On July 22, 2024 Aligos Therapeutics, Inc. (Nasdaq: ALGS, "Aligos"), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, reported that it has entered into a clinical trial collaboration agreement with Xiamen Amoytop Biotech Co., Ltd. ("Amoytop") (Press release, Aligos Therapeutics, JUL 22, 2024, View Source [SID1234644997]).

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Under the terms of the agreement, Amoytop will sponsor and perform a Phase 1b exploratory clinical study evaluating the efficacy and safety of ALG-000184 in combination with PEGBING (Mipeginterferon alfa-2b) in chronic hepatitis B (CHB) patients in China. The clinical study is expected to begin after approval by the National Medical Products Administration in China.

"We are pleased to build on our existing relationship with Amoytop, as they have proven to be a valuable partner," stated Lawrence Blatt, Ph.D., MBA, Chairman, President, and Chief Executive Officer at Aligos Therapeutics. "We look forward to initiating this exploratory study to evaluate the combination of ALG-000184 with PEGBING, one of the approved drugs for CHB patients in China, to assess the potential benefits of a combinatory approach."

ALG-000184 is a potent best/first-in-class oral small molecule capsid assembly modulator (CAM-E) being developed for CHB. It is designed to exploit the dual role of CAMs by disrupting hepatitis B cccDNA levels and its derived transcripts by reducing expression of viral markers such as DNA, RNA, and the relevant antigens (HBsAg, HBeAg, HBcrAg). Phase 1a studies have demonstrated after single and multiple daily doses that ALG-000184 was well-tolerated, with no safety signals observed, and demonstrated linear pharmacokinetics (PK) and excellent antiviral activity. In longer term Phase 1b studies of ALG-000184 300mg x ≤96 weeks ± entecavir (ETV), ALG-000184 monotherapy has demonstrated best-in-class reductions in HBV DNA, RNA, HBsAg, HBeAg, and HBcrAg without viral breakthrough to date.

PEGBING, independently developed by Amoytop, is the world’s first 40kD pegylated interferon α-2b injection. With dual effects of inhibiting viral replication and enhancing immunity, PEGBING is mainly used in the clinical treatment of viral hepatitis and is the first-line drug for the antiviral treatment of chronic hepatitis B, which plays an important role in improving the clinical cure rate of hepatitis B and reducing the risk of liver cancer.

"We are pleased to deepen our cooperation in the field of liver disease treatment and look forward to working together to provide a new treatment solution for patients in need," said Sun Li, Chairman and Chief Executive Officer at Amoytop. "Amoytop is committed to further optimizing the chronic hepatitis B combination treatment pathway and hopes that the cooperation will lead to better clinical value drugs and drug combinations."

The Phase 1b study will be a randomized, double blinded, active controlled study to evaluate the safety, pharmacokinetics, and antiviral activity of oral once daily doses of 300 mg ALG-000184 + PEGBING + entecavir (ETV) compared with 300 mg ALG-000184 + ETV or PEGBING + ETV in treatment naïve or currently-not-treated HBeAg-positive and nucleos(t)ide analog (NA) suppressed HBeAg-negative subjects with CHB for 48 weeks.

On July 22, 2024 Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") and Graduate School of Medicine / Faculty of Medicine, Osaka University (President: Shojiro Nishio "Osaka University") reported that Astellas Institute for Regenerative Medicine (a wholly owned subsidiary of Astellas, "AIRM"), Universal Cells (a wholly owned subsidiary of Astellas) and Osaka University have entered into a research collaboration to develop innovative pluripotent stem cell*1-derived cartilage organoid cell therapy for the treatment of intervertebral disc degenerative disease (Press release, Astellas, JUL 22, 2024, View Source [SID1234644998]).

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Universal Cells holds the rights to Universal Donor Cell (UDC) technology to create cell therapy products from pluripotent stem cells that have reduced risk of immune rejection by genetically modifying Human Leukocyte Antigen (HLA) using gene editing technology.

Under the terms of the agreement, the three parties aim to combine the cartilage tissue creation protocol established by Professor Noriyuki Tsumaki of (Graduate School of Frontier Biosciences / Premium Research Institute for Human Metaverse Medicine) the Department of Tissue Biochemistry and Molecular Biology, Graduate School of Medicine, Osaka University, a leading researcher in cartilage diseases, Universal Cells’ UDC technology, and AIRM’s exceptional R&D expertise in cell therapy, and jointly create an innovative cell therapy for intervertebral disc degenerative disease.

Yoshitsugu Shitaka, Ph.D., Chief Scientific Officer (CScO) of Astellas
"Astellas is committed to achieving our VISION of being "on the forefront of healthcare change, turning innovative science into VALUE for patients". We hope to provide our cutting-edge UDC technology to academia and startups globally, and deliver next-generation cell therapies to patients. This partnership is an important step in the open innovation using UDC technology."

Professor Noriyuki Tsumaki, M.D., Ph.D., (Graduate School of Frontier Biosciences / Premium Research Institute for Human Metaverse Medicine) Department of Tissue Biochemistry and Molecular Biology, Graduate School of Medicine, Osaka University
"We believe that our cartilage-like tissue has the potential to regenerate intervertebral discs. We hope that combining our research with Astellas’ UDC technology and R&D cell therapy system will accelerate and realize the development of regenerative therapies to treat intervertebral disc degenerative disease."

On July 22, 2024 Bicycle Therapeutics plc (NASDAQ: BCYC), a pharmaceutical company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported the acceptance of four abstracts for poster presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024, taking place September 13-17 in Barcelona (Press release, Bicycle Therapeutics, JUL 22, 2024, View Source [SID1234644999]).

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Poster Presentation Details:

Title: BT8009 monotherapy in enfortumab vedotin-naïve patients with metastatic urothelial carcinoma (mUC): Updated results of Duravelo-1
Poster Session Title: Poster session 01
Date and Time: Saturday, Sept. 14, at 9-10 a.m. CEST
Presentation Number: 652P
Speaker: Oscar Reig Torras, M.D., Hospital Clinic de Barcelona

Title: Peripheral neuropathy following treatment with Bicycle Toxin Conjugates BT8009 or BT5528 monotherapy in patients with advanced solid tumors
Poster Session Title: Poster session 01
Date and Time: Saturday, Sept. 14, at 9-10 a.m. CEST
Presentation Number: 654P
Speaker: Bernard Doger de Spéville, M.D., Ph.D., START Madrid-FJD and Hospital Universitario Fundacion Jimenez Diaz

Title: EphA2-targeting Bicycle Toxin Conjugate BT5528 in patients with advanced solid tumors: A phase 1/2 study
Poster Session Title: Poster session 01
Date and Time: Saturday, Sept.14, at 9-10 a.m. CEST
Presentation Number: 647P
Speaker: Elisa Fontana, M.D., Ph.D., Sarah Cannon Research Institute UK

Title: Initial results from a phase 1/2 study of BT7480, a novel Nectin-4/CD137 Bicycle Tumor-Targeted Immune Cell Agonist, in patients with advanced solid tumors
Poster Session Title: Poster session 01
Date and Time: Saturday, Sept.14, at 9-10 a.m. CEST
Presentation Number: 650P
Speaker: Kyriakos P. Papadopoulos, M.D., START San Antonio

The posters will be made available in the Publications section of bicycletherapeutics.com following the presentations.

On July 22, 2024 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, reported that the majority of Tranche B warrants issued under its September 2023 private placement have been exercised for Series E preferred stock, convertible into the company’s common stock, by the participants of the previous financing, led by Rosalind Advisors, in exchange for a reduced, as-converted common stock price of $2.52 and the purchase of new warrants (Press release, Cellectar Biosciences, JUL 22, 2024, View Source [SID1234645000]). The exercised Tranche B warrants and newly purchased warrants will generate gross proceeds of approximately $19.4 million. The new warrants purchased by investors have the potential to generate up to an additional $73.3 million in gross proceeds, if exercised.

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The new warrants purchased by investors include Tranche A, B and C. The Tranche A warrants provide gross proceeds up to approximately $17.0 million based on the exercise price of $2.52, which was the closing market price of the Company’s common stock on July 19, 2024, and include a 10-trading-day trigger for exercise following Cellectar’s public announcement of the Food and Drug Administration (FDA) having assigned a Prescription Drug User Fee Act goal date for review of iopofosine I 131. The Tranche B Warrants provide gross proceeds up to approximately $32.9 million based on an exercise price of $4.00 per share, with a 10-trading-day trigger for investors to exercise upon FDA approval of iopofosine I 131. The Tranche C warrants provide gross proceeds up to approximately $23.5 million based on an exercise price of $5.50 per share, with a 10-trading-day trigger for investors to exercise following Cellectar reporting domestic quarterly revenue from iopofosine I 131 exceeding $10.0 million.

The new warrants have not been registered under the Securities Act of 1933, as amended, or applicable under state securities laws. Accordingly, the securities 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 and such applicable state securities laws. As part of the transaction, the Company has agreed to file a resale registration statement on Form S-3 with the Securities and Exchange Commission within 30 days of the exercise date of the Tranche B warrants to register the resale of the shares of common stock underlying the new warrants.

The company expects to file an NDA for iopofosine I 131 for the treatment of Waldenstrom’s macroglobulinemia in the fourth quarter of 2024 and will be seeking a priority review. Funds generated from the execution of these warrants are expected to advance the company to commercialization.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities described herein, nor shall there be any sale of these securities in any state or 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.

On July 22, 2024 Epigenomics AG (FSE: ECX; ISIN: DE000A37FT41) reported that it has closed its first half of the 2024 fiscal year (January 1 to June 30, 2024) with an expected loss (individual financial statements according to the German Commercial Code) of EUR 0.8 million (comparable period 1H 2023 ("H1"): loss EUR 5.7 million) and with freely available liquid funds (consisting of cash and bank balances) of EUR 1.2 million as of June 30, 2024 (previous year December 31, 2023 ("previous year"): EUR 2.1 million) (Press release, Epigenomics, JUL 22, 2024, View Source [SID1234645001]).

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The preliminary result includes other operating income of EUR 78 thousand (previous year: EUR 438 thousand), as well as personnel expenses of EUR 233 thousand (previous year: EUR 3,502 thousand), other operating expenses of EUR 465 thousand (previous year: EUR 2,575 thousand) and a financial result of EUR -164 thousand (previous year: EUR 306 thousand), mainly consisting of depreciation on financial assets of EUR 178 thousand (previous year: EUR 0 thousand).

Other operating expenses mainly include legal and consulting costs (EUR 152 thousand), costs of stock exchange listing and capital market communication (EUR 97 thousand), IT costs (EUR 62 thousand) and accounting and auditing costs (EUR 56 thousand).

The preliminary balance sheet as of June 30, 2024 according to the German Commercial Code (HGB) shows negative equity of EUR 8,344 thousand (previous year: negative equity EUR 8,016 thousand).

In the forecast report of the last annual financial statements (financial year 2023), the Management Board forecast an annual result in the range of EUR -1.2 million to EUR -0.8 million for the financial year 2024. The Management Board is currently sticking to the existing forecast for the financial year 2024.

The above-mentioned preliminary result is based on the preliminary assessment of the first half of 2024 carried out by the Management Board on July 22, 2024.