On January 23, 2025 Cancer Research UK, Cytovation and the Norwegian Cancer Society reported to have signed an agreement to bring Cytovation’s lead asset, CY-101, into a multi-national Phase 2 clinical trial for patients with adrenocortical carcinoma (ACC) (Press release, Cytovation, JAN 23, 2025, View Source;utm_medium=rss&utm_campaign=cancer-research-uk-cytovation-and-the-norwegian-cancer-society-collaborate-to-advance-treatment-for-rare-cancer [SID1234649848]).

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This rare and aggressive cancer, which affects the adrenal glands, has limited treatment options and an urgent need for new therapies.

CY-101, developed by Cytovation, is a synthetic peptide with a dual function. It selectively targets and destroys cancer cells, triggering a systemic immune response, while simultaneously inhibiting the Wnt/β-catenin signalling pathway, a key driver of immunotherapy resistance in cancers such as ACC.

CY-101’s development builds on compelling data from Cytovation’s Phase 1 CICILIA trial, which demonstrated encouraging outcomes in patients with solid tumours. Notably, two ACC patients had clear clinical benefit, with one achieving 18 months of progression-free survival and continuing treatment on a named-patient basis. These results highlight CY-101’s potential to address the specific mechanisms of ACC.

A collaborative approach
Under the agreement, Cancer Research UK’s Centre for Drug Development (CDD) will sponsor, design and deliver the Phase 2 trial and Cytovation will be responsible for providing CY-101 for the clinical trial. Cancer Research Horizons, Cancer Research UK’s innovation arm, will manage the commercial relationship between the three parties.

The Norwegian Cancer Society’s support provides access to the additional resources, patients and sites required for trials in rare diseases. Due to the rarity of ACC, the clinical trial will run across multiple sites in the UK and Europe, to ensure robust patient recruitment.

Lars Erwig, Director of the Centre for Drug Development, Cancer Research UK, said: "This collaboration represents a critical step toward addressing the needs of ACC patients who currently have very few treatment options. Cytovation has made impressive progress with CY-101 so far and we are excited to build on our existing partnership with the Norwegian Cancer Society to take its development further."

Lars Prestegarden, CEO, Cytovation, said: "We are very excited about this partnership, proud to follow in the footsteps of groundbreaking agents that Cancer Research UK has contributed to developing, and honoured by the Norwegian Cancer Society’s support. We believe CY-101 has the potential to be transformational for the treatment of ACC and other cancer types and are eager to bring this innovation to patients."

Ingrid Stenstadvold Ross, CEO of the Norwegian Cancer Society, said: "The partnership with Cancer Research UK’s Centre for Drug Development marks a milestone for the Norwegian Cancer Society, enabling us to advance the development of groundbreaking cancer treatments. We are thrilled that our first joint project is a Norwegian innovation, focused on patients with a rare cancer and a substantial unmet need. Together with Cancer Research UK’s Centre for Drug Development and Cytovation, we are bringing new hope to patients while highlighting Norwegian research on the international stage."

On January 23, 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 positive updated data from the ASPEN-06 Phase 2 clinical trial demonstrating that the company’s investigational CD47-blocker evorpacept generates a durable clinical response with a well-tolerated safety profile among patients with previously treated HER2-positive advanced gastric cancer (GC) or gastroesophageal junction (GEJ) cancer (Press release, ALX Oncology, JAN 23, 2025, View Source [SID1234649845]). The updated results, which build upon previously announced topline results, will be shared today in an oral presentation (Abstract #332) at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium in San Francisco.

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"The updated data from the ASPEN-06 trial highlight the potential clinical utility of CD47 inhibition from evorpacept in combination with trastuzumab, ramucirumab and paclitaxel in patients with previously treated HER2-positive gastric cancer," said Kohei Shitara, M.D., Director of the Department of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan and the study’s presenter. "Overall, the findings suggest that evorpacept generates durable and clinically meaningful anti-tumor activity in this population of patients who had previously received a HER2-targeted agent, with the largest benefit among those patients with confirmed HER2-positive disease."

ASPEN-06 is a randomized, multi-center, international trial (NCT05002127) evaluating evorpacept, ALX Oncology’s investigational CD47-blocking therapeutic that uniquely combines a high-affinity CD47-binding domain with an inactivated proprietary Fc domain, in combination with trastuzumab, CYRAMZA (ramucirumab) and paclitaxel (collectively, ETRP) against trastuzumab, ramucirumab and paclitaxel (TRP) alone for the treatment of patients with HER2-positive gastric/GEJ cancer, where all patients had received an anti-HER2 agent in prior lines of therapy. Patients were enrolled with either archival or fresh HER2-positive biopsies.

The trial’s primary endpoints were investigator-assessed overall response rate (ORR) in the intent-to-treat (ITT) population and in the population of patients with fresh HER2-positive biopsies, compared to both internal control (TRP) and historical control (ramucirumab and paclitaxel, or RP). Key secondary endpoints were safety, duration of response (DOR), progression-free survival (PFS) and overall survival (OS). The updated dataset being presented today includes results from a December 2, 2024 data cut, including an analysis that assessed patients with HER2-positive tumors via circulating tumor DNA (ctDNA) at baseline. Overall survival data were not yet mature at the time of data cut.

Updated trial results to be shared today at 2025 ASCO (Free ASCO Whitepaper) GI include:

Primary endpoints (December data cut):
ITT patient population ORR (N=127): Evorpacept plus TRP (ETRP) demonstrated an ORR of 41.3% compared to 30% for RP historical control and 26.6% for TRP control.
Fresh HER2-positive biopsy patient population ORR (n=48): ETRP demonstrated an ORR of 59.1% compared to 30% for RP historical control and 23.1% for TRP control.
In the ITT population, ETRP demonstrated a median DOR (mDOR) of 15.7 months and a median PFS (mPFS) of 7.5 months compared to an mDOR of 9.1 months and mPFS of 7.4 months in the TRP control group, with a PFS Hazard Ratio (HR) in this population of 0.77.
In patients with fresh HER2-positive biopsies, ETRP demonstrated an mDOR of 15.7 months and mPFS of 9.5 months compared to an mDOR of 14.5 months and 7.1 months in the TRP control group, with a PFS HR of 0.62.
In patients with confirmed HER2-positive expression as determined by either fresh biopsy or ctDNA HER2-positivity (n=96), the addition of evorpacept to TRP resulted in a 48.9% ORR, an mDOR of 15.7 months and mPFS of 7.5 months, compared to 24.5% ORR, an mDOR of 9.1 months and mPFS of 6.7 months in the TRP control group, with a PFS HR of 0.64.
Evorpacept plus TRP was generally well tolerated, with the incidence of adverse events in the evorpacept population consistent with those in TRP control.
"The results from this trial tell a clear story that when a cancer cell is expressing HER2, evorpacept can combine with a regimen containing an anti-HER2 antibody such as trastuzumab to improve upon the activity you would expect from that regimen alone," said Alan Sandler, M.D., Chief Medical Officer at ALX Oncology. "This is evidenced by the near doubling of PFS at one year among the patients with HER2-positivity confirmed via either fresh biopsy or ctDNA who received ETRP vs control. Additionally, the analysis of this patient population affirms HER2-expression is a key biomarker for evorpacept efficacy and validates the strategy behind evorpacept’s novel design."

The updated ASPEN-06 data add to positive findings from a Phase 1b/2 trial recently presented at the 2024 San Antonio Breast Cancer Symposium (SABCS). These findings suggested that patients with heavily pretreated HER2-positive advanced breast cancer had anti-tumor activity from CD47 inhibition with evorpacept when it is combined with a HER2-targeted agent.

"The dataset shared today from the ASPEN-06 randomized clinical trial suggests durable clinical benefit driven by evorpacept and a differentiated safety profile – a first for any CD47 blocker," said Jason Lettmann, Chief Executive Officer at ALX Oncology. "Based on the collective clinical data we’ve now seen across patients with HER2-positive gastric and breast cancers, we believe evorpacept is working as designed in combination with antibodies when there is HER2 expression, even when patients had been previously treated with other HER2-directed therapies. We look forward to sharing the updated ASPEN-06 data with the FDA and are confident in our path to pursue evorpacept as a therapeutic option for patients."

A copy of the 2025 ASCO (Free ASCO Whitepaper) GI presentation will be available in the "Publications" section of the ALX Oncology website following the presentation.

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to evorpacept for the second-line treatment of patients with HER2-positive gastric or GEJ carcinoma. Additionally, both the FDA and European Commission have granted Orphan Drug Designation for this indication.

Company Conference Call and Webcast on January 23 at 1:00 PM PT/4:00 PM ET
ALX Oncology will host a conference call and webcast today at 1:00 PM PT/4:00 PM ET to 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 PM PT/4:00 PM ET
Webcast Access: View Source

On January 23, 2025 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company") reported that the Company received marketing authorization in China from National Medical Products Administration (NMPA) for the programmed cell death ligand 1(PD-L1)-directed innovative humanized monoclonal antibody ("mAb") tagitanlimab (formerly KL-A167) used in combination with cisplatin and gemcitabine for the first-line treatment of patients with recurrent or metastatic nasopharyngeal cancer (NPC) (Press release, Kelun Biotech, JAN 23, 2025, View Source [SID1234649836]).

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The approval is based on a randomized, double-blinded, placebo controlled, multi-center, phase III clinical study evaluates the efficacy and safety results of tagitanlimab in combination with cisplatin and gemcitabine versus placebo in combination with cisplatin and gemcitabine for the treatment of recurrent or metastatic NPC, which was led by Professor Shi Yuankai of the Cancer Hospital Chinese Academy of Medical Sciences as the principal investigator.

According to the study results, tagitanlimab used in combination with cisplatin and gemcitabine for the first-line treatment for recurrent or metastatic NPC could have better progression-free survival (PFS), higher objective response rate (ORR) and extended duration of response (DoR) compared with chemotherapy, where all the patients could benefit regardless of the PD-L1 expression. The median PFS for tagitanlimab in combination with chemotherapy is not reached compared to 7.9 months for placebo in combination with chemotherapy (HR=0.47, 95% CI: 0.33-0.66, p<0.0001), and the risk of disease progression and death is reduced by 53%; ORR is 81.7% vs 74.5%; median DoR is 11.7 vs 5.8 months (HR=0.48, 95% CI: 0.32-0.70), which has nearly doubled compared to placebo arm; currently the median overall survival (OS) is still not mature, however the beneficial trend for OS of tagitanlimab in combination with chemotherapy has already been observed (HR=0.62, 95％CI: 0.32-1.22), and its risk of death is reduced by 38%[1]. Tagitanlimab also showed a manageable safety profile.

This is the second indication approved for tagitanlimab. Previously, NMPA has approved the marketing in China of tagitanlimab monotherapy for the treatment of patients with recurrent or metastatic NPC who have failed after prior 2L+ chemotherapy.

Dr. Micheal Ge, CEO of Kelun-Biotech said, "We are pleased that the second indication of our self-developed PD-L1 monoclonal antibody was successfully approved for marketing and demonstrated statistically significant and clinically meaningful improvements in PFS. For domestic NPC patients, Tagitanlimab has realized a breakthrough in therapeutic coverage and innovation from the backline to the frontline, which once again strongly validates the excellent strength of Kelun-Biotech’s new drug research and development. In the future, the company will always be based on unmet clinical needs, source innovation, and explore more and more excellent clinical therapeutic solutions to benefit more patients."

On January 22, 2025 Johnson & Johnson reported full year 2024 financial results (Presentation, Johnson & Johnson, JAN 22, 2025, View Source [SID1234650315]).

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On January 22, 2025 Sanofi reported that following the adoption of a positive opinion by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), the EU has approved Sarclisa in combination with a standard-of-care regimen, bortezomib, lenalidomide, and dexamethasone (VRd), for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM) ineligible for autologous stem cell transplant (ASCT), based on data from the IMROZ phase 3 study (Press release, Sanofi, JAN 22, 2025, View Source [SID1234649870]). With the expanded marketing authorization, Sarclisa is the first anti-CD38 therapy in combination with VRd in this patient population in the EU.

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In September 2024, the US Food and Drug Administration (FDA) approved Sarclisa in combination with VRd for the treatment of adult patients with NDMM who are not eligible for ASCT, representing the first global approval for Sarclisa in the front-line setting. In addition, the FDA granted orphan drug exclusivity for Sarclisa in the approved indication. Beyond the US and the EU, regulatory submissions for Sarclisa in NDMM not eligible for ASCT are under review in Japan and in China.

About Sarclisa

Sarclisa (isatuximab) is a CD38 monoclonal antibody that binds to a specific epitope on the CD38 receptor on MM cells, inducing distinct antitumor activity. It is designed to work through multiple mechanisms of action including programmed tumor cell death (apoptosis) and immunomodulatory activity. CD38 is highly and uniformly expressed on the surface of MM cells, making it a target for antibody-based therapeutics such as Sarclisa. In the US, the non-proprietary name for Sarclisa is isatuximab-irfc, with irfc as the suffix designated in accordance with nonproprietary naming of biological products guidance for industry issued by the US FDA.

Currently, Sarclisa is approved in more than 50 countries, including the US and in the EU, across three indications. Based on the ICARIA-MM phase 3 study, Sarclisa is approved in combination with pomalidomide and dexamethasone (Pd) for the treatment of patients with relapsed or refractory MM (R/R MM) who have received ≥2 prior therapies, including lenalidomide and a proteasome inhibitor, and who progressed on last therapy. Based on the IKEMA phase 3 study, Sarclisa is also approved in 50 countries in combination with carfilzomib and dexamethasone, including in the US for the treatment of patients with R/R MM who have received 1–3 prior lines of therapy and in the EU for patients with MM who have received at least 1 prior therapy. In the US and EU, Sarclisa is approved in combination with VRd as a front-line treatment option for adult patients with NDMM, who are not eligible for ASCT, based on the IMROZ phase 3 study.

Sanofi continues to advance Sarclisa as part of a patient-centric clinical development program, which includes several phase 2 and phase 3 studies across the MM treatment continuum spanning six potential indications. In addition, the company is evaluating a subcutaneous administration method for Sarclisa in clinical studies. The safety and efficacy of Sarclisa has not been evaluated by any regulatory authority outside of its approved indications and methods of delivery.

In striving to become the number one immunoscience company globally, Sanofi remains committed to advancing oncology innovation. Through focused strategic decisions the company has reshaped and prioritized its pipeline, leveraging its expertise in immunoscience to drive progress. Efforts are centered on difficult-to-treat often rare cancers such as select hematologic malignancies and solid tumors with critical unmet needs, including multiple myeloma, acute myeloid leukemia, certain types of lymphomas, as well as gastrointestinal and lung cancers.