On August 9, 2016 Genmab reported its Interim Report for First Half 2016 (Press release, Genmab, AUG 9, 2016, View Source [SID:1234514420]).

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Net Sales of DARZALEX (daratumumab) by Janssen for the first half of 2016 were USD 209 million, resulting in royalty income of USD 25 million (DKK 168 million)
2016 financial guidance improved
Announced European conditional marketing authorization of DARZALEX for heavily pre-treated or double-refractory multiple myeloma
Achieved USD 30 million milestone for first commercial sale of DARZALEX in Europe
Announced positive topline result in Phase III POLLUX study of daratumumab in relapsed or refractory multiple myeloma
Announced that U.S. Food and Drug Administration (FDA) granted priority review to sBLA for ofatumumab (Arzerra) in combination with fludarabine and cyclophosphamide (FC) in relapsed chronic lymphocytic leukemia (CLL)
Announced that the Committee for Medicinal Products for Human Use (CHMP) issued a negative opinion for Arzerra as maintenance therapy in relapsed CLL
Announced Phase III studies of ofatumumab in relapsing multiple sclerosis
"The two major highlights during the second quarter were the rapid European approval of DARZALEX and positive Phase III data from the POLLUX study. DARZALEX was successfully launched by our collaboration partner Janssen shortly after the approval, triggering a milestone payment of USD 30 million to Genmab. We were also very excited about the Phase III POLLUX study data which showed that daratumumab in combination with lenalidomide and dexamethasone led to a significant improvement in progression free survival in treatment of relapsed or refractory multiple myeloma," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
Financial Performance First Half
Revenue was DKK 524 million in the first half of 2016 compared to DKK 281 million in the first half of 2015. The increase of DKK 243 million, or 86%, was mainly driven by higher royalty and milestone revenue under our daratumumab collaboration with Janssen.
Operating expenses were DKK 366 million in the first half of 2016 compared to DKK 244 million in the first half of 2015. The increase of DKK 122 million, or 50%, was due to the additional investment in our pipeline of products, including the advancement of tisotumab vedotin, HuMax-AXL-ADC, HexaBody-DR5/DR5, DuoBody-CD3xCD20, and our other pre-clinical programs.
Operating income was DKK 158 million in the first half of 2016 compared to DKK 212 million in the first half of 2015. The decrease of DKK 54 million, or 25%, was driven by the one-time reversal of the ofatumumab funding liability of DKK 176 million in 2015 combined with increased operating expenses in 2016, which were partly offset by higher revenue in 2016.
On June 30, 2016, Genmab had a cash position of DKK 3,762 million compared to DKK 3,493 million at December 31, 2015. This represented a net increase of DKK 269 million, which was driven primarily by income from operations and the proceeds from the exercise of warrants for DKK 82 million.
Business Progress Second Quarter

Daratumumab
May: Achieved a USD 30 million milestone triggered by the first commercial sale of DARZALEX in Europe.
May: Announced that the European Commission (EC) granted a conditional marketing authorization for DARZALEX for heavily pre-treated or double-refractory multiple myeloma. The approval followed a positive recommendation for DARZALEX from the CHMP of the European Medicines Agency (EMA) in April.

May: Announced that the Phase III POLLUX study (MMY3003) of daratumumab in combination with lenalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma met the primary endpoint at a pre-planned interim analysis (Hazard Ratio (HR) = 0.37 (95% CI 0.27-0.52), p<0.0001). Patients who received treatment with daratumumab in combination with lenalidomide and dexamethasone had a 63% reduction in risk of their disease progressing, compared to those who did not receive daratumumab. The median progression free survival (PFS) for patients treated with daratumumab in combination with lenalidomide and dexamethasone has not been reached, compared to an estimated median PFS of 18.4 months for patients who received lenalidomide and dexamethasone alone. Janssen will engage in a dialogue with health authorities about the potential for a regulatory submission for this indication.

April: Reported more detailed data from the Phase III CASTOR (MMY3004) study of daratumumab in combination with bortezomib and dexamethasone versus bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma. The study met the primary endpoint of improving PFS; HR = 0.39, p<0.0001. The median PFS for patients treated with daratumumab has not been reached, compared to median PFS of 7.2 months for patients who did not receive daratumumab.

April: Announced that MorphoSys filed a complaint at the U.S. District Court of Delaware against Genmab and Janssen Biotech, Inc. (Janssen), for patent infringement under U.S. patent no. 8,263,746 based on activities relating to the manufacture, use and sale of DARZALEX in the United States. Genmab and Janssen disagree with the allegations made by MorphoSys in its complaint for patent infringement and intend to vigorously contest those allegations.

Ofatumumab
June: Announced that the CHMP of the EMA issued a negative opinion on the use of Arzerra as maintenance therapy for patients with relapsed CLL.

June: Announced that Novartis will start Phase III studies of the subcutaneous formulation of ofatumumab in relapsing multiple sclerosis (MS) with enrollment of patients to start in September 2016.

May: Announced that the U.S. FDA granted Priority Review to the supplemental Biologics License Application (sBLA) for the use of ofatumumab in combination with FC for the treatment of patients with relapsed CLL.

Subsequent Event
July: The U.S. FDA granted Breakthrough Therapy Designation for DARZALEX injection in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. Breakthrough Therapy Designation is a program intended to expedite the development and review of drugs to treat serious or life-threatening diseases in cases where preliminary clinical evidence shows that the drug may provide substantial improvements over available therapy.

On August 9, 2016 ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP) reported financial results for the second quarter ended June 30, 2016, and provided an update on the Company’s recent activities (Press release, Ziopharm, AUG 9, 2016, View Source [SID:1234514473]).

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"ZIOPHARM had a very productive first half, with the achievement of pipeline and corporate milestones across the breath of our portfolio and the advancement of our goal to position the company at the forefront of those harnessing the immune system to target cancer," said Laurence Cooper, M.D., Ph.D., Chief Executive Officer of ZIOPHARM Oncology. "Central to this effort, we were pleased to have amended the terms of our collaboration with Intrexon to facilitate the commercialization of our immunotherapy assets. The benefit of this new structure is expected to be first realized with our gene therapy Ad-RTS-hIL-12 + veledimex program, which remains on track to move into a registrational trial in advanced glioblastoma in 2017."

Dr. Cooper added: "As we progress through the remainder of 2016, we will continue to work with our collaborators, including Intrexon Corporation and the MD Anderson Cancer Center, to advance new therapies into the clinic. We look forward in 2016 to seeing six clinical trials exploring immuno-oncology approaches and combinations, in addition to preclinical projects advancing towards the clinic. As these programs mature, we expect to see proof-of-concept clinical data that will drive value for all of our stakeholders."

Corporate and Program Updates

Corporate

Amended Exclusive Channel Collaborations with Intrexon to Improve Alignment as Programs Advance through Development. In June, ZIOPHARM and Intrexon Corporation (NYSE:XON) announced amendments to their Exclusive Channel Collaborations (ECCs) in the fields of oncology and graft-versus-host-disease (GvHD) to improve alignment between both companies as ZIOPHARM broadens its pipeline and advances multiple therapeutic programs in the clinic.

Under the terms of the amendments:

Operating profit rates payable to Intrexon from ZIOPHARM on products developed under its two existing collaborations will be reduced from 50% to 20%. This reduction will not apply to royalties or other payments made with respect to the companies’ existing collaboration with Merck Serono, the biopharmaceutical business of Merck KGaA;

Economics from any future sublicensing arrangements with potential third party collaborators will remain evenly split.
In consideration of the amendments, ZIOPHARM has issued shares of a new class of preferred stock that carries an initial stated value of $120 million and a monthly dividend of 1%, payable in additional preferred shares. Only upon the first approval of a product in the United States or upon certain fundamental transactions, such as a change of control of ZIOPHARM, the preferred shares issued to Intrexon will be converted into ZIOPHARM common stock equal to the aggregate stated value divided by the volume weighted average closing price of ZIOPHARM’s common stock over the 20 trading days ending on the date that the product approval or such transaction is announced.

Gene Therapies

Ad-RTS-hIL-12 + veledimex is a gene therapy candidate for the controlled expression of interleukin 12 (IL-12), a critical protein for stimulating an anti-cancer immune response, using the RheoSwitch Therapeutic System (RTS) gene switch. ZIOPHARM is currently enrolling patients in two studies of Ad-RTS-hIL-12 + veledimex: a multi-center Phase 1 study in patients with recurrent or progressive glioblastoma multiforme (GBM), an aggressive form of brain cancer, and a Phase 1b/2 study for the treatment of patients with locally advanced or metastatic breast cancer following standard chemotherapy.

Presented Clinical Data Highlighting Favorable Interim Survival Results in Phase 1 Study of Ad-RTS-hIL-12 + Veledimex in Brain Cancer. ZIOPHARM presented data from its Phase 1, multi-center dose-escalation study of patients with recurrent high-grade gliomas at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting held June 3-7, 2016 in Chicago and updated at an American Society of Hematology (ASH) (Free ASH Whitepaper) Workshop on Genome Editing in Washington D.C. on July 14, 2016. These data demonstrate promising early activity in this medically fragile patient population, with a median overall survival that has not been reached with 11 of 14 patients alive and in follow up, and a median follow up of 8 months with 6 patients out of 7 patients alive in the study’s first dose cohort (20mg veledimex). The study also showed that IL-12 in the bloodstream was found to be proportional to the amount of veledimex administered, demonstrating that this orally-delivered activator crossed the blood brain barrier to activate the IL-12 gene programming deposited in the tumor and turned on the RheoSwitch technology in a dose-dependent manner. In June, ZIOPHARM announced the successful completion of enrollment in the first and second dosing cohorts (40mg veledimex) of the study, as well as the initiation of enrollment in a third cohort (30mg veledimex).

Preclinical Studies Combining Ad-RTS-IL-12 + Veledimex and Immune Checkpoint Inhibitors in Brain Tumor Models Presented at ASGCT (Free ASGCT Whitepaper), Combination Study Expected to Initiate in 2016. In an oral presentation, ZIOPHARM presented data from preclinical studies of Ad-RTS-IL-12 + veledimex combined with immune checkpoint inhibitors (iCPI) in glioblastoma (GBM) mouse models at the 2016 Meeting of the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper), which took place May 4-7, 2016 in Washington, D.C. Results demonstrated that survival of mice treated with Ad-RTS-IL-12 + veledimex and anti-PD-1 therapy was superior to either treatment alone, with a combination showing 100% survival. Because Ad-RTS-IL-12 and anti-PD-1 are clinically available, these data provide impetus for evaluating this combination immunotherapy in humans. ZIOPHARM plans to initiate a combination study in 2016.
Adoptive Cell Therapies

ZIOPHARM is developing various immuno-oncology programs, including chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR), and natural killer (NK) adoptive cell-based therapies. These programs are being advanced in collaboration with Intrexon, MD Anderson Cancer Center, and Merck Serono (CAR-T only).

Announced Plans for Phase I Clinical Trial with CD33 CAR-T Cell Therapy. In July, ZIOPHARM announced plans for a Phase I adoptive cellular therapy clinical trial utilizing autologous T cells transduced with lentivirus to express a CD33-specific chimeric antigen receptor (CAR) in patients with relapsed or refractory acute myeloid leukemia (AML). The trial is based on preclinical studies, including in vitro data demonstrating that lentiviral-transduced CAR-T cells targeting CD33 exhibit specific killing activity for CD33+ AML cells and a proof-of-concept study utilizing an in vivo mouse model for AML, which showed that these CAR-T cells were able to eliminate disease and significantly enhance survival as compared to control groups. These positive preclinical results indicate biological activity and are suggestive of potential therapeutic effect for the treatment of AML.

Announced Publication of First-In-Human Trials using Non-Viral Sleeping Beauty System to Express CD19-Specific CAR in T cells in Journal of Clinical Investigation. In August, ZIOPHARM announced the publication of data highlighting the benefits of using the non-viral Sleeping Beauty (SB) system to genetically modify T cells to express a chimeric antigen receptor (CAR) for use against leukemias and lymphomas. The article, titled "Phase I trials using Sleeping Beauty to generate CD19-specific CAR T cells," was published in the Journal of Clinical Investigation (doi:10.1172/JCI86721), and is available online here.
The paper describes results for 26 patients with multiply relapsed B-lineage acute lymphoblastic leukemia (ALL, n=17) or B-cell non-Hodgkin lymphoma, (NHL, n=9) who were enrolled in two investigator-initiated clinical trials at the University of Texas MD Anderson Cancer Center infused with SB-modified T cells after autologous (n=7) or allogeneic (n=19) hematopoietic stem-cell transplantation (HSCT). Although the primary objective of these trials was not to establish efficacy, the recipients’ outcomes are encouraging, with apparent doubling of survivals compared to historical controls which is attributed to the persistence of the infused T cells. Additionally, by infusing a CD19-specific CAR T cells to target minimal residual disease after autologous and allogeneic HSCT, the approach may improve tolerability by avoiding cytokine storm.

Milestones

ZIOPHARM achieved and expects the following milestones to occur in 2016:

Intra-tumoral IL-12 RheoSwitch programs:
Clinical update presented from the Company’s Phase 1 study of GBM at the Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)
Update on Phase 1/2 study in Breast Cancer with standard of care presented at ASCO (Free ASCO Whitepaper)
Pre-clinical data presented at the American Society of Cell and Gene Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting for combining with checkpoint inhibitor therapy (anti PD-1)
Initiate combination study of Ad-RTS-hIL-12 with anti PD-1
CAR+ T programs:
Continuation of second generation CD19 CAR+ T clinical study
Initiate a CAR+ T clinical study for CD33
Preclinical data presented at ASGCT (Free ASGCT Whitepaper) for shortening the time of ex vivo manufacture of SB-modified T cells
Initiate CAR+ T-cell preclinical studies for other hematological malignancies and solid tumors
TCR-T programs
Initiate TCR-modified T-cell preclinical studies
NK cell programs
Initiate a Phase 1 study of off-the-shelf NK cells for AML
GvHD programs
Initiate preclinical studies
Pediatric programs
Pre-clinical data to be presented in the fall with intra-tumoral IL-12 under RheoSwitch control for brain tumor
The Company is also evaluating additional potential preclinical candidates and continuing discovery efforts aimed at identifying other potential product candidates under its Exclusive Channel Agreement with Intrexon. In addition, the Company may seek to enhance its pipeline in immuno-oncology through focused strategic transactions, which may include acquisitions, partnerships and in-licensing activities.

On August 9, 2016 Vical Incorporated (Nasdaq:VICL) reported financial results for the three and six months ended June 30, 2016 (Press release, Vical, AUG 9, 2016, View Source [SID:1234514566]). Net loss for the second quarter of 2016 was $1.3 million, or $0.14 per share, compared with a net loss of $2.8 million, or $0.30 per share, for the second quarter of 2015. Revenues for the second quarter of 2016 were $4.1 million, compared with revenues of $4.2 million for the second quarter of 2015, reflecting revenues from Astellas Pharma Inc. for manufacturing services performed under the ASP0113 collaborative agreements. ASP0113 is Vical’s therapeutic vaccine designed to prevent cytomegalovirus (CMV) disease and associated complications in transplant recipients.

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Vical had cash and investments of $38.5 million at June 30, 2016. This cash balance does not include the $7.8 million in proceeds received from the Company’s recently completed private placement. The Company’s net cash use for the first six months of 2016 was $3.5 million, which was consistent with the Company’s guidance for the full year. The Company is projecting net cash burn for 2016 between $8 million and $11 million, which includes the cash burn associated with the planned initiation of the HSV-2 Phase 2 clinical program later this year.

Operational updates include:

ASP0113 CMV Vaccine

Recruitment in the multinational Phase 3 registration trial in 500 hematopoietic cell transplant (HCT) recipients is nearing completion with over 90% of the subjects enrolled. Astellas expects enrollment to be completed during the third quarter of 2016, with the top-line data expected to be available in the fourth quarter of 2017. The primary endpoint of this trial is a composite of overall mortality and CMV end organ disease. Vical and Astellas have made substantial progress in process validation activities for the manufacture of the bulk drug product in anticipation of a potential BLA filing in 2018.

One year follow up in the multinational Phase 2 trial in kidney transplant recipients is now complete. Astellas is completing the final verification of all outstanding data and expects to release the top-line trial results during the third quarter of 2016. The primary endpoint of this trial is the incidence of CMV viremia and the study is powered to show an approximately 50% reduction in CMV viremia at 1 year after transplantation. The study also includes a key clinically relevant secondary endpoint, incidence of CMV disease.
HSV-2 Therapeutic Vaccine

Vical plans to initiate a Phase 2 trial of its bivalent HSV-2 therapeutic vaccine during the second half of 2016. The randomized, double-blind, placebo-controlled trial will evaluate the safety and efficacy of the vaccine in approximately 225 otherwise healthy adults aged 18 to 50 years with symptomatic genital HSV-2 infection. Vical is confirming with the FDA the Phase 2 trial design, which is intended to evaluate the vaccine’s efficacy using clinical relevant endpoints rather than virologic endpoints.
VL-2397 Antifungal

Enrollment is ongoing in Vical’s first-in-human Phase 1 trial of its novel antifungal, VL-2397. The randomized, double-blind, placebo-controlled trial is intended to evaluate safety, tolerability and pharmacokinetics of single and multiple ascending doses of VL-2397 in healthy volunteers. The trial is expected to be completed by the end of 2016. Vical is working closely with its expert advisors and the FDA to design a Phase 2 efficacy study for VL-2397 in the treatment of patients with invasive aspergillosis. This fungal infection is associated with a high rate of mortality in immunocompromised patients, and represents a sizeable unmet medical need for new antifungal therapies.
Equity Investment by AnGes

On August 1, 2016, Vical announced an agreement by AnGes, MG, a partner and shareholder in Vical since 2006, to purchase approximately $7.8 million of Vical’s common stock in a private placement. The shares were sold at a price of $4.24 per share, the 90-day volume weighted average price of Vical’s common stock and a premium to the close on the prior trading day. With the new investment, AnGes’ equity position increased to approximately 18.6% of Vical’s outstanding shares. The transaction further strengthens Vical’s relationship with AnGes, which has a strategic interest in DNA vaccines, including one in its own pipeline, and which has demonstrated an appreciation for Vical’s DNA technology, and clinical, regulatory, and manufacturing expertise over the years.

On August 9, 2016 Immune Design (Nasdaq:IMDZ), a clinical-stage immunotherapy company focused on oncology, reported financial results and a corporate update for the second quarter ended June 30, 2016 (Press release, Immune Design, AUG 9, 2016, View Source [SID:1234514421]).

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"The positive data we presented during the second quarter provide a strong rationale for the continued advancement of our two lead programs, CMB305 and G100," said Carlos Paya, M.D., Ph.D., President and Chief Executive Officer of Immune Design. "These two programs offer distinct approaches that use the patient’s immune system to fight cancer, and which are different from previous efforts in this field."

Recent Highlights

Product Development Progress

Specific Antigen Approach: LV305/CMB305 and ZVex-Neo Programs

LV305/CMB305: Positive data in NY-ESO-1 Soft Tissue Sarcoma (STS) patients, Phase 2 combination study in collaboration with Genentech ongoing.

LV305: Positive PFS and OS data in STS
Data from the single agent Phase 1 study in 24 patients with advanced or metastatic soft tissue sarcoma, which were presented at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, revealed:
clinical benefit for 58% of the patients in the form of partial response (PR) or stable disease (SD);
median progression-free survival (PFS) of 4.6 months and a median overall survival (OS) that had not yet been reached, with 81% of the patients alive at one year; and
very favorable safety profile, with no Grade 3/4 adverse events (AEs)
We believe these data compare favorably with approved STS agents and further support the applicability of the mechanism of action of the Prime/Boost agent, CMB305, in STS, and as a potential first registration path for an Immune Design product.
CMB305: (1) positive STS signal in early look; and (2) randomized Phase 2 combination study with Genentech’s anti-PDL1 antibody, TECENTRIQ (atezolizumab) ongoing in STS

Early data from the single agent Phase 1 study in 14 patients with STS showed
the median OS had not been reached, with 93% of the patients alive at one year, and the median PFS was 5.5 months, both of which we believe compare favorably to approved chemotherapy agents for STS patients who have received at least one or more prior therapies;
a favorable safety profile, with only Grade 1/2 AEs; and
a deeper immune response than seen in the LV305 Phase 1 study, including a trend of increased T cell clonality.
A randomized 80-patient Phase 2 study of CMB305 with or without the anti-PD-L1 checkpoint inhibitor, atezolizumab, is ongoing in patients with STS
Part 1 of the study included a safety run in, which was deemed favorable by an independent Data Monitoring Committee, allowing enrollment in part 2 of the study to commence.
ZVex-Neo: Neoantigen Collaboration with Gritstone Oncology
In May 2016, Immune Design announced a collaboration with Gritstone Oncology to combine Immune Design’s ZVex discovery platform with Gritstone’s proprietary genomics and proteomics platform for identification of patient-specific tumor antigens to develop neoantigen-based immunotherapies. The collaboration has commenced, with the intent to begin a study in patients with non-small cell lung cancer in 2017 in combination with a checkpoint inhibitor of the PD-1/PD-L1 axis.
Intratumoral Immune Activation Approach: Positive Clinical and Translational Data

G100: (1) positive final Phase 1 results in Merkel cell carcinoma (MCC); and (2) randomized Phase 2 combination with KEYTRUDA (pembrolizumab) in follicular non-Hodgkin’s lymphoma (NHL) in collaboration with Merck is ongoing
The final results of a 10-patient Phase 1 study of G100 administered intratumorally and combined with radiation in patients with MCC, which were presented at the ASCO (Free ASCO Whitepaper) annual meeting, revealed:
a 50% overall response rate (ORR) per protocol, including one of the complete responses (CR) resulting from single agent G100 alone (no radiation);
no treatment-related AEs were observed, and all AEs were grade 1/2; and
analysis of the tumor microenvironment (TME) in G100-responding patients demonstrated the increase of innate immune molecules that favor (i) immune cell chemotaxis, (ii) increased NK cells and M1 macrophage markers, and (iii) dendritic cell antigen presentation and dynamics of adaptive immunity such as trafficking of CD8 and CD4 T cells from the stroma into the tumor bed, underscoring the transition to a "hot" tumor.
A randomized Phase 2 study of G100 with low dose radiation, with Merck’s checkpoint inhibitor KEYTRUDA (pembrolizumab) in NHL patients is ongoing.
Part 1 (dose escalation of G100 without Keytruda) was deemed safe, allowing the move to Part 2 of the study, in which patients are randomized to receive Keytruda in combination with G100 and radiation or G100 and radiation alone.
Expansion of the Team

Susan L. Kelley M.D. Joins Board of Directors: Addition of Oncology Development Expertise

Dr. Susan L. Kelley joined the Immune Design Board in June 2016, and brings more than 25 years’ experience in oncology and immunology drug development to the company.
Financial Results

Second Quarter

Immune Design ended the second quarter of 2016 with $92.6 million in cash, cash equivalents and short-term investments, compared to $112.9 million as of December 31, 2015. Net cash used in operations for the six months ended June 30, 2016 was $20.4 million.
Net loss and net loss per share for the second quarter of 2016 were $14.3 million and $0.71, respectively, compared to $10.5 million and $0.54, respectively, for the second quarter of 2015.
Revenue for the second quarter of 2016 was $1.1 million and was attributable primarily to the Sanofi G103 (HSV2 therapeutic vaccine) collaboration established in the fourth quarter of 2014 and GLA product sales to collaboration partners Medimmune/Astra Zeneca and Sanofi. Revenue for the second quarter of 2015 was $1.8 million and was attributable primarily to collaboration revenue associated with Sanofi G103 collaboration.
Research and development expenses for the second quarter of 2016 were $11.4 million, compared to $8.5 million for the second quarter of 2015. The $2.9 million increase was primarily attributable to continuing advancement of Immune Design’s ongoing research and development programs, including ongoing Phase 1 and Phase 2 clinical trials.
General and administrative expenses did not materially differ over the comparative periods. For the second quarter of 2016 general and administrative expenses were $3.9 million, compared to $3.8 million for the second quarter of 2015.
Year-to-Date

Net loss and net loss per share for the six months ended June 30, 2016 were $26.6 million and $1.32, respectively, compared to $19.9 million and $1.10, respectively, for the same period in 2015.
Revenue for the six months ended June 30, 2016 was $3.0 million and was attributable primarily to collaboration revenue associated with the Sanofi G103 collaboration established in the fourth quarter of 2014 and GLA product sales to collaboration partners. Revenue for the same period in 2015 was $3.7 million and was attributable primarily to collaboration revenue associated with the Sanofi G103 collaboration.
Research and development expenses for the six months ended June 30, 2016 were $22.0 million compared to $15.9 million for the same period in 2015. The $6.0 million increase was primarily attributable to continuing 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 did not materially differ over the comparative periods. For the six months ended June 30, 2016 general and administrative expenses were $7.9 million, compared to $7.6 million for the same period in 2015.

On August 9, 2016 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported its second quarter 2016 financial results (Press release, Infinity Pharmaceuticals, AUG 9, 2016, View Source;p=RssLanding&cat=news&id=2194286 [SID:1234514475]). Additionally, the company provided an update on its two development programs, duvelisib, an investigational, oral, dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, and IPI-549, an immuno-oncology development candidate that selectively inhibits PI3K-gamma. Infinity is continuing to explore a broad range of strategic options for duvelisib, including a potential sale of the program. In parallel, the company continues to advance key value drivers for duvelisib. Infinity is also proceeding with its planned development of IPI-549 in multiple solid tumors and evaluating the best path forward for this development candidate.

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"Data reported to date have demonstrated that duvelisib could play an important role in the future treatment of patients with hematologic malignancies, particularly for relapsing and/or refractory patients. We are now exploring strategic options for the program that could enable duvelisib to continue to advance toward potential regulatory filings and commercialization," stated Adelene Perkins, president and chief executive officer. "We are also developing IPI-549 and determining the best clinical path forward for this promising immuno-oncology program. The Phase 1 study, which includes evaluation of IPI-549 as a monotherapy and planned evaluation in combination with a checkpoint inhibitor, is progressing well, and new preclinical and clinical data on IPI-549 will be presented at an immuno-oncology conference next month."

Today Infinity also announced that DUO, a Phase 3, randomized monotherapy study of duvelisib compared to ofatumumab in 319 patients with relapsed or refractory chronic lymphocytic leukemia (CLL), will proceed to its final analysis. The primary endpoint of the study is progression-free survival, and the event that will trigger the final analysis is expected to occur in the fourth quarter of 2016. If the DUO data are positive, Infinity continues to believe that the study could provide the basis for regulatory approval in CLL. Earlier this year, Infinity reported that DYNAMO, a registration-focused Phase 2 monotherapy study evaluating the efficacy and safety of duvelisib in patients with refractory indolent non-Hodgkin lymphoma (iNHL), met its primary endpoint of overall response rate and that the company intends to seek feedback on these data from the U.S. Food and Drug Administration (FDA). Infinity is continuing to advance activities to enable potential regulatory filings for duvelisib. While exploring the potential sale of the program, Infinity is suspending its prior guidance on the nature and timing of additional duvelisib program updates, including guidance on data from duvelisib registration-focused trials and timing of potential regulatory filings.

Recent developments include the following:
Duvelisib

Topline data from DYNAMO reported: In June, Infinity announced that DYNAMO, a registration-focused Phase 2 monotherapy study evaluating the efficacy and safety of duvelisib in 129 patients with refractory iNHL, met its primary endpoint of overall response rate. In the study, duvelisib demonstrated an overall response rate (ORR) of 46 percent. The majority of reported side effects were reversible and clinically manageable. Infinity plans to seek feedback from the FDA on these data.

Data from CONTEMPO presented at EHA (Free EHA Whitepaper): In June, researchers presented preliminary data from CONTEMPO, a Phase 1b/2 clinical study evaluating duvelisib in combination with rituximab or obinutuzumab in treatment-naïve patients with follicular lymphoma, at the 21st Congress of the European Hematology Association (EHA) (Free EHA Whitepaper). Duvelisib in combination with Gazyva (obinutuzumab) demonstrated an overall response rate of 100 percent, including a 33 percent complete response rate among nine patients evaluable for response, and duvelisib in combination with Rituxan (rituximab) demonstrated an overall response rate of 80 percent, including a 30 percent complete response among 10 patients evaluable for response. The preliminary safety profile of duvelisib in combination with either obinutuzumab or rituximab in treatment-naïve patients with follicular lymphoma was in line with the safety profile of duvelisib as monotherapy. The CONTEMPO study is ongoing having enrolled 55 patients and is now closed to additional patient enrollment.

Further duvelisib regulatory and clinical update: Infinity continues to advance preparations for potential regulatory submissions to support approval of duvelisib based on the DYNAMO and, if the data are positive, DUO studies. In addition to the DYNAMO, DUO and CONTEMPO studies described earlier, the SYNCHRONY and FRESCO studies are ongoing to support the potential approval and launch of duvelisib in CLL and follicular lymphoma. SYNCHRONY is a Phase 1b combination study of duvelisib plus obinutuzumab in CLL or small lymphocytic lymphoma patients who were previously treated with a Bruton’s tyrosine kinase (BTK) inhibitor. FRESCO is a randomized study of duvelisib in combination with rituximab compared to R-CHOP in patients with relapsed/refractory follicular lymphoma designed to evaluate the potential of duvelisib as an alternative treatment option to chemotherapy. In June, Infinity announced that it was closing BRAVURA, a Phase 3 study of duvelisib in patients with relapsed iNHL, to align resources to its strategic objectives regarding duvelisib.
IPI-549

Phase 1 study of IPI-549 ongoing: A Phase 1 study of IPI-549 is ongoing to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of IPI-549 as a monotherapy and in combination with an anti-PD-1 antibody, a checkpoint inhibitor, in approximately 150 patients with advanced solid tumors, including non-small cell lung cancer and melanoma. IPI-549 is the only investigational PI3K-gamma inhibitor in clinical development. Infinity expects to initiate cohorts studying IPI-549 in combination with an anti-PD-1 antibody this Fall.

New data on IPI-549 to be presented at upcoming scientific meeting: Infinity announced today that preclinical and clinical data on IPI-549 will be presented at the Second CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper): Translating Science into Survival taking place September 25-28, 2016, in New York City.

Manuscript describing discovery of IPI-549 accepted for publication: Infinity reported that a manuscript describing the company’s medicinal chemistry research efforts that led to the discovery of IPI-549 has been accepted for publication in ACS Medicinal Chemistry Letters. The paper, "Discovery of a selective phosphoinositide-3-kinase (PI3K)-gamma inhibitor (IPI-549) as an immuno-oncology clinical candidate," describes the evaluation of a focused group of PI3K-gamma inhibitors resulting in the selection of IPI-549 as a development candidate based on its potency, selectivity, favorable in vitro safety and pharmacokinetic profile and ability to inhibit PI3K-gamma in vivo.1 A preliminary copy of the manuscript is currently available on the ACS Publications website.
Corporate

June restructuring of workforce nearly completed: In June, Infinity undertook two strategic restructurings in order to preserve financial resources. In summary, the company reduced its employee headcount by approximately 66 percent compared to its employee headcount as of December 31, 2015. The June restructurings impacted all functions across the organization and have been nearly completed.
The restructuring also included a non-cash impairment loss of $2.3 million related to fixed assets that were written down to fair value during the three months ended June 30, 2016.

Infinity is also evaluating its current facility leases. If Infinity pursues and successfully restructures these facility leases in 2016, it could potentially incur additional charges during the second half of 2016 upon exit of the space.

Second Quarter 2016 Financial Results

At June 30, 2016, Infinity had total cash, cash equivalents and available-for-sale securities of $146.4 million, compared to $193.0 million at March 31, 2016.

Revenue during the second quarter of 2016 was $9.5 million for research and development (R&D) services associated with the collaboration with AbbVie for duvelisib in oncology up through AbbVie’s opt-out, compared to $4.9 million for R&D services for the second quarter of 2015.

R&D expense for the second quarter of 2016 was $52.9 million, compared to $34.1 million for the second quarter of 2015. The increase in R&D expense was primarily due to restructuring activities as well as higher clinical development expenses for duvelisib. In the second quarter of 2016, the company recognized $11.9 million of restructuring charges within R&D expense.

General and administrative (G&A) expense was $15.7 million for the second quarter of 2016, compared to $9.4 million for the same period in 2015. The increase in G&A expense was primarily related to restructuring activities. In the second quarter of 2016, the company recognized $4.7 million of restructuring charges within G&A expense.

Infinity recorded a non-recurring gain on AbbVie opt-out of the duvelisib collaboration of $112.2 million for the second quarter of 2016. The AbbVie opt-out is irrevocable, and Infinity has no obligation to continue to provide AbbVie any services. There were no gains for the second quarter of 2015.

Net income for the second quarter of 2016 was $53.0 million, or a basic and diluted earnings per common share of $1.05, compared to a net loss of $38.4 million, or a basic and diluted loss per common share of $0.78, for the same period in 2015.
Cash and Investments Outlook
Following the AbbVie opt-out and Infinity’s restructuring activities, Infinity today provided an update on its anticipated year-end 2016 cash and investments balance. In the absence of additional funding or proceeds from business development activities, including the potential sale of duvelisib:

Infinity expects to end 2016 with a year-end cash and investments balance ranging from $45 million to $55 million, compared to prior expectations of $45 million to $65 million.

Infinity expects that its existing cash, cash equivalents and available-for-sale securities at June 30, 2016, will be adequate to satisfy the company’s capital needs into the third quarter of 2017 based on its current operational plans, compared to previous guidance of cash runway through the first quarter of 2017. The extension of the company’s cash runway is the result of its June restructuring activities and expectations that it does not expect to incur duvelisib expenses beyond the fourth quarter of 2016, consistent with Infinity’s current focus on selling the program.