On February 28, 2019 AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on unmet medical needs in inflammation, reported operating results for the fourth quarter and year ended December 31, 2018 and provided pipeline updates (Press release, AnaptysBio, FEB 28, 2019, View Source [SID1234533777]).

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"We continued to advance the clinical development of our wholly-owned etokimab and ANB019 programs for severe inflammatory disease indications during 2018," said Hamza Suria, president and chief executive officer of AnaptysBio. "Top-line data from our etokimab Phase 2a trial in severe adult eosinophilic asthma patients demonstrated rapid and sustained improvement in Forced Exhaled Volume In One Second versus placebo, with corresponding reduction in blood eosinophil levels. We look forward to announcing four Phase 2 top-line data readouts from ongoing clinical trials of etokimab and ANB019 during 2019 and expanding our pipeline with an IND filing for a new wholly-owned anti-inflammatory antibody program."

Etokimab (ANB020 Anti-IL-33 Program)

In September 2018, the Company announced positive top-line proof-of-concept data for etokimab, its investigational anti-IL-33 therapeutic antibody, in a single dose Phase 2a clinical trial in adult patients with severe eosinophilic asthma. Patients administered with etokimab rapidly improved their Forced Exhaled Volume In One Second, or FEV1, which is a measure of lung function, with an eight percent FEV1 improvement over placebo at Day 2. FEV1 improvement was sustained through Day 64, with an 11 percent increase over placebo. Blood eosinophil reduction was sustained through the interim analysis period, with a 31 percent reduction at Day 2 and a 46 percent reduction at Day 64 over placebo, which was consistent with FEV1 improvement observed in this trial. Etokimab was generally well tolerated in all patients and no serious adverse events were reported as of this interim analysis. The Company plans to report full data from this trial at a medical conference in 2019. The Company also plans to continue development of etokimab in eosinophilic asthma with a multi-dose Phase 2b randomized, double-blinded, placebo-controlled trial, which is expected to be initiated in 2019.

The Company is conducting a Phase 2b randomized, double-blinded, placebo-controlled, multi-dose study in 300 adult patients with moderate-to-severe atopic dermatitis, also referred to as the ATLAS trial, to assess different dose levels and dosing frequencies of subcutaneously-administered etokimab, with top-line data expected in the second half of 2019.

The Company is conducting a randomized, placebo-controlled Phase 2 trial in approximately 100 adult patients with chronic rhinosinusitis with nasal polyps, also referred to as the ECLIPSE trial. Patients are being treated with two multi-dosing frequencies of subcutaneously-administered etokimab or placebo, each in combination with mometasone furoate nasal spray as background therapy. The Company anticipates top-line data from the ECLIPSE trial will be available in the second half of 2019.
ANB019 (Anti-IL-36 Receptor Program)

The Company is conducting a 10-patient, single arm, open-label Phase 2 trial of ANB019 in generalized pustular psoriasis, or GPP, also known as the GALLOP trial, with top-line data anticipated in mid-2019.

The Company is conducting a randomized, placebo-controlled 50-patient multi-dose Phase 2 trial in palmoplantar pustulosis, or PPP, also known as the POPLAR trial, with top line data anticipated in the second half of 2019.
Corporate Highlights

On September 28, 2018, the Company completed an underwritten public offering of 2,530,000 shares of common stock at a price to the public of $94.46, which included the exercise by the underwriters of their option to purchase an additional 330,000 shares of common stock. AnaptysBio, received net proceeds from the offering of $227.5 million, after deducting underwriting discounts and commissions.
Fourth Quarter and Full Year Financial Results

Cash, cash equivalents and investments totaled $500.2 million as of December 31, 2018 compared to $324.3 million as of December 31, 2017, for an increase of $175.9 million. The increase primarily relates to net proceeds received by the Company of $227.5 million from the public offering, partially offset by cash used for operating activities.

Collaboration revenue was $5.0 million for the year ended December 31, 2018, related to a milestone for the first Phase 3 trial of TSR-042 by TESARO. Collaboration revenue was $3.0 million and $10.0 million for the three months and year ended December 31, 2017, respectively, for two TESARO related milestones.

Research and development expenses were $15.9 million and $56.2 million for the three months and year ended December 31, 2018, as compared to $7.6 million and $29.4 million for the three months and year ended December 31, 2017. The increase was primarily due to continued advancement of the Company’s etokimab and ANB019 clinical programs and additional personnel-related expenses including share-based compensation during the three months and year ended December 31, 2018.

General and administrative expenses were $3.7 million and $15.5 million for the three months and year ended December 31, 2018, as compared to $2.5 million and $9.3 million for the three months and year ended December 31, 2017. The increase was primarily attributable to additional personnel-related expenses, including share-based compensation.

Net loss was $17.0 million and $61.7 million for the three months and year ended December 31, 2018, or a net loss per share of $0.64 and $2.50, respectively, as compared to a net loss of $6.9 million and $30.1 million for the three months and year ended December 31, 2017, or a net loss per share of $0.30 and $1.52, respectively.
Financial Guidance

AnaptysBio expects that its cash, cash equivalents and investments will fund its current operating plan at least through the end of 2020.

About Etokimab

Etokimab, previously referred to as ANB020, is an antibody that potently binds and inhibits the activity of interleukin-33, or IL-33, a pro-inflammatory cytokine that multiple studies have indicated is a central mediator of atopic diseases, which AnaptysBio believes is broadly applicable to the treatment of atopic inflammatory disorders, such as atopic dermatitis, eosinophilic asthma, chronic rhinosinusitis with nasal polyps, or CRSwNP, and potentially other allergic conditions. Following completion of a healthy volunteer Phase 1 trial of etokimab, AnaptysBio continued clinical development of etokimab into a Phase 2a trial for moderate-to-severe adult atopic dermatitis and a placebo-controlled Phase 2a trial in severe adult eosinophilic asthma patients. AnaptysBio is conducting its ATLAS trial, a randomized, double-blinded, placebo-controlled multi-dose Phase 2b clinical trial of etokimab in 300 moderate-to-severe adult atopic dermatitis patients where top-line data is anticipated in the second half of 2019. The Company is conducting its ECLIPSE trial, a randomized, double-blinded, placebo-controlled Phase 2 trial of etokimab in approximately 100 adult patients with CRSwNP with top-line data anticipated in the second half of 2019. AnaptysBio also plans to initiate a randomized, double-blinded, placebo-controlled, multi-dose Phase 2b trial of etokimab in patients with eosinophilic asthma in 2019.

About ANB019

ANB019 is an antibody that inhibits the function of the interleukin-36-receptor, or IL-36R, which AnaptysBio plans to initially develop as a potential first-in-class therapy for patients suffering from generalized pustular psoriasis, or GPP, and palmoplantar pustulosis, or PPP. AnaptysBio has previously presented data from this Phase 1 clinical trial, which demonstrated favorable safety, pharmacokinetics and pharmacodynamic properties that supported advancement of ANB019 into Phase 2 studies. AnaptysBio is conducting its GALLOP trial, a Phase 2 study of ANB019 in GPP where top-line data is anticipated in mid-2019, and its POPLAR trial, a Phase 2 study in PPP where top-line data is anticipated in the second half of 2019.

On February 28, 2019 NANOBIOTIX (Euronext: NANO – ISIN: FR0011341205), a clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer reported that its unaudited revenues for Q4 and the unaudited annual revenues for the year ended December 31, 2018 (Press release, Nanobiotix, FEB 28, 2019, View Source [SID1234533776]).

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Activity and results
In total, Nanobiotix’s revenue for the fourth quarter amounted to €10,244.

Most of the revenue generated by the company during this period came from services that Nanobiotix provided to its
partners pursuant to its commercial agreements.

Overall, Nanobiotix’s annual revenue in 2018 amounted to €105,364.

In October 2018, the positive results of phase II/III in Soft Tissue Sarcoma with NBTXR3 were presented at the
European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) congress. NBTXR3 is the first radiotherapy enhancer to demonstrate
clinically meaningful benefits for patients with locally advanced Soft Tissue Sarcoma compared to radiotherapy alone.

Furthermore, on October 16, 2018, Nanobiotix announced that it had received the first tranche disbursement of 16
million euros as a loan from European Investment Bank. Proceeds will be used to toward the development of NBTXR3 clinical trial in the head and neck cancers and will support Nanobiotix’s European go-to-market strategy

2019 Financial agenda

Nanobiotix will announce its financial and operating results as follows:

• March 15, 2019 – 2018 Annual results
• April 11, 2019 – Annual General Meeting, Paris, France
• April 30, 2019 – Revenue for Q1
• July 19, 2019 – Revenue for Q2
• September 4, 2019 – Half year results
• October 25, 2019 – Revenue for Q3

On February 27, 2023 Biocure Technology Corp. (CSE:CURE) (OTCQB: BICTF) ("CURE" or the "Company") BiocurePharm, Korea ("BPK"), a wholly owned subsidiary of Biocure Technology Inc. ("CURE") reported that it has closed its non-brokered private placement through its Korean Subsidiary BiocurePharm, Korea ("BPK"), BPK has issued 96,404 shares at $11.45 CAD per share for gross proceeds of $1,103,749 (Press release, Biocure Technology, FEB 27, 2019, View Source,-korea-bpk-announces-closing-of-private-placement [SID1234628756]). After the issuance of new BPK shares, CURE holds now 97.32% interest in BPK.

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The net proceeds from the non-brokered private placement are intended to be used for general working capital and research and development.

On February 27, 2019 Silverback Therapeutics, Inc., a biotechnology company developing a pipeline of systemically delivered, locally active therapies, will present preclinical data on its lead clinical candidate, SBT6050, at the 110th meeting of the American Association of Cancer Research (AACR) (Free AACR Whitepaper), taking place March 29 to April 3 in Atlanta (Press release, Silverback Therapeutics, FEB 27, 2019, View Source [SID1234550490]). SBT6050 is a novel immune-modulatory conjugate that utilizes cell surface expression of HER2 to localize activation of TLR8 (toll-like receptor 8) for the treatment of HER2-expressing tumors.

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The presentation, titled "A Systemically Administered, Conditionally Active TLR8 Agonist for the Treatment of HER2-Expressing Tumors," is the first data to be presented on Silverback’s technology. SBT6050 is comprised of a TLR8 agonist conjugated to a HER2-directed monoclonal antibody, designed to activate myeloid cells only in the presence of HER2-expressing tumor cells with moderate-to-high expression levels. In mouse HER2-expressing tumor models, a surrogate molecule of SBT6050 drives activation of both innate and adaptive immune responses, resulting in single agent efficacy. Due to localized activation of myeloid cells, TLR conjugates do not cause an overproduction of peripheral cytokines in preclinical models. Silverback plans to advance SBT6050 into the clinic in 2020.

"Tumors resistant to checkpoint inhibition lack T cells but are replete with myeloid cells. TLR8 activation of tumor-resident myeloid cells results in potent anti-tumor immune responses, but effective delivery has been the key challenge," said Valerie Odegard, Ph.D., Silverback’s chief scientific officer. "Our preclinical studies demonstrate that systemic delivery of a TLR agonist with tumor-localized activity dramatically rewires the tumor microenvironment, resulting in durable, single agent efficacy in tumors refractory to checkpoint blockade."

"These are the first data we are disclosing publicly that demonstrate the ability of Silverback’s technology to localize delivery of potent therapies to specific sites in the body," said Peter Thompson, M.D., Silverback’s co-founder, chief executive officer and chairman. "Our data show the successful, specific delivery of a TLR agonist to HER2-expressing tumor cells upon systemic administration—thereby addressing a fundamental challenge previously limiting use of innate immune agonists to topical and intratumoral administration, largely due to toxicity arising from widespread myeloid cell activation with systemic use of these agents. With this validating data in hand, we are applying our technology to a broad range of targets and diseases."

Presentation details are as follows:

Presentation Type: Poster (Abstract 3830)
Title: A Systemically Administered, Conditionally Active TLR8 Agonist for the Treatment of HER2-Expressing Tumors
Presenter: Kara Moyes, Ph.D.
Session Date and Time: Tuesday, April 2, 2019 8:00 AM – 12:00 PM
Location: Georgia World Congress Center, Exhibit Hall B

About Silverback’s Platform Technology
Silverback’s proprietary technology and integrated R&D approach enables the design of product candidates that can be administered systemically, but that act only at the sites of disease. The approach is designed to spare healthy tissues from unwanted side effects, while modifying disease processes in a potent and targeted manner. Silverback is directing the platform to modulate fundamental pathways underlying serious or life-threatening diseases, which traditional antibody and small molecule-based approaches have not been able to successfully target with systemic dosing due to inadequate activity and/or unacceptable toxicities. Silverback has filed over 15 patent families covering the platform and related product candidates.

On February 27, 2019 Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported that data from its Phase 1/2 ICONIC trial, an open label trial evaluating JTX-2011 monotherapy and in combination with nivolumab, will be the subject of two poster presentations at the upcoming 2019 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting at the Georgia World Congress Center in Atlanta, GA on March 31- April 3, 2019 (Press release, Jounce Therapeutics, FEB 27, 2019, View Source [SID1234535390]). In addition, Jounce Therapeutics will present a poster that will describe the preclinical evaluation of JTX-8064, a highly specific monoclonal antibody that aims to reprogram human macrophages from an immune suppressive to immune active state by inhibiting the cell surface receptor LILRB2.

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"The JTX-2011 clinical data being presented show that ICONIC patients with emergence of ICOS hi CD4 T cells in the peripheral blood have improved progression free and overall survival. This finding further validates the role of this ICOS pharmacodynamic biomarker in directing the next stage of the clinical development strategy for JTX-2011. Establishing the importance of this biomarker and its association with improved survival leads us to two distinct paths; first, combination with other agents that are known to induce ICOS hi CD4 T cells which JTX-2011 may then further stimulate; and second, using candidate predictive biomarkers identified through analysis of baseline samples of patients with and without emergence of these cells," said Elizabeth Trehu, M.D., chief medical officer of Jounce Therapeutics. "In addition to the data from our JTX-2011 program, we will also highlight JTX-8064 and the preclinical evaluation of this novel product candidate and its role in reprogramming tumor-associated macrophages within the tumor microenvironment."

JTX-2011 Posters Details:
Improved progression-free and overall survival (PFS/OS) in patients (pts) with emergence of JTX-2011 associated biomarker (ICOS high CD4 T cells) on the ICONIC trial
Session Title: Phase II-III Clinical Trials: Part 2
Location: Exhibit Hall B, Poster Section 16
Date and Time: Tuesday April 2, 20191:00 PM – 5:00 PM ET
Poster Board Number: 3; Permanent Abstract Number: CT189

Genetic and molecular profiling of ICOS hi CD4 T cells demonstrates clonal expansion of TH1 effector cells following JTX-2011 treatment in subjects with solid tumors
Session Title: Biomarkers and Immune Monitoring
Location: Exhibit Hall B, Poster Section 22
Date and Time: Tuesday April 2, 20191:00 PM – 5:00 PM ET
Poster Board Number: 16; Permanent Abstract Number: 4053

JTX-8064 Poster Details:
Preclinical evaluation of JTX-8064, an anti-LILRB2 antagonist antibody, for reprogramming tumor-associated macrophages
Session Title: Tumor Immune Microenvironment
Location: Exhibit Hall B, Poster Section 25
Date and Time: Wednesday April 3, 20198:00 AM – 12:00 PM ET
Poster Board Number: 1; Permanent Abstract Number: 5007

The posters will be available at the start of each session on the "Our Approach" section of the Jounce Therapeutics website at www.jouncetx.com.

Jounce Therapeutics to Host Event and Webcast
Jounce Therapeutics will host an investor and analyst event beginning at 6:30 p.m. ET and live webcast beginning at 7:00 p.m. ET, on Tuesday, April 2, 2019. To access the live webcast, please visit the "Events & Presentations" page in the Investors and Media section of the company’s website at www.jouncetx.com. The webcast will be archived and made available for replay on the company’s website approximately two hours after the call and will be available for 30 days thereafter.

About JTX-2011
Jounce’s lead product candidate, JTX-2011, is a monoclonal antibody that binds to and activates ICOS, a protein on the surface of certain T cells. The company is developing JTX-2011 to treat solid tumors as a single agent and in combination with other therapies.

About JTX-8064
JTX-8064 is an anti-Leukocyte Immunoglobulin Like Receptor B2 (LILRB2) antibody and is the first candidate to emerge from Jounce’s Translational Science Platform efforts that focuses on tumor-associated macrophages. JTX-8064 is currently in IND-enabling activities and Jounce anticipates filing an IND and initiating a Phase 1 clinical trial for JTX-8064 in 2019.