On December 7, 2017 Neon Therapeutics, a clinical-stage immuno-oncology company developing neoantigen-based therapeutics, reported that it has entered a clinical trial collaboration with Merck (known as MSD outside the United States and Canada) to evaluate Neon Therapeutics’ proprietary personal neoantigen vaccine, NEO-PV-01, in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), along with chemotherapy (Press release, Neon Therapeutics, DEC 7, 2017, View Source [SID1234522428]).

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NEO-PV-01 is Neon Therapeutics’ most advanced product candidate, and is a personal neoantigen vaccine based on DNA mutations from each patients’ tumor. Neon Therapeutics and Merck will collaborate on a Phase 1b clinical trial that will examine the safety, tolerability and preliminary efficacy of NEO-PV-01 in combination with KEYTRUDA, pemetrexed and carboplatin in patients with untreated advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC). Additionally, the trial will assess neoantigen-specific immune responses in peripheral blood and tumor tissue, and other markers of immune response.

"We believe there is a strong mechanistic rationale to explore the combination of a personal neoantigen cancer vaccine, anti-PD-1 therapy and chemotherapy," said Richard Gaynor, M.D., president of research and development at Neon Therapeutics. "Together with a growing set of clinical collaborators, we are working to amass a diverse set of clinical data to understand the potential of NEO-PV-01 to improve durability and response rates in combination with multiple immuno-oncology targets."

The collaboration agreement is between Neon Therapeutics, Inc. and Merck, through a subsidiary. Additional details were not disclosed.

On December 7, 2017 Champions Oncology, Inc. (Nasdaq: CSBR), engaged in the development of advanced technology solutions and services to personalize the development and use of oncology drugs, reported its financial results for the second fiscal quarter and six months ended October 31, 2017 (Press release, Champions Oncology, DEC 7, 2017, View Source [SID1234522440]).

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Second Quarter and Recent Business Highlights:

•
Record quarterly revenue of $5.2 million, an increase of 16.7% year-over-year
•
Record Translational Oncology Services ("TOS") revenue of $4.8 million, an increase of 21.8% year-over-year
•
Awarded a two-year, $2 million, competitively-bid contract through the Small Business Innovation Research (SBIR) program to build and study an ethnically diverse cohort of metastatic prostate patient-derived xenograft (PDX) models
•
Clinical correlation between patient-derived xenograft (PDX) model responses and patient responses to oncology therapies highlighted in journal, Annals of Oncology; the report was published by the European Society for Medical oncology (ESMO) (Free ESMO Whitepaper), the leading European professional organization for medical oncology in Europe.
•
Reiterated expectations for fiscal year 2018 revenue growth of at least 20% over fiscal year 2017

Ronnie Morris, CEO of Champions, commented, "The continued execution of our strategic growth plan and disciplined management of expenses resulted in quarterly operating profitability and another quarter of record revenue, reinforcing our confidence in achieving at least 20% revenue growth for fiscal 2018 and the longer-term prospects for our business. As expected, revenues reached a level that exceeded our expenses, establishing a trajectory for long-term profitability. As we continue to scale, we expect to further minimize the impact of quarter-to-quarter fluctuations and generate consistent profitability."

"Engagement with existing and potential new clients remains solid, and we are encouraged by the level of interest being expressed for our services and the future growth opportunities we see before us," added Morris. "As we continue to expand our presence and collaborate with pharmaceutical companies on new projects, we are further increasing the value and importance of our models in the pre-clinical and clinical drug development process."

Financial Results

Exhibit 99.1

For the second quarter of fiscal 2018, revenue increased 16.7% to $5.2 million, as compared to $4.5 million for the second quarter of fiscal 2017. Total operating expenses for the second quarter fiscal 2018 and 2017 was $5.3 million and $5 million, respectively, an increase of $300,000 or 6.5%. Revenue was $10.2 million and $8.1 million for the six months ended October 31, 2017 and 2016, respectively, an increase of $2.1 million or 26%. Total operating expenses for the six months ended October 31, 2017 and 2016 was $10.9 million and $11.1 million, respectively, a decrease of $200,000 or (2%).

For the second quarter of fiscal 2018, Champions reported a loss from operations of $70,000, including $148,000 in stock-based compensation, an improvement of $423,000 or 85.8% compared to the loss from operations of $493,000, inclusive of $535,000 in stock-based compensation, in the second quarter of fiscal 2017. Excluding stock based compensation and depreciation, Champions recognized net income from operations of $175,000 for the second quarter 2018.

Net cash generated was $229,000 for the three months ended October 31, 2017. Net cash used for the same period last year was $134,000. The improvement in cash flow is the result of revenue growth and expense management.

The Company ended the quarter with $660,000 of cash and cash equivalents and reiterates its position that it does not currently intend to raise capital in the equity market.

TOS revenue was $4.8 million for the three months ended October 31, 2017 compared to $4 million for the three months ended October 31, 2016, an increase of $800,000 or 21.8%.

TOS cost of sales was $2.4 million for the three months ended October 31, 2017, an increase of $600,000, or 30.9%, compared to $1.8 million for the three months ended October 31, 2016. For the three months ended October 31, 2017 and 2016, gross margin for TOS was 50.4% and 53.8%, respectively. The increase in TOS cost of sales was due to an increase in the number and size of TOS studies. The gross margin often fluctuates quarter to quarter, resulting from timing differences between revenue and expense recognition.

Personalized Oncology Services ("POS") revenue was $378,000 and $497,000 for the three months ended October 31, 2017 and 2016, respectively, a decrease of $119,000 or (23.9%). The decrease is due mainly to a decrease in implant and drug study revenue.

POS cost of sales was $259,000 for the three months ended October 31, 2017, a decrease of $115,000, or (30.7%), compared to $374,000 for the three months ended October 31, 2016. For the three months ended October 31, 2017 and 2016, gross margin for POS was 31.5% and 24.8%, respectively. The improvement is attributed to the increase in higher margin sequencing revenue.

Research and development expense was $1.1 million for the three months ended October 31, 2017, an increase of $100,000, or 10.6%, compared to $1 million for the three months ended October 31, 2016. Sales and marketing expense for the three months ended October 31, 2017 was $551,000, a decrease of $166,000, or (23.2%), compared to $717,000 for the three months ended October 31, 2016. The decrease is mainly due to a reduction of marketing resources for the POS division. General and administrative expense was $1 million for both the three months ended October 31, 2017 and 2016.

Year-to-Date Financial Results

Exhibit 99.1

For the first six months of fiscal 2018, revenue increased 26.0% to $10.2 million, as compared to $8.1 million for the first six months of fiscal 2017. Total operating expenses for the first six months of fiscal 2018 were $10.9 million compared to $11.1 million for the first six months of fiscal 2017, a decrease of $200,000 or (1.9%).

For the first six months of fiscal 2018, Champions reported a loss from operations of $689,000, including $711,000 and $132,000 in stock-based compensation and depreciation, respectively, an improvement of $2.3 million, or 77.2%, compared to the loss from operations of $3 million, inclusive of $1.7 million and $87,000 in stock-based compensation and depreciation, respectively, in the first six months of fiscal 2017. Excluding stock-based compensation and depreciation, Champions recognized income from operations of $155,000 for the six months ended October 31, 2017 compared to net loss of $1.3 million for the six months ended October 31, 2016.

TOS revenue was $9.4 million for the six months ended October 31, 2017 compared to $7.1 million for the six months ended October 31, 2016, an increase of $2.3 million or 32.3%.

TOS cost of sales was $4.6 million for the six months ended October 31, 2017, an increase of $700,000, or 19.8%, compared to $3.9 million for the six months ended October 31, 2016. Gross margin for TOS was 50.7% for the first six months of fiscal 2018 compared to 45.5% for the first six months of fiscal 2017.

POS revenue was $818,000 for the six months ended October 31, 2017 compared to $1.0 million for the six months ended October 31, 2016, a decrease of $182,000 or (18.8%).

POS cost of sales was $646,000 for the six months ended October 31, 2017, a decrease of $201,000, or (23.7%), compared to $847,000 for the six months ended October 31, 2016. Gross margin for POS for the six months ended October 31, 2017 was 21% compared to 15.9% for the six months ended October 31, 2016.

Research and development expense was $2.2 million for both the six months ended October 31, 2017 and 2016. Sales and marketing expense for the six months ended October 31, 2017 was $1.2 million, a decrease of $400,000, or (24.8%), compared to $1.6 million for the six months ended October 31, 2016. General and administrative expense was $2.2 million for the six months ended October 31, 2017, a decrease of $400,000 or (15.3%), compared to $2.6 million for the six months ended October 31, 2016.

Net cash used in operations was $1.7 million for the six months ended October 31, 2017 compared to $2.6 million for the six months ended 2016, a decrease of $900,000 or 34.3%.

Conference Call Information:

The Company will host a conference call today at 4:30 p.m. EST (1:30:00 p.m. PST) to discuss its second quarter financial results. To participate in the call, please call 888-567-1602 (domestic) or 404-267-0373 (international) 10 minutes ahead of the call and give the verbal reference "Champions Oncology."

Full details of the Company’s financial results will be available Friday, December 15, 2017 in the Company’s Form 10-Q at www.championsoncology.com.

* Non-GAAP Financial Information

See the attached Reconciliation of GAAP net loss to non-GAAP net loss for an explanation of the amounts excluded to arrive at non-GAAP net loss and related non-GAAP net loss per share amounts for the three and six months ended October 31, 2017 and 2016. Non-GAAP financial measures provide investors and management with supplemental measures of operating performance and trends that facilitate comparisons between periods before and after certain items that would not otherwise be apparent on a GAAP basis. Certain unusual or non-recurring items that management does not believe affect the Company’s basic operations do not meet the GAAP definition of unusual or non-recurring items. Non-GAAP net loss and non-GAAP loss per share are not, and should not be viewed as a substitute for similar GAAP items. Champions’ defines non-GAAP dilutive loss per share amounts as non-GAAP net loss divided by the weighted average number of diluted shares outstanding. Champions’ definition of non-GAAP net loss and non-GAAP diluted loss per share may differ from similarly named measures used by others.

On December 7, 2017 Sanofi reported that it has launched two new late-stage clinical studies to determine if an investigational biologic called isatuximab, when used in combination with other commonly used cancer treatments, might be an effective treatment option for certain people with multiple myeloma, a rare blood cancer related to lymphoma and leukemia. Isatuximab is an investigational anti-CD38 monoclonal antibody being studied for the treatment of patients with relapsed and previously untreated multiple myeloma (Press release, Sanofi Genzyme, DEC 7, 2017, View Source [SID1234522429]).

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"The start of two new Phase 3 trials will provide further clinical data as we continue to advance the development of isatuximab," said Joanne Lager, M.D. Head of Oncology Development, Sanofi. "Our multi-study program across major multiple myeloma segments aims to demonstrate the value of isatuximab in combination with emerging standard treatment regimens. We are committed to developing a potential new treatment option for a continuum of patients with multiple myeloma, a population with high unmet need."

Late-stage studies include approximately 750 patients with multiple myeloma

IKEMA study is a 325-patient randomized, open-label, global multicenter Phase 3 trial that will compare isatuximab in combination with carfilzomib and dexamethasone against carfilzomib and dexamethasone in patients with relapsed and refractory multiple myeloma that have previously been treated with one-to-three lines of therapy.
IMROZ study is a 425-patient randomized, open-label, global multicenter Phase 3 trial that will compare isatuximab in combination with bortezomib, lenalidomide and dexamethasone against bortezomib, lenalidomide and dexamethasone in newly diagnosed multiple myeloma patients not eligible for transplant.
Both studies will evaluate progression-free survival as the primary endpoint. Key secondary endpoints include overall survival, overall response rate, depth of response, safety and quality of life.

Isatuximab granted orphan designation
Isatuximab has been granted orphan designation in the U.S. and European Union. In December 2016, Sanofi started an additional Phase 3 study (ICARIA), comparing isatuximab in combination with pomalidomide and dexamethasone against pomalidomide and dexamethasone in patients with relapsed and refractory multiple myeloma. The development program for isatuximab will now total three Phase 3 studies.

Other isatuximab data being presented at upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) meeting
Findings from additional ongoing studies of isatuximab will be presented during poster sessions at this year’s American Society of Hematology (ASH) (Free ASH Whitepaper) meeting, December 8-12, in Atlanta, GA, including the following abstracts:

Saturday, December 9, 5:30 p.m.-7:30 p.m.:

Updated Results from a Phase Ib Study of Isatuximab Plus Pomalidomide (Pom) and Dexamethasone (dex) in Relapsed/Refractory Multiple Myeloma (RRMM)
Abstract: 1887
Presenter: Dr. Paul Richardson
"In Vivo Vaccination" Effect in Clinical Responders to Anti-Myeloma Monoclonal Antibody Isatuximab
Abstract: 1830
Presenter: Dr. Tim Luetkens
Sunday, December 10, 6:00 p.m. -8:00 p.m.:

A Phase Ib Study of Isatuximab in Combination with Bortezomib, Cyclophosphamide, and Dexamethasone (VCDI) in Patients with Newly Diagnosed Multiple Myeloma Non-Eligible for Transplantation
Abstract: 3160
Presenter: Dr. Enrique M. Ocio
Pre-Clinical Efficacy of the Anti-CD38 Monoclonal Antibody (mAb) Isatuximab in Acute Myeloid Leukemia (AML)
Abstract: 2655
Presenter: Tomas Jelinek

On December 7, 2017 Enzo Biochem Inc. (NYSE:ENZ) reported improved operating results for the first fiscal quarter ended October 31, 2017, including year over year double digit revenue growth at Enzo Clinical Labs (Press release, Enzo Biochem, DEC 7, 2017, View Source [SID1234522442])

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.

First Quarter’s Highlights (Year Over Year):

· Total revenue in the first fiscal quarter increased to $27.7 million, or 5%, from $26.3 million in the prior year period.
· Clinical Labs revenue totaled $20.3 million, or an increase of 10% from $18.6 million a year ago.
· Gross profit increased 1%, with operating income improving $0.7 million, or 53%. Gross margin was 44%.
· The GAAP and non-GAAP net loss was $0.6 million or ($0.01) per fully diluted share, an improvement of $0.8 million, or 56% over the prior year’s net loss of $1.5 million or $(0.03) per fully diluted share.
· Total cash and cash equivalents at October 31, 2017 was $66.8 million, an increase of $2.7 million from July 31, 2017. Tight cost controls and efficiencies resulted in positive $2.6 million cash flow from operations in the quarter.
· During the quarter, the New York State Health Department issued conditional approval of the final three women’s health related molecular diagnostic tests which completes a 13-analyte panel, placing Enzo in a leading position to benefit from higher-margin proprietary women’s health diagnostics.
· Plant facilities in Farmingdale, NY, undergoing expansion to accommodate anticipated growth in manufacturing of growing roster of new molecular diagnostic assays and to increase laboratory capacity and to support GMP certification.

Barry Weiner, President, Comments:

"The first quarter of fiscal 2018 saw additional progress in moving aggressively towards our model as an integrated, growth-oriented molecular diagnostics company, and a low-cost medically related assay provider and reference service organization. Revenues continued to grow, spurred by double digit growth in the quarter at Clinical Labs, the result of expanded product and service capabilities and geographical expansion, along with increasing volume from our association with leading healthcare insurance providers. Sales, general and administrative costs (SG&A) are being held in check, even as product development and research efforts continue. We are also completing preparations to launch our marketing and sales program of our comprehensive products and reference services menu, while also adding to our Lab’s capability, particularly in the women’s health diagnostic field.

"We are preparing to offer one of the industry’s most advanced and well-rounded 13-analyte women’s health diagnostics panel, which last month was presented at the annual meeting of the prestigious Association for Molecular Pathology. The study our group reported on demonstrated that Enzo’s AMPIPROBE technology provides a new proprietary approach to creating clinically sensitive and specific multiplex real-time PCR assays, which, when run in tandem, can serve as a comprehensive panel for the accurate detection and identification of vaginitis-associated microorganisms. Enhanced by our proprietary AMPIPROBE technology, it offers faster, more specific and more sensitive molecular vaginitis testing, which we expect to improve diagnoses of vaginitis, a leading medical concern among women. Increasingly, when measured against the performance of similar assays, Enzo products continue to outperform, as reported recently in a leading diagnostic pathology publication, which cited our Polyview technology for viewing the clinical morphology of HPV specimens as having no false positives. That compared favorably to other leading competitive products that did have false positives in their tests.

"Our focus is on gaining sustained profitability and advancing healthcare in today’s challenging environment by providing affordable and reliable diagnostic testing. With Medicare reimbursement rates expected to decline materially over the next three years based on a new formula being adopted in place of one used over the past 30 years, the challenges are clear. Enzo’s transformative blueprint may help to alleviate this new challenge to the nation’s independent labs. This opportunity is reflected in our expanding line of medically related, versatile, highly efficient platforms and assays that are increasingly professionally recognized for their sensitivity and economics."

First Quarter Results
Total revenues increased to $27.7 million or 5% higher than the prior year period driven by increased Clinical labs services revenue from MDx tests. Gross profit was $12.2 million or 44% of total revenue. Total operating expenses were $12.9 million, a decline of $0.5 million or 4% over a year ago.

The GAAP and Non-GAAP net loss amounted to $(0.6) million, or $(0.01) per fully diluted share, compared to the year ago net loss of $(1.5) million or $(0.03) per fully diluted share, an improvement of $0.8 million. EBITDA and Adjusted EBITDA were essentially break even compared with a loss of $(0.6) million a year ago, a $0.5 million improvement year over year.

As of October 31, 2017 working capital amounted to $71.4 million, cash and cash equivalents totaled $66.8 million, up $2.7 million from three months earlier. Apart from capital leases, there was no debt.

Quarterly Segment Results

Enzo Clinical Labs revenues increased to $20.3 million, or 10%, from $18.6 million a year ago. As noted above, expansion of its diagnostics services to additional nearby geographical locations, the increased product mix of diagnostic tests, particularly in the women’s health field, and greater volume, all are contributing to its steady test and service growth. Gross profit increased to $8.3 million, from $7.7 million, with gross margin as a percentage of revenues at 41% for both the current and year ago quarters. Total operating expenses increased by 3.6%, to $6.9 million. Operating income amounted to $1.4 million, a nearly 40% increase.

Enzo Life Sciences revenues were $7.1 million compared to $7.4 million a year ago, a decline of $0.3 million or 5%. Gross profit approximated $4 million and gross margin as a percentage of revenue was 54%, compared to $4.4 million and 57%, respectively, a year ago. With the continued focus on reducing costs and improving efficiency, SG&A declined by 11%, to $2.6 million, with total operating expenses declining 12%, to $3.2 million.

Conference Call

The Company will conduct a conference call Friday, December 8, 2017 at 8:30 AM ET. The call can be accessed by dialing 1-888-459-5609. International callers can dial 1-973-321-1024. Please reference PIN number 3678737.

Interested parties may also listen over the Internet at: View Source

To listen to the live call on the Internet, please go to the web site at least fifteen minutes early to register, download and install any necessary audio software. For those who cannot listen to the live broadcast, a replay will be available approximately two hours after the end of the live call, through midnight (ET) on December 22, 2017. The replay of the conference call can be accessed by dialing 1-855-859-2056, and when prompted, use PIN number 3678737. International callers can dial 1-404-537-3406, using the same PIN number.

NON-GAAP Financial Measures

To comply with Regulation G promulgated pursuant to the Sarbanes-Oxley Act, Enzo Biochem attached to this news release and will post to the Company’s investor relations web site (www.enzo.com) any reconciliation of differences between non-GAAP financial information that may be required in connection with issuing the Company’s quarterly financial results.

The Company uses EBITDA as a measure of performance to demonstrate earnings exclusive of interest, taxes, depreciation and amortization. Adjustments to EBITDA are for items of a non-recurring nature and are reconciled on the table provided. The Company manages its business based on its operating cash flows. The Company, in its daily management of its business affairs and analysis of its monthly, quarterly and annual performance, makes its decisions based on cash flows, not on the amortization of

assets obtained through historical activities. The Company, in managing its current and future affairs, cannot affect the amortization of the intangible assets to any material degree, and therefore uses EBITDA as its primary management guide. Since an outside investor may base its evaluation of the Company’s performance based on the Company’s net loss not its cash flows, there is a limitation to the EBITDA measurement. EBITDA is not, and should not be considered, an alternative to net loss, loss from operations, or any other measure for determining operating performance of liquidity, as determined under accounting principles generally accepted in the United States (GAAP). The most directly comparable GAAP reference in the Company’s case is the removal of interest, taxes, depreciation and amortization.

We refer you to the tables attached to this press release which includes reconciliation tables of GAAP to Non-GAAP net income (loss) and EBITDA to Adjusted EBITDA.

On December 7, 2017 Seattle Genetics, Inc. (NASDAQ: SGEN) reported updated data from an ongoing phase 1 clinical trial evaluating ladiratuzumab vedotin in patients with metastatic triple negative breast cancer (TNBC) at the 2017 San Antonio Breast Cancer Symposium (SABCS), taking place December 5-9, 2017 (Press release, Seattle Genetics, DEC 7, 2017, View Source;p=RssLanding&cat=news&id=2321594 [SID1234522430]). Ladiratuzumab vedotin is an investigational antibody-drug conjugate (ADC) designed to deliver a potent and clinically validated cell-killing agent, monomethyl auristatin E (MMAE), to cancer cells which express the protein LIV-1. LIV-1 is expressed on multiple solid tumors including breast, prostate, melanoma, ovarian, uterine, and cervical cancers.

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"Overall, the phase 1 results we’ve presented at SABCS confirm previous findings that single-agent treatment with ladiratuzumab vedotin was generally well-tolerated and showed encouraging antitumor activity in patients with heavily-pretreated metastatic TNBC," said Robert Lechleider, M.D., Senior Vice President, Clinical Development at Seattle Genetics. "We continue to evaluate ladiratuzumab vedotin monotherapy in TNBC, with planned combination studies in earlier lines of treatment, demonstrating our overarching commitment to improve the health of women with this devastating disease."

Findings from this ongoing phase 1 study of ladiratuzumab vedotin in patients with metastatic breast cancer were last presented at the 2016 SABCS. The updated results presented today in a spotlight session describe the safety, tolerability, and antitumor activity of ladiratuzumab vedotin in 28 additional patients with TNBC.

Phase 1 Study of the Antibody-Drug Conjugate Ladiratuzumab Vedotin (SGN-LIV1A) in Patients with Heavily Pretreated Triple-Negative Metastatic Breast Cancer (Poster# PD3-14, Poster Session – Novel Drugs / Predicting Response for HER2+ Breast Cancer at 7:00 – 9:00 a.m. CT on Thursday, December 7, 2017)

A total of 81 patients with LIV-1-expressing metastatic breast cancer were treated with ladiratuzumab vedotin monotherapy given every three weeks. Patients enrolled in the study had received a median of four prior systemic metastatic therapies. Of these patients, 63 were diagnosed with TNBC and 18 had hormone receptor-positive / human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer. At the completion of dose escalation at doses ranging from 0.5 to 2.8 milligrams per kilogram (mg/kg), TNBC expansion cohorts were opened at 2.0 and 2.5 mg/kg to further evaluate safety and antitumor activity of ladiratuzumab vedotin in metastatic TNBC patients. Based on efficacy and safety, the recommended dose is 2.5 mg/kg with a maximum dose of 200 mg per cycle.

Key findings in this heavily pre-treated patient population were presented by Dr. Jennifer Specht, Seattle Cancer Care Alliance and include:

Among the 60 efficacy-evaluable patients with metastatic TNBC, the objective response rate (ORR) was 25 percent, representing all partial responses (PR). The clinical benefit rate (CBR) was 28 percent. CBR is defined as patients achieving complete response (CR) or PR of any duration, plus patients achieving stable disease (SD) lasting at least 24 weeks. Of the 17 efficacy-evaluable patients treated at the recommended dose, 29 percent achieved an objective response (confirmed and unconfirmed), and the CBR was 29 percent.
The median progression-free survival (PFS) and median duration of response (DOR) for patients treated across all dose levels were 11 weeks and 13.3 weeks, respectively. In 19 patients treated at the recommended dose, the median PFS was 12.1 weeks, and the median DOR was 17.4 weeks.
At the recommended dose, ladiratuzumab vedotin was generally well-tolerated and most adverse events were Grade 1/2.
Of the 81 patients treated in the study, peripheral neuropathy events occurred in 16 patients (19.8 percent) and were generally low grade (Grades 1/2) and manageable. Seven patients discontinued treatment due to adverse events.
Grade 3/4 adverse events included neutropenia and anemia. The Grade 3/4 incidence of neutropenia at the 2.5 mg/kg dose was 38.7 percent. As previously reported, two patients experienced febrile neutropenia, and there was one treatment-related death due to presumed sepsis among patients who received doses greater than 200 mg. No other treatment-related deaths occurred in the study.
Enrollment continues for patients with metastatic TNBC at the recommended dose of 2.5 mg/kg, with a maximum dose of 200 mg per cycle.
Additional details about this spotlight poster presentation (Poster PD3-14) are available here. More information about the ladiratuzumab vedotin phase 1 clinical trial in TNBC, including enrollment centers, is available by visiting www.clinicaltrials.gov.

About Triple Negative Breast Cancer

Breast cancer is the most common cancer among women in the United States, excluding some forms of skin cancer. Of the more than 250,000 new cases expected in the United States this year, about 15 to 20 percent will be TNBC, which has a particularly poor prognosis. Breast cancers are commonly categorized by the expression (or lack thereof) of three proteins, which include the estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2). TNBC lacks expression of these three breast cancer-associated proteins that serve as key therapeutic targets. About one-third of breast cancer patients will eventually develop recurrent or metastatic disease, and current therapies for metastatic TNBC only delay progression. New treatment approaches are needed to improve outcomes for women with TNBC, where there are currently no available targeted therapies.

About Ladiratuzumab Vedotin

Ladiratuzumab vedotin is a novel investigational ADC targeted to LIV-1 protein utilizing Seattle Genetics’ proprietary ADC technology. Most metastatic breast cancers express LIV-1, which also has been detected in a number of other cancers, including melanoma, prostate, ovarian, uterine, and cervical cancers. Ladiratuzumab vedotin consists of a LIV-1-targeted monoclonal antibody linked to a potent microtubule-disrupting agent, monomethyl auristatin E (MMAE) by a protease-cleavable linker, using the same technology as ADCETRIS (brentuximab vedotin). This novel ADC agent is designed to bind to LIV-1 on cancer cells and release the cell-killing agent into target cells upon internalization. Ladiratuzumab vedotin may also cause antitumor activity through other mechanisms, including activation of an immune response. Seattle Genetics currently has four clinical studies underway or planned for ladiratuzumab vedotin in breast cancer with a focus on TNBC.