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Incyte Earns $25 Million Milestone as Jakavi® (ruxolitinib) Recommended for Approval in Europe for Polycythemia Vera

On January 23, 2015 Incyte reported that it has earned a $25 million milestone payment from Novartis (Press release Incyte, JAN 23, 2015, View Source [SID:1234501376]). This payment was triggered by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopting a positive opinion for Jakavi (ruxolitinib) for the treatment of adult patients with polycythemia vera (PV) who are resistant to or intolerant of hydroxyurea. Incyte expects to record this amount as contract revenue, and receive the $25 million payment, in the first quarter of 2015.

“We are very pleased with the progress that Novartis has made in the global development and commercialization of Jakavi,” stated Hervé Hoppenot, President and Chief Executive Officer of Incyte. “This recommendation for approval in Europe, the second indication for Jakavi and many months ahead of schedule, is further evidence that our innovative scientific advances can offer significant benefit to patients.”

Under the Incyte-Novartis Collaboration and License Agreement signed in 2009, Novartis received exclusive development and commercialization rights to ruxolitinib outside of the United States for all hematologic and oncologic indications, and sells ruxolitinib under the name Jakavi. Ruxolitinib is marketed by Incyte in the United States as Jakafi (ruxolitinib).

Array Announces Agreement To Acquire ENCORAFENIB (LGX818)

On January 23, 2015 Array BioPharma reported that it has reached a definitive agreement with Novartis Pharma AG to acquire worldwide rights to encorafenib (LGX818), a BRAF inhibitor currently in Phase 3 development (Press release Array BioPharma, JAN 23, 2015, View Source [SID:1234501374]). This agreement is conditional on the closing of transactions announced by Novartis and GlaxoSmithKline PLC (GSK) on April 22, 2014, which are expected to close in the first half of 2015, and the agreement remains subject to the receipt of regulatory approvals. Array previously announced a definitive agreement with Novartis to regain global rights to the Phase 3 MEK inhibitor binimetinib, the material terms of which remain in place following this agreement. In order to address competition concerns raised by the European Commission, Array has agreed to obtain an experienced partner for global development and European commercialization of both binimetinib and encorafenib. The European Commission is expected to issue a decision regarding the Novartis-GSK transaction on January 28, 2015.

“Acquiring worldwide rights to encorafenib, an innovative late-stage oncology product, represents a tremendous opportunity for Array,” said Ron Squarer, Chief Executive Officer, Array BioPharma. “There are currently eleven active encorafenib clinical trials, including the Phase 3 COLUMBUS trial in which encorafenib is being studied in combination with binimetinib for BRAF+ melanoma patients. With rights to both encorafenib and binimetinib, Array would enhance its position to broadly develop and commercialize each product, as well as this MEK/BRAF combination, which may have differentiating advantages when compared to available therapies.”

Terms of the Agreement

Upon satisfaction of all conditions and closing of the deal, Array will acquire global rights to encorafenib. Other than a de minimis payment due to Novartis from Array, there are no milestone payments or royalties payable under this agreement by either party. Novartis has agreed to provide transitional regulatory, clinical development and manufacturing services as specified below and will assign or license to Array all patent and other intellectual property rights Novartis owns to the extent relating to encorafenib. As part of the transaction, Array has agreed to obtain an experienced partner for global development and European commercialization of both binimetinib and encorafenib. If Array is unable to find a suitable partner in the prescribed time period, a trustee would have the right to sell such European rights.

Novartis will conduct and fund the COLUMBUS trial through the earlier of June 30, 2016 or completion of last patient first visit. At that time, Array will assume responsibility for the trial, while Novartis will reimburse Array for out-of-pocket costs along with 50% of Array’s full time equivalent (FTE) costs in connection with completing the COLUMBUS trial. Novartis is responsible for conducting all other encorafenib trials until their completion or transfer to Array for a defined transition period. For all trials transferred to Array, Novartis will reimburse Array for out-of-pocket costs and 50% of Array’s FTE costs in connection with completing the trials.

Novartis will supply encorafenib for clinical and commercial use for up to 30 months after closing and will also assist Array in the technology and manufacturing transfer of encorafenib. Novartis will also provide Array continued access to several Novartis pipeline compounds for use in currently ongoing combination studies, and possible future studies, including Phase 3 trials, with encorafenib. The effectiveness of the agreement is subject to the receipt of regulatory approvals and to the consummation of the Novartis-GSK transaction.

In addition, Array agreed to undertake to obtain certain third party consents or waivers necessary for Array to consummate the transactions under the Novartis Agreement.

BPGbio Unveils Research on the Identification of Novel Pancreatic Cancer Patient Subtypes at ASCO GI 2025 Paving the Way for Tailored Treatment

On January 22, 2025 BPGbio, Inc., a leading biology-first, AI-powered clinical-stage biopharma company focused on mitochondrial biology and protein homeostasis, reported the presentation of new findings in pancreatic cancer subtyping from Project Survival (NCT2781012), the company’s seven-year longitudinal pancreatic cancer precision medicine clinical trial (Press release, BPGbio, JAN 22, 2015, View Source [SID1234649841]). The results will be presented at the ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium, being held January 23–25, 2025, in San Francisco, Calif.

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Aimed at improving pancreatic cancer survival rate, the multi-center clinical trial employed comprehensive biomarker discovery to understand patient survival, enabling the development of new diagnostic, therapeutic, and clinical support solutions. Leveraging the biology-first approach and causal AI capabilities of BPGbio’s proprietary NAi Interrogative Biology platform, researchers conducted a comprehensive multiomics analysis of plasma samples from 280 pancreatic ductal adenocarcinoma (PDAC) patients over seven years and found distinct molecular patterns correlated with both long-term and short-term survival outcomes.

"Pancreatic cancer is not a one-size-fits-all disease. One of the biggest challenges we face in treating it is the rapid progression of the disease, which often leaves us with little time to make critical decisions," said Madappa Kundranda, M.D., Ph.D., Chief of Division of Cancer Medicine, Banner MD Anderson Cancer Center, who was the principal investigator of the study. "Our research aims to address this by identifying pancreatic cancer subtypes quicker, allowing us to better select patients for clinical trials and, ultimately, develop more tailored treatments that can significantly improve patient outcomes."

Notably, elevated cholesterol metabolism was observed in long-term survivors, while reduced levels of specific lipids characterized short-term survivors, among other biomarkers. These findings offer the potential of non-invasive blood-based biomarker panels for precise patient stratification and more tailored treatment.

"This study identifies how critical it is to go beyond genomics in biomarker discovery in order to capture the biological diversity of patients which impacts therapeutic decisions," said Michael A. Kiebish, Ph.D., Vice President of Platform and Translational Sciences, BPGbio. "To effectively treat the patient, not just the disease, we must identify the right molecular signature, which can be revealed through advanced multi-omics technologies that provide a holistic view of the body’s biology."

Pancreatic cancer remains one of the deadliest cancers due to its typically late diagnosis and rapid progression. The current method of identifying tumor tissue subtypes such as ‘Cholesterogenic’ and ‘Classical’ is associated with improved survival, but tissue-based profiling poses challenges due to the invasive nature of sample collection and the time it takes to analyze tissue subtypes, relative to the quick advancement of the disease.

"At BPGbio, we believe that understanding differences in patient biology, such as between diseased and non-diseased populations, requires a systems medicine approach. These findings from Project Survival are a testament to the power of that perspective," said Niven R. Narain, Ph.D., President and CEO of BPGbio. "By expanding our focus beyond cancer tissues and by performing comprehensive molecular profiling on patient plasma, we unlock critical insights into pancreatic cancer biology. This approach enables us to move toward more tailored treatments for various categories of patients, bringing us closer to the ultimate goal of this meaningful project – survival."

ASCO-GI Presentation Details

Abstract #: 775
Abstract Title: Lipogenic and Metabolic Subtypes Define Survival Outcome in Pancreatic Adenocarcinoma Patients
In-Person Session Name: Poster Session B: Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract
In-Person Poster Session Date: January 24, 2025, 11:30 a.m. – 1 p.m. PST
Presenter: Madappa Kundranda, M.D., Ph.D.

About BPM31510

BPM31510IV is BPGbio’s lead candidate in late-stage development for aggressive solid tumors such as glioblastoma multiforme (GBM) and pancreatic cancer. Other topical and oral formulations of the investigational agent are also being developed as a potential treatment for several rare diseases. The compound has demonstrated a tolerable safety profile and shown potential clinical benefits across multiple disease indications. Validated by BPGbio’s NAi Interrogative Biology platform, BPM31510 induces a hallmark shift in the tumor microenvironment (TME) by modulating mitochondrial oxidative phosphorylation in aggressive tumors, leading to cancer cell death. In many mitochondrial diseases, restoring CoQ10 levels can overcome the effect of mutations in genes that lead to mitochondrial dysfunction. BPM31510 has been granted Orphan Drug Designation by the FDA for GBM, pancreatic cancer, and epidermolysis bullosa (EB), as well as Rare Pediatric Disease Designation for primary CoQ10 deficiency and EB.

BlossomHill Therapeutics Doses Patients in the First Cohort of the Phase 1/2 SOLARA Clinical Trial of BH-30643 for EGFR- and HER2-Mutated Non-Small Cell Lung Cancer

On January 22, 2025 BlossomHill Therapeutics, Inc., a privately-held, clinical-stage biotechnology company focused on the design and development of small molecule medicines for treating cancer and autoimmune diseases, reported the first cohort of patients has been dosed in the SOLARA study (NCT06706076) (Press release, BlossomHill Therapeutics, JAN 22, 2015, View Source;and-HER2-Mutated-Non-Small-Cell-Lung-Cancer [SID1234649839]). SOLARA is a global, open label, dose escalation and expansion Phase 1/2 clinical trial assessing the safety, efficacy and tolerability of BH-30643 for locally advanced or metastatic non-small cell lung cancer (NSCLC) bearing EGFR or HER2 mutations.

"EGFR-mutant lung cancer is one of the most common genomic subtypes of lung cancer globally and has been a major target of drug development in recent years, yet an unmet medical need remains for patients," said Dr. Geoff Oxnard, Chief Medical Officer of BlossomHill Therapeutics. "Our thesis is that the novel, macrocyclic design of BH-30643 will provide potent antitumor activity in a broader spectrum of EGFR-mutant lung cancers with reduced toxicity. Dosing the first Phase 1 patient cohort with BH-30643, our second molecule to enter the clinic, marks an important step toward our goal of providing patients with intentionally designed precision medicines."

About the SOLARA study

The Phase 1/2 SOLARA clinical trial evaluates BH-30643, a macrocyclic, reversible, mutant-selective OMNI-EGFR inhibitor for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) bearing EGFR or HER2 mutations. In preclinical studies, BH-30643 demonstrated potent antitumor activity spanning classical EGFR mutations (exon 19 deletions, L858R), atypical EGFR mutations (G719X, L861Q, S768I, etc.), exon 20 insertions, and HER2 mutations. The global study consists of a dose escalation part to identify Recommended Doses for Evaluation (RDE), followed by an expansion part to further evaluate BH-30643 across a range of EGFR and HER2 mutations. Additional details on the design and discovery of BH-30643 will be reported at an upcoming medical meeting.

Advaxis Announces FDA Acceptance of Its Investigational New Drug Application to Commence First-in-Human Clinical Trials of ADXS-HER2

On January 22, 2015 Advaxis reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to conduct a Phase 1 clinical study of ADXS-HER2 (ADXS31-164) for the treatment of patients with metastatic HER2 expressing solid tumors (Press release Advaxis, JAN 22, 2015, View Source [SID:1234501367]). The clinical trial, which will be the first-in-human study of Advaxis’s lead Lm-LLO immunotherapy product for HER2 expressing cancers, is expected to begin patient enrollment in the first half of 2015. In May 2014, Advaxis was granted orphan drug designation by the FDA for ADXS-HER2 in osteosarcoma.

The Phase 1 clinical study is designed to evaluate the safety and tolerability of ADXS-HER2 as a monotherapy in patients with metastatic HER2 expressing solid tumors such as breast, gastric, esophageal, and osteosarcoma. Results from the study will be used to determine the future clinical development program of ADXS-HER2.

"We are very pleased to have received FDA acceptance for our ADXS-HER2 IND application and look forward to commencing the Phase 1 clinical study in HER2 expressing solid tumors," stated Daniel J. O’Connor, President and Chief Executive Officer of Advaxis. "This trial will provide important insights about the potential of ADXS-HER2 in HER2 expressing cancers such as breast, gastric, esophageal and osteosarcoma."

The safety and efficacy of ADXS-HER2 is currently being evaluated in an ongoing Phase 1/2 veterinary clinical study in pet dogs with osteosarcoma, conducted by Nicola Mason, BVet.Med, Ph.D., DACVIM, of the University of Pennsylvania School of Veterinary Medicine. To date, dogs treated (n=15) with ADXS-HER2 immunotherapy, after receiving standard of care (amputation and follow up chemotherapy), had a statistically significant overall survival benefit (p=0.032) compared to dogs (n=13) that only received standard of care. Additionally, the preliminary data suggests immune responses induced by ADXS-HER2 targeted pulmonary micrometastases and prevent the development of metastatic disease in the dog’s lungs.

Advaxis has granted exclusive worldwide rights to Aratana Therapeutics (Nasdaq:PETX) to develop and commercialize ADXS-HER2 for the treatment of osteosarcoma in dogs. In July 2014, Aratana filed a U.S. Department of Agriculture (USDA) product license application for ADXS-HER2 for the treatment of canine osteosarcoma and other cancers. While the USDA has no specific obligation to respond within a prescribed timeframe, the companies expect a response within 12 to 18 months from the date the application was filed.