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.

On April 2, 2025 Senhwa Biosciences, Inc. (TPEx: 6492), a new drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and infectious diseases, reported that the completion of Clinical Study Report (CSR) for Phase 1/Dose Expansion Trial of Silmitasertib (CX-4945) in the Treatment of Basal Cell Carcinoma(BCC), with positive data outcomes (Press release, Senhwa Biosciences, APR 2, 2025, View Source [SID1234651768]). The study included patients who had relapsed after standard therapies and had no other treatment options. Among them, three patients experienced over 30% tumor reduction (PR), and two patients had a progression-free survival (PFS) exceeding 21 months. CX-4945 significantly prolonged survival in advanced cancer patients, marking a major milestone for both the patients and Senhwa.

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Compared to current first- and second-line therapies, CX-4945 demonstrated superior tolerability and disease control potential. Therefore, Senhwa will actively pursue licensing possibilities while carefully evaluating CX-4945’s potential as a monotherapy or in combination with the second-line immunotherapy Libtayo. The company aims to explore further indications and potential as a first-line treatment, offering better options for patients.

Clinical Trial Overview

The trial enrolled 25 patients with locally advanced BCC (laBCC, 20 patients) and metastatic BCC (mBCC, 5 patients). The primary objective was to determine the recommended Phase 2 dose (RP2D) and optimal dosing regimen for CX-4945.

Among 22 patients eligible for efficacy analysis:

Three laBCC patients achieved partial response (PR).
Ten patients had stable disease (SD), including 2 mBCC and 8 laBCC patients.
Disease control rates:
mBCC patients: 80% (4 patients with complete/partial response or stable disease).
laBCC patients: 65% (11 patients with complete/partial response or stable disease).
Further data analysis showed that:

Median progression-free survival (PFS):
laBCC: 9.2 months
mBCC: 3.7 months
Median duration of disease control (DDC):
laBCC: 10.3 months
mBCC: 7.5 months
CX-4945 exhibited promising anti-tumor efficacy and disease stabilization potential in this indication. Additionally, CX-4945 has a lower study drug discontinuation rate of 24% due to AEs, compared to first-line treatments including Vismodegib and Sonidegib, suggesting superior tolerability.

Future Prospects

This trial is particularly noteworthy as it evaluated CX-4945 monotherapy in patients who had already failed first-line HHIs. Notably, 27.3% (6 patients) had also failed second-line PD-1 inhibitors such as Libtayo or Keytruda.

Among the enrolled patients, two advanced-stage patients achieved a progression-free survival (PFS) of over 21 months, lasting 653 days and 667 days, respectively. Notably, the primary lesion of the former patient was almost undetectable by visual inspection.

Given the significant potential of CX-4945 as a monotherapy, Senhwa is now actively pursuing regional licensing to accelerate commercialization through strategic partnerships, ultimately benefiting more patients.

On April 2, 2025 Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, reported that its novel B7-H3-targeting ADC (R&D code: 7MW3711) has been approved by the NMPA to enter Phase Ib/II clinical trial in combination with a PD-1 Inhibitor, with or without antitumor therapies, for the treatment of advanced solid tumors (Press release, Mabwell Biotech, APR 2, 2025, View Source [SID1234651767]).

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7MW3711 is developed by Mabwell’s Interchain-Disulfide Drug Conjugate (IDDC) platform and is pharmaceutical characterized as stable structure, homogeneous composition, high purity, and it is suitable for industrial scale-up. The approved phase Ib/II clinical trial aims to evaluate the safety, tolerability, preliminary efficacy and pharmacokinetic profile of 7MW3711 in combination with a PD-1 inhibitor, with or without antitumor therapies, in patients with advanced solid tumors. Previously, 7MW3711 has been approved for clinical studies in advanced solid tumors by the NMPA and the FDA, respectively, and was granted orphan drug designation (ODD) by the FDA for the treatment of small cell lung cancer.