On March 9, 2018 Pieris Pharmaceuticals, Inc. (NASDAQ: PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for cancer, respiratory and other diseases, reported that financial results for its fiscal year ended December 31, 2017, and provided a corporate update (Press release, Pieris Pharmaceuticals, MAR 9, 2018, View Source [SID1234524603]):

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PRS-343: Pieris continues to advance PRS-343, a tumor-targeted 4-1BB-based immuno-oncology (IO) bispecific, through a phase 1, dose-escalation study, with initial safety, tolerability, pharmacokinetic and pharmacodynamic data expected in the second half of 2018. This program is the first bispecific T cell costimulatory agonist to enter clinical development.
PRS-060: The company continues to enroll healthy subjects in a first-in-human study for PRS-060, an IL-4 receptor alpha antagonist, which began during the fourth quarter of 2017. PRS-060 is the lead product in the company’s respiratory alliance with AstraZeneca. Pieris is sponsoring the phase 1 study, while AstraZeneca is responsible for funding its costs. Initial data from the phase 1 study are expected in the fourth quarter of 2018. AstraZeneca will sponsor and continue to fund clinical development of PRS-060 through phase 2a, after which the company may exercise an option to co-develop PRS-060. Pieris also has an option for U.S. co-commercialization rights for this program.
PRS-080: Pieris continues to enroll dialysis-dependent patients with functional iron deficiency anemia in a phase 2a study for PRS-080. Pieris intends to report safety and pharmacodynamic data from this study, including the change in hemoglobin levels after five weekly doses of PRS-080, in the second half of 2018. If data are positive, the company will seek to partner PRS-080 in territories outside of those for which ASKA Pharmaceutical Co. has an exclusive option (Japan and certain other Asian territories).
Seattle Genetics Collaboration: On February 9, 2018, the company announced a multi-program IO-focused alliance with Seattle Genetics. The collaboration leverages the expertise and core technologies of both companies to develop novel Antibody-Anticalin bispecific fusion proteins utilizing Seattle Genetics’ tumor-targeted monoclonal antibodies and Pieris’ costimulatory engaging Anticalin proteins. Under the collaboration, Seattle Genetics will pay Pieris a $30 million upfront fee. Pieris has the potential to receive up to $1.2 billion in success-based payments in addition to royalties up to the double digits in connection with the sales of commercialized products, as well as an option to co-develop and commercialize one of the programs in the U.S.
Equity Financing: In February 2018, the company completed an underwritten public offering in which it sold 6,325,000 shares of common stock, including the full exercise of the over-allotment of an additional 825,000 shares, to the public at a price of $8.00 per share. Net proceeds of the underwritten public offering, after deducting the underwriting discounts and commissions and financing costs, were $47.3 million.
Cash Position: Cash, cash equivalents and investments totaled $82.6 million as of December 31, 2017. This amount excludes payment of a $12.5 million milestone from AstraZeneca achieved in the fourth quarter of 2017, the $47.3 million in net proceeds from the February 2018 equity financing, and the $30.0 million upfront payment due from Seattle Genetics.
"2017 was a transformational year for Pieris, as we advanced our lead respiratory and IO drug candidates into the clinic, while advancing PRS-080 into a phase 2a study and entering into two major alliances, in respiratory diseases and IO, bringing increased validation to our R&D strategy while retaining commercial rights on several partnered programs and strengthening our cash position," said Stephen S. Yoder, President and CEO. "This momentum continued into 2018 as we signed a significant IO collaboration agreement with Seattle Genetics. We are developing three clinical-stage programs, data from all of which are projected to be available later this year. In addition, we continue to build long-term value by advancing multiple preclinical IO programs with the intention to file two new INDs in 2019, while engaging in a broad research effort developing novel Anticalin proteins against multiple targets in both IO and respiratory diseases. We look forward to sharing data across our pipeline later this year."

Fiscal Year Financial Update:

Cash Position – Cash, cash equivalents and investments totaled $82.6 million as of December 31, 2017, compared to a cash balance of $29.4 million as of December 31, 2016. The increase was driven primarily by a $45.0 million upfront payment received as part of the AstraZeneca respiratory alliance, a EUR30.0 million (approximately $32.0 million) upfront payment received from Servier, and a $2.8 million option payment received from ASKA. This was offset by $39.3 million of operating cash expenditures during the year.

R&D Expense – R&D expenses were $22.3 million for the year ended December 31, 2017, compared to $19.7 million for the year ended December 31, 2016. The Company’s increase in R&D expenses reflects advancement across its pipeline of programs as well as preparation for and advancement of clinical studies.

G&A Expense – G&A expenses for the year ended December 31, 2017 were $17.6 million, compared to $8.9 million for the year ended December 31, 2016. The increase in the 2017 period as compared to the corresponding period in 2016 is attributable in part to transaction fees associated with the company’s partnership agreements and investments in our G&A functions including personnel costs, recruiting costs, and professional services (audit, tax, legal and communications) to support the growing business.

Net Loss – Net loss was $17.6 million or $(0.40) per share for the year ended December 31, 2017, compared to a net loss $22.8 million or $(0.55) per share for the year ended December 31, 2016.

Conference Call:

Pieris management will host a conference call beginning at 8:00 AM Eastern Standard Time on Friday, March 9, 2018, to discuss the full year financial results and provide a corporate update. You can join the call by dialing +1-877-407-8920 (US & Canada) or +1-412-902-1010 (International). An archived replay of the call will be available by dialing +1-877-660-6853 (US & Canada) or +1-201-612-7415 (International) and providing the Conference ID #: 13661472.

Puma Biotechnology has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Puma Biotechnology, 2018, MAR 9, 2018, View Source [SID1234524630]).

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On March 9, 2018 Trillium Therapeutics Inc. (NASDAQ/TSX: TRIL), a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported financial and operating results for the year ended December 31, 2017 (Press release, Trillium Therapeutics, MAR 9, 2018, View Source [SID1234524605]).

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"In 2017 we achieved a marked increase in patient enrollment in both our intravenous and intratumoral trials with TTI-621, which has allowed us to gain further insight into the safety and activity of this novel innate immune checkpoint inhibitor," said Dr. Niclas Stiernholm, President and CEO of Trillium Therapeutics. "We were especially gratified to see single-agent activity, as it may provide us with a relatively direct route to more advanced trials, while still having opportunities to pursue combination therapies in the future. In 2018 we plan to transition from signal-seeking mode to focusing on the most promising indications. We will also be introducing our second clinical CD47 program, TTI-622, leveraging the knowledge gained with TTI-621."

2017 Highlights:

Presented data at the 2017 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting showing locoregional tumor regression in 9/10 cutaneous T cell lymphoma patients receiving intratumoral TTI-621 monotherapy, often after a single injection.

Presented data at the 2017 ASH (Free ASH Whitepaper) Annual Meeting demonstrating that heavily pre- treated patients with relapsed/refractory diffuse large B cell lymphoma can achieve objective responses and/or prolonged progression-free intervals, following intravenous administration of TTI-621 either as monotherapy or in combination with rituximab.

ASH data indicate that TTI-621 is well tolerated by both routes of administration; notably, the transient thrombocytopenia observed after intravenous dosing was shown to be attenuated after the first dose.

Received a "Study May Proceed" letter from the FDA to enable a Phase 1a/b clinical trial of TTI-622 (SIRPa-IgG4 Fc) in cancer patients. This study will consist of a 3+3 intrapatient dose-escalation phase followed by an expansion phase with combination therapy cohorts.

Annual 2017 Financial Results

As of December 31, 2017, Trillium had cash and cash equivalents and marketable securities, and working capital of $81.8 million and $68.9 million, respectively, compared to $50.5 million and $45.5 million, respectively at December 31, 2016. The increase in cash and cash equivalents and marketable securities, and working capital was due mainly to the June and December 2017 financings raising net proceeds of $62.5 million partially offset by cash used in operations of approximately $27.0 million and an unrealized foreign exchange loss of $3.7 million.

Net loss for the year ended December 31, 2017 of $45.1 million was higher than the loss of $31.7 million for the year ended December 31, 2016. The net loss was higher due mainly to higher research and development expenses of $7.3 million in 2017 from two active TTI-621 phase I trials and manufacturing expenses for TTI-622, the recognition of a deferred tax recovery in the year ended December 31, 2016 related to the acquisition of Fluorinov of $3.7 million, and a higher net foreign currency loss of $2.7 million in 2017.

On March 8, 2018 Vaccibody AS, a clinical stage company focused on developing personalized neoepitope cancer vaccines to target solid tumors, reported that approval of Clinical Trial Application (CTA) for its cancer neoantigen phase I/IIa trial by German regulatory authorities (Paul Ehrlich Institute (PEI) (Press release, Vaccibody, MAR 8, 2018, View Source [SID1234525139]).

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Dr. Martin Bonde, Chief Executive Officer in Vaccibody, said "The regulatory approval of this sophisticated study with our individualized neoantigen vaccine VB10.NEO is a critical milestone for the company. We are evaluating the safety, feasibility, and efficacy of VB10.NEO in combination with standard of care checkpoint inhibitor therapy. The clinical trial will enroll patients with locally advanced or metastatic non-small cell lung cancer, melanoma, renal, bladder, and head&neck cancer. A total of 40 patients are planned to be enrolled in the phase I part of the trial."

On March 8th, 2018 Aurigene Discovery and a specialized biotechnology company engaged in discovery and early clinical development of novel and best-in-class therapies to treat cancer and inflammatory diseases, reported plans to initiate a Phase 2 trial of CA-170, a PDL1-VISTA inhibitor to be conducted at sites in India (Press release, Aurigene Discovery, MAR 8, 2018, View Source [SID1234624578]).

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This was announced following the presentation of preliminary data from the initial 34 patients with cancer treated in the dose escalation stage of the Phase 1 trial of CA-170 at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2017 Congress by Aurigene’s collaborator and licensee of CA-170, Curis, Inc., a biotechnology company focused on the development and commercialization of innovative and effective therapeutics for the treatment of cancer. The trial has been conducted in the U.S., South Korea and Spain. The Phase 2 trial is the result of the initial safety data and preliminary evidence of clinical benefit observed in the trial.

CA-170 is an oral small molecule targeting the immune checkpoints PDL1 and VISTA. Data presented at the ESMO (Free ESMO Whitepaper) 2017 conference represent the initial 34 patients treated to date in the dose escalation Phase 1 trial. 30 patients were naïve to prior immunotherapy treatment, while four patients had experienced prior treatment with approved anti-checkpoint antibodies. No dose limiting toxicities were observed at doses ranging from 50 mg to 800 mg once daily dosing examined thus far. CA-170 demonstrated good oral bioavailability and plasma drug levels were shown to increase in a near-linear manner with increasing doses.

Evidence of immune modulation, including an increase in activated CD8+ T cells, was observed in patient blood and tumor biopsy samples examined following treatment. Of the 21 patients evaluable for disease assessment, 13 patients experienced disease stabilization. Four immunotherapy treatment-naïve patients treated with CA-170 experienced shrinkage of their tumors. Six patients remained on drug treatment beyond three months, including all four patients with tumor shrinkages. In addition, seven of the 34 patients remain on study and are continuing with treatment.

"These results are consistent with the observations made in the preclinical setting and further affirm CA-170’s mechanism of action as an oral small molecule checkpoint inhibitor. Based on these initial clinical results, we are excited for the opportunity to expand testing of CA-170, possibly in earlier lines of treatment and in a greater number of immunotherapy treatment-naïve cancer patients," commented Mr. CSN Murthy, Chief Executive Officer of Aurigene. "Together with Curis, we have designed a Phase 2 trial, treating selected populations of patients of interest in the CA-170 program to be treated at major cancer centers in India. Aurigene’s decision to sponsor and fund this trial is further affirmation of our commitment to CA-170 and a reflection of the successful collaboration we have with Curis in multiple development programs. Aurigene has the commercial rights to the program in India and Russia in addition to milestones, royalties other commercial supply rights globally."

"We are pleased with these early results. Evidence of tumor shrinkage and multiple patients remaining on drug treatment for extended periods, along with signals for biomarkers of immune modulation in patient blood and tumor samples, tells us the program continues to move in the right direction. We plan to continue with the dose escalation and continued analysis of patient biopsy samples in the Phase 1 trial," said Ali Fattaey, Ph.D., President and Chief Executive Officer of Curis. "We expect to provide additional updates at upcoming conferences including the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting in November."

"The ability for cancer patients to administer a potential checkpoint inhibitor on their own as a once daily oral drug is a significant and unique opportunity in our field," added Adil Daud, M.D., investigator in the CA-170 Phase 1 trial and director of Melanoma Clinical Research at the UCSF Helen Diller Family Comprehensive Cancer Center. "These initial clinical results are encouraging and merit continued development."