On November 1, 2018 Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a biopharmaceutical company focused on developing and commercializing novel antibiotics to treat life-threatening multidrug-resistant (MDR) infections, reported that company management will host a conference call at 4:30 p.m. ET on Thursday, November 8, 2018 to discuss third quarter financial results and provide a general corporate update (Press release, Tetraphase, NOV 1, 2018, View Source [SID1234530632]).

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The conference call may be accessed by dialing 844-831-4023 (U.S. and Canada) or 731-256-5215 (international) and entering conference ID number 3997765. A live audio webcast of the conference call, or the subsequent archived recording, will be available online from the "Investors – Events & Presentations" section of the Tetraphase website at www.tphase.com.

A replay of the conference call will be available from 7:30 p.m. ET on Thursday, November 8, 2018, through 7:30 p.m. ET on Thursday, November 15, 2018 by dialing 855-859-2056 (U.S. and Canada) and 404-537-3406 for (international) callers. The conference ID number is 3997765. A replay of the webcast will be available for 90 days by visiting Tetraphase’s website.

On November 1, 2018 F-star, a clinical-stage biopharmaceutical company pioneering the development of novel bispecific antibodies that target the immune system to fight cancer, reported that it will present preclinical data on two new proprietary bispecific antibodies at the SITC (Free SITC Whitepaper) Annual Meeting, PEGS Summit Europe and the ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress (Press release, f-star, NOV 1, 2018, View Source [SID1234530648]).

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Checkpoint antagonists dominate the clinical landscape and yet despite encouraging progress, only a small patient population reaches a durable and clinically meaningful response. Current approaches have shown limited efficacy for poorly immunogenic tumours which harness different and often multiple escape or resistance mechanisms to attenuate the local immune response.

FS120 is a dual agonist mAb² simultaneously targeting OX40 (CD134, TNFRSF4) and CD137 (4-1BB). FS222 is an agonist/antagonist mAb² against CD137 and PD-L1 (Programmed Death-Ligand 1). Both OX40 and CD137 are co-stimulatory molecules, part of the Tumour Necrosis Factor Receptor Super Family (TNFRSF). Unlike checkpoint antagonists, engagement of OX40 or CD137 on activated T cells triggers a positive signal that enhances several cellular and effector functions, essential to the elimination of tumour cells.

Neil Brewis, CSO of F-star said "It is only recently that the full complexity of tumour heterogeneity and how this translates into the clinical setting has been appreciated. With the increase in tumour resistance to checkpoint therapies, there is an urgent need to generate new and efficacious treatment options for cancer patients. F-star’s new programmes have the potential to leverage a more targeted, potent and safer immune response, even in highly immune-suppressive tumour microenvironments."

The data to be presented will highlight the potent anti-tumour activity of F-star’s mAb² and how each of them outperforms combinations of monospecific agents in multiple syngeneic tumour models. Furthermore, the results will describe how F-star’s bispecific format can alleviate some of the inherent limitations of an antibody-mediated TNFRSF activation, such as low efficacy or dose-dependent liver toxicity observed in current clinical trials.

Eliot Forster, CEO of F-star said "I am very excited about the presentation of these wholly owned molecules to these conferences. The data on FS120 a dual agonist mAb² and FS222 an agonist/antagonist mAb² demonstrate the versatility and power of our Modular Antibody Technology and its ability to address the known heterogeneity of tumour types and, especially, their immune evasion mechanisms. With the potential to go beyond combination approaches, the two programmes are heading towards INDs in 2019, reinforcing F-star’s commitment to deliver life-changing treatments for cancer patients".

Details of the presentations are below:

SITC Annual Meeting – 7-11 Nov 2018 – Washington DC

Oral presentation information:

Title: FS120 mAb², a dual agonist bispecific antibody targeting OX40 and CD137, activates T cells in vitro and induces potent, FcγR-independent anti-tumour activity
Session: Next Generation Bispecifics and Antibody-Like Molecules
Session date and time: 11 Nov from 08:05-10:30

Poster presentations information:

Title: FS120 mAb², a dual agonist bispecific antibody targeting OX40 and CD137, activates T cells in vitro and induces potent, FcγR-independent anti-tumour activity
Abstract poster number: O44
Poster hall location: Hall E
Poster hall hours: 09 Nov from 08:00 – 20:00 and 10 Nov from 08:00 – 20:30
Poster presentation hours: 10 Nov from 12:20 – 13:50 and 19:00 – 20:30

Title: A novel CD137/PD-L1 bispecific antibody modulates the tumour microenvironment by activating CD8+ T cells and results in tumour growth inhibition
Abstract poster number: P631
Poster hall location: Hall E
Poster hall hours: 09 Nov from 08:00 – 20:00 and 10 Nov from 08:00 – 20:30
Poster presentation hours: 09 Nov from 12:45 – 14:15 and 18:30 – 20:00

PEGS Summit Europe 2018 – 12-16 Nov 2018 – Lisbon

Oral presentation information:

Title: Agonist bispecific antibodies delivering the next Immuno-Oncology breakthrough Session: Advancing Bispecifics and Combination Therapy to the Clinic
Presentation time: 15 Nov at 11:15

ESMO Immuno-Oncology Congress – 13-16 Dec 2018 – Geneva

Poster presentation information:

Title: Optimising TNFRSF Agonism and Checkpoint Blockade with a Novel CD137/PD-L1 Bispecific Antibody
Abstract: 444
Session date and time: 14-15 Dec, lunch time

On November 1, 2018 Unum Therapeutics Inc. (NASDAQ: UMRX), a clinical-stage biopharmaceutical company focused on the development of cellular immunotherapies based on its novel, universal Antibody-Coupled T cell Receptor (ACTR) technology platform, reported that the Company will present preliminary results from the ongoing Phase 1 ATTCK-20-03 study, testing ACTR707 in combination with rituximab in patients with relapsed/refractory CD20+ B cell lymphoma (r/r/ NHL), and the ongoing Phase 1 ATTCK-17-01 study, testing ACTR087 in combination with SEA-BCMA in patients with relapsed/refractory multiple myeloma (r/r MM), at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) meeting taking place December 1-4, 2018, in San Diego, CA (Press release, Unum Therapeutics, NOV 1, 2018, View Source [SID1234530466]).

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"Preliminary data from these two trials demonstrate ACTR T cell activity and a well-tolerated safety profile of both ACTR707 and ACTR087 product candidates in their respective patient populations," said Michael Vasconcelles, Chief Medical Officer of Unum. "We remain encouraged by the emerging potential best-in-class profile of ACTR707 in combination with rituximab in patients with r/r NHL and the early safety data of ACTR087 in combination with the novel antibody, SEA-BCMA, in patients with r/r MM."

Data from the first dose level in the multicenter Phase 1 study, ATTCK-20-03, testing ACTR707 in combination with rituximab in patients with relapsed or refractory CD20+ B cell lymphoma, was presented in September 2018 at the Fourth Annual CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper). Three of the six patients treated at the first dose level in the study achieved a complete response, two of which remained ongoing at the time of the September 4, 2018 data cut off. No dose-limiting toxicities (DLTs) were observed in any of the four DLT-evaluable patients, and no serious or severe adverse events of cytokine release syndrome or neurotoxicity were observed in any patients. Updated data from this cohort, along with data on the subsequent dose cohort will be presented at the ASH (Free ASH Whitepaper) meeting.

In addition, first-in-human dosing of single agent SEA-BCMA, and of ACTR087 in combination with SEA-BCMA, in the ATTCK-17-01 multi-center Phase 1 dose-escalation study was well tolerated, with no dose-limiting toxicities in the first two single-subject cohorts. Following infusion, ACTR+ T cells were detectable in these patients and demonstrated expansion post infusion. These data have supported the continued dose escalation of ACTR087 in combination with SEA-BCMA. Updated data from the first three dose cohorts of the trial will be presented at the ASH (Free ASH Whitepaper) meeting, with subsequent updates anticipated in 2019.

Details on the presentations are as follows:

Presentation Title: Preliminary Clinical Results of a Phase 1 Study Evaluating the Safety and Anti-tumor activity of ACTR707 in Combination with Rituximab in Subjects with Relapsed or Refractory CD20+ B-cell Lymphoma
Session Title: 626. Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive B-Cell Non-Hodgkin Lymphomas) – Results from Prospective Clinical Trials: Poster II
Date & Time: Sunday, 2 December, 2018 from 6:00 – 8:00pm
Location:San Diego Convention Center, Hall GH

Presentation Title: A Phase 1 Study of Two Investigational Agents, ACTR087, an Autologous T Cell Product Expressing an Antibody-Coupled T cell Receptor, in Combination With SEA-BCMA, a Novel Non-fucosylated Monoclonal Antibody, in Subjects with Relapsed or Refractory Multiple Myeloma
Session Title: 653. Myeloma: Therapy, excluding Transplantation: Poster I
Date & Time:Saturday, December 1, 2018 from 6:15 – 8:15pm
Location:San Diego Convention Center, Hall GH

On November 1, 2018 Constellation Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company using its expertise in epigenetics to discover and develop novel therapeutics, reported that it has received Fast Track designation from the United States Food and Drug Administration (FDA) for CPI-0610 in treatment of myelofibrosis (MF) based on preliminary results from the Company’s Phase 2 study, MANIFEST (Press release, Constellation Pharmaceuticals, NOV 1, 2018, View Source [SID1234530508]).

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Constellation is developing CPI-0610 with the goal of providing a new treatment option for patients with MF who have progressed after treatment with Jakafi (ruxolitinib), the only approved therapy for MF. Enrollment is ongoing in the Phase 2 portion of the open-label Phase 1/2 MANIFEST clinical trial, which is exploring CPI-0610’s potential both as a monotherapy and as a combination therapy with Jakafi. As previously reported, preliminary data demonstrated clinical activity, such as spleen volume reduction, symptom improvement, increase in hemoglobin levels, and conversion to transfusion independent status in a patient who was transfusion dependent. Constellation recently expanded the MANIFEST study to include a third cohort, designed to evaluate CPI-0610 as a first-line therapy in combination with ruxolitinib in JAK 1/2-inhibitor-naïve MF patients.

"We believe there is an opportunity to improve the standard of care for MF patients with agents that modify the underlying disease," said Adrian Senderowicz, Senior Vice President and Chief Medical Officer of Constellation Pharmaceuticals. "This Fast Track designation highlights CPI-0610’s potential to address a significant unmet need. Based on promising early data and our progress with site initiation and patient enrollment, we continue to expect to determine proof of concept in mid-2019."

The FDA grants Fast Track designation to facilitate the development and expedite the review of drugs to treat serious or life-threatening diseases and fill unmet medical needs. A drug that receives Fast Track designation is

eligible for more frequent meetings with the FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval, more frequent written communication about the design of the proposed clinical trials and use of biomarkers, eligibility for accelerated approval and priority review, and rolling review.

About Myelofibrosis

MF is part of a collection of progressive blood cancers known as myeloproliferative neoplasms and is associated with significantly reduced quality of life and shortened survival. As the disease progresses, the bone marrow produces fewer red blood cells. Within one year of diagnosis, the incidence of thrombocytopenia (a condition characterized by low platelet counts in the blood) and severe anemia (a condition characterized by low red blood cell counts) and the need for red blood cell transfusion increase significantly. Among other complications, most patients with MF have enlarged spleens, as well as many other physical symptoms, including abdominal discomfort, bone pain, and extreme fatigue.

About CPI-0610

CPI-0610 is a potent and selective small molecule designed to promote anti-tumor activity by selectively inhibiting the function of BET proteins to decrease the expression of abnormally expressed genes in cancer. Constellation’s epigenetics platform includes a deep understanding of the biological contexts in which BET proteins operate, including cancer pathways that are highly sensitive to CPI-0610. The results from preclinical studies, as well as translational insights from the successful first-in-human study of CPI-0610, led to prioritizing the clinical development of CPI-0610 in myelofibrosis (MF). Enrollment is ongoing in the Phase 2 portion of the open-label Phase 1/2 MANIFEST clinical trial of CPI-0610, either as a monotherapy or in combination with ruxolitinib, in patients with MF who are refractory or intolerant or have relapsed or lost response to the standard of care. MANIFEST also includes a third cohort designed to evaluate treatment with CPI-0610 in combination with ruxolitinib as a first-line therapy in JAK 1/2-inhibitor-naïve MF patients. The company expects to determine proof of concept for CPI-0610 in MF in mid-2019.

On November 1, 2018 OncoMed Pharmaceuticals, Inc. (NASDAQ:OMED), a clinical-stage biopharmaceutical company focused on discovering and developing novel anti-cancer therapeutics, reported third quarter 2018 financial results and provided a corporate update (Press release, OncoMed, NOV 1, 2018, View Source [SID1234530524]). As of September 30, 2018, cash, cash equivalents, and short-term investments totaled $70.9 million.

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"As anticipated, our development efforts have culminated in a stream of data this year and set the stage for additional data flow in 2019," said John Lewicki, Ph.D., President and Chief Executive Officer of OncoMed. "The efficacy of navicixizumab, both as a single agent and in combination with chemotherapy, has been impressive in patients with heavily pretreated, late stage recurrent ovarian cancer. We continue to enroll additional patients in our ongoing Phase 1b clinical trial as we consider the possible next steps for this program. Concurrently, clinical investigation and proof of concept continues for our other clinical candidates: etigilimab (anti-TIGIT) and GITRL-Fc in metastatic solid tumor settings."

Pipeline Highlights

Navicixizumab (anti-DLL4/VEGF bispecific; OMP-305B83)

In the third quarter, OncoMed reported publication of results from its Phase 1a study of single-agent navicixizumab in patients with refractory solid tumors in Investigational New Drugs. The results showed that 19 of the 66 patients with various types of refractory solid tumors had tumor shrinkage following treatment with navicixizumab. Notably, 3 of the 12 (25%) heavily pretreated ovarian cancer patients treated in the trial achieved a partial response with single-agent navicixizumab therapy.

In addition, the company announced interim results from its Phase 1b clinical trial of navicixizumab in combination with weekly paclitaxel in ovarian cancer patients who had received a median of four prior therapies. In addition, all patients had previously received paclitaxel and 69% had received bevacizumab. The results, which were presented at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) meeting, showed that 22 of the 26 patients (85%) treated with the novel regimen experienced clinical benefit. Notably 11 of the 26 patients (42%) achieved a partial response, the GCIG CA-125 response rate was 61% and the median progression-free survival was 5.4 months (95% CI: 3.5-8.0 months). Historical response rates for patients with heavily pretreated platinum-resistant ovarian cancer treated with chemotherapy are typically 15% or less.
Etigilimab (Anti-TIGIT monoclonal antibody; OMP-313M32)

Enrollment continues in the company’s Phase 1a/1b clinical trial of etigilimab. Specifically, the company is continuing to enroll patients with select tumor types in the single-agent expansion phase of the study and is also enrolling patients who have progressed on prior immunotherapy in the Phase 1b portion of the trial with these patients being treated with etigilimab plus anti-PD1 (nivolumab). Phase 1a data from the dose-escalation portion of the trial, designed to assess safety and tolerability of escalating doses of etigilimab monotherapy, will be reported at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) meeting in a poster presentation on Friday and Saturday, November 9 and 10, 2018 and in a rapid oral presentation on Saturday, November 10, 2018 from 12:35-1:35 pm Eastern Time.
GITRL-Fc (OMP-336B11)

Enrollment continues in the Phase 1a single-agent study of its wholly-owned GITRL-Fc in patients with advanced or metastatic solid tumors. The company is pleased that enrollment in this trial has been robust to date. GITRL-Fc is a fusion protein with an Fc-linked fully human trimer ligand and is designed to activate the co-stimulatory receptor GITR (glucocorticoid-induced tumor necrosis factor receptor-related protein) to enhance T-cell modulated immune responses. Data from the Phase 1a trial are expected to be presented in 2019.
Third Quarter 2018 Financial Results

Cash, cash equivalents and short-term investments totaled $70.9 million as of September 30, 2018, compared to $103.1 million as of December 31, 2017.

Revenues were $19.5 million for the third quarter of 2018, an increase of $14.4 million, compared to $5.1 million for the same period in 2017. The increase in revenue was due to the Company’s adoption of Accounting Standards Codification (ASC) Topic 606, Revenue from Contracts with Customers effective January 1, 2018.

Research and development (R&D) expenses were $10.0 million for the third quarter of 2018, a decrease of $2.2 million, compared to $12.2 million for the same period in 2017. The decrease in R&D expenses was due to decreases in clinical development costs and a decrease in personnel cost, including stock-based compensation.

General and administrative (G&A) expenses were $3.7 million for the third quarter of 2018, a decrease of $0.2 million, compared to $3.9 million for the same period in 2017. The decrease in G&A expenses was primarily due to a decrease in personnel cost, including stock-based compensation.

Net income was $6.1 million ($0.16 net income per share, basic and diluted) for the third quarter of 2018, compared to a net loss of $10.7 million ($0.28 net loss per share, basic and diluted) for the same period of 2017. The net income in the third quarter of 2018 was primarily due to higher collaboration revenue as a result of the new revenue recognition accounting standard adopted on January 1, 2018 and lower operating expenses.

2018 Financial Guidance

With resource reprioritization and additional cash management measures, OncoMed’s current cash runway has been extended by one quarter and is now estimated to fund operations through at least the fourth quarter of 2019, without taking into account future potential milestone or opt-in payments from its partners. OncoMed estimates 2018 operating cash burn to be less than $55 million, before considering potential milestone or opt-in payments.