- Cabiralizumab continues to advance in randomized Phase 2 trial in pancreatic cancer
- Bemarituzumab has advanced through Phase 1 safety lead-in of Phase 1/3 FIGHT global trial in gastric cancer; preparation for Phase 3 portion underway
- Four product candidates in the clinic, fifth planned by end of 2018
“We are pleased with the progress across our pipeline, including BMS’s
ongoing randomized Phase 2 clinical trial to evaluate cabiralizumab and
OPDIVO® with and without chemotherapy as a second-line
treatment in patients with advanced pancreatic cancer,” said
Mr. Knickerbocker continued, “We are committed to making prudent clinical development decisions. Although we continue to observe efficacy in the PVNS Phase 2 trial, we have decided not to advance cabiralizumab into a pivotal trial in PVNS in 2019 because patients with this chronic, non-malignant disease demonstrate a lower tolerance for side effects, such as periorbital edema, relative to patients with cancer.”
Second Quarter 2018 Business Highlights and Recent Developments
Cabiralizumab (FPA008): An antibody that inhibits CSF1R and has been shown to block the activation and survival of macrophages.
Bristol-Myers Squibb Company (BMS) continues to advance a randomized
Phase 2 clinical trial in patients with locally advanced or metastatic
The Phase 2 clinical trial (NCT03336216) evaluates cabiralizumab
and OPDIVO (nivolumab) with and without mFOLFOX6 or
gemcitabine/Abraxane chemotherapy compared to chemotherapy alone
as a second-line treatment in patients with advanced pancreatic
cancer. The Phase 2 trial is expected to enroll approximately 160
the United States, Europe, Japanand Taiwan.
- The Phase 2 clinical trial (NCT03336216) evaluates cabiralizumab and OPDIVO (nivolumab) with and without mFOLFOX6 or gemcitabine/Abraxane chemotherapy compared to chemotherapy alone as a second-line treatment in patients with advanced pancreatic cancer. The Phase 2 trial is expected to enroll approximately 160 patients from
Enrollment has closed and treatment continues in Five Prime’s Phase
1a/1b clinical trial of cabiralizumab and OPDIVO (nivolumab).
- Five Prime and BMS are evaluating the safety, tolerability and preliminary efficacy of the immunotherapy combination of cabiralizumab with the PD-1 immune checkpoint inhibitor OPDIVO in advanced solid tumors, including in more than 70 patients with pancreatic cancer.
A poster titled “Pharmacodynamics (PD) and Genomic Profiling of
Pts Treated with cabiralizumab (cabira) + nivolumab (NIVO) Provide
Evidence of On-Target Tumor Immune Modulations and Support Future
Clinical Applications” was presented and chosen for oral
discussion at the 2018
American Society of Clinical Oncology( ASCO) Annual Meeting on June 4.
- Data suggest cabiralizumab in combination with nivolumab decreases immunosuppressive macrophages and increases CD8+ effector T-cells in the tumor microenvironment.
- These data, together with preliminary clinical response data observed in patients with low tumor mutational burden, support further clinical development of cabiralizumab plus nivolumab in multiple indications, including pancreatic cancer.
Five Prime has decided not to advance cabiralizumab in pigmented
villonodular synovitis (PVNS), a rare, locally aggressive,
non-malignant tumor of the synovium, into a pivotal trial under the
current dosing schedule.
- Five Prime has been enrolling a second cohort in the Phase 2 portion of a Phase 1/2 clinical trial (NCT02471716) to evaluate dosing every 4-6 weeks instead of every 2 weeks to optimize the therapeutic index of cabiralizumab in PVNS.
- Although Five Prime continues to observe efficacy in this second cohort, the frequency of dose interruptions and discontinuations suggests that the current dosing schedule is unlikely to be optimal for a pivotal trial in this chronic, non-fatal disease.
- The company is considering alternative dosing schedules as there continues to be a high unmet need for patients with PVNS.
Apexigen, Inc.and Yale Cancer Centerannounced a clinical trial collaboration to evaluate APX005M (anti-CD40) in combination with cabiralizumab and OPDIVO. The phase 1/1b study (NCT03502330) is designed to identify a safe dose of APX005M to be added to cabiralizumab and OPDIVO. The expansion portion of the trial will study the triple drug combination in patients with melanoma, non-small cell lung cancer (NSCLC) or renal cell carcinoma (RCC) whose disease has progressed on a prior regimen containing a PD-1 or PD-L1 inhibitor without intervening therapy.
Bemarituzumab (FPA144): A first-in-class isoform-selective antibody with enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) in development as a targeted immuno-therapy for tumors that overexpress FGFR2b.
Five Prime advanced through the Phase 1 safety lead-in portion
(NCT03343301) of the Phase 1/3 FIGHT (FGFR2b
Inhibition in Gastric
and Gastroesophageal Junction Cancer Treatment)
global registrational trial.
The company expects to initiate patient dosing in the randomized,
controlled Phase 3 portion of the trial before the end of the year
in the U.S., Europe and Asia, including China and
South Korea, where the incidence of gastric cancer is high.
- The trial will evaluate bemarituzumab in combination with the modified FOLFOX6 standard-of-care chemotherapy regimen (mFOLFOX6) versus placebo plus mFOLFOX6 in approximately 550 patients with advanced gastric or gastroesophageal junction cancer whose tumors overexpress FGFR2b.
- Five Prime is using immunohistochemistry (IHC) and circulating tumor DNA (ctDNA) tests to identify the estimated 10% of patients with FGFR2b-overexpressing gastric cancer who would be eligible for the trial.
- The company expects to initiate patient dosing in the randomized, controlled Phase 3 portion of the trial before the end of the year in the U.S., Europe and Asia, including China and
A poster titled “FIGHT: A Phase 3 Randomized, Double-Blind, Placebo
Controlled Study Evaluating (Bemarituzumab) FPA144 and Modified
FOLFOX6 (mFOLFOX6) in Patients with Previously Untreated Advanced
Gastric and Gastroesophageal Cancer with a Dose Finding Phase 1
Lead-In” was presented at the 2018 ASCO Annual Meeting on
FPA150 (anti-B7-H4): A first-in-class antibody targeting B7-H4 designed to have two mechanisms of action: to block an inhibitory T-cell checkpoint pathway and to enhance killing of B7-H4 overexpressing tumors by ADCC. B7-H4 is frequently overexpressed in breast, ovarian, endometrial and bladder cancers.
- Five Prime continues to dose patients with FPA150 monotherapy in solid tumors in the dose escalation phase of the Phase 1a/1b clinical trial.
- Dose escalation will be followed by expansion in pre-specified cohorts of patients whose tumors have high B7-H4 expression levels, as measured by an IHC molecular diagnostic test. The initial targeted tumors for the expansion cohorts are breast, ovarian, endometrial and bladder cancers.
- During the dose escalation, Five Prime will also open an exploratory cohort to investigate FPA150 monotherapy in patients with tumors that overexpress B7-H4.
BMS-986258 (anti-TIM-3): A fully-human monoclonal antibody targeting TIM-3 (T-cell immunoglobulin and mucin domain-3), an immune checkpoint receptor that is known to limit the duration and magnitude of T-cell responses.
- In January 2018, BMS began a Phase 1/2 trial (NCT03446040), of BMS-986258, which is testing the antibody both as a single-agent and in combination with OPDIVO.
- BMS-986258 is the first clinical candidate from BMS’s immuno-oncology research collaboration with Five Prime.
Preclinical Research and Development:
FPT155 (CD80-Fc): A first-in-class CD80 fusion protein that uses the binding interactions of soluble CD80 to (i) directly engage CD28 to further enhance its co-stimulatory T-cell activation activity without inducing super agonism, and (ii) block CTLA-4 from competing for endogenous CD80, allowing CD28 signaling to prevail in T-cell activation in the tumor microenvironment.
- Studies in preclinical models suggest FPT155 has the potential to be a potent T-cell co-stimulator with strong monotherapy antitumor activity and may have a synergistic effect when combined with anti-PD1 therapy.
Five Prime anticipates initiating a Phase 1 clinical trial of FPT155
Australiain the fourth quarter of 2018.
Summary of Financial Results and Guidance:
- Cash Position. Cash, cash equivalents and marketable securities
totaled $352.8 million as of June 30, 2018, compared to $292.7
million as of December 31, 2017. The increase in cash, cash
equivalents and marketable securities was primarily attributable to
$107.6 millionin net proceeds from the January 2018public offering of common stock and $34.5 millionin milestone and upfront payments Five Prime received from collaboration partners net of cash used by Five Prime in operations to advance its three clinical stage programs as well as preclinical research and development.
- Revenue. Collaboration and license revenue for the second
quarter of 2018 decreased by $0.2 million, or 3%, to $7.6
million from $7.8 million for the second quarter of 2017. This
decrease was primarily due to decreased revenue recognized under the
cabiralizumab collaboration agreement with BMS and the Fibrosis and
CNS collaboration with UCB, offset by the collaboration and license
revenue from our
Chinacollaboration with Zai Labexecuted in December 2017.
- R&D Expenses. Research and development expenses for the
second quarter of 2018 decreased by
$8.3 million, or 20%, to $33.4 million from $41.7 million in the second quarter of 2017. This decrease was primarily related to decreased spending on preclinical programs offset by an increase in clinical expenses to advance our development programs.
- G&A Expenses. General and administrative expenses for the
second quarter of 2018 increased by
$0.4 million, or 4%, to $9.8 millionfrom $9.4 millionin the second quarter of 2017. This is primarily due to increased consulting and facility costs offset by reduced personnel costs, including stock-based compensation.
- Net Loss. Net loss for the second quarter of 2018 was $34.1 million, or $0.99 per basic and diluted share, compared to a net loss of $44.3 million, or $1.58 per basic and diluted share, for the second quarter of 2017.
- Shares Outstanding. Total shares outstanding were 34.5 million
June 30, 2018.
Cash Guidance. Five Prime expects full-year 2018 net cash used in operating activities to be less than $135 million, which includes the previously mentioned milestone payments earned by Five Prime. Five Prime estimates ending 2018 with approximately $250 million in cash, cash equivalents and marketable securities.
Conference Call Information
Five Prime will host a conference call and live audio webcast today at 4:30 p.m. (ET) / 1:30 p.m. (PT) to discuss its financial results and provide a corporate update. To participate in the conference call, please dial (877) 878-2269 (domestic) or (253) 237-1188 (international) and refer to conference ID 4194786. To access the live webcast please visit the "Events & Presentations" page under the "Investors" tab on Five Prime's website at www.fiveprime.com. An archived copy of the webcast will be available on Five Prime's website beginning approximately two hours after the conference call. Five Prime will maintain an archived replay of the webcast on its website for at least 30 days after the conference call.
Cautionary Note on Forward-looking Statements
This press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995. Words
such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,”
“intend” and similar expressions (as well as other words or expressions
referencing future events, conditions or circumstances) are intended to
identify forward-looking statements. These forward-looking statements
are based on Five Prime's expectations and assumptions as of the date of
this press release. Each of these forward-looking statements involves
risks and uncertainties. Actual results may differ materially from these
forward-looking statements. Forward-looking statements contained in this
press release include statements regarding (i) the timing of the filing
of INDs or their foreign equivalents; (ii) the timing of initiation,
progress and scope of clinical trials for Five Prime’s product
candidates; (iii) the potential use of our product candidates, including
in combination with other products, to treat patients; (iv) the extent
of protein overexpression in certain patient populations; (v) the
prevalence and incidence of certain diseases; (vi) Five Prime’s
full-year 2018 net cash used in operating activities; and (vii) the
amount of Five Prime’s cash, cash equivalents and marketable securities
at the end of 2018. Many factors may cause differences between current
expectations and actual results including unexpected safety or efficacy
data observed during research, preclinical or clinical studies, changes
in expected or existing competition, changes in the regulatory, pricing
or reimbursement environment, and unexpected litigation or other
disputes. Other factors that may cause actual results to differ from
those expressed or implied in the forward-looking statements in this
press release are discussed in Five Prime’s filings with the
|Five Prime Therapeutics, Inc.|
|Selected Balance Sheets Data|
Balance Sheet Data:
|Cash, cash equivalents and marketable securities||$||352,766||$||292,690|
|Total current liabilities (excluding deferred revenue)||26,873||38,268|
|Deferred revenue (in total, including short term portion)||14,156||22,936|
Total stockholders’ equity
|Five Prime Therapeutics, Inc.|
|Condensed Statements of Operations|
|(in thousands, except per share amounts)|
For The Three
For The Three
For The Six
For The Six
|Research and development||33,380||41,744||76,932||75,504|
|General and administrative||9,782||9,363||20,260||19,849|
|Total operating expenses||43,162||51,107||97,192||95,353|
|Loss from operations||(35,582||)||(43,285||)||(57,126||)||(77,396||)|
|Interest and other income, net||1,522||702||2,676||1,370|
|Loss before income tax||(34,060||)||(42,583||)||(54,450||)||(76,026||)|
|Income tax provision||(1,703||)||(1,703||)|
|Basic and diluted net loss per common share||$||(0.99||)||$||(1.58||)||$||(1.63||)||$||(2.79||)|
|Weighted-average shares used to compute basic and diluted net loss per common share||
Five Prime Therapeutics, Inc.
Heather Rowe, 415-365-5737
Senior Director, Investor Relations and Corporate Communications