On July 14, 2015 NewLink Genetics reported shared its strategy for becoming a leading immuno-oncology company at a meeting for analysts and investors in New York (Press release, NewLink Genetics, JUL 14, 2015, View Source [SID:1234506331]). A link to the webcast and the slides can be accessed in the investor relations section of the company’s website, www.newlinkgenetics.com.
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"The key pillars of our strategy continue to build on the emerging scientific and clinical consensus that future treatment options for patients with cancer will need to generate a targeted immune response and disrupt checkpoint blockade," said Charles Link, Jr., M.D., Chairman and Chief Executive Officer. "We believe that our HyperAcute Immunotherapy and IDO pathway inhibitor platform products show great promise and could be important advances for patients with cancer."
The NewLink Genetics management team presented on key areas:
Advancing an industry-leading immuno-oncology therapy pipeline across multiple cancer types with seven product candidates in clinical development from Phase 1 to Phase 3. Through the company’s multi-faceted immuno-oncology treatment strategy, NewLink Genetics is engaged in clinical trials for five distinct HyperAcute Immunotherapy candidates and two indoleamine 2, 3-dioxygenase (IDO) pathway inhibitor product candidates. This pipeline of immuno-oncology products is one of the broadest and most advanced of the emerging companies in the immuno-oncology field, addressing multiple cancers including pancreatic, non-small cell lung, breast, melanoma, prostate, renal and glioblastoma multiforme.
Unique HyperAcute Immunotherapy platform. This proprietary technology produces allogeneic whole-cell vaccines engineered to express alpha gal, a carbohydrate that has been shown to produce hyperacute immune responses. HyperAcute Immunotherapy is being studied in the clinic and suggests the inducement of immune responses against pancreatic cancer, non-small-cell lung cancer, melanoma, prostate cancer and renal cancer.
Multiple small molecules targeting the key IDO checkpoint blockade. Indoleamine 2, 3-dioxygenase (IDO) is a naturally occurring enzyme that allows the human body to suppress its immune system, when needed. Some cancers have developed the ability to employ IDO to evade immune attack. Two NewLink Genetics’ products in clinical development —indoximod and GDC-0919 (partnered with Genentech)—inhibit the IDO pathway to counteract this immune suppression.
Founding scientific and business leadership with proven expertise in drug discovery, manufacturing, clinical development and commercialization. The company has built an effective and efficient organization with the capabilities to perform clinical trials on a broad portfolio of product candidates for numerous indications, to prepare the necessary regulatory filings and to manufacture clinical and commercial drug supply.
Algenpantucel-L has the potential to be the first FDA-approved drug for the adjuvant treatment of patients with resected pancreatic cancer. Algenpantucel-L HyperAcute Immunotherapy was developed to address an unmet medical need in resected pancreatic cancer. Algenpantucel-L is in the late stages of a Phase 3 registration clinical trial (IMPRESS) in patients with surgically resected pancreatic cancer. The company also has begun to build out the commercial infrastructure needed to effectively launch algenpantucel-L should it receive FDA approval.
Proven success in substantial strategic collaborations. The quality of the company’s product pipeline has been validated in its ability to form successful collaborations with two leading biopharmaceutical companies—Genentech in immuno-oncology and Merck in infectious disease.
"Over the next 24 months, we expect significant value-creating news flow," commented Nicholas N. Vahanian, M.D., President and Chief Medical Officer. "In addition to pivotal results from our algenpantucel-L program covering two distinct and potential first-mover indications in pancreatic cancer (IMPRESS for patients with resected pancreatic cancer and PILLAR for patients with locally advanced or borderline resectable pancreatic cancer), we expect clinical advancements across our IDO pathway inhibitor program in multiple cancers, clinical milestones with Genentech on the clinical advancement of GDC-0919, the initiation of new combination trials and potential results from the clinical trials assessing our Ebola vaccine candidate through our partnership with Merck."