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 Prestige BioPharma Ltd. (KRX: 950210) and Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, hereafter referred to as "Dr. Reddy’s") reported that the two companies have entered into a binding agreement for an exclusive partnership for the supply and commercialization of Prestige BioPharma’s proposed trastuzumab biosimilar in select countries in Latin America and Southeast Asia (Press release, Prestige BioPharma, DEC 8, 2021, https://www.businesswire.com/news/home/20211208006154/en/Prestige-BioPharma-and-Dr.-Reddy%E2%80%99s-announce-partnership-to-commercialize-trastuzumab-biosimilar-in-select-countries-in-Latin-America-and-Southeast-Asia [SID1234596624]).

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Prestige BioPharma’s trastuzumab (HD201) is a proposed biosimilar to Roche’s Herceptin and can be prescribed for the treatment of HER2 positive breast and metastatic gastric cancer. Trastuzumab targets human epidermal growth factor 2 (HER2). In some types of cancer cells, HER2 is overexpressed and stimulates the growth of the cancer cells. Trastuzumab works by selectively binding to HER2, thereby stopping the growth of these cancer cells.

The license agreement grants Dr. Reddy’s the exclusive rights to commercialize the proposed biosimilar in select countries in Latin America and Southeast Asia. Under this partnership, Prestige BioPharma will be responsible for sustainable commercial supply of HD201 from its manufacturing facilities in Osong, South Korea, while Dr. Reddy’s will be responsible for local registrations, marketing and sales in the licensed territories.

Lisa S. Park, CEO of Prestige BioPharma, commented: "We are delighted to establish a partnership with Dr. Reddy’s for key Latin American and Southeast Asian markets. Dr. Reddy’s is the ideal partner to commercialize our lead biosimilar in these territories. With this collaboration, we look forward to further strengthening the value of our biosimilar programs in global markets."

M.V. Ramana, CEO – Branded Markets (India & Emerging Markets), Dr. Reddy’s, said: "In keeping with our purpose of accelerating access to affordable and innovative medicines, we are happy to bring this life-saving drug to patients in need. Our partnership with Prestige BioPharma will help us combine their established expertise in the area of biosimilars with our commercial strengths and growth ambition in these markets. This is in line with our stated intention to create a portfolio of oncology products and expand our biosimilar offerings in Emerging Markets."

On December 8, 2021 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of targeted drugs for the treatment of cancer, reported a poster presentation featuring data from the company’s ongoing Phase 2 CLOVER-1 study of iopofosine I-131 at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition being held virtually December 11-14, 2021 (Press release, Cellectar Biosciences, DEC 8, 2021, View Source [SID1234597073]).

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The poster will highlight data from eleven multiple myeloma patients who were at least triple class refractory (immunomodulatory agent, proteasome inhibitor and monoclonal antibody) that were treated with iopofosine I-131 in the company’s Phase 2 CLOVER-1 study, with data current as of the end of May 2021.

Details for the poster presentation are as follows:

Title: CLR 131 (Iopofosine I-131) Treatment in Triple Class Refractory and Beyond Multiple Myeloma Patients: Preliminary Efficacy and Safety Results from the Phase 2 CLOVER-1 Trial
Session/Title: 653/Myeloma and Plasma Cell Dyscrasias: Clinical-Prospective Therapeutic Trials: Poster I
Abstract: 1652
Authors: Sikander Ailawadhi; Patrick Stiff; Emad Ibrahim; Damian J. Green; Brea Lipe; Elizabeth H. Cull; Natalie S. Callander; John Friend; Jarrod Longcor, and Kate Oliver
Date/Time: Saturday, December 11, 2021 at 5:30 pm – 7:30 pm

A copy of the poster will be available after the presentation on the News and Events section of the company’s website.

About iopofosine (also known as CLR 131)

Iopofosine is a small-molecule Phospholipid Drug Conjugate designed to provide targeted delivery of iodine-131 (radioisotope) directly to cancer cells, while limiting exposure to healthy cells. We believe this profile differentiates iopofosine from many traditional on-market treatments. Iopofosine is currently being evaluated in the CLOVER-WaM Phase 2 pivotal study in patients with relapsed/refractory (r/r) Waldenstrom’s macroglobulinemia (WM), a Phase 2b study in r/r multiple myeloma (MM) patients and the CLOVER-2 Phase 1 study for a variety of pediatric cancers. The U.S. Food and Drug Administration granted iopofosine Fast Track Designation for WM patients having received two or more prior treatment regimens, as well as r/r MM and r/r diffuse large B-cell lymphoma (DLBCL). Orphan Drug Designations (ODDs) have been granted for WM, MM, neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma. Iopofosine was also granted Rare Pediatric Disease Designation (RPDD) for the treatment of neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma. The European Commission granted an ODDs for r/r MM and WM.

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 Treadwell Therapeutics, reported a presentation for the Company’s CFI-402257 program, an oral, best-in-class TTK inhibitor, at the 2021 San Antonio Breast Cancer Symposium (SABCS) being held from December 7-10, 2021 (Press release, Treadwell Therapeutics, DEC 8, 2021, View Source [SID1234596605]). This presentation will describe dose escalation and expansion data from CFI-402257-CL-001, an investigator-initiated study of CFI-402257 in advanced solid tumors.

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"The anti-tumor activity observed with CFI-402257 alone or in combination with Fulvestrant in patients with ER+/Her2- breast cancer, including patients previously treated with CDK4/6 inhibitors, is encouraging and warrants further investigation" said Dr. Phillipe Bedard, Study investigator, Associate Professor of Medicine at the University of Toronto and Staff Medical Oncologist at the Princess Margaret Cancer Centre, Toronto, Canada. "We look forward to additional data from this study, as well as the initiation of our company sponsored TWT-203 trial in ER+/Her2- breast cancer," added Dr. Michael Tusche, Treadwell co-CEO.

2021 SABCS Poster Presentations and Details:
CFI-402257-CL-001: An Open-Label, Dose Escalation, Safety, and Pharmacokinetic Study of CFI-402257
Administered Orally to Patients with Advanced Solid Tumors
Poster Number: P1-18-17
Date: December 8th, 7:00 am – 8:30 pm

In this presentation, CFI-402257 demonstrated a tolerable safety profile at doses up to 168 mg QD and linear pharmacokinetics, with 168 mg as the RP2D. In this heavily pre-treated, all-comer patient population (N=67), 25 patients (53.2%) showed disease control (SD+PR+CR) and 5 patients showed confirmed PRs (10.6%), 4 patients with ER+/Her2- breast cancer and 1 with hepatocellular carcinoma. Two of the breast cancer patients were treated with monotherapy and two were treated in combination with fulvestrant. The median duration of response for the breast cancer patients was 256 days with PRs coming after only 2 cycles. The most common drug related toxicities of any grade, which occurred in greater than 10% of patients, were nausea (29.9%), fatigue (22.4%), decreased appetite (20.9%), diarrhea (16.4%), vomiting (13.4%), neutrophil count decrease (11.9%), alopecia (10.4%), neutropenia (10.4%), and white blood cell count decrease (10.4%)