Entos Pharmaceuticals and Circio initiate collaboration to test novel platform for circVec circular RNA delivery

On April 3, 2025 Circio Holding ASA (OSE: CRNA), a biotechnology company developing powerful circular RNA technology for next generation nucleic acid medicine, and Entos Pharmaceuticals U.K. Ltd. (Entos), a clinical-stage genetic medicines company, reported the initiation of a research collaboration (Press release, Circio, APR 3, 2025, View Source [SID1234651783]). The collaboration will involve joint development and in vivo delivery testing of Circio’s optimized circular RNA expression vectors (circVec) using the Entos proprietary Fusogenix PLV nucleic acid delivery technology.

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Under the collaboration, Entos will develop and validate PLV-formulations of Circio´s circVec DNA vectors and perform technical testing in vivo. Initial data from the collaboration is expected in the next three to six months. If successful, the results will create the foundation for a continued collaboration to develop and test future circVec-PLV therapeutic candidates with potential applications in genetic medicine, chronic disease, and vaccines.

Financial details were not disclosed.

"Entos has demonstrated efficient and safe delivery of synthetic non-viral DNA vectors, both in mouse models, primates and clinical trials," said Dr. Thomas Hansen, CTO of Circio. "The unique PLV chemistry enables direct fusion with the cell membrane and bypasses the endosomal uptake pathway. This feature has been shown to enhance delivery efficiency and reduce toxicity of DNA vectors. It is therefore a logical step for Circio to enter this research collaboration with Entos to explore the potential synergy of combining our complementary expression and delivery technologies. If successful, this partnership will aim to provide a joint platform for generating future therapeutic candidates in several disease areas of high unmet medical need."

"Entos is currently partnering with a number of key international genetic medicine companies for the expansion of the use of our Fusogenix PLV drug delivery system to enable the delivery of nucleic acid to target cells through direct fusion," said Jason Ding, CBO of Entos Pharmaceuticals. "We have selected to partner with Circio given their unique and impressive approach to circular RNA vector expression technologies for next generation nucleic acid medicine. This collaboration will seek to use Fusogenix PLV to enhance Circio’s circVec DNA vector delivery efficiency and reduce toxicity compared to LNP-formulations. This could have a considerable impact in novel applications in genetic medicine, chronic disease and vaccines."

Entry into a Material Definitive Agreement

On April 3. 2025 BioXcel Therapeutics, Inc. (the "Company") reported to have entered into an Equity Distribution Agreement (the "Equity Distribution Agreement") with Canaccord Genuity LLC ("Canaccord") to sell shares of the Company’s common stock, par value $0.001 per share (the "Common Stock"), from time to time, through an "at the market" equity offering program under which Canaccord will act as sales agent (Filing, 8-K, BioXcel Therapeutics, APR 3, 2025, View Source [SID1234651782]).

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Subject to the terms and conditions of the Equity Distribution Agreement, Canaccord may sell the shares by methods deemed to be an "at the market offering" as defined in Rule 415 promulgated under the Securities Act of 1933, as amended, including sales made through The Nasdaq Capital Market or on any other existing trading market for the Common Stock. Under the Equity Distribution Agreement, Canaccord will use commercially reasonable efforts to sell the Common Stock from time to time and the Company will set the parameters for the sale of shares, including the number of shares to be issued, the time period during which sales are requested to be made, limitations on the number of shares that may be sold in any one trading day and any minimum price below which sales may not be made. The Company will pay Canaccord a commission of up to 3.0% of the gross proceeds of any Common Stock sold through Canaccord under the Equity Distribution Agreement, and has provided Canaccord with customary indemnification rights. The Company also will reimburse Canaccord for certain specified expenses in connection with entering into the Equity Distribution Agreement.

Any sales of shares under the Equity Distribution Agreement will be made pursuant to the Company’s shelf registration statement on Form S-3 (File No. 333-275261) filed with the Securities and Exchange Commission (the "Commission") on November 2, 2023 and declared effective on November 13, 2023. The Company filed a prospectus supplement with the Commission on April 3, 2025 in connection with the offer and sale of up to $8,135,000 of shares pursuant to the Equity Distribution Agreement.

The foregoing description of the material terms of the Equity Distribution Agreement is qualified in its entirety by reference to the full agreement, a copy of which is filed as Exhibit 1.1 to this Current Report on Form 8-K and is incorporated herein by reference.

Honigman LLP, counsel to the Company, has issued an opinion regarding the validity of the shares of Common Stock to be issued and sold pursuant to the Equity Distribution Agreement. A copy of the opinion is filed as Exhibit 5.1 to this Current Report on Form 8-K.

This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of any offer to buy the securities discussed herein, nor shall there be any offer, solicitation or sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.

BeiGene Provides Update on the Ociperlimab (BGB-A1217) Clinical Development Program

On April 3, 2025 BeiGene, Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company that intends to change its name to BeOne Medicines Ltd., reported the discontinuation of its clinical development program for ociperlimab (BGB-A1217), an anti-TIGIT antibody, as a potential treatment for lung cancer (Press release, BeiGene, APR 3, 2025, View Source [SID1234651781]).

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The Independent Data Monitoring Committee recommended terminating the ongoing Phase 3 AdvanTIG-302 trial (NCT04746924) based on its findings as part of a pre-planned futility analysis. The overall efficacy and safety data assessment suggested that the study was unlikely to meet the primary endpoint of overall survival. No new safety signals were observed. After thorough deliberation, the Company has made the decision to terminate the trial.

"We evaluate our clinical programs to focus our resources on the most promising clinically differentiated candidates while thoughtfully de-prioritizing others. Our commitment remains steadfast: to discover and develop innovative treatments that are more affordable and accessible to cancer patients worldwide," said Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeiGene. "We thank the investigators, their patients, and support staff whose participation and dedication made this research possible."

Results from this study will be shared at a later date to help advance science and the understanding of anti-TIGIT activity.

Akiram Therapeutics initiates Eurostars-funded collaboration to develop next-generation targeted alpha-therapeutics

On April 3, 2025 Akiram Therapeutics, a Swedish biotech company specializing in targeted radiotherapy, reported the launch of PRE-CISE, a Eurostars-funded research collaboration with Danish PreTT and TetraKit Technologies (Press release, Akiram Therapeutics, APR 3, 2025, View Source [SID1234651780]). The aim of the project is to develop a new generation of targeted alpha-therapeutics by expanding Akiram’s proprietary CD44v6-targeting antibody platform using advanced pre-targeting strategies and radiolabeling chemistry.

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The PRE-CISE project combines Akiram’s CD44v6-targeting antibody platform with PreTT’s expertise in pre-targeting technology and TetraKit’s radiolabeling chemistry. Using a two-step approach—where the antibody first binds to the tumor, followed by the separate delivery of a radioactive payload—the collaboration aims to unlock access to alpha-emitting radionuclides that cannot typically be used with conventional antibody-based therapies. This strategy may significantly improve treatment precision while minimizing damage to surrounding healthy tissue.

"By separating the targeting step from the therapeutic phase, we open up new possibilities for designing more precise and effective cancer treatments," says Marika Nestor, CEO of Akiram Therapeutics. "This innovative therapeutic modality builds on our CD44v6 platform and represents an opportunity to expand our pipeline beyond beta-emitting radiotherapies."

"Participating in this project presents a remarkable opportunity to further validate our pretargeting approach, which leverages the targeting properties of antibodies for radioligand therapy. This advancement allows us to broaden the scope of potential treatments for various types of cancer," says Francesco Sergi-Lindell, CEO of PreTT. "Collaborating with the consortium will enable us to enhance our platform technology, as well as expand our pipeline."

"This collaboration will enable us to further develop our TetraKit platform and expand its application into new and highly exciting areas," says Andreas Jensen, CEO of TetraKit Technologies.

The PRE-CISE collaboration is co-funded by the Eurostars program with a total grant of EUR 1 million. Preclinical results are expected in 2026.

About Akiram’s CD44v6 platform and lead candidate
PRE-CISE builds on the CD44v6-targeting platform used in Akiram’s lead candidate, 177Lu-AKIR001, a beta-emitting radiopharmaceutical currently being evaluated in clinical trials.

Developed through antibody phage display and affinity maturation targeting the CD44v6 cancer marker, 177Lu-AKIR001 combines the radiation component lutetium-177 with a targeted molecule. Preclinical studies have demonstrated its potential as a promising, first-in-class radiopharmaceutical therapy for cancers with high CD44v6 expression.

Entry into a Material Definitive Agreement

On April 2, 2025, Akoya Biosciences, Inc. ("Akoya") entered into a securities purchase agreement (the "Securities Purchase Agreement") with Quanterix Corporation ("Quanterix"), pursuant to which Akoya will issue and sell to Quanterix from time to time, in a private placement, one or more convertible promissory notes having an aggregate principal amount of up to $30,000,000 (the "Convertible Notes") (Filing, Akoya Biosciences, APR 2, 2025, View Source [SID1234651803]). Akoya may draw on the Convertible Notes between May 15, 2025 and the earlier of (a) the closing of the transactions contemplated by the Agreement and Plan of Merger, dated as of January 9, 2025, as it may be amended from time to time, by and among Quanterix, Akoya and Wellfleet Merger Sub, Inc. (the "Merger Agreement") and (b) July 9, 2025 if the Merger Agreement is lawfully terminated pursuant to its terms on or prior to such date; provided, however, that if the closing of the transaction contemplated by the Merger Agreement occurs on or prior to May 15, 2025, Akoya may not draw the Convertible Notes. Additionally, if the initial termination date of July 9, 2025 is extended to January 9, 2026 in accordance with the terms of the Merger Agreement, Akoya may draw on the Convertible Notes until January 9, 2026.

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Any Convertible Notes issued under the Securities Purchase Agreement will mature on the earliest to occur of (i) the 91st day following the earlier of (a) November 1, 2027 and (b) the date that Akoya’s indebtedness under the Credit and Security Agreement, dated October 27, 2020, by and among Akoya, Midcap Financial Trust, as a lender and as agent ("MidCap"), and the other lenders named therein (the "Akoya Existing Loan Agreement") is repaid in full and all commitments under such documents have been terminated and (ii) subject to the terms of the Subordination Agreement (as defined below), any acceleration of the Convertible Notes. Any Convertible Note issued under the Securities Purchase Agreement will bear interest at a rate per annum equal to the SOFR interest rate plus an applicable margin specified in the Convertible Note to, but excluding, the date of repayment or conversion of the Convertible Note. Interest on the Convertible Notes will be paid in arrears on the first day of each month and on the maturity date of the Convertible Notes. Subject to the terms of the Subordination Agreement, any interest payments will be made exclusively to Quanterix in cash.

If drawn, the Convertible Notes will be convertible at the election of Quanterix during the period beginning on the date, if any, that the Merger Agreement is terminated and ending on the maturity date of the Convertible Notes into shares of common stock, par value $0.00001, of Akoya ("Akoya Common Stock"), at a conversion price equal to the product of (i) the exchange ratio set forth in the Merger Agreement, as it may be adjusted pursuant to the terms of the Merger Agreement, and (ii) the VWAP of Quanterix’s common stock for the 10 consecutive trading days ending on the trading day prior to the entry into the Merger Agreement, subject to adjustment.

The Convertible Notes prohibit conversion if it would result in the issuance of more than 19.99% of Akoya Common Stock in the aggregate prior to obtaining stockholder approval. The Convertible Notes will also contain customary anti-dilution provisions to adjust the conversion price from time to time based upon certain issuances of securities by Akoya. The Securities Purchase Agreement contains customary representations and warranties and events of default as well as certain operating covenants applicable to Akoya until the closing of the transaction contemplated by the Merger Agreement.

Registration Rights Agreement

At such time as Akoya draws any funds and thereby issues any Convertible Notes, Akoya and Quanterix will enter into a registration rights agreement (the "Registration Rights Agreement"), pursuant to which, among other things, Akoya must prepare and file with the U.S. Securities and Exchange Commission (the "SEC") no later than August 13, 2025 a registration statement with respect to the resale of shares of Akoya Common Stock issuable upon conversion of the Convertible Notes.

Subordination Agreement

At such time as Akoya draws any funds and thereby issues any Convertible Notes, Quanterix, Akoya and MidCap will enter into a subordination agreement (the "Subordination Agreement"), pursuant to which Quanterix and Akoya will agree, among other things, that the Convertible Notes will be subordinate to any debt outstanding and obligations owing under the Akoya Existing Loan Agreement.