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ImmunoGen Reports Recent Progress and First Quarter 2017 Operating Results

On May 5, 2017 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported recent highlights and reported financial results for the quarter ended March 31, 2017 (Press release, ImmunoGen, MAY 5, 2017, View Source [SID1234518855]).

"We have started 2017 with significant progress towards our strategic priorities of advancing our portfolio, supporting our partners, and driving continued innovation in ADCs," said Mark Enyedy, ImmunoGen’s president and chief executive officer. "Following enrollment of our first patient in FORWARD I in January, we have since expanded the study to include additional centers in North America and Europe, and expect to activate more than 100 sites in these geographies before the end of the year. We presented data at the SGO Annual Meeting supporting our patient selection strategy for FORWARD I and delivered nine presentations at the AACR (Free AACR Whitepaper) Annual Meeting highlighting novel ADCs and enhancements to our platform technologies. For the remainder of the year, we look forward to a number of additional milestones, including sharing new efficacy and safety data for mirvetuximab soravtansine at ASCO (Free ASCO Whitepaper) and filing an IND for our CD123-targeting ADC, IMGN632, in the third quarter."

Recent Highlights

Proprietary Portfolio

Treated the first patient in FORWARD I and expanded the study to more than 40 sites in North America and Europe;
Presented expanded Phase 1 data from the biopsy cohort for mirvetuximab soravtansine at the Society for Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer demonstrating that archival tumor tissue can reliably identify patients with folate receptor alpha (FRα)-positive platinum-resistant ovarian cancer and supporting the patient selection strategy for FORWARD I; and
Delivered nine presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting demonstrating improvements to ImmunoGen’s payload and linker technologies and highlighting data with novel ADCs directed to a range of tumor targets.
Partner Programs

Bayer completed enrollment in a registration-enabling Phase 2 study for anetumab ravtansine in mesothelioma; and
Takeda initiated preclinical development with the first ADC using ImmunoGen’s IGN platform directed to a solid tumor.
ASCO Presentations

ImmunoGen will report data on mirvetuximab soravtansine in poster presentations at the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on June 3, 2017:

Gynecologic Cancer: General Poster Session
Location: Hall A
Saturday, June 3, 2017, 1:15 p.m. – 4:45 p.m. CDT

Title: Mirvetuximab soravtansine (IMGN853), a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC), in platinum-resistant epithelial ovarian cancer (EOC) patients (pts): Activity and safety analyses in phase I pooled expansion cohorts. (Abstract No.: 5547, Poster Board No.: 369)
Title: Safety findings from FORWARD II: A phase 1b study evaluating the folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC) mirvetuximab soravtansine (IMGN853) in combination with bevacizumab, carboplatin, pegylated liposomal doxorubicin (PLD), or pembrolizumab in patients (pts) with ovarian cancer. (Abstract No.: 5553, Poster Board No.: 375)
Title: FORWARD I (GOG 3011): A randomized phase 3 study to evaluate the safety and efficacy of mirvetuximab soravtansine (IMGN853) versus chemotherapy in adults with folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian cancer (EOC), primary peritoneal cancer, or primary fallopian tube cancer. (Abstract No.: TPS5607, Poster Board No.: 425b)
Additional Upcoming Events

ImmunoGen expects to present initial Phase 1 data for IMGN779, a CD33-targeting ADC, for the treatment of acute myeloid leukemia in mid-2017. These will be the first clinical data reported with an ADC using ImmunoGen’s DNA-alkylating payload.
The Company anticipates filing an investigational new drug (IND) application in the third quarter of 2017 to support clinical testing with IMGN632, a CD123-targeting ADC integrating a more potent DNA-alkylating payload intended to treat a range of hematological malignancies.
ImmunoGen also anticipates advancing the first development candidate under its collaboration with CytomX into preclinical development in 2017.
Financial Results

Revenues for the quarter ended March 31, 2017 were $28.5 million, compared to $19.7 million for the quarter ended March 31, 2016. License and milestone fees for the first quarter of 2017 included $6 million in partner milestone payments and $12.7 million in amortization of a non-cash fee related to the Company’s license agreement with CytomX, compared with $10 million from partner milestone payments in the same quarter in 2016. Revenues in the first quarter of 2017 included $7.6 million in non-cash royalty revenues, compared with $7.4 million in non-cash royalty revenues for the same quarter in 2016. Revenues for the first quarter of 2017 also included $1.5 million of research and development (R&D) support fees and $0.7 million of clinical materials revenue, compared with $1.1 million and $1.2 million, respectively, for the same quarter in 2016.

Operating expenses for the first quarter of 2017 were $41.4 million, compared to $47.3 million for the same quarter in 2016. Operating expenses in the first quarter of 2017 include R&D expenses of $32.9 million, compared to $36.1 million for the same quarter in 2016. This change is primarily due to a workforce reduction resulting from the strategic review in September 2016, as well as decreased costs associated with manufacturing clinical materials on behalf of ImmunoGen’s partners. Partially offsetting these decreases, clinical trial costs increased in the first quarter of 2017 driven primarily by studies of mirvetuximab soravtansine. Operating expenses include general and administrative expenses of $8.1 million in the first quarter of 2017, compared to $11.2 million in the same quarter in 2016. This decrease is primarily due to a non-cash stock compensation charge in the first quarter of 2016 resulting from the CEO transition, as well as decreased personnel expenses in the first quarter of 2017.

ImmunoGen reported a net loss of $17.3 million, or $0.20 per basic and diluted share, for the first quarter of 2017 compared to a net loss of $31.9 million, or $0.37 per basic and diluted share, for the same quarter last year.

ImmunoGen had approximately $126.6 million in cash and cash equivalents as of March 31, 2017, compared with $160.0 million as of December 31, 2016, and had $100.0 million of convertible debt outstanding in each period. Cash used in operations was $33.0 million for the first quarter of 2017, compared with $26.1 million for the first quarter of 2016. Capital expenditures were $0.4 million and $3.5 million for the quarters ended March 31, 2017 and 2016, respectively.

Financial Guidance

ImmunoGen’s financial guidance for 2017 remains unchanged from that issued in February 2017. ImmunoGen expects:

Revenues between $70 million and $75 million, which includes $28 million of expected upfront and milestone fees from partners;
Operating expenses between $175 million and $180 million; and
Cash and cash equivalents at December 31, 2017 between $35 million and $40 million.
ImmunoGen expects that its current cash plus expected cash revenues from partners and collaborators will enable the Company to fund operations into the second quarter of 2018.

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 .

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]).

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]).

"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.