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."

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.

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.

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.

On April 2, 2025 Boehringer Ingelheim reported a continued rise in the number of patients it reached, 66 million in 2024, up 8.0% from the previous year (Press release, Boehringer Ingelheim, APR 2, 2025, View Source [SID1234654046]). Development of its current product pipeline is well on track, as the company prepares multiple new product launches, starting in 2025. Research & Development (R&D) investments rose to EUR 6.2 billion, or 23.2% of group net sales. Group net sales rose by 6.1%* to EUR 26.8 billion.

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"As our current pipeline continues to mature and more products come closer to a potential market introduction, we have entered a pivotal phase of high investments," said Hubertus von Baumbach, Chairman of the Board of Managing Directors. "It is important that we use every opportunity to bring these new treatments to patients as fast as possible – this is our number one priority."

Human Pharma: investing in existing products and new launches
Human Pharma sales rose by 7.0%* to EUR 21.9 billion, led by JARDIANCE and OFEV. Sales of JARDIANCE, which is now also available for treatment of chronic kidney diseases, in addition to type 2 diabetes and heart failure, rose 14.6%* to EUR 8.4 billion. OFEV, which is used to treat idiopathic pulmonary fibrosis and certain fibrosing interstitial lung diseases, grew 8.9%* to EUR 3.8 billion.

The Human Pharma pipeline includes over ten new Phase II and III trials over the next 12 to 18 months, which will potentially result in a range of significant launches in the next five years. Human Pharma R&D spending rose to EUR 5.7 billion, or 27.6% of the business unit’s net sales.

"If we look at the past five years, Boehringer Ingelheim has invested approximately EUR 25 billion in R&D," said Frank Hübler, Member of the Board of Managing Directors with responsibility for Finance. "With the innovations currently in our pipeline we will further increase investments in R&D in the years to come."

After positive data from pivotal studies, the company is preparing multiple new product launches, starting this year with potential launches of zongertinib and nerandomilast.

Nerandomilast has the potential to advance care for patients with Idiopathic Pulmonary Fibrosis (FIBRONEER-IPF) and Progressive Pulmonary Fibrosis (FIBRONEER-ILD). Full data from both phase III FIBRONEER-trials, which met their primary endpoint, will be presented in the coming months.

If approved, zongertinib would be the first orally administered, targeted therapy for previously treated HER2-mutated lung cancer patients. Zongertinib’s development was accelerated due to positive Phase 1b Beamion LUNG-1 trial data, which showed a response rate of 71% (95% CI, 60–80), p<0.0001**, and disease control rate of 93%. It was generally well tolerated, with a low toxicity-related discontinuation rate (3%). Additional studies in HER2-altered solid tumors are ongoing.

Both zongertinib and nerandomilast have been submitted to regulatory authorities globally and first launches in the US are anticipated in the second half of this year, pending approval.

Animal Health: rapid response against transboundary animal diseases
Animal Health sales rose 1.9%* to EUR 4.7 billion in 2024, mainly driven by Pet Parasiticides and Therapeutics, Poultry and Ruminant. The parasiticides NEXGARD continued to strengthen its position as the top-selling brand in the industry, growing 14.0%* to EUR 1.4 billion.

Last year, Boehringer Ingelheim supported livestock producers and governments by quickly providing vaccines and technical assistance for outbreaks of transboundary animal diseases (TADs), such as avian influenza, bluetongue virus and foot-and-mouth disease. These diseases pose a significant risk to animal health, impede global trade, and constrain food supply.

Sustainable Development
Boehringer Ingelheim is on track in its target to become carbon neutral in its company operations (Scope 1 and 2) by 2030. It increased global renewable electricity purchases to around 75% in 2024, primarily due to transitioning to renewable solutions at various sites, including Japan and China. A new biomass power plant was also commissioned at its Ingelheim site in Germany to boost on-site renewable energy generation to 95% of its energy needs.

As part of its global effort to stop rabies, the company provided 46 million rabies vaccine doses and supported vaccination campaigns in endemic countries. The "Angels" initiative, which aims to optimize the quality of treatment in existing stroke centers, added over 1,000 organizations to the network. It is the largest stroke community in the world, now encompassing 237,000 healthcare professionals from more than 9,000 hospitals in 158 countries and has helped 19 million stroke patients to date.

Outlook
The general trends and developments of the past year are expected to continue to impact 2025. The company expects a continued rise in the number of patients reached, and a slight year-on-year increase in net sales, adjusted for currency and extraordinary effects.

* sales growth numbers are adjusted for currency effects

**one-sided p-value from a z-test of the null hypothesis ORR ≤30%