T-cell cancer immunotherapy derived from a clonal master induced pluripotent stem cell (iPSC) line, which is engineered with the following features designed to improve the safety and efficacy of CAR19 T-cell therapy: a novel 1XX CAR signaling domain, which has been shown to extend T-cell effector function without eliciting exhaustion; integration of the CAR19 transgene directly into the T-cell receptor alpha constant (TRAC) locus, which has been shown to promote uniform CAR19 expression and enhanced T-cell potency; and complete bi-allelic disruption of TCR expression for the prevention of graft-versus-host disease. FT819 demonstrated antigen-specific cytolytic activity in vitro against CD19-expressing leukemia and lymphoma cell lines comparable to that of primary CAR T cells, and persisted and maintained tumor clearance in the bone marrow in an in vivo disseminated xenograft model of lymphoblastic leukemia. FT819 is being investigated in a multicenter Phase 1 clinical trial for the treatment of relapsed / refractory B-cell malignancies, including B-cell lymphoma, chronic lymphocytic leukemia, and acute lymphoblastic leukemia (NCT04629729).

About Fate Therapeutics, Inc.Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for patients with cancer. The Company has established a leadership position in the clinical development and manufacture of universal, off-the-shelf cell products using its proprietary induced pluripotent stem cell (iPSC) product platform. The Companys immuno-oncology pipeline includes off-the-shelf, iPSC-derived natural killer (NK) cell and T-cell product candidates, which are designed to synergize with well-established cancer therapies, including immune checkpoint inhibitors and monoclonal antibodies, and to target tumor-associated antigens using chimeric antigen receptors (CARs). Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit http://www.fatetherapeutics.com.

Forward-Looking StatementsThis release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 including statements regarding the advancement of and plans related to the Company's product candidates, clinical studies and preclinical research and development programs, the Companys progress, plans and timelines for the manufacture and clinical investigation of its product candidates, the Companys initiation and continuation of enrollment in its clinical trials including additional dose cohorts in ongoing clinical trials of its product candidates, the therapeutic and market potential of the Companys product candidates, and the Companys clinical development strategy, including for its product candidate FT819. These and any other forward-looking statements in this release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that the Companys product candidates may not demonstrate the requisite safety or efficacy to warrant further development or to achieve regulatory approval, the risk that results observed in prior studies of the Companys product candidates, including preclinical studies and clinical trials, will not be observed in ongoing or future studies involving these product candidates, the risk of a delay or difficulties in the manufacturing of the Companys product candidates or in the initiation and conduct of, or enrollment of patients in, any clinical trials, the risk that the Company may cease or delay preclinical or clinical development of any of its product candidates for a variety of reasons (including requirements that may be imposed by regulatory authorities on the initiation or conduct of clinical trials, changes in the therapeutic, regulatory, or competitive landscape for which the Companys product candidates are being developed, the amount and type of data to be generated or otherwise to support regulatory approval, difficulties or delays in patient enrollment and continuation in the Companys ongoing and planned clinical trials, difficulties in manufacturing or supplying the Companys product candidates for clinical testing, and any adverse events or other negative results that may be observed during preclinical or clinical development), the risk that results observed in preclinical studies of FT819 may not be replicated in ongoing or future clinical trials, and the risk that FT819 may not produce therapeutic benefits or may cause other unanticipated adverse effects. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Companys actual results to differ from those contained in the forward-looking statements, see the risks and uncertainties detailed in the Companys periodic filings with the Securities and Exchange Commission, including but not limited to the Companys most recently filed periodic report, and from time to time in the Companys press releases and other investor communications. Fate Therapeutics is providing the information in this release as of this date and does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise.

Contact:Christina TartagliaStern Investor Relations, Inc.212.362.1200[emailprotected]

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Fate Therapeutics Announces Preclinical Publication Highlighting Derivation of CD8 T Cells from TCR-CAR+ Induced Pluripotent Stem Cells -...

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BUDDY SCOTT: Love stems from the Father | Brazos Living | thefacts.com - Brazosport Facts

The media continues the one-handed count of patients that seem to be cured of HIV as a man who has lived with the disease since the 1980s has been in remission for 17 months.

The story is always the samethey seem to be cured, and they get a cool nicknamein this case the City of Hope Patient, after Duarte, California, where he was treated.

The difference in this case was the treatmenta bone marrow transplant to treat blood cancer leukemia from a donor who was naturally resistant to the virus.

The most remarkable difference however, is that he is only patient cured of HIV by coincidence.

The man had developed leukemia, and took the bone marrow transplant for that reason. As it happened, the donor was resistant to HIV, and taught the mans body to create an immune response against the virus.

RELATED: Worlds Second Person Cured of HIV: 40-Year-old Man is Confirmed to Be 30 Months Virus-Free

This is also the first one who got it during the epidemic of HIV/AIDS that took so many lives.

When I was diagnosed with HIV in 1988, like many others, I thought it was a death sentence, said the City of Hope Patient. I never thought I would live to see the day that I no longer have HIV.

SIMILAR: Two Patients Make History After Essentially Being Cured of HIV Using Stem Cell Transplant

So far, only three people have been seemingly cured of human immunodeficiency virus (HIV) which weakens the bodys immune system and leads to the more severe AIDS (autoimmune deficiency syndrome) which can be lethal.

The man no longer takes antiretroviral drugs, the only treatment for HIV. A bone marrow transplant is not a likely future cure, do to it being a tricky and side-effectual procedure.

Nevertheless, all cure cases have been those where a patient is given a transplant of some kind, mostly stem cells, that contain the very rarely occurring natural immunity to the virus.

The case was reported at the AIDS 2022 conference in Montreal, Canada.

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Fourth Patient Seemingly Cured of HIV Through Wild Coincidence - Good News Network

MANY people suffer with back pain, whether that's from poor posture or a sporting injury.

Teenager Daniel Greer had been struggling with this - as well as neck pain.

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But rather than an injury or pull - a blood test confirmed a shocking diagnosis.

The 14-year-old from Northern Ireland was told he had acute myeloid leukaemia two months ago.

Now his family are racing to find a stem cell donor - as this is his only chance of survival.

Since his diagnosis, the music fanatic has been staying at the Royal Belfast Hospital for Sick Children and is being treated with aggressive chemotherapy.

Doctors say that a stem cell transplant will help repair his immune system - but only one in four people will find a match within their own family.

His older brother James, sadly isn't a match so Daniel will need a transplant from an unrelated donor.

Mum, Anne, is now speaking out in the hopes of getting more people to sign up to the stem cell register - with the possibility of finding her son a donor.

She said: "Daniel is an amazing, bright young man who lights up any room he walks into.

"His wicked sense of humour keeps our spirits up, even now while hes in hospital receiving chemotherapy.

"I know hes really proud that his story is inspiring people to sign up to the stem cell register.

"Those people will potentially help him, as well as many other people around the world who desperately need a stem cell transplant like Daniel."

When it comes to the stem cell register, young men make up just 18 per cent of those on it, blood cancer charity Anthony Nolan states.

However, this demographic also makes up more than half of all stem cell transplants for blood cancer and blood disorder patients.

Now the charity is helping with an international appeal to get Daniel a donor, dubbed the DoItForDaniel campaign.

Daniel, lives in Newry and so far local pharmacies have got behind the campaign - urging people to sign up to help save the lives of others.

What is leukaemia?

Leukaemia is a type of blood cancer that affects cells in bone marrow and attacks the immune system.

In most cases of leukaemia, there is no obvious cause. Little Azaylia had been diagnosed with Acute Myeloid Leukaemia (AML) , which is a rapidly progressive form of the illness.

Leukaemia is a cancer that leads to the body making too many abnormal white blood cells and means the body is less likely to be able to defend itself against infection.

These blood cells are not fully developed and are called leukaemia cells.

The disease is often classified as the type of cell affected (myeloid or lymphatic) and how it progresses (acute or chronic).

There are four main types of leukaemia.

Acute Lymphocytic Leukaemia (ALL)-A rapidly progressing form of the disease.More common in children.

Acute Myeloid Leukaemia (AML) -Rapidly progressive. More common in adults.

Chronic Lymphocytic Leukaemia (CLL) -Slowly progressing form and more common in adults.

Chronic Myeloid Leukaemia (CML) -Progresses slowly and is more common in adults

There has also been an awareness-raising drive about stem cell donation at Belfast International Airport.

It's hoped that the drive will allow the keen mountain biker and rugby player to continue to do the things he enjoys most.

Anthony Nolan chief executive Henny Braund said that finding a matching donor would mean everything to Daniel and his family.

"We are committed to supporting Daniel as he waits for news of the donor who could save his life.

Last year over 1,300 people around the world with blood cancer or a blood disorder were given a second chance of life because of the wonderful people that are signed up to the Anthony Nolan register.

But too many people, like Daniel, are told there is no matching donor for them.

Signing up to the register is quick and simple, and we urge anyone who is in good general health, especially young men aged 16-30, to come forward and potentially save the life of someone like Daniel.

Anyone aged 16-30 can sign up online through the Anthony Nolan website.

DONATING STEM CELLS & SIGNING THE REGISTER

When you join a stem cell registry you are on standby to be matched and potentially save a life although many people are never called up.

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My little boy is fighting for his life after complaining of back pain you could save him... - The Sun

SOUTH SAN FRANCISCO, Calif., Aug. 01, 2022 (GLOBE NEWSWIRE) -- Tricida, Inc. (Nasdaq: TCDA) today announced that it will report its second quarter 2022 financial results after the close of market on Monday, August 8, 2022. Tricida will host a webcast and conference call at 4:30 pm Eastern Time to discuss its second quarter financial results and business progress. The webcast or call may be accessed as follows:

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Tricida to Report Second Quarter Financial Results and Host Conference Call and Webcast on Monday, August 8, 2022

Model designed to fill need for soluble amyloid beta oligomer reference standards in bioanalytical assays Model designed to fill need for soluble amyloid beta oligomer reference standards in bioanalytical assays

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Acumen presents poster describing method to standardize amyloid beta oligomer assays supporting therapeutic development for early Alzheimer’s...

Patent Improves Differentiated Profile of Ameluz-PDT by Expected Reduced Pain Intensity while Maintaining Efficacy

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Biofrontera Inc. Announces Patent in Australia for Novel Illumination Protocols Granted to Biofrontera Bioscience GmbH

MINNEAPOLIS, Aug. 01, 2022 (GLOBE NEWSWIRE) -- Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, today announced that it will host a conference call on August 15, 2022, at 4:30 PM Eastern Time to discuss results for its second quarter ended June 30, 2022.

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Panbela Schedules Conference Call on, August 15, 2022, to Report 2022 Second Quarter Financial Results

WOBURN, Mass., Aug. 01, 2022 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of a novel class of tumor-directed oncolytic immunotherapies, today announced that members from the Replimune management team will present and host investor meetings at the following two conferences:

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Replimune to Present at Two Upcoming Investor Conferences

STAMFORD, Conn., Aug. 01, 2022 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc. (Nasdaq: CARA), a commercial-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus, today announced the Company will host a conference call and live audio webcast on Monday, August 8, 2022, at 4:30 p.m. ET to report second quarter 2022 financial results and provide a corporate update.

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Cara Therapeutics to Announce Second Quarter 2022 Financial Results on August 8, 2022

DURHAM, N.C., Aug. 01, 2022 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ:CMRX), a biopharmaceutical company whose mission is to develop medicines that meaningfully improve and extend lives of patients facing deadly diseases, today announced that it will host a live conference call and audio webcast on Monday, August 8, 2022 at 4:30 p.m. ET to report financial results for the second quarter ended June 30, 2022, and to provide a business overview.

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Chimerix to Report Second Quarter 2022 Financial Results and Provide an Operational Update on August 8, 2022

Leaders each bring 20+ years of proteomics and genomics industry experience from Genapsys, Agilent, Illumina, Affymetrix, and Encodia to company developing platform for comprehensively quantifying the proteome Leaders each bring 20+ years of proteomics and genomics industry experience from Genapsys, Agilent, Illumina, Affymetrix, and Encodia to company developing platform for comprehensively quantifying the proteome

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Nautilus Biotechnology Appoints Eric Spence as Vice President of Instrument Engineering and Ken Kuhn, Ph.D., as Vice President of Reagent and Platform...

REDWOOD CITY, Calif., Aug. 01, 2022 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing novel covalent small molecules to treat and improve the lives of patients with genetically defined cancers and metabolic diseases, reported second quarter 2022 financial results and business highlights.

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Biomea Fusion Reports Second Quarter 2022 Financial Results and Business Highlights

WALTHAM, Mass., Aug. 01, 2022 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in complement, today announced that the company will host a conference call and webcast to discuss its second quarter 2022 financial results on Monday, August 8, 2022 at 4:30 p.m. ET.

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Apellis Pharmaceuticals to Host Conference Call on Aug 8, 2022 to Discuss Second Quarter 2022 Financial Results

GAINESVILLE, Fla. and CAMBRIDGE, Mass., Aug. 01, 2022 (GLOBE NEWSWIRE) -- Applied Genetic Technologies Corporation (“AGTC” or the “Company”) (Nasdaq: AGTC), a clinical-stage biotechnology company focused on the development and potential commercialization of adeno-associated virus (AAV)-based gene therapies for the treatment of rare and debilitating diseases with an initial focus on inherited retinal diseases, today announced that management will be participating in the following investor conferences:

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AGTC to Participate in Upcoming Investor Conferences

SANTA MONICA, Calif., Aug. 01, 2022 (GLOBE NEWSWIRE) -- Opiant Pharmaceuticals, Inc. (“Opiant” or “Company”) (NASDAQ: OPNT), a specialty pharmaceutical company developing medicines to treat addictions and drug overdose, today announced it will report its financial results for the second quarter ended June 30, 2022, after the financial markets close on Thursday, August 11, 2022.

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Opiant Pharmaceuticals to Report Second Quarter 2022 Financial Results and Host Conference Call and Webcast on August 11, 2022

SAN DIEGO, Aug. 01, 2022 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE), a San Diego based clinical stage biopharmaceutical drug development company targeting untreatable eye diseases, will host a conference call on Thursday, August 11, 2022, at 4:30 p.m. Eastern time to discuss the Company’s financial results for the first half, ended June 30, 2022, and provide a corporate progress update. The financial results will be issued in a press release on Wednesday, August 10, 2022.

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Belite Bio to Host Conference Call on August 11, 2022 to Discuss First Half 2022 Financial Results

CAMBRIDGE, Mass., Aug. 01, 2022 (GLOBE NEWSWIRE) -- Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, today announced that Rob Ross, M.D., chief executive officer, will participate in a virtual panel discussion entitled, “IOs Wide Open - Opportunity and Challenges in Immuno-Oncology” at the 2022 Wedbush PacGrow Healthcare Conference. The panel discussion will take place on Tuesday, August 9, 2022, at 8:00 am ET.

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Surface Oncology to Participate in the 2022 Wedbush PacGrow Healthcare Conference

Montrouge, France, August 1, 2022

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DBV Technologies Reports Second Quarter 2022 Financial Results

NEW YORK, Aug. 01, 2022 (GLOBE NEWSWIRE) -- Cellectis (the “Company”) (Euronext Growth: ALCLS - NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies, today announced that the U.S. Food and Drug Administration (FDA) has cleared Cellectis’ Investigational New Drug (IND) application to initiate a Phase 1/2a clinical trial of UCART20x22 for patients with relapsed or refractory Non-Hodgkin Lymphoma (r/r NHL). The Company plans to begin enrolling patients in the NatHaLi-01 study in the second half of the year.

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Cellectis Receives IND clearance for UCART20x22, its First in-house Manufactured Product Candidate for the Treatment of B-cell Malignancies