On August 2, 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 June 30, 2019 (Press release, ImmunoGen, AUG 2, 2019, View Source [SID1234538082]).

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"In the second quarter, we took important steps towards finalizing the design of the registration study for mirvetuximab soravtansine in folate receptor alpha (FRα)-high platinum-resistant ovarian cancer, prioritizing our portfolio of earlier-stage product candidates, and extending our cash runway with the completion of our operational review," said Mark Enyedy, ImmunoGen’s President and Chief Executive Officer. "Over the back half of 2019, we plan to meet with regulators regarding the final design of the registration study for mirvetuximab with the goal of initiating enrollment by end of year. Additionally, we look forward to presenting the full FORWARD I data and initial FORWARD II triplet data evaluating mirvetuximab in combination with carboplatin and Avastin (bevacizumab) at ESMO (Free ESMO Whitepaper)."

Enyedy continued, "In parallel, we have determined a recommended Phase 2 dose and schedule for IMGN632 and filed a protocol to support combination studies, as well as evaluate single-agent safety and efficacy in acute myeloid leukemia (AML) patients with minimal residual disease (MRD+) following frontline induction therapy. With the benefit of approximately $240 million on the balance sheet and the completion of our operational review, we are in a strong financial position to execute across our prioritized portfolio."

RECENT PROGRESS

Presented mature data demonstrating significant anti-tumor activity, as well as favorable safety and tolerability, from the FORWARD II expansion cohort evaluating mirvetuximab in combination with bevacizumab in patients with FRα-positive platinum-resistant ovarian cancer at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June.
Accelerated enrollment in the FORWARD II mirvetuximab plus bevacizumab combination cohort in ovarian cancer patients for whom a non-platinum-based regimen would be an appropriate next therapy.
Determined the recommended Phase 2 dose and schedule for IMGN632 and filed the protocol to initiate combination studies with Vidaza (azacitidine) and Venclexta (venetoclax) in relapsed/refractory AML patients and to evaluate IMGN632 in MRD+ patients following frontline induction therapy.
Continued enrollment in the Phase 1 expansion study of IMGN632 in patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN).
Advanced IND-enabling activities for IMGC936, a novel ADAM9-targeting ADC in co-development with MacroGenics.
Completed operational review expected to extend the Company’s cash runway through the readout of the mirvetuximab pivotal study in platinum-resistant ovarian cancer.
ANTICIPATED UPCOMING EVENTS

Meet with the United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) in the second half of this year to review the design of the next Phase 3 study of mirvetuximab soravtansine.
Complete enrollment in the FORWARD II mirvetuximab plus bevacizumab combination cohort in the third quarter.
Present full FORWARD I data (oral presentation) and initial FORWARD II triplet data (poster presentation) at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in late September.
Initiate the Phase 3 registration study of mirvetuximab as a monotherapy for women with FRα-high, platinum-resistant ovarian cancer by the end of this year.
Commence enrollment in the IMGN632 combination and single-agent MRD+ Phase 2 cohorts.
Present preclinical combination and updated monotherapy data for IMGN632 at the American Society of Hematology (ASH) (Free ASH Whitepaper) Congress.
FINANCIAL RESULTS

Revenues for the quarter ended June 30, 2019 were $15.5 million, compared with $9.3 million for the quarter ended June 30, 2018. Revenues in the second quarter of 2019 included $10.4 million in non-cash royalty revenues, compared with $7.2 million for the second quarter of 2018. License and milestone fees of $5.1 million for the second quarter of 2019 included recognition and receipt of a $5 million milestone pursuant to a license agreement with Genentech, a member of the Roche Group, compared to $1.3 million of upfront license fees recognized in the second quarter of 2018. Revenues for the prior year period also included $0.4 million of research and development (R&D) support fees and $0.3 million of clinical materials revenue, compared with $0.1 million of similar fees earned in the current period.

Operating expenses for the second quarter of 2019 were $56.6 million, compared with $48.0 million for the same quarter in 2018. The increase was driven by a $19.3 million restructuring charge recorded in the current period resulting from the operational changes announced on June 27, 2019, which includes a one-time severance charge, retention costs, and losses recorded on laboratory equipment, compared to a $0.7 million charge recorded in the second quarter of 2018 related to the decommissioning of the Company’s Norwood facility. R&D expenses were $28.6 million in the second quarter of 2019, compared with $38.7 million for the second quarter of 2018. This decrease was primarily due to lower personnel expenses driven by adjustments made in the current quarter to bonus and stock compensation expense as a result of the restructuring of the business, 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, and lower external manufacturing costs. General and administrative expenses were flat at $8.7 million in the second quarter of both 2019 and 2018.

ImmunoGen reported a net loss of $43.4 million, or $0.29 per basic and diluted share, for the second quarter of 2019, compared with a net loss of $41.6 million, or $0.31 per basic and diluted share, for the same quarter last year. Weighted average shares outstanding increased to 148.1 million from 134.4 million in those quarters.

ImmunoGen had $239.8 million in cash and cash equivalents as of June 30, 2019, compared with $262.3 million as of December 31, 2018, and had $2.1 million of convertible debt outstanding in each period. Cash used in operations was $20.8 million for the first six months of 2019, compared with cash used in operations of $85.3 million for the same period in 2018. The current period benefited from $65.2 million of net proceeds generated from the sale of the Company’s residual rights to Kadcyla (ado-trastuzumab emtasine) royalties in January 2019. Capital expenditures were $2.4 million and $2.1 million for the first six months of 2019 and 2018, respectively.

FINANCIAL GUIDANCE

Following the completion of its operational review in June 2019, ImmunoGen has updated its financial guidance for 2019 as follows:

revenues between $40 million and $45 million;
operating expenses between $175 million and $180 million; and
cash and cash equivalents at December 31, 2019, between $165 million and $170 million.
ImmunoGen expects that its current cash, together with expense reductions resulting from the operational changes previously announced and anticipated cash receipts from partners, will fund operations through the release of top-line results from the upcoming mirvetuximab Phase 3 study in platinum-resistant ovarian cancer, which are expected in the first half of 2022.

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 +1-323-794-2093; the conference ID is 9100112. The call may also be accessed through the Investors and Media section of the Company’s website at www.immunogen.com.

On August 2, 2019 Exact Sciences Corp. (Nasdaq: EXAS) reported that company management will be presenting at the following investor conference and invited investors to participate by webcast (Press release, Exact Sciences, AUG 2, 2019, View Source [SID1234538081]).

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Canaccord Genuity Annual Growth Conference, Boston
Fireside Chat on August 7, 2019, at 9:00 a.m. EDT

The webcast can be accessed in the investor relations section of Exact Sciences’ website at www.exactsciences.com.

On August 2, 2019 Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH), a clinical-stage biopharmaceutical company focused on addressing key mechanisms of tumor drug resistance, reported financial results for the second quarter ended June 30, 2019 and provided an update on clinical and corporate developments (Press release, Deciphera Pharmaceuticals, AUG 2, 2019, View Source [SID1234538080]).

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"In recent months, we’ve made substantial progress across our pipeline of novel candidates from our two Phase 3 GIST trials with ripretinib to the addition of DCC-3116, a potential first-in-class autophagy inhibitor aimed at treating mutant RAS cancers," said Steve Hoerter, President and Chief Executive Officer of Deciphera. "Later this month, we expect to announce top-line data from the INVICTUS pivotal Phase 3 clinical study, the results of which, if favorable, could serve as the basis for our first new drug application, or NDA, filing. We also recently established our first license agreement for ripretinib outside of the U.S., which we believe reflects the growing recognition that ripretinib has the potential to alter the treatment landscape for patients with GIST."

Recent Pipeline Updates

Ripretinib
Deciphera expects to report top-line data from the INVICTUS pivotal Phase 3 clinical study evaluating the safety and efficacy of ripretinib, the Company’s investigational broad-spectrum KIT and PDGFRα inhibitor, in fourth-line and fourth-line plus GIST patients in August 2019. The Company is building its commercial and medical affairs capabilities to support the planned launch of ripretinib in the United States, if approved.
In June 2019, the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for ripretinib for the investigation of the treatment of patients with advanced GIST who have received prior treatment with imatinib, sunitinib and regorafenib.
Deciphera continues to activate sites and enroll patients in the INTRIGUE Phase 3 clinical study comparing ripretinib to sunitinib for the treatment of second-line GIST patients who have previously received imatinib. As of July 26, 2019, 45 sites have been activated.
Rebastinib
Deciphera previously announced the initiation of an open-label, multicenter, Phase 1b/2 combination study of rebastinib, the Company’s investigational small molecule switch control inhibitor of TIE2 kinase, with carboplatin in patients with advanced or metastatic solid tumors.
Deciphera completed enrollment of 43 patients in Part 1 of the Phase 1b/2 combination study of rebastinib with paclitaxel. Part 2 of the Phase 1b/2 study is now enrolling patients. The Company expects to report initial data from Part 1 of this study in the second half of 2019.
DCC-3014
The Company plans to present updated data from the ongoing dose escalation portion of the Phase 1 clinical study of DCC-3014, the Company’s investigational small molecule switch control inhibitor of CSF1R, in patients with advanced malignancies, in the second half of 2019.
The Company continues to enroll patients diagnosed with tenosynovial giant cell tumors (TGCT) in the Phase 1 study evaluating DCC-3014.
DCC-3116
In June 2019, Deciphera announced the addition of a new candidate to its pipeline, DCC-3116, a potential first-in-class small molecule designed to inhibit cancer autophagy, a key tumor survival mechanism, by inhibiting the ULK kinase. Subject to favorable investigational new drug (IND)-enabling studies and filing and activation of an IND, expected in mid-2020, Deciphera intends to develop DCC-3116 for the potential treatment of mutant RAS cancers in combination with inhibitors of downstream RAS effector targets including RAF, MEK, or ERK inhibitors as well as with direct inhibitors of mutant RAS.
Corporate Updates

Ripretinib License Agreement for Greater China.
In June 2019, Deciphera announced an exclusive license agreement with Zai Lab (Shanghai) Co., Ltd. (Zai) to advance the development and commercialization of ripretinib in Greater China, including mainland China, Hong Kong, Macau and Taiwan. Under the terms of the agreement, Deciphera has received an upfront cash payment of $20 million and will be eligible to receive up to $185 million in potential development and commercial milestone payments, including $5 million for an INTRIGUE study-related milestone the Company achieved. In addition, Zai will be obligated to pay Deciphera royalties ranging from low to high teens on annual net sales of ripretinib in Greater China.
New Member of the Board of Directors
In July 2019, Deciphera announced the appointment of Susan L. Kelley, M.D. to its Board of Directors. Dr. Kelley has over 25 years of experience across all stages of oncology drug research and development.
Second Quarter 2019 Financial Results

Cash Position: As of June 30, 2019, cash, cash equivalents and marketable securities were $225.4 million, compared to cash and cash equivalents of $293.8 million as of December 31, 2018. Deciphera expects its cash, cash equivalents and marketable securities as of June 30, 2019, along with the $20.0 million up-front payment from the Company’s recent license agreement with Zai received in the third quarter of 2019, will enable the Company to fund its operating expenses, capital expenditure requirements and debt service payments into the fourth quarter of 2020. This excludes any potential milestone or royalty payments, if any, under Deciphera’s license agreement with Zai.
Revenue: Revenue for the second quarter of 2019 was $25.0 million which was related to the Company’s exclusive license agreement with Zai to advance the development and commercialization of ripretinib in Greater China. Deciphera recognized license revenue of $20.0 million for an upfront fee and $5.0 million for a development milestone related to the INTRIGUE study.
R&D Expenses: Research and development expenses for the second quarter of 2019 were $34.8 million, compared to $18.0 million for the same period in 2018. The increase was primarily due to the INTRIGUE Phase 3 clinical study in second-line GIST, which the Company initiated in December 2018, and to the INVICTUS Phase 3 clinical study in fourth-line and fourth-line plus GIST, which the Company initiated in January 2018. The Company also incurred costs related to other supporting clinical trials for ripretinib. Additionally, expenses related to the rebastinib program increased primarily as a result of an increase in clinical trial costs related to the Phase 1b/2 trial of rebastinib in combination with paclitaxel, which the Company initiated in October 2018, and the second Phase 1b/2 clinical trial of rebastinib in combination with carboplatin, which the Company initiated in January 2019. Personnel-related costs increased $4.0 million primarily due to increased headcount and stock-based compensation expense in research and development functions. Personnel-related costs for the second quarters of 2019 and 2018 included non-cash stock-based compensation expense of $1.8 million and $1.0 million, respectively. Facility-related and other costs included in unallocated expenses increased $2.3 million primarily due to increased consultant fees and other costs in connection with our early-stage drug discovery programs.
G&A Expenses: General and administrative expenses for the second quarter of 2019 were $13.2 million, compared to $4.5 million for the same period in 2018. The increase was primarily due to an increase in professional, consultant and various advisory fees, including those related to commercialization preparedness. Non-cash stock-based compensation was $2.3 million and $1.2 million for the second quarters of 2019 and 2018, respectively. The increase in non-cash stock-based compensation expense was primarily related to the granting of additional employee stock option awards.
Net Loss: For the second quarter of 2019, Deciphera reported a net loss of $21.5 million, or $0.56 per share, compared with a net loss of $21.7 million, or $0.65 per share, for the same period in 2018.

On August 2, 2019 Sysmex Corporation (HQ: Kobe, Japan; Chairman and CEO: Hisashi Ietsugu) reported that it has obtained Japanese manufacturing and marketing approval for the OncoBEAM1 RAS CRC Kit, used for blood-based circulating tumor DNA molecular testing of mutations in the RAS gene2 for colorectal cancer patients (Press release, Sysmex, AUG 2, 2019, View Source [SID1234538074]). This product is the first in vitro diagnostic reagent in Japan to be used for RAS gene mutation testing for colorectal cancer using liquid biopsy. Minimally invasive and simpler than conventional physical biopsies of tumor tissue, the new testing method provides detection results on a par with the use of tumor tissue.3 As a result, this testing method reduces the physical and mental burden on patients, expands testing opportunities, and contributes to the early-stage determination of treatment methods.

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In recent years, demand has grown for the use of liquid biopsy in the diagnosis and selection of treatment methods for cancer and other diseases. Liquid biopsy refers to using blood or other bodily fluids, which place little burden on the patient, rather than physical biopsies, which require taking samples of a cancer tumor or other tissue.4 Sysmex has defined the "resolution of medical issues through products and services" as one of the priority issues (materiality) for realizing a sustainable society and sustainable growth in corporate value for Sysmex through the creation of new technologies and markets. As one aspect of these activities, Sysmex is pursuing R&D toward the realization of personalized medicine, which involves the provision of healthcare optimized for individual patients, and the proliferation of testing to reduce the physical burden on patients.

The OncoBEAM RAS CRC Kit is used to test samples of tumor-derived DNA (circulating tumor DNA, or ctDNA) suspended in the blood of colorectal cancer patients. To help doctors determine treatment methods, this product provides auxiliary test data to determine the appropriateness for patients with colorectal cancer of the molecularly targeted drags—Cetuximab and Panitumumab (gene recombination)—, using BEAMing technology5 that detects RAS gene mutations to a high degree of sensitivity. Jointly developed between Merck KGaA, Darmstadt, Germany, and our subsidiary Sysmex Inostics, the product received CE Marking certification in March 2016, which indicates the product complies with the European IVD Directive, and is already being used for clinical applications in Europe. For the approval as an in vitro diagnostic reagent in Japan, eight medical facilities were involved in a multi-facility evaluation, including the National Cancer Center Hospital East. Gene testing using this product can be used to provide appropriate treatment opportunities for patients that would have difficulty with testing using conventional tumor tissue. Furthermore, rather than physical biopsies, this type of testing allows samples to be obtained from blood samples in a simple and minimally invasive manner. This helps reduce the physical and mental burden on the patient, shortens the time required from the start of testing, and contributes to the early-stage determination of treatment methods.

Going forward, we plan to launch the OncoBEAM RAS CRC Assay Service, an assay service for colorectal cancer using liquid biopsy to detect RAS gene mutations in the blood, at the Sysmex IMP laboratory, located in the Kobe Biomedical Innovation Cluster. To increase the opportunities for more patients to receive the testing, we plan to apply for Japan’s national insurance coverage for this product.

By providing new cancer diagnostic methods to patients at the earliest possible date, such as the OncoBEAM RAS CRC Kit, as well as the OncoGuideTM NCC Oncopanel System,5 which received insurance coverage in Japan on June 1, 2019 for use in cancer genome profiling, Sysmex aims to take the global lead in realizing personalized medicine, contributing to patient quality of life and the advancement of healthcare.

Name: OncoBEAM RAS CRC Kit
Use: To detect RAS (KRAS and NRAS) gene mutations in genomic DNA extracted from plasma
(Auxiliary use to determine the appropriateness of Cetuximab and Panitumumab (gene recombination) for patients with colorectal cancer)
Target market: Japan
Target institutions: Healthcare institutions and clinical testing centers in Japan, other
In vitro diagnostics manufacturing and marketing approval number: 30100EZX00010000 (Obtained on July 19, 2019)
Reference

・
April 6, 2016 press release entitled "New Liquid Biopsy RAS Testing for metastatic colorectal cancer patients now available for clinical practices"
View Source

Terminology

OncoBEAM:
The name of Sysmex’s technology to detect minute gene mutations circulating in the blood with a high degree of sensitivity using BEAMing technology. BEAMing technology is an acronym for "bead, emulsion, amplification and magnetics", a gene analysis method developed at Johns Hopkins University combining digital PCR and flow cytometry technologies for highly sensitive analysis of genetic mutations.

RAS gene:
As the likelihood is high that patients with RAS gene (KRAS/NRAS gene) mutations will not benefit (prolongation of life, tumor reduction) from the administration of anti-EGFR drugs, companion diagnostics may be performed to treat the gene mutation first.

According to the results of multi-facility evaluation, determination results using this method are on a par with those of conventional RAS gene mutation testing using tumor tissue. Source: British Journal of Cancer volume 120, pages 982–986 (2019)

The Guidance on Genetic Testing in the Treatment of Coloretal Cancer Vol. 4.1 (May 2019), published by the Japanese Society of Medical Oncology, indicates the necessity of using liquid biopsy for colorectal cancer and the clinical utility of ctDNA testing.

OncoGuide NCC Oncopanel System (medical device manufacturing and marketing approval No.:23000BZX00398000):
(Reference) May 31, 2019 press release entitled "The OncoGuide NCC Oncopanel System Receives Insurance Coverage for Use in Cancer Genome Profiling" View Source

On August 1, 2019 Pfizer Inc. (NYSE: PFE) reported the closing of its joint venture with GlaxoSmithKline plc (NYSE: GSK) to combine the parties’ respective consumer healthcare businesses to create the world’s largest over-the-counter (OTC) business with robust iconic brands (Press release, Pfizer, AUG 1, 2019, View Source [SID1234553276]). As previously announced, under the terms of the transaction, Pfizer owns a 32% equity stake in the joint venture and GSK owns 68%. The combined business, which will operate globally as GSK Consumer Healthcare, will be led by CEO Brian McNamara.

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"The successful closing of the joint venture represents an important and exciting step in forming a world-class pure-play consumer healthcare business," said Albert Bourla, Chief Executive Officer, Pfizer. "It also furthers Pfizer’s evolution to be a more focused, global leader in science-based, innovative medicines that delivers breakthroughs that change patients’ lives and creates long-term value for shareholders."

The combined brand portfolio forms the world’s largest OTC business with leadership positions in pain relief, respiratory and vitamins, minerals and supplements, and therapeutic oral health. In addition, operating together, the two business will hold the number one OTC position in the U.S. and the number two OTC position in China – the two biggest OTC markets in the world.

As part of the agreement, three out of the nine members of the joint venture’s board have been appointed by Pfizer and include John Young, Group President, Chief Business Officer; Douglas Giordano, Senior Vice President, Worldwide Business Development and Bryan Supran, Senior Vice President, Deputy General Counsel. The transaction is expected to deliver $650 million in peak cost synergies and to be slightly accretive on a full-year basis for Pfizer in each of the first three years following the closing.

GSK intends to separate the joint venture as an independent company via a demerger of its equity interest to its shareholders and a listing of the joint venture on the UK equity market. GSK will have the sole right to decide whether and when to initiate a separation and listing for a period of five years following the closing. GSK may also sell all or part of its stake in the joint venture in a contemporaneous IPO.

Should a separation and listing occur during the first five years after closing, Pfizer has the option to participate through the distribution of its equity interest in the joint venture to its shareholders or the sale of its equity interest in a contemporaneous IPO. After the fifth anniversary of the closing, both GSK and Pfizer will have the right to decide whether and when to initiate a separation and public listing of the joint venture.