On March 10, 2017 Endocyte, Inc. (NASDAQ:ECYT), a leader in developing targeted small molecule drug conjugates (SMDCs) and companion imaging agents for personalized therapy, reported their plan to collaborate with Seattle Children’s Research Institute and Dr. Michael Jensen for the development of Endocyte’s SMDC platform in the chimeric antigen receptor T-cell (CAR T-cell) immunotherapy setting through the use of Endocyte’s proprietary SMDC bi-specific adaptor molecules (Press release, Endocyte, MAR 10, 2017, View Source [SID1234518070]).

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The aim of the research collaboration is to join Endocyte’s SMDC bi-specific adaptor technology with the CAR T-cell immunotherapy research efforts at the Ben Towne Center for Childhood Cancer Research at Seattle Children’s Research Institute, to move these potentially enabling technologies more quickly to patients in the clinic. Dr. Jensen, a recognized leader in the field of CAR T-cell research, is the director of Ben Towne Center for Childhood Cancer Research and the Janet and Jim Sinegal Endowed Chair in Pediatric Solid Tumor Research at Seattle Children’s Research Institute, and a professor of hematology-oncology at the University of Washington School of Medicine.

"This partnership brings together Dr. Jensen’s expertise in the discovery and development of CAR T-cell therapies and Endocyte’s SMDC platform, with the aim of improving the efficacy and safety of CAR T-cell therapies and enabling them in solid tumor indications," said Mike Sherman, president and CEO of Endocyte. "Together, Seattle Children’s Research Institute and Endocyte hope to make a meaningful difference in shaping the future of CAR T-cell therapies and offering an important new treatment option to cancer patients."

"This collaborative project with Endocyte represents a next-generation CAR T-cell therapeutic platform with exciting opportunities to target solid tumors," said Dr. Michael Jensen. "We have been impressed with the potential of Endocyte’s bi-specific adaptor molecules, which enable the engineering of a single universal CAR T-cell that binds with very high affinity, potentially allowing us to address several key challenges of current therapies in this novel area of development."

Research and development activities under the collaboration will be led by Dr. Michael Jensen and Dr. Phil Low, chief scientific officer at Endocyte and professor of chemistry and director of the Center for Drug Discovery at Purdue University.

About Endocyte’s SMDC Bi-Specific Adaptors

Endocyte’s SMDC bi-specific adaptors represent a novel approach that makes possible the engineering of a single universal CAR T-cell, designed to bind with high affinity to fluorescein isothiocyanate (FITC). This universal CAR T-cell can be specifically directed to cancer cells through the administration of a tumor targeted FITC-containing SMDC, known as a bi-specific adaptor, that acts to bridge the universal CAR T-cell with the cancer cells to cause localized T-cell activation. This technology may address or mitigate several challenges of current CAR T-cell therapies, such as i) the inability to control the rate of cytokine release and tumor lysis, ii) the absence of an "off switch" that can terminate cytotoxic activity when tumor eradication is complete, and iii) a requirement to generate a different CAR T-cell for each unique tumor antigen.

On March 10, 2017 Trillium Therapeutics Inc. (NASDAQ/TSX: TRIL), a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported a corporate update and reported financial results for the year ended December 31, 2016 (Filing, Q4/Annual, Trillium Therapeutics, 2016, MAR 10, 2017, View Source [SID1234518068]).

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"2016 marked a year of significant clinical progress with our lead drug candidate TTI-621, which completed Phase 1a dose escalation and advanced into Phase 1b cohort expansion in patients with advanced hematologic malignancies. Late in the year, we also initiated a Phase 1 clinical trial of TTI-621 in solid tumors. These studies will provide data that will guide us in designing the optimal commercial development path for TTI-621. Both trials are recruiting well, and we remain on track to provide updates later this year," said Dr. Niclas Stiernholm, president and CEO of Trillium Therapeutics. "The TTI-621 program momentum continues in 2017. Recent pharmacology data from the Phase 1 a/b trial expand on our preliminary findings and suggest that with weekly dosing we are achieving biologically relevant drug levels."

Corporate Update:

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Trillium recently presented additional pharmacology data from its ongoing Phase 1a/1b trial of TTI-621, demonstrating well-tolerated drug levels that exceed those necessary for anti-tumor activity in preclinical models. Specifically, the following scientific findings were highlighted at the February ASCO (Free ASCO Whitepaper)-SITC Conference :


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Receptor occupancy increases with multiple infusions of TTI-621, conferring robust CD47 blockade on circulating leukemic cells;

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Increases in cytokines associated with macrophage activation suggest rapid engagement of the innate immune system;

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Transient thrombocytopenia due to target mediated clearance is attenuated subsequent to the first infusion of TTI-621, and

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Weekly infusions lead to a longer half-life and accumulation of circulating drug, overcoming the platelet antigen sink.

2016 Highlights:

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Initiated and completed the Phase 1a dose escalation phase of a first-in-human clinical trial of TTI-621 in patients with relapsed or refractory lymphoma, and began enrollment in the Phase 1b dose expansion cohorts in patients with advanced hematologic malignancies. Two additional expansion cohorts were added, including combination therapy of TTI-621 and rituximab in patients with CD20-positive malignancies.

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Presented data from the TTI-621 hematologic malignancy Phase 1a trial at the 2016 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting showing one partial response and decreased tumor volume and/or reduced metabolic activity over extended intervals of continued dosing in several patients.


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Filed a second Investigational New Drug application with the FDA and initiated in January 2017, a Phase 1 trial with intratumoral injection of TTI-621 in patients with percutaneously accessible solid tumors and mycosis fungoides. This study could lead to a more thorough understanding of the mechanism of action of TTI-621 and could provide insight into the tumor micro-environment before, during and after treatment.


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Significantly expanded its preclinical oncology pipeline with the acquisition of Fluorinov Pharma Inc., a discovery engine with a demonstrated ability to generate high quality preclinical development candidates. This proprietary medicinal chemistry platform uses fluorine chemistry, which permits the creation of new chemical entities from validated drugs and drug candidates with improved pharmacological properties, potentially leading to increased safety and efficacy.

2016 Financial Results
(Amounts in Canadian dollars)

As of December 31, 2016, Trillium had cash of $50.5 million. For the year ended December 31, 2016, the company used $22.9 million of cash for operations; $9.6 million for the acquisition of Fluorinov Pharma Inc; and used $3.0 million for capital purchases related to its new office and laboratory facility.

Net loss for the year ended December 31, 2016 of $31.7 million was higher than the loss of $14.7 million for the year ended December 31, 2015. The net loss was higher due mainly to increased research and development program expenses of $11.7 million, higher intangible asset amortization of $3.3 million related mainly to the acquisition of Fluorinov intangible assets, and a net foreign currency loss in 2016 of $2.0 million from holding US denominated cash with a weakening US dollar, compared to a foreign currency gain in the comparable 2015 period of $6.1 million. This was partially offset by the recognition of a deferred tax recovery in relation to the acquisition of Fluorinov of $3.7 million.

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Selected Consolidated Financial Information:


Consolidated statements of loss and comprehensive loss


Year ended Year ended
Amounts in Canadian dollars December 31, 2016 December 31, 2015
Research and development expenses 29,788,795 18,050,091
General and administrative expenses 3,932,910 3,184,347
Net finance costs (income) 1,691,680 (6,510,241 )
Net loss and comprehensive loss for the year 31,733,085 14,733,699
Basic and diluted loss per common share (4.06 ) (2.22 )


Consolidated Statements of Financial Position


As at As at
Amounts in Canadian dollars December 31, 2016 December 31, 2015
Cash 50,472,971 86,770,542
Total assets 66,622,691 90,039,468
Total equity 58,119,519 85,803,868

On March 10, 2017 TG Therapeutics, Inc. (NASDAQ: TGTX) reported its financial results for the fourth quarter and year ended December 31, 2016 and provided recent company developments along with a business outlook for 2017 (Press release, TG Therapeutics, MAR 10, 2017, View Source [SID1234518067]).

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The Company announced that through the combination of an underwritten public offering, and proceeds raised through the utilization of an ATM program, the Company raised combined gross proceeds of approximately $89M before deducting underwriting discounts and commissions and other estimated offering expenses. The underwritten offering consisted of 5,128,206 shares of its common stock (plus a 30-day option to purchase up to an additional 769,230 shares of common stock, which has been exercised) at a price of $9.75 per share, with expected gross proceeds to TG Therapeutics of $57.5 million, less underwriting discounts and commissions. The offering is expected to close on or about March 14, 2017, subject to the satisfaction of customary closing conditions. Prior to the public offering, the Company also issued approximately 3,000,000 shares through the ATM program for gross proceeds of approximately $31 million at an average price of $10.27, these shares were issued on March 9, 2017.

Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer, stated, "2016 was a very productive year for the Company, laying the foundation for pivotal data read-outs in 2017 and 2018. The first of which were reported earlier this week, with the announcement of the positive topline results from our Phase 3 GENUINE clinical trial. For the remainder of 2017, we look forward to the full data presentation from the GENUINE trial in the summer and then in the second half to a meeting with the FDA to discuss a filing for accelerated approval. All along we will continue to remain highly focused on enrolling into our proprietary UNITY programs, which are proceeding nicely and on schedule." Mr. Weiss continued, "This week we also had the opportunity to solidify our cash reserves with the recently conducted offerings, which should provide us with sufficient capital to advance our key programs and get us closer to our goal of bringing our novel treatment options to patients with B-cell malignancies."

2016 Highlights

● Completed enrollment in our Phase 3 GENUINE clinical trial, which resulted in positive topline data
● Launched the UNITY-CLL Phase 3 and UNITY-DLBCL Phase 2b trials for the combination of TG-1101 + TGR-1202
● Announced the positive outcome of our UNITY-CLL Phase 3 DSMB safety review meeting, pursuant to which the study was recommended to continue enrolling both front-line and previously treated patients with no changes recommended to the study
● Launched our first clinical trial in Multiple Sclerosis (MS) for TG-1101
● Announced the issuance of composition of matter patents for both TG-1101 and TGR-1202 providing protection through 2029 and 2033, respectively, both exclusive of available patent term extensions
● Announced two publications in prestigious journals, the first in BLOOD describing a novel mechanism of TGR-1202 with potential in cMYC driven malignancies, and the second in the British Journal of Haematology with data from our Phase 2 clinical trial of TG-1101 plus ibrutinib in patients with Chronic Lymphocytic Leukemia (CLL)
● Presented data at the ASH (Free ASH Whitepaper) annual meeting including 3 oral presentations and 3 poster presentations, with a focus on combination therapy


Key Objectives for 2017

● Present updated clinical data including the full Phase 3 GENUINE data at a major medical meeting in the first half of 2017
● Present clinical data from the Phase 2 Multiple Sclerosis (MS) trial
● Initiate a global Phase 3 trial in MS
● Complete the first interim analysis in the UNITY-CLL Phase 3 trial
● Complete the first interim analysis in the UNITY-DLBCL trial
● Meet with the FDA to review the GENUINE Phase 3 data and discuss suitability for filing for accelerated approval
● Present new and updated data from ongoing trials at various scientific meetings throughout the year, including the ASH (Free ASH Whitepaper) annual meeting in December

Financial Results for the Fourth Quarter and Full Year 2016

● Cash Position: Cash, cash equivalents, investment securities, and interest receivable were $45.0 million as of December 31, 2016. During the first quarter of 2017 the Company raised approximately $84 million of net proceeds from the underwritten public offering of the Company’s common stock and the utilization of the Company’s at-the-market ("ATM") sales.

● R&D Expenses: Research and development (R&D) expenses were $22.3 million and $69.2 million for the three and twelve months ended December 31, 2016, respectively, compared to $15.3 million and $47.7 million for the three and twelve months ended December 31, 2015, respectively. Included in research and development expenses for the three and twelve months ended December 31, 2016, are $9.1 million and $27.0 million, respectively, of manufacturing and CMC expenses for Phase 3 clinical trials and potential commercialization. The increase in R&D expenses for both the three and twelve months ended December 31, 2016, is primarily due to the ongoing clinical development programs and related manufacturing costs for TG-1101 and TGR-1202.

● G&A Expenses: General and administrative (G&A) expenses were $1.8 million and $9.9 million for the three and twelve months ended December 31, 2016, respectively, as compared to $2.4 million and $15.6 million for the three and twelve months ended December 31, 2015, respectively. The period-over-period decrease in G&A expenses from three and twelve months ended December 31, 2015 relates primarily to non-cash compensation expenses related to equity incentive expense recognized during 2015.

● Net Loss: Net loss was $23.7 million and $78.3 million for the three and twelve months ended December 31, 2016, respectively, compared to a net loss of $17.6 million and $62.9 million for the three and twelve months ended December 31, 2015, respectively.

● Financial Guidance: The Company believes its cash, cash equivalents, investment securities, and interest receivable on hand as of December 31, 2016 combined with the additional capital raised in the first quarter of 2017 will be sufficient to fund the Company’s planned operations for approximately the next 24 months.

On March 10, 2017 Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel immuno-oncology therapies, reported financial results for the fourth quarter and year ended December 31, 2016, and provided a business update (Press release, Corvus Pharmaceuticals, MAR 10, 2017, View Source [SID1234518064]).

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"In 2016, Corvus made the successful transition to becoming a public company, initiated clinical investigation of our lead program, CPI-444, and reported promising results, and continued to advance our additional pipeline candidates," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "Preliminary data from our Phase 1/1b study has shown single agent activity, particularly in patients who are resistant or refractory to prior PD-1/PD-L1 therapy. We believe these findings place us in a unique position in the immuno-oncology field and we look forward to reporting updated data at the meeting of the American Association of Cancer Research in April."

RECENT ACHIEVEMENTS AND UPCOMING MILESTONES
Clinical & Preclinical Development

Initiated enrollment of the disease-specific expansion part of the Phase 1/1b clinical study of the Company’s lead oral checkpoint inhibitor, CPI-444, as a single agent and in combination with Genentech’s Tecentriq (atezolizumab), an anti-PD-L1 antibody. This second stage of the study utilizes an optimal oral dose of 100 mg twice daily for 28 days, which was identified in the initial dose-selection part of the study.
Expanded the cohort of renal cell carcinoma patients treated with single-agent CPI-444 from 14 to 26 patients in the Phase 1/1b clinical study, per predefined protocol criteria.
Reported evidence of single agent CPI-444 activity in patients in other disease-specific cohorts, including lung cancer and melanoma. Overall, in 33 patients receiving single agent CPI-444, two patients achieved partial responses and 12 patients had stable disease.
Presented preliminary safety and efficacy data from the dose-selection phase of the Phase 1/1b clinical study at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 31st Annual Meeting.
Continued to progress anti-CD73 antibody and ITK inhibitor programs toward Phase 1 study initiation in 2018.
Plan to present clinical updates from the Phase 1/1b study of CPI-444 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2017 and at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June 2017.
Plan to initiate a registration trial for CPI-444 in renal cell carcinoma patients, if the data warrant.
Anticipate expanding additional disease-specific cohorts in the Phase 1/1b clinical trial, if the data warrant.
Corporate

Appointed Ian T. Clark, former Genentech chief executive officer, to the Board of Directors.
Hold first R&D Day on March 14, 2017 to highlight the emerging role of the adenosine axis in immuno-oncology and provide additional updates on the CPI-444 program. Webcast information for the presentation will be provided closer to the date.
FINANCIAL RESULTS
At December 31, 2016, Corvus had cash, cash equivalents and marketable securities totaling $134.9 million. This compared to cash, cash equivalents and marketable securities of $94.4 million at December 31, 2015. The Company expects net cash utilization of $55 million to $60 million in 2017.

Research and development expenses for the three months and full year ended December 31, 2016 totaled $9.1 million and $29.4 million, respectively, compared to $4.9 million and $11.4 million for the same periods in 2015. In the fourth quarter of 2016, the increase of $4.2 million was primarily due to an increase of $0.6 million in personnel and related costs associated with higher headcount, an increase of $2.4 million in outside costs for the Phase 1/1b clinical trial for CPI-444, and an increase of $1.2 million in outside costs associated with other clinical development programs. For the full year 2016, the increase of $18.0 million was primarily due to an increase of $7.6 million in outside costs for the Phase 1/1b clinical trial for CPI-444, an increase of $4.5 million in personnel and related costs associated with higher headcount, and an increase of $3.7 million in outside costs associated with other clinical development programs.

General and administrative expenses for the three months and full year ended December 31, 2016 totaled $2.1 million and $7.6 million, respectively, compared to $1.2 million and $2.4 million for the same periods in 2015. In the fourth quarter of 2016, the increase of $0.9 million was primarily due to an increase of $0.9 in other personnel and associated costs, primarily due to an increase of $0.6 million in stock compensation costs. For the full year 2016, the increase of $5.2 million was primarily due to an increase of $3.1 million in personnel and associated costs, $0.9 million in costs associated with operating as a public company and an increase of $0.6 million in patent and related costs.

The net loss for the three months and full year ended December 31, 2016 was $11.1 million and $36.4 million, respectively, compared to $6.0 million and $31.3 million for the same periods in 2015. The net loss of $31.3 million in 2015 included a loss of $17.6 million associated with the change in fair value of a convertible preferred stock liability. Total stock compensation expense for the three months and full year ended December 31, 2016 was $1.0 million and $3.8 million, respectively, compared to $0.3 million and $0.4 million for the same periods in 2015.

On March 10, 2017 Endocyte, Inc. (NASDAQ:ECYT), a leader in developing targeted small molecule drug conjugates (SMDCs) and companion imaging agents for personalized therapy, reported financial results for the fourth quarter ending December 31, 2016, and provided a clinical and business update (Press release, Endocyte, MAR 10, 2017, View Source [SID1234518063]).

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"We are pleased to report progress on several aspects of the business during the last several weeks," commented Mike Sherman, president and CEO at Endocyte. "The separately announced collaboration with Seattle Children’s Research Institute and Dr. Michael Jensen, an innovator and thought leader in the field of chimeric antigen receptor T-cell (CAR T-cell) immunotherapies, is an indication of the promise of our technology and a reflection of our commitment to establishing partnerships intended to bring early stage programs to the clinic more rapidly and drive more value from our pipeline. Mike Andriole joining us as chief financial officer also adds significant experience and capacity to pursue value driving partnerships going forward."

"We also anticipate receiving additional clinical data on our lead assets, EC1169 and EC1456, during 2017 as we advance two additional agents toward the clinic," continued Mr. Sherman.

EC1169 (PSMA-tubulysin) Program Outline

Currently enrolling patients in the expansion phase of the EC1169 trial in up to 50 second-line chemotherapy and up to 50 taxane-naïve metastatic castrate-resistant prostate cancer (mCRPC) patients at a maximum clinical once per week dose of 6.5 mg/m2
Patients are scanned with Endocyte’s proprietary imaging agent, EC0652, to identify the presence of disease that expresses prostate-specific membrane antigen (PSMA)
Primary endpoint of this expansion phase is radiographic progression-free survival (rPFS), measured at 5 months for taxane-naïve mCRPC patients and at 3 months for second-line chemotherapy patients
Secondary endpoints which will provide earlier insight into drug activity include overall response rates as measured by response evaluation criteria in solid tumors (RECIST) 1.1 and prostate-specific antigen (PSA)
Enrollment is not limited based on the results of the scan with EC0652 but primary endpoints of the trial are to be assessed in PSMA-positive patients
EC1456 (Folate-tubulysin) Program Outline

Currently enrolling expansion cohort of up to 40 folate-receptor (FR) positive non-small cell lung cancer (NSCLC) patients, as determined by an etarfolatide scan, to receive the maximum clinical twice per week dose of 6.0 mg/m2
Patients included in this expansion phase of the trial will have received first-line chemotherapy and may have also been treated with anti-PD-1 therapy
Exploring a more frequent dosing schedule, four times per week, in indications that are typically FR-positive, such as ovarian and endometrial cancers
Also conducting an ovarian cancer surgical study to assess various attributes of the drug release within targeted tumors
Upcoming Expected Milestones

Safety and efficacy updates for both EC1169 and EC1456 ongoing clinical trials expected at the Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in June, 2017
Updated pre-clinical data for CAR T-cell program expected to be presented at a medical conference in the first half of 2017
Expect to file Investigational New Drug (IND) application for EC2629 in mid 2017. EC2629 leverages a proprietary warhead with a dual mechanism of action: targeting both FR+ cancer cells and tumor associated macrophages (TAMs)
Completion of pre-clinical evaluations for CAR T-cell program expected in second half of 2017
Initiation of enrollment for EC2629 phase 1 trial expected in second half of 2017
Pre-clinical preparatory work on EC2319 in anticipation of potential IND in 2018. EC2319 targets and disables activated macrophages which otherwise produce pro-inflammatory cytokines associated with chronic inflammatory disease
Fourth Quarter 2016 Financial Results

Endocyte reported a net loss of $11.1 million, or $0.26 per basic and diluted share, for the fourth quarter of 2016, compared to a net loss of $9.8 million, or $0.23 per basic and diluted share for the same period in 2015.

Research and development expenses were $8.2 million for the fourth quarter of 2016, compared to $6.4 million for the same period in 2015. The increase was primarily attributable to increases in expenses related to the EC1169 phase 1 trial, including drug manufacturing expenses.

General and administrative expenses were $3.1 million for the fourth quarter of 2016, compared to $3.5 million for the same period in 2015. The decrease was primarily attributable to a decrease in compensation expense, which was partially offset by an increase in expenses related to patent and recruiting fees.

Cash, cash equivalents and investments were $138.2 million at December 31, 2016, compared to $146.7 million at September 30, 2016, and $173.6 million at December 31, 2015.

Financial Expectations

The company anticipates its cash balance at the end of 2017 to be approximately $100 million.

About EC1456 and etarfolatide

EC1456 is an investigational therapeutic SMDC constructed of a high affinity FR-targeting ligand conjugated through a spacer and bioreleasable linker system to a potent cytotoxic microtubule inhibitor, TubBH. Patient FR-status is determined using the investigational companion imaging agent, etarfolatide.

About EC1169 and EC0652

EC1169 is an investigational therapeutic SMDC constructed of a high affinity prostate specific membrane antigen (PSMA)-targeting ligand conjugated through a bioreleasable linker system to a potent microtubule inhibitor, tubulysin B hydrazide (TubBH). Patient PSMA-status is determined using the investigational companion imaging agent, EC0652.