On January 21, 2025 Catalent, Inc., a leader in enabling the development and supply of better treatments for patients worldwide, reported a strategic collaboration with Galapagos NV (Euronext & NASDAQ: GLPG), a biotechnology company with operations in the U.S. and Europe, to support decentralized manufacturing for clinical studies of GLPG5101, Galapagos’ investigational CAR-T therapy for relapsed/refractory non-Hodgkin lymphoma (NHL) indications (Press release, Catalent, JAN 21, 2025, https://www.catalent.com/catalent-news/catalent-announces-collaboration-with-galapagos-to-further-expand-galapagos-decentralized-car-t-manufacturing-network-in-the-u-s/ [SID1234649788]). Catalent’s commercial cell therapy manufacturing facility in Princeton, New Jersey, will support manufacturing for Galapagos’ upcoming trials in New Jersey, New York, and surrounding areas.

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Galapagos’ innovative decentralized manufacturing platform for cell therapies is designed to be deployed close to cancer treatment centers. This class of therapies has shown promising results in patients with NHL, even those who have failed with other therapies. By bringing the manufacturing process closer to patients, Galapagos’ platform has the potential to deliver fresh, fit, stem-like early memory cell therapy with a median vein-to-vein time of seven days, thereby avoiding cryopreservation and eliminating the need for bridging therapy.

"Catalent is passionate about increasing patient access to life-changing cell therapies like those being developed by Galapagos," said Delara Motlagh, at Vice President, Global Cell Therapy and Plasmid DNA at Catalent. "We are delighted by this collaboration to support Galapagos’ decentralized cell therapy approach to bring these pioneering treatments to more patients with certain aggressive forms of NHL in a median vein-to-vein time of seven days. With our highly experienced cell therapy team, state-of-the-art facility network, and central location, we enable timely delivery of these important therapies."

Financial terms of the agreement are not disclosed.

On January 21, 2025 ALX Oncology Holdings Inc., ("ALX Oncology" or the "Company") (Nasdaq: ALXO), a clinical-stage biotechnology company advancing therapies that boost the immune system to treat cancer and extend patients’ lives, reported that the company will host a virtual event on Thursday, January 23, at 1:00 p.m. PT/4:00 p.m. ET to discuss updated data from the ASPEN-06 Phase 2 clinical trial evaluating the company’s investigational CD47-blocker evorpacept in patients with previously treated HER2-positive advanced gastric cancer (GC) or gastroesophageal junction (GEJ) cancer (Press release, ALX Oncology, JAN 21, 2025, View Source [SID1234649787]).

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The ASPEN-06 data will be featured in an oral presentation (Abstract #332) at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO GI) earlier the same day.

2025 ASCO (Free ASCO Whitepaper) GI Presentation Details
Title: Final analysis of the randomized phase 2 part of the ASPEN-06 study: A phase 2/3 study of evorpacept (ALX148), a CD47 myeloid checkpoint inhibitor, in patients with HER2-overexpressing gastric/gastroesophageal cancer (GC).
Abstract Number: 332
Presenter: Kohei Shitara, M.D., Director of the Department of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa in Japan
Presentation Date and Time: Thursday, January 23, 9:15 a.m. – 10:00 a.m. PT
Session Information: Rapid Oral Abstract Session A: Cancers of the Esophagus and Stomach
Location: Level 2 Ballroom

Company Conference Call and Webcast Information
During the virtual company conference call and webcast event for investors, ALX company leadership will review the updated ASPEN-06 data. The event will be webcast live and a replay will be available after the call by visiting the "Investors" section of ALX Oncology’s website and selecting "Events and Presentations."

Date & Time: Thursday, January 23, 1:00 p.m. PT/4:00 p.m. ET
Webcast Access: View Source

On January 20, 2025 Xspray Pharma AB (publ) presented interim data from a food interaction study with the nilotinib product candidate (XS003) (Press release, Xspray, JAN 20, 2025, View Source [SID1234650012]). The results confirm the benefits of the company’s patented HyNap technology platform and its ability to deliver significant benefits for patients compared to existing PKI drugs.

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Key findings from interim data:

Food interaction and safety: Xspray’s amorphous formulation of nilotinib has shown a marked improvement over all currently approved nilotinib products. It eliminates problems with food interaction, a common limitation of the crystalline version. The study shows that bioavailability remains stable and consistent, regardless of food intake. These results confirm that Xspray’s product may offer an improved safety profile – outperforming the existing approved products, improving patients’ quality of life and reducing the risk of serious side effects.
Innovative technology platform and patent protection: Xspray Pharma is a pioneer in the development of amorphous PKI products and has built a strong patent portfolio around its HyNap technology. This offers unique properties that mean clear patient benefits compared to existing nilotinib products. The current study results together with the product candidate’s strong patent protection provide unique competitive advantages that enable Xspray Pharma to take considerable market shares regardless of when the original product’s patent protection expires.

In previous studies, Xspray’s nilotinib product candidate has shown matching bioavailability with Tasigna at more than 50% lower dose. Xspray Pharma is now completing the remaining studies for the nilotinib product candidate and still plans to submit the New Drug Application (NDA) to the FDA in the first half of 2025.

"Xspray Pharma develops PKI products that are 100% amorphous and that improve safety and efficiency for patients. It is gratifying to see that our patented HyNap technology platform continues to show strong results and that we continue to make important progress with several product candidates," says Per Andersson, CEO of Xspray Pharma.

On January 20, 2025 InnoCare Pharma (HKEX: 09969; SSE: 688428) and KeyMed Biosciences (HKEX: 02162) reported that the two companies, together with their joint venture, have jointly entered into an exclusive license agreement with Prolium Bioscience (Prolium) for the development and commercialization of ICP-B02 (CM355), a CD20xCD3 bispecific antibody (Press release, InnoCare Pharma, JAN 20, 2025, View Source [SID1234649776]).

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ICP-B02 binds to CD20 on the tumor cells and CD3 on the T cells, redirects and activates T cells to eradicate tumor cells through T-cell Directed Cellular Cytotoxicity (TDCC), which has demonstrated strong potential in both oncology and non-oncology fields.

Under the terms of the agreement, Prolium will have the exclusive right to develop, register, manufacture and commercialize ICP-B02 in the non-oncology field globally and in the oncology field in ex-Asia regions.

InnoCare and KeyMed will receive aggregate payments of up to $520 million, including upfront and near-term payments and other payments subject to the achievement of certain clinical, regulatory and commercial milestones, as well as a minority equity stake in Prolium. InnoCare and KeyMed are also eligible to receive tiered royalties on future net sales of any product resulting from the collaboration.

Prolium is a Delaware company funded and backed by RTW Investments, LP, a New York-based, global, full life-cycle investment firm that focuses on identifying transformational and disruptive innovations across the biopharmaceutical and medical technologies sectors.

About ICP-B02 (CM355)

ICP-B02 is a CD20×CD3 bispecific antibody jointly developed by InnoCare and KeyMed. A Phase I/II clinical trial in China is ongoing to assess the safety, tolerability, PK and the preliminary anti-tumor activity of ICP-B02 in relapsed / refractory Non-Hodgkin lymphoma (NHL). The study has shown promising early results in both intravenous (IV) and subcutaneous (SC) formulations, particularly in patients with follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL). Based on the encouraging results of ICP-B02 single agent, a dose expansion study of ICP-B02 in combination with other immunochemotherapies is planned to target earlier lines of treatment for NHL patients. The IND for the combination therapies has been approved.

On January 20, 2025 CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, reported that KJ-C2320, an allogeneic CAR T-cell therapy targeting CD38, has administered the first dose to a patient in an investigator-initiated trial (IIT) (Press release, Carsgen Therapeutics, JAN 20, 2025, View Source [SID1234649775]).

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KJ-C2320 is developed based on CARsgen’s THANK-uCAR platform. An investigator-initiated trial is ongoing in China to evaluate KJ-C2320 for the treatment of relapsed/refractory acute myeloid leukemia (R/R AML).

About THANK-uCAR

THANK (Target to Hinder the Attack of NK cells)-uCAR is CARsgen’s proprietary technology to generate allogeneic CAR-T cells with improved expansion and persistence by modifying donor-derived T cells. To minimize graft versus host disease (GvHD) and host versus graft response (HvGR) from allogeneic T cells, we disrupt the genomic loci encoding TCR and beta-2 microglobulin (B2M) to eliminate surface expression of the TCR or the human leukocyte antigen class I (HLA-I), an approach that has been validated by previous research. However, natural killer (NK) cells can attack T cells without HLA-I expression, which then limits the expansion and persistence of the allogeneic CAR-T cells. To protect the allogeneic CAR-T cells from the patient’s NK cells’ attacks, we arm these TCR-/B2M-T cells with a CAR that recognizes NKG2A to hinder the NKG2A-positive NK cell rejection of the CAR T cells and therefore allow the THANK-uCAR-T cells to resist the attack by NK cells. Clinical studies have demonstrated that the BCMA CAR-T therapy developed on the THANK-uCAR platform can expand in patients achieving complete response to levels comparable to autologous CAR-T, showing preliminary evidence of controllable safety and promising efficacy.