On March 7, 2018 CytomX Therapeutics, Inc. (Nasdaq:CTMX), a clinical-stage biopharmaceutical company developing investigational Probody therapeutics for the treatment of cancer, reported full-year 2017 financial results and provided an operational update on the company (Press release, CytomX Therapeutics, MAR 7, 2018, View Source/phoenix.zhtml?c=254195&" target="_blank" title="View Source/phoenix.zhtml?c=254195&" rel="nofollow">View Source;p=RssLanding&cat=news&id=2336902 [SID1234524504]).

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As of December 31, 2017, CytomX had cash, cash equivalents and short-term investments of $374.1 million. Based upon its current operating plan, the Company expects its existing capital resources will be sufficient to fund operations into 2020.

"The CytomX team continued tremendous execution during 2017, driving our transition to a clinical-stage company with the initiation of Phase 1/2 studies for two wholly-owned and one partnered program," said Sean McCarthy, D.Phil., president and chief executive officer of CytomX Therapeutics.

"During 2018, we expect initial data readouts from our PD-L1-targeting Probody therapeutic, CX-072, and our CD166-targeting Probody drug conjugate, CX-2009. We also expect to initiate clinical studies for two additional programs this year, resulting in five clinical-stage Probody therapeutic programs by year end. Our deepening pipeline of innovative therapeutics has the potential to make a meaningful difference in the lives of people with cancer," continued Dr. McCarthy.

2017 Business Highlights and Recent Developments

PROCLAIM-CX-072 (PD-L1 Probody Therapeutic) Clinical Program

CX-072 is a Probody therapeutic targeting PD-L1, a clinically- and commercially-validated anti-cancer target.
Enrollment began in January 2017 in PROCLAIM-CX-072, a Phase 1/2 clinical trial evaluating CX-072 as monotherapy and in combination with Yervoy (ipilimumab) or Zelboraf (vemurafenib) in patients with cancer.
Enrollment is complete in the monotherapy dose escalation arm evaluating CX-072 in patients with advanced unresectable solid tumors or lymphomas (Part A).
Preliminary data from Part A is expected to be presented mid-2018.
Patient enrollment was initiated at a single dose level in an expansion cohort in an undisclosed cancer with known sensitivity to PD-pathway inhibitors (Part D).
Patient enrollment is ongoing in all other dose escalation arms of the study:
Monotherapy expansion in patients with PD-L1-positive tumors at multiple dose levels (Part A2);
Combination of CX-072 plus Yervoy (ipilimumab) in patients with advanced unresectable solid tumors or lymphomas (Part B);
Combination of CX-072 plus Zelboraf (vemurafenib) in patients with V600E BRAF-positive melanoma (Part C).
PROCLAIM-CX-2009 (CD166 Probody Drug Conjugate) Clinical Program

CX-2009 is a Probody drug conjugate (PDC) that targets CD166, an antigen that is broadly and highly expressed in many types of cancer.
Patient enrollment continues in the PROCLAIM-CX-2009 study, a Phase 1/2 clinical trial initiated in June 2017, evaluating CX-2009 as monotherapy in a subset of CD166-positive cancer types (Part A).
Preliminary data from Part A is expected to be presented in the second half of 2018.
Monotherapy expansion at select dose levels and in the same subset of cancers has been initiated in patients selected for the highest levels of CD166 expression (Part A2).
BMS-986249 (CTLA-4 Probody Therapeutic) Clinical Program

Bristol-Myers Squibb (BMS) presented preclinical safety and anti-tumor activity data for an anti-CTLA-4 Probody therapeutic designed to be a potentially safer ipilimumab.
In fourth quarter of 2017, BMS initiated a Phase 1/2 study evaluating BMS-986249 alone and in combination with nivolumab in solid tumors that are advanced and have spread.
BMS-986249 is the first Probody therapeutic to advance to the clinic under the companies’ strategic collaboration.
CX-2029 (CD71 Probody Drug Conjugate) Preclinical Program

CytomX, in collaboration with AbbVie, is advancing CX-2029, a CD71-directed PDC, through Investigational New Drug (IND) application-enabling studies.
CD71, also known as the transferrin receptor 1 (TfR1), is highly expressed in a number of solid and hematologic cancers and has particularly attractive molecular properties for efficient delivery of cytotoxic payloads to tumor cells.
CytomX expects to file an IND application for CX-2029 in the first half of 2018.
CX-188 (PD-1 Probody Therapeutic) Preclinical Program

CytomX is advancing CX-188, a PD-1-directed Probody therapeutic, through IND-enabling studies.
PD-1 is the receptor for the PD-L1 ligand responsible for inhibiting T-cell activation in a variety of cancers and is a clinically- and commercially-validated anti-cancer target.
CytomX expects to file an IND application for CX-188 in the second half of 2018.
Partnerships

AbbVie Partnership

During the third quarter of 2017, CytomX received a $15 million milestone payment ($14 million net of associated license fees) from AbbVie in conjunction with meeting certain criteria allowing the initiation of GLP toxicology studies by CytomX for CX-2029, a CD71-directed PDC.
Amgen Partnership

During the third quarter of 2017, Amgen and CytomX entered into a strategic collaboration in immuno-oncology in the field of Probody T-cell engaging bispecific antibodies (Pro-TCBs), including the co-development of a CytomX Pro-TCB against the Epidermal Growth Factor Receptor (EGFR), a highly validated oncology target expressed on multiple human cancer types.
Under the terms of the agreement, Amgen and CytomX will co-develop a Pro-TCB against EGFR-CD3 with CytomX leading early development.
Amgen will lead later development and commercialization with global late-stage development costs shared between the two companies.
Amgen made an upfront payment of $40 million and purchased $20 million of CytomX common stock.
CytomX is eligible to receive up to $455 million in development, regulatory and commercial milestones payments for the EGFR program and low-double digit to mid-teen percentage royalty payments on resulting EGFR products, and has the ability to opt into a profit share in the U.S.
Amgen is also able to select three additional targets for Pro-TCB discovery and development. Should Amgen ultimately pursue all of these targets, CytomX will be eligible to receive up to $950 million in additional upfront and milestone payments and high-single digit to low-teen percentage royalty payments on any resulting products.
CytomX also received the rights from Amgen to an undisclosed preclinical T-cell engaging bispecific program; Amgen is eligible to receive milestones and mid-single digit to low-double digit percentage royalty payments on any resulting products from this CytomX program.
Bristol-Myers Squibb Collaboration Expansion

During the second quarter of 2017, CytomX and BMS expanded its foundational alliance to discover, develop and commercialize novel therapies using the Probody platform, resulting in a $200 million upfront payment to CytomX.
The expanded collaboration now provides BMS with the selection of up to ten oncology targets and two non-oncology targets.
In the fourth quarter of 2017, CytomX earned a $10 million milestone payment from BMS upon IND clearance of BMS-986249.
Pfizer Collaboration

On March 6, 2018, CytomX received notification of Pfizer’s intent to terminate the companies’ research collaboration, option and license agreement.
The Pfizer collaboration, entered into in 2013, included the selection of up to four PDC targets for the treatment of cancer.
The initial PDC target was EGFR, which Pfizer previously discontinued, with certain rights reverting to CytomX.
Collaboration programs against the second and third targets were terminated during the first quarter of 2018.
Pfizer had previously declined its option to select a fourth target in the collaboration.
None of the programs in the Pfizer collaboration had advanced to clinical candidate stage.
Full-Year Financial Results
Cash, cash equivalents and investments totaled $374.1 million as of December 31, 2017, compared to $181.9 million as of December 31, 2016. The increase reflects cash provided by operations resulting primarily from the $200 million of upfront payments received from BMS for alliance expansion, $40 million of upfront payments and $20 million of proceeds from stock sold as part of the Amgen agreement, and the $15 million milestone payment ($14 million net of associated license fees) received from AbbVie. These cash receipts were partially offset by cash used to fund operations.

Research and development expenses were $92.3 million for the year ended December 31, 2017, compared to $54.8 million for the corresponding period in 2016. The increase in research and development expenses was primarily attributable to a non-cash charge of $10.7 million of in-process research and development expense recognized related to the Amgen agreement; $10.0 million sublicense payment made to UCSB triggered by the $200.0 million upfront payment made by BMS in connection with our expanded collaboration; $2.1 million of UCSB sublicense fees accrued as a result of the Amgen agreement; $1.0 million of UCSB sublicense fees recognized for our achievement of certain milestones required to be met to begin GLP toxicology studies under the AbbVie agreement and the IND filing for the CTLA-4 directed Probody therapeutic by BMS; an increase of $8.5 million in pharmacology studies and clinical trial expenses resulting from the advancement of CX-072, CX-2009, and CX-2029 in 2017; an increase of $5.3 million in personnel-related expenses and allocation of IT and facilities-related expenses due to an increase in headcount; and an increase of $1.7 million in consulting expenses due to the commencement of clinical trials in 2017. These increases were partially offset by a decrease of $2.1 million in manufacturing expenses for our CX-072 and CX-2009 programs due to manufacturing activities occurring in 2016 in preparation for clinical trials in 2017.

General and administrative expenses were $25.6 million for the year ended December 31, 2017, compared to $19.9 million for the year ended December 31, 2016. The increase was predominantly due to an increase of $1.4 million in personnel-related expenses and an increase of $1.0 million in recruitment fees due to an increase in headcount and temporary labor; an increase in stock-based compensation of $1.0 million due to an increase in headcount and an increase in the value of our stock; and an increase of $1.2 million in consulting services expenses primarily due to an increase in tax and accounting compliance activities and investor relations expenses.

Teleconference Scheduled Today at 5:00 p.m. ET
Conference Call/Webcast Information
CytomX management will host a conference call today at 5:00 p.m. ET. Interested parties may access the live audio webcast of the teleconference through the Investor and News page of CytomX’s website at View Source or by dialing 1-877-809-6037 and using the passcode 5686339. A replay will be available on the CytomX website or by dialing 1-855-859-2056 and using the passcode 5686339. The replay will be available from March 7, 2018, until March 14, 2018.

On March 7, 2018 Seattle Genetics, Inc. (NASDAQ: SGEN) reported dosing of the first patient in a phase 1 clinical trial evaluating the safety and tolerability of SGN-CD48A for patients with relapsed or refractory multiple myeloma (MM) (Press release, Seattle Genetics, MAR 7, 2018, View Source;p=RssLanding&cat=news&id=2336726 [SID1234524488]). SGN-CD48A is an investigational ADC targeted to the protein CD48, which is highly expressed on MM cells. SGN-CD48A uses the company’s latest ADC technology advancement, a PEGylated glucuronide linker that improves stability, reduces off-target uptake, and enables conjugation of more molecules of the microtubule-disrupting cytotoxic agent monomethyl auristatin E (MMAE) per antibody. With this novel linker, SGN-CD48A has demonstrated promising antitumor activity in preclinical studies.

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"Multiple myeloma is the second most common blood cancer in the US and remains an incurable disease despite recent medical advances. Patients are in need of new targeted treatment options that increase durable remissions," said Robert Lechleider, M.D., Senior Vice President, Clinical Development at Seattle Genetics. "SGN-CD48A uses our latest ADC technology, and the initiation of this phase 1 trial in relapsed or refractory multiple myeloma highlights our continued leadership in ADCs as we address this challenging disease."

The phase 1 study is a multicenter open-label dose-escalation trial designed to enroll approximately 75 patients with relapsed or refractory MM. SGN-CD48A will be administered at an initial dosing interval of every three weeks. The primary objectives of the trial are to evaluate the safety and tolerability of SGN-CD48A and to identify the maximum tolerated dose (MTD). Key secondary objectives include assessing the antitumor activity and identifying the recommended single-agent dose and schedule.

For more information about the phase 1 clinical trial (NCT03379584), please visit www.clinicaltrials.gov.

About Multiple Myeloma

Multiple myeloma (MM) is a rare and aggressive cancer that forms in white blood cells called plasma cells. Cancerous plasma cells can crowd out healthy blood cells, impair bone strength and weaken the immune system. MM is the second most common blood cancer in the US. According to the American Cancer Society, more than 30,000 new cases of MM were expected in the US in 2017, with over 12,500 deaths. Despite recent medical advances, MM still remains an incurable disease. It is managed with sequential lines of treatment that typically yield shorter durations of disease control with each subsequent relapse, and some patients receive more than four lines of treatment over the course of their disease.

About SGN-CD48A

SGN-CD48A is a novel investigational ADC targeted to CD48, a cell surface protein highly expressed in multiple myeloma. The ADC uses Seattle Genetics’ latest technology innovation, a next generation PEGylated glucuronide linker that enables conjugation of eight molecules of the microtubule-disrupting cytotoxic agent monomethyl auristatin E (MMAE) to a CD48-targeted monoclonal antibody. SGN-CD48A is designed to be highly stable in circulation and release an increased amount of MMAE upon internalization into CD48-expressing cells, producing greater antitumor activity in preclinical studies.

On March 7, 2018 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) reported that the first patient has been dosed in a global phase 2 study evaluating the safety and efficacy of DS-8201, an investigational HER2-targeting antibody drug conjugate (ADC), in patients with HER2-expressing advanced colorectal cancer who have received at least two prior lines of standard treatment (Press release, Daiichi Sankyo, MAR 7, 2018, View Source [SID1234524505]).

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An increase in the number of approved targeted therapies for advanced colorectal cancer over the past decade has helped improve outcomes for some patients, however efficacy and tolerability of second and third-line treatments remain limited.[1], [2], [3], [4], [5]Approximately 3 percent of colorectal cancers overexpress the HER2 protein, which is a well-established therapeutic target in breast and gastric cancer.1 In addition, research indicates that HER2 amplification may be associated with resistance to anti-epidermal growth factor receptor (EGFR)-targeted therapy and shorter survival.[6],[7] Currently, no approved HER2-targeting therapies exist for patients with colorectal cancer.

"Given the existing unmet medical need for advanced colorectal cancer, we are exploring the smart delivery of chemotherapy with DS-8201 as a potential new type of targeted treatment for patients with HER2-expressing disease who have progressed on or become resistant to standard therapies," said Antoine Yver, MD, MSc, Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo. "Similar to our breast and gastric cancer programs, we are pursuing a development path focused first on patients with HER2-overexpressing tumors followed by potential expansion to include patients with advanced colorectal cancer with lower levels of HER2 expression."

About the DS-8201 Colorectal Cancer Phase 2 Study

The global, multi-center, phase 2, open-label, three-cohort study will investigate the safety and efficacy of DS-8201 in patients with HER2-expressing advanced colorectal cancer. The first part of the study will enroll patients with HER2-positive (defined as IHC3+ or IHC2+/ISH+) advanced colorectal cancer. The primary endpoint of the study is overall response rate. Secondary endpoints include progression-free survival, overall survival, duration of response, disease control rate, pharmacokinetics and safety. Exploratory endpoints include time to response and biomarker analysis. This part of the study is expected to enroll approximately 50 patients in North America, Europe and Japan.

Following the outcome of the first part of the study, two additional exploratory cohorts may proceed to enroll patients whose tumors have lower levels of HER2-expression. For more information about the study, visit ClinicalTrials.gov.

About Colorectal Cancer

Colorectal cancer is the third most common cancer worldwide. In 2012, there were approximately 1.36 million new cases diagnosed and 690,000 deaths worldwide.[8] Approximately 25 percent of patients have metastatic disease at diagnosis, meaning the disease has spread to distant organs, and about 50 percent of patients with colorectal cancer will eventually develop metastases.[9] Prognosis for these patients remains poor.[10]

About DS-8201

DS-8201 is the lead product in the investigational ADC Franchise of the Daiichi Sankyo Cancer Enterprise. ADCs are targeted cancer medicines that deliver cytotoxic chemotherapy ("payload") to cancer cells via a linker attached to a monoclonal antibody that binds to a specific target expressed on cancer cells. Designed using Daiichi Sankyo’s proprietary ADC technology, DS-8201 is a smart chemotherapy comprised of a humanized HER2 antibody attached to a novel topoisomerase I inhibitor payload by a tetrapeptide-based linker. It is designed to target and deliver chemotherapy inside cancer cells and reduce systemic exposure to the cytotoxic payload (or chemotherapy) compared to the way chemotherapy is commonly delivered.

In addition to the phase 2 study in HER2-expressing advanced colorectal cancer, DS-8201 is currently in pivotal phase 2 clinical development for HER2-positive unresectable and/or metastatic breast cancer resistant or refractory to T-DM1 (DESTINY-Breast01) in North America, Europe and Asia, and pivotal phase 2 development for HER2-positive advanced gastric cancer resistant or refractory to trastuzumab (DESTINY-Gastric01) in Japan and South Korea. DS-8201 is also in phase 1 development for other HER2-expressing advanced/unresectable or metastatic solid tumors.

DS-8201 has been granted Breakthrough Therapy designation for the treatment of patients with HER2-positive, locally advanced or metastatic breast cancer who have been treated with trastuzumab and pertuzumab and have disease progression after ado-trastuzumab emtansine (T-DM1), and Fast Track designation for the treatment of HER2-positive unresectable and/or metastatic breast cancer in patients who have progressed after prior treatment with HER2-targeted therapies including T-DM1 by the U.S. Food and Drug Administration (FDA). DS-8201 is an investigational agent that has not been approved for any indication in any country. Safety and efficacy have not been established.

ImmunoGen has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, ImmunoGen, 2018, MAR 7, 2018, View Source [SID1234524547]).

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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

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On March 7, 2018 Foundation Medicine (NASDAQ:FMI) reported financial and operational results for the fourth quarter and year ended December 31, 2017 (Press release, Foundation Medicine, MAR 7, 2018, View Source [SID1234524506]). Highlights for the quarter and year included:

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Fourth quarter revenue of $48.9 million, 70% year-over-year growth;
Full year 2017 revenue of $152.9 million, 31% year-over-year growth;
20,044 clinical tests reported in the fourth quarter, 57% year-over-year growth;
67,375 clinical tests reported in 2017, 54% year-over-year growth;
Received approval from the U.S. Food & Drug Administration (FDA) under the parallel review process for FoundationOne CDx, the first broad comprehensive genomic profiling test for all solid tumors incorporating multiple companion diagnostics. Simultaneously, the Centers for Medicare and Medicaid Services (CMS) issued a preliminary National Coverage Determination (NCD) for FoundationOne CDx;
Entered into new and expanded biopharma collaborations for molecular information solutions including companion diagnostics, molecular profiling, data insights, and biomarker discovery, validation and development such as tumor mutational burden (TMB) and tumor mutational burden in blood (bTMB); and
Published 95 peer-reviewed manuscripts in top medical and scientific journals and presented 141 podium talks and posters at scientific and medical meetings.
"Foundation Medicine’s 2017 results and achievements, including record revenue and clinical volume and the landmark FDA approval of FoundationOne CDx, position our company for continued value creation and competitive differentiation," stated Troy Cox, chief executive officer of Foundation Medicine. "Our strategic priorities in 2018 include the successful commercial launch of FoundationOne CDx, driving global clinical adoption of our solutions, expanding reimbursement progress, and entering new biopharma partnerships, all of which we believe will accelerate our business and keep us on the leading edge of innovation."

Foundation Medicine reported total revenue of $48.9 million in the fourth quarter of 2017, compared to $28.8 million in the fourth quarter of 2016. Total revenue for the year ended December 31, 2017 was $152.9 million, compared to $116.9 million in 2016.

Revenue from biopharmaceutical companies was $33.4 million in the fourth quarter of 2017 and $99.7 million for the full year ended December 31, 2017, compared to $19.0 million and $78.8 million in the fourth quarter and full year ended December 31, 2016, respectively. The company reported 6,206 tests to biopharmaceutical customers in the fourth quarter of 2017 and 15,587 tests for the full year ended December 31, 2017.

Revenue from clinical testing was $15.5 million in the fourth quarter of 2017 and $53.2 million for the full year ended December 31, 2017, compared to $9.8 million and $38.1 million in the fourth quarter and full year ended December 31, 2016, respectively. The company reported 20,044 clinical tests to ordering physicians in the fourth quarter of 2017, compared to a total of 12,788 tests reported during the fourth quarter of 2016, an increase of 57%. A total of 67,375 clinical tests were reported to ordering physicians for the full year ended December 31, 2017, compared to 43,686 clinical tests reported in 2016, an increase of 54%.

Based on the new revenue reporting the company initiated during 2017, Molecular Information Services revenue was $37.4 million in the fourth quarter of 2017 and $117.2 million for the full year ended December 31, 2017, compared to $20.4 million and $81.7 million in the fourth quarter and full year ended December 31, 2016, respectively. Pharma Research and Development Services revenue was $11.5 million in the fourth quarter of 2017 and $35.7 million for the full year ended December 31, 2017, compared to $8.4 million and $35.1 million in the fourth quarter and full year ended December 31, 2016, respectively.

Total operating expenses for the fourth quarter of 2017 were approximately $59.9 million compared with $47.1 million for the fourth quarter of 2016. For the full year, operating expenses were $228.6 million, compared to $173.9 million in 2016. Net loss was $38.1 million in the fourth quarter of 2017, or $1.05 loss per share, and net loss for the full year was $161.5 million, or a $4.50 loss per share.

Cash and cash equivalents at December 31, 2017 was approximately $71.4 million, including $30 million in new borrowings received during the fourth quarter under the company’s Credit Facility Agreement with Roche Finance.

2018 Outlook

The company expects 2018 revenue will be in the range of $200 million to $220 million.
The company expects to deliver between 90,000 and 100,000 clinical tests in 2018.
The company expects operating expenses will be in the range of $250 million to $260 million in 2018.
Conference Call and Webcast Details
The company will conduct a conference call today, Wednesday, March 7th at 4:30 p.m. Eastern Time to discuss its financial performance for the 2017 fourth quarter and other business activities, including matters related to future performance. To access the conference call via phone, dial 1-877-270-2148 from the United States or dial 1-412-902-6510 internationally. Dial in approximately ten minutes prior to the start of the call. The live, listen-only webcast of the conference call may be accessed by visiting the investors section of the company’s website at investors.foundationmedicine.com. A replay of the webcast will be available shortly after the conclusion of the call and will be archived on the company’s website for two weeks following the call.