On May 2, 2022 Orna Therapeutics, a biotechnology company dedicated to designing and delivering a new class of fully engineered circular RNA therapeutics, reported multiple data presentations at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 25th Annual Meeting taking place in Washington, D.C., or virtually, from May 16 – 19, 2022 (Press release, Orna Therapeutics, MAY 2, 2022, View Source [SID1234613335]). Oral presentations will describe Orna’s pipeline for the first time, revealing key data on its in situ CAR (isCAR) program, amongst others, and detail the development of a powerful, new screening platform (FoRCE). Poster presentations will provide additional information on the development of delivery solutions for the isCAR platform and on the development of our muscle genetic disease program.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Details for the presentations are shared below.

Oral Presentations:
In-situ CAR Therapy Using oRNA Lipid Nanoparticles Regresses Tumors in Mice
Presenter: Tom Barnes, Ph.D., CEO
Date/Time/Location: Monday, May 16, 2022 from 9:10 – 9:45 a.m. ET in Room 207
Session: Scientific Symposium: Function and Therapeutics Applications of Circular RNAs (circRNAs)
Summary: Orna will introduce its pipeline along with key data from its isCAR program. Data from iterative animal studies will demonstrate that oRNA lipid nanoparticles (oRNA-LNPs) can be designed to overcome current challenges of engineered cell therapies. Orna will also present progress on oRNA-LNP (non-viral) delivery of long forms of dystrophin and advances with vaccine therapies.

Discovery of Translation Initiation Elements Enabled by a Parallel Arrayed Screen of Full-length Viral UTRs in Synthetic Circular RNA
Presenter: Alexander Wesselhoeft, Ph.D., Director, Molecular Biology
Date/Time/Location: Monday, May 16, 2022 from 11:30 – 11:45 a.m. ET in Salon H
Session: Oral Abstract Session: Oligonucleotide Therapeutics
Summary: Newly discovered internal ribosome entry sites (IRES) show greater activity (vs EMCV, a common IRES) and some produce different expression levels based on cell type, granting more options for improved expression and control of oRNA.

Poster Presentations:
Improved Immune Cell Expression with Circular RNA (oRNA) in vivo
Presenter: Kevin Kauffman, Ph.D., Principal Scientist
Date/Time/Location: Monday, May 16, 2022 at 5:30 p.m. ET in Hall D
Session: Poster Session: Oligonucleotide Therapeutics I
Summary: oRNA lipid nanoparticles (oRNA-LNPs) show higher splenic T cell expression and biodistribution to the spleen in vivo with improved formulation characteristics compared to their linear mRNA-LNP counterparts.

Systemic Delivery of Circular RNA Encoding Partial Dystrophins and Expression in Skeletal Muscle
Presenter: Tatiana Fontelonga, Ph.D., Scientist
Date/Time/Location: Tuesday, May 17, 2022 at 5:30 p.m. ET in Hall D
Session: Poster Session: Oligonucleotide Therapeutics II
Summary: Micro and mini versions of the dystrophin gene can be encoded in a high capacity oRNA, delivered via LNP, and properly expressed in primary human cells and the mdx mouse model of Duchenne muscular dystrophy.

On May 2, 2022 Ambrx Biopharma Inc., or Ambrx, (NYSE: AMAM), a clinical stage biopharmaceutical company using an expanded genetic code technology platform to create Engineered Precision Biologics, reported that it filed its annual report on Form 20-F (the "Form 20-F") for the year ended December 31, 2021 with the U.S. Securities and Exchange Commission ("SEC") on April 26, 2022 (Press release, Ambrx, MAY 2, 2022, View Source [SID1234613334]). The Form 20-F can be accessed by visiting either the SEC’s website at www.sec.gov or the Company’s website at www.ambrx.com.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Company will provide a hard copy of the annual report containing its audited consolidated financial statements, free of charge, to its shareholders and holders of its American Depositary Shares upon request. Requests should be directed in writing by email to [email protected].

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.