On August 23, 2024 CanariaBio Inc, a leading late-stage biotechnology company, reported the successful completion of enrollment of 88 patients in a randomized Phase 2 study of oregovomab in combination with chemotherapy (paclitaxel and carboplatin) as neo-adjuvant treatment of patients with newly diagnosed advanced epithelial ovarian cancer (Press release, CanariaBio, AUG 23, 2024, https://www.prnewswire.com/news-releases/canariabio-inc-announces-enrollment-completion-of-randomized-phase-2-study-of-oregovomab-in-combination-with-chemotherapy-as-neo-adjuvant-treatment-of-patients-with-advanced-ovarian-cancer-302228497.html [SID1234646075]).

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This trial, known as FLORA-6 (NCT05605535) is a Phase 2, double-blinded, placebo-controlled, multi centered clinical trial in neo-adjuvant setting in patients with newly diagnosed advanced epithelial ovarian cancer. The study will assess 12 months progression free survival (PFS) rate, PFS, overall survival (OS), disease control rate, the immunological and early humoral response of concomitant oregovomab and chemotherapy.

Ovarian cancer is known for its high recurrence rate. Despite numerous clinical trials conducted, the development of an effective and specific treatment has proven challenging due to treatment resistance, toxicity, and limited efficacy. In this difficult landscape, oregovomab has the potential of emerging as a promising immunotherapeutic agent.

About Oregovomab

Oregovomab is a murine monoclonal antibody against CA 125, a biomarker commonly found in ovarian cancer. Indirect immunization with oregovomab interacts with immune modulating properties of infused paclitaxel and carboplatin resulting in synergistic clinical benefits as observed in a Phase II trial (Gynecology Oncology (2020) 156:523-529). Oregovomab is currently undergoing multiple clinical trials for the treatment of ovarian cancer in various setting including a Phase 3 study (NCT04498117, NCT05605535, NCT05335993, NCT05407584, NCT04938583)

On August 23, 2024 Abogen Biosciences ("Abogen" or the "Company") reported a publication titled "Efficient circularization of protein-encoding RNAs via a novel cis-splicing system " in Nucleic Acids Research (Press release, Abogen Biosciences, AUG 23, 2024, View Source [SID1234646074]). In the article, Abogen has revealed a highly efficient RNA circularization cis-splicing system (referred to as the "Cis-System") which enables the production of circular RNA ("circRNA") with significantly extended protein expression, reduced innate immune activation, and flexible splice site design that offers substantial market potential.

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In recent years, circular RNA technology has gained significant attention from the biopharmaceutical industry, several circular RNA start-up companies raised a total of over 1 billion dollars in financing. Among the most notable are Flagship-incubated Sail Biomedicines (formed through the merger of Laronde and Senda Biosciences), which has raised nearly $800 million, and Orna Therapeutics, founded by MIT Professor Daniel Anderson, secured over $300 million in funding and recently acquired ReNAgade Therapeutics to accelerate its clinical development.

Abogen’s Cis-System-based circRNA not only has global IP, but also improves over PIE System

The conventional technology for circRNA synthesis is the PIE method (Permuted Introns and Exons), patented by Orna and other companies. However, the Cis-System not only circumvents the patent restrictions by the PIE system, but also simplifies the circularization process and makes it more suitable for industrial production. As described in the publication, the Cis-System embeds a ribozyme core structure at one end of the precursor RNA, rendering the need for additional spacer elements between the ribozyme and the target gene. This invention significantly enhances the circularization efficiency thus offers a "scarless" and highly efficient translation process with less process-related impurities.

The Cis-System-based circRNA shows promising prospects for the future

The Cis-System reported in this study can achieve high circularization efficiency with essentially unrestricted base and sequence composition at the ends of RNA molecules, enabling truly efficient and scarless circularization. Furthermore, the Cis-System is designed to be more flexible, allowing customization based on specific therapeutic needs and compatibility with RNA molecule of different lengths. All these technological advances will lead to more sustained protein expression, reduced innate immune stimulation, and potential tissue-specific expression, which potentially bring more hopes in chronic disease treatment and immunotherapies where repeated dosing may be required.

Dr. Shaojun Qi, Senior Scientist in mRNA Innovation department at Abogen commented:

"I deeply appreciated the innovative culture at Abogen which is crucial for our success in overcoming the key bottlenecks in circular RNA technology. "

Dr. Peng Gao, Vice President of Abogen (corresponding author of the publication), commented:

"After over two years of commitment and continuous efforts, our team has finally overcome the critical technical hurdle presented in circRNA technology. Preliminary results from further studies have reinforced the great value and application potential of this technology. We hope to rapidly translate this achievement into clinical solutions to address the unmet medical needs."

Link for the Original Paper

Shaojun Qi, Huiming Wang, Guopeng Liu, Qianshan Qin, Peng Gao, Bo Ying, Efficient Circularization of Protein-Encoding RNAs via a Novel Cis-Splicing System, *Nucleic Acids Research*, 2024;, gkae711, [View Source]" target="_blank" title="View Source]" rel="nofollow">View Source(View Source)

On August 19, 2024, Veru Inc. (the "Company") delivered notice to Jefferies LLC (the "Agent") to terminate its Open Market Sales Agreement, dated May 12, 2023 (the "Sales Agreement"). Termination of the Sales Agreement is effective September 3, 2024, pursuant to Section 7(b) of the Sales Agreement (Filing, 8-K, Veru, AUG 23, 2024, View Source [SID1234646073]). The Company is not subject to any termination penalties related to the termination of the Sales Agreement.

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Pursuant to the terms of the Sales Agreement, the Company could issue and sell, from time to time through or to the Agent, shares of its common stock as set forth in the Sales Agreement with an aggregate value of up to $75 million. As a result of the termination of the Sales Agreement, the Company will not issue or sell any additional shares of common stock under the Sales Agreement. Since inception of the Sales Agreement, the Company sold 1,367,415 shares of common stock resulting in net proceeds to the Company of $1.1 million.

The foregoing description of the Sales Agreement is not complete and is qualified in its entirety by reference to the full text of the Sales Agreement, a copy of which was filed as Exhibit 1.1 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on May 12, 2023, and incorporated herein by reference.

On August 23, 2024, Labcorp Holdings Inc. (the "Company") and certain of its subsidiaries, reported to have entered into a three-year $300 million accounts receivable securitization facility (the "Securitization Facility") with PNC Bank, National Association ("PNC"), as administrative agent (Filing, 8-K, LabCorp, AUG 23, 2024, View Source [SID1234646071]). The Securitization Facility permits Labcorp Receivables (as defined below) to draw up to a total of $300 million, subject to the outstanding amount of the eligible receivables pool and other factors. The Securitization Facility contains an accordion to increase the facility limit up to $700 million subject to satisfaction of certain conditions.

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In connection with the Securitization Facility, on August 23, 2024, Laboratory Corporation of America Holdings ("LCAH") and Laboratory Corporation of America (the "Originators") sold and/or contributed all of their existing, and committed to continue to sell and/or contribute their future accounts receivable and certain related assets to Labcorp Receivables LLC, a special purpose vehicle and wholly-owned subsidiary of the Company and LCAH (the "Labcorp Receivables") pursuant to the terms of the Sale and Contribution Agreement, dated as of August 23, 2024 (the "Sale Agreement"), among the Originators, any additional originators from time to time party thereto, LCAH, as servicer, and Labcorp Receivables. Pursuant to the Receivables Purchase Agreement, dated as of August 23, 2024 (the "Receivables Purchase Agreement"), among Labcorp Receivables, the purchasers from time to time party thereto (the "Purchasers") and PNC Capital Markets LLC, Labcorp Receivables may sell and/or obtain financing for the accounts receivable assets and grants a security interest in all of its assets. LCAH will service the accounts receivables on behalf of Labcorp Receivables for a fee. In addition, pursuant to a Performance Guaranty, dated August 23, 2024 by the Company in favor of PNC, the Company has agreed to guarantee the performance of the Originators and LCAH, in its capacity as servicer, of their respective obligations under the agreements governing the Securitization Facility. Neither the Company nor the Originators guarantee the collectability of the receivables under the Securitization Facility.

Labcorp Receivables is a separate legal entity with its own separate creditors who will be entitled to access Labcorp Receivables assets before the assets become available to the Company. Accordingly, Labcorp Receivables assets are not available to pay creditors of the Company or any of its subsidiaries (other than Labcorp Receivables), although collections from the receivables in excess of amounts required to repay the Purchasers and other creditors of Labcorp Receivables may be remitted to the Company.

Loans or investments under the Securitization Facility accrue interest at a rate equal to a daily SOFR rate or term SOFR rate plus 0.10% SOFR adjustment or a base rate, in each case, plus an applicable margin. Additionally, Labcorp Receivables will pay certain additional fees to the agents and the Purchasers under the Securitization Facility.

The Sale Agreement and the Receivables Purchase Agreement contain customary representations and warranties, affirmative and negative covenants, and events of default (subject to cure periods), including, among others, failure by Labcorp Receivables to pay amounts when due, certain defaults on other material indebtedness, a change of control and bankruptcy and insolvency events.

The foregoing descriptions of the Receivables Purchase Agreement, the Sale Agreement and the Performance Guaranty do not purport to be complete and are qualified in their entirety by reference to the full text of such agreements, copies of which are filed herewith as Exhibits 10.1, 10.2 and 10.3, respectively, and the terms of which are incorporated herein by reference.

On August 23, 2024 Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company developing first-in-class1 targeted and immune-mediated therapeutics to fight cancer, reported that the Compensation Committee of the Company’s Board of Directors granted one employee nonqualified stock options to purchase an aggregate of 60,000 shares of its common stock under the Company’s 2023 Inducement Plan (Press release, Tempest Therapeutics, AUG 23, 2024, View Source [SID1234646070]).

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The stock options will vest over a four-year period, with 25% of each of the options vesting on the first anniversary of such employee’s start date, and 1/48th of the total shares vesting monthly thereafter, subject to continued employment on each vesting date.