Exelixis has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Exelixis, 2017, NOV 1, 2017, View Source [SID1234521412]).

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On November 1, 2017 Intrexon Corporation (NYSE: XON), a leader in the engineering and industrialization of biology to improve the quality of life and health of the planet, reported it will release third quarter 2017 financial results after the market closes on Thursday, November 9th, 2017 (Press release, Intrexon, NOV 1, 2017, View Source [SID1234521389]). The Company will host a conference call that day at 5:30 PM ET to discuss the results and provide a general business update.

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The conference call may be accessed by dialing 1-888-317-6003 (Domestic US), 1-866-284-3684 (Canada), and 1-412-317-6061 (International) and providing the number 7741944 to join the Intrexon Corporation Call. Participants may also access the live webcast through Intrexon’s website in the Investors section at View Source

On November 1, 2017 Immune Design (Nasdaq:IMDZ), a clinical-stage immunotherapy company focused on oncology, reported financial results and a corporate update for the third quarter ended September 30, 2017 (Press release, Immune Design, NOV 1, 2017, View Source [SID1234521433]).

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“During the third quarter, we made significant progress on our strategy to bring a novel cancer vaccine to market. Our discussions with the FDA resulted in positive feedback on a Phase 3 trial design and approval criteria for CMB305 as a monotherapy for synovial sarcoma patients in the maintenance setting — a significant milestone for the company,” said Carlos Paya, M.D., Ph.D., President and Chief Executive Officer of Immune Design. “In addition, at ESMO (Free ESMO Whitepaper) we presented interim analysis data from our ongoing randomized Phase 2 study of CMB305 and atezolizumab showing that patients receiving the combination therapy experienced greater clinical benefit and immune response than those receiving atezolizumab alone.”

Recent Highlights

CMB305 Monotherapy: progressing to pivotal Phase 3 in synovial sarcoma patients
Based on productive discussions with the FDA, Immune Design announced plans to initiate a pivotal Phase 3 randomized trial to support a Biologics License Application for CMB305 in patients with synovial sarcoma.
The trial will compare CMB305 vs. placebo in NY-ESO-1+ locally advanced unresectable or metastatic synovial sarcoma patients without evidence of progression after first-line chemotherapy (“maintenance setting”).
Immune Design intends to start the study in mid-2018 and enroll 248 patients aged 12 and older.
Progression free survival (PFS) and overall survival will be co-primary endpoints.
PFS analysis may occur as early as 24 months from the first patient dosed, depending on the number of events.
CMB305 Combination Therapy (CMB305+Atezolizumab vs Atezolizumab) Randomized Phase 2 Trial: interim analysis presented at ESMO (Free ESMO Whitepaper) 2017 shows greater benefit in sarcoma patients receiving the combination
The interim analysis (n=36 patients) data showed that NY-ESO-1+ synovial sarcoma or mixoid round cell liposarcoma patients receiving the combination of CMB305 and Genentech’s checkpoint inhibitor, Tecentriq (atezolizumab) experienced greater clinical benefit, in the form of Disease Control Rate (including partial responses), median Progression Free Survival and Time to Next Treatment, as well as immune response, than those receiving atezolizumab alone.
In the full study population (n=88), the trend of greater clinical benefit on the combination arm remains consistent.
G100 +/- pembrolizumab data in follicular NHL patients to be presented at ASH (Free ASH Whitepaper); receipt of EMA Orphan Drug designation
The American Society of Hematology (ASH) (Free ASH Whitepaper) has accepted an Immune Design presentation for its Annual Meeting in December 2017.
Data from a randomized, 26-patient, Phase 2 study evaluating G100, the novel, synthetic TLR4 agonist injected intratumorally, and low-dose radiation (XRT), versus G100 and XRT with the systemic administration of Merck’s anti-PD-1 antibody, Keytruda (pembrolizumab) will be presented.
The data in the submitted abstract show:
a 31% ORR for patients receiving G100+XRT+pembrolizumab (G+P), as compared to a 15% ORR for patients receiving G100+XRT (G); and
shrinkage of untreated (abscopal) tumors in 62% of patients receiving G+P and 46% of patients receiving G.
These abstract data are earlier (June 2017) than the data that will be presented in the planned presentation. The updated data appear to demonstrate a stronger clinical response and biomarker profile for those patients receiving G100, XRT and pembrolizumab, as compared to those patients receiving G100 and XRT alone.
G100 received Orphan Drug Designation for the treatment of follicular non-Hodgkin’s lymphoma from the EMA in October 2017.
Additional Upcoming Presentations

The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) has accepted five Immune Design abstracts for presentation at its 32nd Annual Meeting, November 8-12, 2017 in National Harbor, Maryland. The oral and poster presentations are as follows:

Novel Biomarkers in Next-generation Cancer Vaccines: Public NY-ESO-1 specific TCRs as novel biomarkers for immune monitoring of NY-ESO-1 positive cancer patients
Combination Therapy (Cancer Vaccine + Intratumoral Immunization): G100 and ZVex-based combination immunotherapy induces near complete regression of established glioma tumors in mice
Multi-Target Cancer Vaccines: Transduction of MAGE-A1, A3, A4, A10 and IL-12 by ZVex, a dendritic cell targeting platform induces robust multi-antigen T-cell immune responses without antigenic interference or immunodominance
Next-Generation Intratumoral Vaccination Using ZVex: Intratumoral expression of IL12 using the ZVex dendritic cell-targeting lentiviral vector exerts potent anti-tumor effects via induction of multiple immune effectors, including CD8 T cell responses
Anti-NY-ESO-1 Immune Response and Survival Benefit After LV305 Therapy in Patients With Advanced Sarcoma and Other Solid Tumors
In addition to an investigator-sponsored presentation, at the Connective Tissue Oncology Society (CTOS) Annual Meeting being held in Maui from November 8-11, Immune Design will be presenting data from the ASCO (Free ASCO Whitepaper) annual meeting in two presentations:

A Phase 2 Study of CMB305 and Atezolizumab in NY-ESO-1+ Soft Tissue Sarcoma: Interim Analysis of Immunogenicity, tumor control and survival.
Association of NY-ESO-1 Expression with Baseline Immunity and Clinical Outcomes in Soft Tissue Sarcoma Patients Treated with LV305 or CMB305.
Completion of Follow-On Financing

On October 27, 2017, Immune Design completed an underwritten follow-on public offering, which resulted in the sale of 22,425,000 shares of common stock, inclusive of the full exercise by the underwriters of the 30-day option to purchase 2,925,000 additional shares, at a public offering price of $4.10 per share. Estimated net proceeds from the offering were $86.6 million after deducting underwriting discounts and commissions and estimated offering expenses of $5.4 million. Both new and existing investors participated in the offering.

Financial Results

Third Quarter

Immune Design ended the third quarter of 2017 with $67.5 million in cash, cash equivalents, short-term investments and other receivables, compared to $110.4 million as of December 31, 2016. Net cash used in operations for the nine months ended September 30, 2017 was $43.2 million.

Net loss and net loss per share for the third quarter of 2017 were $13.4 million and $0.52, respectively, compared to $12.4 million and $0.60, respectively, for the third quarter of 2016.

Revenue for the third quarter of 2017 was $0.5 million and was primarily attributable to collaboration revenue associated with the Sanofi G103 HSV therapeutic vaccine product collaboration. Revenue for the third quarter of 2016 was $8.2 million and was primarily attributable to $7.0 million in license revenue, $0.4 million in product sales associated with Immune Design’s collaboration partner Sanofi and $0.8 million in collaboration revenue associated with the Sanofi G103 product collaboration.

Research and development expenses for the third quarter of 2017 were $10.2 million compared to $11.2 million for the same period in 2016. The $1.0 million decrease was primarily attributable to a decrease in in-licensing royalties and fees to other third parties that the company licenses various technologies from and a decrease in contract manufacturing activities primarily driven by the timing of when services are performed. These decreases were offset by an increase in personnel-related expenses and facility costs to support the company’s advancing research and clinical pipeline.

General and administrative expenses for the third quarter of 2017 were $3.9 million compared to $9.6 million for the same period in 2016. The $5.7 million decrease was primarily attributable to the settlement and license agreements with TheraVectys SA (TVS) involving the acquisition of certain present and future intellectual property rights from TVS and resolving the litigation initiated by TVS in July 2014 against the company, as well as related claims and counterclaims.
Year-to-Date

Net loss and net loss per share for the nine months ended September 30, 2017 were $39.9 million and $1.56, respectively, compared to $39.1 million and $1.92, respectively, for the same period in 2016.

Revenue for the nine months ended September 30, 2017 was $6.7 million and was primarily attributable to $6.4 million in collaboration revenue associated with the Sanofi G103 product collaboration and $0.3 million in product sales to other third parties. Revenue for the same period in 2016 was $11.2 million and was primarily attributable to $7.0 million in license revenue, $1.2 million in product sales associated with Immune Design’s collaboration partner Sanofi and $3.0 million in collaboration revenue associated with the Sanofi G103 product collaboration.

Research and development expenses for the nine months ended September 30, 2017 were $35.1 million compared to $33.1 million for the same period in 2016. The $2.0 million increase was primarily attributable to continued advancement of Immune Design’s ongoing research and development programs, including ongoing Phase 1 and Phase 2 clinical trials and an increase in personnel-related expenses to support the company’s advancing research and clinical pipeline.

General and administrative expenses for the nine months ended September 30, 2017 were $11.9 million compared to $17.4 million for the same period in 2016. The $5.5 million decrease was primarily attributable to the settlement and license agreements with TVS involving the acquisition of certain present and future intellectual property rights from TVS and resolving the litigation initiated by TVS in July 2014 against the company, as well as related claims and counterclaims.
Cash Guidance

Based on current expectations following Immune Design’s recent follow-on offering, the company expects to have cash to fund operations into 2020.

Conference Call Information

Immune Design will host a conference call and live audio webcast this afternoon at 1:30 p.m. Pacific time / 4:30 p.m. Eastern time to discuss the third quarter 2017 financial results and provide a corporate update.

The live call may be accessed by dialing 844-266-9538 for domestic callers and 216-562-0391 for international callers. A live webcast of the call will be available online from the investor relations section of the company website at View Source A telephone replay of the call will be available for five days by dialing 855-859-2056 for domestic callers or 404-537-3406 for international callers and entering the conference code:4793869

An archived copy of the webcast will be available on Immune Design’s website beginning approximately two hours after the conference call. Immune Design will maintain an archived replay of the webcast on its website for at least 30 days after the conference call.

On November 1, 2017 Inovio Pharmaceuticals, Inc. (NASDAQ:INO) reported initiated a phase 1b/2a immuno-oncology trial in patients with newly diagnosed glioblastoma (GBM) designed to evaluate cemiplimab (also known as REGN2810), a PD-1 inhibitor developed by Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN), in combination with Inovio’s INO-5401 T cell activating immunotherapy encoding multiple antigens and INO-9012, an immune activator encoding IL-12 (Press release, Inovio, NOV 1, 2017, View Source [SID1234521388]).

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The open-label trial of 50 patients will be conducted at approximately 30 U.S. sites, and the primary endpoints are safety and tolerability. The study will also evaluate immunological impact, progression-free survival and overall survival.

GBM is a devastating disease for both patients and caregivers. It is the most aggressive brain cancer and its prognosis is extremely poor, despite a limited number of new therapies approved over the last 10 years. The median overall survival for patients receiving standard of care therapy is approximately 15 months and the average five-year survival rate is less than three percent.

Dr. J. Joseph Kim, Inovio’s President and Chief Executive Officer, said, “Inovio is successfully executing on its immuno-oncology strategy through both combination and in monotherapy trials. Our clinical partnerships and collaborations with MedImmune, Genentech and Regeneron each provide for clinical evaluation of Inovio immunotherapies combined with checkpoint inhibitors, given a strong scientific rationale to combine an immunotherapy, which generates antigen-specific killer T cells, with a checkpoint inhibitor which augments T cell activity. I believe that INO-5401, a three antigen product targeting WT-1, PSMA and hTERT, offers great potential to address multiple cancers. Our INO-5401 combination study in GBM, as well as its sister study in advanced bladder cancer, represents an important opportunity for Inovio and its collaborators to address significant unmet medical need.”

Under a May 2017 agreement between Inovio and Regeneron, the combination trial will be solely conducted and funded by Inovio, based upon a mutually agreed upon trial design, and Regeneron will supply cemiplimab. Inovio and Regeneron will jointly conduct immunological analyses in support of the study. Regeneron, as part of their immuno-oncology collaboration with Sanofi, is developing cemiplimab both as a monotherapy and in combination with other therapies for the treatment of various cancers.

On November 1, 2017 Cellectis (Alternext: ALCLS – Nasdaq: CLLS), a clinical-stage biopharmaceutical company focused on developing immunotherapies based on gene-edited allogeneic CAR T-cells (UCART), reported that abstracts regarding the Company’s allogeneic, off-the-shelf, CAR T product candidates have been accepted for presentation at the 59th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (Press release, Cellectis, NOV 1, 2017, View Source [SID1234521419]). The meeting will be held from December 9 to 12, 2017 in Atlanta, GA.

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Oral presentations:

UCARTCS1 product candidate targeting Multiple Myeloma
502. Universal SLAMF7-Specific CAR T-Cells As Treatment for Multiple Myeloma

Abstract: View Source

Session Name: 652. Myeloma: Pathophysiology and Pre-Clinical Studies, excluding Therapy: Novel Immunotherapeutic Strategies in Multiple Myeloma Session

Sunday, December 10, 2017 at 5:15 PM

Location: Bldg B, Lvl 3, B308-B309 (Georgia World Congress Center)

Rohit Mathur1, Zheng Zhang1, Jin He1, Roman Galetto2, Agnès Gouble2, Isabelle Chion-Sotinel2, Stéphanie Filipe2, Annabelle Gariboldi2, Tanooha Veeramachaneni1, Elisabet E. Manasanch1, Sheeba K. Thomas1, Hans C. Lee1, Krina K. Patel1, Donna M. Weber1, R. Eric Davis1, Robert Z. Orlowski1, Julianne Smith3, Jing Yang1, and Sattva S. Neelapu1

1Department of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd., Houston, TX 77030, USA

2Cellectis SA, 8 rue de la croix Jarry, 75013 Paris, France

3Cellectis Inc, 430 East 29th Street, 10016 New York, NY, USA



UCART22 product candidate targeting B-Acute Lymphoblastic Leukemia
808. Pre-clinical Activity of Allogeneic Anti-CD22 CAR T-Cells for the Treatment of B-cell Acute Lymphoblastic Leukemia

Abstract: View Source

Session Name: 614. Acute Lymphoblastic Leukemia: Therapy, excluding Transplantation: CAR-T Cell Immunotherapy

Monday, December 11, 2017: 5:15 PM

Location: Bldg C, Lvl 1, Hall C4 (Georgia World Congress Center)



Julia Wells PhD1, Tianyu Cai, PhD1, Cécile Schiffer-Manniou PhD2, Stéphanie Filipe, PhD2, Agnès Gouble, PhD2, Roman Galetto, PhD2, Nitin Jain MD1, Elias Jabbour MD1, Julianne SmithPhD3 and Marina Konopleva, MD, PhD1

1Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX

2Cellectis SA, Paris, France

3Cellectis Inc, New York, NY

Poster Presentation:

UCART123 product candidate targeting Blastic Plasmacytoid Dendritic Cell Neoplasm
2625. Pre-Clinical Studies of Allogeneic Anti-CD123 CAR T-Cells for the Therapy of Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

Abstract: View Source

Session Name: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Poster II

Sunday, December 10, 2017 from 6:00 PM to 8:00 PM

Location: Bldg A, Lvl 1, Hall A2 (Georgia World Congress Center)

Tianyu Cai1, Roman Galetto2, Agnès Gouble2, Julianne Smith3, Antonio Cavazos1, Lina Han1, Qi Zhang1, Vinitha Kuruvilla1, Sergej Konoplev4, Sattva S. Neelapu5, Andrew A. Lane6, Monica Guzman7, Hagop Kantarjian1, Naveen Pemmaraju1, Marina Konopleva1

1Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX

2Cellectis SA, Paris, France

3Cellectis Inc, New York, NY

4Department of Hematopathology, The University of MD Anderson Cancer Center, Houston, TX

5Department of Lymphoma and Myeloma, The University of MD Anderson Cancer Center, Houston, TX

6Dana-Farber Cancer Institute, Boston

7Department of Medicine, Weill Cornell Medical College, New York, NY