On April 2, 2025 Imugene Limited (ASX: IMU), a clinical-stage immuno oncology company, reported it has received clearance from the Cohort Review Committee (CRC) to escalate the dose level in the intravenous (IV) combination arm of its Phase 1 onCARlytics trial (Press release, Imugene, APR 2, 2025, View Source [SID1234651765]).

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With the successful completion of the safety observation period the IV combination arm will progress to a higher dose level.

Known as OASIS, the Phase 1 dose escalation onCARlytics clinical trial is targeting adult patients with advanced or metastatic solid tumours. The trial aims to evaluate the safety and efficacy of two routes of administration, intratumoural (IT) injection and intravenous (IV) infusion of either onCARlytics (a CD19-expressing oncolytic virus) alone, or in combination with CD19 targeting bispecific monoclonal antibody blinatumomab (Blincyto), which is a cancer immunotherapy.

OASIS is being conducted at seven sites in the U.S. including City of Hope, University of Cincinnati, MD Anderson Cancer Center, Emory, Roswell Park, University of Pittsburgh, Northwestern and University of Nebraska, with the potential to open a total of 10 sites to recruit approximately 40-50 patients with advanced solid cancers that have spread.

Imugene’s Managing Director and Chief Executive Officer, Leslie Chong, said:

"CD19 is a very significant target for blood cancers, but solid cancers like breast, lung or gastric do not have a common target on their cell surface, and therefore the aim with onCARlytics is to make available a target for CD19 therapies to treat these solid cancers. As the trial continues to progress and dose escalation is executed, we are eager to learn of the potential impact our treatment is having for patients in need."

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.

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%

On April 2, 2025 BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) reported that the company plans to present at the 24th Annual Needham Virtual Healthcare Conference on Wednesday, April 9, 2025, at 9:30 a.m. ET (Press release, BioCryst Pharmaceuticals, APR 2, 2025, View Source [SID1234651750]).

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Link to the live audio webcast and replay of the presentation may be accessed in the Investors & Media section of BioCryst’s website at http://www.biocryst.com.

On April 2, 2025 Enliven Therapeutics, Inc. (Enliven or the Company) (Nasdaq: ELVN), a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics, reported the Company will present five posters at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, taking place April 25-30, 2025, in Chicago, Illinois (Press release, Enliven Therapeutics, APR 2, 2025, View Source [SID1234651766]).

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Poster Presentation Details

Abstract 4712 – ELVN-002, a potent, selective HER2 inhibitor with a differentiated binding mode conferring the potential for enhanced efficacy in combination with HER2-targeting antibody-drug conjugates
Date/Time: Tuesday, April 29, 2025, 9:00 a.m. – 12:00 p.m. CDT
Session: Targeted Therapies and Combinations 2
Location: Poster Section 34

Abstract 4361 – Development and application of a mechanistic pharmacokinetic pharmacodynamic (PKPD) model to predict anti-chronic myeloid leukemia (CML) effects of tyrosine kinase inhibitors
Date/Time: Tuesday, April 29, 2025, 9:00 a.m. – 12:00 p.m. CDT
Session: Pharmacokinetics and Pharmacodynamics of Cancer Therapeutics
Location: Poster Section 20

Abstract LB295 – ELV-3111, a type 1 pan-RAF inhibitor, that safely combines with MEK inhibitors for enhanced anti-tumor activity in NRAS and BRAF mutant cancers including the most common mechanisms of BRAF inhibitor clinical resistance
Date/Time: Tuesday, April 29, 2025, 9:00 a.m. – 12:00 p.m. CDT
Session: Late-Breaking Research: Experimental and Molecular Therapeutics 3
Location: Poster Section 52

Abstract LB294 – Mechanism of tumor-selective inhibition of dimeric RAF by a Type 1 RAF inhibitor
Date/Time: Tuesday, April 29, 2025, 9:00 a.m. – 12:00 p.m. CDT
Session: Late-Breaking Research: Experimental and Molecular Therapeutics 3
Location: Poster Section 52

Abstract 5515 – ELVN-001, a highly selective ATP-competitive ABL1 tyrosine kinase inhibitor for the treatment of chronic myeloid leukemia alone or in combination with asciminib
Date/Time: Tuesday, April 29, 2025, 2:00 p.m. – 5:00 p.m. CDT
Session: Drug Resistance in Molecular Targeted Therapies 3
Location: Poster Section 17