The T-cell therapy market is anticipated to rise at a stellar growth rate for the forecast period between 2020 and 2030. The shift in medical practices from small molecule and protein-based therapies to adoptive therapies that has attracted strategic investments by both public and private agencies is creating opportunities in the T-cell therapy.

Key parameters based on which the T-cell therapy market is divided in this report are modality, therapy type, indication, and region.

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The report provides an in-depth analysis of demand drivers, trends, and opportunities in the T-cell therapy market for the 2020 2030 forecast period. Furthermore, the report throws lights on key segments along with their growth rate estimations for the aforementioned forecast period. Last but not the least, the report discusses the competitive landscape of the T-cell therapy market. This includes insights into growth strategies of key players along with their revenue share estimation in the T-cell therapy market for the 2020 2030 forecast period.

T-cell Therapy Market: Competitive Landscape

The T-cell therapy market is fiercely competitive due to the presence of some large players in the fray. With increasing approvals of T-cell therapy and expanding manufacturing capabilities, competition in the market is expected to intensify in the future. For example, in December 2020, the European Medicine Agency issued market authorization for Tecartus the only CAR-T therapeutic product from Kite Pharma for mantle cell lymphoma.

Key players operating in the T-cell therapy market include;

T-cell Therapy Market: Key Trends

First and foremost, substantial application of T-cell mechanism in cancer immunotherapy due to its high success rate fuels growth in the T-cell therapy market. As of June 2020, above 350 CAR-T clinical trials registered in China. This data indicates the increasing significance of Chimeric Antigen Receptor therapy for the treatment of cancer.

Besides this, expanding role of gene therapy for the treatment of a number of rare diseases is spawning demand for CAR-T therapies. With increasing adoption of gene therapy, the T-cell therapy market is expected to touch new frontiers over the forecast period from 2020 to 2030.

Over the COVID-19 pandemic, increasing investments to decipher the application of T-cell therapies for viral infection research is adding a new dimension to the growth of T-cell therapy market. In this context, a study published in December 2020 demonstrates the potential of T-cell therapy to treat high-risk COVID-19 patients.

In another similar case study, in September 2020, the U.S. FDA sanctioned the IND application for the use of ALVR109 to treat COVID-19 patients. This is likely to expand the adoption of T-cell therapies for viral infections.

T-cell Therapy Market: Regional Assessment

North America is the leader among other key regions in the T-cell therapy market. Factors such as a robust research infrastructure for clinical trials of T-cell therapies and a commercial base for T-cell therapies makes the region leader in the overall T-cell therapy market.

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The U.S. and Canada predominantly steer growth in the T-cell therapy market in the region. The increasing number of regulatory approvals along with changing reimbursement scenario in the U.S. and Canada have accelerated the uptake of T-cell therapies in these countries. This bolsters the T-cell therapy market in the region.

China has emerged as a key region in the CAR-T therapies market in recent years. The high number of clinical trials undertaken pertaining to these therapies is creating opportunities in the T-cell therapy market in China.

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T-cell Therapy Market Trends, Share and Future Growth Analysis Report to 2030 - BioSpace

Image credits: Bone Therapeutics

A few years back, the concept of altering genes to treat disease was considered science fiction. However, it is now a reality. Thanks to technological advancements, numerous other cutting-edge approaches are reshaping how we treat and cure diseases.

Cell therapy is one such approach that involves injecting new cells into a patients body to replace or repair damaged tissue to treat a disease. According to the report, a total of 1342 active cell-based therapy clinical trials have been identified and characterised based on cell type, target indication, and trial phase.

Recently, the winners of the 2021 Future Hamburg Award were announced.

Nowadays, various medical organisations use cell therapies that are clinically approved. Based in Gosselies, Belgium, Bone Therapeutics is a biopharmaceutical company focused on innovative cell therapy products to treat bone diseases.

Recently, the company secured a 16M loan from the European Investment Bank (EIB) to accelerate the clinical development of ALLOB, Bone Therapeutics scalable allogeneic cell therapy platform.

Further, EIB will also support and prepare Bone Therapeutics lead product, viscosupplement JTA-004, for future regulatory approval and commercialisation.

ALLOB is an allogeneic cell therapy platform consisting of human allogeneic bone-forming cells derived from ex-vivo cultured bone marrow mesenchymal stromal cells (MSC) from healthy adult donors. It is currently in two Phase I/IIA proof-of-concept trials for the treatment of delayed-union fractures and spinal fusion procedures.

The patient recruitment is expected to complete in the first half of 2022 and the results in the second half.

JTA-004 is Bone Therapeutics next generation of intra-articular injectable, which is currently in phase III development for treating osteoarthritic pain in the knee.

JTA-004 consists of a unique patented mix of plasma proteins, hyaluronic acid a natural component of knee synovial fluid, and a fast-acting analgesic. It intends to provide added lubrication and protection to the cartilage of the arthritic joint and to alleviate osteoarthritic pain and inflammation.

The Belgian company plans to submit a marketing authorisation application to European regulatory authorities in the first half of 2022. Additionally, the company continues to engage with potential partners to develop and commercialise JTA-004 in Europe, the US, and Asia.

The EIB will be disbursing the loan in two tranches of 8M each, subject to conditions precedent.

The first 8M will be available upon approval of the issuance of associated warrants by Bone Therapeutics General Meetings before the end of August 2021.

The next 8M will be released when specific clinical and commercial milestones have been achieved.

The loan facility will be in the form of a senior loan, repayable to the EIB in a single payment five years following the disbursement of each of the two tranches. The loan carries a fixed interest of 2 per cent per year paid annually and a 3% capitalized interest, says the press release.

Founded in 2006, Bone Therapeutics has an extensive portfolio of cell and biological therapies at different stages ranging from pre-clinical programs in immunomodulation to mid-to-late stage clinical development for orthopedic conditions.

Bone Therapeutics is building towards a very important set of milestones, including moving towards potential regulatory approval and commercialisation of therapy for over 250 million patients, as well as continuing with the clinical development of its allogeneic cell therapy platform ALLOB. In addition, we are building on our success in orthopedics and moving our formidable MSC capabilities to target wider indications. The support of a major European financial institution such as the EIB will be an additional important component to this activity, says Jean-Luc Vandebroek, Chief Financial Officer, Bone Therapeutics.

This financing committed by the EIB will allow Bone Therapeutics to further advance the clinical development of its lead product candidates JTA-004 and ALLOB, further accelerating paths to approval and commercialisation, he adds.

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Belgium's Bone Therapeutics secures 16M loan from EIB to develop new cell therapy-based orthopaedic treatments - Silicon Canals

Abstracted presented recently at the American Society of Clinical Oncology annual meeting offered promising data for 2 chimeric antigen receptor (CAR) T-cell therapies, one in relapsed/refractory (R/R) B-cell acute lymphoblastic leukemia (B-ALL) and one in R/R multiple myeloma.

Approved in 2020 for patients with R/R mantle cell lymphoma, brexucabtagene autoleucel, sold as Tecartus, is also now being studied in patients with R/R B-ALL, with the recent conference data suggesting the treatment offers a clinical benefit in these patients.1

After a median follow-up of 16.4 months, median overall survival (OS) was not reached among the patients who responded to Tecartus. These patients had a mean relapse-free survival of 14.2 months.

Across the 55 patients receiving Tecartus, 71% achieved a complete response (CR) or CR with incomplete hematologic recovery (CRi), 97% of which were negative for minimal residual disease.

The patients included in the study were heavily pretreated, with 45% having previously received blinatumomab, 22% having previously received inotuzumab ozogamicin, and 42% having previously received allogeneic stem cell transplant.

Ninety-five percent of patients experienced grade 3 adverse events. The most common adverse events included anemia (49%) and neutropenia (49%). Grade 3 cytokine release syndrome and neurologic eventscommonly reported among patients treated with CAR T-cell therapieswere reported in 24% and 25% of patients, respectively, with a median time to onset of 5 days and 9 days, respectively. According to the researchers, they were generally reversible.

Novel therapy in multiple myeloma. During the conference, researchers also offered data from 2 different time points of an ongoing phase 1 study of CART-ddBCMA in R/R multiple myeloma. CART-ddBCMA is an autologous CAR-T cell therapy that uses a novel BCMA-targeting binding domain and is designed to reduce the risk of immunogenicity and have high stability.

As of January 29, 2021, there were 9 evaluable patients, all of which responded to CART-ddBCMA. Four patients achieved a stringent CR (sCR), one achieved a very good partial response (VGPR), and 4 achieved a PR. One of the patients who achieved a PR had disease relapse and was retreated, while the rest of the patients had ongoing responses.

Similar findings were seen as of April 2021,3 with all 12 evaluable patients achieving a response, including 5 sCR, 1 CR, 3 VGPR, and 3 PR. Eleven of these responses are ongoing and data from the study suggests that responses deepen over time. According to the researchers, despite previously progressing on BCMA-targeted therapy, a patient still achieved a VGPR.

All 12 of these patients have received at least 3 prior lines of therapy, and 10 were penta-refractory.

References

1. Shah B, Ghobadi A, Oluwole O, et al. Phase 2 results of the ZUMA-3 study evaluating KTE-X19, an anti-CD19 chimeric antigen receptor (CAR) T-cell therapy, in adult patients (pts) with relapsed/refractory B-cell acute lymphoblastic leukemia (R/R B-ALL). J Clin Oncol. 2021; 39(Suppl 15): abstr 7002. doi: 10.1200/JCO.2021.39.15_suppl.7002

2. Frigault M. Phase 1 Study of CART-ddBCMA, a CAR-T therapy utilizing a novel synthetic binding domain, for the treatment of subjects with relapsed and refractory multiple myeloma. J Clin Oncol. 2021; 39(Suppl 15): abstr 8015. doi: 10.1200/JCO.2021.39.15_suppl.8015

3. Arcellx Announces Presentation of Positive Clinical Results from Ongoing Phase 1 Study of CART-ddBCMA at the 2021 ASCO Annual Meeting. News release. June 4, 2021. Accessed July 2, 2021. https://arcellx.com/arcellx-announces-presentation-of-positive-clinical-results-from-ongoing-phase-1-study-of-cart-ddbcma-at-the-2021-asco-annual-meeting/

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Studies Offer Promising Data on CAR T-cell Therapy in B-ALL, Multiple Myeloma - AJMC.com Managed Markets Network

This article was originally published here

Clin Rev Allergy Immunol. 2021 Jul 5. doi: 10.1007/s12016-021-08866-1. Online ahead of print.

ABSTRACT

Autoimmunity is caused by an unbalanced immune system, giving rise to a variety of organ-specific to system disorders. Patients with autoimmune diseases are commonly treated with broad-acting immunomodulatory drugs, with the risk of severe side effects. Regulatory T cells (Tregs) have the inherent capacity to induce peripheral tolerance as well as tissue regeneration and are therefore a prime candidate to use as cell therapy in patients with autoimmune disorders. (Pre)clinical studies using Treg therapy have already established safety and feasibility, and some show clinical benefits. However, Tregs are known to be functionally impaired in autoimmune diseases. Therefore, ex vivo manipulation to boost and stably maintain their suppressive function is necessary when considering autologous transplantation. Similar to autoimmunity, severe coronavirus disease 2019 (COVID-19) is characterized by an exaggerated immune reaction and altered Treg responses. In light of this, Treg-based therapies are currently under investigation to treat severe COVID-19. This review provides a detailed overview of the current progress and clinical challenges of Treg therapy for autoimmune and hyperinflammatory diseases, with a focus on recent successes of ex vivo Treg manipulation.

PMID:34224053 | DOI:10.1007/s12016-021-08866-1

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Improving the Efficacy of Regulatory T Cell Therapy - DocWire News

This article was originally published here

Curr Med Sci. 2021 Jul 3. doi: 10.1007/s11596-021-2391-5. Online ahead of print.

ABSTRACT

Chimeric antigen receptor T (CAR-T) cell therapy is the novel treatment strategy for hematological malignancies such as acute lymphoblastic leukemia (ALL), lymphoma and multiple myeloma. However, treatment-related toxicities such as cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) have become significant hurdles to CAR-T treatment. Multiple strategies were established to alter the CAR structure on the genomic level to improve efficacy and reduce toxicities. Recently, the innovative gene-editing technology-clustered regularly interspaced short palindromic repeats (CRISPR)/CRISPR-associated nuclease9 (Cas9) system, which particularly exhibits preponderance in knock-in and knockout at specific sites, is widely utilized to manufacture CAR-T products. The application of CRISPR/Cas9 to CAR-T cell therapy has shown promising clinical results with minimal toxicity. In this review, we summarized the past achievements of CRISPR/Cas9 in CAR-T therapy and focused on the potential CAR-T targets.

PMID:34218353 | DOI:10.1007/s11596-021-2391-5

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Combination of CRISPR/Cas9 System and CAR-T Cell Therapy: A New Era for Refractory and Relapsed Hematological Malignancies - DocWire News

DGAP-News: APEIRON Biologics AG / Key word(s): Study06.07.2021 / 08:00 The issuer is solely responsible for the content of this announcement.

APEIRON Biologics launches next clinical trialwith innovative cancer therapy APN401Important development step for promising cell therapy

Vienna, Austria, 06 July 2021: APEIRON Biologics AG announced today the start of a Phase Ib clinical trial with its product candidate APN401 for the treatment of solid tumors. The principle of cell therapy with APN401 by inhibiting the immune checkpoint Cbl-b aims at the patient's own immune cells. These are modified to recognize and destroy cancer cells without being permanently genetically altered.

The open-label, multi-center Phase Ib clinical trial is expected to enroll approximately 60 patients at multiple sites in Austria. The study objective is to evaluate the safety, tolerability and immunological effects of the treatment on patients with various solid tumors. This will build on the experience of the two previous Phase I clinical studies, which already successfully demonstrated good tolerability and the first signs of clinical efficacy by activating the immune cells that are crucial to tumor defense.

The clinical study is divided into two parts. Part A of the study aims to determine the optimal dosing, i.e. the quantity of treated cells reinfused back to the patient. Patients will receive APN401 treatment every three weeks. In part B of the study, patients with specific tumor indications (three groups of 15 patients each) will be treated to generate further efficacy signals, which will be used to determine the tumor indication for a subsequent Phase II clinical study. The Phase I clinical study will start at the Medical University of Vienna (MUW) where the GMP-certified production of the cell therapy and treatment of the patients will take place.

For the treatment, the patient's own peripheral blood mononuclear cells (PBMCs) are collected, specifically modified outside the body using RNAi technology and then reinfused into the patient. APEIRON uses a specially developed system for this purpose, which enables an automated process from cell processing to reinfusion within just one day. This GMP-certified system increases patient safety and the reproducibility of the manufacturing process. APEIRON's technology thus enables personalized cell therapy in solid tumors.

Peter Llewellyn-Davies, CEO of APEIRON Biologics AG, says: "We are thrilled to be contributing a groundbreaking cancer treatment with this truly pioneering step in development of our APN401 cell therapy. The short outpatient administration process, which can also be used for solid tumors, plays a key advantage compared to other autologous cell therapies. APN401 could offer critically ill patients, with previously difficult-to-treat cancers, new individualized treatment options and thus new hope. The APEIRON team is highly motivated to develop much needed new treatment options with this major next step."

Dr. Romana Gugenberger, Chief Medical & Scientific Officer (CMSO) of APEIRON Biologics AG, explains: "The immune system is the most effective weapon against tumor disease and offers many advantages over conventional therapies such as chemotherapy. Cbl-b is a master checkpoint in the immune system that controls important processes of the immune response, especially in cancer. APN401, by blocking Cbl-b using RNA interference (RNAi), is designed to reactivate the patient's immune system, allowing it to fight solid tumors. The flexibility of RNAi technology could expand the applicability of cell therapy to additional immune checkpoints and holds enormous potential for new therapeutic approaches."

Prof. Dr. Nina Worel, Head of Cell Therapy at the Department of Transfusion Medicine at AKH / Medical University of Vienna and lead investigator of the study, adds: "Patients with advanced solid tumors urgently need new, safe and effective therapeutic options. Using cell therapy to enable the patient's immune system to directly attack the tumor is a very promising approach. APEIRON's APN401 could become superior in safety and efficacy to standard oncology therapies as well as to currently available cell therapies, due to its rapid applicability and central immune activation. We are excited to initiate this study here in Vienna and other sites and gain new insights."

About APN401

Immune checkpoints are receptors with immunoregulatory activity. Tumor cells can make use of these immune checkpoints to escape recognition by the immune system. Cbl-b represents a new class of intra-cellular immune checkpoints in contrast to the immune checkpoint molecules PD-1/PD-L1 and CTLA-4, which are localized at cell surfaces.

APN401, an autologous cell therapy, was designed to transiently, i.e. temporarily, inactivate Cbl-b ex-vivo in autologous PBMCs. These altered autologous PBMCs are then returned to the patient, with the entire procedure performed on an outpatient basis over one day. APN401 is well tolerated, has a good safety profile, and has shown early evidence of clinical activity in patients with advanced solid tumors in two Phase I studies.

More information on checkpoint inhibition of Cbl-b and APN401 can also be found on our website.

About APEIRON Biologics AG

APEIRON Biologics is a privately held European biotech company based in Vienna, Austria, focused on the discovery and development of treatments for respiratory diseases and novel cancer immunotherapies.

APEIRON received EU marketing approval for APN311 (dinutuximab beta, Qarziba(R)) in 2017 for the treatment of pediatric neuroblastoma patients and out-licensed global, exclusive rights for this product to EUSA Pharma Ltd.

APEIRON is developing a promising drug for COVID-19: APN01 (rhsACE2, alunacedase alfa), a soluble recombinant version of the SARS-CoV-2 cell entry receptor ACE2. APN01 has three distinct potential clinical benefits for COVID-19 and has completed a double blind, placebo-controlled Phase II trial in Europe and Russia. Based on promising results, APN01 was selected for a publicly funded, large-scale study in COVID-19 by the U.S. government which is scheduled to start in Q3 2021.

APN401's proprietary cellular therapy process brings in a paradigm change in cancer treatment to fight solid tumors. The clinical program is a first-in-class ambulatory autologous transient therapy to strengthen immune reactivity via an intracellular master checkpoint inhibitor, Cbl-b.

APEIRON Biologics' projects and technologies are based on a strong patent portfolio and partnerships with leading pharmaceutical companies and academic institutions.

Further information, visit http://www.apeiron-biologics.com and connect with us on twitter and LinkedIn.

For further information please contact:

APEIRON Biologics AGPeter Llewellyn-DaviesCEOEmail: investors@apeiron-biologics.comwww.apeiron-biologics.com

Media and Investor RelationsMC Services AGJulia Hofmann, Andreas JungferT +49 89 210 228 0Email: apeiron@mc-services.eu

FORWARD LOOKING STATEMENTS

Information set forth in this press release contains forward-looking statements, which involve a number of risks and uncertainties. The forward-looking statements contained herein represent the judgement of APEIRON Biologics as of the date of this press release. Such forward-looking statements are neither promises nor guarantees but are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any such statements to reflect any change in our expectations or any change in events, conditions or circumstances on which any such statement is based.

06.07.2021 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.The issuer is solely responsible for the content of this announcement.

The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Archive at http://www.dgap.de

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APEIRON Biologics launches next clinical trial with innovative cancer therapy APN401 - Yahoo Eurosport UK

Nova Scotians fighting some types of lymphoma will soon be able to receive a potentially life-saving therapy in their home province.

A new CAR T-cell treatment program is being made possible through $18 million in investments in cancer careannounced Monday by the provincial government.

CAR T-cell therapy is a method of immunotherapy that modifies a person's immune cells or T-cells in a way that the cells are able to detect the cancer and fight it within the patient for the rest of their lives.

About $6.7 million of that funding will be spent annually on the new therapy.

"This will literally be the difference between life and death for patients diagnosed with certain types of cancer," said Dr. Helmut Hollenhorst,the senior medical director of Nova Scotia Health's Cancer Care Program.

Hollenhorstsaid that non-Hodgkin's lymphomas are the fifth most common cancers in Canada and advances in treatment can now cure the illness in about two-thirds of patients.

But the remaining third are only expected to survive for about six monthswhen cancer recurs, he said.

"The CAR T-cell is a type of personalized medicine that has the potential to cure non-Hodgkin's lymphoma when other treatment methods are not available," saidHollenhorst.

The therapy has been approved by Health Canada but specialist staff and equipment are needed, so the proposal for the new program took a couple of years to come to fruition.

About eight patients every year travel from Nova Scotia to Boston for the treatment but others decide not to go due to extra financial costs and added stress to their families.

It's expected now the treatment will be available in Halifax that double that number will take what Hollenhorst describes as a last chance treatment.

"We are committed to providing Nova Scotians with the cancer care and support they need, closer to home," said Health and Wellness Minister Zach Churchill. "These changes add another treatment option not previously available in Nova Scotia and will expand eligibility and ensure patients pay less for travel, accommodations, supplies and cancer drugs."

Churchill said conversations will happen with other Atlantic provinces about the possibility of residents from neighbouring provinces being able to access the treatment.

The Nova Scotia government will also spend $11.1 million in the next three years to reduce out-of-pocket costs for travel, accommodations, supplies and cancer drugs for patients.

About $225,000 of that money will go to the Canadian Cancer Society's Dr. Susan K Roberts Lodge That Gives, which provides free accommodations for people who live outside Halifax while they undergo cancer treatment.

Churchill said the new funds being announced are the result of the 2018 review of cancer services in Yarmouththat included input from patients, physicians, staff and people in the community.

The new CAR T-cell therapy is expected to be available in six months at the QEII Health Sciences Centre.

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N.S. to become first Atlantic province to offer potentially life-saving cancer treatment - CBC.ca

SOUTH SAN FRANCISCO, Calif., June 30, 2021 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) therapies for cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ALLO-605, the Companys next-generation AlloCAR T therapy targeting BCMA for the treatment of relapsed or refractory multiple myeloma. The FDA granted Fast Track designation based on the potential of ALLO-605 to address the unmet need for patients who have failed other standard multiple myeloma therapies. The Phase 1 dose escalation portion of the IGNITE trial evaluating ALLO-605 was initiated in Q2 2021.

ALLO-605 is the Companys first TurboCAR clinical candidate. TurboCAR is a proprietary, next generation platform technology based upon programmable cytokine signaling designed to improve the function and potency of AlloCAR T cells. These properties may also enable CAR T therapy to succeed in solid tumors and increase efficacy in hematologic malignancies. Preclinical results from the ALLO-605 study were presented in a poster session at the American Society of Hematology (ASH) annual meeting in December of 2020.

We are very pleased with the continued momentum of our anti-BCMA portfolio for patients with multiple myeloma and look forward to making allogeneic CAR T therapy a potential option for these patients, said Rafael Amado, M.D., Executive Vice President of Research and Development and Chief Medical Officer. With studies now underway for ALLO-715 alone and in combination with a gamma secretase inhibitor, as well as ALLO-605 as our next generation CAR T, we are taking an aggressive three-pronged approach aimed at exploring the unique attributes of AlloCAR T therapies for patients with rapidly progressing disease.

Initial results from the Phase 1 UNIVERSAL study of ALLO-715 in relapsed/refractory multiple myeloma were presented at an oral session of the ASH annual meeting in December 2020. In April 2021, ALLO-715 was granted Regenerative Medicine Advanced Therapy (RMAT) designation by the FDA. Separately, the UNIVERSAL study began enrolling patients in the first half of 2021 to evaluate ALLO-715 in combination with SpringWorks Therapeutics investigational gamma secretase inhibitor, nirogacestat.

Fast Track is designed to accelerate the development and review of treatments for serious and life-threatening diseases where no treatment exists or where the treatment in discovery may be better than what is currently available.

About ALLO-605ALLO-605 is a next-generation AlloCAR T investigational therapy that targets the B-cell maturation antigen (BCMA) for the treatment of patients with relapsed/refractory multiple myeloma and other BCMA-positive malignancies. This study uses ALLO-647, Allogene's proprietary monoclonal antibody (mAb), as a part of its differentiated lymphodepletion regimen. ALLO-605 incorporates Allogenes proprietary TurboCAR technology, which allows for cytokine activation signaling to be engineered selectively into CAR T cells. Preclinical results with ALLO-605 were presented at the American Society of Hematology (ASH) annual meeting in December 2020. In June 2021, ALLO-605 was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the potential treatment of relapsed/refractory multiple myeloma.

About Allogene TherapeuticsAllogene Therapeutics, with headquarters inSouth San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T) therapies for cancer. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of off-the-shelf CAR T cell therapy candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visitwww.allogene.com, and follow @AllogeneTx on Twitter and LinkedIn.

Cautionary Note on Forward-Looking StatementsThis press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The press release may, in some cases, use terms such as "predicts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the ability to progress the Phase 1 IGNITE trial of ALLO-605; the ability of ALLO-605 and other TurboCAR candidates to improve the function and potency of AlloCAR T cells, enable success in solid tumors and increase efficacy in hematologic malignancies; and the potential benefits of AlloCAR T therapy. Various factors may cause differences between Allogenes expectations and actual results as discussed in greater detail in Allogenes filings with the SEC, including without limitation in its Form 10-Q for the quarter ended March 31, 2021. Any forward-looking statements that are made in this press release speak only as of the date of this press release. Allogene assumes no obligation to update the forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

AlloCAR T and TurboCAR are trademarks of Allogene Therapeutics, Inc.

ALLO-605 and ALLO-715 utilize TALEN gene-editing technology pioneered and owned by Cellectis. Allogene has an exclusive license to the Cellectis technology for allogeneic products directed at BCMA and holds all global development and commercial rights for this investigational candidate.

Allogene Media/Investor Contact:Christine CassianoChief Communications Officer(714) 552-0326Christine.Cassiano@allogene.com

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Allogene Therapeutics Granted FDA Fast Track Designation for ALLO-605, the First TurboCAR T Cell Therapy, for the Treatment of Relapsed/Refractory...

Each Monday, CancerNetwork highlights the most important content from the previous week in oncology news.

This week, the recap is headlined by an article investigating the differences in genetic risk for breast cancer in Black and non-Hispanic White women. Then, a pair of thought leaders share their thoughts on research presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting.

Black and non-Hispanic White Women Found to Have No Differences in Genetic Risk for Breast Cancer

Differences in frequency of germline pathogenic variants were not seen in patient subsets by ethnicity when comparing 12 genes linked with breast cancer.

At a time when Black men and women are more likely to be diagnosed with cancer at later stages when it is less treatable, [the Black & BRCA initiative] seeks to empower people to understand their family health history and take action to prevent cancer from one generation to the next, said first author Susan Domchek, MD, executive director of the Basser Center for BRCA.

Navigating an Optimal Treatment Course for Advanced Kidney Cancer

Benjamin A. Teply, MD, considers the optimal treatment of renal cell carcinoma in a peer perspective accompanying an article by Tiffany Y. Shaw, MD, and colleagues.

A remarkable sea change has occurred over the past 3-plus years, as the results of 5 separate positive phase 3 studies have demonstrated superiority of immunotherapy-containing regimens over monotherapy with the anti-VEGF tyrosine kinase inhibitor (TKI) sunitinib (Sutent) in the first-line setting.

Neal D. Shore, MD, on the Importance of Multidisciplinary Care in Advanced Prostate Cancer

At the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, CancerNetwork spoke with Neal D. Shore, MD, FACS, regarding the importance of multidisciplinary care for patients with advanced prostate cancer.

Incorporating a multidisciplinary approach for patients with advanced prostate cancer is essential in order to provide patients with further therapeutic benefit and improve quality of life.

Friendly Competition Fosters Progress in Hematologic Malignancies

With options for transplant, chimeric antigen receptor T-cell therapy, tyrosine kinase inhibitors, and immunotherapy in most tumor types, appropriate therapy selection for a given patient is far from straightforward or standard.

To discuss this and emerging breakthroughs, Elias Jabbour, MD, a professor of medicine in the Department of Leukemia, Division of Cancer Medicine, at The University of Texas MD Anderson Cancer Center in Houston, reflected on his body of work and how competition among colleagues motivated his contributions to the field of medicine.

Stephen Liu, MD, on How Targeted Therapy Results in Significant Efficacy for RET-Altered Tumors

CancerNetwork sat down with Stephen Liu, MD, of the Georgetown Lombardi Comprehensive Cancer Center in Washington, DC, at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, to discuss what multidisciplinary providers can learn from outcomes of the phase 2 ARROW trial (NCT03037385) of pralsetinib in patients with RET fusionpositive nonsmall cell lung cancer.

For more updates from CancerNetwork, make sure to follow us on Facebook, Twitter, and LinkedIn to stay up to date on the latest in oncology.

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CancerNetwork's Week in Review: July 5th, 2021 - Cancer Network

American Gene Technologies is celebrating a milestone in its HIV Cure Program, which is currently in Phase 1 human trial. The first participant, an unidentified man.

ROCKVILLE, Md. At a biotechnology company in Rockville, Md., a team of molecular biologists is working to develop cures for cancer, HIV and a range of other diseases.

American Gene Technologies (AGT) is celebrating a milestone in its HIV Cure Program, which is currently in Phase 1 human trial. The first participant, an unidentified man, was treated in late May.

Now, the Food and Drug Administration (FDA) is reviewing the safety of AGTs new cell therapy product, AGT103-T, which is intended to cure HIV.

Were putting viruses in their bodies that are going to specific cells and that are making very, very specific changes in a targeted way, said American Gene Technologies CEO, Jeff Galvin.

The first patient was stellar, Galvin said. Initial safety data is cause to celebrate because what it says is that the process by which we are doing a cell modification for these patients seems to be showing safety.

Galvin is expecting a decision this month, from the Data Safety and Monitoring Board to find out if his team can move forward with treating additional patients.

Most drugs fall out of the development process because of adverse events, so in other words, the drug itself might work on the disease, but the problem may be, people cant tolerate the treatment itself.

With the FDAs approval, Galvin said his team took blood from a man with HIV, to extract his infected T-cells.

HIV is known for hijacking the bodys T-cells, which are cells that fight off some viral infections, thus, weakening the immune system.

Galvins team modified those extracted T-cells from the first participant, to make them resistant to HIV. The reprogrammed cells were infused back into the patient, which, if all goes as planned, would keep the virus from spreading.

We have learned so much about viruses, specifically about HIV, that we can now crack them open, scoop out their disease software, Galvin said. We are so excited at the company and we are trying to contain our excitement because the HIV community has been waiting for a cure for so long.

If AGT gets the green light to move forward with other patients this month, Galvin said, by years end, theyll take blood samples from those participants to see if the modified T-cells are healthy and working as intended. Galvin called it an efficacy signal that will be convincing to the scientific community that the cure for HIV has been achieved or is tremendously close.

This year, we may prove that a functional cure is possible and see the end of HIV in our lifetime, Galvin said.

From that point, and with additional approval from the FDA, researchers would ask some of the participants to stop taking their antiretroviral medication to see what happens to the virus in their bloodstream. After 21 days, Galvin said, theyd have clear indicators revealing the effectiveness of this treatment.

There have been promises of a cure since the first cases of what would later be known as HIV/AIDS.

The Centers for Disease Control and Prevention (CDC) published a report on June 5, 1981, describing a Pneumonia-like disease discovered in five previously healthy gay men in Los Angeles.

Since that study, millions of people have died from HIV/AIDS globally.

What was once a virtual death sentence, is now a manageable disease for some, because of the development of antiretroviral treatments.

In the immediate Washington metropolitan area, 26,824 people are living with HIV, including 39-year-old, Dr. Ravi Perry.

Ive lived far longer than I ever thought I would on the day I was diagnosed, Dr. Perry said. "I genuinely treat every day as a blessing. My immune system still is somewhat compromised. When I get a cold, my colds used to last for a day or two, now it may last four to six days. Your body has a slower response."

Dr. Perry was a junior in college when he was diagnosed on September 4, 2003. While antiretroviral medicines were available at the time, he said, some were too toxic. Dr. Perry was in the hospital consistently because his immune system was weakening and his mental state, waning.

"I certainly remember thinking that I would never be in a relationship, never thought that I would get married, never thought I would have sex again and thought that my life was on its way to its expiration date, Dr. Perry recalled.

For the last 15 years, Dr. Perry said, hes been undetectable.

Ive been able to live a mostly normal life, even with HIV. Its not something I expected to get, but I was 21 when I was diagnosed. Ive grown accustomed to telling that story because I think its important for younger people, Perry said.

As Chair of the Political Science Department at Howard University, Dr. Perry reminds students on campus about the seriousness of this virus. He also tells his story at local churches and community events.

My hope is that people realize the seriousness of HIV, but that people are living with HIV and not dying as much from AIDS anymore. The stigma associated with it, I think, certainly has no place in society, Dr. Perry added.

While Dr. Perry doesnt expect a cure to be developed in his lifetime, he said there are steps to take to eliminate HIV. First, with equal emphasis on prevention and intervention.

We seem to be focused on prevention because of course, most of the world is negative, Dr. Perry said. We all can be doing more to help ensure this disease doesnt ravage another generation. We can be donating our time to HIV/AIDS organizations. We can be lobbying the Red Cross to lift their ban on gay men not being allowed to give blood. We can be lobbying our congress members to eliminate these HIV criminalization laws that are abhorrent and from another era. We can of course in our own personal and private lives be ensuring we are having conversations with our nieces, our nephews, our cousins about HIV and sexual health."

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'We're in it to win it' | Maryland company progresses with development of HIV 'functional cure' - WUSA9.com