On May 5, 2022 SQZ Biotechnologies (NYSE: SQZ) reported that the company will present data from the first non-clinical studies of its point-of-care (POC) manufacturing system at the 2022 American Society for Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting on May 18 (Press release, SQZ Biotech, MAY 5, 2022, View Source [SID1234613703]). The data will demonstrate an ability to produce SQZ cell therapy candidates with comparable or improved performance relative to conventional clean room manufacturing processes. In addition, SQZ announced a collaboration with STEMCELL Technologies to co-develop and commercialize a research-use-only (RUO) microfluidic intracellular delivery system. The new RUO system will be based on SQZ’s Cell Squeeze technology and will offer the life sciences community access to a unique cell engineering capability to advance preclinical research. These activities support SQZ’s mission to unlock the full potential of cell therapies for multiple therapeutic areas.

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"SQZ’s vision is to improve patient care by creating transformative cell therapies that can be broadly accessible around the world through rapid, cost-efficient manufacturing," said Armon Sharei, Ph.D., CEO and Founder at SQZ Biotechnologies. "We are advancing these important goals through the development of our POC manufacturing system, which has the potential to substantially improve the accessibility and economic feasibility of cell therapies. Through our collaboration with STEMCELL, we intend to broaden technology access for research use and hope to facilitate advancement of the cell therapy field by the life sciences community."

"This is an exciting collaboration that combines STEMCELL’s life sciences research and product development capabilities with SQZ’s cell engineering expertise," said Allen Eaves, M.D., Ph.D., President and CEO of STEMCELL Technologies. "The development of this RUO system, which will be well complemented by our various cell isolation and culture product portfolios, will provide the research community with a significant opportunity for their cell engineering investigations. By adapting the proven Cell Squeeze technology, with its ability to deliver multiple biological cargoes to a range of cell types, we anticipate the RUO system will offer enhanced flexibility to the scientific community. We look forward to our continued collaboration with SQZ and the development of this system."

SQZ’s Cell Squeeze technology has enabled the development of three oncology therapeutic candidates in active Phase 1/2 clinical trials. In addition to these programs, the company intends to file its first IND using the POC system for a SQZ TAC clinical candidate against celiac disease in the first half of 2023. The Cell Squeeze technology has also led to a number of preclinical developments in the areas of infectious disease and cell regeneration.

SQZ’s automated POC manufacturing system in development integrates, among other things, cell isolation, cell washing, intracellular delivery, and product filling. The system is designed to process patient material within a closed, single-use sterile disposable kit. The prototype system offers the potential to be operated outside of a clean room—which could ultimately allow decentralized cell therapy manufacturing by SQZ POC systems in a variety of care settings. SQZ will present data from the initial non-clinical studies of the POC system at ASGCT (Free ASGCT Whitepaper).

STEMCELL Technologies will present data from the first functional study findings for the RUO system at the ASGCT (Free ASGCT Whitepaper) Annual Meeting. The data will demonstrate an ability to efficiently deliver cargoes to primary immune cell types. SQZ will also present new cell engineering data in hematopoietic stem cells using mRNA and CRISPR/Cas9 at the meeting.

ASGCT PRESENTATION TITLES AND TIMING

SQZ Point-of-Care Manufacturing Presentation
Title: A Decentralized and Integrated Manufacturing System for the Rapid and Cost-Effective Production of Cell Therapy Drug Products
SQZ Presenter: Maisam Dadgar
Session Title: Cell Therapy Product Engineering, Development or Manufacturing
Abstract Number: 1171
Date & Time: Wednesday, May 18, 2022, from 5:30-6:30 PM

STEMCELL TECHNOLOGIES Immune Cell Engineering Research Poster Presentation
Title: A New Benchtop System for Simple and Versatile Introduction of Macromolecules into Human Lymphocytes by Microfluidic Squeezing
STEMCELL Presenter: Eric Ouellet, Ph.D.
Session Title: Synthetic/Molecular Conjugates and Physical Methods for Delivery II
Abstract Number: 997
Date & Time: Wednesday, May 18, 2022, from 5:30-6:30 PM

SQZ Hematopoietic Stem Cell Research
Title: Rapid, Gentle, and Scalable Engineering of Hematopoietic Stem Cells Using Vector-Free Microfluidic Cell Squeeze Technology
SQZ Presenter: Murillo Silva, Ph.D.
Session Title: Cell Therapy Product Engineering, Development or Manufacturing
Abstract Number: 1176
Date & Time: Wednesday, May 18, 2022, from 5:30-6:30 PM

On May 5, 2022 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing first-in-class allogeneic gamma delta chimeric antigen receptor (CAR) T cell therapies for cancer, reported data from a preclinical evaluation of ADI-001 at the International Society for Cell and Gene Therapy (ISCT) Annual Meeting taking place in San Francisco, May 4-7, 2022 (Press release, Adicet Bio, MAY 5, 2022, View Source [SID1234613702]). ADI-001 is currently being evaluated in an ongoing dose escalation Phase 1 study evaluating the safety and tolerability of ADI-001 for the potential treatment of relapsed or refractory B-cell Non-Hodgkin’s lymphoma (NHL).

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The extensive preclinical evaluation reported at ISCT observed that ADI-001 exhibited a predominantly naïve-like T cell memory phenotype, expressed multiple chemokine and innate-activating cell receptors and exhibited robust in vitro and in vivo tumor growth inhibition against multiple human lymphoma cell lines, with adaptive and innate activation pathways contributing to the anti-tumor activity of ADI-001.

Susceptibility to host versus graft targeting was also evaluated using mixed-lymphocyte reactions incorporating up to 13 different allogeneic lymphocyte samples. Non-gene-edited ADI-001 gamma delta CAR T cells demonstrated high levels of endogenous HLA-E expression in the unmodified state and were associated with superior resilience to lymphocyte-mediated clearance when compared to approaches commonly deployed in gene-edited allogeneic cell therapy platforms (β2MKO with or without HLA-E overexpression).

"In this first view comparing Adicet’s non-gene-edited gamma delta CAR T cells to alternative and popularly-reported gene editing strategies, we appreciate the lower preclinical susceptibility to host versus graft targeting demonstrated by non-gene-edited ADI-001," said Blake Aftab, Ph.D., Chief Scientific Officer at Adicet. "Together, the results of this extended characterization highlight potential advantages of our allogeneic gamma delta T cell platform, with adaptive and innate mechanisms contributing to the anti-tumor activity of ADI-001."

Poster Presentation Details

Title: Evaluation of non-gene edited allogeneic "off-the-shelf" Vδ1 γδ (gamma delta) CAR T cells targeting CD20 for B cell malignancies

ePoster Presentation: Thursday, May 5 at 4:00 p.m. PT

On May 5, 2022 Lantern Pharma Inc. (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") and machine learning (ML) platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported that the Company’s management will be speaking at five investor and scientific conferences in May 2022 (Press release, Lantern Pharma, MAY 5, 2022, View Source [SID1234613701]).

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Dr. Kishor Bhatia, Lantern’s Chief Scientific Officer, will be speaking at the 9th Drug Discovery Strategic Summit on May 9th, and presenting on the synthetic lethality potential of Lantern’s drug candidates. Additionally, Panna Sharma, Lantern’s Chief Executive Officer and President, will be speaking at four events in May, including the Strategic Investment Conference on May 13th, the MedVentures Conference on May 18th, the Augmented Intelligence in Drug Discovery Xchange East Coast on May 19th, and the Bioinformatics Strategy Meeting East Coast USA on May 23rd.

Further information on these conferences and events, including registration links, can be found below:

9th Drug Discovery Strategic Summit
Presentation Information: May 9th, 2022 / 4:40 p.m. ET / Boston, MA
Presenter: Kishor Bhatia, Ph.D.
Registration Link: View Source

Strategic Investment Conference 2022
Presentation Information: May 13th, 2022 / 2:45 p.m. ET / Virtual
Presenter: Panna Sharma
Registration Link: View Source

MedVentures Conference
Presentation Information: May 18th, 2022 / 9:30-10:30 a.m. CT / Dallas, TX
Presenter: Panna Sharma
Registration Link: View Source

Augmented Intelligence in Drug Discovery Xchange East Coast
Presentation Information: May 19th, 2022 / 9:05 a.m. ET / Woburn, MA
Presenter: Panna Sharma
Registration Link: https://www.hub-xchange.com/augmented-intelligence-in-drug-delivery-xchange-east-coast-2022/#anchor1

Bioinformatics Strategy Meeting East Coast USA 2022
Presentation Information: May 23rd, 2022 / 3:50 & 4:50 p.m. ET / Cambridge, MA
Presenter: Panna Sharma
Registration Link: https://proventainternational.com/events/rd/usa-east/boston/bioinformatics-strategy-meeting-east-coast-usa-2022/

On May 5, 2022 Gamida Cell Ltd. (Nasdaq: GMDA), the leader in the development of NAM-enabled cell therapies for patients with solid and hematological cancers and other serious diseases, reported that it will share preclinical data at the International Society for Cell & Gene Therapy (ISCT) 2022, being held in San Francisco, CA, May 4-7, 2022 on GDA-301 and GDA-601, two product candidates in the Company’s NAM-enabled genetically modified natural killer (NK) pipeline (Press release, Gamida Cell, MAY 5, 2022, View Source [SID1234613700]).

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"The preclinical data generated from our expanding pipeline of NAM-enabled cell therapies is already showing signs of meaningful potential as a future approach to fighting cancer," said Julian Adams, Ph.D., Chief Executive Officer of Gamida Cell. "With evidence of enhanced cytotoxicity demonstrated across hematologic cancers and solid tumors with these diverse, genetically modified NK cell immunotherapy programs, we look forward to continuing our progress toward opening new frontiers in cancer immunotherapy."

GDA-301 is an investigational genetically modified NAM-NK cell therapy candidate aimed at targeting hematologic malignancies and solid tumors. The poster (#501), titled "GDA-301: Engineered NAM-NK Cells via CISH Knockout and Membrane-Bound IL-15 Expression Increases Cytotoxicity Against Malignancies," demonstrated that after six hours of co-culture with a chronic myelogenous leukemia (K562) or multiple myeloma (RPMI) cell line, GDA-301, a combined genetic manipulation of CISH gene editing and the engineered expression of mb IL-15, showed increased cytotoxicity compared with control NAM-NK cells. Additional in vitro assays showed elevation of degranulation marker CD107a, and intracellular proinflammatory cytokines interferon-γ and tumor necrosis factor-α, suggesting increased potency of GDA-301 compared with control. The potency and cytotoxicity data suggest that GDA-301 represents a novel potential immunotherapeutic targeting hematologic malignancies as well as solid tumors.

The poster on GDA-301 was selected for presentation at the conference’s Elevator Pitch Session 2 on Thursday, May 5, 2022 at 6:00 p.m. EST/3:00 p.m. PST – 7:00 p.m. EST/4:00 p.m. PST.

GDA-301 is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.

GDA-601 is an investigational genetically engineered NAM-NK cell therapy candidate designed to target multiple myeloma (MM) cells. The poster (#517), titled "GDA-601: NAM-NK Cells With CD38 Knockout Expresses Enhanced CD38 Chimeric Antigen Receptor and Targets Multiple Myeloma Cells With Increased Cytotoxicity," showed that in vitro killing assays performed six hours after co-culture of GDA-601 with a MM (RPMI) cell line showed increased cytotoxicity compared with control NAM-NK cells. Fratricide attributable to CD38 antigen was effectively eliminated with GDA-601. There was a significant enhancement of potency against CD38-positive MM cells demonstrated by elevation of the degranulation marker CD107a and intracellular proinflammatory cytokines interferon-γ and tumor necrosis factor-α in vitro. These results suggest that GDA-601 displays superior antitumoral responses against MM cells and represent a promising adoptive cell therapeutic strategy against MM.

Both posters will be presented on Thursday, May 5, 2022 at Poster Session 2, at 5:45 p.m. EST/2:45 p.m. PST – 7:15 p.m. EST/4:15 p.m. PST.

GDA-601 is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.

For more information, please visit isctglobal.org.

About NAM Technology

Our NAM-enabling technology, supported by positive Phase 3 data, is designed to enhance the number and functionality of targeted cells, enabling us to pursue a curative approach that moves beyond what is possible with existing therapies. Leveraging the unique properties of NAM (Nicotinamide), we can expand and metabolically modulate multiple cell types — including stem cells and natural killer cells — with appropriate growth factors to maintain the cells’ active phenotype and enhance potency. Additionally, our NAM technology improves the metabolic fitness of cells, allowing for continued activity throughout the expansion process.

On May 5, 2022 Aeglea BioTherapeutics, Inc. (NASDAQ:AGLE), a clinical-stage biotechnology company developing a new generation of human enzyme therapeutics as innovative solutions for rare metabolic diseases, reported that it has entered into a securities purchase agreement with certain institutional investors providing for the purchase and sale of registered securities of the Company in a registered direct offering for gross proceeds to Aeglea of approximately $45 million, prior to deducting placement agent fees and estimated offering expenses (Press release, Aeglea BioTherapeutics, MAY 5, 2022, View Source [SID1234613699]). The financing includes participation from Bain Capital Life Sciences, LP, Great Point Partners, LLC, clients of Nantahala Capital Management, Sio Capital Management, LLC and other institutional investors.

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The financing includes 10,752,688 shares of the Company’s common stock at a price of $1.60 per share and pre-funded warrants to purchase 17,372,397 shares of common stock, at a price of $1.5999 per pre-funded warrant, which represents the per share offering price for the common stock less the $0.0001 exercise price for each pre-funded warrant. The offering is expected to close on or about May 9, 2022, subject to customary closing conditions.

JonesTrading Institutional Services LLC is acting as placement agent for the registered direct offering.

The shares of common stock and pre-funded warrants were offered pursuant to a shelf registration statement on Form S-3 (File No. 333-239706), which was declared effective by the United States Securities and Exchange Commission ("SEC") on July 14, 2020. The Company intends to use the proceeds from the offering, together with its existing cash resources, to fund the Company’s activities related to our ongoing Biologics License Application submission for pegzilarginase and its potential commercialization in the United States for patients with Arginase 1 Deficiency, advance the clinical development of AGLE-177 through its Phase 1/2 clinical trial and prepare for a potential Phase 3 trial for the treatment of patients with Homocystinuria, and to advance AGLE-325 for Cystinuria through IND-enabling activities, and the remainder to fund continued research and development, manufacturing, working capital and general corporate purposes. The Company expects the net proceeds from this offering, together with its existing cash, cash equivalents, and marketable securities, to fund operations through the second quarter of 2023.

A prospectus supplement relating to the shares of common stock will be filed by the Company with the SEC. When available, copies of the prospectus supplement, together with the accompanying prospectus, can be obtained at the SEC’s website at www.sec.gov or from JonesTrading Institutional Services LLC at [email protected].