On May 17, 2023 Xbiotech Inc. (NASDAQ: XBIT) ("Xbiotech") reported that it commenced a "modified Dutch auction" issuer tender offer to purchase up to $80,000,000 in value of its common shares, or such lesser number of common shares as are properly tendered and not properly withdrawn, at a price not greater than $4.00 nor less than $3.80 per common share, to the seller in cash, less any applicable withholding taxes and without interest (the "Offer") (Press release, XBiotech, MAY 17, 2023, View Source [SID1234631814]). The Offer is made upon the terms and subject to the conditions described in an offer to purchase dated May 17, 2023, the related letter of transmittal and the website established for purposes of effectuating the Offer. The closing price of XBiotech’s common shares on the NASDAQ Global Select Market on May 17, 2023, the last trading day before the commencement of the Offer, was $3.48 per share. The Offer is scheduled to expire at 5:00 p.m., Eastern Time, on June 15, 2023, unless the Offer is extended.

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XBiotech believes that the Offer represents an efficient mechanism to provide XBiotech’s shareholders with the opportunity to tender all or a portion of their shares and thereby receive a return of some or all of their investment in XBiotech if they so elect. The Offer provides shareholders with an opportunity to obtain liquidity with respect to all or a portion of their shares without the potential disruption to XBiotech’s share price.

The Offer is not contingent upon obtaining any financing. However, the Offer is subject to a number of other terms and conditions, which are described in detail in the offer to purchase. Specific instructions and a complete explanation of the terms and conditions of the Offer are contained in the offer to purchase, the letter of transmittal, the offer website and the related materials. The offer to purchase, the letter of transmittal (which contains information on how to access the offer website) and the related materials are being mailed to shareholders of record.

None of XBiotech, the members of its board of directors (including the Independent Committee of its board of directors who authorized the Offer), the information agent or the depositary makes any recommendation as to whether any shareholder should participate or refrain from participating in the Offer or as to the price or prices at which shareholders may choose to tender their shares in the Offer.

Computershare Trust Company, N.A. will serve as the depositary for the Offer and Georgeson LLC will serve as information agent for the Offer. Shareholders with questions, or who would like to receive additional copies of the Offer documents may call or email the information agent for the Offer at (877) 278-4775 or [email protected].

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.