on February 28, 2019 Heat Biologics, Inc. (NASDAQ: HTBX), a biopharmaceutical company developing immunotherapies designed to activate a patient’s immune system against cancer, reported updated interim results from its ongoing Phase 2 study investigating HS-110 in combination with Bristol-Myers Squibb’s anti-PD-1 checkpoint inhibitor, nivolumab (Opdivo), in patients with advanced non-small cell lung cancer (NSCLC) (Press release, Heat Biologics, FEB 28, 2019, View Source [SID1234533839]). The results were presented today at the ASCO (Free ASCO Whitepaper)-SITC Clinical Immuno-Oncology Symposium by Daniel Morgensztern, M.D., Associate Professor of Medicine and Director of Thoracic Oncology, Washington University School of Medicine, and Lead Investigator in the trial. Data were presented on both Cohort A and Cohort B of the trial. Cohort A enrolls only previously treated patients who have never received a checkpoint inhibitor (CPI), while Cohort B enrolls patients who received a minimum of 4 months of treatment with a CPI as part of their prior therapy, but subsequently had documented progressive disease.

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"The treatment landscape for NSCLC has fundamentally changed as the number of patients who receive first line checkpoint inhibitor therapy is rapidly increasing," said COL(ret) George E Peoples, MD, FACS, Heat’s Chief Medical Advisor. "The preliminary data from our Cohort B is increasingly relevant and potentially exciting as it suggests that the addition of HS-110 to nivolumab may restore anti-tumor activity in patients whose disease has progressed after treatment with a CPI."

Jeff Hutchins, Ph.D., Chief Scientific and Operating Officer of Heat said, "The observed response rates and durability of disease stabilization support our mechanistic hypothesis that the broad, T-cell mediated immune response activated by HS-110 may improve patient survival when administered in combination with a CPI. The Cohort B data suggest that HS-110 may improve clinical outcomes for patients who have lost the benefit of treatment with a checkpoint inhibitor. We look forward to completing enrollment in this trial in Q2 and releasing additional results later this year as the data matures."

Highlights for both cohorts are presented below:

Cohort B (patients who progressed after ≥ 4 months of prior treatment with a checkpoint inhibitor)

Of first 20 patients enrolled in this cohort:

Partial response (PR) in 3 patients (15%) per RECIST 1.1 and 4 patients (20%) per investigator assessment

Disease control rate (DCR) of 55%

The 3 RECIST 1.1 PR patients had documented progression on CPI monotherapy immediately preceding study entry

Median progression free survival (mPFS) was 2.7 months (95% CI; 1.8 – 4.0 months)

Cohort A (patients who have never received a CPI prior to study entry)

Of 42 patients enrolled by the cutoff date:

PR in 9 patients (21%) per RECIST 1.1

DCR of 50%

Median overall survival not yet reached (60% still alive with a median follow-up of 14.4 months)

Responses and disease stabilization are durable and long-lasting

Subgroup analyses, predefined in the clinical protocol, were performed for levels of tumor-infiltrating lymphocytes (CD8+ TILs) present in tumors at baseline. A survival benefit [hazard ratio (HR) = 0.39] was observed in patients with levels CD8+ TIL <10% (i.e. "cold" tumors), a population that typically responds poorly to checkpoint inhibitors. The treatment benefit appeared to be independent of PD-L1 status (HR = 0.85)

Immune reactivity to HS-110 was measured via ELISPOT assay (high vs. low compared to median) on patient peripheral blood mononuclear cells obtained before and during treatment with a median overall survival benefit of 6.2 months in the high ELISPOT group

Overall survival was significantly higher in patients that experienced at least one dermal injection site reaction to HS-110 at any time during study treatment, supporting HS-110’s mechanism of action (HR = 0.15 [95% CI: 0.05-0.45], p=0.0001)

For both cohorts, treatment with HS-110 in combination with nivolumab was well tolerated, with no additional toxicities beyond those observed with single agent CPI therapy.

Importantly, data from Cohort B suggest that HS-110 in combination with nivolumab reduced tumor burden in patients whose disease progressed after treatment with a checkpoint inhibitor at any time prior to study entry. Additionally, the deepest responses were observed in three patients whose last treatment immediately preceding enrollment was checkpoint inhibitor monotherapy.

Also of interest is the data regarding overall survival (OS) in patients with low CD8+ TIL (tumor infiltrating lymphocytes) at baseline. Protocol-defined subgroup analysis of patients categorized as ‘high’ or low’ TIL, based on levels of CD8+ cells present in the stroma of their tumor tissue at baseline, demonstrate a survival advantage for the ‘low TIL’ group as compared to the ‘high TIL’ group (not reached vs. 13.8 months; HR = 0.39 [95% CI; 0.06-2.31]. These data are very encouraging as prior studies with nivolumab alone suggest that "cold" tumor patients with lower levels of baseline CD8+ TILs have lower response rates compared to "hot" tumor patients with high levels of CD8+ TILs1.

Trial results are summarized in the company’s updated corporate presentation, along with the official ASCO (Free ASCO Whitepaper)-SITC poster.

Trial Design

The Phase 2 trial is designed to evaluate the safety and efficacy of HS-110 combined with an immune checkpoint inhibitor for the treatment of advanced non-small cell lung cancer. Patients receive weekly HS-110 (1 x 107 cells) administered as 5 intradermal 0.1 mL injections for 18 weeks in combination with bi-weekly nivolumab 240 mg IV administered until confirmed disease progression or unacceptable toxicity, whichever occurs first. The primary endpoint is objective response rate (ORR); secondary endpoints include overall survival (OS), progression-free survival (PFS), disease control rate (DCR) and duration of response (DOR). Exploratory endpoints include correlation of clinical outcomes to baseline CD8+ TILs, PD-L1 expression, peripheral blood tumor mutation burden and ELISPOT analysis.

For further details about the trial and the results presented at ASCO (Free ASCO Whitepaper)-SITC, refer to Heat Bio’s updated corporate presentation, which can be found on the Investors tab of the corporate website View Source

On February 28, 2019 G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, reported financial results for the fourth quarter and full-year ended December 31, 2018 (Press release, G1 Therapeutics, FEB 28, 2019, View Source [SID1234533798]). The company also highlighted 2018 operational results and upcoming 2019 milestones.

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"Data from four randomized Phase 2 trials showed the benefits of trilaciclib across different indications, lines of therapy and chemotherapy regimens," said Raj Malik, M.D., Chief Medical Officer and Senior Vice President, R&D. "We have scheduled meetings with U.S. and European regulatory authorities in the first half of 2019 to discuss the totality of data and next steps for the development of trilaciclib. We will provide an update on these meetings in the second quarter."

"We made substantial progress across our three clinical-stage product candidates in 2018. We reported positive results from all four Phase 2 trilaciclib trials, presented proof-of-concept data on lerociclib in breast cancer, initiated a trial of lerociclib in non-small cell lung cancer, and brought our oral selective estrogen receptor degrader G1T48 into the clinic," said Mark Velleca, M.D., Ph.D., Chief Executive Officer. "These accomplishments will drive a number of important clinical and regulatory milestones in 2019 in the advancement of our pipeline."

Corporate Highlights

Reported positive multi-lineage myelopreservation data from three randomized, double-blind, placebo-controlled Phase 2 trials of trilaciclib in small cell lung cancer (SCLC): In the fourth quarter, the company presented additional data from its Phase 2 trial of trilaciclib in combination with chemotherapy in first-line SCLC at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress, and reported preliminary data from Phase 2 trials in first-line SCLC in combination with chemotherapy/Tecentriq (atezolizumab) and second/third-line SCLC in combination with chemotherapy. In these trials, patients receiving trilaciclib showed statistically significant improvements in duration and occurrence of severe neutropenia (primary endpoints) and clinically meaningful reductions in G-CSF administrations and red blood cell transfusions. Treatment was well tolerated and the safety profile of trilaciclib was consistent across the three trials.

Presented preliminary improved progression-free survival data from randomized Phase 2 trial of trilaciclib in combination with chemotherapy in patients with metastatic triple-negative breast cancer (mTNBC): In December, the company presented data from its Phase 2 trial of trilaciclib in patients with mTNBC at the 2018 San Antonio Breast Cancer Symposium. Preliminary median progression-free survival (PFS) was 5.4 months in the chemotherapy arm, 8.8 months in the chemotherapy and trilaciclib (dosed the day of chemotherapy) arm (hazard ratio 0.52, p=0.0669), and 7.3 months in the chemotherapy and trilaciclib (dosed the day prior to and day of chemotherapy) arm (hazard ratio 0.49; p=0.0546). A combined analysis of trilaciclib-treated patients showed PFS of 5.4 months for the chemotherapy arm and 7.9 months for chemotherapy and trilaciclib (hazard ratio 0.50, p=0.0189). Patients on trilaciclib received more chemotherapy cycles than those in the control arm. The safety profile of trilaciclib was consistent with previously reported trials; no trilaciclib-related serious adverse events were reported.

Anticipated Milestones for 2019

Meet with U.S. and European regulatory authorities in the first half of 2019 and announce the next steps for trilaciclib development in the second quarter of 2019.

Initiate additional randomized trials for trilaciclib in the second half of 2019, pending feedback from regulatory authorities.

Report additional data from all four randomized Phase 2 trilaciclib clinical trials.

Present additional data from the Phase 1b clinical trial of lerociclib/Faslodex (fulvestrant) in ER+, HER2- breast cancer in the second half of 2019.

Present preliminary dose-escalation data from the Phase 1b clinical trial of lerociclib/Tagrisso (osimertinib) in non-small cell lung cancer in the second half of 2019.

Present preliminary dose-escalation data from the Phase 1 clinical trial of G1T48, an oral selective estrogen receptor degrader (SERD), in ER+ breast cancer in the second half of 2019.

Fourth Quarter and Full-Year 2018 Financial Highlights

Cash Position: Cash, cash equivalents and short-term investments totaled $369.3 million as of December 31, 2018, compared to $390.5 million as of September 30, 2018, and $103.8 million as of December 31, 2017.

Operating Expenses: Operating expenses were $26.1 million for the fourth quarter of 2018, compared to $17.3 million for the fourth quarter of 2017. GAAP operating expenses include stock-based compensation expense of $3.3 million for the fourth quarter of 2018, compared to $1.0 million for the fourth quarter of 2017. Operating expenses for the full-year 2018 were $89.3 million, compared to $61.0 million for the prior year. Stock-based compensation expense for the full-year 2018 was $10.2 million, compared to $3.4 million for the prior year.

Research and Development Expenses: Research and development (R&D) expenses for the fourth quarter of 2018 were $19.1 million, compared to $15.1 million for the fourth quarter of 2017. The increase in expense was due to an increase in clinical program costs, drug manufacturing costs to support clinical programs, external research studies and personnel costs due to additional headcount. R&D expenses for the full-year 2018 were $70.7 million, compared to $53.9 million for the prior year.

General and Administrative Expenses: General and administrative (G&A) expenses for the fourth quarter of 2018 were $7.0 million, compared to $2.2 million for the fourth quarter of 2017. The increase in expense was largely due to an increase in professional fees and personnel-related costs. G&A expenses for the full-year 2018 were $18.6 million, compared to $7.1 million for the prior year.

Net Loss: G1 reported a net loss of $24.1 million for the fourth quarter of 2018, compared to $17.0 million for the fourth quarter of 2017. Net loss for the full-year 2018 was $85.3 million, compared to a net loss of $60.1 million for the prior year.

Webcast and Conference Call

The management team will host a webcast and conference call at 4:30 p.m. ET today to provide a financial update for the fourth quarter and full-year of 2018. The live call may be accessed by dialing 866-763-6020 (domestic) or 210-874-7713 (international) and entering the conference code: 2698949. A live and archived webcast will be available on the Events & Presentations page of the company’s website: www.g1therapeutics.com. The webcast will be archived on the same page for 90 days following the event.

Clinical program updates will be provided at the Investor Day 2019 meeting on March 6.

On February 28, 2019 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq:SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported that it will release its fourth quarter 2018 financial results on Thursday, March 7, after the close of the U.S. financial markets (Press release, Syndax, FEB 28, 2019, View Source [SID1234533815]).

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In connection with the earnings release, Syndax’s management team will host a conference call and live audio webcast at 4:30 p.m. ET on Thursday, March 7, to discuss the Company’s financial results and provide a general business update.

The live audio webcast and accompanying slides may be accessed through the Events & Presentations page in the Investors section of the Company’s website at www.syndax.com. Alternatively, the conference call may be accessed through the following:

Conference ID: 8252397
Domestic Dial-in Number: (855) 251-6663
International Dial-in Number: (281) 542-4259
Live webcast: View Source

For those unable to participate in the conference call or webcast, a replay will be available for 30 days on the Investors section of the Company’s website, www.syndax.com.

on February 28, 2019 PTC Therapeutics, Inc. (NASDAQ: PTCT) reported financial results for the fourth quarter and full year ending December 31, 2018 (Press release, PTC Therapeutics, FEB 28, 2019, View Source [SID1234533840]).

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"We are proud to be in the strong position of having a growing revenue base and robust pipeline with both small molecule and gene therapy programs," said Stuart W. Peltz, Ph.D., Chief Executive Officer, PTC Therapeutics, Inc. "In our corporate presentation we have outlined our vision to develop these commercial and pipeline programs to achieve potential revenues of $1.5 billion by 2023."

Key Fourth Quarter and Other Corporate Highlights:

Advancing gene therapy portfolio

PTC plans to submit a Biologics Licensing Application (BLA) with the FDA by late 2019 followed by a Marketing Authorization Application (MAA) in Europe for the AADC deficiency gene therapy program. A U.S. commercial launch is expected in 2020. Identification of patients with AADC deficiency has been a priority for PTC, with approximately 100 patients identified to date in the U.S. and Europe and additional patients being identified on a weekly basis. Starting this quarter, PTC expects to screen about 100,000 patients who are at risk for AADC deficiency before the regulatory approval to maximize patient benefit at time of launch.

Friedreich’s ataxia program is advancing with an expected IND submission in late 2019 and subsequent entry into the clinic.

PTC continues to build its gene therapy pipeline through investment in internal research and in-house manufacturing capabilities.

Risdiplam SMA regulatory submission planned for 2019

Based on recent regulatory interactions, an NDA/MAA is planned for the second half of 2019 with the intention to support a broad label to treat SMA Types 1, 2, & 3 patients.

Successfully completed enrollment of pivotal portion of FIREFISH & SUNFISH trials in 2018.

The SMA program is a collaboration between PTC, Roche and the SMA Foundation.

As an orally available small molecule, risdiplam has the potential to be the most competitive SMA product globally. Net sales over $1B would be subject to mid-teens royalties to PTC from Roche, resulting in potential royalties to PTC in excess of $200M

per year. Potential remaining regulatory and sales-based milestones are approximately $400M.

Expanding commercial platform

TEGSEDI application filed with Brazilian regulatory authority (ANVISA) and granted priority review, with expected approval by year end 2019.

Duchenne franchise expected to continue to grow over the next 5 years. Translarna ex-U.S. launch in patients 2 to 5 years of age now initiated. Non-ambulatory label expansion is currently under EMA regulatory review.

PTC recently submitted a supplementary NDA (sNDA) for Emflaza for patients 2 to 5 years old and has recently received an approval action date of July 4, 2019.

Growing pipeline and R&D capabilities

PTC’s splicing platform has generated another development candidate, PTC258, for Familial dysautonomia, a rare genetic neurological disorder causing life-threatening medical complications from birth. PTC258 is advancing to IND-enabling studies to enter the clinic in late 2019. This program is in collaboration with Massachusetts General Hospital and NYU.

Translarna’s dystrophin study was initiated in 4Q 2018 for potential U.S. regulatory re-submission for accelerated approval in 2020.

PTC’s oncology portfolio continues to advance with the initiation of a study in AML with PTC299 and a DIPG study for PTC596. PTC expects these studies to fully enroll by the end of 2019.

Fourth Quarter and Full year 2018 Financial Highlights:

Total revenues were $86.3 million for the fourth quarter of 2018, compared to $78.0 million for the fourth quarter of 2017. Total revenues were $264.7 million for the full year 2018, compared to $194.4 million for the full year 2017. The change in total revenue was a result of revenue from Emflaza, which launched in May 2017, and the expanded commercialization of Translarna.

Translarna net product revenues were $56.0 million for the fourth quarter of 2018, compared to $41.0 million for the fourth quarter of 2017. Translarna net product revenues were $171.0 million for the full year 2018, compared to $145.2 million for the full year 2017.

Emflaza net product revenues were $29.8 million for the fourth quarter of 2018, compared to $17.0 million for the fourth quarter of 2017. Emflaza net product revenues were $92.0 million for the full year 2018, compared to $28.8 million for the full year 2017.

GAAP R&D expenses were $53.6 million for the fourth quarter of 2018, compared to $29.2 million for the fourth quarter of 2017. GAAP R&D expenses were $172.0 million for the full year 2018, compared to $117.5 million for the full year 2017. The increase in R&D expenses reflects costs associated with advancing the gene therapy platform and increased investment in research programs as well as advancement of the clinical pipeline.

Non-GAAP R&D expenses were $49.6 million for the fourth quarter of 2018, excluding $4.0 million in non-cash, stock-based compensation expense, compared to $25.7 million for the fourth quarter of 2017, excluding $3.5 million in non-cash, stock-based compensation expense. Non-GAAP R&D expenses were $155.9 million for the full year 2018, excluding $16.1 million in non-cash, stock-based compensation expense, compared to $102.0 million for the full year 2017, excluding $15.5 million in non-cash, stock-based compensation expense.

GAAP SG&A expenses were $48.7 million for the fourth quarter of 2018, compared to $35.5 million for the fourth quarter of 2017. GAAP SG&A expenses were $153.6 million for the full year 2018, compared to $121.3 million for the full year 2017. The increase in SG&A expenses was primarily due to continued investment in commercial activities for Emflaza and Translarna.

Non-GAAP SG&A expenses were $44.2 million for the fourth quarter of 2018, excluding $4.5 million in non-cash, stock-based compensation expense, compared to $32.5 million for the fourth quarter of 2017, excluding $3.0 million in non-cash, stock-based compensation expense. Non-GAAP SG&A expenses were $136.4 million for the full year 2018, excluding $17.2 million in non-cash, stock-based compensation expense, compared to $106.2 million for the full year 2017, excluding $15.1 million in non-cash, stock-based compensation expense.

Change in the fair value of deferred and contingent consideration was $19.3 million for the fourth quarter and full year 2018. The change in fair value of deferred and contingent consideration is related to the fair valuation of potential future consideration to be paid to former Agilis’ equity holders in connection with PTC’s acquisition of Agilis, which closed in August 2018.

Net loss was $48.3 million for the fourth quarter of 2018, compared to net income of $1.3 million for the fourth quarter of 2017. Net loss was $128.1 million for the full year 2018, compared to net loss of $79.0 million for the full year 2017.

Cash, cash equivalents, and marketable securities was $227.6 million at December 31, 2018, compared to $191.2 million at December 31, 2017.

Shares issued and outstanding as of December 31, 2018 were 50.6 million.

PTC recently completed a public offering of 7,563,725 shares of common stock resulting in net offering proceeds of $224.1 million.

Full Year 2019 Guidance:

PTC anticipates full year DMD franchise net product revenues to be between $285 and $305 million.

PTC anticipates GAAP R&D and SG&A expense for the full year 2019 to be between $395 and $405 million.

PTC anticipates Non-GAAP R&D and SG&A expense for the full year 2019 to be between $360 and $370 million, excluding estimated non-cash, stock-based compensation expense of approximately $35 million.

Non-GAAP Financial Measures:

In this press release, the financial results and financial guidance of PTC are provided in accordance with accounting principles generally accepted in the United States (GAAP) and using certain non-GAAP financial measures. In particular, the non-GAAP financial measure exclude non-cash, stock-based compensation expense. These non-GAAP financial measures are provided as a complement to financial measures reported in GAAP because management uses these non-GAAP financial measures when assessing and identifying operational trends. In management’s opinion, these non-GAAP financial measures are useful to investors and other users of PTC’s financial statements by providing greater transparency into the historical and projected operating performance of PTC and the company’s future outlook. Non-GAAP financial measures are not an alternative for financial measures prepared in accordance with GAAP. Quantitative reconciliations of the non-GAAP financial measures to their respective closest equivalent GAAP financial measure are included in the table below.

Today’s Conference Call and Webcast Reminder:
Today’s conference call will take place at 4:30 pm ET and can be access by dialing (877) 303-9216 (domestic) or (973) 935-8152 (international) five minutes prior to the start of the call and providing the passcode 3370226. A live, listen-only webcast of the conference call can be accessed on the investor relations section of the PTC website at www.ptcbio.com. The company slide presentation will be posted on the investor relations section of the PTC website. A webcast replay of the call will be available approximately two hours after completion of the call and will be archived on the company’s website for two weeks.

on February 28, 2019 Amgen (NASDAQ:AMGN) reported that new data from its early-stage oncology pipeline will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Atlanta, March 29 – April 3, 2019 (Press release, Amgen, FEB 28, 2019, View Source;p=RssLanding&cat=news&id=2389545 [SID1234533864]).

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"At Amgen, we are searching for and finding answers to incredibly complex questions to advance care and improve lives for cancer patients," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "In a significant milestone in the oncology community, we will share the latest preclinical data from our KRASG12C inhibitor, AMG 510. KRAS has eluded targeting despite more than 30 years of industry and academic research. Our program is the first to reach the clinical stage, which will evaluate its potential against a target that is easily identifiable and present in a wide range of solid tumors."

For the first time, preclinical data will be presented on AMG 510, a first-in-class investigational KRAS­G12C inhibitor being evaluated for the treatment of solid tumors. Data at the meeting will also showcase Amgen’s novel bispecific T cell engager (BiTE) platform, including preclinical data evaluating the use of AMG 757, a DLL3-targeted BiTE molecule, in resistant subtypes of melanoma. Additional research to be presented will include preclinical data evaluating the use of Amgen’s intravenous investigational MCL-1 inhibitor, AMG 176, in combination with standard of care therapies in acute myeloid leukemia.

A complete listing of abstracts can be found on the AACR (Free AACR Whitepaper) website. Notable abstracts of interest include:

KRASG12C Inhibition:

Discovery of AMG 510: A Noval Covalent Inhibitor of KRASG12C, Now in a Phase 1 Clinical Trial for Patients with Solid Tumors Harboring the KRAS P.G12C Allele
Oral Presentation, Sunday, March 31 from 4:28-4:52 p.m. ET in Georgia World Congress Center, Building A, Level 3, Room A305
Discovery and In Vitro Characterization of AMG 510, a Potent and Selective Covalent Small Molecule Inhibitor of KRASG12C
Abstract #4484, Oral Presentation, Tuesday, April 2 from 3-5 p.m. ET in Georgia World Congress Center, Building C, Level 3, Georgia Ballroom 3
Discovery of AMG 510, a First-In-Human Covalent Inhibitor of KRASG12C for the Treatment of Solid Tumors
Abstract #4455, Oral Presentation, Tuesday, April 2 from 3-5 p.m. ET in Georgia World Congress Center, Building B, Level 2, Room B206
In Vivo Characterization of AMG 510, A Potent and Selective KRASG12C Covalent Small Molecule Inhibitor in Preclinical KRASG12C Cancer Models
Abstract #3090/24, Poster Presentation, Tuesday, April 2 from 8 a.m.-noon ET in Georgia World Congress Center, Exhibit Hall B, Section 14
BiTE Antibody Construct:

Melanoma Subtypes that Emerge During Adaptive Resistance to Therapy are Targets for Bispecific T Cell Engager (BiTE) Antibody Constructs Directed to CDH19 And DLL3
Abstract #553/17, Poster Presentation, Sunday, March 31 from 1-5 p.m. ET in Georgia World Congress Center, Exhibit Hall B, Section 23
Evaluation of Mesothelin BiTE Antibody Constructs in Models of Pancreatic Ductal Adenocarcinoma
Abstract #1561/30, Poster Presentation, Monday, April 1 from 8 a.m.-noon ET in Georgia World Congress Center, Exhibit Hall B, Section 25
Additional Preclinical Data:

AMG 176 Exhibits Robust Antitumor Activity in Combination with Standard of Care Agents in Models of Acute Myeloid Leukemia
Abstract #2180/2, Poster Presentation, Monday, April 1 from 1-5 p.m. ET in Georgia World Congress Center, Exhibit Hall B, Section 14
CSF-1 Receptor-Mediated Macrophage Depletion Can Induce Immunomodulatory Resistance Mechanisms in Murine Tumor Models
Abstract #2803/19, Poster Presentation, Tuesday, April 2 from 8 a.m.-noon ET in Georgia World Congress Center, Exhibit Hall B, Section 3
About KRAS
The subject of more than three decades of research, RAS proteins make up the most frequently mutated gene family in human cancers.1,2 Within this family, KRAS is the most prevalent variant and is particularly common in solid tumors.2 A specific mutation known as KRASG12C accounts for approximately 12 percent of all KRAS mutations across tumor types.3 Amgen is exploring the potential of KRASG12C inhibition across a broad variety of tumor types.

About BiTE Technology
Bispecific T cell engager (BiTE) antibody construct is an innovative technology that can be engineered to target any tumor antigen expressed by any type of cancer. The protein molecules are designed to kill malignant cells using the patient’s own immune system by bridging T cells to tumor cells. BiTE antibody construct helps connect the T cells to the targeted cell, with the intent of causing T cells to inject toxins which trigger cancer cell death (apoptosis). Amgen is developing BiTE antibody constructs to uniquely (or specifically) target numerous hematologic malignancies and solid tumors.

About Amgen’s Commitment to Oncology
Amgen is committed to helping patients take on some of the toughest cancers, such as those that have been resistant to drugs, those that progress rapidly through the body and those where limited treatment options exist. Amgen’s supportive care treatments help patients combat certain side effects of strong chemotherapy, and our targeted medicines and immunotherapies focus on more than a dozen different malignancies, ranging from blood cancers to solid tumors. With decades of experience providing therapies for cancer patients, Amgen continues to grow its portfolio of innovative and biosimilar oncology medicines.