On November 4, 2015 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN)reported financial results for the third quarter of 2015 and provided an update on development programs (Filing, 8-K, Regeneron, NOV 4, 2015, View Source [SID:1234507951]).

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Financial Highlights

"Our commercial business continues to advance with increased demand for EYLEA, our marketed medicine for serious retinal diseases, and continued launch progress with Praluent, our new therapy for hypercholesterolemia," said Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron. "Regeneron also continues to progress the next wave of candidates from our strong pipeline, including sarilumab for rheumatoid arthritis, the BLA for which was recently submitted to the U.S. FDA, and dupilumab, which is in Phase 3 trials for atopic dermatitis and asthma."

Business Highlights

EYLEA (aflibercept) Injection for Intravitreal Injection

• In the third quarter of 2015, net sales of EYLEA in the United States increased 65% to $734 million from $445 million in the third quarter of 2014. Overall distributor inventory levels remained within the Company’s one- to two-week targeted range.

• Bayer HealthCare commercializes EYLEA outside the United States. In the third quarter of 2015, net sales of EYLEA outside of the United States(1) were $371 million, compared to $277 million in the third quarter of 2014. In the third quarter of 2015, Regeneron recognized $131 million from its share of net profit from EYLEA sales outside the United States, compared to $85 million in the third quarter of 2014.

• In October 2015, the European Commission granted marketing authorization of EYLEA for the treatment of visual impairment due to myopic choroidal neovascularization.

Praluent (alirocumab) Injection for the Treatment of High Low-Density Lipoprotein (LDL) Cholesterol

• In July 2015, following the U.S. Food and Drug Administration (FDA) approval of Praluent for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD), who require additional lowering of LDL cholesterol, the Company and Sanofi commenced their launch of Praluent. The effect of Praluent on cardiovascular morbidity and mortality has not been determined.

• In the third quarter of 2015, net sales of Praluent in the United States were $4 million. Product sales for Praluent are recorded by Sanofi, and the Company shares in any profits or losses from the commercialization of Praluent.

• In October 2015, Praluent was included in the Express Scripts National Preferred Formulary, the nation’s largest formulary covering approximately 25 million Americans.

• In September 2015, the European Commission granted marketing authorization of Praluent for the treatment of adult patients with primary hypercholesterolemia (HeFH and non-familial) or mixed dyslipidemia as an adjunct to diet (a) in combination with a statin, or statin with other lipid-lowering therapies in patients unable to reach their LDL-cholesterol goals with the maximally-tolerated statin, or (b) alone or in combination with other lipid-lowering therapies for patients who are statin intolerant, or for whom a statin is contraindicated.

• In July 2015, the Company and Sanofi reported that the Phase 3 ODYSSEY JAPAN trial met its primary endpoint.

• The Phase 3 ODYSSEY program remains ongoing.

Pipeline Progress
Regeneron has thirteen fully human monoclonal antibodies generated using the Company’s VelocImmune technology in clinical development, including five in collaboration with Sanofi(5). In addition to Praluent, highlights from the antibody pipeline include:
Sarilumab, the Company’s antibody targeting IL-6R for rheumatoid arthritis, is currently being studied in the global Phase 3 SARIL-RA program. A Biologics License Application (BLA) in the United States was recently submitted to the FDA.

Dupilumab, the Company’s antibody that blocks signaling of IL-4 and IL-13, is currently being studied in atopic dermatitis, asthma, nasal polyps, and eosinophilic esophagitis.

• Multiple Phase 3 studies of dupilumab in atopic dermatitis are currently underway. Phase 3 pivotal trials in atopic dermatitis are fully enrolled.

• The Phase 2 study in atopic dermatitis in adolescents and children completed enrollment.

• The second pivotal study of dupilumab in patients with uncontrolled persistent asthma continues to enroll patients.

Fasinumab, an antibody targeting Nerve Growth Factor (NGF), entered Phase 2b/3 clinical development (sixteen-week study) for pain due to osteoarthritis in the second quarter of 2015. In September 2015, the Company and Mitsubishi Tanabe Pharma Corporation (MTPC) entered into a strategic collaboration providing MTPC with exclusive development and commercial rights to fasinumab in Japan and certain other countries in Asia.

REGN2222, an antibody targeting the respiratory syncytial virus (RSV), entered Phase 3 clinical development in the third quarter of 2015.

Third Quarter 2015 Financial Results

Product Revenues: Net product sales were $738 million in the third quarter of 2015, compared to $449 million in the third quarter of 2014. EYLEA net product sales in the United States were $734 million in the third quarter of 2015, compared to $445 million in the third quarter of 2014.

Total Revenues: Total revenues, which include product revenues described above, increased by 57% to $1,137 million in the third quarter of 2015, compared to $726 million in the third quarter of 2014. Total revenues also include collaboration revenues of $382 million in the third quarter of 2015, compared to $269 million in the third quarter of 2014. Collaboration revenues in the third quarter of 2015 increased primarily due to higher reimbursement of the Company’s research and development expenses under its antibody collaboration with Sanofi and an increase in the Company’s net profit from commercialization of EYLEA outside the United States. Refer to Table 4 for a summary of collaboration revenue.

Research and Development (R&D) Expenses: GAAP R&D expenses were $426 million in the third quarter of 2015, compared to $338 million in the third quarter of 2014. The higher R&D expenses in the third quarter of 2015 were principally due to higher development costs related to dupilumab and higher headcount to support the Company’s increased R&D activities. In addition, in the third quarter of 2015, R&D-related non-cash share-based compensation expense was $64 million, compared to $46 million in the third quarter of 2014.

Selling, General, and Administrative (SG&A) Expenses: GAAP SG&A expenses were $210 million in the third quarter of 2015, compared to $144 million in the third quarter of 2014. The increase in SG&A expenses was primarily due to higher headcount and headcount-related costs and higher commercialization expenses related to Praluent. These increases were partly offset by a third quarter 2014 incremental charge related to the Branded Prescription Drug Fee, based on final regulations issued by the Internal Revenue Service (IRS) in July 2014. In addition, in the third quarter of 2015, SG&A-related non-cash share-based compensation expense was $36 million, compared to $21 million in the third quarter of 2014.

Cost of Goods Sold (COGS): GAAP COGS was $67 million in the third quarter of 2015, compared to $34 million in the third quarter of 2014. COGS primarily consists of royalties as well as costs in connection with producing U.S. EYLEA commercial supplies, and various start-up costs in connection with the Company’s Limerick, Ireland commercial manufacturing facility. COGS increased principally due to the increase in U.S. EYLEA net product sales.

Income Tax Expense: GAAP income tax expense was $183 million in the third quarter of 2015, compared to $98 million in the third quarter of 2014. The effective tax rate was 46.5% for the third quarter of 2015, compared to 54.1% for the third quarter of 2014.

Non-GAAP and GAAP Net Income: The Company reported non-GAAP net income of $403 million, or $3.90 per basic share and $3.47 per diluted share, in the third quarter of 2015, compared to non-GAAP net income of $295 million, or $2.93 per basic share and $2.52 per diluted share, in the third quarter of 2014.

The Company reported GAAP net income of $210 million, or $2.04 per basic share and $1.82 per diluted share, in the third quarter of 2015, compared to GAAP net income of $83 million, or $0.83 per basic share and $0.73 per diluted share, in the third quarter of 2014.

A reconciliation of the Company’s GAAP to non-GAAP results is included in Table 3 of this press release.

On November 04, 2015 OncoMed Pharmaceuticals Inc. (NASDAQ:OMED) reported that new data comparing the anti-tumor immune response of its anti-DLL4/VEGF bispecific alone and in combination with anti-Programmed Cell Death Protein 1 (PD1) will be presented at the upcoming Society of Immunotherapy for Cancer (SITC) (Free SITC Whitepaper) 30th Annual Meeting taking place November 4-8, 2015 in National Harbor, MD (Press release, OncoMed, NOV 4, 2015, View Source [SID:1234507950]).

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Saturday, November 7, 2015 – 12:45 pm — 2:00 pm

Title: Co-Targeting of Delta-like ligand 4 (DLL4) and vascular endothelial growth factor A (VEGF) with Programmed Death 1 (PD1) blockade inhibits tumor growth and facilitates anti-tumor immune responses

Lead author: Angie Park, PhD, Director of Immunotherapy and Stem Cell Biology, of OncoMed

Session: Optimizing Combination Immunotherapy

On November 4, 2015 Navidea Biopharmaceuticals (NYSE MKT:NAVB) reported financial results for the quarter ending September 30, 2015 (Press release, Navidea Biopharmaceuticals, NOV 4, 2015, View Source;p=RssLanding&cat=news&id=2106411 [SID:1234507949]). The Company achieved the following financial highlights:

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Third quarter 2015 total revenue of $4 million; comprised of $3 million in Lymphoseek (technetium Tc 99m tilmanocept) injection sales, $550,000 in Lymphoseek license revenue, and $477,000 in grant and other revenue
50% sequential quarterly and 168% year-over-year third quarter Lymphoseek product sales growth
Year-to-date gross margins on product sales of 82%
$6.8 million in 2015 year-to-date product sales, which puts the Company on track to achieve our product revenue guidance.
"We continue to execute on the new commercial strategy we put in place to start the year for our immuno-diagnostic product, Lymphoseek," said Rick Gonzalez, President and Chief Executive Officer. "Sales growth is anticipated to continue in the fourth quarter and into 2016 and beyond based on further penetration of the sentinel lymph node market; expansion to lymphatic mapping with additional solid tumors; and the impact from additional hospital system and institution-wide sales activities."

Mr. Gonzalez continued, "To position us for longer-term growth, clinical development will begin next year for new imaging applications in Kaposi’s sarcoma, rheumatoid arthritis and cardiovascular disease. These pipeline opportunities create a valuable bridge to potential immuno-therapeutics, which, similar to Lymphoseek, would take advantage of the Manocept platform’s ability to selectively target disease-associated immune cells."

PRODUCT & PIPELINE UPDATES

Lymphoseek

Published results in the Annals of Surgical Oncology showing a statistically significant reduction in pain for Lymphoseek vs. sulfur colloid, a key differentiator for patients and physicians
Continued market development activities with Company and investigator-initiated studies in cervical cancer, pediatric solid tumors, anal-rectal cancer, and for further confirmation of workflow efficiency compared to sulfur colloid

Technetium Tc 99m tilmanocept Pipeline

Advanced development efforts for intravenous and subcutaneous delivery
Awarded NIH grants to develop the product for early detection of rheumatoid arthritis (RA) and cardiovascular disease
Academic collaborators continued development for clinical imaging of Kaposi’s sarcoma tumor lesions
Manocept Therapeutic Development Pipeline

Received Manocept-bound Accurins from BIND Therapeutics, Inc. for potential use in targeting analysis of disease-associated macrophages
Reported data demonstrating that a Manocept-doxorubicin (MT-1001) conjugate selectively targets tumor-associated macrophages and destroys the cells through an apoptotic mechanism

FINANCIALS

"Growth in Lymphoseek sales combined with funding from grants and our continued efforts to contain costs have contributed to an overall trend of reduction in our quarterly cash burn," said Brent Larson, Navidea’s Chief Financial Officer. "We remain confident that we will see additional commercial momentum during the fourth quarter and into 2016 as a result of the impact from the field sales force we deployed in May. This expected increase, coupled with an estimated gross margin in excess of 80%, means that each incremental dollar of revenue our sales force generates has a significant positive impact on our cash flow. During 2015, we have continued making limited investment in the NAV4694 clinical trial process based on our expectation that we will be successful in ultimately securing a partnership that will provide us some level of return on this investment. However, in addition to a potential return, the elimination of expenses related to this asset is also expected to have positive near-term contribution to our cash burn."

Revenue & Gross Profit

Total revenue for the quarter ended September 30, 2015 reached $4 million, and for the nine months then ended, reached $9 million. Of these amounts, Lymphoseek sales revenue grew to $3 million for the quarter and $6.8 million for the nine months ended September 30, 2015, which represents 168% and 143% in year over year growth for the respective periods. The primary driver of this increase was increased adoption of Lymphoseek by new customers. Third quarter 2015 margins also remained above 80% contributing to a total gross profit of $3.5 million for the quarter.

Operating Expenses, Income & Balance Sheet

The Company reduced net loss for the quarter and nine months ended September 30, 2015 compared to the same periods in the prior year. Two of the key factors in these reductions were the sales growth and decreased R&D expenses on a year-to-date basis related to the Company’s non-core neuroimaging assets coupled with decreased headcount costs. This was offset by an increase to SG&A expenses due primarily to net increases in commercial headcount costs coming from the addition of the sales force and an increase in professional services costs offset by a decrease in medical science liaison costs. Net losses attributable to common stockholders include the cash interest expense on our outstanding debt, as well as significant non-cash charges related to interest, loss on debt extinguishment and changes in the fair value of financial instruments.

The Company ended the quarter with $11.4 million in cash.

MILESTONES

Select milestones Navidea expects to achieve in the near-term include the following:

Divest or partner the Company’s non-core Phase 3 Alzheimer’s diagnostic imaging candidate, NAV4694
Complete preclinical studies for intravenous delivery of tilmanocept and initiate clinical trials in RA
Achieve $10 to $12 million in Lymphoseek product sales for 2015

On November 04, 2015 Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA) reported its financial results for the third quarter ended September 30, 2015 (Press release, Momenta Pharmaceuticals, NOV 4, 2015, View Source [SID:1234507948]).

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For the third quarter of 2015, the Company reported total revenues of $13.8 million, including $8.7 million of GlatopaTM (glatiramer acetate injection) profit share. For the nine months ended September 30, 2015, the Company reported total revenues of $67.3 million, including $27.9 million in product revenues from Sandoz’s sales of Glatopa. Momenta reported a net loss of $(30.1) million, or $(0.44) per share for the third quarter compared to a net loss of $(29.1) million, or $(0.56) per share for the same period in 2014. For the nine months ended September 30, 2015, the Company reported a net loss of $(54.1) million, or $(0.88) per share compared to a net loss of $(82.6) million, or $(1.61) per share for the same period in 2014. At September 30, 2015, the Company had cash, cash equivalents, and marketable securities of $374.9 million.

"The launch of Glatopa is going according to plan with Glatopa scripts currently representing approximately 25% to 30% of the once daily glatiramer acetate market," said Craig A. Wheeler, President and Chief Executive Officer of Momenta Pharmaceuticals. "As the first marketed generic version of a multiple sclerosis drug, Glatopa is bringing value to both patients and payors."

"We continue to advance our biosimilar and novel drug programs. Our Phase 2 study of necuparanib in pancreatic cancer is advancing and M923, our biosimilar HUMIRA candidate, has entered a pivotal clinical trial," continued Mr. Wheeler. "Our ongoing development activities should also allow us to move M834, our biosimilar ORENCIA candidate, and our two novel recombinant autoimmune candidates into the clinic in 2016."

Third Quarter Highlights and Recent Events

Complex Generics:
GlatopaTM, generic version of daily COPAXONE 20 mg (glatiramer acetate injection)

Sandoz launched Glatopa on June 18, 2015. In the third quarter of 2015, Momenta recorded $8.7 million in product revenues from Sandoz’s Glatopa sales. Glatopa is experiencing positive trade uptake, although the impact on third quarter sales was limited as launch inventory continues to be worked through. In the second quarter of 2015 Momenta’s share of profit on sales of Glatopa was $28.2 million, and after a deduction of $9.0 million in reimbursement to Sandoz of the Company’s share of pre-launch Glatopa-related legal expenses, the Company recorded $19.2 million in product revenue.
The ANDA for a three-times-a-week generic COPAXONE 40 mg (glatiramer acetate injection), submitted by Sandoz, is under FDA review.

Enoxaparin Sodium Injection

The Company continues to pursue the patent infringement case related to Momenta’s U.S. Pat. 7,575,886 against Amphastar and Actavis. In July 2015, the U.S. Solicitor General, at the request of the Court of Appeals for the Federal Circuit, filed a brief in the case that supported Momenta’s interpretation of the scope of the "safe harbor" provisions under the Hatch Waxman Act. A CAFC decision is expected in 2015.

Biosimilars:

In October 2015, Momenta and Baxalta announced the initiation of a pivotal clinical trial for M923, a biosimilar version of HUMIRA (adalimumab). The trial is a randomized, double blind, active control, multi-center, global study in patients with chronic plaque psoriasis to compare the safety, efficacy and immunogenicity of M923 with HUMIRA. The companies are targeting first regulatory submission in 2017 and a first commercial launch in 2018.
Momenta continues to develop M834, a biosimilar version of ORENCIA (abatacept), and its portfolio of other biosimilar candidates and is in active discussions with potential partners to collaborate on the development and commercialization of a portfolio of its biosimilar candidates.

Novel Drug:
Necuparanib (novel oncology candidate)

Momenta’s Phase 2 trial to evaluate the antitumor activity of necuparanib in combination with Abraxane (nab-paclitaxel) plus gemcitabine, versus Abraxane plus gemcitabine alone, is enrolling. The Company expects to have clinical data available in the first half of 2017.
The Company continues to collect data from the Phase 1 study and plans to publish and/or present updated results following completion of the study.

Autoimmune Drugs
Momenta’s three novel autoimmune candidates are in preclinical development. These candidates include a hyper-sialylated IVIg (hsIVIg), a high potency alternative to IVIg, and two recombinant molecules: M230, a Selective Immunomodulator of Fc receptors (SIF3) and M281, an anti-FcRn monoclonal antibody. The Company is advancing the recombinant candidates with a goal of entering the clinic in late 2016, and is continuing its efforts to identify and explore potential partnering opportunities for the further development and commercialization of its hsIVIg program.

Third Quarter 2015 Financial Results

Total revenues for the third quarter of 2015 were $13.8 million compared to $9.3 million for the same period in 2014. Total revenues for the third quarter of 2015 includes $8.7 million in product revenue, which represents 50% of contractual profit earned from Sandoz’s sale of Glatopa.

Enoxaparin product revenue decreased from $4.7 million for the third quarter of 2014 to zero for the same period in 2015. The decrease in enoxaparin product revenue was primarily due to the amendment of the enoxaparin sodium injection collaboration agreement in June 2015 which replaced Sandoz’ obligation to pay the Company a royalty on net sales with an obligation to pay 50% of profit on sales. In the third quarter of 2015, Sandoz did not earn a profit on its sales of enoxaparin due to continued competitive pricing.

Collaborative research and development revenue for the third quarter of 2015 was $5.1 million, compared to the $4.6 million recorded in the same quarter last year. The increase is primarily due to an increase in the quarterly amortization of the upfront payment under the Baxalta collaboration.

Research and development expenses for the third quarter of 2015 were $31.7 million, compared to $27.5 million for the same period in 2014. The increase of $4.2 million, or 15%, from the 2014 period primarily resulted from increases of $2.0 million in nonclinical and manufacturing expenditures to advance the novel autoimmune programs, $1.8 million in clinical trial expenses as the necuparanib Phase 2 clinical trial continued to enroll patients and $0.3 million in share-based compensation expense associated with performance-based stock awards.

General and administrative expenses for the quarter ended September 30, 2015, were $12.5 million, compared with $11.1 million for the same period in 2014. The increase of $1.4 million, or 13%, from the 2014 period primarily resulted from increases of $0.8 million in share-based compensation associated with performance-based stock awards and $0.3 million in professional fees.

At September 30, 2015, Momenta had $374.9 million in cash, cash equivalents and marketable securities. This cash position excludes restricted cash of $20.7 million, of which $17.5 million is reserved as collateral for a security bond related to enoxaparin legal proceedings, and $3.2 million for letters of credit related to the company’s two leased facilities.

Financial Guidance
Today, Momenta provided guidance that it expects its operating expenses, excluding stock-based compensation and net of collaborative revenues, to be approximately $40 – $42 million per quarter for the fourth quarter of 2015.

On November 4, 2015 Genocea Biosciences, Inc. (NASDAQ: GNCA), a biopharmaceutical company developing T cell-directed vaccines and immunotherapies, reported findings that support the potential of ATLAS, the Company’s proprietary rapid antigen identification screening system, to profile responses to immunotherapies for cancer (Press release, Genocea Biosciences, NOV 4, 2015, View Source [SID:1234507945]). This analysis, in which ATLAS identified the specificity and characteristics of T cell responses in cancer patients, will be presented as a late-breaker at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 30th Anniversary Annual Meeting & Associated Programs in National Harbor, Maryland. The poster, #342, entitled Immunoprofiling of T cell responses in melanoma patients undergoing CPI therapy, will be presented on Saturday, November 7, 2015 between 12:00 – 2:00 p.m. ET.

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In this pilot study, funded by the Ludwig Trust, Genocea partnered with Darren Higgins, Ph.D., professor of microbiology and immunobiology at Harvard Medical School and F. Stephen Hodi, Jr., M.D., director of the Melanoma Center at Dana-Farber Cancer Institute, to conduct a retrospective analysis of 10 checkpoint inhibitor (CPI) treated patients’ T cell responses to 23 known tumor-associated antigens. By analyzing the immune responses of both responders and non-responders to CPI therapy, ATLAS successfully identified the cancer antigens to which either (or both) CD4+ or CD8+ T cells became activated. Although this research was not powered to draw firm conclusions, the analysis of T cell responses in patients receiving CPI therapy revealed a pattern indicating a greater breadth of T cell activation for responders than non-responders. The study also revealed preliminary evidence that different characteristics of T cell responses emerge when comparing patients who respond and those who do not. Some T cell responses did not correspond with improved patient outcomes, and may be classified as "decoys," further validating the ability of ATLAS to distinguish clinically relevant targets of T cell responses.

"The breakthroughs we’ve seen in the immuno-oncology field to date have been profound, yet emerging treatment approaches do not yet include an understanding of who may respond to therapy and why," said Jessica Baker Flechtner, Ph.D., senior vice president of research at Genocea. "These findings provide strong proof of concept that ATLAS can take a panoramic view of a large, diverse population of cancer patients and reveal clinically relevant signatures of protective responses. We believe we are uniquely positioned to utilize our technology to enable smarter profiling – indicating what must be present to see a benefit from therapy – as well as smarter identification of T cell antigens to drive cancer vaccine development."

The collaboration with Dana-Farber is ongoing as Genocea continues to analyze more blood samples to characterize T cell response profiles that may be prognostic of CPI efficacy, and to identify T cell antigens that may be included in novel immunotherapies.

About ATLAS

ATLAS is a first of its kind proprietary rapid antigen identification screening system that finds targets of protective T cell responses. The technology solves challenges to date associated with finding targets of T cell responses. ATLAS can examine T cell responses from large, diverse human populations, and comprehensively screen every potential antigen from a pathogen or target indication in a rapid, high-throughput manner, taking weeks versus years to find relevant antigens. Because targets identified by ATLAS are based on actual human immune responses to all potential antigens, with no guesswork or predictions, by the time these candidates reach clinical trials there may be a greater likelihood of success in clinical development. This approach provides the ability to identify smarter targets for use in developing vaccines and immunotherapies to treat infectious disease, cancer and autoimmunity.