On November 8, 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 third quarter ended September 30, 2019 and provided pipeline updates (Press release, AnaptysBio, NOV 8, 2019, View Source [SID1234550747]).

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"While we are disappointed with the top-line results of our etokimab ATLAS trial, we intend to re-evaluate our etokimab development strategy following additional data from ATLAS and top-line results from ECLIPSE in the first quarter of 2020," said Hamza Suria, president and chief executive officer of AnaptysBio. "We look forward to advancing ANB019, ANB030 and additional preclinical programs in our wholly-owned pipeline."

Etokimab (ANB020 Anti-IL-33) Program

The Company reported topline data from its ATLAS trial, a Phase 2b randomized, double-blinded, placebo-controlled, multi-dose study in approximately 300 adult patients treated with etokimab in moderate-to-severe atopic dermatitis. Each of the etokimab dosing arms failed to meet the primary endpoint of the trial, which was demonstration of statistically greater improvement in the Eczema Area and Severity Index (EASI) relative placebo at week 16.

AnaptysBio 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 topline data from an interim analysis of the ECLIPSE trial in the first quarter of 2020.

The Company has decided to postpone the initiation of its planned Phase 2b etokimab clinical trial in eosinophilic asthma, a multi-dose, randomized, double-blinded, placebo-controlled trial in 300-400 patients, until it has the opportunity to analyze the full data set from the ATLAS trial.

ANB019 (Anti-IL-36 Receptor) Program

In September, AnaptysBio announced positive topline data from an interim analysis of its Phase 2 clinical trial of ANB019 monotherapy in moderate-to-severe generalized pustular psoriasis, or GPP, also known as the GALLOP trial. In this interim analysis, both patients achieved the primary endpoint of disease score improvement at Day 29 and Day 113 without requiring rescue therapy, demonstrated rapid and sustained mJDA score improvement, with reduction of 58% at Day 8 and 63% at Day 113, and showed complete clearance of skin pustules by Day 8 and through Day 113, with CRP levels decreasing to nearly normal. Enrollment is ongoing in the GALLOP study, and the Company anticipates additional clinical data and a regulatory strategy update for the development of ANB019 in GPP during 2020.

The Company is also conducting a randomized, placebo-controlled, multi-dose Phase 2 trial in 50 patients with palmoplantar pustulosis, or PPP, also known as the POPLAR trial, with topline data anticipated in the first half of 2020.

ANB030 (Anti-PD-1 Agonist) Program

ANB030 is a wholly-owned antibody that binds PD-1 in an agonistic manner, leading to reduced T cell activity and anti-inflammatory effects in vivo. Genetic mutations in the PD-1 pathway are associated with increased susceptibility to various inflammatory conditions and we believe ANB030 has the potential to suppress inflammatory diseases by restoring insufficient PD-1-mediated negative signaling on activated T cells. The Company plans to focus future clinical development of ANB030 on certain autoimmune diseases where PD-1 checkpoint receptor function may be under-represented and anticipates filing an Investigational New Drug Application (IND) in the fourth quarter of 2019 and initiating a Phase 1 clinical trial in 2020. Preclinical data from the ANB030 was presented in June at the 2019 FOCIS Annual Meeting.
Board of Directors

In September, the Company appointed Laura J. Hamill to its board of directors. Most recently, Ms. Hamill served as Executive Vice President, Worldwide Commercial Operations, for Gilead Sciences, where she was involved in the strategic direction and long-term planning of the organization. Previously, Ms. Hamill held a number of US and international executive roles at Amgen, culminating with Senior Vice President and General Manager where she led ~$20B in U.S. commercial operations
Third Quarter Financial Results

Cash, cash equivalents and investments totaled $444.4 million as of September 30, 2019 compared to $500.2 million as of December 31, 2018, for a decrease of $55.8 million. The decrease relates primarily to cash used for operating activities.

Collaboration revenue was zero and $5.0 million for the three and nine months ended September 30, 2019, which related to a milestone for initiation of a Phase 3 trial in a second indication for dostarlimab, the anti-PD-1 antagonist antibody partnered with TESARO, a GlaxoSmithKline (GSK) company, compared to $5.0 million for the three and nine months ended September 30, 2019.

Research and development expenses were $29.9 million and $77.9 million for the three and nine months ended September 30, 2019, compared to $17.9 million and $40.3 million for the three and nine months ended September 30, 2018. The increase was due primarily to continued advancement of the Company’s etokimab and ANB019 clinical programs and additional personnel-related expenses, including share-based compensation.

General and administrative expenses were $3.8 million and $12.3 million for the three and nine months ended September 30, 2019, compared to $4.0 million and $11.8 million for the three and nine months ended September 30, 2018. The change was due primarily to personnel-related expenses, including share-based compensation.

Net loss was $31.0 million and $77.1 million for the three and nine months ended September 30, 2019, or a net loss per share of $1.15 and $2.85, compared to a net loss of $16.0 million and $44.7 million for the three and nine months ended September 30, 2018, or a net loss per share of $0.66 and $1.86.
Financial Guidance
AnaptysBio expects that its cash, cash equivalents and investments will fund its current operating plan, taking into account the adjustments to etokimab clinical development activities referenced above, at least into 2021. The Company expects to re-evaluate its current operating plan in light of the topline data from the ATLAS trial and to make adjustments as appropriate to manage the Company’s available cash resources.

On November 8, 2019 TG Therapeutics, Inc. (NASDAQ: TGTX), reported that a conference call will be held, Tuesday, November 12, 2019 at 8:30 AM ET to discuss results for the third quarter of 2019 and provide a business outlook for the remainder of the year (Press release, TG Therapeutics, NOV 8, 2019, http://ir.tgtherapeutics.com/news-releases/news-release-details/tg-therapeutics-host-conference-call-third-quarter-2019 [SID1234550765]). Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer will host the call.

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In order to participate in the conference call, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics Third Quarter 2019 Business Update Call. A live audio webcast will be available on the Events page, located within the Investors & Media section, of the Company’s website at View Source An audio recording of the conference call will also be available for replay on the Company’s website, for a period of 30 days after the call.

TG Therapeutics will announce its financial results for this period in a press release to be issued prior to the call.

On November 8, 2019 BioInvent International AB (publ) (OMXS: BINV) reported it will make a poster presentation with preclinical data on BI-1206 at the annual American Society of Hematology (ASH) (Free ASH Whitepaper) meeting in Orlando, Florida held December 7-10 (Press release, BioInvent, NOV 8, 2019, View Source [SID1234550797]).

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The abstract, published here, highlights a preclinical study of BI-1206 in an ibrutinib-venetoclax dual resistant PDX model derived from a doubly-resistant mantle cell lymphoma (MCL) patient. Single agent BI-1206 had potent anti-MCL activity in the FcγRIIb-expressing MCL PDX model to overcome ibrutinib-venetoclax dual resistance.

FcγRIIb was further shown to be highly expressed in 27/27 primary patient MCL samples examined. Along with previously published data demonstrating an important role for FcγRIIB in resistance to rituximab-based cancer immunotherapy, and BI-1206 in boosting rituximab efficacy and overcoming rituximab-resistance, these data indicate the significant potential of BI-1206 to address a significant unmet need in MCL and hematologic malignancy.

BioInvent CEO Martin Welschof said: "These pre-clinical data indicate a broad and clinically important role of FcγRIIb in mantle cell lymphoma, and highlight the potential of BI-1206 to help overcome resistance in this indication. This further reinforces our belief that FcγRIIb will become a key element for treating hematological and solid malignancies, and the potential of BI-1206 to play an important role in combating these diseases."

BI-1206, one of BioInvent’s proprietary anti-FcyRIIB antibodies and its lead compound, is currently being investigated in clinical trials in non-Hodgkin lymphoma, chronic lymphocytic leukemia and solid tumors.

Details of the poster:

Title: BI-1206, a Monoclonal Antibody Against FcyRIIIb, Showed Superior Anti-Tumor Activity in an Ibrutinib-Venetoclax Dual Resistant PDX Model in Mantle Cell Lymphoma

Session Name: 625. Lymphoma: Pre-Clinical-Chemotherapy and Biologic Agents: Poster II

Time: Sunday, December 8, 2019, 6:00 – 8:00 PM

Location: Orange County Convention Center, Hall B

On November 8, 2019 Cerus Corporation (Nasdaq:CERS) reported that Kevin D. Green, Cerus’ chief financial officer, will present at the Stephens Nashville Investment Conference on Wednesday, November 13, 2019 at 10:30 a.m. CT (Press release, Cerus, NOV 8, 2019, View Source [SID1234550748]).

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A live webcast of the presentation will be available on the Investor Relations page of the Cerus web site at View Source A replay of the webcast will be available for approximately two weeks following the completion of the event.

On November 8, 2019 Replimune Group, Inc. (NASDAQ: REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic platform, reported that it will present data from the Phase 1 part of its Phase 1/2 clinical trial of RP1 as monotherapy and in combination with Opdivo during a poster presentation at the 34th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (SITC 2019) in National Harbor, Maryland (linked here) (Press release, Replimune, NOV 8, 2019, View Source [SID1234550766]). The Company has also separately released data from initial melanoma patients (linked here) and updated data from CSCC patients (linked here) treated in the Phase 2 part of the clinical trial.

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As previously announced, an investor event will begin on November 8, 2019 at 6:30 p.m. ET to review this data. A link to the presentation can be found here and a simultaneous webcast will be available in the Investors and Media section of Replimune’s website at www.replimune.com. A replay will be available for 30 days following the conference.

The data demonstrates that RP1 alone and in combination with Opdivo is well tolerated, with clear anti-tumor activity, and confirms the mechanism of action of RP1 alone and in combination with Opdivo. Based on the clinical activity seen, the Company is now planning a new clinical trial in melanoma patients who are refractory to anti-PD1 therapy, along with the previously announced expansion of its CSCC program to include a new clinical trial in solid organ transplant recipients.

"We are very pleased with the data showing that RP1 is well tolerated both alone and in combination with Opdivo, which was the primary objective of the Phase 1 part of the study," said Robert Coffin, Ph.D., President and CEO of Replimune. "In addition to being well tolerated, there was clear evidence of anti-tumor efficacy, particularly in the tumor types where further development of RP1 is focused, as well as strong biomarker data which indicates that broad immune activation was achieved. Based on the strength of this data, we intend to expand our clinical development program for RP1 to include a clinical trial of RP1 in combination with anti-PD1 therapy in melanoma patients who are refractory to treatment with anti-PD1 therapy."

The Phase 1 part of Replimune’s Phase 1/2 clinical trial of RP1 enrolled 36 patients with advanced heavily pre-treated cancers who were refractory to available therapy. Treatment with RP1 alone was given up to five times at various dose levels injected into a single tumor to determine the recommended Phase 2 dose (N=22), following which RP1 was given up to eight times at the recommended dose in combination with Opdivo starting with the second dose of RP1 (N=14). Based on the data, which showed a favorable safety profile for both RP1 alone and in combination with Opdivo, the RP1 dosing regimen moved forward into Phase 2 development was an initial dose of up to 10mL of 1×106 pfu/ml followed by subsequent doses of up to 10mL of 1×107 pfu/ml.

In the dose rising monotherapy part of the Phase 1/2 clinical trial, RP1 was associated with tumor destruction, including delayed systemic post-study tumor reduction without further therapy. In the combination portion of the Phase 1 part of the clinical trial, anti-tumor activity was demonstrated in multiple patients with a variety of tumor types, particularly in CSCC and melanoma, but also in microsatellite instability high (MSI-H) colorectal cancer and esophageal cancer patients. Additionally, the first three of four patients with anti-CTLA-4 and anti-PD-1 refractory cutaneous melanoma treated with RP1 combined with Opdivo are responding to therapy (two patients from the Phase 1 part of the study and one from Phase 2) and clinical activity has been seen in four of the first five patients treated with CSCC. Of particular note, substantial tumor reduction was observed in a number of patients after just the first dose of RP1, but before the introduction of Opdivo two weeks later.

Biomarker data further confirmed the mechanism of action of RP1 alone and in combination with Opdivo, suggesting that RP1 provides broad anti-tumor immune activation. Increases in CD8 T Cells and PD-L1 were seen in serial tumor biopsies across tumor types, and the kinetics of virus detection suggests that robust virus replication in tumors occurs.

Continued recruitment of the Phase 2 part of the clinical trial in cohorts of 30 patients each with melanoma, non-melanoma skin cancers, bladder cancer, and MSI-H tumors is ongoing. Additional data from the Phase 2 part of the clinical trial is expected to be presented in 2020.

About RP1
RP1 is Replimune’s lead Immulytic product candidate and is based on a proprietary new strain of herpes simplex virus engineered to maximize tumor killing potency, the immunogenicity of tumor cell death and the activation of a systemic anti-tumor immune response.