On May 3, 2019 ImmunoGen, Inc., (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported financial results for the quarter ended March 31, 2019 (Press release, ImmunoGen, MAY 3, 2019, View Source [SID1234535656]).

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"Following the readout of the top-line results from FORWARD I, we have undertaken a comprehensive analysis of the data and see a consistent efficacy signal across a range of parameters in the pre-specified subset of ovarian cancer patients with high folate receptor alpha (FRα) expression. Specifically, in comparison to chemotherapy, we have observed higher response rates, more durable responses, and longer progression-free and overall survival in patients with high FRα expression treated with mirvetuximab," said Mark Enyedy, ImmunoGen’s President and Chief Executive Officer. "With the benefit of this analysis and input from our clinical and regulatory advisors, we will be meeting with the FDA this quarter to discuss a potential path to registration for mirvetuximab as a monotherapy."

Enyedy continued, "In parallel, our FORWARD II combination trial continues to enroll patients and we look forward to presenting mature data for mirvetuximab in combination with Avastin in platinum-resistant ovarian cancer patients at ASCO (Free ASCO Whitepaper). In addition, we ended the quarter with $270 million on the balance sheet and are conducting an operational review to enable us to extend our cash runway and execute against our goal of delivering more good days to people with cancer."

RECENT PROGRESS

Mirvetuximab Soravtansine

Top-line results announced from the Phase 3 FORWARD I study of mirvetuximab soravtansine in FRα-positive, platinum-resistant ovarian cancer; data from the pre-specified subset of patients with high FRα expression suggest a favorable benefit-risk profile in this population.
Enrollment initiated for FORWARD II Avastin (bevacizumab) cohort in ovarian cancer patients for whom a non-platinum-based regimen would be an appropriate next therapy; this "platinum agnostic" population will include patients progressing after PARP inhibitor maintenance therapy, who represent an increasing share of the market.
IGN Programs, Early-Stage Pipeline, and Research

Enrollment continues in expansion cohorts of a Phase 1 study of IMGN632 in patients with relapsed or refractory adult acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm (BPDCN); study expanded to Europe.
Enrollment nearing completion for Phase 1 study of IMGN779 in AML patients.
IND-enabling activities on track for IMGC936, a novel ADAM9-targeting ADC being developed in collaboration with MacroGenics.
Eleven posters presented at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in March demonstrating continued innovation from the Company’s research platform.
Operational Updates

Sale of residual rights to receive royalty payments on commercial sales of Kadcyla (ado-trastuzumab emtansine) to the Ontario Municipal Employees Retirement System (OMERS), the defined benefit pension plan for municipal employees in the Province of Ontario, Canada, completed for $65 million.
Operational review of the business underway with the objective of extending the Company’s cash runway.
ANTICIPATED UPCOMING EVENTS

Meet with the U.S. Food and Drug Administration (FDA) in Q2 to discuss a potential path to registration for mirvetuximab soravtansine as a monotherapy for the treatment of platinum-resistant ovarian cancer patients with high FRα expression; the Company also plans to engage with the European Medicines Agency (EMA) around conditional marketing authorization;
Present mature data from the FORWARD II expansion cohort evaluating mirvetuximab in combination with Avastin in patients with platinum-resistant ovarian cancer at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting; additional data from an investigator-sponsored study evaluating mirvetuximab in combination with gemcitabine will also be presented;
Present full FORWARD I data and initial FORWARD II triplet data at a medical meeting later this year;
Present updated IMGN632 data with additional AML and BPDCN patients, and establish the recommended Phase 2 dose and schedule; initiate IMGN632 combination studies;
Establish IMGN779 recommended Phase 2 dose and schedule; and
Submit an IND for IMGC936 before the end of 2019.
FINANCIAL RESULTS
Revenues for the quarter ended March 31, 2019 were $8.6 million, compared with $19.8 million for the quarter ended March 31, 2018. Revenues in the first quarter of 2019 included $8.5 million in non-cash royalty revenues, compared with $7.2 million for the first quarter of 2018. Revenues for the prior year period also included $11.5 million of recognized upfront license and milestone fees previously received from partners, $0.4 million of research and development (R&D) support fees, and $0.7 million of clinical materials revenue, compared with $0.1 million of similar fees earned in the current period.

Operating expenses for the first quarter of 2019 were $50.2 million, compared with $56.6 million for the same quarter in 2018. The decrease was driven by R&D expenses, which were $38.9 million in the first quarter of 2019, compared with $44.8 million for the first quarter of 2018. This decrease was primarily due to lower clinical trial costs in the current period, driven by patient enrollment in the FORWARD I Phase 3 clinical trial during the prior year period. General and administrative expenses in the first quarter of 2019 were $10.8 million, compared to $10.0 million in the first quarter of 2018, primarily due to increased personnel costs driven by greater stock-based compensation and severance expense, partially offset by decreased third-party service fees. Operating expenses for the first quarter of 2019 also included a $0.6 million restructuring charge related to a loss recorded on leased office space, compared to a $1.7 million charge recorded in the first quarter of 2018 related to the decommissioning of the Company’s Norwood facility.

ImmunoGen reported a net loss of $43.8 million, or $0.30 per basic and diluted share, for the first quarter of 2019, compared with a net loss of $38.6 million, or $0.30 per basic and diluted share, for the same quarter last year. Weighted average shares outstanding increased to 147.8 million from 130.6 million in those quarters.

ImmunoGen had $270.4 million in cash and cash equivalents as of March 31, 2019, compared with $262.3 million as of December 31, 2018, and had $2.1 million of convertible debt outstanding in each period. Cash provided by operations was $10.2 million for the first quarter of 2019, compared with cash used in operations of $(50.0) million for the first quarter of 2018. The current period benefited from $65.2 million of net proceeds generated from the sale of the Company’s residual rights to Kadcyla royalties in January 2019. Capital expenditures were $2.1 million and $1.0 million for the first quarter of 2019 and 2018, respectively.

FINANCIAL GUIDANCE
ImmunoGen will provide an update on the Company’s 2019 financial guidance following the completion of the operational review.

CONFERENCE CALL INFORMATION
ImmunoGen will hold a conference call today at 8:00 am ET to discuss these results. To access the live call by phone, dial 323-994-2093; the conference ID is 8980567. The call may also be accessed through the Investors and Media section of the Company’s website, www.immunogen.com. Following the live webcast, a replay of the call will be available at the same location through May 17, 2019.

On May 3, 2019 Oncoceutics, Inc. reported the publication of two scientific research articles demonstrating that members of the imipridone family ONC201 and ONC212 directly activate a mitochondrial protease called caseinolytic protease P (ClpP) (Press release, Oncoceutics, MAY 3, 2019, View Source [SID1234558356]).

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One research article, featured on the cover of the journal Cancer Cell, demonstrates that ONC201 and ONC212 hyperactivate ClpP by altering its structural conformation, leading to mitochondrial dysfunction and apoptosis in leukemia. In AML, ClpP is over-expressed in patient samples and its hyperactivation selectively kills cancer cells independent of p53 status, while not affecting normal cells.

Another research article, published in the journal ACS Chemical Biology, similarly demonstrates that ONC201 and ONC212 directly bind to and activate ClpP.

ClpP is a protease located in the mitochondrial matrix that is overexpressed in tumor cells and plays a central role in mitochondrial protein quality control by degrading misfolded proteins. Modulating the activity of ClpP can cause impaired oxidative phosphorylation that selectively kills cancer cells in vitro and in vivo without affecting normal cells.

The two research studies concordantly demonstrate that imipridones are capable of targeting ClpP in tumor cells, which has emerged as a therapeutic target in oncology. ClpP activation by imipridones is consistent with select downstream effects of these compounds that have been previously reported, such as integrated stress response activation and disruption of mitochondrial structure and function in tumor cells.

"The unique phenotypic effects of ONC201 and its imipridone family members that have been studied in a broad range of cancers point to a novel mechanism of action," said Dr. Joshua Allen, PhD, Senior Vice President of R&D at Oncoceutics. "The discovery that ONC201 targets ClpP, in addition to DRD2, expands the biomarker panel for the molecule and other impridones. ClpP activation also helps us interpret downstream effects of imipridones on the mitochondria, as well as their activity in tumor types beyond those that depend on the dopamine pathway."

"ClpP activation in cancer and disruption of the resulting mitochondrial dysfunction by ONC201 provides a mechanism of action that reinforces the basis for its efficacy spectrum across cancer that differentiates from other DRD2 antagonists," said Dr. Keith Flaherty, MD, Director of Clinical Research at Massachusetts General Hospital and Member of Oncoceutics’ Scientific Advisory Board.

On May 3, 2019 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with a pipeline of immune modulating antibodies, cancer vaccines, adjuvants and adoptive cell therapies reported that it will release its first quarter 2019 financial results before the market opens on Thursday, May 9, 2019 (Press release, Agenus, MAY 3, 2019, View Source [SID1234535699]). In connection with the earnings release, Agenus executives will host a conference call and live webcast at 8:30 a.m. ET the same day to discuss the results and provide Company updates.

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Conference Call and Webcast Information:

Date: Thursday, May 9, 2019
Time: 8:30 a.m. ET
Domestic Dial-in Number: (866) 682-6100
International Dial-in Number: (862) 298-0702
Conference ID: Agenus

Live Webcast: accessible from the Company’s website at View Source or with this link View Source

A replay will be available on the Company’s website approximately two hours after the call and will remain available for 90 days.

On May 3, 2019 Athenex, Inc. (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported preliminary data showing promising early clinical responses in the first part of a two part study of Oraxol (oral paclitaxel and encequidar, also known as HM30181A) monotherapy in patients with unresectable cutaneous angiosarcoma (Press release, Athenex, MAY 3, 2019, View Source;p=RssLanding&cat=news&id=2397066 [SID1234535700]).

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To date, 10 patients have been enrolled in the clinical study, which is being conducted in four sites in the U.S. and Hong Kong. The first 7 patients have received at least six weeks of treatment, which is the timepoint for the first response assessment; 3 patients have not yet reached the first assessment timepoint. Oraxol is being administered once daily for three consecutive days every week during the treatment period.

All 7 patients showed significant and visible reduction of the cutaneous angiosarcoma within one or two weeks of treatment. Three patients had complete responses based on RECIST v1.1 criteria, with two complete responses occurring by 6 weeks of treatment.

Selected images showing early visible response in one week, from a patient with complete response (Patient A) are available at

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Selected images showing a patient with complete response after 6 weeks of treatment (Patient B) are available at

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None of the patients enrolled have discontinued treatment due to death, disease progression, or adverse events. No peripheral neuropathy has been reported.

Based on the preliminary data, the study has met the criteria required to proceed to full enrollment.

Dr. Rudolf Kwan, Chief Medical Officer of Athenex, stated, "I am impressed by the rapid clinical response to Oraxol monotherapy treatment in this group of difficult-to-treat patients. The high response rate observed, including three patients who had early complete response, is consistent with the hypothesis that oral delivery of paclitaxel can potentially achieve a more desirable pharmacokinetic profile and a better clinical outcome. I believe the good tolerance of Oraxol in this older patient population would be welcome by both clinicians and patients. This may represent a paradigm shift in the treatment of patients with cutaneous angiosarcoma."

Dr. Johnson Lau, Chairman and Chief Executive Officer of Athenex, commented, "The consistently high response rate observed in various clinical settings, including in the treatment of metastatic breast cancer, unresectable gastric cancer, and now cutaneous angiosarcoma, highlight the potential of Oraxol as an effective therapeutic for a broad range of cancers. With results showing high response rates, lack of significant neuropathy and oral convenience with no need for concomitant use of intravenous steroid pre-treatment, I believe Oraxol also has the potential to transform treatment regimens that use a high potency chemotherapeutic agent in combination with other newly developed anti-cancer therapeutics. We are already evaluating the combination of Oraxol with ramucirumab and Oraxol with an anti-PD1 (pembrolizumab) in clinical studies."

Oraxol (oral paclitaxel and encequidar, or HM30181A) was granted Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of angiosarcomas in April 2018.

The clinical trial, designed and led by Principal Investigator Vinod Ravi, M.D., associate professor of Sarcoma Medical Oncology at The University of Texas MD Anderson Cancer Center, is open at MD Anderson in Houston, Fred Hutchinson Cancer Center in Seattle and Prince of Wales Hospital, Shatin, in Hong Kong. For more details about the clinical study, please visit ClinicalTrials.gov at View Source

Athenex is completing a Phase III clinical trial of Oraxol in the treatment of metastatic breast cancer. In April 2019, the company presented an abstract on preclinical data of oral paclitaxel and HM30181A (encequidar) in angiosarcoma at the American Association of Cancer Research Annual Meeting 2019 in Atlanta, Georgia. In December 2018, Athenex announced positive second cohort results of Oraxol-plus-ramucirumab Phase 1b clinical trial in gastric cancer (more details can be found here). In October 2018, Athenex presented encouraging clinical trial efficacy and safety results of Oraxol in the treatment of metastatic breast cancer in a Phase II clinical trial in Taiwan at ESMO (Free ESMO Whitepaper) 2018 (more details can be found here).

The Orascovery platform was initially developed by Hanmi Pharmaceuticals and licensed exclusively to Athenex for all major worldwide territories except Korea, which is retained by Hanmi.

About Angiosarcoma
Angiosarcomas are a type of soft tissue sarcoma characterized by rapidly proliferating, extensively infiltrating, anaplastic cells derived from blood and lymphatic vessels. Angiosarcomas arise in various body sites, including cutaneous, soft tissue, and visceral locations. Angiosarcomas are frequently metastatic at diagnosis, with a natural history complicated by local recurrence, distant metastases, and poor overall survival. Angiosarcomas represent about 2% of soft tissue sarcomas and 5.4% of cutaneous soft tissue sarcomas.

There is no approved treatment for angiosarcoma and survival is limited with treatments currently available. However, reports in the literature of objective tumor response support the use of intravenous paclitaxel in the treatment of angiosarcoma.

On May 3, 2019 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported its financial results and operational highlights for the quarter ended March 31, 2019 (Press release, Oncolytics Biotech, MAY 3, 2019, View Source [SID1234535703]). All dollar amounts are expressed in Canadian currency unless otherwise noted.

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”Our primary focus remains the breast cancer program and the timely completion of our AWARE-1 study of pelareorep in combination with the immune checkpoint inhibitor Tecentriq. We remain on track to report interim data in the second half of this year,” said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech. ”We expect the results of this important study to confirm the clinical utility of using T cell clonality as a biomarker for patient response to pelareorep, as well as pelareorep’s ability to prime the immune system to recognize cancer cells and enhance the potential efficacy of checkpoint inhibitors. This data will assist in the final design of our registrational study of pelareorep as a treatment for metastatic breast cancer and serve to confirm the broader utility of this biomarker, currently established in pancreatic cancer and multiple myeloma, across multiple cancer types.”

Selected highlights since January 1, 2019

Clinical & Scientific Updates

Announced the identification of T cell clonality as a potentially predictive and prognostic biomarker of pelareorep therapy in a poster presentation delivered at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2019 annual meeting
Treated the first patient in the AWARE-1 window of opportunity study, which is being conducted in collaboration with SOLTI, in which patients will receive the appropriate intervention for their breast cancer sub-type plus pelareorep with or without Roche’s anti PD-L1 Tecentriq, followed by surgery
Published data in the journal Blood Advances highlighting the synergistic effect of pelareorep in combination with proteasome inhibitor bortezomib for the treatment of multiple myeloma
Hosted a key opinion leader meeting with investors and analysts to discuss the emerging role of biomarkers and oncolytic viruses in the treatment of cancer, featuring Dirk Arnold, MD, PhD, Executive Board Member of the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) and Chief of Oncology at Asklepios Klinik Altona
Anticipated Milestones

Publish and present findings at leading U.S. and European oncology conferences including ASCO (Free ASCO Whitepaper), ESMO (Free ESMO Whitepaper) and ASH (Free ASH Whitepaper)
Initiate combination study with Merck’s Keytruda in multiple myeloma in mid-2019*
Expect to report interim data from AWARE-1 study in the second half of 2019
Prepare for registration study with pelareorep in mBC after AWARE-1
* Guidance provided by principal investigator

Financial

At March 31, 2019, the company reported $14.2 million in cash and cash equivalents
As at May 2, 2019, the company had an unlimited number of authorized common shares with 20,298,482 common shares issued and outstanding, 16,443,500 warrants exercisable into 1,730,894 common shares with a $9.025 strike price and 1,567,510 options and share units
Operating expense for the first quarter of 2019 was $1.8 million compared to $1.8 million in the first quarter 2018
Research and development expense for the first quarter of 2019 was $3.2 million compared to $2.9 million in the first quarter 2018
The net loss for the first quarter of 2019 was $4.9 million compared to $4.7 million in the first quarter 2018, which equates to a loss of $0.27 per share in 2019 compared to a net loss of $0.31 per share in 2018, on a consolidated basis
About Pelareorep

Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.