On October 8, 2020 eHealth, Inc. (NASDAQ: EHTH), a leading private online health insurance exchange, reported that the company plans to release third quarter 2020 financial results on October 22, 2020 (Press release, eHealth Insurance, OCT 8, 2020, View Source [SID1234568242]).

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Chief Executive Officer Scott Flanders and Chief Financial Officer Derek Yung will host the earnings conference call beginning at 5 p.m. Eastern Time on October 22nd to discuss these results.

Individuals interested in listening to the conference call may do so by dialing (877) 930-8066 for domestic callers and (253) 336-8042 for international callers. The participant passcode is 8351208.

A telephone replay will be available two hours following the conclusion of the call for a period of 7 days and can be accessed by dialing (855) 859-2056 for domestic callers and (404) 537-3406 for international callers. The call ID for the replay is 8351208. The live and archived webcast of the call will also be available on the company’s website at www.ehealthinsurance.com under the Investor Relations section.

On October 8, 2020 Foresee Pharmaceuticals Co., Ltd. (6576.TWO) ("Foresee") reported that the 505(b)(2) New Drug Application (NDA) for FP-001 LMIS 50mg, or CAMCEVI 42MG, a ready-to-use 6-month depot formulation of leuprolide mesylate, has been accepted for review by the U.S. Food and Drug Administration (FDA) (Press release, Foresee Pharmaceuticals, OCT 8, 2020, View Source [SID1234568241]).

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In its Day-74 letter, the FDA stated that the New Drug Application (NDA) for CAMCEVI 42MG is sufficiently complete to permit a substantive review. The goal date under the Prescription Drug User Fee Act (PDUFA) is May 27, 2021.

"This marks another important regulatory milestone for the CAMCEVI franchise," said Dr. Ben Chien, Founder and Chairman of Foresee. "We are confident that if approved, with a strong commercial partnership in the US, CAMCEVI 42MG and the CAMCEVI franchise will provide patients, as well as healthcare providers, a safe and easy-to-use treatment option with its differentiated ready-to-use profile. We look forward to the successful launch of the CAMCEVI franchise."

The NDA submission for CAMCEVI 42MG is supported by a previously communicated successful Phase 3 clinical study in 137 Advanced Prostate Carcinoma patients, where treatment with CAMCEVI 42MG injection every 6 months was demonstrated to be effective, safe and well tolerated.

On October 8, 2020 Ascentage Pharma (6855.HK), a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, reported that the US Food and Drug Administration (FDA) has granted two Orphan Drug Designations (ODDs) to two of the company’s apoptosis-targeting assets: the MDM2-p53 inhibitor, APG-115, for the treatment of acute myeloid leukemia (AML); and the Bcl-2/Bcl-xL inhibitor, APG-1252, for the treatment of small-cell lung cancer (SCLC) (Press release, Ascentage Pharma, OCT 8, 2020, View Source [SID1234568240]). With these two latest designations, Ascentage Pharma has obtained a total of six ODDs from the FDA for four of the company’s investigational drug candidates .

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The term "orphan drugs" refers to pharmaceutical products developed for the prevention, diagnosis, and treatment of rare diseases or conditions. In the United States, an orphan disease is defined as a disease or condition with a prevalence of less than 200,000 patients in the country. Since the Orphan Drug Act was passed in 1983, the US government has provided incentives and policy support to encourage development of orphan drugs. Drug candidate granted ODDs by the FDA will qualify for various development incentives, including a tax credit on expenditures incurred in clinical studies, a waiver of the New Drug Application (NDA) fee, research grant awarded by the FDA, and, most importantly, 7 years of US market exclusivity upon approval.

The MDM2-p53 inhibitor APG-115 for the treatment of AML

AML is a highly heterogenous hematologic malignancy that is more common in the elderly population with a median age at diagnosis of 68 years[1]. The most recent data from the Surveillance, Epidemiology, and End Results Program (SEER) of the US National Cancer Institute (NCI) estimates that there will be 19,940 new cases of AML and an estimated 11,180 deaths from this disease in the United States in 2020. Despite the recent advances in therapeutics, the 5-year survival rate of AML remains at 25%–30%, which still represents a significant unmet medical need.

APG-115 is an orally administered, selective, small-molecule inhibitor of MDM2. APG-115 has strong binding affinity to MDM2 and is designed to activate the tumor-suppressing activity of p53 by blocking the MDM2-p53 protein-to-protein interaction (PPI). APG-115 is the first MDM2-p53 inhibitor entering clinical development in China, with multiple ongoing clinical studies in solid tumors and hematologic malignancies in China and the US.

The Bcl-2/Bcl-xL inhibitor APG-1252 for the treatment of SCLC

Lung cancer remains the leading cause of cancer death in the United States[2]. Lung cancer is divided into two main histopathological types: non-small cell lung cancer (NSCLC) and SCLC, with 13-15% of lung cancers classified as SCLC[2],[3]. SCLC is a rare and highly aggressive cancer with a low 5-year survival rate[3]. Patients with relapsed/refractory SCLC have few treatment options, all of which offer modest response rates.

Being developed by Ascentage Pharma, APG-1252 is a novel small-molecule drug candidate that restores apoptosis by selectively inhibiting Bcl-2 and Bcl-xL proteins simultaneously. APG-1252 is currently being investigated in Phase I dose-escalation studies in patients with advanced cancers in the US and Australia, a Phase Ib/2 study of APG-1252 plus paclitaxel in patients with relapsed/refractory SCLC in the US, and a Phase I dose-escalation study of APG-1252 single agent in patients with SCLC in China. The clinical data of APG-1252 generated thus far have shown a favorable safety profile and preliminary efficacy in patients with SCLC and other advanced solid tumors.

"AML and SCLC are both devastating and life-threatening diseases which have high unmet clinical needs globally. For APG-115, this designation marks the second ODD of the molecule from the FDA, while it is the very first time for APG-1252 to obtain an ODD," said Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. "All the ODD-related supporting policies in the US will help us to accelerate the global clinical development and commercialization of these two drug candidates, and allow more patients to benefit as soon as possible."

References

[1] DeSantis CE, Lin CC, Mariotto AB, et al. Cancer Treatment and Survivorship Statistics, 2014. CA Cancer J Clin 2014;64:252-271.

[2] Siegel R, Miller K, Jemal A. Cancer Statistics, 2020. American Cancer Society. CA Cancer J Clin 2020;70:7–30.

[3] Lu T, Yang X, Huang Y, et al. Trends in the incidence, treatment, and survival of patients with lung cancer in the last four decades. Cancer Manag Res. 2019; 11: 943–953.

On October 8, 2020 ChromaDex Corp. (NASDAQ:CDXC) reported highlighted a new study from Nature Immunology that found nicotinamide riboside (NR) helped energize tumor infiltrating T-cells (TILs) in samples extracted from mice (Press release, ChromaDex, OCT 8, 2020, View Source [SID1234568239]. In a preclinical mouse model, NR was shown to improve T-cell function, which is a component of new cancer immunotherapies such as PD-1 and PDL-1 inhibitors. These findings lend further data to the potential role of NR in supporting healthy mitochondrial function.

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T-cells are immune cells tasked with recognizing and eliminating infected, damaged or cancerous cells. The researchers from the University of Lausanne and the Ludwig Institute for Cancer Research found that NR could prevent mitochondrial dysregulation and exhaustion in T-cells. By doing so, NR was also shown to improve T-cell mitochondrial function and responsiveness to anti-PD-1 cancer immunotherapy, a mainstay of cancer treatment approved for use against many solid tumor types. The tumor bearing mice fed with NR experienced less tumor growth, and an additive antitumor effect was observed when NR was combined with immunotherapy.

This research built upon a previous preclinical study, also conducted at the University of Lausanne, that found NR could promote hemopoietic stem cell (HSC) maturation in mice by stimulating mitochondrial function. Immune cells such as T-cells arise from these stem cells, as do essential red blood cells and platelets.

The prior study suggested that NR supplementation could facilitate cancer treatment by preventing myelosuppression in mice, (i.e. depletion of stem cells and all the cells they produce, caused by repeated chemotherapies).

This latest study from Nature Immunology indicates a new potential niche for NR supplementation by suggesting a synergistic effect with T-cell immunotherapies used for many solid tumors. NR has also been shown preclinically to possibly prevent neuropathy caused by paclitaxel, a common chemotherapy used for breast cancer treatment.

More research is required to validate this preclinical data and translate the findings into humans. Over 50 human trials investigating NR’s various health benefits are registered on ClinicalTrials.gov, 11 of which have been peer-reviewed and published through the ChromaDex External Research Program (CERP).

"We’re excited to see the discovery of so many potential applications for NR’s proven ability to promote mitochondrial function," said Dr. Andrew Shao, ChromaDex Senior Vice President of Global Scientific & Regulatory Affairs. "We know mitochondrial function is essential to the function of energy-expensive cells, including stem cells and immune cells. Their proper function, in turn, may play a key role in avoiding a wide array of diseases, including many cancers. We’re pleased to see that NR can support these essential cells and hope to elucidate its potential in human health and disease with further trials."

ChromaDex, the exclusive licensee of Dr. Charles Brenner’s patented NR, has invested over $35 million in investigating, manufacturing and offering NR in the form of Niagen and has secured more than 20 patents. ChromaDex has demonstrated the safety and efficacy of Niagen in 11 published human trials (and over 20 additional ongoing studies further evaluating its safety and efficacy) and has achieved government regulatory acceptance in the United States, Canada, the European Union, and Australia.

On October 8, 2020 Shattuck Labs, Inc. ("Shattuck"), a clinical-stage biotechnology company pioneering the development of bi-functional fusion proteins as a new class of biologic medicine for the treatment of cancer and autoimmune disease, reported the pricing of its upsized initial public offering of 11,882,352 shares of common stock at a public offering price of $17.00 per share (Press release, Shattuck Labs, OCT 8, 2020, View Source [SID1234568238]). The gross proceeds to Shattuck from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Shattuck, are expected to be approximately $202 million. All of the shares are being offered by Shattuck. The shares are expected to begin trading on The Nasdaq Global Select Market on October 9, 2020 under the ticker symbol "STTK." In addition, Shattuck has granted the underwriters a 30-day option to purchase up to an additional 1,782,352 shares of common stock at the initial public offering price, less underwriting discounts and commissions. The offering is expected to close on October 14, 2020 subject to the satisfaction of customary closing conditions.

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Citigroup, Cowen, and Evercore ISI are acting as joint book-running managers for the offering. Needham & Company is acting as lead manager for the offering.

The registration statements relating to these securities have been filed with the Securities and Exchange Commission and became effective on October 8, 2020. The offering is being made only by means of a prospectus. Copies of the final prospectus relating to the offering may be obtained, when available, from Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717 or by telephone at (800) 831-9146; Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, Attention: Prospectus Department, by telephone at (833) 297-2926; or Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, NY 10055, by telephone at (888) 474-0200, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.