On March 9, 2018 LabCorp (NYSE: LH), a leading global life sciences company, reported that its Covance Drug Development (Covance) business has formed a global immunology and immunotoxicology (I&I) unit dedicated to the specific needs of biologic drug development (Press release, Covance, SEP 9, 2018, View Source [SID1234524652]). This team brings together Covance’s operational expertise in flow cytometry, immunoassays and cell-based assays with its scientific expertise in immunotoxicology study design, direction and operation to provide a more comprehensive offering for large-molecule drugs.

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"With the formation of this team, we continue to demonstrate Covance’s commitment to strengthening our biologics solutions with key investments in scientific staff, technology and facilities"

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"With the formation of this team, we continue to demonstrate Covance’s commitment to strengthening our biologics solutions with key investments in scientific staff, technology and facilities," said John Ratliff, CEO of Covance. "Biologics make up more than one-third of biopharma’s pipeline. Integrating our scientific and operational know-how into a seamless group allows us to deliver even richer scientific insights and faster cycle times for clients’ biologic programs, which helps our clients bring cutting-edge new drugs to patients faster."

Covance’s immunology and immunotoxicology experts, overseen by Shawn Heidel, D.V.M., Ph.D., vice president and global head, Safety Assessment, Metabolism and Lead Optimization, support and advise in the development of biologic projects from pre-clinical evaluation to new drug regulatory submission and clinical study sample analysis. The new I&I unit’s comprehensive offering also includes a seamless bridge to bioanalysis for use in regulatory submissions and to Covance Phase I clinical research units for first-in-human and first-in-patient studies. As studies progress, the I&I team can complete its unique set of solutions by drawing on additional expertise from Covance’s clinical development and commercialization, translational biomarker, immuno-oncology and central laboratory teams, as well as LabCorp’s specialist scientific and technical capabilities. The formation of Covance’s I&I unit illustrates LabCorp’s continued focus on biologics, which extends through LabCorp Diagnostics’ expanding suite of biologic therapeutic drug monitoring tests.

Covance’s initial investment in I&I capabilities focused on increasing global capacity by expanding dedicated laboratory space, state-of-the-art instrumentation and scientific and operations teams. In 2017 alone, Covance more than doubled its I&I laboratory footprint, including additional space in three locations and establishing a new innovation laboratory for method development and validation. Staff size has also doubled, driven by an increase in the number of scientists with advanced degrees. Covance’s recent investments in technology and innovation capabilities have enabled the business to further scale production, as well as support the development and implementation of new services within the rapidly growing biologics market.

"Our growing I&I team is capitalizing on the global experience of our established facilities in the U.S., Germany and the U.K. to deliver comprehensive support for large-molecule development, from innovative testing methods to insightful data analysis and interpretation," said Steve Street, Ph.D., senior vice president of Covance Early Development. "In addition to study design, development and direction, the global innovation team within our I&I unit will focus on new assay development and validation, keeping Covance at the forefront of biologic research and development."

Rexahn 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, Rexahn, 2018, MAR 9, 2018, View Source [SID1234524636]).

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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.

Cascadian Therapeutics 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, Cascadian Therapeutics, 2018, MAR 8, 2018, View Source [SID1234524549]).

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On March 8, 2018 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development and commercialization of innovative and effective therapeutics for the treatment of cancer, reported its financial results for the fourth quarter and year ended December 31, 2017 (Press release, Curis, MAR 8, 2018, View Source [SID1234524538]).

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"2017 exemplified Curis’s business strategy, marking the Company’s first time with three anti-cancer drug candidates in clinical development" said Ali Fattaey, Ph.D., Chief Executive Officer of Curis. "We are excited about CUDC-907 treatment providing durable responses in nearly 1 in 4 DLBCL patients whose cancers have MYC alterations. We are working closely with regulatory authorities to define a pivotal path to register CUDC-907 in this patient population, which has no viable treatment options."

"Our progress with testing CA-170, the first and only oral small molecule checkpoint inhibitor, has now extended beyond the Phase 1 trial, with our partner Aurigene having initiated a Phase 2 trial in India. This will greatly accelerate access to select populations of patients that have not experienced prior immunotherapy."

"As noted, with initiation of patient enrollment in CA-4948’s Phase 1 lymphoma study, for the first time, Curis has 3 different cancer drugs in clinical testing at the same time. We are excited about the prospects for these drugs and their value to Curis’s success in 2018."

Full Year and Fourth Quarter 2017 Financial Results

For the year ended December 31, 2017, Curis reported a net loss of $53.3 million, or $(0.36) per share on both a basic and diluted basis, as compared to a net loss of $60.4 million, or $(0.45) per share on both a basic and diluted basis in 2016. For the fourth quarter of 2017, Curis reported a net loss of $8.0 million or $(0.05) per share on both basic and diluted basis, as compared to a net loss of $11.3 million, or $(0.08) per share on both basic and diluted basis for the same period in 2016. The net loss for the year ended December 31, 2016, includes a non-cash in-process research and development charge of $18.0 million related to the amendment of Curis’s license agreement with Aurigene.

Revenues for the year ended December 31, 2017 were $9.9 million, as compared to $7.5 million for the same period in 2016. Revenues for both periods comprise primarily royalty revenues recorded on Genentech and Roche’s net sales of Erivedge. Revenues for the fourth quarters of 2017 and 2016 were $3.3 million and $2.4 million, respectively.

Operating expenses were $59.7 million for the year ended December 31, 2017, as compared to $65.6 million for the same period in 2016. Operating expenses for the fourth quarter of 2017 were $10.4 million, as compared to $13.1 million for the same period in 2016, and comprised the following:

Costs of Royalty Revenues. Costs of royalty revenues, primarily amounts due to third-party university patent licensors in connection with Genentech and Roche’s Erivedge net sales, were $0.5 million for the year ended December 31, 2017, as compared to $0.4 million for the same period in 2016. Cost of royalty revenues were $0.2 million for the fourth quarter of 2017, as compared to $0.1 million for the same period in 2016.

In-Process Research and Development Expense. The Company recorded a one-time in-process research and development expense of $18.0 million for the year ended December 31, 2016, related to the issuance of common stock to Aurigene. These shares were issued as consideration for the rights granted under the terms of the September 2016 amendment to the collaboration agreement.

Research and Development Expenses. Research and development expenses were $45.1 million for the year ended December 31, 2017, as compared to $31.6 million for the same period in 2016. The increase was primarily due to two payments to Aurigene for $3.8 million each, for an exclusivity option which were paid in January 2017 and September 2017 as well as increased costs related to ongoing clinical activities for CA-170. Employee-related expenses increased over the prior year period primarily due to higher stock based compensation and personnel costs. Research and development expenses were $6.9 million for the fourth quarter of 2017, as compared to $9.2 million for the same period in 2016.

General and Administrative Expenses. General and administrative expenses were $14.1 million for the year ended December 31, 2017, as compared to $15.6 million for the same period in 2016. The decrease in general and administrative expenses was driven primarily by lower legal, professional and consulting services and other administrative expenses, offset slightly by higher stock-based compensation for the period. General and administrative expenses were $3.3 million for the fourth quarter of 2017, as compared to $3.8 million for the same period in 2016.

Other expense, net was $3.6 million for the year ended December 31, 2017, as compared to $2.4 million for the same period in 2016. Other expense, net primarily consisted of interest expense related to the debt obligations of Curis Royalty (a wholly owned subsidiary of Curis). The increase in interest expense in the current year was related to a higher principal balance of Curis Royalty’s outstanding debt with HealthCare Royalty, which was refinanced in the first quarter of 2017. Other expense, net was $0.9 million for the fourth quarter of 2017, as compared to $0.6 million for the same period in 2016.

As of December 31, 2017, Curis’s cash, cash equivalents, marketable securities and investments totaled $60.2 million and there were approximately 164.2 million shares of common stock outstanding.

Recent Operational Highlights

Precision oncology, CUDC-907:

In December 2017, investigators presented results from the combined analysis of the Phase 1 and Phase 2 trial results of CUDC-907 in patients with relapsed/refractory DLBLC, including those with MYC-altered disease, at the American Society of Hematology (ASH) (Free ASH Whitepaper)’s annual meeting in Atlanta, Georgia.
Precision oncology, CA-4948 (IRAK4 Kinase Inhibitor; Aurigene collaboration):

In December 2017, Curis scientists presented non-clinical results demonstrating significant anti-tumor activity when CA-4948 was combined with the BCL2 antagonist drug venetoclax, at the American Society of Hematology (ASH) (Free ASH Whitepaper)’s annual meeting in Atlanta, Georgia.
In January 2018, Curis announced initiation of patient dosing in a Phase 1 trial of CA-4948 for treatment of patients with lymphoma. CA-4948 was discovered at Aurigene and is the second licensed program from the Curis-Aurigene collaboration to enter the clinic.
Immuno-oncology, CA-170 (PDL1 / VISTA antagonist; Aurigene collaboration):

In November 2017, investigators presented preliminary results from the dose escalation stage of the Phase 1 trial of CA-170 in patients with advanced solid tumors or lymphomas, at the annual meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), in National Harbor, Maryland.
Curis collaborator, Aurigene, initiated patient enrollment of cancer patients in a Phase 2 clinical study of CA-170 at trial sites in India.
Immuno-oncology, CA-327 (PDL1 and TIM3 antagonist; Aurigene collaboration):

In November 2017, Curis scientists presented non-clinical results demonstrating CA-327’s ability to modulate tumor immune profile in mouse models, as well as its anti-cancer activity as a single agent or in combination with CA-170, at the annual meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), in National Harbor, Maryland.
Upcoming Activities

Curis expects that it will make presentations at the following conferences through April 2018:

Cowen & Company 38th Annual Health Care Conference (March 12-14) in Boston
Conference Call Information

Curis management will host a conference call today, March 8, 2018, at 8:30 a.m. EST, to discuss these financial results, as well as provide a corporate update.

To access the live conference call, please dial (877) 870-4263 from the United States or (412) 317-0790 from other locations, shortly before 8:30 a.m. EST. The conference call can also be accessed on the Curis website at www.curis.com in the Investors sectio