On December 3, 2021 AQILION AB (publ) reported that it has strengthened its pipeline with an innovative development program in the field of chronic inflammation (Press release, Aqilion, DEC 3, 2021, View Source [SID1234596433]). With this acquisition, Aqilion is taking over all rights to the program, now under the name Regulus, from LEO Pharma. The project is ready for clinical trials and Aqilion plans to begin clinical development in 2022.

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Aqilion has acquired all rights to Regulus from LEO Pharma, who developed the project from early internal discovery research. Under the terms of the agreement, Aqilion will make an upfront payment that is a combination of cash and equity and LEO Pharma will become a shareholder of Aqilion. Furthermore, Aqilion will make additional payments from either product sales or through out-licensing revenues.

Regulus is a novel next-generation selective JAK1 inhibitor previously developed as LEO 142397, now AQ280. Drugs with a similar mechanism of action have shown clinical efficacy in autoimmune and inflammatory diseases. Aqilion will initially investigate AQ280 as a potential therapy for eosinophilic esophagitis (EoE), an inflammatory disease of the esophagus. To date, no drugs with the same mechanism of action have been developed for EoE and there is a high unmet medical need. Aqilion will conduct the Regulus project in-house with the aim of starting a Phase 1 safety study in healthy volunteers in 2022, followed by a Phase 2a study in patients.

"It is both gratifying and inspiring for us at Aqilion to be able to expand our chronic inflammation pipeline with such an innovative, high quality and exciting program as Regulus. Expanding our pipeline with a project in early clinical development has been a priority and we now look forward to advancing Regulus, while benefiting from synergies with our pipeline of preclinical projects," says Sarah Fredriksson, CEO of Aqilion.

"We are always excited to see our R&D operations bring forward new compounds that has the potential to help patients in any indication. In this case EoE where Aqilion is the right partner to pursue the potential of LEO 142397 – now Regulus. LEO Pharma will continue our dedication to bringing forward new innovative treatments that are either first or best in class and changing the standards of care within medical dermatology," says Thorsten Thormann, VP Research and Early Development in LEO Pharma.

About eosinophilic esophagitis
Eosinophilic esophagitis (EoE) is a rare chronic disease involving inflammation of the esophageal mucosa; its main symptom is swallowing difficulties. EoE is a relatively new diagnosis that is increasing in incidence. The disease, which has a progressive course, is also known as "allergic esophagitis" and is thought to be triggered by food allergens. Both children and adults can be affected and the diagnosis is most common in children in their teens and in adults aged 30-50. The condition is more common in men.

On December 3, 2021 Secura Bio, Inc. (Secura Bio) – (www.securabio.com), an integrated pharmaceutical company dedicated to the worldwide development and commercialization of impactful oncology therapies, reported that it has voluntarily withdrawn the U.S. COPIKTRA indication for the treatment of patients with relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies (Press release, Secura Bio, DEC 3, 2021, View Source [SID1234596449]). The relapsed or refractory FL indication received accelerated approval in September 2018 with the requirement that an additional confirmatory trial be conducted in order for the product to be granted full approval.

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After a Secura Bio strategic assessment of COPIKTRA and subsequent consultation with the U.S. Food and Drug Administration (FDA), the company made the determination that the current treatment landscape for FL patients in the U.S. and the logistics, cost and timing of the post-marketing requirements (PMR) for COPIKTRA in FL was no longer merited. Secura Bio has determined that a more prudent application of future effort and resource is in new applications for T-cell lymphoma where initial data appear encouraging. The company is looking forward to working with the FDA and gaining guidance regarding an appropriate regulatory and clinical plan.

This is a business decision and is not related to any changes in either the efficacy or safety associated with COPIKTRA. This decision impacts only the relapsed or refractory FL indication in the U.S. and does not affect other approved indications for COPIKTRA in the U.S. and other countries, including the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies.

Secura Bio will work with the FDA over the coming weeks to complete the label revision process, including notification of U.S. healthcare professionals in a timely manner about the label change. Patients in the U.S. being treated with COPIKTRA for relapsed or refractory FL should discuss their care with their healthcare provider. Patients, or their healthcare providers, who have questions or concerns are encouraged to contact Secura Bio at (805) 479-7793 for assistance. Secura Bio patient support specialists can help answer questions, including insurance coverage and reimbursement options.

About COPIKTRA (duvelisib)

COPIKTRA is an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first United States FDA approved dual inhibitor of PI3K-delta and PI3K-gamma, two enzymes known to help support the growth and survival of malignant cells. PI3K signaling may lead to the proliferation of malignant cells and is thought to play a role in the formation and maintenance of a supportive tumor microenvironment. COPIKTRA is indicated in the United States for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies.. COPIKTRA is also being developed for the treatment of peripheral T-cell lymphoma (PTCL), for which it has received Fast Track designation in the United States. COPIKTRA is being investigated in combination with other agents across several types of solid and hematologic malignancies, through investigator-sponsored studies. For more information on COPIKTRA, please visit www.COPIKTRA.com. Information about duvelisib clinical trials can be found on www.clinicaltrials.gov.

IMPORTANT SAFETY INFORMATION ABOUT COPIKTRA

WARNING: FATAL AND SERIOUS TOXICITIES: INFECTIONS, DIARRHEA OR COLITIS, CUTANEOUS REACTIONS, and PNEUMONITIS

See full prescribing information for complete boxed warning

Fatal and/or serious infections occurred in 31% (4% fatal) of COPIKTRA-treated patients. Monitor for signs and symptoms of infection. Withhold COPIKTRA if infection is suspected.
Fatal and/or serious diarrhea or colitis occurred in 18% (<1% fatal) of COPIKTRA-treated patients. Monitor for the development of severe diarrhea or colitis. Withhold COPIKTRA.
Fatal and/or serious cutaneous reactions occurred in 5% (<1% fatal) of COPIKTRA-treated patients. Withhold COPIKTRA.
Fatal and/or serious pneumonitis occurred in 5% (<1% fatal) of COPIKTRA-treated patients. Monitor for pulmonary symptoms and interstitial infiltrates. Withhold COPIKTRA.
INDICATIONS AND USAGE

COPIKTRA is a kinase inhibitor indicated for the treatment of adult patients with:

Relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies.

WARNINGS AND PRECAUTIONS

Hepatotoxicity: Monitor hepatic function.
Neutropenia: Monitor blood counts.
Embryo-Fetal toxicity: COPIKTRA can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception.
ADVERSE REACTIONS

The most common adverse reactions (≥20%) are diarrhea or colitis, neutropenia, rash, fatigue, pyrexia, cough, nausea, upper respiratory infection, pneumonia, musculoskeletal pain, and anemia.

DRUG INTERACTIONS

CYP3A inducers: Avoid co-administration with strong CYP3A inducers.
CYP3A inhibitors: Monitor for COPIKTRA toxicities when co-administered with strong or moderate CYP3A inhibitors. Reduce COPIKTRA dose to 15 mg twice daily when co-administered with strong CYP3A4 inhibitors.
CYP3A substrates: Monitor for signs of toxicities when co-administering COPIKTRA with sensitive CYP3A substrates.
USE IN SPECIFIC POPULATIONS

Lactation: Advise women not to breastfeed.

On December 3, 2021 Crescendo Bioscience reported In the breast cancer research and clinical communities, one of the biggest events of the year is the San Antonio Breast Cancer Symposium (Press release, Crescendo Bioscience, DEC 3, 2021, View Source [SID1234596472]). It’s a place where leaders in the field come together to share the latest advances, discoveries, and validation studies relevant to the treatment of breast cancer.

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At this year’s meeting, Myriad Genetics team members will be presenting two posters reporting results from studies that showcase the importance of genetic testing and precision medicine as integral components of both breast cancer treatment recommendations and risk assessment.

Here’s a look at some highlights from each poster.

Identifying homologous recombination deficiency in breast cancer: genomic instability score thresholds differ in breast cancer subtypes P5-13-09 Poster Session 5, December 10, 2021, 7:00 a.m. – 8:30 a.m. (CST)

Presenter: Kirsten Timms

This poster, from researchers at Myriad Genetics, the Mayo Clinic, Johns Hopkins School of Medicine, Indiana University, and University College Cork, describes the results of a study designed to assess the differences in genomic instability score (GIS) thresholds for triple-negative breast cancer and estrogen receptor-positive breast cancer. The team used the GIS for ovarian cancer as a comparator to guide the identification of potential candidates for treatment with PARP inhibitors. GIS markers highlight the presence of homologous recombination-deficient tumors that may benefit from DNA damaging agents such as PARP inhibitors. Researchers analyzed more than 1,000 tumors and determined that different cancers require different GIS thresholds, and that more inclusive levels could allow more people to receive beneficial PARP treatment.

Integration of an ancestry-inclusive polygenic risk score with the Tyrer-Cuzick breast cancer risk model

P2-11-21 Poster Session 2, December 8, 2021, 5:00 p.m. – 6:30 p.m. (CST)

Presenter: Elisha Hughes

Based on a collaborative team from Cleveland Clinic, University of Pennsylvania, Dana-Farber Cancer Institute, and other institutions, this study validates the integration of an ancestry-inclusive breast cancer polygenic risk score with a clinical and family history-based model in the development of a risk assessment tool for breast cancer. The team reviewed data for nearly 69,000 women, looking for cases where risk would have been reclassified based on the addition of genomic information. They found that risk stratification improved with the incorporation of a polygenic risk score, allowing for personalized five-year and lifetime risk estimates for women of all ancestries.

These posters reflect Myriad Genetics’ ongoing commitment to improve risk prediction and treatment for breast cancer so that women can be empowered to take charge of their health. We congratulate all of the scientists and clinicians who participated in these important studies!

On December 3, 2021 Global pharma major, Lupin Limited (Lupin) reported that they have entered into an exclusive distribution and marketing agreement with Biomm SA in Brazil (Press release, Lupin, DEC 3, 2021, View Source [SID1234596434]). Under the terms of agreement, Biomm will distribute and market biosimilar Pegfilgrastim in Brazil.

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Lupin had earlier received the U.S. FDA acceptance of the Biologics License Application (BLA) for its proposed biosimilar to Neulasta (pegfilgrastim) through a filing using the 351(k) pathway.

Pegfilgrastim is indicated to reduce the duration of neutropenia and the incidence of febrile neutropenia in patients receiving chemotherapy.

On December 3, 2021 Isofol Medical AB (publ) (Nasdaq Stockholm: ISOFOL), reported that the U.S. Food and Drug Administration (FDA) denied a request from the company to adjust the analysis of the pivotal AGENT study’s secondary endpoint of progression-free survival (PFS) (Press release, Isofol Medical, DEC 3, 2021, View Source [SID1234596451]). However, the decision will not affect the study’s primary endpoint, objective response rate, previously agreed upon with the FDA. The secondary endpoint may have to be somewhat modified.

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In the AGENT study, more patients than expected have proceeded to other treatments before they reached tumor progression (PFS). Isofol is blinded to the study data, and therefore it is not possible for Isofol to know whether the change is occurring in one or both treatment arms of the study, or the reason for patients proceeding to other treatments. However, the study’s Data Safety Monitoring Board has repeatedly reviewed the safety data of the study with no resulting changes. The consequence of the treatment change is that Isofol will be unable to reach its target of 300 PFS events with the current censoring rules.

Isofol requested that the censoring rules be adjusted in accordance with the ICH (International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use) guidelines adopted by the FDA in 2021. However, during a "Type C" meeting the FDA denied the request and will analyze the study results based on the original censoring rules for the primary analysis of PFS. The decision may cause a delay of top-line results of arfolitixorin in advanced, metastatic colorectal cancer. Isofol is currently analyzing the options to address the feedback received from the FDA and what impact it will have on the PFS endpoint. However, the AGENT study’s primary endpoint of overall response rate (ORR) is not affected. The study is continuing according to plan.

"We had expected the FDA to accept our proposal to adjust the analysis in line with the new ICH guidelines. Our ongoing discussions with the FDA, including the additional opportunities for interaction that the new Fast Track Designation enables, are productive. We remain optimistic and hopeful that the AGENT study will have a positive outcome for the benefit of patients, their caregivers and our shareholders," said Ulf Jungnelius, CEO of Isofol.

This is information that Isofol Medical AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 20:15 CET on December 3, 2021.

About arfolitixorin

Arfolitixorin is Isofol’s proprietary drug candidate being developed to increase the efficacy of standard of care chemotherapy for advanced colorectal cancer. The drug candidate is currently being studied in a global pivotal Phase III study, AGENT. Arfolitixorin is the first and only immediately active folate and can potentially benefit more patients with advanced colorectal cancer, as it does not require complicated metabolic activation to become effective.

About the AGENT study

The Phase III AGENT study is a randomized, controlled, multi-centre study assessing the efficacy and safety of arfolitixorin, [6R]-5,10-methylene-THF acid (MTHF), compared to leucovorin, both used in combination with 5-FU, oxaliplatin, and bevacizumab, in first line metastatic colorectal cancer patients. Patients are randomized in a 1:1 ratio and the primary endpoint is overall response rate (ORR). The key secondary endpoints are progression free survival (PFS) and duration of response (DOR). Other secondary endpoints include overall survival (OS), number of curative metastasis resections, safety, and patient reported outcomes such as quality of life (QoL). Exploratory endpoints include pharmacokinetic (PK) measurements and level of gene expression of folate relevant genes in tumour cells. The study is designed to show superiority for arfolitixorin over leucovorin.

The study has involved approximately 90 clinics in the U.S., Canada, Europe, Australia and Japan. In December 2020, the last of the AGENT study’s 440 patients were recruited, which is the basis in the statistical analysis plan. Isofol is now focusing on completing the ongoing global AGENT study where the patients receive first-line standard treatment for metastatic colorectal cancer (mCRC) with either leucovorin or arfolitixorin. The company expects that top-line results of the AGENT study will be available during H1 2022. Further information about the study, including patient eligibility requirements, is available at www.clinicaltrials.gov id:NCT03750786.