On January 8, 2018 NewLink Genetics Corporation (NASDAQ:NLNK) reported Indigo301, the name of its upcoming Phase 3 trial of indoximod plus PD-1 inhibitors for patients with advanced melanoma, and outlined 2018 business priorities to support this trial (Press release, NewLink Genetics, JAN 8, 2018, View Source [SID1234523015]). In addition, the company updated clinical and financial guidance and provided preliminary unaudited financial information for year-end 2017.

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These updates were made in conjunction with the 36th Annual JP Morgan Healthcare Conference that begins today in San Francisco. NewLink Genetics’ Chairman and Chief Executive Officer, Charles J. Link, Jr., M.D., will discuss the Company’s continued execution of its corporate strategy and 2018 priorities as part of a live presentation on Thursday, January 11, 2018, at 11:00 AM PT/2:00 PM ET. The slide presentation with updated guidance has been posted on the Company’s website and may be found here. The oral presentation will be webcast and available on the NewLink Genetics website under the Investors & Media tab under Events & Presentations.

Indigo301 is a randomized Phase 3 study of indoximod or placebo plus KEYTRUDA (pembrolizumab) or OPDIVO (nivolumab) for patients with unresectable or metastatic melanoma. The choice of PD-1 inhibitors will be at the physician’s discretion, mirroring the general clinical setting. The study will consist of a planned 624 patients enrolled at approximately 100 sites in multiple countries and will include co-primary endpoints of Progression-Free Survival (PFS) and Overall Survival (OS), with a secondary endpoint of Objective Response Rate (ORR).

"NewLink has focused its business priorities on the execution of Indigo301 for patients with advanced melanoma," said Dr. Link. "We will also initiate a randomized Phase 2 trial in collaboration with AstraZeneca for patients with metastatic pancreatic cancer, and we anticipate clinical data from additional development programs."

To expedite the enrollment of Indigo301, NewLink Genetics has expanded the planned number of trial sites both within and outside of the US and plans several clinical recruitment initiatives to engage with the oncology community with the goal to enroll the majority of patients in 2018. As a result of these clinical planning efforts, NewLink Genetics is accordingly updating its guidance for clinical trials as follows:

Clinical Guidance and Milestones

Enroll the majority of Indigo301 trial by the end of 2018
Phase 2 results for indoximod + PD-1 blockade in advanced melanoma expected in 2018
Phase 2 results for indoximod + gem/nab-paclitaxel in pancreatic cancer expected 1H 2018
Phase 2 randomized AstraZeneca collaboration in pancreatic cancer to initiate 1H 2018
Financial Guidance and Outlook

"Entering 2018, we have aligned our business and investments to drive Indigo301 and other high-potential development programs," said Jack Henneman, Executive Vice President and Chief Financial Officer for NewLink Genetics. "As we continue to progress, we remain committed to maintaining the strength of our balance sheet in support of our most promising clinical programs."

NewLink Genetics ended 2017 with approximately $158 million in cash and cash equivalents. Updated guidance for use of cash is provided in the slide presentation available on the company’s website.

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, pancreatic cancer and other malignancies.

On January 8, 2018 Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, reported key 2018 priorities in conjunction with its presentation at the 36th Annual J.P. Morgan Healthcare Conference in San Francisco (Press release, Agios Pharmaceuticals, JAN 8, 2018, View Source [SID1234522985]). The presentation will outline how Agios’ clinical and research programs have the potential to provide meaningful benefit to a large number of patients. The company will webcast its presentation today at 9:30 a.m. PT (12:30 p.m. ET) at investor.agios.com.

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"We presented a significant amount of clinical data across our portfolio in 2017, including data supporting the approval of our first internally discovered medicine, which proves that our research and development engine has the ability to deliver important precision medicines from a discovery in the lab to patients as an approved drug," said David Schenkein, M.D., chief executive officer at Agios. "We are very pleased with the early launch performance of IDHIFA and expect to repeat this success with ivosidenib upon FDA approval in 2018, while continuing our label expansion opportunities for frontline AML and solid tumors and bringing our next drug candidate targeting genetically defined cancers, AG-270, into the clinic. In rare genetic diseases, AG-348 has demonstrated proof of concept in pyruvate kinase deficiency and in addition to beginning pivotal trials in this disease, we are exploring the utility of PK activation in other anemias, starting with a Phase 2 study in thalassemia."

The company plans to achieve the following key milestones in 2018:

Cancer:

Potential FDA approval and commercialization of ivosidenib for relapsed/refractory (R/R) acute myeloid leukemia (AML) with an isocitrate dehydrogenase-1 (IDH1) mutation in the United States in the second half of 2018.

Plan to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for ivosidenib for IDH1m R/R AML in the fourth quarter of 2018.

Support with Celgene an intergroup sponsored, global, registration-enabling Phase 3 trial combining ivosidenib or enasidenib and standard induction (7+3) and consolidation chemotherapy with a primary endpoint of event free survival (EFS) in frontline AML patients with an IDH1 or IDH2 mutation in the fourth quarter of 2018.

Initiate a perioperative ‘window’ trial with ivosidenib and AG-881 in low-grade glioma to further investigate their effects on brain tumor tissue in the first half of 2018.

Initiate a Phase 1 dose-escalation trial for AG-270, a first-in-class methionine adenosyltransferase 2a (MAT2A) inhibitor, in methylthioadenosine phosphorylase (MTAP)-deleted tumors in the first quarter of 2018.
Rare Genetic Diseases:

Initiate two global pivotal trials for AG-348 in PK deficiency:

ACTIVATE-T: A single arm trial of approximately 20 regularly transfused patients is expected to initiate in the first quarter of 2018.

ACTIVATE: A 1:1 randomized, placebo-controlled trial of 80 patients who do not receive regular transfusions is expected to initiate in the second quarter of 2018.

Initiate a global registry for adult and pediatric patients with PK deficiency (PEAK) in the first quarter of 2018 to increase understanding of the long-term disease burden of this chronic anemia.

Initiate a Phase 2 proof of concept trial of AG-348 in thalassemia in the fourth quarter of 2018.
Research:

Submit an investigational new drug (IND) application for our latest development candidate, an inhibitor of the metabolic enzyme dihydroorotate dehydrogenase (DHODH) for the treatment of hematologic malignancies in the fourth quarter of 2018.
The company plans to host an analyst day in the first half of 2018 to review Agios’ commercial readiness and broad clinical development programs and highlight the depth of the research portfolio across oncology, rare genetic disease and metabolic immuno-oncology.

The company also highlighted key 2017 achievements:

Collaborated with Celgene to achieve the U.S. Food and Drug Administration (FDA) full approval and subsequent launch of IDHIFA (enasidenib) for the treatment of adult patients with R/R AML with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA approved diagnostic test.

Submitted a new drug application (NDA) to the FDA for ivosidenib for the treatment of patients with R/R AML with an IDH1 mutation.

Initiated a global, registration-enabling Phase 3 study (AGILE) combining ivosidenib and VIDAZA in newly diagnosed AML patients with an IDH1 mutation ineligible for intensive chemotherapy.

Finalized two global, pivotal trial designs evaluating AG-348 in adults with pyruvate kinase (PK) deficiency.

Achieved FDA clearance of an IND application for AG-270, a MAT2A inhibitor, targeting MTAP-deleted tumors.
2017 Year-End Cash and Updated Guidance

Agios ended 2017 with approximately $568 million of cash, cash equivalents and marketable securities. Based on its expanded clinical and research programs announced today, the company now expects that its existing cash, cash equivalents and marketable securities as of December 31, 2017, together with anticipated interest income, anticipated expense reimbursements, and royalty payments under our collaboration agreements, but excluding any additional program-specific milestone payments, will enable the company to fund its anticipated operating expenses and capital expenditure requirements through the end of third quarter of 2019.

Presentation at 36th Annual J.P. Morgan Healthcare Conference

Agios will webcast its corporate presentation from the 36th Annual J.P. Morgan Healthcare Conference in San Francisco on Monday, January 8, 2018 at 9:30 a.m. PT (12:30 p.m. ET). A live webcast of the presentation can be accessed under "Events & Presentations" in the Investors section of the company’s website at agios.com. A replay of the webcast will be archived on the Agios website for at least two weeks following the presentation.

On January 8, 2018 Critical Outcome Technologies Inc. (TSX VENTURE:COT)(OTCQB:COTQF) ("COTI" or the "Company"), a clinical-stage pharmaceutical company advancing a pipeline of targeted therapies for the treatment of cancer, reported a name change from "Critical Outcome Technologies Inc." to "Cotinga Pharmaceuticals Inc (Press release, Critical Outcome Technologies, JAN 8, 2018, View Source [SID1234533160])." The effective date of the name change, approved by shareholders in December 2017, is expected to be January 10, 2018.

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This new brand signifies the Company’s evolution from a technology-driven company to a clinical-stage pharmaceutical company. The name is derived from the Cotingas, one of the world’s largest and most diverse bird species, and symbolizes the Company’s focus on developing innovative therapies to treat a wide spectrum of cancers.

"We are excited to officially introduce Cotinga Pharmaceuticals," said Alison Silva, President & CEO. "After a close review of the business, we have launched a new brand that reaffirms our identity, recognizes our achievements in the clinic, and underscores our continued commitment to develop therapeutics for patients suffering from various cancers. We have made considerable progress advancing our pipeline of targeted therapies to date, and we look forward to building on this progress in the year ahead as we continue the Phase 1 trial of our lead compound, COTI-2, in head and neck squamous cell carcinoma (HNSCC) and prepare our second compound, COTI-219, for an investigational new drug (IND) submission."

On January 8, 2018 Teneobio, Inc., a next generation multi-specific antibody therapeutics company announced today the initiation of a research collaboration and licensing agreement with TESARO, Inc., an oncology-focused biopharmaceutical company, to develop novel multi-specific antibodies for up to six undisclosed oncology targets (Press release, TeneoBio, JAN 8, 2018, View Source [SID1234585553]).

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Under the terms of the agreement, Teneobio will generate product candidates using its proprietary UniRat transgenic human antibody ‘heavy-chain only’ rodent platform and its state-of-the-art sequence-based discovery engine, TeneoSeek. TESARO will have exclusive licenses to the antibodies for clinical development and commercialization on a global basis.

Teneobio Inc. will receive an upfront of $10 million and is eligible for research fees and up to $50M in development milestones per product. Teneobio would also receive royalties on world–wide net sales of each multi-specific product. Additional terms of the agreement were not disclosed.

Roland Buelow, CEO of Teneobio, added, "We are excited to embark on a productive research collaboration with TESARO. The rapid, sequence-based discovery of UniRat-derived modular human variable heavy-chain antibody domains (UniDabs), enables the assembly of robust, optimized multi-specific therapeutics with excellent manufacturability. Complementing our internal pipeline, our strategic alliance with TESARO further leverages the bandwidth and efficiency of Teneobio’s state-of-the-art discovery platforms to advance specific biotherapeutics to the clinic. TESARO’s track record and focus on immuno-oncology are a great match to our interests and our goal to address unmet medical needs with novel mechanisms of action that are now afforded by breakthrough multi-specifics."

"Single domain antibodies have emerged as a leading platform that enables targeted immune activation," said Mary Lynne Hedley, Ph.D., President and COO of TESARO. "This strategic research collaboration with Teneobio will allow us to develop biologic drug candidates with novel mechanisms of action. We look forward to working with the Teneobio team, which has a strong track record of success in designing biologic drug candidates."

On January 8, 2018 Novavax, Inc. presented Investor Presentation (Presentation, Novavax, JAN 8, 2018, View Source [SID1234522978]).

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