Category Archives: Cell Therapy

CARLSBAD, Calif.--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that it will report its second quarter 2022 financial and operating results on Thursday, August 11, 2022, following the close of the U.S. financial markets. Lineage management will also host a conference call and webcast on Thursday, August 11, 2022, at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss its second quarter 2022 financial and operating results and to provide a business update.

Interested parties may access the conference call by dialing (800) 715-9871 from the U.S. and Canada and (646) 307-1952 from elsewhere outside the U.S. and Canada and should request the Lineage Cell Therapeutics Call or provide conference ID number 6448886. A live webcast of the conference call will be available online in the Investors section of Lineages website. A replay of the webcast will be available on Lineages website for 30 days and a telephone replay will be available through August 18, 2022, by dialing (800) 770-2030 from the U.S. and Canada and entering conference ID number 6448886.

About Lineage Cell Therapeutics, Inc.

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineages programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineages clinical programs are in markets with billion dollar opportunities and include five allogeneic (off-the-shelf) product candidates: (i) OpRegen, a retinal pigment epithelial cell therapy in Phase 1/2a development for the treatment of geographic atrophy secondary to age-related macular degeneration, which is being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineages VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy, and (v) PNC1, a photoreceptor neural cell therapy for the treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit http://www.lineagecell.com or follow the company on Twitter @LineageCell.

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Lineage Cell Therapeutics to Report Second Quarter 2022 Financial Results and Provide Business Update on August 11, 2022 - Business Wire

`S-HERTOGENBOSCH, Netherlands--(BUSINESS WIRE)--Amphera B.V., a late-stage biotechnology company developing cell therapies to treat cancer, announces that the last patient has completed the active follow-up in the Phase II/III DENIM study of MesoPher cell therapy to treat pleural mesothelioma.

Ilona Enninga PhD, COO of Amphera said: Despite the challenges experienced during the pandemic, we were able to maintain strong enrolment to the study. The first patient was included in 2018, the last patient was included in June 2021 and completed the 12 month follow-up in June 2022. In total 176 patients were included. I would like to thank our investigators and the clinical study team for their exceptional efforts in keeping the study on track. We are now focused on database lock and subsequent statistical analysis.

Rob Meijer, CEO of Amphera said: This is another significant milestone in the development of MesoPher after the promising efficacy results in pancreatic cancer reported earlier this year. The DENIM study is designed to be pivotal following discussions with the regulators. We plan to report topline results early in Q4 2022. The results are expected to be the basis for an EMA Marketing Authorization Application in H1 2023, starting the process of bringing this new therapy to mesothelioma patients.

The DENIM (DENdritic cell Immunotherapy for Mesothelioma) study is a randomised open-label Phase II/III study of patients with pleural mesothelioma. The objectives are to assess the efficacy and anti-tumour activity of MesoPher as maintenance treatment after chemotherapy. Patients received 3 bi-weekly injections of MesoPher, plus two further injections of MesoPher after 4 and 7 months. Patients in the control arm received best supportive care alone. The primary endpoint of the study is overall survival.

In Q4 2022, Amphera will also present the survival data of the expansion cohort of 28 patients in the Phase II REACtiVe study of MesoPher in resected pancreatic cancer. The promising results of the first cohort were recently published in the European Journal of Cancer (https://www.ejcancer.com/article/S0959-8049(22)00159-9/fulltext).

Notes to Editors

About Amphera - http://www.amphera.nl

Amphera is a late-stage biotechnology company developing cell therapies to treat cancer. MesoPher is comprised of autologous dendritic cells loaded with PheraLys, a lysate of tumour cell lines. PheraLys contains a broad repertoire of tumour-associated antigens, many of which are present in pancreatic cancer and other cancers.

Five clinical programmes are ongoing with MesoPher. The lead programme DENIM is a pivotal phase II/III study in pleural mesothelioma a cancer of the lining of the lungs. The REACtiVe study is assessing MesoPher in resected pancreatic cancer. The REACtiVe-2 study assesses the safety and efficacy of a CD40 agonist in combination with MesoPher in patients with metastatic pancreatic cancer. In addition, MesoPher is investigated in abdominal mesothelioma and in pleural mesothelioma in combination with surgical resection. Amphera has obtained FDA and EMA orphan-designation for MesoPher for mesothelioma.

ENDS

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Last patient completed follow-up period in Phase II/III study of Amphera's MesoPher cell therapy in mesothelioma - Business Wire

The Food and Drug Administration (FDA) lifted its clinical hold on the phase 1b KEYNOTE-B79 clinical trial examining CYAD-101 plus FOLFOX chemotherapy (leucovorin, 5-fluorouracil and oxaliplatin) and then Keytruda (pembrolizumab) in patients with unresectable metastatic colorectal cancer with microsatellite stable/mismatch-repair proficient disease.

Celyad Oncology, the pharmaceutical company developing CYAD-101, originally paused the trial in February 2022 to investigate two deaths that occurred on the trial. Then in March, the FDA put a clinical hold on the trial, meaning that no new patients could be recruited and administered CYAD-101, and those already on the trial should not be administered the drug unless specified by the FDA.

Recently, Celyad made changes to who is eligible to participate in the trial, resulting in the FDA lifting the clinical hold.

Researchers on KEYNOTE-B79 are now enrolling patients with unresectable adenocarcinoma of the colon or rectum who have a confirmed non-microsatellite instability high and mismatch-repair proficient tumors. Patients must have measurable disease, that has progressed after one or more lines of systemic therapy, including FOLFOX, are due to receive FOLFOX and do not have major neurotoxicity from prior chemotherapy.

Eligible participants must also have an ECOG performance status of 0 or 1 (meaning that they are able to perform all or most of their daily tasks independently) and have adequate organ, lung and heart function.

Patients cannot enroll in the trial if: they received another investigational drug or device within four weeks of the first study treatment; received another anticancer drug within four weeks of the first study treatment; are currently taking filgrastim or similar growth factors within seven days of the first study treatment; have previously been treated with an antiPD-1, PD-L1, or PD-2 drug; undergo radiotherapy within two weeks of the first study treatment; or undergo major surgery within four weeks before the start of the study treatment.

CYAD-101 is a novel CAR-T cell therapy that uses cells from healthy donors, rather than the patients.

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FDA Lifts Hold on Novel CAR-T Cell Therapy for Colorectal Cancer - Curetoday.com

Avenge Bio expects to initiate a Phase 1 clinical trial in the second half of 2022 for patients with metastatic peritoneal cancers with an initial focus on platinum-resistant ovarian cancer

NATICK, Mass., Aug. 3, 2022 /PRNewswire/ -- Avenge Bio, Inc. ("Avenge Bio, "Avenge" or "the Company"), a biotechnology company developing the LOCOcyte immunotherapy platform for the precision administration of potent immune effector molecules to treat solid tumors, today announced that the Food and Drug Administration ("FDA") cleared the Investigational New Drug ("IND") application for AVB-001 in peritoneal malignancies.

The LOCOcyte platform leverages immunomodulators and biomaterials for a synergistic impact in a single, controlled, allogeneic cell therapy. AVB-001 is the first clinical implementation of the platform, encapsulating cells engineered to secrete native IL-2 in immune-activating alginate capsules. The first-in-human clinical trial is the intraperitoneal administration of AVB-001 for the treatment of platinum resistance ovarian cancer, a condition with very limited treatment options.

"We are very pleased to be advancing AVB-001 into the upcoming clinical trial as a potential treatment for patients with metastatic ovarian cancer, a life threatening disease. The FDA's clearance of our IND represents a significant milestone for Avenge and the first to be cleared leveraging the LOCOcyte technology platform," said Michael Heffernan, Chief Executive Officer of Avenge Bio.

"Ovarian cancer is one of the most difficult cancers to treat. It is typically not detected until later stages, and most patients will recur after an initial treatment, which is often fatal. As a clinician, I am looking forward to the potential impact for these patients. Patients with metastatic peritoneal cancer are uniquely positioned to benefit from this novel cellular therapy," added Dr. Claudio Dansky Ullmann, Avenge Bio's Chief Medical Officer.

The Phase 1, multi-center clinical trial is expected to be initiated in the second half of 2022 and will evaluate the tolerability of AVB-001, determine a recommended dose for Phase 2, measure immunological changes in the blood and peritoneal environment, and assess anti-tumor activity.

About LOCOcyte Platform

Our LOCOcyteallogeneic cell-based immunotherapy platform enables potent localized modulation of the immune system which also precipitates a systemic immune response, allowing us to treat previously intractable cancers. The technology leverage three unique advantages: (1) Potent immune effector molecules are generated by synthetically engineering allogeneic cells creating a ready-to-use therapy, (2) Therapy is localized in proximity to the primary tumor site and generates innate and adaptive immune response, and (3) The immunomodulator trains the patient's immune system generating a robust immune response that seeks and eradicates distal metastasis without systemic toxicity.

About Avenge Bio

Avenge Bio, Inc. ("Avenge") is an oncology-focused biotechnology company developing transformative cell-based immunotherapeutic products for the treatment of intractable solid tumors by incorporating its LOCOcyte platform. The LOCOcyte platform leverages proprietary engineered cells delivered to the local tumor environment that generate high concentrations of immune effector molecules in proximity to the tumor. This initiates a robust, local, and durable systemic immune response while avoiding toxicities associated with systemic immunotherapies. Avenge's most advanced product candidate, AVB-001, produces native IL-2 immunotherapy and is initially being studied in metastatic peritoneal cancers such as ovarian cancer. Avenge has additional pipeline candidates for the treatment of a wide range of cancers including pancreatic, lung and breast cancers. Avenge was founded in 2019 based upon technology developed in the laboratory of Omid Veiseh, Ph.D. and has an exclusive license from Rice University for this technology. To learn more about Avenge visit: http://www.avengebio.com and follow us on LinkedIn and Twitter.

SOURCE Avenge Bio, Inc.

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Avenge Bio Announces FDA Clearance of the AVB-001 IND for the Treatment of Ovarian Cancer, a Novel Cellular Therapy Leveraging the LOCOcyte...

China-based startup OriCell Therapeuticshas announced the completion of Series B financing totaling over $120 million. This round of financing was jointly led by Qiming Venture Partners and Quan Capital with participation by several leading international and Chinese investment funds, as well as existing shareholder C&D Emerging Capital.

The new funding will go toward the development of OriCell's cell therapy pipeline, and Company's proprietary discovery platform, as well as the construction of a manufacturing plant for both clinical and commercial purposes.

OriCell's Investigational New Drug (IND) submission for Ori-C101, company's first internally developed CAR-T product targeting GPC3 for the treatment of advanced liver cancer, was accepted by the National Medical Products Administration (NMPA) of China in June of this year. In data published at the 2021 American Society of Clinical Oncology (ASCO) annual meeting, Ori-C101 demonstrated superior safety and efficacy in patients with GPC3-positive advanced liver cancer with an objective response rate (ORR) of 44% and disease control rate (DCR) of 78%. The longest follow-up thus far is more than 22 months, with additional follow-ups ongoing.

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OriCell Therapeutics raises over $120 M to advance cell therapies for cancer immunology - BSA bureau

Iovance Biotherapeutics Inc

First Biologics License Application (BLA) Submission on Track in August 2022

SAN CARLOS, Calif., Aug. 04, 2022 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies (tumor infiltrating lymphocyte, TIL, and peripheral-blood lymphocyte, PBL), today reported second quarter and first half 2022 financial results and corporate updates.

Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive Officer of Iovance, stated, Iovance continues to solidify our global leadership across all three aspects of our mission to innovate, develop and deliver TIL therapy for patients with cancer. During the second quarter we executed toward our top priority, to submit the BLA for lifileucel in metastatic melanoma, while preparing for commercialization and advancing our robust immuno-oncology pipeline. Following our recent pre-BLA meeting in late July, we are finalizing our BLA to begin submission this month. With many opportunities to create significant value for cancer patients and our shareholders, Iovance is a true pioneer in the industry, driven by our experienced executive leadership team and talented organization with deep cell therapy experience.

Second Quarter 2022 Highlights and Recent Corporate Updates

Regulatory

Iovance TIL therapy (lifileucel) in metastatic melanoma (post-anti-PD-1): Iovance held a successful pre-BLA meeting with the U.S. Food and Drug Administration (FDA) inlate July 2022. The FDA provided favorable feedback on the clinical efficacy data from Cohorts 2 and 4 of the C-144-01 clinical trial, including duration of follow up, and the potency assay matrix. The FDA agreed the clinical and safety dataset was sufficient for BLA review. Iovance will commence a rolling BLA submission for lifileucel inmetastatic melanoma this month and complete the submission during the fourth quarter.

Clinical

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Iovance TIL therapy (LN-145) in second-line mNSCLC: Enrollment is ongoing at more than 30 active clinical sites in the U.S., Canada and Europe for the IOV-LUN-202 trial of LN-145 in patients with mNSCLC. Iovance is engaged in discussions with the FDA about the potential for IOV-LUN-202 to serve as a registrational trial for LN-145 in mNSCLC and intends to execute an updated regulatory strategy based on this dialogue and feedback.

First in human trial of genetically modified Iovance TIL therapy IOV-4001: site activation and patient recruitment are underway in the IOV-GM1-201 clinical trial of Iovances first genetically modified TIL therapy, IOV-4001, for the treatment of previously treated advanced melanoma or mNSCLC. IOV-4001 leverages the gene editing TALEN technology licensed from Cellectis to inactivate PD-1 expression.

Iovance TIL therapy (lifileucel) in advanced cervical cancer: Following FDA discussions and feedback on a registration strategy to address the shift in frontline standard of care, Iovance plans to reopen Cohort 2 of the ongoing C-145-04 trial to enroll additional patients who have received prior anti-PD-1 therapy. The expanded Cohort 2 is intended to support a BLA in cervical cancer following progression on chemotherapy and pembrolizumab.

Research Programs for Next-Generation TIL Therapies and Related Technologies

Several targets for genetic modification using the gene-editing TALEN technology, including double genetic knock-out programs, are advancing in preclinical development.

Additional research and preclinical studies include approaches to increase TIL potency using CD39/69 double negative TILs and gene knock-in targets as well as development of a novel interleukin-2 (IL-2) analog (IOV-3001).

Manufacturing

The Iovance Cell Therapy Center (iCTC) is currently operating flex suites for clinical manufacturing and core suites for BLA readiness activities.

Iovance is building capacity to treat thousands of cancer patients annually, with capacity at iCTC for 2,000+ patients and flexibility to expand existing shell space to supply 5,000+ patients per year.

Corporate

Iovance entered into an amendment to its license agreement with the National Institutes of Health (NIH) to include additional exclusive, worldwide patent rights to TIL products expressing IL-12, expanded rights to TIL selection technologies, and additional non-exclusive, worldwide patent rights to certain technologies related to enhancing TIL potency.

Cash position of $430.9 million at June 30, 2022 is expected to be sufficient into 2024.

Iovance currently owns more than 50 granted or allowed U.S. and international patents for TIL compositions and methods of treatment and manufacturing in a broad range of cancers, with Gen 2 patent rights expected to provide exclusivity into 2038. More information on Iovances patent portfolio can be found on the Intellectual Property page on http://www.iovance.com.

Second Quarter and First Half 2022 Financial Results

Iovance had$430.9 millionin cash, cash equivalents, investments and restricted cash at June 30, 2022, compared to$602.1 millionatDecember 31, 2021. The cash position is expected to be sufficient to fund current and planned operations into 2024.

Jean-Marc Bellemin, Chief Financial Officer of Iovance, said, As a late-stage oncology company approaching potential commercialization, we continue to maintain a strong balance sheet through prudent investments in commercial launch preparations, internal manufacturing and pipeline expansion. Our cash position is expected to take us through several milestones to create value for patients and shareholders.

Net loss for the second quarter ended June 30, 2022,was$99.3 million, or$0.63per share, compared to a net loss of$81.4 million, or $0.53 per share, for the second quarter endedJune 30, 2021.Net loss for the six months ended June 30, 2022, was $191.0 million, or $1.21 per share, compared to a net loss of $156.8 million, or $1.04 per share, for the same period ended June 30, 2021.

Research and development expenses were$73.4 millionfor the second quarter endedJune 30, 2022, an increase of$11.3 millioncompared to$62.1 millionfor the same period endedJune 30, 2021. Research and development expenses were $141.7 million for the six months ended June 30, 2022, an increase of $23.6 million compared to $118.1 million for the same period ended June 30, 2021.

The increases in research and development expenses in the second quarter and first half of 2022 over the prior year periods were primarily attributable to growth of the internal research and development team, including stock-based compensation expense, as well as facility-related and internal research program costs, which were partially offset by lower clinical and manufacturing costs driven by completion of enrollment of pivotal clinical trials.

General and administrative expenses were$26.3 millionfor the second quarter endedJune 30, 2022, an increase of$7.0 millioncompared to$19.3 millionfor the same period endedJune 30, 2021. General and administrative expenses were $49.7 million for the six months ended June 30, 2022, an increase of $10.8 million compared to $38.9 million for the same period ended June 30, 2021.

The increase in general and administrative expenses in the second quarter and first half of 2022 compared to the prior year periods were primarily attributable to growth of the internal general and administrative and commercial teams, including stock-based compensation expense, facility-related costs associated with the build out of the new corporate headquarters, as well as costs associated with pre-commercial activities.

For additional information, please see the Companys Selected Condensed Consolidated Balance Sheet and Statement of Operations below.

Webcast and Conference Call

To participate in the conference call, please register at https://register.vevent.com/register/BI25a798dba7074946a0aa3082d603bf41. The live and archived webcast can be accessed in the Investors section of the Companys website, IR.iovance.com. The archived webcast will also be available for one year.

AboutIovance Biotherapeutics, Inc.

Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) 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 Statements

Certain 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 inmetastatic 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.

IOVANCE BIOTHERAPEUTICS, INC. Selected Condensed Consolidated Balance Sheet Data(in thousands)

June 30, 2022(Unaudited)

December 31, 2021

Cash, cash equivalents, and investments

$

424,458

$

595,998

Restricted cash

$

6,430

$

6,084

Total assets

$

610,878

$

777,333

Stockholders' equity

$

472,690

$

621,659

IOVANCE BIOTHERAPEUTICS, INC. Condensed Consolidated Statements of Operations(unaudited, in thousands, except per share information)

For the Three Months Ended

For the Six Months Ended

June 30,

June 30,

2022

2021

2022

2021

Costs and expenses*

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Iovance Biotherapeutics Reports Second Quarter and First Half 2022 Financial Results and Corporate Updates - Yahoo Finance

EMERYVILLE, Calif., Aug. 4, 2022 /PRNewswire/ -- Berkeley Lights, Inc. (Nasdaq: BLI), a leader in digital cell biology, and the Jaime Leandro Foundation for Therapeutic Cancer Vaccines (JLF), today announced the discovery, functional characterization, and recovery of a patient-derived T cell receptor sequence against a cancer neoantigen.

(PRNewsfoto/Berkeley Lights)

Together, Berkeley Lights and JLF were able to measure and identify T cells that were reactive against peptides used in a cancer vaccine that was administered to a patient to successfully stimulate an immune response against their advanced-stage pancreatic cancer leading to complete remission. The patient was treated under the supervision of physicians at Washington University in St. Louis.

The unprecedented speed of these results relied on the Berkeley Lights Beacon system. Applying the cell therapy development workflow, thousands of phenotypic measurements of single T cells were performed within one week. These measurements identified T cells that were cytotoxic and capable of secreting cytokines in response to antigen encounter, which were therefore predicted to be functional and subsequently sequenced at a single cell level. Cloning these T cell receptor sequences and expressing them in nave T cells enabled functional validation against an antigen of interest. This function-first measurement capability of the Berkeley Lights platform is a significant differentiator compared to frequency-based assessments of TCRs which result in functional validation bottlenecks, adding to a growing number of highly differentiated service offerings at Berkeley Lights.

"This unique workflow combines Berkeley Lights' core strength of functional analysis of live cells, along with the use of the new Biofoundry services organization to help customers accelerate their therapeutic discoveries in a faster, more scalable way," said Siddhartha Kadia, Ph.D., chief executive officer of Berkeley Lights. "We look forward to continuing to work with JLF and their partners in evaluating immune response to cancer vaccines, mapping TCRs to neoantigens and ultimately supporting this important work to save patient lives."

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The JLF has the mission of providing personalized neoantigen cancer vaccines for appropriate patients who have advanced cancers and seek compassionate use treatment.

"The data is exceedingly clear that, together, we have successfully identified a functional, patient- and antigen-specific TCR validating both our treatment methodology and the Berkeley Lights technology for personalized cancer vaccines compared to conventional approaches," said William Hoos, president of the Jaime Leandro Foundation for Therapeutic Cancer Vaccines. "This is an exciting advancement in our mission."

From the clinical team, Dr. William Gillanders, professor of surgery at Washington University School of Medicine, commented:

"The Berkeley Lights technology can take immune monitoring to the next level by evaluating multiple quantitative measurements of live cell behavior and recover that cell for molecular characterization. This is going to be tremendously useful for the field by providing a much deeper dataset to further understand cancer vaccines and predict clinical outcomes as well as to serve the growing need of combination therapies where TCR-T can be utilized."

1Daniel A King, Amber R Smith, Gino Pineda, et al. Complete remission in a patient with widely metastatic HER2-amplified pancreatic adenocarcinoma following multimodal therapy informed by tumor sequencing and organoid profiling. medRxiv 2021.12.16.21267326; doi: https://doi.org/10.1101/2021.12.16.21267326

About Berkeley Lights

Berkeley Lights is a leading digital cell biology company focused on enabling and accelerating the rapid development and commercialization of biotherapeutics and other cell-based products for our customers. The Berkeley Lights Platform captures deep phenotypic, functional, and genotypic information for thousands of single cells in parallel and can also deliver the live biology customers desire in the form of the best cells. Our platform is a fully integrated, end-to-end solution, comprising proprietary consumables, including our OptoSelect chips and reagent kits, advanced automation systems, and application software. We developed the Berkeley Lights Platform to provide the most advanced environment for rapid functional characterization of single cells at scale, the goal of which is to establish an industry standard for our customers throughout their cell-based product value chain.

Berkeley Lights' Beacon and Lightning systems and Culture Station instrument are FOR RESEARCH USE ONLY. Not for use in diagnostic procedures.

Forward-Looking Statements

To the extent that statements contained in this press release are not descriptions of historical facts regarding Berkeley Lights or its products, they are forward-looking statements reflecting the current beliefs and expectations of management. Such forward-looking statements involve substantial known and unknown risks and uncertainties that relate to future events, and actual results and product performance could differ significantly from those expressed or implied by the forward-looking statements. Berkeley Lights undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties relating to the Company's growth and continual evolution see the statements in the "Risk Factors" sections, and elsewhere, in our filings with the U.S. Securities and Exchange Commission.

Cision

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Berkeley Lights and the Jaime Leandro Foundation Announce the Discovery, Functional Characterization, and Recovery of a Patient-Derived T cell...

NEW YORK Valo Therapeutics has reimagined oncolytic virus treatments by adding an exterior coating of tumor-specific peptides designed to stimulate an immune response against the tumor.

This enhancement, according the company, has opened development pathways for personalized therapy based on its PeptiCRAd technology.

PeptiCRAd uses electrostatic interactions to attach immunogenic peptides with a positively charged lysine tail to the negatively charged outside surface of a virus or bacteria. It was developed at the University of Helsinki, which spun out Valo in 2016.

The Finnish firm's lead product, PeptiCRAd-1, is an engineered adenovirus coated with NY-ESO-1 and MAGE-A3 tumor antigens genetically modified for increased tumor cell infection, high viral replication within the tumor, and increased immunogenicity. It also carries two co-stimulatory molecules as transgenes. One encodes a CD40 ligand to drive CD8+ T-cell responses. Another encodes an OX40 ligand for increased clonal expansion and survival of CD8+ T cells, and formation of a larger pool of memory T cells.

In nature, oncolytic viruses infect and kill cancer cells. Their potential as therapeutics has been harnessed through engineering of oncolytic viruses to have specific cancer-fighting properties. The US Food and Drug Administration approved Amgen's Imlygic (talimogene laherparepvec) for melanoma as the first oncolytic viral immunotherapy in 2015, and a number of others are in clinical trials, including some that use biomarker strategies and others in which oncolytic viruses are being combined with autologous CAR T-cell treatments.

Examples include a Phase I trial of the oncolytic virus Vaxinia (CF33-hNIS) and Merck's Keytruda (pembrolizumab) in metastatic solid tumors started by Imugene and City of Hope in May; and Phase I and Phase II trials by Vyriad of an attenuated measles virus and vesicular stomatitis virus alone and in combination with checkpoint inhibitors. The biomarker of interest in the City of Hope/Imugene and Vyriad trials is PD-L1 expression. Meanwhile, Mustang Bio is testing out an oncolytic virus with an autologous CAR T-cell therapy in brain cancer patients.

According to Valo CEO Paul Higham, what differentiates Valo's approach from others is the peptide coating, which gives the virus additional vaccine-like properties on top of the oncolytic effect of the virus. Because the peptides are attached weakly to the virus exterior by electrostatic charge rather than chemical bonds, they are released in the tumor environment, stimulating an immune response.

"Oncolytic viruses in the past stimulated a strong immune response. But most of that has been directed against the virus itself, not against the tumor," said Higham. "We're really shifting the focus of the immune system away from the virus and onto the tumor."

In preclinical research, the Helsinki-based company has shown that a PeptiCRAd virus targeting MAGE-A1 eradicated tumors in humanized mice with melanomas and increased the population of MAGE-A1-specific CD8+ T cells. "We've seen in our preclinical work, we have something close to a 90 percent response rate in the mice that we've treated," said Higham, adding that the effect is increased when a PeptiCRAd therapy is combined with checkpoint inhibitors.

Higham said Valo has also conducted experiments in which two identical tumors are grafted onto a mouse, one on the right side and one on the left, and PeptiCRAd therapy is injected into one of the tumors. Researchers observed an expected effect in the PeptiCRAd-injected tumor, but they also saw a "really strong effect" on the untreated tumor on the other side of the body.

"The only way you can really explain that is that we've stimulated the immune system in the right way and the relevant immune cells mainly T cells have gone throughout the mouse's body, identified that there's a tumor on the other side, and attacked that tumor," Higham said. Those results from mouse studies suggest that in humans this therapy could be active against metastases via a systemic immune reaction, even when only the primary tumor is treated.

Valo is hoping to see this effect in an upcoming Phase I clinical trial, in which it is combining PeptiCRAd-1 with Keytruda in 15 patients with melanoma, triple-negative breast cancer, and non-small cell lung cancer. Higham said patients in the study will receive four injections of PeptiCRAD-1 into their tumors followed by checkpoint inhibitor therapy "to take down any barrier there may be to T cells getting in and killing tumor cells." Researchers will measure changes in immune cells throughout the body indicating they are recognizing tumor antigens as well as patients' responses to therapy.

Valo, which is currently raising money for the study, has started recruiting patients at sites in Germany and expects to begin dosing patients before year end. The trial will report data before the end of 2023. "Within less than 18 months from now, we hope to have the full results of the study available," Higham said.

The company's acquisition of the PeptiCHIP platform from the University of Helsinki last month adds personalization capability to its development plans for its pipeline of PeptiCRAd therapies. PeptiCHIP combines microfluidic chip technology with a software algorithm to identify antigens from a tumor. Valo plans to develop individualized, n-of-1 therapies by using PeptiCHIP to test a patient's tumor for antigens and treating the patient with a PeptiCRAd therapy targeted to those antigens specifically.

That could happen in one of two ways. First, the company could create a bespoke therapy based on the patient's tumor antigen profile. A second option, Higham said, might be to create a library of the most common peptide antigens patients with a specific tumor type tend to have and cross-match an individual's PeptiCHIP analysis with that library to find an off-the-shelf PeptiCRAd therapy.

While a similar analysis using conventional methods might take two or three days, Higham said that Valo hopes to develop a method that will complete the tumor antigen analysis in two to three hours.

Toward that end, Higham said Valo's Phase I study would serve as proof of concept to show that the PeptiCRAd platform works. Once that's established, the company will expand into personalization strategies. That would put the start of clinical trials at least two years out, Highman estimated.

Another possibility being explored by Valo is repeating the antigen screening periodically during treatment and in follow-up in order to adapt the therapy to changes in the tumor, which often leads to loss of effectiveness of immunotherapies over time. "The targets we initially choose may not, six months or a year down the line, be the most relevant targets," said Higham. "We may have the adaptability to flex with the tumor as it changes."

While Valo is able to go after a variety of cancers with PeptiCRAd therapies, one limitation is that the tumor must be accessible to inject with a needle. Higham said that liver cancer and bladder cancer could be future areas of study for the company, but that with personalized therapy, the type of cancer "becomes a little bit irrelevant because we're treating individual tumors in a particular patient. If we can get biopsy sample from them, we can create a therapy."

Comparing a personalized PeptiCRAd therapy to autologous CAR T cell-therapy, which is also an n-of-1 treatment, Higham noted that adapting the therapy to changes in the tumor would require starting over, which would be expensive and time-consuming. "CAR T therapies can cost up to $400,000," Higham said. "Our therapy would be well below $100,000 because we're using a simpler, off-the-shelf oncolytic virus. That doesn't change. We just change the antigens."

In terms of regulation, Higham said the pathway for its Phase I PeptiCRAd product is "fairly straightforward." The company has permission from the German Regulatory Agency to proceed with its Phase I trial, and oncolytic viruses are an established mode of therapy. "The trickier thing is the adaptability we want to build in regarding the personalized therapy, and there may be a number of ways of doing that," Higham said.

That's where the use of a library may be helpful. "What we'd aim to do is have the peptides in the library approved by the regulatory authority so we're then free to select down from that library at any time and not have to seek individual regulatory approval for each patient or each therapy."

Because the peptide-coating technology is applicable to any oncolytic virus, Higham said that Valo is talking with other oncolytic virus companies about potential partnerships to apply the PeptiCRAd technology to their viruses. "It's a way our technology platform can [move] forward into Phase II and III studies very quickly, because we'd simply be enhancing what's already there," Higham said.

The firm is eyeing opportunities to work with companies developing checkpoint inhibitors or cell-based therapies, as PeptiCRAd therapies can potentially be combined with those, as well as with companies in need of a platform for validating neoantigens.

Continue reading here:
Valo Therapeutics Advancing Plans for Oncolytic Virus Treatments With Tailored Immunogenic Peptides - Precision Oncology News

Independent Testing Performed by Innovacell Demonstrates the DermaPrecise Control Leads to Unparalleled Post-Injection Cell Survival and Viability Consistency

VANCOUVER, BC / ACCESSWIRE / August 2, 2022 / RepliCel Life Sciences Inc. (OTC PINK:REPCF)(TSXV:RP)(FRA:P6P2) ("RepliCel" or the "Company"), a company developing next-generation technologies in aesthetics and orthopedics, announced today it has received test results showing that cells injected through the DermaPrecise Injector maintained >99% viability.

Innovacell, a cell therapy company headquartered in Tokyo, Japan with a manufacturing facility in Innsbruck, Austria, tested RepliCel's DermaPrecise Injection System to measure for loss of cells and/or cell viability when injected through the system. Study results showed consistent cell viability over 99% when cells were injected through the DermaPrecise Injection System. Equally important as it relates to clinical practice, cells remained viable in the device for up to 90 minutes after which cells injected through the DermaPrecise Injector still maintained >98% viability with a simple pre-injection "rotation" of the injector wand to reverse any sedimentation.

Alternative dermal injection systems are either manual - and thus inherently inconsistent - or involve injection forces which are harmful to cells. Traditional manual injection techniques do not control for injection variability in shear stress, depth, dose, speed, or injection force. All these factors are known to influence cell viability and have a likely impact on clinical outcomes and yet, surprisingly, remain uncontrolled in many clinical cell therapy studies.

The DermaPrecise is an electronically controlled dermal injector with highly precise, pre-fixed volume and depth parameters which dictate exact consistency of every injection. Additionally the DermaPrecise system is programmable to ensure injection delivery speed does not exceed the shear force harmful to cells after factoring in cell density, needle gauge, and patient tissue density. Furthermore, the DermaPrecise injects cells while the needle is being withdrawn, leaving the cells behind in the channel created by the needle, thus additionally reducing the amount of stress imposed upon injected cells.

Story continues

RepliCel Life Sciences, Inc., Tuesday, August 2, 2022, Press release picture

Given the system's control over injection depth, the injection can be optimized to deliver cells where they need to be to have an optimal clinical effect. DermaPrecise thus assists product developers and clinicians in controlling for delivery variability as an influence on clinical outcome variability.

"One of the things we've always believed about RepliCel's RCH-01 cell therapy, for example," stated R. Lee Buckler, President and CEO of RepliCel Life Sciences which has developed and owns all rights to the DermaPrecise product line, "is that it will be critical to optimizing the treatment outcome to consistently deliver the cells in the entire hair-thinning region of the scalp at the depths in which the hair follicle bulbs exist. What is exciting about the results of the recent study done at Monasterium Laboratory, when combined with the results of this Innovacell study, is that we are now clearly showing the ability to consistently inject a 100L volume using a 9-needle head in a 1cm2 array at 8mm maximum needle travel with the injection performed during needle withdrawal and, as per the image attached to this release demonstrates, ensure deposition in the mid-to-lower dermis and upper subcutaneous fat layer, at depths consistent with the location of hair follicle bulbs in androgenetic alopecia affected scalp. We believe this will be enormously valuable to our RCH-01 program by eliminating two important variables which are known to be linked to the success of clinical outcomes."

"The test results show that DermaPrecise has the potential to greatly improve consistent post-injection cell viability in the delivery of cells injected into dermal or subcutaneous tissue. Improved, controllable, consistent, validated cell-delivery tools are required to optimize cell therapy outcomes for patients and the companies developing these valuable therapies," stated Kevin McElwee, RepliCel's Chief Science Officer.

Study Design

RepliCel's non-bulbar dermal sheath (NBDS) cells (which form the basis of the Company's RCS-01 and RCS-01 products) were cultured and placed into a standard injection solution, injected through the DermaPrecise injector using the system's 9-needle consumable, cells were collected post-injection and stained, then processed through a flow cytometer to count the post-injection cell survival rate.

Market Demand for Controlled Delivery Systems

In a 2017 publication in the Nature Partner Journal, Regenerative Medicine*, authors from the University of Nottingham (UK) and University of Pittsburgh (PA, USA), stated:

"existing cell-delivery approaches have shown limited success, with numerous studies showing fewer than 5% of injected cells persisting at the site of injection within days of transplantation."

The authors, in exploring a variety of reasons for this loss of post-injection cell viability including variability in mechanical injection force used by manual injectors, the damage subjected to cells by shear force when injection pressures are too high, and a lack of focus on controlling for cell delivery protocols or technologies, concluded:

"There is a growing recognition that conventional needle-based cell transplantation tools have considerable inadequacies that may affect clinical translation."

"An integrated approach to the evaluation of cell-delivery success is needed to improve the assessment of delivery efficacy and to allow for sound interpretations of clinical results. Improved cell-delivery tools are also required to streamline the delivery of cell-based therapeutics from the donor to the patient without compromising quality. Finally, pre-clinical planning and testing of the desired administration protocol with cell-type specificity is essential to achieve good clinical trial design."

* Amer MH, Rose FRAJ, Shakesheff KM, Modo M, White LJ. Translational considerations in injectable cell-based therapeutics for neurological applications: concepts, progress and challenges. NPJ Regen Med. 2017 Aug 10;2:23. doi: 10.1038/s41536-017-0028-x. PMID: 29302358; PMCID: PMC5677964. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5677964/.

About Innovacell AG

Innovacell AG was founded in 2004 in Innsbruck, Austria and is, since 2021, a 100% subsidiary of Innovacell K.K. in Tokyo, Japan. Innovacell is a biotechnology company focused on developing, producing and marketing cell therapies for treating fecal and urinary incontinence. Innovacell has also developed technologies for isolating, multiplying, using and delivering muscle cells. Patents for these technologies have already been granted or their applications filed. Innovacell aims at marketing the products it has developed in the five key European countries (Germany, France, Italy, Spain and the United Kingdom) as well as in Japan and the USA. The goal is to become a global leader in the field of regenerative medicine with a focus on innovative, personalized cell therapies. Innovacell also performs select contract development and manufacturing services for clients such as RepliCel Life Sciences, Inc.

About the DermaPrecise Injector Product Line

The DermaPrecise Injector platform is an electronic injection system which will bring new levels of control over intra-dermal or subcutaneous injections where precision of depth, dose and/or delivery matters.

About RepliCel Life Sciences

RepliCel is a regenerative medicine company focused on developing cell therapies for aesthetic and orthopedic conditions affecting what the Company believes is approximately one in three people in industrialized nations, including aging/sun-damaged skin, pattern baldness, and chronic tendon degeneration. These conditions, often associated with aging, are caused by a deficit of healthy cells required for normal tissue healing and function. These cell therapy product candidates are based on RepliCel's innovative technology, utilizing cell populations isolated from a patient's healthy hair follicles.

The Company's cell therapy product pipeline is comprised of RCT-01 for tendon repair, RCS-01 for skin rejuvenation, and RCH-01 for hair restoration. RCH-01 has been the subject of successful safety and dose-finding clinical studies and is now the subject of its third clinical study evaluating efficacy for the treatment of male and female hair loss due to androgenetic alopecia. This ongoing study is being funded by Shiseido Company Limited pursuant to a license agreement which has now been terminated, but is the subject of an arbitration regarding Shiseido's rights to the product for Asia. RepliCel maintains the undisputed rights to RCH-01 for the rest of the world. RCT-01 and RCS-01 are exclusively licensed in Greater China to YOFOTO (China) Health Company. RepliCel and YOFOTO are currently co-developing these products in China. RepliCel maintains the rights to these products outside of Greater China.

RepliCel has also developed a proprietary injection device (DermaPrecise) and related consumables, which is expected to improve the administration of its cell therapy products and certain other injectables. YOFOTO has exclusively licensed the commercial rights for the DermaPrecise device and consumables in Greater China for dermatology applications and is expected to first launch the product in Hong Kong upon it being approved for market launch in either the United States or Europe. Please visit replicel.com for additional information.

Notable Facts:

RepliCel's three cell therapy products have now been tested in over 100 patients in four countries on three continents.

RepliCel now has key strategic regional partners each of which are now investing heavily in the further clinical testing and development of RepliCel's products for their markets. Data from each of the clinical programs will strengthen the product development initiatives for RepliCel and its other partners worldwide.

For more information, please contact:Lee Buckler, CEO and President604-248-8693info@replicel.com

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

SOURCE: RepliCel Life Sciences, Inc.

View source version on accesswire.com: https://www.accesswire.com/710326/DermaPreciseTM-Injection-System-Shown-to-Produce-Consistently-High-Cell-Count-and-Viability-for-Cell-Therapy-Injections

Original post:
DermaPrecise(TM) Injection System Shown to Produce Consistently High Cell Count and Viability for Cell Therapy Injections - Yahoo Finance

CASE SUMMARY

A 54-year-oldwoman presented with Revised International Staging System stage II multiple myeloma, based on evaluations that showed a hemoglobin level of 7.0 g/dL, 2-microglobulin of 6 mg/dl, albumin 3.2 g/dL, calcium 11.3 mg/dL, lactate dehydrogenase of 200 U/L, and creatinine clearance of 45 mL/min. Bone marrow showed 22% clonal plasma cells. Serum kappa free light chains were 24 mg/dL. She had no cytogenetic abnormalities and an ECOG performance score of 1. A PET/CT scan showed multiple bone lesions in the vertebrae. She had no extramedullary disease. She was diagnosed with IgG-kappa myeloma and was considered transplant eligible.

Daratumumab (Darzalex), bortezomib (Velcade), lenalidomide (Revlimid), and dexamethasone (Dara-VRd) induction therapy was initiated. She achieved a very good partial response (VGPR) post induction therapy. She underwent stem cell mobilization and 2 months later underwent autologous stem cell transplant (ASCT). Her post-ASCT response was a VGPR.

DISCUSSION QUESTIONS

CAITLIN COSTELLO, MD: This patient did get a quadruplet regimen with dara-VRd. She achieved a VGPR post-induction, had stem cells mobilized, underwent her transplant, and post-transplant her response is a VGPR. What would you do next?

THOMAS DEKKER, MD: Consolidation with CAR [chimeric antigen receptor] T-cell therapy.

COSTELLO: With CAR T cell, sure. Youre going for it; I like it. This patient is post-transplant, they have a VGPR. The GRIFFIN study [NCT02874742] would give these patients consolidation with dara-VRd.

PREETI CHAUDHARY, MD: I would not do CAR T-cell therapy.

COSTELLO: What would you do?

CHAUDHARY: In my opinion, in multiple myeloma, patients do a maximum of 11 months with CAR T-cell therapy. It has a good response, but I dont think thats sustainable.

COSTELLO: I appreciate throwing ideas out there. That is not something we have an option to do right now. Its an interesting option, and something we can talk about; but yes, I agree with you. I think for the meantime, short of trials that are looking at doing CAR T-cell therapyparticularly for those patients who have not had an adequate response to transplant or consolidation, or patients who relapse shortly after their transplantI think the standard of care as it stands now is doing consolidation or trying to find a maintenance regimen to get them to minimal residual disease [MRD] negativity.

With all that being said, what are we going to do now for these patients? Weve talked about what these transplant eligible patients are getting consolidation and maintenance; weve talked about maintenance approaches for these patients who get quadruplets, to put them on doublets. Seeing all those deep response rates, is anyone getting cold on transplants? If we are going to get 90% remission rates, does anyone reconsider the role of transplant here?

PAMELA MIEL, MD: I dont make that call, meaning I still send patients to the transplant doctors to see if theyre going to proceed with the transplant or not. But, if theyre transplant eligible, they get referred.

COSTELLO: As a transplanter, I thank you for that. We want to see these patients, make the decisions, have the discussion with the patients so we can look at their risk/benefit profile, and understand their responses to their current therapy. So, please still send them in their third cycle, if not earlier, so we can have those discussions and make plans.

There are a lot of maintenance regimens that are out there, and different things to choose from; a whole other conversation in and of itself. Lenalidomide is the mainstay where we have an overall survival benefit, where we dont have it in any other maintenance regimens.1 But it does allow for the option of continued doublets. I think we will soon see daratumumab and lenalidomide as a doublet get added on to that maintenance therapy once we have some of these randomized trials that are going on that show the continued benefit of patients to get daratumumab in the maintenance setting if they did not receive it in the up-front setting.

DISCUSSION QUESTION

How likely are you to change your practice with respect to management of transplant eligible newly diagnosed myeloma?

DEKKER: I already use quadruplet.

MILAN SHETH, MD: I feel that we still need a lot of long-term data to get a better sense of what it is that were achieving with the quadruplet therapy. Im still not convinced everybody needs quadruplet therapy. I think somebody else had already said that we know were going to get better responses because were using great drugs, but do we need to use everything up-front? I feel like theres still a lot of unanswered questions here.

MIEL: Ive been wanting to put patients on quadruplet treatment. I dont know if you know Nina Shah, MD, over at UC San Francisco, but Ive attended some of her talks, and shes pushing for the quadruplet treatment. The only thing that changed my mind was that when I spoke to the transplant doctor at UC San Diego, he said, If its not very high-risk disease, Id go with VRd [bortezomib, lenalidomide, and dexamethasone]. So, I put the patient on VRd. But I probably would want to put someone on dara-VRd, given the chance.

COSTELLO: Yes. I think that my takeaway from the data has been that we would, of course, love long-term data to come out, butwe have to wait a long time for it. While were waiting for some of these phase 3 studies to go on, which are happening now to look at real randomized data, to play out, I find that this is just too intriguing to not do quadruplets for everybody now.

Since [these data were presented at [the 2021 American Society of Hematology annual meeting], Ive transitioned just about everyone whos at least transplant eligible over to quadruplet regimens now.2 Any patients who are on the fence, where Im not sure if theyre going to be eligible for transplant, I still will try and give them the benefit of a quadruplet regimen, and very quickly drop the bortezomib if I get worried about them, and end up with dara-Vd [daratumumab, lenalidomide, dexamethasone]. But I think these MRD negativity rates are just too good, and if that is going to be the true surrogate end point that were all aiming for, dara-VRd has been my go-to for the last 6-plus months or so for these patients, until someone tells me otherwise.

References

1. Ho M, Zanwar S, Kapoor P, et al. The effect of duration of lenalidomide maintenance and outcomes of different salvage regimens in patients with multiple myeloma (MM).Blood Cancer J. 2021;11(9):158. doi:10.1038/s41408-021-00548-7

2. Laubach JP, Kaufman JL, Sborov DW, et al. Daratumumab (DARA) plus lenalidomide, bortezomib, and dexamethasone (RVd) in patients (pts) with transplant-eligible newly diagnosed multiple myeloma (NDMM): updated analysis of GRIFFIN after 24 months of maintenance. Blood. 2021;138(Suppl_1):79. doi:10.1182/blood-2021-149024

Excerpt from:
Treating Multiple Myeloma Following Quadruplet Induction Therapy and ASCT - Targeted Oncology