On June 30, 2023 Enterome, a clinical-stage company developing first-in-class immunomodulatory drugs for solid and liquid malignancies and inflammatory diseases based on its unique Mimicry platform, reported that the first patient was dosed in the Phase 1/2 ‘AUDREY’ trial evaluating EO4010, the Company’s third OncoMimics candidate, for the treatment of patients with unresectable, previously treated, metastatic colorectal cancer (CRC) (Press release, Enterome, JUN 30, 2023, View Source [SID1234633006]).

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EO4010 is an innovative, off-the-shelf immunotherapy that combines five synthetic OncoMimics peptides. These non-self, microbial-derived peptides correspond to CD8 HLA-A2 epitopes that exhibit molecular mimicry with the tumor-associated antigens (TAAs) BIRC5/survivin, FOXM1, UBE2C, CDC20 and KIF2C. EO4010 also includes universal cancer peptide 2 (UCP2), a helper peptide representing the CD4+ epitope.

The five selected TAAs are associated with critical cell-cycle functions and are highly expressed in CRC tumors but not significantly in healthy tissues. The selection of OncoMimics peptides corresponding to these TAAs ensures broad tumor coverage designed to overcome tumor heterogeneity and reduce tumor escape.

The AUDREY study (EOCRC2-22/NCT05589597) is a multicenter, open-label Phase 1/2 trial assessing safety, tolerability, immunogenicity and preliminary efficacy of EO4010 in monotherapy and in combination with the immune checkpoint inhibitor nivolumab for treatment of metastatic colorectal cancer. A total of 42 patients are expected to be enrolled in Europe and the US.

AUDREY represents the fourth trial investigating Enterome OncoMimics immunotherapy candidates in solid and liquid malignancies. The Company is also initiating a Phase 2 clinical study in patients with ctDNA-defined, Minimal Residual Disease of colorectal cancer, with its fourth candidate EO2040.

Dr. Romain Cohen, medical oncologist (MCU-PH) Department of medical oncology, Saint-Antoine hospital, AP-HP, and Assistant Professor of Oncology at Sorbonne University (Paris, France), is Coordinating Investigator for the AUDREY study in France. Dr. Cohen main clinical and research interests include the study of cancers harboring microsatellite instability, particularly their treatment with immune-oncology. He is principal investigator of several clinical trials dedicated to colorectal cancers.

Dr. Cohen commented, "After they have received the main standard of care treatments, patients with metastatic colorectal cancer have limited options for more efficacious treatment and as a result have poor clinical outcomes. We look forward to assessing the potential benefits of the novel immunotherapy approach of EO4010 in this frequent and underserved indication and providing updates on the progress of the AUDREY study."

Pierre Bélichard, Chief Executive Officer of Enterome, added, "This new trial evaluating EO4010 in patients with advanced disease of colorectal cancer is another significant milestone for Enterome. Building on the promising data from our ongoing trials investigating EO2401 in recurrent glioblastoma and adrenal tumors, and EO2463 in non-Hodgkin lymphoma, we believe that our upcoming studies with EO4010 and EO2040 in colorectal cancer will reinforce Enterome’s position as a leader in next-generation cancer immunotherapies. Through our OncoMimics immunotherapies, we are able to break the immune tolerance to self-antigens with a technology that is off-the-shelf and enables multi-targeting of tumor antigens. This groundbreaking approach so far demonstrates both efficacy and safety for the patients, instilling real hope in the fight against cancer."

On June 30, 2023 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of conditionally activated, localized biologics, reported that it has entered into an agreement with BVF Partners L.P. ("BVF") for a private placement that is expected to result in initial gross proceeds of approximately $30 million (Press release, CytomX Therapeutics, JUN 30, 2023, View Source [SID1234633005]). In the private placement, CytomX is selling pre-funded warrants to purchase up to 14,423,077 shares of common stock, accompanying Tranche 1 warrants to purchase up to 5,769,231 shares of common stock and accompanying Tranche 2 warrants to purchase up to 5,769,231 shares of common stock, at a combined price of $2.08 per share of pre-funded warrant and accompanying common warrants, representing a premium of 25% to volume weighted average price over the prior 30 trading days through June 28, 2023.

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Each pre-funded warrant will have an exercise price of $0.00001 per share of common stock, will be exercisable immediately and will be exercisable for 20 years. The accompanying Tranche 1 common warrants will have an exercise price of $4.16 per share of common stock, will be immediately exercisable and expire on July 3, 2025 and the accompanying Tranche 2 common warrants will have an exercise price of $6.24 per share of common stock, will be immediately exercisable and expire on July 3, 2026.

CytomX anticipates aggregate initial gross proceeds from the offering will be approximately $30 million, which are expected to extend the Company’s cash runway into the second half of 2025, based on CytomX’s current operating plan. CytomX also has the potential to receive up to an additional $60 million if all warrants are fully exercised for cash.

"This strategic financing with BVF is based upon an aligned vision that the localization of potent biologic therapies will continue to be a foundational area of oncology research and development and that CytomX’s pipeline has the potential to deliver meaningful products to cancer patients over time. Building on business development transactions with Regeneron and Moderna last year, this transaction further strengthens our financial position by extending cash runway into the second half of 2025 and should enable our next-generation pipeline to reach inflection points over this period," said Sean McCarthy, D.Phil., chief executive officer and chairman of CytomX Therapeutics.

The financing is subject to customary closing conditions and is expected to close on July 3, 2023. The securities to be sold in the private placement, including the shares of common stock underlying the warrants and pre-funded warrants, have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or any applicable state securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state security laws. CytomX has agreed to file a registration statement with the U.S. 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 and the pre-funded warrants to be issued in the private placement.

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 such state or jurisdiction.

On June 30, 2023 Cyteir Therapeutics, Inc. ("Cyteir" or the "Company") (Nasdaq: CYT) reported that it is discontinuing all development of CYT-0851, its investigational monocarboxylate transporter inhibitor, and that Cyteir’s Board of Directors has determined, after consideration of potential strategic alternatives, it is in the best interests of its shareholders to dissolve Cyteir, liquidate its assets following an orderly wind down of the Company’s operations, and return remaining cash to shareholders (Press release, Cyteir Therapeutics, JUN 30, 2023, View Source [SID1234633004]).

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CYT-0851 was being evaluated in a Phase 1 combination study with capecitabine or gemcitabine in advanced ovarian cancer and other solid tumors. While durable responses were observed in both combination arms, the overall clinical efficacy data did not meet Cyteir’s criteria to advance the program into the next phase of clinical development. Given the resources required to identify predictive biomarkers to identify who could potentially benefit from treatment with CYT-0851, and the current financial and regulatory environment, continuation of development of CYT-0851 by Cyteir was determined not to be feasible. The Company will continue to treat patients currently enrolled in the Company’s Phase 1 combination study with capecitabine or gemcitabine prior to the effectiveness of the Company’s dissolution.

"The Board of Directors and management devoted substantial time and effort in identifying development paths for CYT-0851 and strategic options for Cyteir," said Markus Renschler, MD, President and CEO of Cyteir. "We would like to thank the patients who enrolled in our trial, the staff at our clinical trial sites, all employees of Cyteir, the Board of Directors and our investors who have supported Cyteir over the years. While we wish that the outcome was different today, we believe that discontinuation of our programs and a dissolution of the Company will maximize shareholder value."

Planned Liquidation and Dissolution

Due to the planned discontinuation of CYT-0851 development, and the previously announced discontinuation of Cyteir’s discovery pipeline, the Company’s Board of Directors intends to approve a Plan of Liquidation and Dissolution ("Plan of Dissolution") that would, subject to shareholder approval, include the distribution of remaining cash to shareholders following an orderly wind down of the Company’s operations, including the proceeds, if any, from the sale of its assets. Prior to winding down operations, the Company intends to complete regulatory and patient obligations from the ongoing clinical trial. The Company will engage independent advisors, who are experienced in the dissolution and liquidation of companies, to assist in the Company’s dissolution and liquidation. The Company also intends to call a special meeting of its shareholders in the second half of 2023 to seek approval of the Plan of Dissolution and will file proxy materials relating to the special meeting with the Securities and Exchange Commission (the "SEC"). If the Company’s shareholders approve the Plan of Dissolution, the Company would then file a certificate of dissolution, delist its shares of common stock from The Nasdaq Global Select Market, satisfy or resolve its remaining liabilities, obligations and costs associated with the dissolution and liquidation, make reasonable provisions for unknown claims and liabilities, attempt to convert all of its remaining assets into cash or cash equivalents, including through a potential sale of CYT-0851, and return remaining cash to its shareholders. The Company will provide an estimate of any such amount that may be distributed to shareholders in the proxy materials to be filed with the SEC. However, the amount of cash actually distributable to shareholders may vary substantially from any estimate provided by the Company based on a number of factors.

Upon the filing of the certificate of dissolution, the Company intends to cease trading in its common stock, close its stock transfer books and discontinue recording transfers of shares of its capital stock, in accordance with applicable law. The Company will establish a reserve, which will be used to pay all expenses (including operating expenses up until the filing of the certificate of dissolution) and other known, non-contingent liabilities and obligations, and will include reasonable provision for future expenses of liquidation and contingent and unknown liabilities as required by Delaware law. The Company currently expects that its existing capital resources together with the anticipated net proceeds from the sale of certain assets will enable it to meet its remaining liabilities and obligations with sufficient reserves.

The Company does not intend to comment on the planned liquidation and dissolution until the Company files a proxy statement related to the special meeting with the SEC.

IMPORTANT ADDITIONAL INFORMATION

In connection with the proposed Plan of Dissolution, the Company intends to file with the SEC a proxy statement and other relevant materials. BEFORE MAKING ANY VOTING DECISION, INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE DEFINITIVE PROXY STATEMENT, ANY AMENDMENTS OR SUPPLEMENTS THERETO, ANY OTHER SOLICITING MATERIALS AND ANY OTHER DOCUMENTS TO BE FILED WITH THE SEC IN CONNECTION WITH THE PLAN OF DISSOLUTION AND RELATED MATTERS OR INCORPORATED BY REFERENCE IN THE PROXY STATEMENT WHEN IT BECOMES AVAILABLE BECAUSE IT WILL CONTAIN IMPORTANT INFORMATION ABOUT THE CYTEIR THERAPEUTICS, INC. PLAN OF DISSOLUTION AND RELATED MATTERS. Shareholders may obtain a free copy of the proxy statement and the other relevant materials (when they become available), and any other documents filed by the Company with the SEC, at the SEC’s website at View Source or on the "Investors & Media" section of Cyteir’s website at www.cyteir.com.

Participants in the Solicitation

Cyteir and its executive officers and directors may be deemed to be participants in the solicitation of proxies from its shareholders with respect to the proposed Plan of Dissolution and related matters, and any other matters to be voted on at the special meeting of shareholders. Information regarding the names, affiliations and interests of such directors and executive officers will be included in the proxy statement (when available). Additional information regarding such directors and executive officers is included in Cyteir’s Proxy Statement on Schedule 14A, which was filed with the SEC on April 27, 2023. Information regarding the persons who may, under SEC rules, be deemed participants in the solicitation of proxies of Cyteir’s shareholders in connection with the Plan of Dissolution and related matters and any other matters to be voted upon at the special meeting will be set forth in the proxy statement (when available). These documents are available free of charge as described in the preceding section.

On June 30, 2023 Imugene Limited (ASX: IMU), a clinical stage immunooncology company, reported new and significant HER-Vaxx data has been presented at the World Congress of Gastrointestinal Cancer in Barcelona (Press release, Imugene, JUN 30, 2023, View Source [SID1234632980]).

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Abstract Title: HERIZON: A Phase 2 study of HER-Vaxx (IMU-131), a HER-2-targeting peptide vaccine plus SOC chemotherapy in patients with HER-2+ advanced stomach Cancer — Correlation of the antibody responses and clinical outcome.
Session Title: Basic Gastric Cancer – Biomarkers and Translational Research.
Session Number: Poster Discussion D-8.
Presentation Session: 29 June 2023, 9:30 am – 5:40 pm CEST.
Presenting Author: Dr Joshua Tobias, Medical University of Vienna, Vienna, Austria.

Conclusions drawn from the study include;

• HER-Vaxx treatment produced robust anti-HER-2-IgG* and IgG1 antibody responses (p<0.001).

• HER-Vaxx-based vaccination of patients with HER-2 overexpressing gastric/gastro-esophageal junction cancer (GC) induced anti-HER-2-IgG and IgG1 subclass antibody responses (p<0.001).

• HER-Vaxx induced antibodies correlated with tumour reduction (p=0.001) • Compared to chemotherapy alone, the vaccination resulted in a statistically significant overall survival benefit.

• The present data further validate the proof of concept for a first-in-class B-cell immunotherapy based on HER-2/neu peptides.

* IgG-Immunoglobulin G is a type of antibody. Representing approximately 75% of serum antibodies in humans, IgG is the most common type of antibody found in blood circulation.

For 25 years, the World Congress on Gastrointestinal Cancer has been the foundation for sharing the most advanced research and innovations impacting the field of Gastrointestinal Cancer.

As the largest global gathering in the field, the Congress brings together leading gastroenterology, oncology, pathology, and hepatology experts, clinicians, and surgeons, as well as clinical researchers from across the globe to share pioneering research, approaches, and best practices in treating patients with cancers of the gastrointestinal tract.

On June 29, 2023 Heidelberg Pharma AG (FSE: HPHA) reported that Eli Lilly and Company will purchase the shares in Emergence Therapeutics AG, Duisburg, Germany, (Emergence), including shares from the conversion of the Emergence convertible bonds, that are held by its subsidiary Heidelberg Pharma Research GmbH as part of Eli Lilly and Company’s acquisition of all of the outstanding shares of Emergence (Press release, Eli Lilly, JUN 29, 2023, View Source [SID1234639896]).

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As a result of the transaction, Heidelberg Pharma expects a cash inflow of about USD 7 million in 2023. If defined guarantees are fulfilled and depending on clinical and regulatory milestones further inflows of up to USD 5 million are possible.