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.

On January 22, 2025 Lisata Therapeutics, Inc. (Nasdaq: LSTA) ("Lisata" or the "Company"), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, reported preliminary Cohort A data from the ongoing Phase 2 ASCEND trial (NCT05042128) being conducted at 25 sites across Australia and New Zealand led by the Australasian Gastro-Intestinal Trials Group (AGITG) and coordinated by the National Health and Medical Research Council (NHMRC) Clinical Trial Centre at the University of Sydney (Press release, Lisata Therapeutics, JAN 22, 2025, View Source [SID1234649846]). The data will be presented in a poster session, entitled, "AGITG ASCEND: Randomized, double-blind Phase II study of certepetide or placebo added to gemcitabine plus nab-paclitaxel in patients with untreated metastatic pancreatic ductal adenocarcinoma: Initial results," at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal (ASCO GI) Cancers Symposium on Friday, January 24th at 11:30 a.m. – 1:00 p.m. (PST) in San Franscisco, California. For a detailed summary of the poster presentation, please see the abstract available on the ASCO (Free ASCO Whitepaper) GI website: meetings.asco.org/abstracts-presentations/241497.

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The Phase 2 double-blind, randomized (2:1 ratio), placebo-controlled trial is evaluating certepetide, Lisata’s proprietary investigational iRGD cyclic peptide product candidate, in combination with standard-of-care (SoC) chemotherapy (gemcitabine and nab-paclitaxel) for the treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC). Following the acquisition of Cend Therapeutics, Lisata collaborated with AGITG to amend the inherited trial’s protocol to ensure it respected international regulatory standards and was optimized to generate clinically meaningful data that would effectively guide the next stages of development. The amended protocol is designed to assess the efficacy of two different dosing regimens of certepetide in two separate treatment cohorts: Cohort A, with 95 patients receiving a single intravenous (IV) dose of certepetide 3.2 mg/kg or placebo in combination with SoC, and Cohort B, with 63 patients receiving two IV doses of certepetide 3.2 mg/kg or placebo administered 4 hours apart in combination with SoC.

Cohort A of the ASCEND trial completed enrollment in the third quarter of 2023. The preliminary data from Cohort A demonstrate a median overall survival (mOS) of 12.68 months for the certepetide treated group, compared to 9.72 months for the placebo treated group. Despite a numerical trend in 6-month PFS favoring the certepetide treatment group, no significant improvement in median PFS was observed (mPFS of 5.5 months in both groups). However, the observed mOS and objective response rate (ORR) benefit are positive with 4/65 (6.2%) complete responses in the certepetide treated group, compared to 0/28 (0%) the placebo treated group.

"The data from Cohort A are as we expected and corroborate our decision to add Cohort B to the ASCEND protocol," stated Kristen K. Buck, M.D., Executive Vice President of Research and Development and Chief Medical Officer of Lisata. "The increase in overall survival and the observation of 4 complete responses in the certepetide-treated group compared to none in the placebo group for Cohort A, coupled with our expectation of even better outcomes in Cohort B, where we believe early indications show a strong separation in mPFS benefiting patients treated with certepetide, support our plans to advance certepetide development to Phase 3 in early 2026."

About Certepetide

Certepetide (formerly LSTA1), an internalizing RGD (arginylglycylaspartic acid or iRGD), cyclic peptide product candidate, is an investigational drug designed to activate a novel uptake pathway that allows co-administered or tethered anti-cancer drugs to target and penetrate solid tumors more effectively. Certepetide actuates this active transport system in a tumor-specific manner, resulting in systemically co-administered anti-cancer drugs more efficiently penetrating and accumulating in the tumor. Certepetide also has been shown to modify the tumor microenvironment resulting in tumors which are more susceptible to immunotherapies. We and our collaborators have amassed significant non-clinical data demonstrating enhanced delivery of a range of emerging anti-cancer therapies, including immunotherapies and RNA-based therapeutics. To date, certepetide has also demonstrated favorable safety, tolerability, and clinical activity in completed and ongoing clinical trials designed to test its ability to enhance the effectiveness of standard-of-care chemotherapy for pancreatic cancer. Lisata is exploring the potential of certepetide to enable a variety of treatment modalities to treat a range of solid tumors more effectively. Certepetide has been awarded Fast Track designation (U.S.) and Orphan Drug Designation for pancreatic cancer (U.S. and E.U.) as well as Orphan Drug Designation for glioma (U.S.) and osteosarcoma (U.S.). Additionally, certepetide has received Rare Pediatric Disease Designation for osteosarcoma (U.S.).