On May 2, 2022 Catamaran Bio, Inc., a biotechnology company developing off‑the-shelf chimeric antigen receptor (CAR)-NK cell therapies to treat cancer, reported that the company will present two posters at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting, being held in Washington, DC, on May 16-18, 2022 (Press release, Catamaran Bio, MAY 2, 2022, View Source [SID1234613333]). Catamaran scientists will present data supporting CAR‑NK cell therapy design strategies to neutralize the immunosuppressive effects of the tumor microenvironment, including use of synthetic biology-enabled chimeric switch receptors which convert the inhibitory signal of TGF-β into positive NK cell activation signals.

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"We look forward to sharing our progress in engineering CAR-NK cells to confer them with the functional attributes to enable durable efficacy in solid tumors," said Vipin Suri, PhD, MBA, Chief Scientific Officer of Catamaran Bio. "Our presentations at ASGCT (Free ASGCT Whitepaper) describe approaches to mitigate the effects of TGF-β, a highly immunosuppressive cytokine known to reduce the anti-tumor activity of immune cells. We will show data on the activities of multiple TGF-β based synthetic receptors that confer a range of benefits to CAR-NK cells and enhance anti-tumor activity in high TGF-β environments."

Details of the poster presentations are as follows:

Presentation Title: Engineered allogeneic CAR natural killer cells resist tumor microenvironment immunosuppression by expression of a TGF-βR2 dominant negative receptor
Session Title: Cancer – Immunotherapy, Cancer Vaccines I
Session Date & Time: Monday May 16, 2022, 5:30 p.m. ET
Location: Hall D
Abstract Number: 313
Poster Board Number: M-194

Presentation Title: A synthetic biology approach to address the immunosuppressive tumor microenvironment: Novel TGF-β switch receptors convert inhibitory signals to enhance NK cell activity
Session Title: Cancer – Immunotherapy, Cancer Vaccines I
Session Date & Time: Monday May 16, 2022, 5:30 p.m. ET
Location: Hall D
Abstract Number: 331
Poster Board Number: M-212

The abstracts will be available on the ASGCT (Free ASGCT Whitepaper) conference website.

On May 2, 2022 CERo Therapeutics, Inc., a biopharmaceutical company pioneering the development of novel autologous engineered immune cell therapies, reported new preclinical data to be presented at the 25th Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) demonstrating significant anti-tumor effects of chimeric engulfment receptor (CER) T cells when combined with small molecule therapies in both hematologic and solid tumor models (Press release, Cero Therapeutics, MAY 2, 2022, View Source [SID1234613332]).

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CER T cells are multifunctional, genetically engineered T cells that elicit dual cytotoxic and myeloid-like anti-tumor function. CER T-cells, which target a phagocytic ligand that can be induced by small molecules, offer the potential for broad anti-tumor synergisms through a differentiated mechanism of tumor clearance. The data indicate the potential for the unique CER T-cell reprogramming technology to restore immune dysfunction in advanced tumor microenvironments when used in combination with small molecule inhibitors. The differentiated and combined approach offers the potential for more complete and durable responses than targeted agents alone.

"Our technology platform reprograms cytotoxic T cells to build in innate immune functions, creating multifunctional CER T cell products that intersect conventional T-cell and myeloid cell-like functions to attack tumors," said Daniel Corey, MD, founder and Chief Scientific Officer of CERo. "These data show that CER T cells synergize with current standard-of-care targeted therapies and result in improved tumor clearance and immune activation than either therapy alone in lymphoma and ovarian cancer models. We now have evidence in clinically relevant disease models supporting our approach and look forward to advancing our lead candidate toward IND-enabling studies."

In the ovarian cancer model, CER T cells synergized with sub-clinical doses of the poly (ADP-ribose) polymerase (PARP) inhibitors olaparib and niraparib to eliminate tumor cells in vitro. In these studies, the addition of PARP inhibitors drove CER T-cell cytokine and proliferation responses against ovarian cancer cell targets compared to untreated samples. By comparison, CER T cells or PARP inhibitors alone demonstrated minimal anti-tumor function. Synergisms were also observed in mantle cell lymphoma (MCL) models with the Bruton’s tyrosine kinase inhibitor ibrutinib. The combinatorial approach cleared 90% of tumor cells at sub-therapeutic concentrations of ibrutinib. CER T cells also proliferated and produced T-cell activation cytokines upon target engagement.

Notably, CER T cells exhibited a differentiated mechanism of tumor clearance via enhanced endo/phagocytosis. In co-cultures with MCL tumor cells, CER T cells showed a 15-fold increase in engulfment activity compared to unmodified T cells. Further, in a model system, CER T cells demonstrated the ability to capture, process, and present tumor antigen, and trigger antigen-specific T-cell responses. Finally, in vivo MCL xenograft studies showed that CERs reduced tumor volume relative to controls, with no overt morbidity.

An oral presentation of the abstract entitled "Tim-4-Chimeric Engulfment Receptor (CER) T Cell Therapy Elicits Phosphatidylserine-Dependent Cytotoxic and Antigen-Presenting Cell-Like Function and Synergizes with Approved BTK Inhibitors for the Treatment of Hematologic Malignancies" (abstract 89) will take place on Monday, May 16, 2022 at 4:45-5:00 p.m. ET during the "CAR T-cells and Beyond" session in Room 102 A/B.

Data from the poster entitled "Tim-4-Chimeric Engulfment Receptor (CER) T Cells Elicit Phosphatidylserine-Dependent Cytotoxic and Innate-Like Function and Synergize with Approved PARP Inhibitors in an Ovarian Cancer Model" (abstract 314) will be presented on Monday, May 16.

About CERo’s Platform Technology
CERo’s technology aims to expand the therapeutic potential of engineered T cell-based therapies by introducing distinct and complementary tumor cell clearance pathways into a single T cell. By engineering T cells to express CERs, CERo’s platform technology enables T cells to target tumors, induce cellular damage, engulf tumor fragments, and clear tumors, effectively harnessing the anti-tumor attributes of both innate and adaptive immune responses. CER T-cell products are designed to generate a more complete and durable anti-tumor response. This novel biology amends itself to combinations with classic CAR T-cell or small molecule therapy and has potential applications in hematologic malignancies and solid tumors.

On May 2, 2022 Perimeter Medical Imaging AI, Inc. (TSX-V:PINK)(OTC:PYNKF) (FSE:4PC) ("Perimeter" or the "Company"), a medical technology company driven to transform cancer surgery with ultra-high-resolution, real-time, advanced imaging tools to address high unmet medical needs, reported financial results for the year ended December 31, 2021 and provided a corporate update (Press release, Perimeter Medical Imaging AI, MAY 2, 2022, View Source [SID1234613331]).

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Key Highlights

Perimeter officially progresses to commercial stage with its first S-Series OCT installation.
Clinical development of B-Series OCT with ImgAssist AI advances into late-stage validation activities with the initiation of a multi-center, randomized, two-arm pivotal clinical trial.
The Company issues full-year 2022 commercial installation guidance of 15-20 units.
Jeremy Sobotta, Perimeter’s Chief Executive Officer stated, "We continue to build upon the significant momentum generated in 2021, which represented a transformative year for Perimeter that was marked by the Company’s first commercial placement of its flagship Perimeter S-Series OCT imaging platform and the initiation of a pivotal trial on our FDA breakthrough-designated device for our investigational Perimeter B-Series OCT combined with ImgAssist artificial intelligence."

Mr. Sobotta continued, "We are grateful for the support from long-term shareholders, as well as Social Capital, who led a recent financing which resulted in gross proceeds of approximately $48.7 million to further strengthen our balance sheet at this critical stage. Moving forward, I believe we are well-positioned to execute on our commercial and clinical development goals. Perimeter is uniquely positioned to draw upon its industry-leading expertise in advanced medical imaging combined with the benefits of machine learning and artificial intelligence tools to support our vision of delivering truly ‘best-in-class’ medical technology solutions to our customers with the goal of improving patient outcomes and reducing healthcare costs."

Corporate and Commercial Milestones

Perimeter received 510(k) clearance for its S-Series OCT imaging platform from the U.S. Food and Drug Administration (FDA), enabling its commercial launch in the U.S. Subsequently, under the leadership of Steve Sapot, Chief Commercial Officer, Perimeter continues to build upon its sales and marketing infrastructure – including key hires of market development managers to cover regions across the U.S.
Perimeter partnered with Minnetronix Medical, a leading medical technology and operations partner to global medical device companies, to secure commercial-scale manufacturing of Perimeter S-Series OCT imaging systems.
Subsequent to year-end, in January 2022, Perimeter closed a private placement resulting in gross proceeds of C$48.7 million to the Company, which included a C$43.4 million strategic investment in the Company by Social Capital.
Clinical and Product Development Milestones

Perimeter received U.S. FDA Breakthrough Device Designation for Perimeter B-Series OCT combined with proprietary ImgAssist artificial intelligence (AI) software – providing a potential expedited pathway for development and adoption of this innovative technology.
Perimeter initiated a multi-center, randomized, two-arm pivotal clinical trial to evaluate its Perimeter B-Series OCT with ImgAssist AI for use during breast conservation surgery.
Summary of 2021 Financial Results

All of the amounts are expressed in Canadian dollars unless otherwise indicated and are presented in accordance with International Financial Reporting Standards as issued by the International Accounting Standards Board ("IFRS") applicable to the preparation of interim financial statements, including International Accounting Standard ("IAS") 34, Interim Financial Reporting.

Operating expenses for the year ended 2021 were $16,153,514 compared to $10,159,444 during the previous year.

For the year ended December 31, 2021, the net loss was $16,644,231 compared to $7,885,966 in the prior year.

For the year ended December 31, 2021, cash used in operating activities was $13,912,389.

As at December 31, 2021, cash and cash equivalents were $4,720,003. Subsequent to December 31, 2021, the Company raised additional capital through a private placement resulting in gross proceeds of approximately $48.7 million.

For detailed financial results, please see Perimeter’s filings at www.sedar.com and on the company’s website at View Source

Company Outlook

Perimeter’s sales and marketing efforts will continue to focus on placing its commercially available, flagship Perimeter S-Series OCT at leading hospitals where key opinion leaders can act as champions of this innovative technology, with the goal of reaching an S-Series install base of 15 to 20 units by the end of 2022. In parallel, Perimeter’s clinical team will focus on the continued enrollment of patients and onboarding of healthcare institutions in the ongoing pivotal trial evaluating its next-gen investigational Perimeter B-Series OCT with ImgAssist AI when used in breast lumpectomy procedures, with the goal of gathering data from over 300 patients across 8 sites and completing enrollment in 2022.

Conference Call

Perimeter will host a conference call and audio webcast tomorrow (Tuesday, May 3, 2022) at 5:00 pm Eastern Time to discuss the year-end results and to provide a corporate update. The webcast will be broadcast live on the Investors section of the Perimeter website. To participate in the call, please dial 1-877-704-4453 of 1-201-389-0920 for international callers and provide conference ID number 13729526. To participate in the call, please dial (877) 407-0789 or (201) 689-8562 for international callers and provide conference ID number 13727220.

The webcast will also be archived on the Investors section of the Perimeter website for at least 90 days, and a telephonic playback of the conference call will be available for 14 days following the event by dialing (844) 512-2921 or (412) 317-6671 for international callers and referencing conference ID 13729526.

About the Clinical Development of Perimeter B-Series OCT with ImgAssist AI

Perimeter is advancing the development of its proprietary, next gen "ImgAssist" artificial intelligence (AI) technology under its ATLAS AI project, which is made possible, in part, by a US$7.4 million grant awarded by the Cancer Prevention and Research Institute of Texas (CPRIT). A multi-center, randomized, two-arm clinical trial is underway to measure the effectiveness of the breakthrough-device-designated Perimeter B-Series OCT + ImgAssist AI in reducing the number of unaddressed positive margins in breast lumpectomy procedures when used in addition to standard intraoperative margin assessment. Approximately 300 patients undergoing breast conservation surgery across eight U.S. clinical sites will participate in the pivotal study led by Principal Investigator, Dr. Alastair Thompson at Baylor College of Medicine, with study enrollment anticipated by the end of 2022.

On May 2, 2022 Agendia, Inc., a commercial stage company focused on enabling optimized decision-making by providing physicians with next-generation diagnostic and information solutions that can be used to help improve outcomes for breast cancer patients worldwide, reported it will present new data from ongoing clinical research evaluating its comprehensive genomic tests at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO) (Free ASCO Whitepaper), taking place June 3-7, 2022 in Chicago, Illinois (Press release, Agendia, MAY 2, 2022, View Source [SID1234613330]).

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Data will highlight Agendia’s clinical focus on whole transcriptome analysis as well as breast cancer care for underserved populations, in addition to several sub-studies derived from the company’s FLEX Registry, the real-world, multicenter, prospective, observational breast cancer study. Two abstracts selected by ASCO (Free ASCO Whitepaper) for oral discussion will feature an investigation of the ImPrint genomic test, currently for research use only, from the I-SPY trial series and an analysis from FLEX of hormone receptor-positive breast cancer in Black women classified by BluePrint.

The company believes the FLEX Registry’s approach to cancer research is accelerating impactful data generation, aimed at redefining cancer care. Its patient-centric design and national network of participating sites is backed by Agendia’s infrastructure, allowing its investigator-initiated sub-studies to produce important results that have the potential to drive science forward, like those being shared at ASCO (Free ASCO Whitepaper) 2022.

Following are details of the nine Agendia abstracts that have been accepted for poster discussion or poster sessions at the ASCO (Free ASCO Whitepaper) 2022 Annual Meeting:

Poster discussion sessions

The ImPrint immune signature to identify patients with high-risk early breast cancer who may benefit from PD1 checkpoint inhibition in I-SPY2
Authors: Kuilman, MM., et al.
Presenter: Lorenza Mittempergher, PhD | Research and Development, Agendia NV
Session: Breast Cancer – Local/Regional/Adjuvant
Poster Discussion: Monday, June 6, 2022 | 1:15 PM-2:45 PM CDT
Abstract #: 514
Whole transcriptomic analysis of HR+ breast cancer in Black women classified as basal-type by BluePrint
Authors: Reid, S., et al.
Presenter: Sonya A. Reid, MD, MPH | Vanderbilt University Medical Center
Session: Breast Cancer – Local/Regional/Adjuvant
Poster Discussion: Monday, June 6, 2022 | 1:15 PM-2:45 PM CDT
Abstract #: 517
Poster sessions

Whole transcriptome analysis of tumors with discordant oncotype and MammaPrint results in the FLEX trial
Authors: Socoteanu, M., et al.
Session: Breast Cancer – Local/Regional/Adjuvant
Session Date & Time: Monday, June 6, 2022 | 8:00 AM-11:00 AM CDT
Abstract #: 556
Clinical implications for patients with discordant oncotype and MammaPrint results
Authors: Socoteanu, M., et al.
Session: Breast Cancer – Local/Regional/Adjuvant
Session Date & Time: Monday, June 6, 2022 | 8:00 AM-11:00 AM CDT
Abstract #: 560
Investigation of a genomic signature for transcription factor MAF gene amplification and lack of bisphosphonate benefit in early breast cancer
Authors: Nasrazadani, A., et al.
Session: Breast Cancer – Local/Regional/Adjuvant
Session Date & Time: Monday, June 6, 2022 | 8:00 AM-11:00 AM CDT
Abstract #: 559
Identification of transcriptional changes with MammaPrint and BluePrint in early-stage breast cancer after neoadjuvant chemotherapy
Authors: Chung, A., et al.
Session: Breast Cancer – Local/Regional/Adjuvant
Session Date & Time: Monday, June 6, 2022 | 8:00 AM-11:00 AM CDT
Abstract #: 585
Distribution of breast cancer molecular subtypes within receptor classifications: Lessons from the I-SPY2 trial and FLEX Registry
Authors: Cha, J., et al.
Session: Breast Cancer – Local/Regional/Adjuvant
Session Date & Time: Monday, June 6, 2022 | 8:00 AM-11:00 AM CDT
Abstract #: 592
FLEX, the 30,000 breast cancer transcriptome project: A platform for early breast cancer research using full-genome arrays paired with clinical data
Authors: Ma, C., et al.
Session: TBC
Session Date & Time: Monday, June 6, 2022 | 8:00 AM-11:00 AM CDT
Abstract #: TPS612
Defining transcriptomic profiles of early-stage mucinous breast cancers: A FLEX sub study
Authors: Sivapiragasam, A., et al.
Session: Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology
Session Date & Time: Sunday, June 5, 2022 | 8:00 AM-11:00 AM CDT
Abstract #: 3134
Agendia will be sharing important updates on its Twitter, Facebook and LinkedIn pages throughout the conference. The event program can be found at the ASCO (Free ASCO Whitepaper) 2022 website.

On May 2, 2022 Agendia, Inc., a commercial stage company focused on enabling optimized decision-making by providing physicians with next-generation diagnostic and information solutions that can be used to help improve outcomes for breast cancer patients worldwide, reported that it will present new data at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Breast Cancer Congress 2022 taking place in Berlin, Germany on May 3-5, 2022 (Press release, Agendia, MAY 2, 2022, View Source [SID1234613327]).

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The first of the two poster presentations, entitled Equivalence of NGS-based MammaPrint 70-gene signature risk of recurrence and BluePrint 80-gene signature of molecular subtyping tests to the centralized microarray tests [234P], concludes that the next-generation sequencing (NGS) version of MammaPrint and BluePrint[1] is equivalent to the centralized microarray test, as demonstrated by results from various labs globally. This enables a more accurate decentralized solution to breast cancer care fostering worldwide accessibility to more reliable genomic testing.

"The accessibility of breast cancer care is crucial and by validating the interchangeability of the NGS version of MammaPrint and BluePrint compared to the standardized microarray tests, new doors are opened for global physicians who may need to rely on in-country platforms in order to secure the MammaPrint and BluePrint results their patients may require," said Annuska Glas, Senior Vice President Research and Development and Innovation at Agendia. "MammaPrint is a valuable tool to support treatment planning for breast cancer patients and with the decentralized NGS platform, this can be offered in even more countries. These findings further confirm that MammaPrint and BluePrint can provide the same accurate results through NGS."

Agendia is expanding novel ways to ensure accessibility of care worldwide by advancing solutions with a decentralized option for testing kits to run on an NGS platform, and innovative modalities such as digital AI pathology. This data presented at ESMO (Free ESMO Whitepaper) Breast follows an announcement from Agendia earlier this year that it is progressing its Digital MammaPrint artificial intelligence (AI)-powered platform in Brazil to potentially fundamentally change the way breast cancer is treated by providing essential information more quickly and elevating the capabilities of global physicians treating women with breast cancer in their local communities.

A second poster presentation, entitled Budget impact analysis for the Health Care Package by using MammaPrint in Belgium [238P], builds on earlier research from the landmark MINDACT trial and combines this with the results of the interim analysis of the pilot study performed in Belgium (unpublished data). The budget impact model shows that use of MammaPrint yields savings for breast cancer care in Belgium for the Belgian Health Care Package when compared to no gene expression profiling testing. According to the budget impact model, the use of MammaPrint in patients selected according to criteria of the pilot study leads to high savings. If gene expression profiling was performed for all clinical high risk patients, savings would even be higher.

By combining the cost of genomic testing with the savings made due to a net reduction in chemotherapy usage, the annual savings add up to more than €5,800,000, an average savings of €3,900 per patient, compared with standard clinical care of a patient with breast cancer in Belgium. MINDACT has produced previous multi-country health savings analyses, published in the European Journal of Cancer, showing that genomic testing is beneficial as it provides valuable insights that potentially allow patients to avoid the complexity of chemotherapy, passing down significant financial savings to them while also triggering significant cost savings for large health systems around the world.

"Drawing from the impact data used from the pilot study performed in Belgium, we are able to determine new insights that the use of MammaPrint could grant substantial cost savings to women who may not require chemotherapy and could ultimately alleviate some of the burden on Belgium’s health care system as a whole," said Pino Cusumano, MD, Breast Surgeon, Centre Hospitalier Chrétien, Liège in Belgium. "Data has previously demonstrated that by de-escalating women with Low Risk cases from chemotherapy treatment, outcomes are still as good and women are able to follow a more personalized treatment plan. We believe these data demonstrate that the previous analysis holds for the state of breast cancer care in Belgium in 2022, and that the overall patient benefit extends beyond physical care into financial wellness too."

Taken together, the two posters presented at ESMO (Free ESMO Whitepaper) Breast 2022 suggest that regardless of where the patient is located, she is able to receive the same high-quality results with the added benefit of cost-effective treatment planning.

"The studies presented at EMSO 2022 underpin our central efforts at Agendia to ensure our genomic tests are widely accessible and affordable, without compromising scientific integrity or decision-making, to bring the clarity women with breast cancer seek to guide their treatment planning," said Bastiaan van der Baan, Chief Clinical and Business Development Officer at Agendia. "Through our steadfast commitment to enable global adoption of MammaPrint and BluePrint, we look forward to continuing studies such as these to grow evidence supporting our mission to serve women with breast cancer throughout their treatment journey."

1MammaPrint and BluePrint next-generation sequencing kits are not yet cleared for sale in the United States by the US Food and Drug Administration; BluePrint has been CE-marked for use in Europe. BluePrint is also commercialized as a Laboratory Developed Test (LDT) and audited under CAP/CLIA in the United States.