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 Huonslab Co., Ltd. ("Huonslab"), a subsidiary of Huons Global (KOSDAQ: 084110), reported that its abstract titled "The Role of HyDIFFUZE in Co-formulation with Subcutaneous Infliximab" has been selected for poster presentation at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, taking place on April 28, 2025 (Press release, Huons Global, APR 2, 2025, View Source [SID1234651773]).

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The study demonstrated that HyDIFFUZE (rHuPH20) significantly improves the relative bioavailability of co-formulated infliximab compared to infliximab without rHuPH20 when administered subcutaneously.

These findings suggest that co-formulation with HyDIFFUZETM (rHuPH20) may reduce the required dose of infliximab while maintaining equivalent therapeutic efficacy and potentially extending dosing interval in the maintenance regimen.

Huonslab previously validated the role of HyDIFFUZE (rHuPH20) as a locally acting, transient permeation enhancer for subcutaneous delivery of high-dose, high-volume biotherapeutics, supported by dye dispersion studies in nude mice and in vivo comparative pharmacokinetic (PK) studies in Sprague-Dawley rats.

In parallel, Huonslab is currently conducting a pivotal Phase 1 clinical trial in South Korea for Hydizyme, a stand-alone recombinant human hyaluronidase (rHuPH20) drug product, with the goal of obtaining product approval from the Ministry of Food and Drug Safety (MFDS) by 2026.

"Huonslab is committed to converting high-dose, high-volume antibody-based biotherapeutics from intravenous (IV) infusion to subcutaneous (SC) injection using human hyaluronidase PH20," said Dr. Young Sun Lee, Chief Business Officer of Huonslab.

Lee added, "Our HyDIFFUZE (rHuPH20) drug delivery technology is redefining the landscape of SC antibody development and expanding patient access to more convenient and effective subcutaneous antibody therapies."

On April 2, 2025 Nuvation Bio Inc. (NYSE: NUVB), a global biopharmaceutical company tackling some of the greatest unmet needs in oncology, reported that David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio, and Philippe Sauvage, Chief Financial Officer of Nuvation Bio, will participate in a fireside chat at the Jones Healthcare and Technology Innovation Conference on Wednesday, April 9, 2025, at 10:00 a.m. PT/1:00 p.m. ET in Las Vegas, NV (Press release, Nuvation Bio, APR 2, 2025, View Source [SID1234651772]).

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An audio replay of the fireside chat will be available following the event on the Nuvation Bio website at View Source An archived recording will be available for 90 days following the event.

On April 2, 2025 Landmark Bio reported it has been acquired by Artis BioSolutions ("Artis"), a newly launched company dedicated to streamlining the discovery, process development, and manufacturing of genetic medicines (Press release, Landmark Bio, APR 2, 2025, View Source [SID1234651771]). The acquisition enables Landmark Bio to continue to deliver on its mission of translating groundbreaking research into life-changing therapies, while scaling its capabilities to accelerate development and manufacturing of advanced therapies.

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"Landmark Bio was born from a bold vision shared by our founding partners – to remove barriers in the manufacturing of advanced therapies and accelerate the development of life-changing medicines. In just a few short years, we’ve built a world-class team and capabilities that have become a vital force in the life sciences innovation ecosystem. Joining Artis BioSolutions marks an exciting new chapter for Landmark Bio. Together, we will stay true to our mission as we scale our operations to bring breakthrough therapies to more patients," said Ran Zheng, chief executive officer (CEO) of Landmark Bio.

Since its founding in 2021, Landmark Bio has built a robust platform to address persistent bottlenecks in advanced therapy development, serving as a partner to academic institutions, biotechnology companies, and global biopharma firms. The organization was established by leaders from academia, industry, and Boston’s leading research hospitals. Together with Artis BioSolutions, Landmark Bio will enhance its ability to provide integrated, end-to-end solutions that span preclinical development through commercialization, with expanded capabilities in process, analytical and formulation development, GMP manufacturing and QC testing, CMC consulting and IND enabling services, and manufacturing technology development.

"This next chapter for Landmark Bio is a testament to the vision, science, and dedication of its founding partners," said John Shaw, vice provost for research at Harvard University and chair of Landmark Bio’s board of directors. "Landmark Bio plays an important role in the development of new therapies, and we are confident that this transition will strengthen its position as a cornerstone of the advanced therapy ecosystem."

"Ran and the team at Landmark Bio have established an outstanding foundation built on scientific excellence, operational precision, and a strong collaborative mission," said Brian Neel, CEO of Artis BioSolutions. "We are thrilled to join forces with such a talented team and look forward to driving transformative progress together – expanding access, accelerating innovation, and ultimately enabling our partners to deliver life-changing medicines to patients more efficiently."

As part of Artis, Landmark Bio will continue to operate as a distinct entity, providing critical services in translational research, process development, and manufacturing for clinical and commercial cell and gene therapy products. The acquisition by Artis supported by initial funding from Oak HC/FT, marks a significant step toward expanding access to high-quality development and manufacturing capabilities across the advanced therapy ecosystem. Landmark Bio will remain headquartered in Watertown, MA, and continue to operate its state-of-the-art facility and teams in place.

On April 2, 2025 Lomond Therapeutics Holdings, Inc. ("Lomond Therapeutics"), a clinical-stage biotechnology company dedicated to discovering and developing potentially best-in-class and first-in-class medicines for the treatment of hematological malignancies, reported the addition of two new investors, Yosemite Management and QIA Investments, coincident with a second and third closing, respectively, and the raising of an additional $20 million private placement financing (Press release, Lomond Therapeutics, APR 2, 2025, View Source [SID1234651770]).

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"We are delighted to expand the funding syndicate with the addition of these top tier investors," said Iain Dukes M.A. D.Phil., co-founder and chief executive officer at Lomond Therapeutics."

This transaction provides the additional resources necessary to advance our potentially best-in-class or first-in-class programs, lomonitinib, lonitoclax and our menin inhibitor, through clinical development. Lomonitinib is currently being evaluated in a Phase 1b clinical trial in patients with mutated FLT3 relapsed refractory AML – an area of important unmet need. Lomond enrolls CLL and selected lymphoma patients in a Phase 1b clinical trial to evaluate lonitoclax, a potentially first in class oral targeted selective B-cell lymphoma-2 ("BCL-2-2") inhibitor.

The offering was exempt from registration under Section 4(a)(2) of the United States Securities Act of 1933, as amended, and Rule 506 of Regulation D promulgated by the U.S. Securities and Exchange Commission ("SEC") thereunder. The Common Stock in the offering was sold to "accredited investors," as defined in Regulation D, and was conducted on a "reasonable best efforts" basis.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

Raymond James and Wedbush & Co. acted as the placement agents.