On January 13, 2021 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, announced that it will report fourth quarter and full year 2020 results on Thursday, February 4, 2021, before the market opens (Press release, Quest Diagnostics, JAN 13, 2021, View Source [SID1234573980]). It will hold its quarterly conference call to discuss the results beginning at 8:30 a.m. Eastern Time on that day.

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The conference call can be accessed by dialing 888-455-0391 within the U.S. and Canada, or 773-756-0467 internationally, using the passcode: "7895081." The earnings release and live webcast will be posted on www.QuestDiagnostics.com/investor. The company suggests participants dial in approximately 10 minutes before the call.

A replay of the call may be accessed online at www.QuestDiagnostics.com/investor or by phone at 866-461-2735 for domestic callers or 203-369-1352 for international callers; no passcode is required. Telephone replays will be available from approximately 10:30 a.m. Eastern Time on February 4, 2021 until midnight Eastern Time on February 18, 2021.

Anyone listening to the call is encouraged to read the company’s periodic reports on file with the Securities and Exchange Commission, including the discussion of risk factors and historical results of operations and financial condition in those reports.

On January 13, 2021 Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, reported that clinical and preclinical updates at the 39th Annual J.P. Morgan Healthcare Conference (Press release, Precigen, JAN 13, 2021, View Source [SID1234573979]). Helen Sabzevari, PhD, President and CEO of Precigen, presented a summary of 2020 clinical achievements and set forth Precigen’s clinical goals for 2021.

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In addition to reviewing the latest clinical updates for Precigen’s PRGN-3005 UltraCAR-T, PRGN-3006 UltraCAR-T, AG019 ActoBiotics, the presentation included the following additional announcements:

UltraCAR-T Library Approach: Precigen introduced the Company’s vision for a new UltraCAR-T library approach to transform the personalized cell therapy landscape for cancer patients. Precigen’s goal is to develop and validate a library of non-viral plasmids to target tumor-associated antigens. Enabled by design and manufacturing advantages of UltraCAR-T, coupled with the capabilities of the UltraPorator system, Precigen is working to empower cancer centers to deliver personalized, autologous UltraCAR-T treatment with overnight manufacturing to any cancer patient. Based on the patient’s cancer indication and biomarker profile, one or more non-viral plasmids would be selected from the library to build a personalized UltraCAR-T treatment. After initial treatment, this approach has the potential to allow for redosing of UltraCAR-T targeting the same or new tumor-associated antigen(s) based on the treatment response and the changes in antigen expression of the patient’s tumor. Precigen believes that the combination of the advanced UltraVector DNA construction platform and the ease of overnight manufacturing gives this library approach a proprietary advantage over traditional T-cell therapies.
PRGN-2009 AdenoVerse Immunotherapy in HPV-associated Cancers: For the first time, Precigen provided preliminary data for the ongoing Phase I/II study of the first-in-class PRGN-2009 AdenoVerse immunotherapy to treat HPV-positive (HPV+) solid tumors. The Phase I study is evaluating safety and response of PRGN-2009 alone (Arm A) and in combination with bintrafusp alfa, an investigational bifunctional fusion protein, (Arm B) in patients with HPV-associated cancers under a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI).
PRGN-2009 differentiation: PRGN-2009 leverages Precigen’s UltraVector and AdenoVerse platforms to optimize HPV 16/18 antigen design for delivery via a proprietary gorilla adenovector with a large genetic payload capacity and the ability for repeat administrations.
Preclinical activity: Preclinical studies show that PRGN-2009 treatment induced a strong HPV-specific immune response and anti-tumor response in a syngeneic mouse model of HPV+ cancer.
Addressable patient population: HPV infections account for 5% of all cancers globally1 and 690,000 new cancer cases are attributable to HPV infections per year.2
Enrollment: Enrollment in the Phase I monotherapy dose escalation arm (Arm A) is complete and enrollment in the Phase I combination arm (Arm B) has initiated.
Clinical activity: All patients (N=6) enrolled in the Phase I monotherapy arm (Arm A) have received multiple PRGN-2009 administrations to date and repeated administration of PRGN-2009 treatment has been well-tolerated with no dose-limiting toxicities.
Preliminary correlative analysis of peripheral blood mononuclear cells (PBMC) from patients treated at Dose Level 1 demonstrated an increase in HPV 16 and/or HPV 18-specific T-cell response post PRGN-2009 administration in 100% (3 out of 3) of patients; and
An increase in magnitude and breadth of immune response has been shown with respect to repeat administration of PRGN-2009.
Preclinical data for two new AdenoVerse immunotherapies:
PRGN-2012 AdenoVerse Immunotherapy in Recurrent Respiratory Papillomatosis (RRP): Precigen presented data from preclinical studies in which PRGN-2012 was shown to induce robust HPV 6 and HPV 11-specific T-cell response in RRP patient samples in vitro. Precigen recently announced that the US Food and Drug Administration (FDA) cleared the Investigational New Drug (IND) application to initiate the Phase I clinical trial of PRGN-2012 AdenoVerse immunotherapy in adult patients with recurrent respiratory papillomatosis (RRP).
PRGN-2013 AdenoVerse Immunotherapy in Hepatitis B Virus (HBV) Infection: Precigen shared preclinical data for PRGN-2013, which incorporates novel HBV antigen design in a proprietary gorilla adenovector, which showed that PRGN-2013 induces superior cytotoxic T-cell response against more HBV epitopes in mice than a competitor vaccine candidate and decreases plasma levels of HBsAg, the key marker of chronic HBV infection.
"In spite of the challenges presented by the COVID-19 pandemic, Precigen has accomplished all of the clinical milestones we set for ourselves in 2020," said Helen Sabzevari, PhD, President and CEO of Precigen, "I am proud of the team and collaborators for their commitment and execution during this challenging time which made possible the continued advancement of our differentiated therapeutics aimed at benefiting patients with severe unmet needs."

Precigen’s J.P. Morgan presentation is available on the Company website in the Events & Presentations section at investors.precigen.com/events-presentations.

On January 13, 2021 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing innovative medicines worldwide, reported that its anti-PD-1 antibody tislelizumab has received approval from the China National Medical Products Administration (NMPA) for use in combination with two chemotherapy regimens as a first-line treatment for patients with advanced squamous non-small cell lung cancer (NSCLC) (Press release, BeiGene, JAN 13, 2021, View Source [SID1234573977]). This is the third approval in China for tislelizumab, and its first in a lung cancer indication.

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"This approval for tislelizumab is an important milestone for BeiGene, for tislelizumab, and for the patients and healthcare practitioners in China fighting advanced squamous NSCLC," commented Xiaobin Wu, Ph.D., General Manager of China and President of BeiGene. "This is our sixth global approval for an internally-developed product, and our first approval for tislelizumab in a lung cancer indication, an area where we believe tislelizumab can have a large impact for patients."

"With the recent announcement that the RATIONALE 303 trial met its primary endpoint of overall survival at its interim analysis, three Phase 3 trials of tislelizumab in NSCLC have achieved a positive outcome at interim analysis," commented Yong (Ben) Ben, M.D., Chief Medical Officer, Immuno-Oncology at BeiGene. "Tislelizumab is being investigated in a broad clinical program, including five Phase 3 trials in lung cancer indications. We believe that it is an important immunotherapy and demonstrates our work at BeiGene to bring innovative, impactful, and quality treatments to patients in need."

"Lung cancer is the leading cause of cancer-related death in China, and with NSCLC comprising the most common form of the disease, there is significant patient need. We are grateful to have a new treatment available in the front-line setting for patients with advanced squamous non-small cell lung cancer," said Jie Wang, M.D., Ph.D., National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College. "In its Phase 3 trial in this indication, tislelizumab, combined with standard chemotherapy demonstrated a clinically meaningful benefit as assessed by progression-free survival and response rates."

"The approval of tislelizumab for patients with advanced squamous NSCLC was made possible by the courageous patients who participated in the trial, the dedicated clinicians who helped conduct the trial, and our hard-working team at BeiGene. We are humbled by the expeditious review of our supplemental new drug application and hope our broad development program for tislelizumab will continue its momentum and benefit additional patients," said Wendy Yan, Senior Vice President and Global Head of Regulatory Affairs at BeiGene.

The approval of tislelizumab for the treatment of patients with advanced squamous NSCLC was supported by clinical results from a Phase 3 trial of tislelizumab combined with either paclitaxel and carboplatin or nab-paclitaxel (ABRAXANE) and carboplatin compared to paclitaxel and carboplatin alone in patients with untreated stage IIIB or IV squamous NSCLC from mainland China (NCT03594747). A total of 360 patients were randomized 1:1:1 to receive tislelizumab in combination with either chemotherapy regimen or chemotherapy alone. As announced in January 2020, the trial met the primary endpoint of statistically significant improvement in progression-free survival (PFS), as assessed by independent review committee (IRC), in the pre-planned interim analysis. The safety profile of tislelizumab in both combinations was consistent with the known risks of each study treatment, and no new safety signals were identified. The results of the interim analysis of the trial were presented at the 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Scientific Program.

About Non-Small Cell Lung Cancer

In contrast to most Western countries, where lung cancer death rates are decreasing, the lung cancer incidence rate is still increasing in China.i,ii There were approximately 815,563 new cases of lung cancer in China in 2020 and it is the leading cause of cancer-related death in both men and women, with approximately 714,699 deaths in China in 2020.iii Non-small cell lung cancer (NSCLC) is the most common form of lung cancer, accounting for approximately 80 to 85 percent of all case.iv

About Tislelizumab

Tislelizumab (BGB-A317) is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells.v Tislelizumab is the first drug from BeiGene’s immuno-oncology biologics program and is being developed internationally as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers.

The China National Medical Products Administration (NMPA) has granted tislelizumab full approval for first-line treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) in combination with chemotherapy. Tislelizumab has also received conditional approval from the NMPA for the treatment of patients with classical Hodgkin’s lymphoma who received at least two prior therapies and for the treatment of patients with locally advanced or metastatic urothelial carcinoma with PD-L1 high expression whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Complete approval for these indications is contingent upon results from ongoing randomized, controlled confirmatory clinical trials.

In addition, two supplemental new drug applications for tislelizumab have been accepted by the Center for Drug Evaluation (CDE) of the NMPA and are under review for first-line treatment of patients with advanced non-squamous NSCLC in combination with chemotherapy, and for previously treated unresectable hepatocellular carcinoma.

Currently, 15 potentially registration-enabling clinical trials are being conducted in China and globally, including 13 Phase 3 trials and two pivotal Phase 2 trials.

Tislelizumab is not approved for use outside of China.

About Tislelizumab Clinical Program

Clinical trials of tislelizumab include:

Phase 3 trial comparing tislelizumab to salvage chemotherapy in patients with relapsed/refractory classical Hodgkin Lymphoma (NCT04486391);
Phase 3 trial in patients with locally advanced or metastatic urothelial carcinoma (NCT03967977);
Phase 3 trial comparing tislelizumab with docetaxel in the second- or third-line setting in patients with NSCLC (NCT03358875);
Phase 3 trial of tislelizumab in combination with chemotherapy versus chemotherapy as first-line treatment for patients with advanced squamous NSCLC (NCT03594747);
Phase 3 trial of tislelizumab in combination with chemotherapy versus chemotherapy as first-line treatment for patients with advanced non-squamous NSCLC (NCT03663205);
Phase 3 trial of tislelizumab in combination with platinum-based doublet chemotherapy as neoadjuvant treatment for patients with NSCLC (NCT04379635);
Phase 3 trial of tislelizumab combined with platinum and etoposide versus placebo combined with platinum and etoposide in patients with extensive-stage small cell lung cancer (NCT04005716);
Phase 3 trial comparing tislelizumab with sorafenib as first-line treatment for patients with hepatocellular carcinoma (HCC; NCT03412773);
Phase 2 trial in patients with previously treated unresectable HCC (NCT03419897);
Phase 3 trial comparing tislelizumab with chemotherapy as second-line treatment for patients with advanced esophageal squamous cell carcinoma (ESCC; NCT03430843);
Phase 3 trial of tislelizumab in combination with chemotherapy as first-line treatment for patients with ESCC (NCT03783442);
Phase 3 trial of tislelizumab versus placebo in combination with chemoradiotherapy in patients with localized ESCC (NCT03957590);
Phase 3 trial of tislelizumab combined with chemotherapy versus placebo combined with chemotherapy as first-line treatment for patients with gastric cancer (NCT03777657);
Phase 2 trial in patients with MSI-H/dMMR solid tumors (NCT03736889); and
Phase 3 trial of tislelizumab combined with chemotherapy versus placebo combined with chemotherapy as first-line treatment in patients with nasopharyngeal cancer (NCT03924986).

On January 13, 2021 Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases, reported the pricing of an underwritten public offering of 6,842,106 shares of its common stock at a public offering price of $9.50 per share (Press release, Aldeyra Therapeutics, JAN 13, 2021, View Source [SID1234573976]). The gross proceeds from the offering, before deducting underwriting discounts and commissions and estimated offering expenses payable by Aldeyra, are expected to be approximately $65.0 million. In addition, Aldeyra granted the underwriters a 30-day option to purchase up to 1,026,315 additional shares of common stock at the public offering price, less the underwriting discounts and commissions. All of the shares in the offering are being sold by Aldeyra. Aldeyra anticipates using the net proceeds from the offering for the continued development of Aldeyra’s lead compound, reproxalap, and its other product candidates, as well as for working capital, and other general corporate purposes. The offering is expected to close on or about January 19, 2021, subject to customary closing conditions.

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Jefferies LLC and SVB Leerink LLC are acting as joint book-running managers for the offering. BTIG LLC and Oppenheimer & Co. Inc. are acting as co-lead managers for the offering.

The shares of common stock described above are being offered by Aldeyra pursuant to a shelf registration statement on Form S-3 previously filed with the Securities and Exchange Commission (SEC) and declared effective by the SEC on July 27, 2018. A preliminary prospectus supplement relating to and describing the terms of the offering has been filed with the SEC and is available on the SEC’s web site at www.sec.gov. Copies of the final prospectus supplement (when available) and accompanying prospectus relating to these securities may also be obtained by sending a request to: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, New York 10022, by telephone at 877-821-7388 or by email at [email protected], or from SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, Massachusetts 02110, by telephone at 1-800-808-7525, ext. 6132, or by email at [email protected].

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

On January 13, 2021 NantKwest, Inc. (NASDAQ: NK), a clinical-stage, natural killer cell-based therapeutics company, and ImmunityBio, Inc., a privately-held immunotherapy company, reported early interim results of its PD-L1 t-haNK protocols showing median survival rates more than doubled that of the historic rate in patients with advanced metastatic pancreatic cancer for which no other FDA-approved treatment exists (Press release, NantKwest, JAN 13, 2021, View Source [SID1234573975]). These trials, which were based on the original Cancer Moonshot hypothesis and exploratory QUILT trials initiated in 2017, appear to validate the theory that by orchestrating natural killer and T-cell therapy, survival rates could be improved without high-dose chemotherapy.

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The early collaborative Cancer Moonshot trials involved the combination of cell therapy and immunotherapeutics from multiple biotech and pharmaceutical companies, including NantKwest, ImmunityBio, Celgene, and Pfizer. These trials explored the hypothesis that by activating the patient’s own immune system, a paradigm change in cancer therapy could evolve to eradicate cancer cells without high-dose chemotherapy. From 2017 to 2020, multiple QUILT clinical trials exploring this combination of cell therapy, immunomodulating antibodies, adenovirus-based cancer vaccines, and low-dose chemotherapy provided preliminary results showing the median survival rate can be more than doubled and a complete remission can be achieved in patients with metastatic pancreatic cancer for which there are no other FDA-approved treatment options. Based on the data from these trials, ImmunityBio is conducting a pivotal, three-cohort pivotal trial (QUILT 88) in metastatic pancreatic cancer.

Interim Study Results

In the Cancer Moonshot QUILT trials of haNK combined with PD-L1 inhibitor avelumab, which were completed in 2019, the median overall survival rate more than doubled (three months historic control versus 8 months in the treatment arm) in the 12-patient study. See related press release here for details.
A complete remission was achieved when replacing haNK and PD-L1 inhibitor avelumab with PD-L1 t-haNK and four out of five patients who had not yet reached median survival time (three months) are alive 8-16 months since beginning treatment on these expanded protocols
A single-arm Phase 2 study (QUILT 88, Cohort C) was initiated in October 2020, for which the primary endpoint is overall survival and 15 out of 18 (83%) of patients enrolled with second-line or greater pancreatic cancer remain alive to date.
A randomized Phase 2 study (QUILT 88, Cohorts A and B) for first- and second-line metastatic pancreatic cancer is actively enrolling at three sites.
"The goal of the Cancer Moonshot program was to explore the hypothesis that by orchestrating natural killer cells and T cells, a paradigm change for the treatment of cancer could evolve. The initial results of these Cancer Moonshot trials combining immunotherapy molecules—including Abraxane from Celgene, haNK from NantKwest, Anktiva from ImmunityBio, and a PD-L1 inhibitor Avelumab from Pfizer—provided promising early data that a doubling of median overall survival rate in patients with advanced metastatic disease across multiple tumor types was possible," said Patrick Soon-Shiong, M.D., Chairman, and CEO of ImmunityBio.

"For five patients for whom no other treatment was available, we replaced haNK and avelumab with the investigational NK cell therapy PD-L1 t-haNK and were pleased to observe a complete remission in the first patient to receive this combo therapeutic," continued Soon-Shiong. "To date, four out of five of these patients remain alive since beginning treatment. These observations confirmed the promise of our hypothesis that activating the patient’s own immune system with low-dose chemo immunomodulation therapy could improve outcomes. On the basis of our initial studies, we initiated our QUILT 88 randomized trials in metastatic pancreatic cancer and are pleased to present today those findings, including Cohort C survival rates. While this data is still early, a doubling of the survival rate is encouraging and warrants further confirmation through QUILT 88."

QUILT 88 Study Details

This Phase 2, randomized, three-cohort, open-label study will evaluate the comparative efficacy and overall safety of standard-of-care chemotherapy versus standard-of-care chemotherapy in combination with PD-L1 t-haNK, Anktiva (N-803), and aldoxorubicin in subjects with locally advanced or metastatic pancreatic cancer (QUILT 88, NCT04390399). Each treatment setting, as well as each first- and second-line or later maintenance treatment, will be evaluated independently as Cohort A, Cohort B, and Cohort C, respectively, with cohorts A and B having independent experimental and control arms. The study will initially enroll 298 subjects across all three cohorts. The primary objective of Cohorts A and B is progression-free survival (PFS) and the objective of Cohort C is overall survival (OS) per RECIST V1.1. Secondary objectives include initial safety and additional efficacy measures, including overall response rate (ORR), complete response (CR) rate, durability of response (DoR), disease control rate (DCR), and overall survival (OS).

Cancer Moonshot QUILT trial numbers include QUILT 3.039, 3.060, 3.070, and 3.080.

QUILT 88 Trial Sites and Enrollment

Currently, three trial sites have been activated: Hoag Memorial Hospital Presbyterian in Orange County, Calif.; The Chan Soon-Shiong Institute for Medicine in Los Angeles County, Calif.; and Avera McKennan Hospital and University Health Center in Sioux Falls, South Dakota, which will serve patients in the tri-state area (Iowa, Nebraska, and South Dakota). More than 50 patients are currently enrolled in or being evaluated for the trial.

Pancreatic cancer is the fourth leading cause of cancer-related death in the U.S., with an estimated 47,050 deaths and 57,600 new cases expected in 2020. It is the 12th most common cancer worldwide, with around 338,000 new cases diagnosed in 2012 (2% of all cancer diagnoses). Pancreatic cancer continues to increase today with no standard of care available for patients beyond second line. A clear unmet medical need exists in these patients with short expected survival time and high levels of existing comorbidities.

NantKwest Transaction

As previously announced, on December 21, 2020, ImmunityBio entered into an agreement to combine in a stock-for-stock transaction with NantKwest. The combination, which is expected to close in the first half of 2021, would create a leading immunotherapy and cell therapy company focused on oncology and infectious disease.