Year: 2017

Alligator Bioscience presents promising immuno-oncology data at US conference; – Strong new preclinical findings for ADC-1013 and ATOR-1015

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).

10-Q – Quarterly report [Sections 13 or 15(d)]

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

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10-Q – Quarterly report [Sections 13 or 15(d)]

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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Corvus Pharmaceuticals Reports First Quarter 2017 Financial Results and Provides Business Update

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.

MIRATI THERAPEUTICS REPORTS FIRST QUARTER 2017 FINANCIAL RESULTS

On May 4, 2017 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical stage oncology biotechnology company, reported financial results for the first quarter 2017 and provided an update on its product development programs (Press release, Mirati, MAY 4, 2017, View Source [SID1234518877]).

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"As anticipated, 2017 will be an important and defining year for Mirati. Our single agent precision medicine programs and immuno-oncology combination programs are advancing and we remain on track to report key data in the second half of the year," said Charles M. Baum, M.D., Ph.D., President and Chief Executive Officer. "We have made significant progress in our pre-clinical KRAS and LSD-1 programs and we are very encouraged by the data from these programs".


Single Agent Programs
Glesatinib (MGCD265)
Mirati is enrolling patients in its registration-enabling Phase 2 NSCLC AMETHYST clinical trial, which is evaluating single agent glesatinib for the treatment of NSCLC patients with MET driver mutations. The Company expects to provide an update on efficacy data from the AMETHYST trial in the second half of 2017.

Sitravatinib (MGCD516)
The Phase 1b expansion clinical trial of sitravatinib is enrolling NSCLC patients with RET, CHR4q12 and CBL genetic alterations. The Company expects to provide an update on efficacy data in the third quarter of 2017.


Immuno-oncology Combination Programs
Sitravatinib plus nivolumab
The multicenter Phase 2 NSCLC clinical trial is evaluating sitravatinib in combination with nivolumab, a checkpoint inhibitor approved for the treatment of patients with a variety of solid tumors including NSCLC. The trial is enrolling patients who have relapsed after treatment with a checkpoint inhibitor. Sitravatinib is a potent inhibitor of the TAM (Tyro, Axl, Mer) and split (KDR, KIT) tyrosine kinase families which regulate multiple aspects of the immune system thought to enhance anti-tumor immunity. The Company expects to provide an initial update on this combination trial in the second half of 2017.

Mocetinostat (MGCD103) plus durvalumab
Mirati is collaborating with Medimmune/Astra Zeneca on a Phase 2 clinical trial combining mocetinostat, an orally administered spectrum-selective Class 1 HDAC inhibitor, and durvalumab, MedImmune’s monoclonal antibody inhibiting PD-L1. The combination trial is exploring the potential of mocetinostat to enhance the effectiveness of checkpoint inhibitors in NSCLC and the Company expects to provide an update in mid 2017.




Preclinical Programs
•
KRAS Inhibitor Program: A mutant-selective (G12C) KRAS inhibitor program is advancing rapidly. Potent and selective inhibitors have been identified and have demonstrated marked tumor regression in KRAS mutant xenograft tumor models. An IND candidate selection is anticipated by second half of 2017.

•
LSD1 Inhibitor Program: A highly-potent and potentially best-in-class LSD1 inhibitor has been identified with potential for rapid clinical proof-of-concept in small cell lung cancer or acute myeloid leukemia. An investigational new drug (IND) submission is planned for this compound in the fourth quarter 2017.


First Quarter 2017 Financial Results

In January 2017, we completed a public offering of our common stock and pre-funded common stock warrants that generated net proceeds of $66.8 million. Cash, cash equivalents, and short-term investments were $105.5 million at March 31, 2017, compared to $56.7 million at December 31, 2016. We continue to expect that our currently available cash, cash equivalents and short-term investments are sufficient to fund operations into late 2018.

Research and development expenses for the first quarter of 2017 were $14.4 million, compared to $18.0 million for the same period in 2016. The decrease in research and development expenses is primarily driven by a decrease in manufacturing expenses associated with glesatinib, offset by an increase in expenses associated with our ongoing Phase 1b clinical trial of sitravatinib.

General and administrative expenses for the first quarter of 2017 were $3.7 million, compared to $4.1 million for the same period in 2016. The decrease in general and administrative expense is largely the result of a decrease in non-cash share-based compensation expense, which is due to lower exercise prices for options granted during the last half of 2016 and first quarter of 2017.

Net loss for the first quarter of 2017 was $17.8 million, or $0.73 per share basic and diluted, compared to net loss of $21.9 million, or $1.13 per share basic and diluted for the same period in 2016.