Category Archives: Cell Therapy

SALT LAKE CITY, Oct. 11, 2022 /PRNewswire/ --DiscGenics, Inc., a clinical stage biopharmaceutical company focused on developing regenerative cell-based therapies that alleviate pain and restore function in patients with degenerative diseases of the spine, today announced that Matthew F. Gornet, MD, Board Certified Spine Surgeon at The Orthopedic Center of St. Louis, will present two-year follow-up data from the Company's first-in-human clinical study of its allogeneic discogenic progenitor cell therapy (IDCT) for lumbar disc degeneration at the North American Spine Society (NASS) 37th Annual Meeting to be held October 12 15, 2022 at McCormick Place West in Chicago.

DiscGenics previously announced the primary efficacy endpoint of the study was achieved with statistically significant improvement in low back pain observed in the high dose IDCT group at the one-year timepoint. High dose IDCT also produced clinically meaningful, statistically significant improvements in function and quality of life by 12 weeks following intradiscal injection with durability sustained at the one-year interim readout.

Dr. Gornet will present final two-year clinical data for three key patient-reported outcome measures of pain, function, and quality of life, as well as MRI results across four study groups: low dose IDCT (n=20), high dose IDCT (n=20), vehicle (n=10) and saline placebo (n=10).

"We are thrilled to have Dr. Gornet, a world-renowned spine surgeon, present this data," said Kevin T. Foley, MD, Chief Medical Officer of DiscGenics and Chairman of Semmes-Murphey Neurologic & Spine Institute. "Dr. Gornet was the highest enroller in our study and provides tremendous perspective on the IDCT data given his years of surgical experience and clinical trial involvement in concert with SPIRITT Research in St. Louis."

The study is an FDA-approved, prospective, randomized, double-blinded, controlled, multicenter study designed to evaluate the safety and preliminary efficacy of IDCT for the treatment of symptomatic lumbar degenerative disc disease versus vehicle and saline controls. For more information on the study, visit: https://clinicaltrials.gov/ct2/show/NCT03347708.

Dr. Gornet's presentation will take place on Wednesday, October 12 at 1:06PM Central Time during the Lumbar Degenerative Pathology Abstract Presentations in Room W471ab.

DiscGenics is a sponsor of NASS 2022 and will host Booth# 5040 in the Exhibit Hall.

In attendance from DiscGenics will be Flagg Flanagan, Chief Executive Officer and Chairman, Dr. Kevin Foley, Chief Medical Officer, Bob Wynalek, Chief Operating and Commercial Officer, and Lindsey Saxon, Communications and Business Development.

About DiscGenics

DiscGenics is a privately held, clinical-stage biopharmaceutical company developing regenerative cell-based therapies that alleviate pain and restore function in patients with degenerative diseases of the spine. DiscGenics's first product candidate, IDCT (rebonuputemcel), is an allogeneic, injectable discogenic progenitor cell therapy for symptomatic, mild to moderate lumbar disc degeneration. IDCT is a mixture of live Discogenic Cells, which are a unique progenitor cell population derived from donated adult human intervertebral disc tissue, and a viscous carrier. As the only company in the world to develop an allogeneic cell therapy derived from intervertebral disc cells to treat diseases of the disc, DiscGenics has a unique opportunity to offer a non-surgical, potentially regenerative solution for the treatment of patients suffering from the debilitating effects of back pain. For more information, visit discgenics.com.

SOURCE DiscGenics, Inc.

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Two-Year Clinical Data for DiscGenics's Progenitor Cell Therapy for Lumbar Disc Degeneration to Be Presented at NASS 2022 - PR Newswire

Roughly 620,000 new cases of lymphoma were diagnosed worldwide, according to the World Cancer Research Fund International's 2020 report. Survival rates have improved as advances develop in treatment, such as chimeric antigen receptor-T cell therapy (CAR-T cell therapy).

CAR-T cell therapy is a personalized treatment giving hope to patients diagnosed with various lymphomas.

"Lymphoma in plain terms is essentially a cancer of your immune system," says Dr. Madiha Iqbal, a Mayo Clinic hematologist and oncologist.

Patients who are newly diagnosed with lymphoma are offered a combination of chemotherapy and antibody-based treatments. But for those who do not respond to two or more lines of such treatments, CAR-T cell therapy may be an option.

"Prior to the advent of CAR-T cell therapy, patients who had failed two lines of chemotherapy had a very poor survival of around six months," says Dr. Iqbal.

Receiving CAR-T cell therapy can take a few weeks as a patient's T cells, which normally help fight off infections, are collected and genetically engineered to target lymphoma.

After low-dose chemotherapy, the modified cells are infused back into the patient. These cells can then attack and destroy the lymphoma.

"Patients who had a very poor prognosis can now potentially be cured of their disease," says Dr. Iqbal.

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Mayo Clinic Minute: What is CAR-T cell therapy? - Finger Lakes Times

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Merck and Moderna are moving forward with a personalized cancer vaccine as Merckexercised its option to develop and commercialize mRNA-4157/V940, the companies announced Wednesday.

The option is based on an existing Collaboration and License Agreement originally inked in 2016 and amended in 2018.

The two companies will develop and commercialize mRNA-4157/V940 together. It is currently being tested by Moderna in a Phase II trial in combination with Mercks anti-PD-1 checkpoint inhibitor Keytruda (pembrolizumab) in the KEYNOTE-942 trial as adjuvant treatment for patients with high-risk melanoma. The trial has enrolled 157 patients.

After surgical resection, patients were randomized to receive 9 doses of the vaccine every three weeks and 200 mg of Keytruda or Keytruda alone every three weeks for about one year until disease recurrence or therapy-related toxicity forced them to stop.

Keytruda was chosen because it is the standard of care for this patient population. The primary endpoint is recurrence-free survival. Secondary endpoints include distant metastasis-free survival and overall survival. A data readout is expected before the end of the year.

PCVs are developed to stimulate the immune system so the patients own cells can create a specific antitumor response to their tumor mutation signature. mRNA-4157/V940 is engineered to stimulate an immune response by generating T-cell responses based on the patients mutational signature.

With data expected this quarter on PCV, we continue to be excited about the future and the impact mRNA can have as a new treatment paradigm in the management of cancer, stated Stephen Hoge, M.D., president of Moderna.

Under the deal, Merck will pay Moderna $250 million for the option. Merck will expense the payment in the third quarter of this year and include it in its non-GAAP financial results. The two companies will split costs and any profits equally under the global deal.

This long-term collaboration combining Mercks expertise in immuno-oncology with Modernas pioneering mRNA technology has yielded a novel tailored vaccine approach, stated Eliav Barr, M.D., SVP and head of global clinical development, CMO, Merck Research Laboratories.

Moderna vs. BioNTech

In April, John Haanen, M.D., Ph.D., of the Netherlands Cancer Institute (NCI) in Amsterdam, Netherlands, presented data from BioNTechs ongoing first-in-human Phase I/II trial of its own mRNA-based cancer vaccine. BNT211, a CAR-T cell therapy, is being investigated in patients with advanced solid tumors.

BNT211 consists of two drug products: an autologous CAR-T cell therapy targeting the oncofetal antigen Claudin-6 (CLDN6) and a CLDN6-encoding CAR-T cell amplifying RNA vaccine (CARVac). It uses BioNTechs mRNA-lipoplex technology, which is used in the COVID-19 vaccines developed with Pfizer. Tumor indications include testicular cancer, ovarian cancer, endometrial cancer, fallopian tube cancer, sarcoma and gastric cancer.

The trial data presented demonstrated 6 of 14 evaluable patients had a partial response, and 5 had stable disease with their target lesions shrinking. In addition to demonstrating overall target efficacy, the results were proof-of-concept of mRNA technology outside infectious diseases.

In addition to mRNA-4157/V940, Moderna also has a KRAS vaccine (mRNA-5671) and a checkpoint vaccine (mRNA-4359) along with others in the cancer space.

BioNTech and Regeneron Pharmaceuticals are collaborating on an mRNA vaccine for advanced melanoma, BNT111, which is in Phase II. Late last year, the FDA granted the vaccine fast-track designation based on available preclinical and clinical data showing the potential of BNT111 to overcome current limitations in the treatment of inoperable therapy-resistant advanced-stage melanoma.

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Merck and Moderna Move Forward with Personalized Cancer Vaccine - BioSpace

STATE COLLEGE, Pa., Oct. 12, 2022 /PRNewswire/ -- Gamma Biosciences, a leading provider of tools and technologies for cell and gene therapy manufacturing, through their BioMagnetic Solutions business,today announced a strategic collaboration with Lonza. Under the multi-year agreement, BioMagnetic Solutions will supply its proprietary research and cGMP manufacturing grade FerroSelect reagents to Lonza for use in developing CAR-T and other immunotherapeutic products using Lonza's Cocoon Platform.

"We are looking forward to working together with the team at Gamma Biosciences to offer cell and gene therapy developers added cell selection functionality on the Cocoon Platform" said Adam Bryan, Vice President of Personalized Medicines at Lonza. "The BioMagnetic Solutions ferrofluid technology provides efficient, high-performance cell selection reagents for research, clinical, and commercial-scale cell separations in a workflow that can be easily integrated into our automated, closed-system Cocoon manufacturing platform. This collaboration speaks to Lonza's commitment to expanding the flexibility and functionality of our automated manufacturing technology to address a broader range of needs for the cell therapy industry."

"We are thrilled to collaborate with Lonza in further developing and adapting FerroSelect reagents for use with the Cocoon Platform," said Phil Vanek, Chief Technology Officer at Gamma Biosciences. "The Lonza platform can be an alternative to our FerroSelectArray cell selection platform, demonstrating that our proprietary reagents can be applied to other automated manufacturing technologies. The agreement gives BioMagnetic Solutions technical direction on new applications, and access to some of the best process developers in the industry. In return, Lonza gains early access to certain BioMagnetic Solutions FerroSelect reagents to complement the growing demand for their Cocoon Platform technology."

Ted Liberti, Chief Commercial Officer at BioMagnetic Solutions concluded, "This is an exciting time for us. In late 2021, we achieved ISO 9001:2015 and 13485:2016 certification for our Quality Systems through NQA and have been working steadily to build out an extensive repertoire of cell specific antibodies. The alignment with Lonza helps both companies contribute to expanding access to therapeutic cell selection capabilities across the market with space to grow to meet evolving customer needs."

The collaboration between Gamma Biosciences and Lonza provides a framework for additional clinical grade reagents to be developed. It also opens up the possibility of other collaborations as Gamma Biosciences expands its portfolio of tools and technologies supporting the bioprocessing, vaccine, cell and gene therapy industries.

About BioMagnetic SolutionsBioMagnetic Solutions develops advanced ferrofluid-based immunomagnetic cell selection systems for clinical and commercial applications. BioMagnetic Solutions' product platform leverages proprietary magnetic ferrofluids thatenable superior performance as compared toexisting immunomagnetic cell separation systems. Visitwww.BioMagneticSolutions.comto register interest.

About Gamma BiosciencesGamma Biosciences is a leading life sciences company providing products and services to support the development and manufacturing of advanced biologic therapies. Our operating companies are committed to advancing the science and art of bioprocessing by delivering market-ready innovation and expertise that helps our customers. Gamma Biosciences encompass biopharmaceutical companies, contract developers and manufacturing companies. Our goal is to safely bring therapies to patients quickly and efficiently. Gamma is a global company with offices and major manufacturing facilities in North America, the U.K. and Belgium.

About LonzaLonza is the preferred global partner to the pharmaceutical, biotech and nutrition markets. We work to enable a healthier world by supporting our customers to deliver new and innovative medicines that help treat a wide range of diseases. We achieve this by combining technological insight with world-class manufacturing, scientific expertise and process excellence. Our unparalleled breadth of offerings enables our customers to commercialize their discoveries and innovations in the healthcare industry.

Founded in 1897 in the Swiss Alps, today, Lonza operates across five continents. With approximately 16,000 full-time employees, we comprise high-performing teams and individual talent that make a meaningful difference to our own business, as well as to the communities in which we operate. The company generated salesof CHF 5.4 billion with a CORE EBITDAof CHF 1.7 billion in Full-Year 2021. Find out more at http://www.lonza.com.

Follow @Lonza on LinkedInFollow @LonzaGroup on Twitter

SOURCE Gamma Biosciences

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Gamma Biosciences and Lonza Collaborate to Co-develop Reagents for Clinical Cell Selection in the Cocoon Platform USA - English - USA - English - PR...

The phase 1/2 clinical trial of MB-106 is demonstrating high efficacy, durable responses, and a favorable safety profile as the first patient treated did not experience cytokine release syndrome or immune effector cell-associated neurotoxicity syndrome

The first patient has been treated in the phase 1/2 clinical trial (NCT05360238) evaluating the safety and efficacy of MB-106 in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL) and chronic lymphocytic leukemia (CLL), according to Mustang Bio, Inc.1

MB-106 is a CD20-targeted, autologous chimeric antigen receptor (CAR) T-cell therapy. The agent, which was developed by researchers at the Fred Hutchinson Cancer Research Center (Fred Hutc), is a third-generation CAR derived from a fully human antibody.

The patient treated with MB-106 did not experience cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS), leading the ongoing clinical trial of MB-106 to continue to elicit high efficacy, durable responses, and a favorable safety profile across wide range of hematologic malignancies.

The first clinical trial under Mustangs investigational new drug application is an important milestone in the ongoing development and evaluation of MB-106. Data presented at several prestigious medical meetings earlier this year from the initial, ongoing phase 1/2 clinical trial at Fred Hutch show that MB-106 continues to demonstrate high efficacy and a favorable safety profile across patients with a wide range of hematologic malignancies, said Manuel Litchman, MD, president and chief executive officer of Mustang Bio, Inc, in the press release, We look forward to providing updates on our multicenter MB-106 clinical trial as it progresses and anticipate reporting efficacy data in the fourth quarter of this year.

The multicenter, open-label, non-randomized, phase 1/2 study aims to evaluate the safety, tolerability, and efficacy of MB-106 in patients with relapsed or refractory B-NHL or CLL.2 However, the study is open to patients with a variety of selected CD20-expressing malignancies, including follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), and mantle cell lymphoma (MCL).

Part 1 of the study will enroll approximately 287 patients with aggressive B-NHL, including DLBCL, and MCL, as well as patients with indolent NHL like FLL. Patients with CLL of small lymphocytic lymphoma (SLL) will also be evaluated in this portion of the trial.

The phase 1 part of the study will administer patients escalating doses of MB-106 in a 3 + 3 study design. The coprimary end points are the incidence of treatment-emergent adverse events (TEAEs) in patients with relapsed or refractory CD20-positive B-NHL or CLL and to determine the recommended phase 2 dose of the agent. Secondary end points for phase 1 are ORR, duration of response (DOR), and minimal residual disease (MRD) in patients with CLL.

In the phase 2 portion of the study, patients with relapsed/refractory DLBCL, including those with MYC, BCL2, BCL6 rearrangement and primary mediastinal large B-cell lymphoma or transformed FL will be enrolled. Patients with B-NHL subtypes that progressed after available therapy, including MCL, marginal zone lymphoma, Waldenstrom macroglobulinemia, Burkitt-like lymphoma, hairy cell leukemia, and CLL/SLL will also be included.

For phase 2, the primary end point of the study is ORR with the secondary end points of DOR, the incidence of TEAEs, and the total number of patients with MRD in CLL.

Patients aged 18 years and older are eligible to enroll in the trial if they have relapsed after treatment with CD19 CAR-T cell therapy, have an ECOG performance status of 0-1, a life expectancy of 16 weeks, meet all laboratory criteria, adequate pulmonary function, and have left ventricular ejection fraction 50%. Further, all patients must be capable of consenting to treatment and be able to follow the visit scheduled and other protocol requirements. Female patients of childbearing potential must provide a negative pregnancy test, and patients of all genders must agree to use contraception for the duration of study.

Interim data from the initial 28 patients treated in the ongoing multicenter, open-label, non-randomized, phase 1/2 clinical trial continue to support the use of MB-106 in B-NHLs and CLL.

Interim data as of September 9, 2022, show the agent to elicit an overall response rate (ORR) of 96% and complete response (CR) rate of 75% in heatologic malignancies, including follicular lymphoma, CLL, diffuse large B-cell lymphoma, and Waldenstrom macroglobulinemia

A total of 12 patients have experienced CR for more than 12 months with 10 ongoing and 4 patients have had a CR for more than 2 years. The longest CR currently seen in a patient in the trial is 33 months. Further, 6 patients had a partial response which improved to a CR. All of these patients remain in ongoing CR. Among the 3 patients previously treated with CD19 CAR T-cell therapy, all have responded to treatment with MB-106.

Regarding safety, MB-106 has shown a favorable safety profile as an outpatient therapy so far with no patients having grade 3 or higher CRS or ICANS. CAR T-cell persistence results in deepening responses following initial 28-day assessments.

Enrollment in this clinical trial of MB-106 is ongoing and data from the study is expected to be released at the end of 2022.

We are excited to broaden the evaluation of MB-106 with this multicenter clinical trial under Mustangs IND. To date, the data from the initial, ongoing clinical trial at Fred Hutch continue to demonstrate a high rate of complete and durable responses, said Mazyar Shadman, MD, MPH, study chair, associate professor and physician at Fred Hutch and University of Washington, in the press release. In addition, MB-106 has shown potential to treat patients in an outpatient setting and provide another immunotherapy option for patients treated previously with CD19-directed CAR T-cell therapy.

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First Patient With B-NHL or CLL Treated With MB-106 in Phase 1/2 Study - Targeted Oncology

MaxCyte, Inc

ROCKVILLE, Md., Oct. 12, 2022 (GLOBE NEWSWIRE) -- MaxCyte, Inc., (NASDAQ: MXCT; LSE: MXCT), a leading commercial cell-engineering company focused on providing enabling platform technologies to advance innovative cell-based research as well as next-generation cell therapeutic discovery, development and commercialization, today announced that it will release financial results for the third quarter of 2022 after the U.S. market close on Wednesday, November 9th, 2022. Company management will host a conference call to discuss financial results at 4:30 p.m. Eastern Time.

Conference Call DetailsInvestors interested in listening to the conference call are required to register online. It is recommended to register at least a day in advance. A live and archived webcast of the event will be available on the Events section of the MaxCyte website at https://investors.maxcyte.com/.

About MaxCyteMaxCyte is a leading commercial cell-engineering company focused on providing enabling platform technologies to advance innovative cell-based research as well as next-generation cell therapeutic discovery, development and commercialization. Over the past 20years, we have developed and commercialized our proprietary Flow Electroporation platform, which facilitates complex engineering of a wide variety of cells.Our ExPERT platform, which is based on our Flow Electroporation technology, has been designed to support the rapidly expanding cell therapy market and can be utilized across the continuum of the high-growth cell therapy sector, from discovery and development through commercialization of next-generation, cell-based medicines. The ExPERT family of products includes: four instruments, the ATx, STx GTx and VLx; a portfolio of proprietary related processing assemblies or disposables; and software protocols, all supported by a robust worldwide intellectual property portfolio.

MaxCyte Contacts:

US IR AdviserGilmartin GroupDavid Deuchler, CFA+1 415-937-5400ir@maxcyte.com

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Nominated Adviser and Joint Corporate BrokerPanmure GordonEmma Earl / Freddy CrossleyCorporate BrokingRupert Dearden+44 (0)20 7886 2500

UK IR AdviserConsilium Strategic CommunicationsMary-Jane Elliott / Chris Welsh+44 (0)203 709 5700maxcyte@consilium-comms.com

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MaxCyte to Report Third Quarter 2022 Financial Results on November 9, 2022 - Yahoo Finance

First Genetically Modified (TALEN-edited) Iovance TIL Therapy with Inactivated PD-1 Expression

SAN CARLOS, Calif., Oct. 10, 2022 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, announced that the first patient was dosed, and completed the safety observation period, in the IOV-GM1-201 trial of Iovances genetically modified, PD-1 inactivated TIL therapy, IOV-4001. IOV-GM1-201 is a Phase 1/2, first-in-human study investigating the safety and efficacy of IOV-4001 in patients with previously treated metastatic non-small cell lung cancer (NSCLC) or advanced melanoma.

Friedrich Graf Finckenstein, M.D., Chief Medical Officer of Iovance, stated, Dosing the first patient with IOV-4001 is an important first step in providing proof-of-concept for delivering genetically modified TIL therapy to solid tumor patients with significant unmet needs and few treatment options. We look forward to dosing the next patient. This trial may also support our broader platform of genetically modified Iovance TIL therapies to potentially address difficult-to-treat solid tumor cancers.

To inactivate the gene coding for the PD-1 protein, IOV-4001 utilizes the gene-editing TALEN technology licensed from Cellectis (Euronext Growth: ALCLS - NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene-editing platform to develop potentially life-saving cell and gene therapies. This single genetic modification in IOV-4001 may enhance the antitumor activity of the TIL mechanism to directly target and kill tumor cells.

Jason Chesney, M.D., Ph.D.,Director and Endowed Professor, UofL Health Brown Cancer Center, University of Louisville, and an IOV-GM1-201 principal investigator, stated, I am excited about the potential for gene-editing to open new doors for TIL therapy in patients with solid tumor cancers that do not respond well to current treatment options. As the first multicenter clinical trial to investigate a genetically modified TIL therapy, the IOV-GM1-201 trial may pave the way for a promising new treatment approach to cancer.

PD-1 is a checkpoint protein found on T cells that normally acts as an off switch to help to prevent T cells from attacking other cells in the body. It works by binding to PD-L1, a protein found on both normal and cancerous cells, thereby shutting down an attack by a T cell. As a TIL therapy that is genetically modified to remove this important barrier for T cells to attack cancer, IOV-4001 has the potential to become an optimized, next generation TIL therapy for several solid tumor cancers. A poster on preclinical data was presented at the American Association for Cancer Research (AACR) 2022 Annual Meeting.

IOV-GM1-201 is actively enrolling adult participants with advanced NSCLC or unresectable or metastatic melanoma. For more information, eligibility criteria, and trial locations, please visit http://www.clinicaltrials.gov (NCT05361174) or contact clinical.inquiries@iovance.com.

AboutIovance Biotherapeutics, Inc.Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) cell therapies for patients with cancer. We are pioneering a transformational approach to cure cancer by harnessing the human immune systems ability to recognize and destroy diverse cancer cells in each patient. Our lead late-stage TIL product candidate, lifileucel for metastatic melanoma, has the potential to become the first approved one-time cell therapy for a solid tumor cancer. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, that may extend and improve life for patients with cancer. For more information, please visit http://www.iovance.com.

Forward-Looking StatementsCertain matters discussed in this press release are forward-looking statements of Iovance Biotherapeutics, Inc. (hereinafter referred to as the Company, we, us, or our) within the meaning of the Private Securities Litigation Reform Act of 1995 (the PSLRA). All such written or oral statements made in this press release, other than statements of historical fact, are forward-looking statements and are intended to be covered by the safe harbor for forward-looking statements provided by the PSLRA. Without limiting the foregoing, we may, in some cases, use terms such as predicts, believes, potential, continue, estimates, anticipates, expects, plans, intends, forecast, guidance, outlook, may, could, might, will, should or other words that convey uncertainty of future events or outcomes and are intended to identify forward-looking statements. Forward-looking statements are based on assumptions and assessments made in light of managements experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and we undertake no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and other factors, many of which are outside of our control, that may cause actual results, levels of activity, performance, achievements and developments to be materially different from those expressed in or implied by these forward-looking statements. Important factors that could cause actual results, developments and business decisions to differ materially from forward-looking statements are described in the sections titled "Risk Factors" in our filings with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, and include, but are not limited to, the following substantial known and unknown risks and uncertainties inherent in our business: the effects of the COVID-19 pandemic; risks related to the timing of and our ability to successfully develop, submit, obtain and maintain U.S. Food and Drug Administration (FDA) or other regulatory authority approval of, or other action with respect to, our product candidates, and our ability to successfully commercialize any product candidates for which we obtain FDA approval; whether clinical trial results from our pivotal studies and cohorts may support registration and approval by the FDA; preliminary and interim clinical results, which may include efficacy and safety results, from ongoing clinical trials or cohorts may not be reflected in the final analyses of our ongoing clinical trials or subgroups within these trials or in other prior trials or cohorts; the risk that enrollment may need to be adjusted for our trials and cohorts within those trials based on FDA and other regulatory agency input; the changing landscape of care for cervical cancer patients may impact our clinical trials in this indication; the risk that we may be required to conduct additional clinical trials or modify ongoing or future clinical trials based on feedback from the FDA or other regulatory authorities; the risk that our interpretation of the results of our clinical trials or communications with the FDA may differ from the interpretation of such results or communications by the FDA (including from the recent pre-BLA meeting with the FDA); the risk that the rolling BLA submission for lifileucel in metastatic melanoma may take longer than expected; the acceptance by the market of our product candidates and their potential reimbursement by payors, if approved; our ability or inability to manufacture our therapies using third party manufacturers or our own facility may adversely affect our potential commercial launch; the results of clinical trials with collaborators using different manufacturing processes may not be reflected in our sponsored trials; the risk that unanticipated expenses may decrease our estimated cash balances and forecasts and increase our estimated capital requirements; and other factors, including general economic conditions and regulatory developments, not within our control.

CONTACTS

Iovance Biotherapeutics, Inc:Sara Pellegrino, IRCSenior Vice President, Investor Relations & Corporate Communications650-260-7120 ext. 264Sara.Pellegrino@iovance.com

Jen SaundersDirector, Investor Relations & Public Relations267-485-3119Jen.Saunders@iovance.com

TALEN is a trademark owned by Cellectis

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Iovance Biotherapeutics Announces First Patient Dosed with PD-1 Inactivated Tumor Infiltrating Lymphocyte (TIL) Therapy - GlobeNewswire

Gothenburg, October 12, 2022 - Elicera Therapeutics AB (publ) ("Elicera"), a clinical stage cell and gene therapy company developing next generation immuno-oncological treatments based on enhanced oncolytic viruses and CAR T-cells, today announced that the PhD thesis of the company's co-worker Jing Ma was awarded the best Swedish PhD thesis of the year within the field of gene and cell therapy for 2021 by the Swedish Society for Gene and Cell Therapy (SSGCT).

Jing Ma's PhD thesis describes the development of Elicera's iTANK-platform and the upcoming CAR T-cell study in treatment of B-cell lymphoma. Jing Ma was invited to present her work at the SSGCT board meeting on October 11, 2022.

Jing Ma was supervised by Elicera Therapeutic's co-founder, Associate Professor Di Yu.

For further information please contact:

Jamal El-Mosleh, CEO, Elicera Therapeutics AB

Phone: +46 (0) 703 31 90 51 jamal.elmosleh@elicera.com

About the iTANK platform

The iTANK- (immunoTherapies Activated with NAP for efficient Killing) platform is the company's own fully developed technology platform for arming and enhancing CAR T-cells to meet two of the major challenges CAR T-cell therapies face in the treatment of solid tumors: tumor antigen heterogeneity and a hostile tumor microenivornment. The technology is used to incorporate a transgene into CAR T-cells encoding a neutrophil activating protein (NAP) from the bacterium Helicobacter pylori. Upon activation, NAP secreted from the CAR(NAP) T-cells has been shown to be able to enhance the function of the CAR T-cell in addition to activating a parallel immune response via CD8+ killer T-cells. This is expected to lead to a broad attack against most antigen targets on cancer cells. The iTANK-platform is used to enhance the company's own CAR T-cells but can also be universally applied to other CAR T-cell therapies under development. More information about iTANK-platform is available here: https://www.elicera.com/technology

About Elicera Therapeutics AB

Elicera Therapeutics AB is a clinical stage cell and gene therapy company that develops next generation immuno-oncology treatments based on enhanced oncolytic viruses and CAR T-cells. The work is based on high-profile long-standing research conducted by Professor Magnus Essand's research group at Uppsala University and has resulted in the development of four drug candidates, including two CAR T-cells and two oncolytic viruses. In addition, Elicera has developed a technology platform called iTANK that can be used to optimize all CAR T-cells in development and activate killer T-cells against cancer. The company's share (ELIC) is traded on Nasdaq First North Growth Market. G&W Fondkommission has been appointed the Company's Certified Adviser. E-mail: ca@gwkapital.se, tel: +468-503 000 50.

For more information, please visit http://www.elicera.com

https://news.cision.com/elicera-therapeutics/r/elicera-therapeutics--phd-thesis-describing-the-itank-platform-awarded-best-of-the-year-2021-in-swed,c3646903

https://mb.cision.com/Main/20218/3646903/1637620.pdf

(c) 2022 Cision. All rights reserved., source Press Releases - English

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Elicera Therapeutics: PhD thesis describing the iTANK-platform awarded best of the year 2021 in Sweden in the field of gene and cell therapy -...

CAR-T cell therapy is an individualized cell-based technique that involves removing some of your own white blood cells, including T cells. To make CAR-T cells, the collected T cells are genetically treated in the lab to produce special receptors called chimeric antigen receptors, or CARs. These CARs allow the T cells to recognize an antigen (or marker) at the surface of cancer cells and activate T cells' ability to kill these cancer cells. The CAR-T cells are infused back into your body to identify and destroy certain cancers. This immunotherapy is one of the most promising areas of cancer treatment.

The FDA-approved conditions for CAR-T cell therapy include:

People who have relapsed or refractory disease may be eligible for CAR-T cell therapy.

Most people have a reaction to CAR-T cells that requires them to stay in the hospital for days to weeks for monitoring and management. Typically, the reaction happens within hours to days after the infusion. Side effects may include:

Side effects are generally reversible. Your care team will talk with you about how to monitor for reactions. The long-term toxicity of CAR-T cell therapy is still being studied. Talk with your doctor about the potential risks of treatment.

Feb. 19, 2022

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About CAR-T cell therapy - Mayo Clinic

In an interview with Targeted Oncology, Peter A. McSweeney discussed the ways in which community oncology centers are implementing chimeric antigen receptor T-cell therapy into their practice and the challenges that come with it.

Community oncology practices come in all shapes and sizes with larger centers often having more resources to provide patients with. The same goes for chimeric antigen receptor (CAR) T-cell therapies and their availability in larger oncology centers vs the smaller ones.

There is anincreasing use of CAR T-cell therapies being seen as they make an entrance as a potential second-line therapy in different patient populations.

According to Peter A. McSweeney, MD, the larger community oncology centers typically can administer CAR T-cell therapy the same way or similarly to how it is done in academic centers. However, in smaller community practices, the resources for administering CAR T-cell therapy are not always available, and usually requires a referral to an academic center.

McSweeney also notes that administering CAR T cells in the community setting can be challenging as oncologists need the proper expertise and infrastructure to do so properly.

The biggest challenges for administering these CAR T cells in the community are developing a program that has the appropriate expertise and infrastructure for this type of work. It's a very multifaceted type of therapy that draws on inpatient and outpatient arrangements that meet the needs of the patients. Also, there is a need for subspecialty support in the hospital for patients who have complications with the therapy, stated McSweeney, hematologist/oncologist at the Colorado Blood Cancer Institute, in an interview with Targeted OncologyTM.

In the interview, McSweeney discussed the ways in which community oncology centers are implementing CAR T-cell therapy into their practice and the challenges that come with it.

Targeted Oncology: How are community practices handling the logistics of administering CAR T-cell therapies and the RMS requirements associated with CAR T use?

McSweeney: Community practices come in different types. There are some quite large community malignancy programs, which are clinically the equivalent of academic centers. They handle all this pretty much according to the same algorithms as the academic centers. The issue of smaller oncology practices in this area is not an issue right now. Theres been very little penetration of CAR T-cell therapy, and these types of cellular therapies to those practices, although they are subtly showing interest in trying to develop capability.

What are the biggest challenges with administering CAR T-cell therapy in community practices?

The biggest challenge for administering these CAR T cells in the community is developing a program that has the appropriate expertise and infrastructure for this type of work. It's a very multifaceted type of therapy, it draws on inpatient and outpatient arrangements that meet the needs of the patients, and there is a need for subspecialty support in the hospital for patients who have complications with the therapy.

Now that CAR T cells are entering the second-line for some cancers, how does this change how community practices may choose treatments for patients?

What I think is very important for second-line therapy is that the community practice is aware of these changes because patients are now moving into this as the therapy at first relapse, or at least incorporate this into the treatment strategy at first relapse, so one needs to know this. In some instances, the timing of therapy and the urgency of referral is a big issue. The physicians in the community who are not administering this therapy need to be aware and get the patient referred quickly to the appropriate places, particularly for diseases like diffuse large B-cell lymphoma in initial relapse or that is resistant to primary therapy.

What is your advice on when to give CAR T-cell therapy in a second-line setting?

The administration of CAR T-cell therapy in the second-line is disease dependent. It is indicated now for either initial resistance of diffuse large B-cell lymphoma or relapse diffuse large B-cell lymphoma in the first year after treatment. That is the aggressive B cell lymphomas. That's the main setting for second-line therapy. It can also be employed in B-cell acute lymphoblastic leukemia, mantle cell lymphoma, and select patients in the second-line.

How are community practices addressing and/or preventing toxicities seen with CAR T cells or bispecific antibodies?

The use of CAR T cells and bi-specific molecules can generate cytokine release syndrome and neurotoxicity, which are unique side effects that are not generally encountered in the general oncology setting. These are sort of specialized problems. There are some community hematologic malignancy programs that deal with these routinely. But in general, these are not going to be in the domain of the general oncologist.

When would you recommend referring a patient to an academic center for CAR T administration or to manage the toxicities for CAR T cells?

I think the academic centers play a big role in this. There are other very well-developed malignancy centers that provide equivalent sort of services. But if you're a general oncologist, you must be referring patients with the appropriate diseases to those centers. You are not going to try to take this on yourself. A lot of the toxicities that have to do with CAR T-cells and bispecifics are closely related to their administration, so they're not really falling under the jurisdiction of the general oncologist. There are late adverse events however, that remain for general oncologists as patients transition back to these doctors.

How comfortable are community practices when it comes to administering therapies like CAR T Cells and bispecific antibodies?

Community practices will only be comfortable administering these types of therapies if they have the appropriate infrastructure and have physicians who are experienced with managing them. For community oncologists or oncology networks, to think about managing these patients, they have to drill down on what they need to put in place. They're not going to be at all comfortable trying to manage these patients until I've tackled that issue.

Excerpt from:
Integrating CAR T-Cell Therapy Into Community Oncology Practices - Targeted Oncology