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Corcept Therapeutics Announces Extension of Previously Announced Tender Offer

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 Stockholders who have validly tendered and not withdrawn their shares do not need to re-tender their shares or take any other action in response to the extension of the tender offer.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.

Checkpoint Therapeutics Announces Initiation of CONTERNO Phase 3 Trial of Cosibelimab Combined with Chemotherapy in Patients with First-Line Non-Squamous Non-Small Cell Lung Cancer

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.

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.

Celyad Oncology Announces Closing of $32.5 Million Private Placement with Fortress Investment Group Affiliate

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).

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.

Almac Diagnostic Services’ claraT Report Assists Researchers In Uncovering New Oncology Findings

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.

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

Actinium Pharmaceuticals, Inc. Announces Participation in Two Panel Discussions at the 3rd Targeted Radiopharmaceuticals Summit

On December 8, 2021 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium" or the "Company"), a leader in the development of targeted radiotherapies for patients with unmet needs reported its participation in the Targeted Radiopharmaceuticals Summit being held virtually December 7 – 9, 2021 (Press release, Actinium Pharmaceuticals, DEC 8, 2021, View Source [SID1234596585]). The Targeted Radiopharmaceuticals Summit brings together experts and thought leaders in the field with the goal to achieve meaningful clinical efficacy with theragnostic radionuclide therapies in a mono and combinatorial setting & deliver a robust, cGMP compliant manufacturing supply chain. Representatives from Actinium’s R&D and Clinical Development teams have been invited to participate as expert speakers in two panel presentations during the Targeted Radiopharmaceuticals Summit. The panel details are as follows:

Panel: Review of the Last 12 Months of Development of Alpha Emitting Therapies

Session: Next Generation Alpha Emitter Based Therapeutics

Actinium Expert Speaker: Helen Kotanides, Ph.D., Vice President, Translational Research and Preclinical Development

Date and Time: December 9, 2021, 5:30 pm CET, 11:30 am EST

Panel: High Dose – Low Dose Therapeutic Strategy: Tailoring the Dose of Radiopharmaceuticals for Opportunity and Outcomes

Session: Optimizing Treatment Regimens

Actinium Expert Speaker: Mary Chen, M.D., Ph.D., Vice President, Clinical Development

Date and Time: December 9, 2021, 6:30 pm CET, 12:30 pm EST

Learn more about the Targeted Radiopharmaceuticals Summit at www.targeted-radiopharma.com.