On May 5, 2022 BiomX Inc. (NYSE American: PHGE) ("BiomX" or the "Company"), a clinical-stage microbiome company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, reported that the Company will host a conference call and a live audio webcast on Wednesday, May 11, 2022, at 8:00 a.m. EDT, to report first quarter 2022 financial results and provide business updates (Press release, BiomX, MAY 5, 2022, View Source [SID1234613706]). To participate in the conference call, please dial 1-877-407-0724 (U.S.) or 1-201-389-0898 (International). The live and archived webcast will be available in the Investors section of the Company’s website at www.biomx.com.

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On May 15, 2022 Elpiscience Biopharmaceuticals, Inc. ("Elpiscience"), a clinical-stage biopharmaceutical company focused on developing next-generation immunotherapies to benefit cancer patients worldwide, reported partner Compass Therapeutics reported positive interim ES104 (also known as CTX-009) Phase 2 data in combination with paclitaxel in patients with biliary tract cancers (BTC) (Press release, Elpiscience, MAY 5, 2022, View Source [SID1234613705]). ES104 is a bispecific antibody that simultaneously blocks Delta-like ligand 4/Notch (DLL4) and vascular endothelial growth factor A (VEGF-A) signaling pathways, which are critical to angiogenesis and tumor vascularization.

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In the study, ES104 demonstrated:

42% overall response rate (ORR) based on 10 patients with Partial Responses (PRs), including 9 PRs confirmed by RECIST 1.1 and 1 PR pending confirmation
Anti-tumor activity in previously treated patients with a clinical benefit rate (CBR) of 92% based on 22 patients with a PR or stable disease (SD) out of 24 enrolled patients
Well-tolerated and preliminary safety profile consistent with prior studies
The Phase 2 study in patients with BTC is currently being conducted at four leading medical centers in Korea and Compass Therapeutics plans to open additional sites in the United States. In China, Elpiscience is currently enrolling patients in a ES104 Phase 1/2 study for the treatment of unresectable locally advanced or metastatic colorectal cancer (CRC). ES104 is currently the only clinical-stage bispecific antibody targeting VEGF and DLL4 in China.

"We are encouraged by the impressive interim Phase 2 data in BTC patients from our partner," said Steve Chin, Chief Medical Officer of Elpiscience. "ES104 in combination with paclitaxel showed a high ORR including responses in all four BTC subtypes and good overall tolerability consistent with prior studies. We believe in the clinical strategy to simultaneously target VEGF and DLL4 and look forward to our study findings in advanced CRC patients."

For more information on the Phase 1/2 clinical study in patients with unresectable locally advanced or metastatic CRC, refer to Clinicaltrials.gov identifier NCT05167448.

About ES104

ES104 is a bispecific antibody that simultaneously blocks Delta-like ligand 4/Notch (DLL4) and vascular endothelial growth factor A (VEGF-A) signaling pathways, which are critical to angiogenesis and tumor vascularization. Pre-clinical and early clinical data of ES104 show that blocking both pathways provides robust anti-tumor activity across several solid tumors, including colorectal, gastric, cholangiocarcinoma, pancreatic, and non-small cell lung cancer. Partial responses to ES104 as monotherapy have been observed in heavily pre-treated cancer patients, who were resistant to currently approved anti-VEGF therapies. ES104 has completed a Phase 1 monotherapy dose-escalation and expansion study (NCT03292783). Phase 1b and Phase 2 clinical studies (NCT04492033) in combination with chemotherapy are ongoing. Elpiscience licensed ES104 greater China rights from Compass Therapeutics in January 2021 and is conducting Phase 1/2 study in China for treatment in patients with unresectable locally advanced or metastatic colorectal cancer.

On May 5, 2022 Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, reported a late-breaking abstract presentation on 18F-rhPSMA-7.3 at the upcoming 2022 AUA Annual Meeting (AUA2022), to be held May 13 to 16 in New Orleans, La (Press release, Blue Earth Diagnostics, MAY 5, 2022, View Source [SID1234613704]). 18F-rhPSMA-7.3 is an investigational Prostate-Specific Membrane Antigen-targeted radiohybrid (rh) PET imaging agent. The SPOTLIGHT study (NCT04186845) is a Phase 3, multi-center, single-arm imaging study, conducted in the United States and Europe, to evaluate the safety and diagnostic performance of 18F-rhPSMA-7.3 PET imaging in men with suspected prostate cancer recurrence based on elevated PSA following prior therapy. Details of the presentation are listed below.

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Highlighted Oral Presentation

Friday, May 13, 2022 Morning Plenary Session

Presentation:

Impact of 18F-rhPSMA-7.3 PET on upstaging of patients with prostate cancer recurrence: results from the prospective, Phase 3, multicenter SPOTLIGHT study

Abstract Number:

Late-Breaking Abstract PLLBA-02

Presenter:

Mark T. Fleming, MD, Virginia Oncology Associates, U.S. Oncology Research, Norfolk, Va., on behalf of the SPOTLIGHT Study Group

Session Title & Times:

Plenary Session 7:30 AM – 11:30 AM CT

Oral Presentation:

11:13 – 11:21 AM CT

Location:

New Orleans Ernest N. Morial Convention Center, Great Hall A

Blue Earth Diagnostics invites participants at AUA2022 to attend the presentation above and to learn more about the Company at Booth 455. For full session details and scientific presentation listings, please see the AUA online program here.

About Radiohybrid Prostate-Specific Membrane Antigen (rhPSMA)

rhPSMA compounds consist of a radiohybrid ("rh") Prostate-Specific Membrane Antigen-targeted receptor ligand which attaches to and is internalized by prostate cancer cells and they may be radiolabeled with 18F for PET imaging, or with isotopes such as 177Lu or 225Ac for therapeutic use – creating a true theranostic technology. They may play an important role in patient management in the future, and offer the potential for precision medicine for men with prostate cancer. Radiohybrid technology and rhPSMA originated from the Technical University of Munich, Germany. Blue Earth Diagnostics acquired exclusive, worldwide rights to rhPSMA diagnostic imaging technology from Scintomics GmbH in 2018, and therapeutic rights in 2020, and has sublicensed the therapeutic application to its sister company Blue Earth Therapeutics. Blue Earth Diagnostics has completed two Phase 3 clinical studies evaluating the safety and diagnostic performance of 18F-rhPSMA-7.3 PET imaging in prostate cancer: ("SPOTLIGHT," NCT04186845), in men with recurrent disease and ("LIGHTHOUSE," NCT04186819), in men with newly diagnosed prostate cancer. Currently, rhPSMA compounds are investigational and have not received regulatory approval.

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