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.

On 3 December 2021 Recordati announces the signing of a share purchase agreement to acquire EUSA Pharma (UK) Ltd, a global specialty pharmaceutical company with headquarters in the United Kingdom, focused on rare and niche oncology diseases and controlled by funds managed by EW Healthcare Partners (Press release, Recordati, DEC 3, 2021, View Source [SID1234652186]).

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Recordati is acquiring EUSA Pharma for an enterprise value of €750 million; the payment of the consideration will be funded via existing liquidity and bridge financing fully underwritten by J.P. Morgan and Mediobanca.

EUSA Pharma was founded in March 2015 and has grown rapidly into a world-class pharmaceutical company with a portfolio of 4 rare and niche oncology products with approximately €130 million LTM(1) Net Sales at 30 June 2021 and Net Debt of around €26 million at that same date. The company has extensive commercial operations in the EMEA and United States, alongside a presence in other international markets. The company employs more than 200 people with strong patient centric culture and deep disease area expertise. EUSA Pharma’s products include: Qarziba, an anti-GD2 monoclonal antibody indicated for high-risk neuroblastoma approved in Europe and other countries, and with potential for expansion in the US; Sylvant, an anti-IL-6 monoclonal antibody, the first and only ever approved treatment for Idiopathic Multicentric Castleman’s disease (iMCD) in US and in Europe, marketed also in other countries and well positioned in a market with limited options for patients; Fotivda, an oral highly selective small molecule tyrosine kinase inhibitor (TKI) of vascular endothelial growth factor (VEGF) receptors 1,2 and 3, approved for first-line treatment of advanced renal cell carcinoma in Europe and other countries; Caphosol , a medical device for oral mucositis due to chemo and radio therapy, approved in US, EU and other markets. The transaction would provide Recordati with an expanded portfolio of rare disease pharmaceutical products which is expected to contribute in 2023 revenue of over €150 million and EBITDA(2) of approximately €50 million. Non-recurring costs in 2022-2023 from on-going manufacturing technology transfer and acquisition and integration related expenses are estimated to be approximately €35 million (subject to timing of close).

On December 3, 2021 SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, reported the exercise of warrants to purchase 1.2 million shares of SCYNEXIS common stock by Federated Hermes Kaufmann Small Cap Fund and Dafna Lifescience LP for which SCYNEXIS accepted a reduced exercise price (Press release, Scynexis, DEC 3, 2021, View Source [SID1234596435]). Proceeds to SCYNEXIS are approximately $7.9 million. The exercised warrants were issued in SCYNEXIS’s December 2019 financing. The remaining warrants issued in the December 2019 financing covering approximately 3.2 million shares of common stock expired unexercised on December 2, 2021.

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"We believe the exercise of warrants by two of our largest stockholders provides a significant sign of confidence in the future of SCYNEXIS, after a year that included the approval and launch of our first U.S. commercial product and continued progress in our clinical development programs to treat serious fungal infections in the hospital setting," said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. "This additional cash influx strengthens our balance sheet and supports our important mission."