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 4, 2017 Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel immuno-oncology therapies, reported financial results for the first quarter ended March 31, 2017, and provided a business update (Filing, Q1, Corvus Pharmaceuticals, 2017, MAY 4, 2017, View Source [SID1234518836]).

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"We are continuing to make significant progress in our Phase 1/1b trial, which is designed to rapidly identify the diseases where our lead product candidate, CPI-444, has the greatest potential both as a single agent and in combination with atezolizumab," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "This strategic design has allowed us to identify four cohorts for expansion based on the demonstration of anti-tumor activity in renal cell cancer and non-small cell lung cancer, especially in patients that are resistant or refractory to prior treatment with anti-PD(L)-1 antibodies, and whose tumors are PDL-1 negative, an extremely difficult to treat patient population. We look forward to presenting additional clinical data from these cohorts in an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June 2017."

Recent Achievements and Upcoming Milestones
Clinical & Preclinical Development

Expanded four cohorts from 14 to 26 patients in the ongoing disease-specific expansion part of the Phase 1/1b clinical study of the Company’s lead oral checkpoint inhibitor, CPI-444. The expanded cohorts include treatment with both CPI-444 as a single agent and in combination with atezolizumab (Tecentriq), an anti-PD-L1 antibody, in renal cell cancer (RCC) and non-small cell lung cancer (NSCLC).
Presented interim safety data on 113 patients and efficacy data for 96 patients enrolled the Company’s Phase 1/1b study at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2017. The data showed that treatment with CPI-444 was well tolerated, provided disease control and induced tumor regression in a number of patients with extensive disease, especially in patients who were resistant/refractory to prior treatment with anti-PD(L)-1 antibodies.
Plan to present clinical data from the four disease expansion cohorts in both RCC and NSCLC at the ASCO (Free ASCO Whitepaper) Annual Meeting in June 2017.
Continued to progress anti-CD73 antibody and ITK inhibitor programs toward Phase 1 study initiation in 2018.
Corporate Development

On May 1, 2017, Corvus expanded its collaboration agreement with Genentech, a member of the Roche Group. Under the new agreement, CPI-444 administered in combination with atezolizumab (Tecentriq) will be evaluated in a Phase 1b/2 randomized, controlled clinical study as second-line therapy in patients with non-small cell lung cancer (NSCLC) who are resistant/refractory to prior therapy with an anti PD(L)-1 antibody. It is anticipated that the study will enroll up to 65 patients in the treatment arm. Genentech will manage study operations for the Phase 1b/2 trial, which is expected to begin enrolling patients in the second half of 2017. Corvus retains global development and commercialization rights to CPI-444.
Financial Results

At March 31, 2017, Corvus had cash, cash equivalents and marketable securities totaling $122.1 million. This compared to cash, cash equivalents and marketable securities of $134.9 million at December 31, 2016.

Research and development expenses for the three months ended March 31, 2017 totaled $13.5 million compared to $5.4 million for the same period in 2016. The increase of $8.1 million was primarily due to an increase of $2.1 million in outside costs for the Phase 1/1b clinical trial for CPI-444, an increase of $1.7 million in drug manufacturing costs for our anti-CD73 antibody program, an increase of $0.8 million in personnel and related costs associated with higher headcount and a $3.0 million milestone payment made to Vernalis plc pursuant to our license agreement.

General and administrative expenses for the three months ended March 31, 2017 totaled $2.7 million compared to $1.0 million for the same period in 2016. The increase of $1.7 million was primarily due to an increase of $0.9 million in personnel and associated costs, primarily due to an increase in headcount and a $0.5 million increase in legal and accounting costs.

The net loss for the three months ended March 31, 2017 was $16.0 million compared to $6.4 million for the same period in 2016. Total stock compensation expense for the three months ended March 31, 2017 was $1.5 million compared to $0.4 million for the same period in 2016.

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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MacroGenics has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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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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