On March 10, 2021 Natera, Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA testing, reported that the first patient has been screened in a new phase III clinical trial that uses its tumor-informed, personalized molecular residual disease (MRD) test, Signatera, as a companion diagnostic to identify muscle-invasive urothelial carcinoma (MIUC) patients eligible for investigational treatment with Genentech’s, a member of the Roche group, cancer immunotherapy drug atezolizumab (Tecentriq) (Press release, Genentech, MAR 10, 2021, View Source [SID1234576441]).

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The IMvigor011 study, sponsored by Genentech, is a global, randomized, placebo-controlled, phase III clinical trial to evaluate the safety and efficacy of adjuvant treatment with the PD-L1 inhibitor, atezolizumab, in patients with MIUC who are MRD-positive after surgery. Eligible patients will be screened with Signatera within the first 20 weeks after surgery, and the first approximately 500 patients who test MRD-positive will be enrolled and randomized to receive either atezolizumab or placebo for 12 cycles, or up to one year. The primary endpoint of the study will be disease-free survival.

"There is a strong unmet need in this population, as bladder cancer patients with residual disease post-surgery are known to be at the highest risk of recurrence," said Thomas Powles, M.D., Professor, Barts Cancer Institute, and Principal Investigator of the study. "The Signatera MRD test offers a personalized, real-time diagnostic to identify bladder cancer patients who need additional therapy and may benefit from adjuvant treatment with Tecentriq."

In an exploratory analysis from the phase III, randomized, controlled IMvigor010 trial, presented at the ESMO (Free ESMO Whitepaper) Immuno-Oncology conference in December 2020, the 37% of patients who tested MRD-positive with Signatera after surgery experienced significant benefit from adjuvant atezolizumab vs. observation (HR 0.59, p<0.001), while the 63% of patients who tested MRD-negative experienced zero treatment benefit. In an independent study of 68 patients with MIUC, published in the Journal of Clinical Oncology in 2019, Signatera detected relapse with 100% sensitivity and 98% specificity, reporting a median lead time of 96 days.1

"This partnership with Genentech marks a significant milestone for Natera and for the field of personalized medicine," said Solomon Moshkevich, Natera’s General Manager of Oncology. "We look forward to a successful clinical trial, pairing atezolizumab with Signatera in an effort to bring highly effective treatment to the right set of patients at the earliest possible time."

About Signatera

Signatera is a custom-built circulating tumor DNA (ctDNA) test for treatment monitoring and molecular residual disease (MRD) assessment in patients previously diagnosed with cancer. The test is available for clinical and research use, and in 2019, it was granted Breakthrough Device Designation by the FDA. The Signatera test is personalized and tumor-informed, providing each individual with a customized blood test tailored to fit the unique signature of clonal mutations found in that individual’s tumor. This maximizes accuracy for detecting the presence or absence of residual disease in a blood sample, even at levels down to a single tumor molecule in a tube of blood. Unlike a standard liquid biopsy, Signatera is not intended to match patients with any particular therapy; rather, it is intended to detect and quantify how much cancer is left in the body, to detect recurrence earlier and to help optimize treatment decisions. Signatera test performance has been clinically validated in multiple cancer types including colorectal, non-small cell lung, breast, and bladder cancers. Signatera has been developed and its performance characteristics determined by Natera, the CLIA-certified laboratory performing the test. The test has not been cleared or approved by the US Food and Drug Administration (FDA). CAP accredited, ISO 13485 certified, and CLIA certified.

On March 9, 2021 Jounce Therapeutics, Inc. (Nasdaq: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported that it has priced an underwritten public offering of 5,000,000 shares of common stock at a public offering price of $11.25 per share, which would result in gross proceeds of approximately $56.25 million, before underwriting discounts and commissions (Press release, Jounce Therapeutics, MAR 10, 2021, View Source [SID1234576366]).

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The proceeds of the offering are expected to be used to fund ongoing and planned clinical trials, including the INNATE trial of JTX-8064, to fund research and development to advance Jounce’s pipeline, and for working capital and other general corporate purposes. All shares are being offered by Jounce. Closing of the offering is expected to occur on or about March 12, 2021, subject to customary closing conditions. Jounce has also granted the underwriters a 30-day option to purchase up to an additional 750,000 shares of common stock offered in the public offering on the same terms and conditions.

Cowen and Piper Sandler are acting as joint book-running managers for the offering.

The offering is being made pursuant to a shelf registration statement that was filed with the Securities and Exchange Commission ("SEC") on March 8, 2018 and declared effective by the SEC on May 1, 2018. The offering will be made only by means of the prospectus and prospectus supplement that form a part of the registration statement. 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.

The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering can be obtained from Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, or by telephone at 833-297-2926; or from Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, or by telephone at 800-747-3924.

This press release does not constitute an offer to sell or the solicitation of an offer to buy, 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.

On March 10, 2021 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing innovative medicines worldwide, reported that the first patient has been dosed in a Phase 1 clinical trial of BGB-15025, its investigational hematopoietic progenitor kinase 1 (HPK1) inhibitor (Press release, BeiGene, MAR 10, 2021, View Source [SID1234576392]). BGB-15025 is designed to be a potent and highly selective small molecule oral inhibitor of HPK1, a kinase downstream of the T cell receptor (TCR) signaling pathway that is believed to play a key role in T cell activation.

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"We are incredibly proud of BeiGene’s research organization, which now has over 450 people, and its ability to discover not only potentially best-in-class cancer treatments but also investigational agents like BGB-15025, which we believe to be among the first HPK1 inhibitors to enter the clinic and represent a novel immuno-oncology approach targeting T cell activation to fight cancer growth," commented Lai Wang, Ph.D., Senior Vice President, Head of Global Research, Clinical Operations & Biometrics and APAC Clinical Development at BeiGene. "We believe that the unique nature of BGB-15025 and the HPK1 pathway provides us with a compelling scientific rationale for investigating it as a monotherapy and in combination with our anti-PD-1 antibody, tislelizumab. We are excited to advance its clinical development globally."

This first-in-human Phase 1 trial (NCT04649385) will assess the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of BGB-15025 alone and in combination with tislelizumab in patients with advanced solid tumors. This trial will be conducted in multiple countries globally.

About BGB-15025

BGB-15025 is an investigational hematopoietic progenitor kinase 1 (HPK1) inhibitor discovered and being developed by BeiGene. HPK1 is a key negative feedback regulator of T-cell receptor signaling, which is believed to play a key role in antitumor immune response. In preclinical studies, the inhibition of HPK1 enhanced T-cell activation, which is expected to enhance the anti-tumor activity of anti-PD-1 inhibitors such as BeiGene’s tislelizumab.

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. Tislelizumab is the first approved medicine from BeiGene’s immuno-oncology biologics program and is being developed globally as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers.

Tislelizumab is approved in China 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 in China for the treatment of patients with classical Hodgkin’s lymphoma (cHL) who received at least two prior therapies, and for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) 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. Full approval for these indications is contingent upon results from ongoing randomized, controlled confirmatory clinical trials.

In addition, three supplemental Biologics License Applications for tislelizumab have been accepted and are under review in China for first-line treatment of patients with advanced non-squamous NSCLC in combination with

chemotherapy, for the second- or third-line treatment of patients with locally advanced or metastatic NSCLC who progressed on prior platinum-based chemotherapy, and for previously treated unresectable hepatocellular carcinoma.

Currently, 15 potentially registration-enabling clinical trials are being conducted in China and globally, including 12 Phase 3 trials and two pivotal Phase 2 trials.

In January 2021, BeiGene and Novartis entered into a collaboration and license agreement to develop, manufacture, and commercialize tislelizumab in North America, Europe, and Japan.
Tislelizumab is not approved for use outside of China.

On March 10, 2021 InDex Pharmaceuticals Holding AB (publ) reported that CEO Peter Zerhouni will present the company at Barclays Global Healthcare Conference on Thursday March 11, 2021 and at Carnegie Nordic Virtual Healthcare Seminar on Friday March 12, 2021, both at 13:30 CET (Press release, InDex Pharmaceuticals, MAR 10, 2021, View Source [SID1234576408]).

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The presentation at Barclays Global Healthcare Conference can be followed live or seen afterwards at View Source, and will also be available on InDex’s website (www.indexpharma.com) after the event.

Publication
The information was submitted for publication through the agency of the contact person set out above at 11:30 CET on March 10, 2021.

On March 10, 2021 Humanigen, Inc. (Nasdaq: HGEN) ("Humanigen"), a clinical stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’ with its lead drug candidate, lenzilumab, reported financial results for the year ending December 31, 2020 and announced objectives for 2021 (Press release, Humanigen, MAR 10, 2021, View Source [SID1234576424]).

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"We are proud of all the advances Humanigen made in 2020, not just as a company, but as a key player in the development of an effective treatment for hospitalized COVID-19 patients," said Cameron Durrant, MD, MBA, Chief Executive Officer, Humanigen. "We were able to take lenzilumab from the context of preventing and treating cytokine storm in other therapeutic categories and adapt it at unprecedented speed to respond to the COVID-19 pandemic. We also succeeded in achieving our ambitious fundraising goals, culminating with our uplisting to Nasdaq, and expanded our leadership team with a number of critical hires. We look forward to reporting our progress on the ambitious goals we’ve set for 2021 and, if granted an EUA, provide a therapeutic option for hospitalized COVID-19 patients."

2020 Highlights Include:

Clinical Development – Lenzilumab for COVID-19

Lenzilumab’s clinical development program was augmented in 2020 with the filing of an Emergency IND and initiation of a Phase 3 study in hospitalized COVID-19 patients. The study fully enrolled 520 patients, with topline data anticipated to be released before the end of March 2021.
The results of the case-cohort study conducted by the Mayo Clinic were published in a peer-reviewed journal, showing that treatment with lenzilumab significantly reduced risk of mechanical ventilation or death and decreased length of hospital stay compared to patients treated with standard of care.
Lenzilumab was selected by NIH for inclusion in its fully funded and sponsored, 200-patient ACTIV-5/Big Effect Trial comparing lenzilumab and remdesivir to remdesivir alone.
In preparation for potential launch under EUA, Humanigen entered into several supply agreements with contract manufacturing organizations to supply bulk drug, fill/finish, and commercial packaging.
Clinical Development – CAR-T and Oncology

Lenzilumab was administered to the first patient in the ZUMA-19 study, a CAR-T clinical collaboration with Kite (a Gilead company).
A Phase 1 clinical trial of ifabotuzumab, Humanigen’s proprietary anti-EphA3 monoclonal antibody, in solid tumors completed enrollment.
Corporate

The company raised approximately $140 million in net proceeds in two equity financings, and its stock began trading on Nasdaq under the symbol "HGEN."
Humanigen executed a Cooperative Research and Development Agreement ("CRADA") with the Department of Defense ("DoD") and the Biomedical Advanced Research and Development Authority ("BARDA") for developing lenzilumab as a potential treatment for patients with COVID-19 in support of Operation Warp Speed.
Humanigen licensed development and commercial rights of lenzilumab for South Korea and the Philippines to KPM Tech/Telcon.
The company augmented its intellectual property portfolio, securing its first patent for the use of lenzilumab in CAR-T cell therapy.
The company expanded the leadership team with experienced executives, including Dr. Dale Chappell, Chief Scientific Officer; Timothy Morris, Chief Operating Officer and Chief Financial Officer; Edward Jordan, Chief Commercial Officer; and Bob Atwill, Head of Asia-Pacific Region.
2021 Objectives Include:

Submit an EUA for lenzilumab as a treatment for hospitalized and hypoxic patients with COVID-19 pending positive results from the Phase 3 clinical trial.
Begin distribution of lenzilumab under the EUA, if granted.
Submit, for conditional approval, a Marketing Authorization Application ("MAA") for lenzilumab in COVID-19 to the European Medicines Agency for use in Europe.
Submit, for conditional approval, a MAA for lenzilumab in COVID-19 to the Medicines and Healthcare Products Regulatory Agency for use in the United Kingdom.
Submit a Biologics License Application ("BLA") for lenzilumab in COVID-19 to FDA.
Report results on the ongoing Phase 1b/2 ZUMA-19 CAR-T clinical trials with Kite (a Gilead company) and the completed Phase 1 study with ifabotuzumab.
Initiate studies of lenzilumab in acute Graft versus Host Disease ("GvHD") and chronic myelomonocytic leukemia ("CMML").
Secure partnerships to distribute lenzilumab in other regions outside the United States.
Year Ended December 31, 2020 Financial Results

Net loss for the year ended December 31, 2020 was $89.5 million or $2.42 per share as compared to $10.3 million or $0.46 per share for the year ended December 31, 2019. The increase in net loss for the year was largely due to an increase in Research and Development ("R&D") expense of $70.1 million from $2.6 million for the year ended December 31, 2019 to $72.7 million for the year ended December 31, 2020.

The increase in R&D expense is primarily due to increased clinical trial and clinical material manufacturing costs related to the COVID-19 lenzilumab Phase 3 clinical trial. The company expects development costs to decrease in 2021 as a result of the completion of the COVID-19 Phase 3 clinical trial and related manufacturing costs, which will be classified as Cost of Goods Sold if an EUA is granted.

The increase in the net loss for the year ended December 31, 2020 was also due to an increase in Selling, General and Administrative ("SG&A") expenses of $9.5 million from $6.3 million for the year ended December 31, 2019 to $15.8 million for the year ended December 31, 2020. The increase is primarily due to increased compensation costs, including stock-based compensation expense related to the hiring of functional heads in the third quarter of 2020, and an increase in commercial preparation activities as the company prepared for a potential launch of lenzilumab in 2021 under an EUA.

Three Months Ended December 31, 2020 Financial Results

Net loss for the three months ended December 31, 2020 was $32.3 million or $0.63 per share as compared to $2.0 million or $0.09 per share for the three months ended December 31, 2019. The increase in net loss for the period was largely due to an increase in R&D expense of $28.0 million from $0.5 million for the three months ended December 31, 2019 to $28.5 million for the three months ended December 31, 2020.

The increase in R&D expense is primarily due to increased clinical trial and clinical material manufacturing costs related to the COVID-19 Phase 3 clinical trial.

The increase in the net loss for the three months ended December 31, 2020 was also due to an increase in SG&A expenses of $2.9 million from $1.2 million for the three months ended December 31, 2019 to $4.1 million for the three months ended December 31, 2020. The increase in SG&A expense is primarily due to the items noted above for the year ended December 31, 2020.

Cash and Cash Equivalents

Net cash used in operating activities, net of balance sheet changes, was $69.9 million for the year ended December 31, 2020. During 2020, the company raised $139.8 million in net proceeds from its private placement in June and its underwritten public offering in September 2020. As of December 31, 2020, the company had cash and cash equivalents of $67.7 million.