On February 28, 2019 Genocea Biosciences, Inc. (NASDAQ: GNCA), a biopharmaceutical company developing neoantigen cancer immunotherapies, reported its operating and financial results for the fourth quarter and fiscal year ended December 31, 2018 (Press release, Genocea Biosciences, FEB 28, 2019, View Source [SID1234533787]). The company also announced the appointment of a new Chief Financial Officer, Diantha Duvall, a seasoned life science industry professional. Ms. Duvall will join the company on March 5th.

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"We are very pleased to welcome Diantha to Genocea," said Chip Clark, president & CEO of Genocea. "She joins us at a truly exciting time. With our recently completed equity financing and advancing pipeline, we look forward to an eventful 2019. We foresee important near-term milestones in two programs, each driven by our unique ATLAS neoantigen identification platform: first, our Phase 1/2a clinical program for our neoantigen cancer vaccine candidate, GEN-009, from which we expect to see the first immunogenicity data in mid-2019, and second, our GEN-011 program, a neoantigen adoptive T cell therapy, for which we plan to file an IND in the first half of 2020."

Ms. Duvall joins Genocea from Bioverativ, Inc., where she served as Vice President, Controller and Chief Accounting Officer since the company’s spin out from Biogen, where she had served as U.S. and then Global Commercial Controller. Prior to Biogen, Ms. Duvall held a variety of financial and accounting positions at Merck and Co. and PricewaterhouseCoopers.

Recent Operational Highlights

Strengthened senior management team, adding Thomas Davis, M.D., as Chief Medical Officer and Derek Meisner, J.D., as General Counsel in the Fall of 2018, Girish Aakalu, Ph.D. as Chief Business Officer in December 2018, and, as announced today, Diantha Duvall as CFO.
Completed a private placement financing in mid-February, the first closing of which resulted in aggregate gross proceeds of $15.0 million (before deducting fees to the placement agents and other expenses).
Announced a major clinical milestone in early January, dosing the first patients and completing enrollment in Part A of its Phase 1/2a clinical trial for GEN-009. The first immunogenicity data from this study are expected in mid-2019.
Presented additional ATLAS data at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) meeting in November 2018. The posters further highlighted the advantages of Genocea’s ATLAS platform over in silico methods in identifying both neoantigens for vaccine inclusion and "inhibitory" neoantigens for exclusion, and presented, for the first time, data in a mouse model providing evidence that these neoantigen-specific inhibitory responses could be tumor-promoting.
Fourth-Quarter 2018 Financial Results

Cash position: As of December 31, 2018, cash and cash equivalents were $26.4 million compared to $12.3 million, as of December 31, 2017; this does not include approximately $15.0 million in aggregate gross proceeds (before deducting fees to the placement agents and other expenses) from the company’s recently closed private placement.
Research and Development (R&D) expenses: R&D expenses were $6.3 million for the quarter ended December 31, 2018, compared to $7.9 million for the same period in 2017.
General and Administrative (G&A) expenses: G&A expenses were $2.6 million for the quarter ended December 31, 2018, compared to $2.5 million for the same period in 2017.
Net income/loss: Net income was $0.4 million for the quarter ended December 31, 2018, compared to a net loss of $1.7 million for quarter ended December 31, 2017.
Full-Year 2018 Financial Results

Research and Development (R&D) expenses: R&D expenses were $25.2 million for the year ended December 31, 2018, compared to $39.2 million for the year ended December 31, 2017.
General and Administrative (G&A) expenses: G&A expenses were $14.3 million for the year ended December 31, 2018, compared to $13.4 million for the year ended December 31, 2017.
Net loss: Net loss was $27.8 million for the year ended December 31, 2018, compared to a net loss of $56.7 million for year ended December 31, 2017.
Guidance
Genocea expects that its existing cash and cash equivalents are sufficient to support its operations into the first quarter of 2020.

Genocea continues to explore strategic alternatives for GEN-003, its Phase 3-ready investigational immunotherapy for the treatment of genital herpes.

Genocea’s Board of Directors has adopted a resolution approving and recommending that stockholders support a proposal in the company’s upcoming proxy statement to effect a reverse stock split of the company’s issued and outstanding common stock, if necessary, to maintain the company’s NASDAQ Capital Market listing.

Conference Call
Genocea will host a conference call and webcast today at 9:00 a.m. ET. The conference call may be accessed by dialing (844) 826-0619 (domestic) or (315) 625-6883 (international) and referring to conference ID number 6953999. A live webcast of the conference call will be available online from the investor relations section of the Company’s website at View Source A webcast replay of the conference call will be available on the Genocea website beginning approximately two hours after the event and will be archived for 90 days.

On February 28, 2019 Incyte Corporation (Nasdaq:INCY) reported that seven abstracts showcasing data from its cancer research portfolio will be presented at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019 (Press release, Incyte, FEB 28, 2019, View Source [SID1234533786]). The meeting will be held March 29 – April 3, 2019, at the Georgia World Congress Center in Atlanta, Georgia.

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Accepted abstracts feature data from clinical studies involving Incyte’s anti-PD-1 monoclonal antibody, INCMGA00121, in patients with advanced solid tumors, as well as pre-clinical characterizations of the Company’s oral, small molecule PD-L1 inhibitor program and its PD-L1xCD137 bispecific antibody.

"Data accepted for presentation during the upcoming AACR (Free AACR Whitepaper) Annual Meeting demonstrate our ongoing commitment to advancing innovative research as we seek to bring forward novel therapies for patients with cancer," stated Dashyant Dhanak, Ph.D., Chief Scientific Officer, Incyte. "In particular, we are pleased to present, for the first time at a major medical meeting, early data on our oral PD-L1 inhibitor program—whose lead candidate, INCB86550, recently entered clinical trials."

Key abstracts include:

Clinical

Pharmacodynamic correlates in a phase 1 study of INCMGA00012, a PD-1 antagonistic monoclonal antibody (Abstract #CT085/9, Phase 1 Clinical Trials: Part 3)

Monday, April 1, 2019, 1:00 p.m. – 5:00 p.m. ET, Poster Section 16
Assessment of flat dosing strategy for INCMGA00012 in patients with advanced tumors(Abstract #LB-268/14, Late-Breaking Research: Experimental and Molecular Therapeutics)

Wednesday, April 3, 2019, 8:00 a.m. – 12:00 p.m. ET, Poster Section 40
Pre-Clinical

Oral Presentations

Novel small-molecule antagonists of the PD-1/PD-L1 axis that mediate cell surface PD-L1 dimerization and internalization (Abstract #4483, Novel Therapeutics)

Tuesday, April 2, 2019, 3:00 p.m. – 5:00 p.m. ET, Georgia Ballroom 3 – Georgia World Congress Center (Building C)
Preclinical characterization of potent and selective oral PD-L1 small-molecule antagonists (Abstract #4480, Novel Therapeutics)

Tuesday, April 2, 2019, 3:00 p.m. – 5:00 p.m. ET, Georgia Ballroom 3 – Georgia World Congress Center (Building C)
Poster Presentations

A bispecific Fc-silenced IgG1 antibody (MCLA-1452) requires PD-L1 binding to activate CD137 (Abstract #539/3, Therapeutic Antibodies I)

Sunday, March 31, 2019, 1:00 p.m. – 5:00 p.m. ET, Poster Section 23
An unbiased screen identifies a CD137xPD-L1 bispecific IgG1 antibody with unique T cell activation and binding properties (Abstract #541/5, Therapeutic Antibodies I)

Sunday, March 31, 2019, 1:00 p.m. – 5:00 p.m. ET, Poster Section 23
Characterization of human cancer cell line xenografts in humanized mice (Abstract #1050/1, Human in Mouse)

Monday, April 1, 2019, 8:00 a.m. – 12:00 p.m. ET, Poster Section 4
Full session details and data presentation listings for AACR (Free AACR Whitepaper) 2019 can be found at: View Source!/6812.

On February 28, 2019 Aduro Biotech, Inc. (NASDAQ: ADRO) reported that three abstracts will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019, which will be held from March 29 through April 3, 2019 in Atlanta, GA (Press release, Aduro Biotech, FEB 28, 2019, View Source;p=RssLanding&cat=news&id=2389463 [SID1234533780]). Presentations will highlight the company’s lead programs, STING agonist ADU-S100, and anti-APRIL antibody BION-1301.

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Details of the presentations are as follows:

Abstract 1202: Tumor cell intrinsic STING signaling demonstrates minimal contribution to the anti-tumor response elicited by the STING agonist ADU-S100 (MIW815)

Session: Tumor-immune Interactions
Date/Time: Monday Apr 1, 2019 8:00 AM – 12:00 PM
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 9

Abstract CT107: Phase 1/2 Safety and Pharmacokinetics of BION-1301 Targeting APRIL, a Proliferation-Inducing Ligand, in Adults with Relapsed or Refractory Multiple Myeloma

Session: Phase I-III Trials in Progress: Part 1
Date/Time: Monday Apr 1, 2019 1:00 PM – 5:00 PM
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 17

Abstract 1203: Preclinical development of ADU-1805, a highly selective pan-allele anti-SIRPα antibody that blocks the SIRPα-CD47 innate immune checkpoint

Session: Tumor-immune Interactions
Date/Time: Monday, Apr 1, 2019 8:00 AM – 12:00 PM
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 9

To view these abstracts, please visit the AACR (Free AACR Whitepaper) website located at View Source

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