Circle Pharma Achieves Major Milestone with the Selection of a Clinical Development Candidate Directly Inhibiting Cyclins A and B

On July 19, 2023 Circle Pharma, a biopharmaceutical company advancing the discovery and development of intrinsically cell-permeable macrocycles, reported the selection of CID-078 for its first clinical development program (Press release, Circle Pharma, JUL 19, 2023, View Source [SID1234633312]). CID-078 is the first-and-only-in-class dual inhibitor of Cyclins A and B, which play essential roles in regulating cell cycle progression. Inhibiting Cyclins A and B selectively induces synthetic lethality in certain cancers exhibiting cell cycle dysregulation while sparing healthy cells.

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Circle Pharma recently presented pre-clinical data for its dual Cyclin A/B inhibitors at this year’s American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. The data demonstrated activity across a wide range of human tumor cell lines including tumor regression in xenograft models of small cell lung carcinoma (SCLC) and ovarian cancer. SCLC has a five-year survival rate of 3.5%, and its treatment has seen minimal progress in the last 30 years. Ovarian cancer patients commonly face poor outcomes and resistance to the current standard of care. In advance of human clinical trials for CID-078, further preclinical studies using patient-derived models (PDX) are underway in breast cancer (including triple negative breast cancer), non-small cell lung cancer, gastric cancer, pancreatic cancer, and other tumor types.

"The selection of CID-078 represents a major milestone for our team; we are excited to advance this molecule into clinical development and to realize its potential to bring new hope for the many cancer patients who currently have woefully inadequate treatment options," said David Earp, J.D., Ph.D., President and Chief Executive Officer of Circle Pharma. "This achievement is also a reflection of the capabilities of our macrocycle discovery platform as the cyclins have until now been considered undruggable."

ABOUT CID-078
CID-078 is an orally bioavailable macrocycle with dual cyclin A and B inhibitory activity that drives synthetic lethality in multiple tumor types. In biochemical and cellular studies, CID-078 has been shown to potently and selectively disrupt the protein-protein interaction between Cyclins A and B and their key substrates, including E2F (a substrate of Cyclin A) and Myt1 (a substrate of Cyclin B). Preclinical studies have demonstrated the ability of CID-078 to cause pronounced tumor regression in multiple xenograft models. Circle Pharma plans to file an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) for CID-078 and initiate clinical development in 2024.

Cerus Corporation to Release Second Quarter 2023 Financial Results on August 2, 2023

On July 19, 2023 Cerus Corporation (Nasdaq: CERS) reported that its second quarter 2023 financial results will be released on Wednesday, August 2, 2023, after the close of the stock market (Press release, Cerus, JUL 19, 2023, View Source [SID1234633311]). The Company will host a conference call and webcast at 4:30 P.M. ET that afternoon, during which management will discuss the Company’s financial results and provide a general business overview and outlook.

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To listen to the live webcast and view the presentation slides, please visit the Investor Relations page of the Cerus website at View Source Participants may register for the call here. While not required, interested participants are encouraged to join 10 minutes prior to the start of the event.

A replay will be available on Cerus’ website and will be available approximately three hours after the call through August 16, 2023.

Alkermes to Report Second Quarter Financial Results on July 26, 2023

On July 19, 2023 Alkermes plc (Nasdaq: ALKS) reported that it will host a conference call and webcast presentation at 8:00 a.m. ET (1:00 p.m. BST) on Wednesday, July 26, 2023 to discuss the company’s second quarter financial results (Press release, Alkermes, JUL 19, 2023, View Source [SID1234633310]).

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The webcast player and accompanying slides may be accessed on the Investors section of Alkermes’ website at www.alkermes.com. The conference call may be accessed by dialing +1 877 407 2988 for U.S. callers and +1 201 389 0923 for international callers. A replay of the webcast will be available approximately two hours after the completion of the event and may be accessed by visiting Alkermes’ website.

Imugene Oncolytic Virotherapy CF33 Patent Allowed in the US

On July 19, 2023 Imugene Limited (ASX:IMU) a clinical stage immunooncology company reported it has received a Notice of Allowance from the US Patent and Trademark Office (USPTO) for patent application number 16/324,541 which protects its oncolytic virotherapy CF33, including VAXINIA (CF33-hNIS) and CHECKVacc (CF33-hNIS-antiPDL1) (Press release, Imugene, JUL 19, 2023, View Source [SID1234633298]).

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The patent titled "CHIMERIC POXVIRUS COMPOSITION AND USES THEREOF" (inventors Yuman Fong and Nanhai Chen from the City of Hope) protects the method of composition and method of use of Imugene’s licensed oncolytic virotherapy to 2037.

CF33 is a chimeric vaccinia poxvirus from the lab of inventor Professor Yuman Fong, Chair of Sangiacomo Family Chair in Surgical Oncology at City of Hope, and a noted expert in the oncolytic virus field.

Oncolytic viruses (OVs) are designed to both selectively kill tumour cells and activate the immune system against cancer cells, with the potential to improve clinical response and survival.

Imugene MD & CEO Leslie Chong said: "Imugene receiving this patent allowance for the CF33 family of oncolytic viruses from the US patent office is a crucial step forward and with the US being the largest healthcare market in the world, this is a particularly important patent milestone."

For more information please contact:
Leslie Chong
Managing Director and Chief Executive Officer

Molecure completes successful Secondary Public Offering of approximately USD 12 million with proceeds to be used to fund and build a first in class, sustainable pipeline of breakthrough therapies

On July 18, 2023 Molecure S.A. ("Molecure", WSE ticker: MOC), a biotechnology company discovering and developing drugs to the clinical stage, which leverages its globally unique expertise in medicinal chemistry and biology to explore and develop first-in-class small-molecule drugs that directly modulate protein activity and mRNA function to treat a wide range of incurable diseases, reported that it has successfully closed the SPO and entered into subscription agreements for all 2,776,000 H shares offered by way of private placement, within the authorized capital (Press release, Molecure, JUL 18, 2023, View Source [SID1234640061]). The issue price was set at PLN 18, bringing the gross value of the offering to approximately USD 12 milion (PLN 50 million).

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"We have successfully closed the H-share offering, which garnered significant interest from investors, including those who previously were not part of our shareholder base. We would like to thank all investors for participating in the offering and for the trust they have placed in Molecure. During the discussions with investors throughout the offering, we encountered a very good reception to our Strategy and a positive evaluation of the Company’s growth potential, which translated into investors’ interest several times higher than the number of shares offered. Considering the current market conditions, we view the execution of the share issue as a remarkable achievement. The proceeds from the offering will be utilized to finance the advancement of Molecure’s research programmes, aimed at developing effective therapies to address numerous incurable diseases afflicting patients" – says Marcin Szumowski, CEO and shareholder of Molecure S.A.

The proceeds raised through the offering will co-finance the implementation of the Company’s strategic plans for 2023-2025, including, in particular, significant progress in the clinical development of two flagship programmes, namely OATD-01 (a first-in-class chitotriosidase 1 inhibitor, CHIT1) and OATD-02 (a first-in-class dual arginase inhibitor). Additionally, efforts will be intensified in a portfolio of early-stage programmes, including breakthrough small-molecule drug technology that modulates mRNA translation and therapeutics targeting previously unexplored protein targets. These initiatives are bolstered by advanced machine learning and generative artificial intelligence (GenAI) methods. Molecure estimates that the capital expenditure associated with the strategy from mid-2023 to the end of 2025 will amount to approximately PLN 250 million.

Molecure is the exclusive owner – as the only biotech company in Poland – two first-in-class compounds at the clinical trial stage and is consistently building the value of these programmes, aiming to secure at least one high-value partnership agreement between 2023 and 2025, which could translate into tangible benefits for Shareholders.

"The primary business objective of our strategy is to transform the intellectual value we have created into commercial success. We anticipate concluding a partnering agreement for at least one of our clinical assets before 2025, while also establishing commercial collaborations for programmes currently at an earlier stage of development. We are pleased that investors participating in the share offering have recognised our progress thus far and our Strategy for future growth. The funds raised from the share issue, combined with other sources of funding, will provide vital support for the successful and on-track progress of our programme development and further strengthen our negotiating position with partners" – adds Marcin Szumowski.

LEGAL DISCLAIMER

This material is for information purposes only. It is published by the Company solely for the purpose of providing relevant information regarding the terms and conditions of the offer of H Shares. This material is in no way intended to promote, directly or indirectly, the offer, subscription or purchase of H Shares, nor does it constitute any advertisement or promotional material prepared or published by the Company for the purpose of promoting the H Shares, their subscription, purchase or offer or for the purpose of encouraging investors, directly or indirectly, to purchase or subscribe for H Shares. The Company has not published to date and does not intend to publish after the date of this current report any material for the purpose of promoting the Series H Shares, their subscription or purchase.

This material does not identify or suggest, and is not intended to identify or suggest, any risks [direct or indirect] that may be associated with an investment in the H Shares. Any investment decision to subscribe for or purchase H Shares pursuant to an offer, subscription or sale of such shares must be made solely on the basis of publicly available information.

This material does not constitute an invitation to underwrite, subscribe for or otherwise acquire or dispose of any securities in any jurisdiction. This material does not constitute a recommendation regarding an investor’s decision to offer, subscribe for or purchase H Shares. Each investor or potential investor should conduct its own investigation, analysis and evaluation of the business and data described in this material and publicly available information. The price and value of securities can go up as well as down. Past performance is not a guide to future performance.