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.

On September 25, 2017 Atossa Genetics Inc. (NASDAQ:ATOS), a clinical-stage pharmaceutical company developing novel therapeutics and delivery methods for breast cancer and other breast conditions reported that it has contracted with a leading European hospital to conduct a Phase 2 study of its proprietary topical Endoxifen for the treatment of women with mammographic breast density, or MBD (Press release, Atossa Genetics, SEP 25, 2017, View Source [SID1234520621]). Studies by others have shown that a reduction in MBD reduces the risk of developing breast cancer. The Phase 2 study will be conducted at Stockholm South General Hospital in Sweden and will be led by principal investigator Dr. Per Hall, MD, Ph.D., Head of the Department of Medical Epidemiology and Biostatistics at Karolinska Institutet.

“Dr. Hall is widely regarded as a leading researcher in the field of breast cancer and prevention. He is heading the unique KARMA (Karolinska Mammography Project for Risk Prediction of Breast Cancer) Cohort, including over 70,000 women, which is regarded as the best characterized breast cancer cohort in the world and serves as a resource for studies about breast cancer risk assessment and prevention, and the Karisma Intervention Study, which is studying the change in MBD in women taking various doses of oral tamoxifen. We are honored to be working with Dr. Hall and his colleagues on our Phase 2 study of MBD as their unique experience and qualifications are simply unmatched anywhere in the world,” said Dr. Steven C. Quay, CEO and President of Atossa Genetics.

Atossa plans to apply for approval from the Institutional Review Board and Swedish regulatory authority (Medical Products Agency) within the next 30 days. The placebo-controlled, double-blinded study is expected to enroll up to 480 subjects. The primary endpoint is MBD reduction, which will be measured after six and twelve months of dosing, as well as safety and tolerability.

Atossa’s Proprietary Endoxifen

Endoxifen is an active metabolite of tamoxifen. Tamoxifen is an FDA-approved drug to prevent new breast cancer as well as recurrent breast cancer in breast cancer patients. Tamoxifen itself must be broken down by the liver into active compounds (metabolites), of which Endoxifen is the most active. Atossa has completed a comprehensive Phase 1 clinical study using both a topical and an oral formulation of Endoxifen. Preliminary results from the topical arm of the study indicated that the topical formulation was safe, well tolerated and that topical Endoxifen crossed the skin barrier in a dose-dependent fashion.

Topical Endoxifen Opportunity: MBD. Atossa is developing its proprietary topical Endoxifen to reduce MBD, which has been shown in studies conducted by others to be an independent risk factor for developing breast cancer. To date, 30 U.S. states require that findings of MBD be directly communicated to the patient. Although oral tamoxifen has been shown to reduce MBD, the benefit-risk ratio is generally not acceptable to most physicians and their patients. For example, it is estimated that only ~ 2% of women at high-risk of developing breast cancer, including those with MBD, take oral tamoxifen to prevent breast cancer because of the risk of, or actual side-effects of, oral tamoxifen.

Oral Endoxifen Opportunity. Approximately one million breast cancer survivors take oral tamoxifen annually; however, up to half of them do not properly metabolize tamoxifen and do not have desired levels of Endoxifen (meaning they are “refractory”). Low Endoxifen levels in breast cancer patients taking oral tamoxifen are associated with an increased risk of recurrence or the development of new breast tumors. Providing oral Endoxifen directly to the patient without having to be metabolized by the liver may help to address this problem.

Based on the number of women at high-risk of developing breast cancer and the number of patients who have survived breast cancer but are refractory to tamoxifen, Atossa estimates that the potential markets for its proprietary oral and topical formulations of Endoxifen could each potentially exceed $1 billion in annual sales.