Abeona Therapeutics Announces $35 Million Private Placement Financing

On November 3, 2022 Abeona Therapeutics Inc. (Nasdaq: ABEO) reported that it has entered into a securities purchase agreement to sell 7,065,946 shares of its common stock, and, in lieu of shares of common stock, pre-funded warrants exercisable for 543,933 shares of common stock, and accompanying warrants to purchase 7,609,879 shares of its common stock to a group of new and existing institutional investors in a private placement (Press release, Abeona Therapeutics, NOV 3, 2022, View Source [SID1234622855]). The offering price for each share of common stock and accompanying warrant was $4.60, and the offering price for each pre-funded warrant and accompanying warrant was $4.59, which equals the offering price per share of the common stock and accompanying warrant, less the $0.01 per share exercise price of each pre-funded warrant. Each accompanying warrant will represent the right to purchase one share of the Company’s common stock at an exercise price of $4.75 per share of common stock. The pre-funded warrants and the accompanying warrants will be exercisable immediately, and will expire five years from the date of issuance. Gross proceeds of the private placement are expected to be approximately $35,000,000, before deducting placement agent fees and other expenses. The private placement is expected to close on November 7, 2022, subject to the satisfaction of customary closing conditions.

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The private placement included participation from new and existing institutional investors including Adage Capital Management LP, Armistice Capital, Deerfield Management Company, L.P., EcoR1 Capital and Nantahala Capital as well as other specialist biotech investors.

Abeona intends to use the net proceeds from the proposed private placement for development, working capital and general corporate purposes. Abeona estimates that the net proceeds from the proposed private placement plus its existing financial resources are sufficient to fund operations into the third quarter of 2024.

Cantor Fitzgerald & Co. acted as sole placement agent on the transaction.

The securities being issued and sold in the private placement, including the shares of common stock underlying the warrants, have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or any states’ securities laws and may not be offered or sold in the United States, except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act. Abeona has agreed to file a registration statement with the Securities and Exchange Commission (the "SEC") registering the resale of the shares of common stock and the shares of common stock issuable upon exercise of the warrants issued in this private placement. Any offering of securities under a resale registration statement will only be made by means of a prospectus.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of securities of Abeona in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

Pacylex Announces FDA Clearance of IND Application for PCLX-001 to Treat Acute Myeloid Leukemia

On November 2, 2022 Pacylex, a clinical-stage NMT inhibitor company developing first-in-class therapies for leukemia, lymphoma, and solid tumor cancers, reported that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for PCLX-001 for the treatment of acute myeloid leukemia (AML) (Press release, Pacylex Pharmaceuticals, NOV 2, 2022, View Source [SID1234645059]). The open IND enables a Phase 1/2 clinical study to start in the coming months at The University of Texas MD Anderson Cancer Center, which was recently awarded a US Department of Defense (DOD) grant for this purpose.

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Last month the U.S. FDA also granted PCLX-001 Orphan Drug Designation for "treatment of patients with acute myeloid leukemia." PCLX-001 is a first-in-class N-myristoylation inhibitor in clinical development by Pacylex. PCLX-001 is currently being studied in non-Hodgkin lymphoma (NHL) and solid tumor cancer patients at 4 sites in Canada. Pacylex has the first and only NMT inhibitor in clinical studies.

"With this IND clearance, Pacylex opens up a second clinical indication for the investigation of PCLX-001 in patients," said Michael Weickert, PhD, CEO of Pacylex. In the ongoing studies of PCLX-001, seventeen patients have been accrued through 5 dose levels of oral, once-per-day PCLX-001 with no dose limiting toxicities observed.

"Non clinical data suggests that AML may be the cancer type most sensitive to NMT inhibitors, so we are excited to move PCLX-001 into clinical studies in AML patients in the near future," said John Mackey, MD, CMO of Pacylex. Luc Berthiaume, PhD, CSO of Pacylex commented, "It is gratifying to see the pre-clinical work pioneered in my lab, translating to clinical investigations and the potential to help patients in the near future." Data on the scientific rationale for PCLX-001 in AML patients, will be presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition from 10-13 December 2022.

The ongoing clinical PCLX-001 trial in NHL and solid tumor patients is registered at ClinicalTrials.gov Identifier: NCT04836195.

PCLX-001

PCLX-001 (aka DDD86481) is a first-in-class, small molecule NMT inhibitor originally developed by the University of Dundee Drug Discovery Unit as part of a program to treat African sleeping sickness, funded by Welcome Trust. Pacylex is developing PCLX-001 in the form of a once-a-day pill initially to treat leukemia and lymphoma. PCLX-001 has also been shown to inhibit the growth of lung and breast cancer tumors in animal models. In leukemia, lymphoma and breast cancer patients, the levels of NMT2 are correlated with survival, suggesting an important biological role in these cancers.

Aptamer Science, ‘ApDC immune anti-cancer drug’ selected for national new drug development project

On November 2, 2022 Aptamer Science that ‘CD25-ApDC immune anticancer agent’, an aptamer-based immune cell targeting anticancer drug delivery technology, was selected for the new drug base expansion research project of the National New Drug Development Project (Press release, Aptamer Sciences, NOV 2, 2022, View Source;idx=231 [SID1234641616]).

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The National New Drug Development Project is a pan-ministerial national R&D project that supports all stages of new drug development to strengthen the global competitiveness of the domestic pharmaceutical and bio industry and secure pharmaceutical sovereignty.

Aptamer Science plans to secure a foundation for expanding aptamer-based drug delivery technology (ApDC) to the area of ​​immunotherapy and anti-cancer drugs by receiving research funding through this project selection and to pursue research in earnest.

‘CD25-ApDC immune anti-cancer drug’ is a treatment that combines a drug with an aptamer that inhibits signal transduction through specific binding to CD25, a biomarker of regulatory T cells that function to suppress immunity in tumor tissue.

The concept is to eliminate tumors by increasing immune activity around the tumor by selectively suppressing the function of Treg cells and relatively inducing the activation of cytotoxic T cells and antigen-labeling cells.

Daegyeon Lee, Director of the New Drug Research Institute, said, "Cancer treatment through controlling the immune environment of tumor tissue is becoming a major strategy that is leading the paradigm shift in overall anticancer drug development.

"As the aptamer-based immunotherapy technology was selected for the national new drug development project, it served as an opportunity to confirm the potential and development competitiveness of the aptamer-drug complex technology that Aptamer Science is focusing on."

"Through this, we have laid the foundation to confirm non-clinical development materials early and promote non-clinical development in earnest," he said.

Aptamer Science attracted 16.5 billion won in investment on October 4 for the purpose of promoting full-scale clinical trials of ‘AST-201 targeted anti-cancer drug’ and developing follow-up pipelines such as new immuno-anticancer drugs and brain disease treatments.

We also plan to promote early technology transfer at the non-clinical stage.

Go to article: Aptamer Science, ‘ApDC immune anti-cancer drug’ selected for national new drug development project

10-Q – Quarterly report [Sections 13 or 15(d)]

United Therapeutics has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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Pacylex Announces FDA Clearance of IND Application for PCLX-001 to Treat Acute Myeloid Leukemia

On November 2, 2022 Pacylex, a clinical-stage NMT inhibitor company developing first-in-class therapies for leukemia, lymphoma, and solid tumor cancers, reported that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for PCLX-001 for the treatment of acute myeloid leukemia (AML) (Press release, Greenfire, NOV 2, 2022, View Source [SID1234624501]). The open IND enables a Phase 1/2 clinical study to start in the coming months at The University of Texas MD Anderson Cancer Center, which was recently awarded a US Department of Defense (DOD) grant for this purpose.

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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

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Last month the U.S. FDA also granted PCLX-001 Orphan Drug Designation for "treatment of patients with acute myeloid leukemia." PCLX-001 is a first-in-class N-myristoylation inhibitor in clinical development by Pacylex. PCLX-001 is currently being studied in non-Hodgkin lymphoma (NHL) and solid tumor cancer patients at 4 sites in Canada. Pacylex has the first and only NMT inhibitor in clinical studies.

"With this IND clearance, Pacylex opens up a second clinical indication for the investigation of PCLX-001 in patients," said Michael Weickert, PhD, CEO of Pacylex. In the ongoing studies of PCLX-001, seventeen patients have been accrued through 5 dose levels of oral, once-per-day PCLX-001 with no dose limiting toxicities observed.

"Non clinical data suggests that AML may be the cancer type most sensitive to NMT inhibitors, so we are excited to move PCLX-001 into clinical studies in AML patients in the near future," said John Mackey, MD, CMO of Pacylex. Luc Berthiaume, PhD, CSO of Pacylex commented, "It is gratifying to see the pre-clinical work pioneered in my lab, translating to clinical investigations and the potential to help patients in the near future." Data on the scientific rationale for PCLX-001 in AML patients, will be presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition from 10-13 December 2022.

The ongoing clinical PCLX-001 trial in NHL and solid tumor patients is registered at ClinicalTrials.gov Identifier: NCT04836195.

PCLX-001
PCLX-001 (aka DDD86481) is a first-in-class, small molecule NMT inhibitor originally developed by the University of Dundee Drug Discovery Unit as part of a program to treat African sleeping sickness, funded by Welcome Trust. Pacylex is developing PCLX-001 in the form of a once-a-day pill initially to treat leukemia and lymphoma. PCLX-001 has also been shown to inhibit the growth of lung and breast cancer tumors in animal models. In leukemia, lymphoma and breast cancer patients, the levels of NMT2 are correlated with survival, suggesting an important biological role in these cancers.