On October 6, 2020 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, metabolic, autoimmune and other major diseases, reported the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (the "HSR Act"), in connection with the previously announced global expansion collaboration agreement between Innovent and Eli Lilly and Company ("Lilly") for TYVYT (sintilimab injection) (Press release, Innovent Biologics, OCT 6, 2020, View Source [SID1234568170]). The agreement now becomes effective immediately. This milestone triggers the $200 million upfront payment milestone referenced in the parties’ August 18, 2020 press release.

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About TYVYT (Sintilimab Injection)

TYVYT (sintilimab injection), an innovative drug with global quality standards jointly developed in China by Innovent and Lilly, has been granted marketing approval by the NMPA for the treatment of relapsed or refractory classic Hodgkin’s lymphoma after two lines or later of systemic chemotherapy, and included in the 2019 Guidelines of Chinese Society of Clinical Oncology for Lymphoid Malignancies. TYVYT (sintilimab injection) is the only PD-1 inhibitor that has been included in the new Catalogue of the National Reimbursement Drug List (NRDL), in November 2019. In April 2020, the NMPA accepted the sNDA for TYVYT (sintilimab injection) in combination with ALIMTA (pemetrexed) and platinum chemotherapy as first-line therapy for the treatment of patients with non-squamous non-small cell lung cancer (NSCLC). In May 2020, TYVYT (sintilimab injection) monotherapy met the primary endpoint in the ORIENT-2 study as second-line therapy in patients with advanced or metastatic esophageal squamous cell carcinoma. In August 2020, the NMPA accepted the sNDA for TYVYT (sintilimab injection) in combination with GEMZAR (gemcitabine for injection) and platinum chemotherapy as first-line therapy in squamous NSCLC. In September 2020, TYVYT (sintilimab injection) in combination with BYVASDA (bevacizumab injection) as a first-line treatment in advanced hepatocellular carcinoma met the predefined primary endpoints in an interim analysis of the Phase 3 ORIENT-32 study.

TYVYT (sintilimab injection) is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1 / PD-Ligand 1 (PD-L1) pathway and reactivates T-cells to kill cancer cells. Innovent is currently conducting more than 20 clinical studies for TYVYT (sintilimab injection) to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registrational or pivotal clinical trials. Meanwhile, Innovent is conducting clinical research studies on TYVYT (sintilimab injection) worldwide.

On October 6, 2020 Guardant Health, Inc. (Nasdaq: GH) ("Guardant Health"), a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets and advanced analytics, reported the commencement of a proposed underwritten public offering of 7,000,000 shares of its common stock being offered for sale by SoftBank Investment Advisers (Press release, Guardant Health, OCT 6, 2020, View Source [SID1234568169]). In addition, SoftBank Investment Advisers expects to grant the underwriter a 30-day option to purchase up to 700,000 additional shares of common stock at the public offering price, less underwriting discounts and commissions. Guardant Health is not selling any of its shares in the offering and will not receive any of the proceeds from the sale of shares in the offering by SoftBank Investment Advisers. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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J.P. Morgan Securities LLC is acting as sole book-running manager of the offering.

The public offering is being made pursuant to an automatic shelf registration statement on Form S-3 that was filed by Guardant Health with the U.S. Securities and Exchange Commission (the "SEC") and automatically became effective upon filing. A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. When available, copies of the preliminary prospectus supplement and accompanying prospectus may be obtained by contacting: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at [email protected].

On October 6, 2020 NanoString Technologies, Inc. (NASDAQ:NSTG), a leading provider of life science tools for discovery and translational research, reported that preliminary financial and operational highlights for the third quarter of 2020 (Press release, NanoString Technologies, OCT 6, 2020, View Source [SID1234568168]).

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Financial Highlights:

Product and Service Revenue was $30.1 million, 14% year-over-year growth. Pro forma growth was 22% and reflects the impact of the Veracyte transaction on revenue recorded for Prosigna IVD kits
Instrument revenue was $12.9 million, 60% year-over-year growth. Instrument revenue includes $7.5 million recognized from sales of our GeoMx Digital Spatial Profiler (DSP)
Consumables revenue was $13.7 million, 11% year-over-year decline. Pro forma for the impact of the Veracyte transaction, consumables revenue was flat. Consumables revenue includes $1.4 million from sales of GeoMx DSP consumables
Service revenue was $3.5 million, 16% year-over-year growth
Cash, cash equivalents and short-term investments were approximately $230 million at September 30, 2020.
Operational Highlights:

Received orders for more than 25 GeoMx DSP instruments in the third quarter, bringing cumulative orders received to more than 150 instruments since launch
Announced the launch of GeoMx DSP compatibility with Illumina’s next generation sequencers, as well as the commercial availability of the Cancer Transcriptome Atlas (CTA), the first in a portfolio of GeoMx DSP products that will utilize NGS read-out
Continued commercial momentum of GeoMx DSP launch during Q3, as evidenced by more than 75 new Technology Access Program (TAP) orders, of which more than 50% included NGS read-out, 5 new peer-reviewed publications utilizing GeoMx DSP technology bringing the cumulative total to 28, and approximately 1,200 leads generated at our virtual Spatial Biology Conference held in September 2020
Grew installed base to approximately 915 nCounter Analysis Systems and approximately 100 GeoMx DSP systems at September 30, 2020
"I’m extremely pleased with our third quarter performance, which included double-digit growth in product and service revenue and more than 25 new orders for our GeoMx DSP platform," said Brad Gray, NanoString’s president and chief executive officer. "We extended our leadership in the spatial genomics market with translational researchers, and we entered the discovery research market in Q3 with the launch of GeoMx DSP read-out capabilities using NGS. In the third quarter, we saw substantial demand from both translational and discovery markets and leading indicators suggest continued success."

The amounts set forth above are preliminary estimates. We are in the process of finalizing the actual results of operations for the three months ended September 30, 2020 and therefore final results are not yet available. These preliminary estimates are based solely upon information available to us as of the date of this press release and our actual results may differ from these estimates due to the completion of our quarter-end closing procedures, final adjustments, review by our independent registered public accounting firm and developments that may arise between now and the time our financial results for the three months ended September 30, 2020 are finalized. Refer to our actual results included in our unaudited consolidated financial statements for the three and nine months ended September 30, 2020 once they become available. The preliminary financial data included in this press release have been prepared by, and are the responsibility of, our management. Ernst & Young LLP has not audited, reviewed, compiled, or applied agreed-upon procedures with respect to the preliminary financial data. Accordingly, Ernst & Young LLP does not express an opinion or any other form of assurance with respect thereto.

In addition, although we expect to experience an operating and net loss for the third quarter of 2020, we are not able to provide an estimate of such results at this time. We expect our operating loss and net loss for the third quarter of 2020 may increase compared to the third quarter of 2019. However, no conclusions should be drawn as to the size of our third quarter of 2020 operating loss or net loss based on the foregoing revenue estimates. Our expectations regarding third quarter of 2020 revenue are not necessarily indicative of results expected in future periods.

Pro Forma Financial Information

As used in this press release, "pro forma" percentages are calculated by comparing the applicable period-over-period financial results to reflect the impact of the Veracyte transaction as if such transaction had occurred on January 1, 2019, the beginning of the earliest period presented. Further disclosure regarding the terms and pro forma impact of the Veracyte transaction can be obtained in the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on December 4, 2019.

On October 6, 2020 NantKwest, Inc. (NASDAQ: NK), a clinical-stage, natural killer cell-based therapeutics company, and ImmunityBio, a privately-held immunotherapy company, reported they have added a third cohort to their ongoing Phase 2 trial of a novel immunotherapy for locally advanced or metastatic pancreatic cancer (Press release, NantKwest, OCT 6, 2020, View Source [SID1234568167]). The third cohort enables pancreatic cancer patients who have failed all approved standards of care to participate in the trial.

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The randomized, open-label study is evaluating safety and efficacy of a combination immunotherapy comprising NantKwest’s PD-L1 t-haNK, ImmunityBio’s IL-15 superagonist Anktiva (N-803), and aldoxorubicin, plus standard of care. The results will be compared to standard-of-care chemotherapy for first- and second-line treatment; the third-line cohort is a single arm, with no comparator. Each cohort will be studied independently to provide more precise comparative data for each disease stage.

"Pancreatic cancer is one of the deadliest forms of cancer, with a five-year survival rate of just five percent, so new and more effective therapies are desperately needed," said Patrick Soon-Shiong, M.D., Chairman and Chief Executive Officer of NantKwest and ImmunityBio. "By adding the third cohort to this important study, we’re able to enroll patients at all stages of the disease, even those who experience disease progression after the first- or second-line treatment."

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). Forty patients are currently enrolled in or being evaluated for the trial.

NantKwest and ImmunityBio’s combination immunotherapy is designed to harness the body’s immune system to target, kill, and "remember" cancer cells. The agents in this trial are designed to find pancreatic cancer cells and initiate a large immune response against them. This may allow the body to develop its own antibodies to fight the cancer.

"Our research in pancreatic cancer, as well as many other forms of cancer, is focused on how we can recruit and amplify the power of the human body’s own immune system to target and destroy even the most difficult cancer cells," said Dr. Soon-Shiong. "Our goal is to attack the disease aggressively so that we can provide more time and a higher quality of life to patients who today have a very poor prognosis."

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).

Pancreatic cancer is the fourth leading cause of cancer-related death in the US, with an estimated 47,050 deaths and 57,600 new cases expected in 2020.1. It is the 12th most common cancer worldwide, with around 338,000 new cases diagnosed in 2012 (2% of all cancer diagnoses).

1.Siegel RL, Miller KD, and Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020;70:7-30

On October 6, 2020 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, reported the completion of the manufacturing of the GP2 active ingredient for its planned Phase III clinical trial (Press release, Greenwich LifeSciences, OCT 6, 2020, View Source [SID1234568166]). After having met all drug specifications and release criteria in compliance with current Good Manufacturing Practice (cGMP), the GP2 active ingredient has been released for formulation and filling into vials, which is the last step before storage and distribution of GP2 to clinical sites.

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Snehal Patel, CEO of Greenwich LifeSciences commented, "We are pleased to have completed this major manufacturing milestone. Last week we completed our IPO, in which members of senior management and directors invested funds aggregating in approximately 15% of the IPO gross proceeds. Our success in scaling up GP2 to large scale cGMP manufacturing and our recent fundraising moves us closer to commencing the upcoming Phase III clinical trial."

The Company’s commercial manufacturing partner, Polypeptide Laboratories, located in San Diego, California and a specialist in the manufacture of clinical and commercial grade peptides, initiated this clinical lot in 2019, which is at a commercial scale that can produce 50,000 doses and treat up to 4,500 patients. In addition, analytical methods were validated and a stability program has been initiated per cGMP requirements.

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 266,000 new breast cancer patients and 3.1 million breast cancer survivors in 2018. HER2/neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.