On December 17, 2019 ImmunoGen Inc., (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that the U.S. Food and Drug Administration (FDA) has advised that a new single-arm study in platinum-resistant ovarian cancer could support accelerated approval for mirvetuximab soravtansine (Press release, ImmunoGen, DEC 17, 2019, View Source [SID1234552431]). Based on this guidance, the company will initiate SORAYA, a pivotal trial to evaluate mirvetuximab monotherapy in women with folate receptor alpha (FRhigh platinum-resistant ovarian cancer who have been previously treated with Avastin (bevacizumab).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"We have engaged in constructive discussions with FDA and evaluated all avenues to bring mirvetuximab to patients more quickly," said Mark Enyedy, ImmunoGen’s President and Chief Executive Officer. "Having aligned with the agency that women with FRα-high platinum-resistant ovarian cancer that has progressed after prior treatment with bevacizumab require better therapeutic options, we are pleased to advance mirvetuximab in this patient population with SORAYA, which, if successful, would enable us to submit an application for accelerated approval during the second half of 2021. We anticipate enrolling the first patient in SORAYA next quarter and expect top-line data from the study in mid-2021."

ImmunoGen’s mirvetuximab program now includes two new trials, SORAYA and MIRASOL, which will enroll concurrently.

SORAYA: Pivotal Trial

SORAYA is a single-arm trial with mirvetuximab that will enroll approximately 100 patients. Eligibility criteria include patients with platinum-resistant ovarian cancer whose tumors express high levels of FRα using the PS2+ scoring method, and who have been treated with up to three prior regimens – at least one of which included bevacizumab. The primary endpoint of this study is overall response rate by investigator assessment and the key secondary endpoint is duration of response.

MIRASOL: Confirmatory Trial

MIRASOL is a randomized Phase 3 trial in which 430 patients will be randomized 1:1 to receive either mirvetuximab or investigator’s choice of single-agent chemotherapy (weekly paclitaxel, pegylated liposomal doxorubicin, or topotecan). Eligibility criteria include patients with platinum-resistant ovarian cancer whose tumors express high levels of FRα using the PS2+ scoring method, and who have been treated with up to three prior regimens. The primary endpoint of this study is progression free survival by investigator assessment. The key secondary endpoints include: overall response rate, overall survival, and patient-reported outcomes.

"We have reviewed the data generated from our Phase 1 and FORWARD I studies using the PS2+ scoring method and have identified 70 patients who would meet the key eligibility criteria for SORAYA. The overall response rate in these patients was 31.4% with 95% CI (20.9%, 43.6%) and a median duration of response of 7.8 months with 95% CI (3.98, -)," said Anna Berkenblit, MD, Senior Vice President and Chief Medical Officer of ImmunoGen. "These data compare quite favorably to the response rate seen with single agent chemotherapy in platinum resistant disease, which was 12% in the AURELIA and CORAIL trials, and included patients naïve to and previously treated with bevacizumab."

Berkenblit continued, "Replicating these data in SORAYA would support an application for accelerated approval in advance of the completion of MIRASOL, which would thereafter provide the randomized data needed for conversion to full approval. We are delighted to advance both studies as soon as possible."

CONFERENCE CALL INFORMATION

ImmunoGen will hold a conference call today at 8:00 a.m. ET to discuss these results. To access the live call by phone, dial (877) 621-5803; the conference ID is 7190603. The call may also be accessed through the Investors and Media section of immunogen.com. Following the call, a replay will be available at the same location.

ABOUT MIRVETUXIMAB SORAVTANSINE

Mirvetuximab soravtansine (IMGN853) is the first folate receptor alpha (FRα)-targeting ADC. It uses a humanized FRα-binding antibody to target the ADC specifically to FRα-expressing cancer cells and a potent anti-tumor agent, DM4, to kill the targeted cancer cells.

On December 17, 2019 ArcherDX, Inc., a molecular diagnostics company dedicated to developing breakthrough solutions that advance the application of personalized genomic medicine, reported the close of a $55 million Series C financing round led by Perceptive Advisors, which was joined by new investors Redmile Group, Soleus Capital, Driehaus Capital Management and ArrowMark Partners, as well as existing investors Sands Capital, Longwood Fund, PBM Capital and its affiliates, Boulder Ventures and others (Press release, ArcherDX, DEC 17, 2019, View Source [SID1234552448]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Proceeds of the financing are intended to be used in part to expand the ArcherDX global commercial footprint, support the registration and launch of the STRATAFIDE pan-solid tumor companion diagnostic (CDx) and, in concert with ongoing biopharma collaborations, to support development of ArcherDX’s Personalized Cancer Monitoring (PCM) platform.

"We are grateful to receive such enthusiastic support from both new and existing investors. They share our vision of a future where all patients have access to personalized genomic information to better inform their care. The proceeds position ArcherDX to, upon approval, launch STRATAFIDE to deliver the first multi-gene, pan-solid tumor companion diagnostic that accepts both tissue and blood, to benefit late stage cancer patients," said Jason Myers, Ph.D., co-founder and chief executive officer of ArcherDX. "We will also advance our Personalized Cancer Monitoring platform, which is intended to leverage ArcherDX technology to improve detection of minimal residual disease (MRD) and address critical needs in the early stage solid tumor setting, including recurrence surveillance and therapy monitoring and evolution. We believe millions of cancer patients could benefit from a more accurate, personalized means of detecting relapse, when the cancer burden is low and more treatable. We remain driven to enable personalized molecular diagnostics that are accurate, actionable and local."

Based on patented technology, with more than 150 peer-reviewed publications, STRATAFIDE identifies actionable genomic alterations in tissue or blood samples, including alterations targeted by emerging therapies undergoing clinical trials, therapies already recommended in clinical guidelines such as NCCN, and therapies approved by the FDA. Unlike current centralized testing, STRATAFIDE allows tissue and blood samples to be analyzed at any local lab with a sequencer, thereby enabling faster turnaround times, while providing physicians with critical information needed to deliver targeted, personalized care. STRATAFIDE was granted FDA Breakthrough Device Designation in January 2019.

"We are delighted to continue to support ArcherDX as it works to launch multiple novel diagnostic products. We expect the Company’s flagship products to enable tailored therapeutic selection for cancer patients by providing actionable insights," said Mike Altman, Managing Director, Perceptive Advisors. "Moreover, ArcherDX’s AMP technology enables decentralized testing, which we believe uniquely positions the Company to broadly impact the molecular cancer testing market."

On December 17, 2019, Ultragenyx Pharmaceutical Inc. (the "Company") reported that it has entered into a Royalty Purchase Agreement (the "Agreement") with RPI Finance Trust ("Royalty Pharma"), pursuant to which Royalty Pharma paid $320 million in cash to the Company in consideration for the right to receive future royalty payments (the "Royalties") due to the Company from Kyowa Kirin Co., Ltd. ("KKC") based on net sales of Crysvita in the European Union, the United Kingdom, and Switzerland under the terms of the Company’s Collaboration and License Agreement with KKC dated as of August 29, 2013, as amended. The Agreement will automatically expire, and the payment of Royalties to Royalty Pharma will cease, in the event aggregate royalty payments received by Royalty Pharma are equal to or greater than $608 million prior to December 31, 2030, or in the event aggregate royalty payments received by Royalty Pharma are less than $608 million prior to December 31, 2030, when aggregate royalty payments received by Royalty Pharma are equal to or greater than $800 million.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The Agreement contains other customary terms and conditions, including representations and warranties, covenants and indemnification obligations in favor of each party. The above description of the Agreement is a summary of the material terms, does not purport to be complete and is qualified in its entirety by reference to the Agreement, which will filed as an exhibit to the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2019.

On December 17, 2019 IMMUNOPRECISE ANTIBODIES LTD. (the "Company" or "IPA") (TSX VENTURE: IPA) (OTCQB: IPATF) reported that it has released its financial results for the second quarter ended October 31, 2019 (Press release, ImmunoPrecise Antibodies, DEC 17, 2019, View Source [SID1234552432]). The financial statements and related management’s discussion and analysis ("MD&A") can be viewed on SEDAR at www.sedar.com.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Financial Highlights:

Revenue. During the three months ended October 31, 2019, the company generated revenues of $3,162,365, compared to revenues of $2,716,791 in the 2018 fiscal period. This represents a 16% rise in revenue for the three-month period. The increasing revenue trend is due to growth in both the volume of contracts as well as an increase in the financial value of individual client programs resulting in a larger average value per program. Revenue outlook is positive for third quarter.

Gross Margin. During the three months ended October 31, 2019, the Company achieved a gross profit of $2,490,015 compared to $1,401,725 in the 2018 fiscal period. Gross profit increased by 78% over the same period last year. In percentage terms, the Company’s gross profit increased to 79% from 52% in 2018. The higher gross profit in 2019 was mostly attributable to the Company investing heavily in research and development initiatives, broadening the breadth and value of its intellectual property in both therapeutic oncology assets as well as advanced technologies in the discovery and analysis of human antibody sequences. Gross profit was positivity affected by an increase in the average value per program.

Net Loss. During the three months ended October 31, 2019, the Company recorded a net loss of $1,363,545 compared to net loss of $1,485,732 for the three months ended October 31, 2018. The net loss decreased in 2019 due to $1,088,290 higher gross profit and lower advertising and consulting expense, offset by higher non-cash expenses including amortization of acquired companies’ intangible assets, depreciation of leased assets as a result of implementing IFRS 16, Leases, and higher office expenses.

Non-IFRS Measures*. Non-IFRS Adjusted EBITDA was ($63,418) in the second quarter of 2019 compared to ($744,054) in the second quarter of 2018. The reduction in loss is due primarily to non-cash expenses reconciling IFRS Net Loss to Adjusted EBITDA. The reduction in EBITDA Loss for the quarter is due to higher gross profit ($1,088,290) offset by higher Adjusted Operating Expenses ($407,654) primarily due to the Company’s investment in research and development and information technology.

Reflecting on the calendar year of 2019, Dr. Jennifer Bath, CEO and President, added, "During 2019 we won an increased number of large pharma clients requiring more comprehensive therapeutic discovery and development outsourcing. These wins have been a core priority for ImmunoPrecise as we grow, which required substantive, strategic investments in our global infrastructure to attract, win and retain large pharma. Onboarding of these programs differs from our pipeline to date in terms of timing and workflow management. While it is a significant positive that we are winning larger programs, we have been cognizant that short-term revenue recognition can be affected by the timing of project activity. We have worked diligently to ensure that these are coupled with renewing, smaller projects to attain business continuity, thoughtful space and equipment utilization and therefore greater profitability going into 2020."

On December 17, 2019 Herantis Pharma Plc ("Herantis" or "Company") reported that patient recruitment in the Company’s Phase 2 clinical trial AdeLE ("Adenoviral gene therapy for the treatment of LymphEdema") has been completed (Press release, Herantis Pharma, DEC 17, 2019, View Source [SID1234552451]). All of the 39 patients with breast cancer associated lymphedema have been randomized to receive either Lymfactin or placebo treatment, and their treatments have been completed according to the study protocol. The AdeLE trial will continue with a 12-month blinded follow-up to evaluate the safety and efficacy of Lymfactin in the treatment of breast cancer associated lymphedema, when combined with a conventional lymph node transplantation surgery. Herantis expects to unblind the study and announce its top-line results in the first quarter of 2021.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"The rapid enrolment completion demonstrates not only that there is a significant need for novel treatment options in lymphedema, but it is also an important milestone for our Lymfactin program as we are advancing into late-stage clinical development. We are truly grateful to the patients who participated in the AdeLE study, the supporting physicians and staff at the study sites, and to the international patient organization LE&RN, which fights to raise awareness for lymphedema as a significant unmet clinical need," commented Pekka Simula, CEO of Herantis. "Based on the cumulated safety data and assessments of the trial’s independent Data Safety Monitoring Board, we are encouraged by the established safety profile of Lymfactin. We look forward to the efficacy read-outs that could bring new hope to lymphedema patients all around the world."

Study Design

The AdeLE study is a multi-center, randomized, double-blind, placebo-controlled Phase 2 trial that evaluates the safety and efficacy of Lymfactin in the treatment of breast cancer associated lymphedema, when combined with a conventional lymph node transplantation surgery. In total, 39 patients with breast cancer associated lymphedema have been recruited in the study and randomized 1:1 to receive a single dose of either Lymfactin or placebo as an adjunct to surgery. The active patient treatment period was completed with last dosing in December 2019 and the study continues with a 12-month blinded follow-up.

Study Objectives

The primary endpoint of the AdeLE study is efficacy in the treatment of breast cancer associated lymphedema. Efficacy will be assessed by changes in the volume of the affected arm compared with the unaffected arm, quality of life of the patient based on the Lymphedema Quality of Life Inventory and the assessment of the lymph flow of the affected arm by quantitative lymphoscintigraphy.

Further Information:

Herantis Pharma Plc, Pekka Simula, CEO, telephone: +358-40-7300-445
Company web site: www.herantis.com
Certified Advisor: UB Securities Ltd, telephone: +358-9-25-380-225

About Lymfactin

Lymfactin is the world’s first and only clinical stage gene therapy that repairs damages of the lymphatic system. It expresses the human growth factor VEGF-C, which is naturally associated with the development of lymphatic vessels. Based on preclinical studies, Lymfactin triggers the growth of new functional lymphatic vasculature in the injured area and thus repairs the underlying cause of secondary lymphedema. The first target indication for Lymfactin is Breast Cancer Associated Lymphedema; Herantis believes that Lymfactin may also be suitable for the treatment of other forms of secondary lymphedema if its safety and efficacy are established in the first indication. Based on cumulated data from a Phase 1 clinical study in 15 patients with breast cancer associated lymphedema, Lymfactin is safe and well tolerated. The efficacy of Lymfactin is currently studied in the Phase 2 clinical study AdeLE in Finland and Sweden.

Lymfactin, patented by Herantis, is based on the internationally renowned scientific research of academy professor Kari Alitalo and his research group, a national center of excellence at the University of Helsinki. For more information please see View Source

About Breast Cancer Associated Lymphedema

Approximately 20% of breast cancer patients who undergo axillary lymph node dissection develop secondary lymphedema: a progressive, disabling, and disfiguring disease that severely affects the quality of life. Symptoms include a chronic swelling of an upper limb, thickening and hardening of skin, loss of mobility and flexibility, pain, and susceptibility to secondary infections. Secondary lymphedema is currently treated with compression garments, special massage, and exercises. While these therapies may relief the symptoms in some patients, they do not address the underlying cause of lymphedema, which results from damage to the lymphatic system. There are currently no approved medicines for the treatment of secondary lymphedema.