On December 8, 2021 EpiAxis Therapeutics reported it is commencing a pre-clinical collaboration focused on inhibiting Protein Kinase C theta (PKC theta), which could provide a potential new approach to treating cancer (Press release, EpiAxis Therapeutics, DEC 8, 2021, View Source;utm_medium=rss&utm_campaign=epiaxis-expands-pkc-theta-pre-clinical-program [SID1234596591]).

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PKC theta is upregulated in a variety of solid and haematological cancers and is associated with promoting tumour aggressiveness, metastasis, and resistance to therapy. PKC theta also plays an important role in immune regulation.

EpiAxis is collaborating with Dr Hanna Y Irie, MD, PhD, Associate Professor of Medicine, Hematology and Medical Oncology, Icahn School of Medicine at Mount Sinai and a leading research scientist in the PKC theta cancer sector. Under the collaboration, EpiAxis will provide Dr. Irie with its PKC theta inhibitors for evaluation in breast cancer models.

Mt Sinai oncology

"This is an important collaboration for EpiAxis as we expand our pre-clinical program to advance our PKC theta assets," said EpiAxis CEO Dr Jeremy Chrisp. "We are delighted to be collaborating with Dr Irie’s team at the Icahn School of Medicine as this complements and strengthens our existing focus on LSD1 in breast cancer."

"This is an exciting opportunity to validate novel inhibitors against a promising therapeutic target for triple negative breast cancer, a particularly aggressive subtype that we have been studying for many years," said Mount Sinai’s Dr Irie about the partnership with EpiAxis.. "Once validated, we hope to translate these inhibitors for the benefit of patients."

Dr Irie (above) is a physician-scientist at Mount Sinai’s Tisch Cancer Institute whose research program is focused on identifying, validating, and translating novel therapeutic targets for high-risk breast cancers, especially drug-resistant and metastatic disease. While maintaining an active clinical practice as a breast medical oncologist, she has led translational efforts at Mount Sinai’s Dubin Breast Center, including the creation of the Breast Tumor Biorepository and generation of patient-derived xenograft (PDX) models of high risk and metastatic breast cancers, particularly triple negative, from diverse populations. Dr Irie’s research team has used phenotypic, genetic, and pharmacologic screening strategies to identify novel candidate therapeutic targets for breast cancer cells that are resistant to current standard-of-care treatments.

Dr Irie has published research papers in Nature Communications, Cell Reports, Cancer Research, NPJ Breast Cancer, Breast Cancer Research and Oncotarget, and her research on PKC theta has been supported by the American Association for Cancer Research (AACR) (Free AACR Whitepaper) and the Breast Cancer Research Foundation.

She received her MD and PhD degrees from Harvard Medical School, where she also completed her post-doctoral research fellowship. Dr Irie completed her clinical fellowship in Medical Oncology at the Dana-Farber Cancer Institute and Massachusetts General Hospital.

On December 8, 2021 Corcept Therapeutics Incorporated (NASDAQ: CORT) ("Corcept") a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol, reported that it has extended the expiration of its previously announced tender offer for shares of its common stock from one minute after 11:59 P.M., New York City time, on December 7, 2021 until one minute after 11:59 P.M., New York City time, on December 15, 2021 (unless further extended or earlier terminated) (Press release, Corcept Therapeutics, DEC 8, 2021, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-announces-extension-previously-announced [SID1234596589]).

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Based on information provided by Continental Stock Transfer & Trust Company, the depositary for the tender offer, to date, 8,282,336 shares have been tendered for purchase in the tender offer. Stockholders who have validly tendered and not withdrawn their shares do not need to re-tender their shares or take any other action in response to the extension of the tender offer.

The tender offer is contingent upon at least three million shares being tendered. The tender offer is also subject to terms and conditions, which are described in detail in the offer to purchase. Except for the extension of the expiration of the tender offer as set forth above, the terms and conditions of the tender offer remain the same.

None of Corcept, the members of its Board of Directors, the dealer manager, the financial advisor, the information agent or the depositary for the tender offer makes any recommendation as to whether or not any stockholder should participate in the tender offer or as to the purchase price or purchase prices at which stockholders may choose to tender their shares.

The sole dealer manager for the tender offer is Truist Securities, Inc. D.F. King is serving as the information agent for the tender offer and Continental Stock Transfer & Trust Company is serving as the depositary. Canaccord Genuity LLC is serving as a financial advisor. For all questions relating to the tender offer, please contact the information agent, D.F. King & Co., Inc. at [email protected] or call toll-free at 1 (800) 431-9646, or call the dealer manager, Truist Securities, Inc. at 1 (404) 926-5832.

On December 8, 2021 Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ: CKPT), a clinical-stage immunotherapy and targeted oncology company, reported the initiation of the CONTERNO study, a global, randomized Phase 3 trial of cosibelimab in combination with pemetrexed and platinum chemotherapy for the first-line treatment of patients with non-squamous non-small cell lung cancer (NSCLC) (Press release, Checkpoint Therapeutics, DEC 8, 2021, View Source [SID1234596588]). The primary endpoint for the CONTERNO Phase 3 trial is overall survival (OS), and the study is designed to support full regulatory approvals worldwide.

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James F. Oliviero, President and Chief Executive Officer of Checkpoint, stated, "We are excited to develop this combination in NSCLC, with the goal of extending the lives of patients with lung cancer and providing expanded access and fewer obstacles to potentially life-saving immunotherapy treatment." Mr. Oliviero continued, "Our strategy since our founding has been to enter the largest markets in this class with a focus on highly competitive pricing, and there is no more impactful indication to execute on this approach than NSCLC with approximately 1.7 million new worldwide cases reported in 2020."

About the CONTERNO Study
The CONTERNO study (ClinicalTrials.gov, NCT04786964) is a Phase 3, open-label, multi-center, randomized trial investigating cosibelimab (1200mg every three weeks) combined with pemetrexed and investigator’s choice of platinum chemotherapy (either carboplatin or cisplatin) versus pemetrexed and platinum chemotherapy alone in patients with previously untreated stage IV non-squamous NSCLC and with no EGFR mutations or ALK translocations. The primary endpoint is OS. Key secondary endpoints include progression-free survival, objective response rate and safety. Approximately 560 subjects will be randomized in a 2:1 ratio to receive cosibelimab in combination with chemotherapy or chemotherapy alone.

About Non-Small Cell Lung Cancer
Lung cancer is the most common cancer worldwide according to the World Health Organization, accounting for more than 2 million new cases diagnosed each year. Non-small cell lung cancer (NSCLC) accounts for approximately 85% of lung cancer diagnoses, resulting in approximately 1.7 million new cases each year. Currently, the five-year survival rate for lung cancer is less than 20%, decreasing further when the disease is diagnosed at later stages. The majority of people with NSCLC are diagnosed with advanced or Stage III or IV disease. Lung cancer is by far the leading cause of cancer death among both men and women, making up almost 25% of all cancer deaths.

On December 8, 2021 Celyad Oncology SA (Euronext & Nasdaq: CYAD) ("Celyad" or the "Company"), a clinical-stage biotechnology company focused on the discovery and development of chimeric antigen receptor T cell (CAR T) therapies for cancer, reported the closing of its previously announced private placement with an affiliate of Fortress Investment Group (such affiliate "Fortress") (Press release, Celyad, DEC 8, 2021, View Source [SID1234596587]). The Company issued 6,500,000 ordinary shares at a price of USD 5.00 (about EUR 4.42) for gross proceeds of USD 32.5 million (about EUR 28.7 million).

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The Company intends to use net proceeds from the private placement to fund research and development expenses, including the clinical development of its allogeneic CAR T candidates CYAD-101 and CYAD-211, to advance the current pipeline of preclinical CAR T candidates, to discover and develop additional preclinical product candidates using its proprietary non-gene edited short hairpin RNA (shRNA) technology platform, as well as for working capital, other general corporate purposes, and the enhancement of the Company’s intellectual property.

SVB Leerink acted as the exclusive placement agent for the private placement, Goodwin Procter LLP and Harvest acted as legal counsel to the Company. Skadden, Arps, Slate, Meagher & Flom LLP and Eubelius acted as legal counsel to Fortress.

The securities issued in the private placement have not been registered under the Securities Act of 1933 or applicable state securities laws and may not be resold in the United States absent registration under the Securities Act or an applicable exemption from such registration requirements. The Company has agreed to customary registration rights covering the resale of the ordinary shares (in the form of American Depositary Shares) sold in the private placement.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state. Any offering of the securities under the resale registration statement will only be by means of a prospectus.

On December 8, 2021 Almac Diagnostic Services, a member of the Almac Group, reported that its unique software driven solution for gene expression data analysis – claraT – has assisted oncology researchers at The University of Arkansas for Medical Sciences (US) and Queen’s University Belfast (UK) in the study of brain and breast cancers (Press release, Almac, DEC 8, 2021, View Source [SID1234596586]). The studies, recently published in the MDPI Cancer Journal and the British Journal of Cancer, have the potential to lead to better therapeutic outcomes for patients.

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The research teams, led by Dr Analiz Rodriguez at the University of Arkansas for Medical Sciences and Dr Stuart McIntosh at Queen’s University Belfast, cite use of Almac’s claraT report as a key method used to uncover new findings in their oncology studies.

Almac’s claraT report assists in the analysis of gene expression data by classifying the most biologically relevant gene expression signatures into a comprehensive easy-to-interpret report that covers all 10 Hallmarks of Cancer.

In Dr Analiz Rodriguez’s study, claraT was utilised as a method to facilitate the molecular profiling of brain metastases. Together with other genomic and transcriptomic tools, claraT helped identify novel molecular subtypes and new drivers of brain cancer progression in parallel to novel drug targets. These findings have been published in the MDPI Cancer Journal.

Dr Rodriguez said "We are grateful for the Almac Group’s claraT platform as it allowed us to evaluate hundreds of gene expression signatures and single gene targets that correlated to the Hallmarks of Cancer. Transcriptome data can be difficult to analyze, especially in our heterogenous dataset which included brain metastases samples from various primary cancer subtypes. The claraT software solution immensely simplified our workflow and helped us identify a novel subgroup of brain metastases which warrants further investigation."

Dr McIntosh’s study at Queen’s University Belfast demonstrated that the Almac DNA-damage immune-response (DDIR) assay could be used to identify a group of breast cancer patients more likely to benefit from DNA damaging chemotherapy prior to surgery. The team then used transcriptome profiling and the claraT report to demonstrate that patients with low baseline immune signalling or "cold" tumours could be immune primed through the prior use of DNA damaging chemotherapy, potentially sensitizing these tumours to immune checkpoint therapy. Taken together, these results could help refine the treatment of breast cancer patients and lead to better therapeutic outcomes. These results have been published in the British Journal of Cancer.

Dr McIntosh said "The increasing use of neoadjuvant chemotherapy for breast cancer has great potential to benefit patients, but there is a real need for validated biomarkers to identify those patients who will benefit from it. Furthermore, although there is increasing interest in the use of immune checkpoint therapies in breast cancer, we still don’t know which patients are likely to respond, nor what the best accompanying chemotherapeutic regimen is to sensitise patients to these. The use of Almac’s claraT report in our study has given us a valuable insight into the underlying biology of breast tumours before and during neoadjuvant chemotherapy, allowing us the potential to develop studies with a sound scientific rationale to further improve outcomes for these women."

Professor Richard Kennedy, Global VP and Medical Director, Almac Diagnostic Services stated: "We are delighted to be able to equip leading cancer researchers like Professor Rodriguez and Dr McIntosh with a valuable gene expression analysis platform which has supported the identification of exciting new data in their studies. We congratulate them and their teams on their recent publications and look forward to seeing how their studies progress towards new therapeutic interventions in both brain and breast cancer."

To see the current list of publications, posters and presentations that Almac’s claraT report has assisted research institutions with. Please see: View Source