On May 17, 2023 Sigyn Therapeutics, Inc. ("Sigyn" or the "Company") (OTCQB: SIGY), a development-stage medical technology company, reported that it has submitted a provisional patent application entitled: "DEVICES FOR ENHANCING THE ACTIVITY OF THERAPEUTIC ANTIBODIES" to the United States Patent and Trademark Office ("USPTO") (Press release, Sigyn Therapeutics, MAY 17, 2023, View Source [SID1234631813]). Associated with this patent submission, the Company further disclosed that a trademark application to register ImmunePrepTM has also been filed with the USPTO.

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ImmunePrepTM is a development-stage commercialization platform for antibody-based immunotherapies and their corresponding biosimilars. The platform is designed to permit the potential creation of selective plasma depletion devices that enhance the delivery of therapeutic antibodies without increasing drug toxicity.

Therapeutic antibodies are market-cleared to treat a variety of indications, including but not limited to Alzheimer’s disease, autoimmune disorders, and cancer. However, patient response to these therapies is often suboptimal as just a small portion of infused antibodies reach their intended therapeutic target. In many cases, infused antibodies are bound by drug decoys that display the antibody’s antigen binding site on their surface. As a result, these decoys are empowered to bind and sequester antibodies from being delivered to their therapeutic targets (such as cancer cells).

ImmunePrepTM is designed to allow for a monoclonal antibody to be the active component of a selective plasma depletion device that preemptively eliminates bloodstream decoys that would subsequently block the infused delivery of the same antibody. The mechanistic objective of this pre-treatment strategy is to increase the availability of antibodies to interact with their intended therapeutic targets without increasing drug toxicity. Concurrently, the ability of therapeutic targets to evade antibody interactions would be diminished.

The Company believes that the ImmunePrepTM platform establishes a novel strategy to create selective plasma depletion therapies that incorporate either market-approved or clinical-stage monoclonal antibodies. As of June 30, 2022, the Umabs antibody database reported 162 antibody therapies to be market-approved by at least one regulatory agency, including 122 approvals in the US, followed by 114 in Europe, 82 in Japan and 73 in China. In December 2022, the Antibody Society reported nearly 1200 therapeutic antibodies to be in clinical studies.

The World Health Organization’s (WHO) International Agency for Research on Cancer projects the market for therapeutic monoclonal antibodies will grow from $208.68 billion (USD) in 2023 to $566.72 billion (USD) in 2032.

On May 17, 2023 Prime Medicine, Inc. (Nasdaq: PRME), a biotechnology company committed to delivering a new class of differentiated one-time curative genetic therapies, reported the presentation of new preclinical data that further demonstrated the potential of Prime Editing to correct the causative mutation of chronic granulomatous disease (CGD) and preclinical data that showcased the potential application of the Prime Editing Assisted Site-Specific Integrase Gene Editing (PASSIGETM) platform to generate multiplex-edited CAR-T cells for the treatment of certain cancers and immune diseases (Press release, Prime Medicine, MAY 17, 2023, View Source [SID1234631812]). The data are being presented today during the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 26th Annual Meeting, being held May 16-20, 2023, in Los Angeles, California.

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"We are very pleased to present these new data for our CGD program and PASSIGE platform today at ASGCT (Free ASGCT Whitepaper), which underscore our belief in the breadth and potential of Prime Editing to offer curative treatments for many diseases," said Jeremy Duffield, M.D., Ph.D., Chief Scientific Officer of Prime Medicine. "Our CGD program is progressing well, and with today’s data demonstrating the reproducibility of PM359 to correct the disease-causing mutation in CD34+ cells ex vivo with no off-target editing detected in the comprehensive set of studies done to date, we look forward to the PM359 program’s advancement through Investigational New Drug-enabling studies. Further, while the benefits of autologous CAR-T therapies are well established, their full potential is often hindered by manufacturing and delivery challenges. With our PASSIGE platform, we believe we can create allogeneic products that may overcome these challenges with a one-step, non-viral approach that could expand the applicability of T cell therapies for the potential treatment of tumors and immune diseases."

CGD Presentation Highlights
CGD is a rare inherited disease that leads to recurrent, debilitating and often life-threatening infections. It is caused by mutations in genes, including NCF1, that encode proteins that form NADPH oxidase, an enzyme that kills bacteria and fungi to control infection. Prime Medicine is advancing an ex vivo Prime Editing program that aims to correct the disease-causing mutation in NCF1 in CGD patient CD34+ hematopoietic stem cells (HSCs) and restore NADPH oxidase function. Prime Medicine has previously shared data from the CGD program that demonstrated the ability of Prime Editing to correct a CGD causative mutation in CD34+ cells ex vivo. The Prime Edited CD34+ cells engrafted long-term in vivo with editing levels greater than 92%. Today’s findings added to that, showing:
•Prime Editing was highly reproducible, demonstrating greater than 90% Prime Editing in CD34+ cells from each of four donors
•16-week engrafted Prime Edited CD34+ cells repopulated the bone marrow, reconstituted production of human blood cells, and biodistributed to the spleen and peripheral blood
•Comprehensive off-target analyses demonstrated no detected off-target activity, large deletions or translocations in Prime Edited CD34+ cells
•These findings provide further support for the advancement of the company’s first development candidate, PM359, as a potential treatment for CGD

PASSIGE Presentation Highlights
Prime Medicine is advancing a platform technology known as PASSIGE, which combines Prime Editing with an integrase or site-specific recombinase enzyme to enable the introduction of large-sized cargo into the genome as a potential one-time therapy. This approach is designed to expand the versatility of Prime Editing with the intent to broaden the range of permanent genomic edits that Prime Editing can make to potentially treat disease, including the ability to insert, delete or invert gene-sized pieces of DNA. In today’s presentation, Prime Medicine highlighted expanded work using PASSIGE technology and a non-viral approach to generate CD19 CAR-T cells, as well as
robust disruption of relevant target genes (TRAC and B2M) using Prime Editing in primary human T cells. Results showed:

•Single-step PASSIGE-mediated insertion of a CD19-CAR at the TRAC genetic locus in primary human T cells led to greater than 90% loss of T cell receptor expression and 60% targeted integration of a 3.5 kb CD19 CAR transgene, with no observed impact on T cell viability or T cell expansion
•PASSIGE-generated CD19 CAR-T cells exhibited potent anti-tumor activity in vitro and in vivo
•Prime Editing of the B2M gene in primary human T cells led to greater than 90% knock-out of B2M protein expression
•Efficient multiplex Prime Editing at three genomic target sites in primary human T cells
•These results support the potential of PASSIGE and Prime Editing to provide a modular, one-step system to create best-in-class, potent and targeted, allogeneic CAR-T cell therapies

Presentation Details
Abstract Title: (101) Prime Editing of Human CD34+ Long-Term Hematopoietic Stem Cells Precisely Corrects the Causative Mutation of p47phox Chronic Granulomatous Disease and Restores NADPH Oxidase Activity in Myeloid Progeny
Date & Time: Wednesday, May 17, 2023, 5:15 – 5:30 p.m. PT
Room: Room 515 AB
Session Title: Genome Editing Therapies & Safety I
Presenter: Jennifer Gori

Abstract Title: (602) An All-Prime Editing One-Step Approach for Non-Viral Generation of a Multiplex-Edited Allogeneic CAR-T Cell Product
Date & Time: Wednesday, May 17, 2023, 12:00 p.m. PT
Session Title: Wednesday Poster Session
Presenter: Emily Pomeroy

On May 17, 2023 Prelude Therapeutics presented its corporate presentation (Presentation, Prelude Therapeutics, MAY 17, 2023, View Source [SID1234631810]).

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On May 17, 2023 NuCana plc (NASDAQ: NCNA) reported financial results for the first quarter ended March 31, 2023 and provided an update on its broad clinical development program with its transformative ProTide therapeutics (Press release, Nucana BioPharmaceuticals, MAY 17, 2023, View Source [SID1234631809]).

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As of March 31, 2023, NuCana had cash and cash equivalents of £31.0 million compared to £41.9 million at December 31, 2022. NuCana continues to advance its various clinical programs and reported a net loss of £7.9 million for the quarter ended March 31, 2023, as compared to a net loss of £8.4 million for the quarter ended March 31, 2022. Basic and diluted loss per share was £0.15 for the quarter ended March 31, 2023, as compared to £0.16 per share for the comparable quarter ended March 31, 2022.

"Building off of a productive 2022 and executing on a number of milestones that continued to demonstrate the potential of our ProTides, we entered 2023 with strong momentum," said Hugh S. Griffith, NuCana’s Founder and Chief Executive Officer. "We continue to advance NUC-3373 and plan to provide data updates in 2023 from each of the three ongoing studies evaluating this ProTide, which we believe has the potential to replace 5-FU across multiple tumor types. These studies are: the Phase 2 portion of the NuTide:302 study evaluating NUC-3373 combined with leucovorin and either irinotecan (NUFIRI) or oxaliplatin (NUFOX) plus bevacizumab in patients with second-line colorectal cancer; the randomized Phase 2 NuTide:323 study of NUFIRI plus bevacizumab compared to the standard of care FOLFIRI plus bevacizumab in patients with second-line colorectal cancer; and the Phase 1b/2 NuTide:303 modular study of NUC-3373 both in combination with pembrolizumab in patients with solid tumors and in combination with docetaxel in patients with lung cancer."

Mr. Griffith continued: "We recently presented data on NUC-7738 highlighting its multi-faceted mechanisms of action at the AACR (Free AACR Whitepaper) 2023 Annual Meeting, which continues to support our clinical development strategy. NUC-7738 is based on a novel nucleoside analogue, 3’-deoxyadenosine, and is being evaluated in the Phase 2 part of the NuTide:701 study both as a monotherapy in patients with solid tumors and in combination with pembrolizumab in patients with melanoma. This study is progressing well and we anticipate sharing additional data later this year."

Mr. Griffith concluded: "With numerous upcoming value-driving milestones and a cash runway expected to fund operations into 2025, we are well positioned and look forward to an exciting year as we advance our mission of developing safer and more effective treatment options for patients with cancer."

2023 Anticipated Milestones

NUC-3373 (a ProTide transformation of 5-FU)

In 2023, NuCana expects to:

Announce data from the Phase 2 (NuTide:302) study of NUC-3373 combined with irinotecan and bevacizumab (NUFIRI-bev) and in combination with oxaliplatin and bevacizumab (NUFOX-bev) in second-line patients with colorectal cancer;
Announce data from the randomized Phase 2 (NuTide:323) study of NUFIRI-bevacizumab versus the standard of care FOLFIRI-bevacizumab for the second-line treatment of patients with colorectal cancer; and
Announce data from the Phase 1b (NuTide:303) modular study of NUC-3373 in combination with pembrolizumab in patients with solid tumors and in combination with docetaxel in patients with lung cancer to identify additional indications for development.
NUC-7738 (a ProTide transformation of 3’-deoxyadenosine)

In 2023, NuCana expects to:

Announce data from the Phase 1 part of the NuTide:701 study of NUC-7738 in patients with solid tumors; and
Announce data from the Phase 2 part of the NuTide:701 study of NUC-7738 both as monotherapy in patients with solid tumors and in combination with pembrolizumab in patients with melanoma.

On May 17, 2023 NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – the ‘‘Company’’), a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, reported an update on operational progress and reported financial results for the for the first quarter of 2023 (Press release, Nanobiotix, MAY 17, 2023, View Source [SID1234631808]).

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"2023 will be a foundational year for Nanobiotix, and we are energized to further advance late-stage development of our radioenhancer NBTXR3 in head and neck cancer. The recent operational efficiencies implemented last year are working, and we are seeing enrollment progress well in our pivotal Phase 3 study, NANORAY-312, with 122 sites activated in 24 countries to date," said Laurent Levy, co-founder of Nanobiotix and chairman of the executive board. "We remain focused on our near-term milestones including final data for Study 102, and a first look at NBTXR3 in pancreatic cancer as part of our MD Anderson collaboration. We are excited to welcome a new Chief Medical Officer in the third quarter of this year who will help further enhance our clinical development strategy. We believe that the clinical and corporate framework we are establishing will strongly position us for growth and successful execution across our programs in the years ahead."

Pipeline Status and Expected Upcoming Milestones

Chief Medical Officer (CMO) candidate with strategically aligned experience in oncology and immuno-oncology is expected to join the organization in Q3 2023
Locally Advanced Head and Neck: Priority Registration Pathway in Locally Advanced Head & Neck Squamous Cell Carcinoma (LA-HNSCC), Local Control as Single Agent Activated by Radiotherapy (RT):

NANORAY-312 Phase 3 trial evaluating RT-activated NBTXR3 ± cetuximab vs RT ± cetuximab in elderly patients with LA-HNSCC
Futility analysis to be conducted following 25% of planned PFS events expected in H1 2024
Initial Phase 3 interim efficacy and safety data expected after 67% of planned PFS events in H2 2024
Study 102 Phase 1 trial evaluating RT-activated NBTXR3 in LA-HNSCC
Final safety and efficacy data expected in H2 2023
Recurrent/Metastatic Head and Neck: Priority Pathway in Immunotherapy for Recurrent/Metastatic Head & Neck Squamous Cell Carcinoma (R/M HNSCC), Priming Immune Response Followed by an Anti-PD-1 Treatment:

Study 1100 Phase 1 dose escalation and expansion trial evaluating RT-activated NBTXR3 followed by an anti-PD-1 in patients with advanced cancers
Phase 1 data update anticipated at a time to be determined
Phase 3 registrational program for patients with unresectable locoregional recurrent (LRR) or recurrent or metastatic HNSCC resistant to previous anti-PD-1/PD-L1 therapy
Company plans to consult with incoming CMO prior to continuing discussions with FDA on potential registration pathway for an NBTXR3-immunotherapy approach, and expects to provide an update in Q3 2023
Pancreatic, Lung and others: Expanding NBTXR3 Opportunity, Collaborating with a World-Class Partner to Validate Tumor-Agnostic, Combination-Agnostic Therapeutic Profile:

Ongoing collaboration with The University of Texas MD Anderson Cancer Center
Preliminary Phase 1b dose escalation safety data in PDAC expected in H2 2023
Completion of enrollment in Phase 1b dose expansion trial for PDAC expected in H2 2023
Determination of RP2D for NBTXR3 in non-small cell lung cancer (NSCLC) expected in H2 2023
Initial Phase 1b/2 data for NBTXR3 in combination with chemotherapy in patients with esophageal cancer expected in 2024
First Quarter Financial Updates

Cash and Cash Equivalents:

Based on the current operating plan and financial projections, Nanobiotix anticipates that the cash and cash equivalents of €30.2 million as of March 31, 2023, will fund its operations into the third quarter of 2023, assuming no additional cash inflows, no business development transaction is consummated and assuming the European Investment Bank does in fact exercise the covenant requiring the Company to have a cash and cash equivalents balance at least equal to the principal of the loan balance currently at €25.3 million.

Next Annual General Meeting of the Company

The Company announced that its next Annual General Meeting ("AGM") will be held on June 27, 2023, at its headquarters, 60 rue de Wattignies, 75012 Paris, France. The notice of meeting of this AGM will be published shortly in the French legal bulletin and will include the agenda, the proposed resolutions as well as instructions to participate and vote in this AGM. All documentation regarding this AGM will be published on the Company’s website.