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, Akeso Inc. (9926.HK) reported that it had received payment from Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. ("Sichuan Kelun") for their collaboration on the development of tagitanlimab, an innovative humanized monoclonal antibody targeting PD-L1, following its recent marketing approval by China’s National Medical Products Administration (Press release, Akeso Biopharma, JAN 22, 2025, https://www.prnewswire.com/news-releases/akeso-received-payment-for-the-development-collaboration-on-tagitanlimab-302357079.html [SID1234649835]).

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In 2014, Akeso signed a cooperation agreement with Sichuan Kelun for the development of tagitanlimab. Under the terms of the agreement, Akeso will receive royalties from the commercial sales of tagitanlimab in addition to the development payment.

Tagitanlimab marks Akeso’s second oncology product to yield commercial royalties, following pucotenlimab, a PD-1 monoclonal antibody developed in collaboration with Lepu Biopharma in 2016.

Dr. Yu Xia, founder, chairwoman, president, and CEO of Akeso, said: "Congratulations to our partners. We are thrilled about continuously successful approval of our innovative products, and truly anticipate their outstanding commercialization performance. This achievement highlights Akeso’s strong R&D capabilities and our commitment to innovation. Since its inception, Akeso has established multiple external collaborations, including ivonescimab with Summit Therapeutics, quavonlimab with Merck and pucotenlimab with Lepu Biopharma. These partnerships not only benefit patients but also deliver significant returns for both Akeso and our collaborators. Looking ahead, Akeso will continue to pursue a diversified strategy for new drug development, leveraging global resources to drive the high-quality commercialization of our independently developed innovative therapeutics."

On January 22, 2025 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, reported that patient enrolment has been completed in the investigator-initiated EFTISARC-NEO trial (Press release, Immutep, JAN 22, 2025, https://www.immutep.com/detail/patient-enrolment-completed-for-eftisarc-neo-phase-ii-trial.html [SID1234649801]). EFTISARC-NEO is evaluating eftilagimod alpha (efti) in combination with radiotherapy plus KEYTRUDA (pembrolizumab) in the neoadjuvant setting for patients with resectable soft tissue sarcoma (STS).

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The Phase II trial conducted by the Maria Skłodowska-Curie National Research Institute of Oncology (MSCNRIO) in Warsaw, the national reference centre for STS in Poland, has reached its enrolment target of 40 patients.

As previously announced, positive data from EFTISARC-NEO was presented at the Connective Tissue Oncology Society (CTOS) Annual Meeting in November 2024. Among 21 patients available for primary endpoint assessment, the triple combination achieved a greater than three-fold increase in tumour hyalinization/fibrosis (median 50%) at the time of surgical resection as compared to a historical median 15% from radiotherapy alone. This is an early surrogate endpoint at the time of surgery as tumour hyalinization/fibrosis has been associated with improved survival for STS patients.1,2

Additionally, the treatment has been safe with no grade ≥3 toxicities related to efti and pembrolizumab.

Data updates from EFTISARC-NEO are expected in 2025. For more information on the trial, please visit clinicaltrials.gov (NCT06128863).

On January 22, 2025 Abbott (NYSE: ABT) reported financial results for the fourth quarter ended Dec. 31, 2024 (Press release, Abbott, JAN 22, 2025, View Source [SID1234649819]).

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Fourth-quarter sales increased 7.2 percent on a reported basis, 8.8 percent on an organic basis, and 10.1 percent on an organic basis, excluding COVID-19 testing-related sales.
Fourth-quarter GAAP diluted EPS of $5.27 and adjusted diluted EPS of $1.34, which excludes specified items (see table titled "Non-GAAP Reconciliation of Financial Information").
Full-year 2024 sales of $42.0 billion increased 4.6 percent on a reported basis, 7.1 percent on an organic basis, and 9.6 percent on an organic basis, excluding COVID-19 testing-related sales.
Full-year 2024 gross margin as a percent of sales improved 60 basis points on a GAAP basis compared to 2023 and improved 70 basis points on an adjusted basis.
Full-year 2024 GAAP diluted EPS of $7.64 and adjusted diluted EPS of $4.67, which excludes specified items (see table titled "Non-GAAP Reconciliation of Financial Information").
For the full-year 2024, Abbott achieved the upper end of the initial guidance ranges the company provided in January 2024 for both organic sales growth and adjusted earnings per share.
During 2024, Abbott announced more than 15 new growth opportunities coming from the company’s highly productive R&D pipeline. These include a combination of new product approvals and new treatment indications.
Abbott projects full-year 2025 organic sales growth to be in the range of 7.5% to 8.5%.
Abbott projects full-year 2025 adjusted operating margin to be 23.5% to 24.0% of sales, which reflects an increase of 150 basis points at the midpoint compared to 2024.
Abbott projects full-year 2025 adjusted diluted EPS of $5.05 to $5.25, which reflects double-digit growth at the midpoint.
"We finished the year with very strong momentum. Sales growth and earnings per share growth in the fourth quarter were the highest of the year," said Robert B. Ford, chairman and chief executive officer, Abbott. "We continued our track record for delivering on our commitments by achieving the upper end of our initial guidance ranges for 2024 and are well-positioned to deliver another year of strong growth in 2025."

FOURTH-QUARTER BUSINESS OVERVIEW
Management believes that measuring sales growth rates on an organic basis, which excludes the impact of foreign exchange and the impact of discontinuing the ZonePerfect product line in the Nutrition business, is an appropriate way for investors to best understand the core underlying performance of the business. Management further believes that measuring sales growth rates on an organic basis excluding COVID-19 tests is an appropriate way for investors to best understand underlying base business performance in 2024, as the COVID-19 pandemic has shifted to an endemic state, resulting in significantly lower demand for COVID-19 tests.

Note: In order to compute results excluding the impact of exchange rates, current year U.S. dollar sales are multiplied or divided, as appropriate, by the current year average foreign exchange rates and then those amounts are multiplied or divided, as appropriate, by the prior year average foreign exchange rates.

On January 22, 2025 GI Innovation (KQ:358570) reported that it signed a Memorandum of Understanding (MOU) with LaNova Medicines (LaNova) for the development of GI-102 and ADC pancreatic cancer combination therapy (Press release, GI Innovation, JAN 22, 2025, View Source;adc-pancreatic-cancer-combination-therapy-302356896.html [SID1234649837]).

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This MOU was held on January 15th, local time, during JP Morgan Healthcare Conference (San Francisco, USA).

From the left, Rhee Byung-geon, Chairman and CEO of GI Innovation, Dr. Crystal Quin, CEO of LaNova Medicines, and Jang Myoung-ho, CSO of GI Innovation. (Source: GI Innovation)
From the left, Rhee Byung-geon, Chairman and CEO of GI Innovation, Dr. Crystal Quin, CEO of LaNova Medicines, and Jang Myoung-ho, CSO of GI Innovation. (Source: GI Innovation)
The two companies have been conducting combination therapy study of the immuno-oncology drug GI-102 and ADC LM-302 targeting Claudin18.2 and recently observed excellent anticancer activity in a preclinical pancreatic cancer model.

Both substances are in the clinical stage. GI-102 has completed phase 1 clinical trial in the US and Korea and can quickly enter phase 2. LM-302 is currently in phase 3 clinical trial for 3L and above gastric cancer in China. Pancreatic cancer has no approved immunotherapy, and the only approved treatment is a chemotherapy cocktail, but its treatment efficacy is low and its toxicity is high. Through this agreement, both companies will conduct clinical trial targeting patients with metastatic pancreatic cancer.

Dr. Myoung Ho Jang, CSO said, "We are delighted to be conducting a combination study with LaNova, which is recognized by global pharma companies. LaNova’s ADC, which directly destroys tumor cells to increase the response rate, and GI-102, which can enhance immune memory to increase overall survival, are expected to be a combination therapy that can change the pancreatic cancer treatment paradigm."

"GI-102 exemplifies GI Innovation’s robust R&D capabilities in immunotherapy. We are excited to explore its combination with LaNova’s Claudin18.2 ADC, LM-302, which holds the potential to provide a novel therapeutic option for pancreatic cancer patients" Dr. Crystal Qin, LaNova CEO emphasized.