On November 7, 2018 BioInvent International AB (OMXS: BINV), focused on the discovery and development of novel and first-in-class immuno-regulatory antibodies to treat cancer, and Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies, reported they will be presenting two back-to-back posters featuring positive data supporting their ongoing collaboration to develop a novel oncolytic virus encoding for an anti-CTLA-4 antibody at the annual meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) to be held November 7-11 in Washington, D.C (Press release, Transgene, NOV 7, 2018, View Source [SID1234530909]).

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This novel oncolytic virus combines a Transgene Invir.IO Vaccinia virus (VV)-based oncolytic vector, with BioInvent’s human anti-CTLA-4 antibody (IgG1) and a human cytokine.

BioInvent and Transgene are together creating a novel armed oncolytic virus that will be able to infect and selectively replicate within the tumor, inducing cancer cell destruction, and to elicit a strong immune response that is further enhanced by the local expression of the immune checkpoint inhibitor and the cytokine. This novel oncolytic virus is expected to deliver better treatment outcomes with an improved safety profile as the patient is not exposed to the potential systemic toxicity of the anti-CTLA-4 antibody.

In the posters, Transgene and BioInvent provide further details on the strengths and advantages of their respective technologies:

Transgene’s VV is a highly oncolytic and immunogenic viral vector that has demonstrated its ability to ensure the expression of a fully functional, full-length antibody in the tumor and trigger a massive immune infiltration into the tumor with low systemic exposition to the molecule;
BioInvent has developed a potent anti-CTLA-4 antibody, selected and characterized for its improved FcγR-dependent Treg depleting efficacy. FcγR-dependent Treg depletion was recently found to play a key role in the anti-CTLA-4 antibody’s efficacy in vivo.
Björn Frendéus, Chief Scientific Officer of BioInvent said: "Having identified a lead human anti-CTLA-4 antibody candidate with improved Treg-depleting activity compared with ipilimumab, we are looking forward to advancing the program presented at the SITC (Free SITC Whitepaper) in collaboration with Transgene, and develop a potentially safe and more efficacious strategy to combine anti-CTLA-4 and anti-PD-1/PDL1 checkpoint inhibition in the context of oncolytic virotherapy."

Eric Quéméneur, Pharm.D., Ph.D., Executive VP, Chief Scientific Officer of Transgene, said: "We are very pleased with the progress of our collaboration with BioInvent. The data that both companies present at SITC (Free SITC Whitepaper) underline the potential of combining our synergistic expertise to generate a novel oncolytic virus capable of delivering a potent anti-CTLA-4 antibody directly into the tumor micro-environment. The concept of combining the merits of our respective technologies was already demonstrated in preclinical experiments and we look forward to demonstrating its potential in the clinic."

The posters will be on display both Friday, November 9 and Saturday, November 10 in the Poster Hall (Hall E). They will also be available after the conference on the companies’ respective websites, www.transgene.fr and www.bioinvent.com.

Antibody-armed oncolytic Vaccinia virus to block immunosuppressive pathways in the tumor microenvironment – Poster P615

Authors: Marchand JB, Semmrich M, Fend L, Tornberg UC, Silvestre N, Frendéus B, Quéméneur E
Generation and characterization of a CTLA-4 antibody with improved FcγR-dependent

Treg deletion for tumor microenvironment-targeted oncolytic virotherapy of cancer – Poster 602

Authors: Semmrich M, Marchand JB, Holmkvist P, Mårtensson L, Tornberg UC, Fend L, Kovacek M, Teige I, McAllister A, Quéméneur E, Frendéus B

On November 7, 2018 Clovis Oncology, Inc. (Nasdaq: CLVS) reported that Patrick J. Mahaffy, Chief Executive Officer and President, will present at the 27th Annual Healthcare Conference on Wednesday, November 14, 2018 at 11:30 AM Mountain Time (Press release, Clovis Oncology, NOV 7, 2018, View Source [SID1234530945]). The conference will be held at the Phoenician in Scottsdale.

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A live webcast of the presentation can be accessed through the investor relations section of the Company’s website at www.clovisoncology.com. Following the live presentation, a replay of the webcast will be available on the Company’s website for 30 days.

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On November 7, 2018 Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage pharmaceutical company focused on discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer, reported its financial results for the third quarter ended September 30, 2018 (Press release, Calithera Biosciences, NOV 7, 2018, View Source [SID1234531158]). As of September 30, 2018, cash, cash equivalents and investments totaled $141.5 million.

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"Calithera continues to advance the development of our novel oncometabolism clinical candidates," said Susan Molineaux, PhD, President and Chief Executive Officer of Calithera. "In this quarter we broadened the development of the novel glutaminase inhibitor CB-839 with two new clinical trial collaborations with Pfizer. We are actively enrolling CANTATA and ENTRATA, two randomized trials of CB-839 for the treatment of patients with renal cell carcinoma, with data from the ENTRATA trial expected in 2019. In addition, we and our partner Incyte expect data on INCB001158 to be presented at a medical meeting in the first half of 2019."

Third Quarter 2018 and Recent Highlights

Announced two new clinical trial collaborations to evaluate Pfizer’s CDK4/6 inhibitor palbociclib, also known as IBRANCE, and the dual-mechanism poly (ADP-ribose) polymerase (PARP) inhibitor talazoparib also known as TALZENNA, each in combination with Calithera’s glutaminase inhibitor CB-839. Calithera will initiate Phase 1/2 clinical studies in the first quarter of 2019. Preclinical data suggest that CB-839 synergizes with CDK4/6 inhibitors by enhancing cell cycle arrest and blocking cancer cell proliferation. CB-839 also synergizes preclinically with PARP inhibitors to impair DNA synthesis, enhance DNA damage, and block cancer cell proliferation.

Two Randomized Combination Trials of CB-839 in Combination for the Treatment of Renal Cell Carcinoma. The ENTRATA trial, a randomized double-blind study of late line patients, will enroll approximately 66 patients to receive either CB-839 plus everolimus or everolimus alone. Topline results are expected in 2019. The CANTATA trial is a randomized, global, double-blind trial comparing patients treated with cabozantinib and CB-839 to patients treated with cabozantinib alone. Topline results are expected in 2020. The trial will enroll patients with clear cell renal cell carcinoma who have previously received one or two prior lines of therapy. The trial, originally designed to enroll 300 patents has been enlarged to approximately 400 patients. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for CB-839 in combination with cabozantinib for the treatment of this patient population. Updated Phase 1b data of CB-839 combined with cabozantinib presented in the quarter demonstrated a disease control rate of 100%, and response rate of 50% in 10 evaluable patients with clear cell RCC.

INCB001158 Arginase Inhibitor Immuno-oncology Program. INCB001158 is being evaluated in multiple clinical trials for the treatment of patients with solid tumors both as a monotherapy, and in combination with immunotherapies and chemotherapy. INCB001158 is being developed as part of a collaboration and license agreement with Incyte. Data from INCB001158 is expected to be presented at a medical meeting in the first half of 2019.

CB-280 Arginase Inhibitor for the Treatment of Cystic Fibrosis. Arginase is believed to be critical in the pathology of cystic fibrosis. It impairs production of nitric oxide and generates metabolites of arginine that may impair lung function. CB-280 is an orally administered small molecule inhibitor of arginase. An investigational new drug (IND) application for CB-280 with the FDA is planned for the first half of 2019.

CB-708 Oral Small Molecule CD73 Inhibitor. The immuno-oncology target CD73 is an enzyme that plays a critical role in the process of ATP conversion to adenosine. An IND application for CB-708, an orally administered small molecule inhibitor of CD73, is planned for 2019.

Selected Third Quarter 2018 Financial Results

Cash, cash equivalents and investments totaled $141.5 million at September 30, 2018.

Research and development expenses were $16.4 million for the three months ended September 30, 2018, compared with $10.8 million for the same period in the prior year. The increase of $5.6 million was due to an increase in the CB-839 program, including for the CANTATA trial which opened in 2018, an increase in the INCB001158 program, including Incyte’s co-funding of development costs, an increase in the CB-280 program, as well as investment in early stage research.

General and administrative expenses were $3.1 million for both the three months ended September 30, 2018 and 2017 due to consistent headcount and stock-based compensation expense.

Net loss from operations for the three months ended September 30, 2018 was $18.8 million, or $0.52 per share.

Conference Call Information

Calithera will host an update conference call today, November 7, at 2:00 p.m. Pacific Time/ 5:00 p.m. Eastern Time. The call can be accessed by dialing (855) 783-2599 (domestic) or (631) 485-4877 (international), and referring to conference ID 9368596. To access the live audio webcast or the subsequent archived recording, visit the Investors section of the Calithera website at www.calithera.com. The webcast will be recorded and available for replay on Calithera’s website for 30 days.

On November 7, 2018 Nektar Therapeutics (Nasdaq: NKTR) reported its financial results for the third quarter ended September 30, 2018 (Press release, Nektar Therapeutics, NOV 7, 2018, View Source [SID1234531174]).

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Cash and investments in marketable securities at September 30, 2018 were $2.0 billion as compared to $353.2 million at December 31, 2017.

"We have made tremendous progress advancing our portfolio of immuno-oncology, immunology and pain programs in 2018," said Howard W. Robin, President and CEO of Nektar. "We are implementing the broad joint development plan for NKTR-214 with partner Bristol-Myers Squibb across a range of tumor types, with the first Phase 3 trial in melanoma initiated in September and the next seven trials in renal cell carcinoma, urothelial cancer and non-small cell lung cancer starting over the next several months. In addition, our new collaboration with Pfizer underscores the promise of NKTR-214 as a backbone therapy in multiple cancer treatment regimens. NKTR-358 continues to advance with the ongoing clinical study in lupus patients and NKTR-181 is continuing through the NDA review process with the FDA. Finally, we are in an exceptionally strong financial position to execute on our strategy, ending the quarter with $2.0 billion in cash."

Revenue in the third quarter of 2018 was $27.8 million as compared to $152.9 million in the third quarter of 2017. Year-to-date revenue for 2018 was $1.2 billion as compared to $212.2 million in the first nine months of 2017 and included the recognition of $1.06 billion of license revenue from the Bristol-Myers Squibb collaboration agreement. Revenue in the third quarter of 2017 included recognition of $127.6 million of the $150.0 million upfront payment from Nektar’s collaboration with Eli Lilly & Company for the development and commercialization of NKTR-358.

Total operating costs and expenses in the third quarter of 2018 were $126.4 million as compared to $83.4 million in the third quarter of 2017. Year-to-date total operating costs and expenses in 2018 were $365.3 million as compared to $247.9 million for the same period in 2017. Total operating costs and expenses increased primarily as a result of increased research and development (R&D) expense.

Research and development expense in the third quarter of 2018 was $102.9 million as compared to $65.7 million in the third quarter of 2017. Year-to-date R&D expense for 2018 was $290.7 million as compared to $187.0 million for the same period in 2017. R&D expense was higher in the third quarter and first nine months as compared to the same periods in 2017 primarily because of expenses for our pipeline programs, including the continued development of NKTR-214 in Phase 1/2 studies and Phase 3 preparatory activities and related manufacturing costs, costs related to the NKTR-181 New Drug Application and NKTR-181 pre-commercial manufacturing, Phase 1 clinical studies of NKTR-358, the Phase 1 study of NKTR-262 in combination with NKTR-214 and IND-enabling activities for NKTR-255.

General and administrative (G&A) expense was $18.7 million in the third quarter of 2018 as compared to $12.1 million in the third quarter of 2017. G&A expense in the first nine months of 2018 was $57.7 million as compared to $40.0 million for the same period in 2017. G&A expense was higher in the third quarter and first nine months of 2018 as compared to the same periods in 2017 primarily due to an increase in non-cash stock based compensation expense.

Net loss in the third quarter of 2018 was $96.1 million or $0.56 basic and diluted loss per share as compared to net income of $60.9 million or $0.37 diluted earnings per share in the third quarter of 2017. Net income in the first nine months of 2018 was $779.5 million or $4.34 diluted earnings per share as compared to net loss of $62.9 million or $0.41 basic and diluted loss per share in the first nine months of 2017.

Third Quarter 2018 and Recent Business Highlights

·In November, Nektar entered into an oncology clinical collaboration with Pfizer Inc. to evaluate several combination regimens in multiple cancer settings including metastatic castration-resistant prostate cancer (mCRPC) and squamous cell carcinoma of the head and neck (SCCHN). Under the new collaboration, Pfizer will initiate a Phase 1b/2 clinical trial to evaluate the anti-cancer activity of the combined agents, avelumab, talazoparib and NKTR-214, as well as avelumab, enzalutamide and NKTR-214.

·In October, Nektar appointed Karin Eastham as an independent director to its Board of Directors. Ms. Eastham brings more than 35 years of experience as both an executive and independent director in the biotechnology industry, with particular expertise in finance and operations.

·In September, Nektar and Bristol-Myers Squibb initiated a Phase 3 study of NKTR-214 combined with nivolumab versus nivolumab in participants with previously untreated unresectable or metastatic melanoma.

·In July, the U.S. Food and Drug Administration accepted Nektar’s New Drug Application (NDA) for NKTR-181, a first-in-class opioid investigational drug candidate, to treat chronic low back pain in adult patients new to opioid therapy. The NDA has been assigned a PDUFA (Prescription Drug User Fee Act) target action date of May 29, 2019 by the FDA.

The Company also announced the following upcoming presentations through year-end 2018:

2018 Society for Immunotherapy and Cancer (SITC) (Free SITC Whitepaper) Annual Meeting, Washington D.C.:

· Oral Presentation: "Immune monitoring after NKTR-214 plus nivolumab (PIVOT-02) in previously untreated patients with metastatic Stage IV melanoma"
o Session: Cytokines Reinvented
o Presenter: Dr. Adi Diab, MD Anderson Cancer Center
o Date: Friday, November 9, 2018, 5:05 p.m. – 6:30 p.m. Eastern Standard Time

Poster Presentations:

Session: Combination Therapy

· Abstract #P348: "Survival and immune modulation in homologous recombination deficient murine ovarian tumors using the PARP inhibitor, rucaparib and immune agonist, NKTR-214", Charych, D., et al.
o Date: Friday, November 9th from 8 a.m. – 8 p.m. and Saturday, November 10th from 8 a.m. – 8:30 p.m. Eastern Standard Time

· Abstract #P364: "Systemic anti-tumor immunity and immune memory formation by a novel TLR7/8 targeting agent NKTR-262 combined with CD122-biased immunostimulatory cytokine NKTR-214", Kivimae, S., et al.
o Date: Friday, November 9th from 8 a.m. – 8 p.m. and Saturday, November 10th from 8 a.m. – 8:30 p.m. Eastern Standard Time

· Abstract #P368: "Combination of a Dipeptidyl Peptidase Inhibitor BXCL701 and Biased CD122 Agonist NKTR-214 with Anti-PD1 Provides Functional Immunological Memory through Inflammatory Cell Death", MacDougall, J., et al.
o Date: Friday, November 9th from 8 a.m. – 8 p.m. and Saturday, November 10th from 8 a.m. – 8:30 p.m. Eastern Standard Time

· Abstract #P378: "NKTR-214 (CD122-biased agonist) and NKTR-262 (TLR7/8 agonist) combination treatment pairs local innate immune activation with systemic CD8+ T cell expansion to enhance anti-tumor immunity", Rolig, A., et al.
oDate: Friday, November 9th from 8 a.m. – 8 p.m. and Saturday, November 10th from 8 a.m. – 8:30 p.m. Eastern Standard Time

Session: Cytokines in Anti-Tumor Immunity

·Abstract #P418: "Pre-clinical investigation of NKTR-255, a polymer-conjugated IL-15 with a potent NK cell dependent anti-tumor efficacy", Miyazaki, T., et al.
oDate: Friday, November 9th from 8 a.m. – 8 p.m. and Saturday, November 10th from 8 a.m. – 8:30 p.m. Eastern Standard Time

·Abstract #P419: "NKTR-214 in combination with radiation produces a potent in situ vaccine in the syngeneic B78 melanoma model", Sondel, P., et al.
oDate: Friday, November 9th from 8 a.m. – 8 p.m. and Saturday, November 10th from 8 a.m. – 8:30 p.m. Eastern Standard Time

·Abstract #P422: "A polymer-associated human IL-15 (NKTR-255) has optimized biological activity and unique mechanisms of action on CD8 T Cells and NK Cells", Robinson T., et al.
oDate: Friday, November 9th from 8 a.m. – 8 p.m. and Saturday, November 10th from 8 a.m. – 8:30 p.m. Eastern Standard Time

·Abstract #P424: "NKTR-214, an engineered IL-2, selectively depletes intratumoral Tregs and expands immunotherapy-induced effector T cell responses", Sharma, M., et al.
oDate: Friday, November 9th from 8 a.m. – 8 p.m. and Saturday, November 10th from 8 a.m. – 8:30 p.m. Eastern Standard Time

Session: Mechanisms of Resistance to Immunotherapy

·Abstract #P557: "Overcoming genetically-based resistance mechanisms to PD-1 blockade", Torrejon, D., et al.
oDate: Friday, November 9th from 8 a.m. – 8 p.m. and Saturday, November 10th from 8 a.m. – 8:30 p.m. Eastern Standard Time

2018 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, San Diego, CA;

·Publication #2952: "Pharmacokinetic and Pharmacodynamic Study of NKTR-255, a Polymer-Conjugated Human IL-15, in Cynomolgus Monkey", Miyazaki, T., et al.
oSession 625: Lymphoma: Pre-Clinical—Chemotherapy and Biologic Agents: Poster II
oDate: Sunday, December 2nd from 6:00 p.m. – 8:00 p.m. Pacific Time
oLocation: San Diego Convention Center, Hall GH

Conference Call to Discuss Third Quarter 2018 Financial Results

Nektar management will host a conference call to review the results beginning at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time today, Wednesday, November 7, 2018.

This press release and a live audio-only webcast of the conference call can be accessed through a link that is posted on the home page and Investors section of the Nektar website: View Source The web broadcast of the conference call will be available for replay through Monday, December 10, 2018.

To access the conference call, follow these instructions:

Dial: (877) 881-2183 (U.S.); (970) 315-0453 (international)

Passcode: 9395678 (Nektar Therapeutics is the host)

In the event that any non-GAAP financial measure is discussed on the conference call that is not described in the press release, or explained on the conference call, related information will be made available on the Investors page at the Nektar website as soon as practical after the conclusion of the conference call.