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.

On January 22, 2025 Alligator Bioscience reported full year financial results for 2024 and for Q4 2024 and provides a business update (Press release, Alligator Bioscience, JAN 22, 2025, View Source [SID1234649820]).

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On January 22, 2025 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) reported the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ZL-1310, a potential highly active first-in-class DLL3 antibody-drug conjugate (ADC), for the treatment of small cell lung cancer (SCLC) (Press release, Zai Laboratory, JAN 22, 2025, View Source [SID1234649838]).

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"Receiving an Orphan Drug Designation for ZL-1310 recognizes its potential to treat patients with SCLC. These patients have an urgent need for innovative treatment options with improved efficacy, safety and ready access in tertiary care and community settings," said Rafael G. Amado, M.D., President, Head of Global Research and Development, Zai Lab. "ZL-1310 has demonstrated promising objective response rates and a favorable safety profile from the ongoing Phase 1 trial in patients with recurrent SCLC recently disclosed. We look forward to continuing to advance the clinical development of this promising asset across lines of therapy in SCLC and other DLL3-expressing tumors."

ZL-1310 will be eligible for certain development incentives, including a waiver of the Prescription Drug User Fee Act registration application fee, tax credits for certain clinical trials and the potential to receive a seven-year U.S. market exclusivity period granted upon product approval.

This important regulatory designation follows promising data from the ongoing global Phase 1a/1b study in patients with previously treated extensive-stage SCLC (ES-SCLC) after at least one prior platinum-based chemotherapy regimen, which was presented at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) (ENA) Symposium 2024 in October 2024.

About ZL-1310

ZL-1310 is a novel ADC in Zai Lab’s growing, global oncology pipeline that targets Delta-like ligand 3 (DLL3), an antigen that is overexpressed in many neuroendocrine tumors, is typically associated with poor clinical outcomes, and is a validated therapeutic target for SCLC. ZL-1310 comprises a humanized anti-DLL3 monoclonal antibody linked to a novel camptothecin derivative (a topoisomerase 1 inhibitor) as its payload. The compound was designed with a novel ADC technology platform called TMALIN, which leverages the tumor microenvironment to overcome challenges associated with first-generation ADC therapies, including off-target payload toxicity.

The ongoing Phase 1a/1b clinical trial is evaluating ZL-1310 as monotherapy and in combination with atezolizumab, an immune checkpoint inhibitor, for the treatment of ES-SCLC.

About Small Cell Lung Cancer (SCLC)

SCLC is one of the most aggressive and lethal solid tumors, accounting for ~15% of approximately 2.5 million patients diagnosed with lung cancer worldwide each year1,2. Two-thirds of all SCLC patients are diagnosed at extensive stage3, which is associated with high rates of relapse and poor prognosis. The outcomes of the patients with ES-SCLC are dismal, with median survival of approximately 12 months following initial therapy4 and a 5~10% overall five-year survival rate5. Treatment options are limited when patients progress, with the current standard of care resulting in limited clinical benefit. Despite recent advancements, new readily available treatment options with improved efficacy and manageable safety are needed.