On May 4, 2017 NewLink Genetics Corporation (NASDAQ:NLNK), reported consolidated financial results for the first quarter 2017, as well as progress in its clinical development programs (Press release, NewLink Genetics, MAY 4, 2017, View Source [SID1234518856]).

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Recent Highlights:

Presented promising interim Phase 2 data of the IDO pathway inhibitor, indoximod, in combination with KEYTRUDA (pembrolizumab) for patients with advanced melanoma at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) plenary session on April 4, 2017
Presented a poster on NLG802, "A novel prodrug of indoximod with enhanced pharmacokinetic properties," at AACR (Free AACR Whitepaper) on April 4, 2017
Abstract accepted for presentation at the 2017 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) for a randomized double-blind, placebo-controlled Phase 2 study of indoximod in combination with the vaccine, PROVENGE (sipuleucel-T), for patients with metastatic castration resistant prostate cancer
Abstract accepted for presentation at the 2017 ASCO (Free ASCO Whitepaper) Annual Meeting submitted by our partner on a Phase 1b dose-escalation study of navoximod (GDC-0919) in combination with TECENTRIQ (atezolizumab) in multiple solid tumors
"We believe that the emerging clinical data from NewLink Genetics and other companies are validating the fundamental hypothesis that the IDO pathway is central to immuno-suppression in cancer," said Charles J. Link, Jr. MD, Chairman, Chief Executive Officer and Chief Scientific Officer. "We have two distinct IDO pathway inhibitors advancing in the clinic, indoximod – which is wholly-owned by NewLink Genetics – and navoximod (GDC-0919), which is partnered to Genentech/Roche. In addition, we have a next-generation compound, a novel prodrug of indoximod, NLG802, which we expect to enter the clinic by the end of Q3 this year."

Guidance for remainder of 2017:

Metastatic castration resistant prostate cancer: Randomized, placebo-controlled Phase 2 clinical trial data to be presented at ASCO (Free ASCO Whitepaper) on Monday, June 5, 2017
Metastatic pancreatic cancer: Indoximod in combination with gemcitabine + ABRAXANE (nab-paclitaxel) Phase 2 trial to be presented at an upcoming medical meeting in the second half of 2017
Acute Myeloid Leukemia (AML): Interim data from a Phase 1b dose-escalation study of indoximod in combination with standard of care chemotherapy for patients with newly diagnosed AML to be presented second half of 2017
The Company announced that it intends to initiate a pivotal trial of indoximod plus anti-PD-1 inhibitors for patients with advanced melanoma by the end of 2017. The trial is expected to use an adaptive design that incorporates a brief dose confirmation stage followed by a definitive randomized stage.

"The clinical data for indoximod in advanced melanoma establishes the basis for this pivotal trial," said Nicholas N. Vahanian, MD, President and Chief Medical Officer.

Financial Results:

Cash Position: NewLink Genetics ended the first quarter with cash and cash equivalents totaling $118.2 million compared to $131.5 million for the year ending December 31, 2016.

We expect to end 2017 with approximately $75 million in cash and equivalents, which excludes any cash that may be received from financings or milestones.

R&D Expenses: Research and development expenses were $15.7 million in the first quarter of 2017 compared to $21.9 million in the first quarter of 2016. The decrease was due primarily to a $4.6 million decline in clinical trial and manufacturing-related spend, a decrease in personnel-related spend of $1.4 million, and a decrease in licensing and consulting fees of $1.0 million, offset by an increase in stock compensation expense of $822,000.

G&A Expenses: General and administrative expenses in the first quarter of 2017 were $8.2 million compared to $9.2 million in the first quarter of 2016. The decrease was due to a decline of $700,000 in consulting and legal fees, a decrease of $700,000 in personnel-related spend, offset by an increase in stock compensation expense of $437,000.

Net Loss: NewLink Genetics reported a net loss of $20.9 million or loss of $0.72 per diluted share for the first quarter of 2017 compared to a net loss of $23.7 million or loss of $0.82 per diluted share for the first quarter of 2016.

NewLink Genetics ended Q1 2017 with 29,219,661 shares outstanding.

Mirati has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Mirati, MAY 4, 2017, View Source [SID1234518853]).

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On May 4, 2017 Alligator reported that it will host a live webcast for analysts, investors and media on Friday, 5 May 2017, at 13:30 CET to discuss the data (Press release, Alligator Bioscience, MAY 4, 2017, View Source [SID1234538690]).

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ADC-1013, licensed to Janssen Biotech Inc., was shown to induce synergistic anti-tumor effects in combination with PD-1 receptor blockade in a pre-clinical bladder cancer model. Moreover, ADC-1013 indicated the potential to augment the effect of cancer vaccines in a lymphoma model.

"The new data supports that ADC-1013 may act synergistically with other immunotherapies, notably PD-1 checkpoint blockade and cancer vaccines, and holds great promise for the clinical programme." says Per Norlén, CEO at Alligator Bioscience.

The ATOR-1015 mechanism of action was confirmed in vitro and in vivo, and demonstrated tumor-directed immune activation. ATOR-1015 activated effector T-cells and suppressed regulatory T-cells in tumors, but not elsewhere in the body. Additional data included demonstration of anti-tumor effects in multiple tumor models and a strong data package on critical development properties including high solubility, thermal stability and manufacturing yield.

"The tumor-directed immune activation demonstrated by ATOR-1015 is remarkable. The predicted mechanism of action is confirmed and, based on the data, immune activation may be confined to the tumor area. The objective of adding clinical efficacy without adding significant toxicity seems to be within reach, and we are very much looking forward to initiating clinical development of ATOR-1015 in 2018," Per Norlén adds.

Webcast
The webcast can be accessed live on the link below and will be available on the company website 30 minutes after the broadcast.

View Source

Phone numbers for participants from:
UK: +442030089803
SE:+46856642696
US: +18558315946

For further information, please contact:
Per Norlén, CEO
Telephone: + 46 46 286 42 80 (switchboard)
E-mail: [email protected]

Rein Piir, VP Investor Relations at Alligator
Telephone: +46 708 537292
E-mail: [email protected]

Per-Olof Schrewelius, CFO
Telephone: +46 46 286 42 85
E-mail: [email protected]

This information is such information as Alligator Bioscience AB (publ) is obligated to disclose in accordance with EU market abuse regulation. The information was submitted, through the above contact persons, for publication on 4 May 2017 at 20:20 (CET).

On May 3, 2017 Saniona, a leading biotech company in the field of ion channels, reported that it has partici-pated in formation of Scandion Oncology A/S, a company focused on developing drugs for treatment of cancer. (Press release, Saniona, MAY 3, 2017, View Source [SID1234573560]). Saniona AB owns 51% of Scandion Oncology, which has subsequently acquired a clinical candidate and related platform from Saniona A/S. Scandion Oncology management and Saniona is currently considering various alternatives for financing the company including a private placement and a public listing, which may potentially include the distribution of Saniona’s shares in Scandion Oncology to Saniona’s shareholders in accordance to Lex ASEA under the Swedish income tax act.

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"The founders of Scandion Oncology have discovered that one of Saniona’s development compounds (termed SCO101) is able to reduce cancer growth by increasing the effects of standard chemotherapy through a new mode of action. The founders of Scandion Oncology and Saniona have filed a patent application covering this invention. By combining the invention with the knowledge of the Scandion Oncology Founders and the technology from Saniona, we can create a new interesting company to the benefit of cancer patients and Saniona’s shareholders," says Jørgen Drejer, CEO of Saniona.

"Scandion Oncology will be able to initiate Phase 2 clinical trials within a relatively short time frame and thereby provide proof of concept for the technology, which addresses one of the most important problems in modern oncology. With approximately 14 million new cancer cases worldwide annually, the business potential for an effective new drug, which improve the efficacy of standard chemotherapy is expected to reach that of a blockbuster," says Kim Arvid Nielsen, CEO of Scandion Oncology.

The program, which Scandion Oncology acquires from Saniona, comprises a development compound, SCO101, which has been evaluated in Phase 1 studies and a platform comprising a large series of chemical analogues as well as associated know-how. Saniona acquired these assets from NeuroSearch in 2012. Saniona was not planning to develop these assets internally since a clinical program in a different therapeutic indication was not successful. In 2015, Saniona granted scientists at the University of Copenhagen, Denmark, rights to test some of the compounds in their screening systems leading to the discovery that compounds with this mechanism of action enhance the effect of standard chemotherapy. The parties filed a patent and have subsequently been awarded a grant from Innovation Fund Denmark. Apart from mentioning the grant in a press release on July 5, 2016, Saniona has not discussed these assets publicly previously.

For clarity, the founders, management and the other shareholders of Scandion Oncology are independent of Saniona’s board, management and major shareholders of Saniona.

Altimmune has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Altimmune, 2017, MAY 3, 2017, View Source [SID1234521236]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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