On September 25, 2017 CombiMatrix Corporation (NASDAQ: CBMX) (“CombiMatrix” or the “Company”), a family health molecular diagnostics company specializing in DNA-based reproductive health and pediatric testing services, reported it has set important dates for a special meeting of its stockholders to vote on matters related to the proposed merger with Invitae Corporation (“Invitae”) (Filing, 8-K, CombiMatrix, SEP 25, 2017, View Source [SID1234520629]).

The special meeting of stockholders will be held at 1:00 pm, local time, on November 10, 2017, at the offices of Stradling Yocca Carlson & Rauth, P.C., 660 Newport Center Drive, Suite 1600, Newport Beach, California. CombiMatrix’s stockholders of record as of the close of business on September 26, 2017 are entitled to receive notice of, and to vote at, the special meeting.

The merger has been unanimously approved by the boards of directors of both companies. The proposed merger is expected to close in the fourth quarter of 2017 (subject to the approval of the stockholders of CombiMatrix and acceptance by at least 90% of CombiMatrix’s holders of Series F warrants to tender their warrants in exchange for Invitae common stock in the Series F warrants tender exchange offer that will be conducted simultaneously with the CombiMatrix merger proxy solicitation).

On September 25, 2017 Immune Design (Nasdaq:IMDZ), a clinical-stage immunotherapy company focused on oncology, reported that four abstracts have been accepted for presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 32nd Annual Meeting, November 8-12, 2017 in National Harbor, Maryland.

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The oral and poster presentation information 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

Oral Presentation/ SITC (Free SITC Whitepaper) Pre-Conference Program
Session title: Immuno-Oncology Biomarkers: Today’s Imperatives for Tomorrow’s Needs
Date: November 8, 2017
Time: 8 a.m. to 12:30 p.m.
Presenter: Hailing Lu, MD, PhD, Principal Scientist, Immune Design

Poster Presentation:
Poster Number: P58
Date: Saturday, November 11, 2017
Time: 12:30 — 2 p.m. and 6:30 — 8 p.m.
Presenter: Hailing Lu, MD, PhD, Principal Scientist, Immune Design

Combination Therapy (Cancer Vaccine + Intratumoral Immunization):

G100 and ZVex-based combination immunotherapy induces near complete regression of established glioma tumors in mice

Poster Number: P256
Date: Saturday, November 11, 2017
Time: 12:30 — 2 p.m. and 6:30 — 8 p.m.
Presenter: Tina Chang Albershardt, PhD, Scientist II, Immune Design

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

Poster Number: P127
Date: Friday, November 10, 2017
Time: 12:30 — 2 p.m. and 6:30 — 8 p.m.
Presenter: Jardin Leleux, Postdoctoral Researcher, Immune Design

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

Poster Number: P401
Date: Friday, November 10, 2017
Time: 12:30 — 2 p.m. and 6:30 — 8 p.m.
Presenter: Tina Chang Albershardt, PhD, Scientist II, Immune Design

On September 25, 2017 NewLink Genetics Corporation (Nasdaq: NLNK) reported that it has entered into a clinical collaboration agreement with AstraZeneca to evaluate the combination of indoximod, NewLink Genetics’ small molecule IDO pathway inhibitor, and durvalumab, AstraZeneca’s anti-PD-L1 monoclonal antibody, along with standard of care chemotherapy for patients with metastatic pancreatic cancer (Press release, NewLink Genetics, SEP 25, 2017, View Source [SID1234520626]).

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The primary objective for this randomized placebo-controlled, Phase 2 study is to evaluate the efficacy and safety of the immuno-oncology-based combination compared to gemcitabine/ABRAXANE alone. Patients will also be enrolled into a smaller cohort evaluating the combination of durvalumab with gemcitabine/ABRAXANE.

The Phase 2 trial will be funded equally by both companies, with NewLink Genetics serving as the study sponsor. NewLink Genetics’ share of the aggregate expense of the trial is not expected to have a material effect on its financial position.

“We are pleased to initiate a joint immuno-oncology clinical collaboration with AstraZeneca,” said Dr. Charles J. Link, Jr., Chairman, Chief Executive Officer and Chief Scientific Officer of NewLink Genetics. “As recent data have indicated, indoximod combinations with immunotherapy and chemotherapy show promise of improving outcomes for patients with multiple tumor types.”

About Durvalumab

Durvalumab (Imfinzi), a human monoclonal antibody directed against PD-L1, blocks PD-L1 interaction with PD-1 and CD80 on T cells, countering the tumour’s immune-evading tactics and inducing an immune response.

Durvalumab is being assessed in Phase III trials as a monotherapy in various stages of NSCLC, in small-cell lung cancer (SCLC), in metastatic urothelial cancer (mUC) and in head and neck squamous cell carcinoma (HNSCC). The combination of durvalumab and tremelimumab is being assessed in Phase III trials in NSCLC, SCLC, mUC and HNSCC and in Phase I/II trials in hepatocellular carcinoma and haematological malignancies.

Imfinzi received accelerated approval from the US Food and Drug Administration for previously treated patients with advanced bladder cancer and is under review in Canada and Australia for similar use.

About Indoximod

Indoximod is an investigational, orally available small molecule targeting the IDO pathway. The IDO pathway is one of the key immuno-oncology targets involved in regulating the tumor microenvironment and immune escape.

NewLink Genetics is currently evaluating indoximod in multiple combination studies for patients with various types of cancer including melanoma, acute myeloid leukemia, pancreatic cancer and prostate cancer.

About Metastatic (Stage IV) Pancreatic Cancer1

Approximately 53,670 new cases of pancreatic cancer in the US will be diagnosed in 2017 according to the National Cancer Institute (NCI), and a little over 43,000 people will die of the disease this year. Pancreatic cancer is difficult to detect in its early stages. Because of this, approximately 52% of all pancreatic cancers are metastatic, or advanced, in nature and are associated with a poor prognosis. The 5-year survival rate for pancreatic cancer overall is only 8.2%, and drops to a low of 2.7% for individuals whose pancreatic cancer has metastasized to farther regions of the body.

1National Cancer Institute: Pancreas Cancer

On September 25, 2017 Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company discovering and developing novel vaccines and immunotherapies targeting T cell antigens, reported a strategic shift to immuno-oncology and a focus on the development of neoantigen cancer vaccines, including GEN-009, its lead candidate for which it expects to file an Investigational New Drug (IND) application by early 2018 (Press release, Genocea Biosciences, SEP 25, 2017, View Source [SID1234520624]). Genocea also announced it is exploring strategic alternatives for GEN-003, its Phase 3-ready investigational immunotherapy for the treatment of genital herpes. Consequently, Genocea is ceasing GEN-003 spending and activities and is reducing its workforce by approximately 40 percent.

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Genocea has confidence that it is positioned for leadership in the development of neoantigen cancer vaccines through its unique antigen identification capabilities and vaccinology expertise. More specifically, the company believes that antigen selection is a crucial determinant of neoantigen vaccine efficacy and that previously presented head-to-head data show that ATLAS, the only platform to comprehensively identify the actual neoantigens to which a patient’s CD4+ and CD8+ T cells respond, is a superior approach for identifying neoantigens for personalized vaccines compared to methods used by others developing similar products.

The company plans to initiate a Phase 1 clinical trial for GEN-009 in a range of tumor types in the first half of 2018 and expects to report initial immunogenicity data in the first half of 2019. GEN-009 is an adjuvanted peptide vaccine designed to direct a patient’s T cells to attack their tumor. Antigens in a patient’s vaccine are selected by Genocea’s proprietary ATLAS platform.

Chip Clark, president and chief executive officer of Genocea, commented: “With our research and development efforts now focused entirely on neoantigen cancer vaccines, we believe the power of ATLAS to identify the right vaccine antigens, combined with our vaccinology expertise, gives us the opportunity to create value for our shareholders by developing best-in-class vaccines for cancer patients and achieving leadership in this exciting field.

“To our teammates who’ve given so much to advance GEN-003, we offer our profound thanks for their dedication. Due to their efforts, GEN-003 has the potential to serve as a cornerstone treatment for genital herpes infections. We see this strategic process, which is already underway, as the best way to drive to commercial launch of and maximize shareholder value from GEN-003.”

Financial Guidance
As a result of the workforce restructuring, which is anticipated to be completed by the end of the third quarter, Genocea estimates annualized savings of approximately $6.5 million in personnel-related costs, with estimated one-time severance and related costs of approximately $1.1 million in the third quarter of 2017. Genocea now expects that its existing cash and cash equivalents are sufficient to support its operating expenses and capital expenditure requirements into the middle of 2018.

On September 25, 2017 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported that it has expanded its existing clinical collaboration with Bristol-Myers Squibb evaluating IPI-549 in combination with Opdivo to include patients with triple negative breast cancer (TNBC) who have not been previously exposed to anti-PD-1 or anti-PD-L1 therapy (Press release, Infinity Pharmaceuticals, SEP 25, 2017, View Source [SID1234520623]). IPI-549 is an oral, selective phosphoinositide-3-kinase gamma (PI3K-gamma) inhibitor which targets immune-suppressive tumor macrophages, and Opdivo is a PD-1 immune checkpoint inhibitor designed to overcome immune suppression. IPI-549 is currently being evaluated in a Phase 1/1b clinical study in patients with advanced solid tumors and is believed to be the only selective PI3K-gamma inhibitor in clinical development.

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Preclinical data have demonstrated that M2, or pro-tumor, macrophages are associated with resistance to checkpoint inhibitor monotherapy, and treatment with IPI-549 in combination with checkpoint inhibitors can overcome this resistance by reprogramming macrophages from the M2 phenotype to the M1, or anti-tumor, phenotype.1,2 A component of this ongoing Phase 1/1b study is designed to explore the potential of combining these two agents to overcome resistance in patients previously treated with checkpoint inhibition. The addition of a cohort of patients with TNBC who have not previously received anti-PD-1 or anti- PD-L1 therapy provides an important opportunity to explore the potential of the combination of IPI-549 and Opdivo to improve efficacy for patients with a type of cancer where there is limited benefit from monotherapy treatment with checkpoint inhibitors.

“The expansion of our ongoing clinical study of IPI-549 and our clinical collaboration with Bristol-Myers Squibb represents an important component of our strategy to bring better treatment options to patients,” stated Adelene Perkins, chief executive officer at Infinity. “Particularly, expanding our study to include patients with triple negative breast cancer who have not been previously treated with a PD-1 or PD-L1 immune checkpoint inhibitor allows us to evaluate whether IPI-549 in combination with Opdivo can increase the number of patients who respond to checkpoint inhibition. To date, very few patients with triple negative breast cancer respond to checkpoint inhibitors alone, leaving these patients with very limited therapeutic options.”

The ongoing Phase 1/1b study being conducted by Infinity is designed to evaluate the safety, tolerability, activity, pharmacokinetics and pharmacodynamics of IPI-549 as a monotherapy and in combination with Opdivo in approximately 200 patients with advanced solid tumors.3 The four-part study includes monotherapy and combination dose-escalation components, in addition to monotherapy expansion and combination expansion components. Patient enrollment is complete in monotherapy dose-escalation, and monotherapy expansion is ongoing. Combination dose-escalation is also ongoing, and combination expansion is expected to begin in the second half of 2017.

The combination expansion component includes multiple cohorts designed to evaluate IPI-549 in patients with specific types of cancer, including patients with non-small cell lung cancer (NSCLC), melanoma, and head and neck squamous cell carcinoma (HNSCC) whose tumors show initial resistance or subsequently develop resistance to immune checkpoint blockade therapy. This combination expansion component will now also add a cohort of patients with TNBC who have not been previously exposed to immune checkpoint blockade therapy. Although there has been great progress in the treatment of cancer, there remains a need for additional treatment options. NSCLC, melanoma, HNSCC and TNBC account for more than 22 percent of all new cancer cases in the U.S.4,5

About IPI-549
IPI-549 is an investigational, orally administered immuno-oncology development candidate that selectively inhibits PI3K-gamma. In preclinical studies, IPI-549 reprograms macrophages from a pro-tumor, M2, to an anti-tumor, M1, phenotype and is able to overcome resistance to checkpoint inhibition as well as to enhance the activity of checkpoint inhibitors.1,2 As such, IPI-549 may have the potential to treat a broad range of solid tumors and represents a potentially complementary approach to restoring anti-tumor immunity in combination with other immunotherapies such as checkpoint inhibitors. IPI-549 is an investigational compound and its safety and efficacy has not been evaluated by the U.S. Food and Drug Administration or any other health authority.