On March 11, 2020 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported its financial results for the fourth quarter and full year ended December 31, 2019 (Press release, Navidea Biopharmaceuticals, MAR 11, 2020, View Source [SID1234555427]).

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"During the fourth quarter, Navidea made great strides in its enrollment of the NAV 3-31 Phase 2B trial in patients with rheumatoid arthritis," said Mr. Jed A. Latkin, Chief Executive Officer of Navidea. "The Company continued its dialogue with several key potential partners and we anticipate providing updates on those initiatives in the very near future. Furthermore, with the most recent financing, the Company put in place the steps necessary to launch the next critical trials."

Fourth Quarter 2019 Highlights and Subsequent Events

Continued with double-digit subject enrollment in the Company’s NAV3-31 Phase 2b study in rheumatoid arthritis ("RA") and completed enrollment of subjects in Arms 1 and 2.
Announced positive results of the first interim analysis of the NAV3-31 Phase 2b study, demonstrating that Tc99m tilmanocept imaging can provide robust, quantitative imaging in healthy controls and in patients with active RA, and that this imaging is stable, reproducible, and can define joints with and without RA-involved inflammation.
Completed enrollment in NAV3-24, a Phase 1 Kaposi’s Sarcoma trial; All imaging has been completed and the Company is currently compiling results.
Continued enrollment in the Investigator Initiated Phase 2 trial being run at the Massachusetts General Hospital evaluating Tc99m tilmanocept uptake in atherosclerotic plaques of HIV-infected individuals.
Entered into a collaboration agreement with IMV Inc., a clinical-stage immuno-oncology company, to explore the combinatory effect of Navidea’s and IMV’s proprietary immuno-oncology platforms.
Converted the Tilmanocept Uptake Value quantitative imaging analysis provisional patent to an A1 patent application, and filed an additional provisional patent relevant to both imaging and therapeutic applications.
Executed agreements with five investors, including an existing investor, to purchase approximately 2.1 million shares of the Company’s common stock in a private placement for aggregate gross proceeds to Navidea of approximately $1.9 million.
Won summary judgment in the Court of Common Pleas for Franklin County, Ohio (the "Ohio Court") related to the Company’s ongoing litigation with Capital Royalty Partners II, L.P., et al ("CRG"), in the amount of $4.3 million plus interest (the "Judgment"). The Ohio Court also found that there was no unjust enrichment or conversion by CRG. The decision is a final appealable order and terminated the case.
Executed a binding term sheet to sell the Judgment for $4.2 million of proceeds to Navidea.
Executed agreements with two existing investors to purchase approximately 4.0 million shares of the Company’s common stock for aggregate gross proceeds to Navidea of approximately $3.4 million.
Following the funding transactions described above, the Company regained compliance with the NYSE American’s continued listing standards with stockholders’ equity of $6.0 million.
Michael Rosol, Ph.D., Chief Medical Officer for Navidea, said, "The clinical research team has been working diligently to advance the technology in key disease areas, with an emphasis on our ongoing RA trials. We continue to advance our Phase 2B trial in RA, building upon last quarter’s announced interim analysis results, and with an eye towards the second interim analysis. We are also planning for the start of our second Phase 2B trial comparing tilmanocept imaging to synovial tissue biopsy samples of RA patients as well as the Phase 3 trial."

Financial Results

Navidea’s consolidated balance sheets, statements of operations, and statements of stockholders’ equity have been restated, as required, for all periods presented to reflect the April 2019 reverse stock split as if it had occurred on January 1, 2018. The consolidated statements of cash flows were not impacted by the reverse stock split.

Total revenues for the fourth quarters of both 2018 and 2019 were $119,000. Total revenues for fiscal 2019 were $658,000, compared to $1.2 million in 2018. The year-to-year decrease was primarily due to a decrease in license revenue related to the sublicense of the Company’s NAV4694 technology, which included a non-refundable upfront payment in 2018, coupled with a reduction in grant revenue related to Small Business Innovation Research grants from the National Institutes of Health supporting Manocept development.
Research and development ("R&D") expenses for the fourth quarter of 2019 were $1.7 million, compared to $854,000 in the same period of 2018. R&D expenses in 2019 were $5.3 million, compared to $4.2 million in 2018. The increase was primarily due to net increases in drug project expenses, which includes Manocept diagnostic and Tc99m tilmanocept development costs, offset by decreased Manocept therapeutic and NAV4694 development costs.
Selling, general and administrative ("SG&A") expenses for the fourth quarter of 2019 were $1.2 million, compared to $1.4 million in the same period of 2018. SG&A expenses for 2019 were $6.3 million, compared to $7.7 million in 2018. The decrease was primarily related to the resignation of the Company’s former CEO in 2018, coupled with net decreases in salaries and bonuses, investor relations, general office expenses and taxes, offset by increased legal and professional services, primarily related to litigation with the Company’s former CEO.
Navidea’s net loss attributable to common stockholders for the fourth quarter of 2019 was $2.8 million, or $0.15 per share, compared to a net loss attributable to common stockholders of $3.2 million, or $0.33 per share, for the same period in 2018. Navidea’s net loss attributable to common stockholders for 2019 was $10.9 million, or $0.76 per share, compared to a net loss attributable to common stockholders of $16.1 million, or $1.89 per share, for 2018.
Navidea ended the fourth quarter of 2019 with $1.0 million in cash and investments. Per Navidea’s recent filings with the SEC, the Company executed funding transactions totaling $7.6 million in proceeds during the first quarter of 2020.
Conference Call Details

Investors and the public are invited to dial into the earnings call through the information listed below, or participate via the audio webcast on the company website. Participants who would like to ask questions during the question and answer session will be prompted by the moderator, who will provide instructions.

Event:

Q4 2019 Earnings and Business Update Conference Call

Date:

Wednesday, March 11, 2020

Time:

5:00 p.m. (EDT)

U.S. & Canada Dial-in:

877-407-0312

International Dial-in:

+1 201-389-0899

Conference ID:

13699935

Webcast Link: View Source

A live audio webcast of the conference call will also be available on the investor relations page of Navidea’s corporate website at www.navidea.com. In addition, the recorded conference call can be replayed and will be available for 90 days following the call on Navidea’s website.

On March 11, 2020 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported it will release its fourth quarter and full year 2019 financial results after the market closes on Wednesday, March 25, 2020 (Press release, Personalis, MAR 11, 2020, View Source [SID1234555426]). In conjunction with the release, the Company will host a conference call and webcast that day at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time to discuss its financial results and recent highlights.

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Interested parties may access the live call via telephone by dialing (866) 220-8061 for domestic callers or (470) 495-9168 for international callers, using conference ID: 3623198. The live webinar of the call may be accessed by visiting the Events section of the company’s website at investors.personalis.com. A replay of the webinar will be available shortly after the conclusion of the call and will be archived on the company’s website.

On March 11, 2020 Transgene (Euronext Paris: TNG) (Paris:TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, reported its financial results for 2019 and provides an update on its product portfolio (Press release, Transgene, MAR 11, 2020, View Source [SID1234555425]).

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Philippe Archinard, Chairman and Chief Executive Officer of Transgene, commented:

"We achieved multiple important advances with our novel myvac and Invir.IO platforms during the course of 2019. We completed all the regulatory steps required to start the US and European clinical trials of TG4050, the first individualized therapeutic vaccine based on the myvac platform in January 2020. The clinical development is being co-funded by our partner NEC.

Our collaboration with AstraZeneca, based on our Invir.IO platform, is progressing well with the first multifunctional oncolytic viruses already being delivered to them. This platform has also generated a number of exciting new oncolytic candidates, including BT-001, which is being co-developed with BioInvent. The preclinical results generated with BT-001 have been remarkable and we are working hard to make sure we can take our first multifunctional Invir.IO oncolytic into the clinic before the end of 2020.

On the clinical front, we had a year of contrasts with on the one hand, the very encouraging initial results of TG4001, which were presented at ESMO (Free ESMO Whitepaper) 2019, and on the other hand, the disappointing outcome of the Phase 2 trial of TG4010 and the decision to stop Pexa-Vec trials in HCC.

We remain confident in the potential of our four clinical assets TG4001, TG4050, TG6002 and BT-001 as well as in our highly innovative technologies and platforms myvac and Invir.IO.

We also have sufficient financial visibility to pursue our developments with determination and confidence."

2020: multiple clinical milestones expected

Transgene’s portfolio currently consists of four immunotherapy drug candidates in clinical development:

Two therapeutic vaccines: TG4001 currently being evaluated in a Phase 2 trial and TG4050, the first individualized treatment based on the myvac platform, assessed in two Phase 1 trials.
Two oncolytic viruses: TG6002, which is being assessed in two Phase 1/2a trials, and BT-001, the first oncolytic virus based on the Invir.IO platform, and which is expected to enter the clinic before the end of 2020.
Clinical results for TG4001 and TG6002 are expected in the second quarter of 2020:

The Phase 2 trial of TG4001 in combination with avelumab in HPV-positive cancers is ongoing. Patient recruitment is in line with projections and interim results are expected in the second quarter of 2020.
The Phase 1 trial of TG6002 administered intravenously in patients with gastrointestinal cancers is ongoing. First data are also expected in the second quarter of 2020.
With myvac and Invir.IO, Transgene has two next-generation platforms whose potential has been validated by collaboration deals with NEC and AstraZeneca respectively:

myvac platform

Transgene is developing the therapeutic vaccine TG4050, together with NEC. This is the first individualized vaccine based on the myvac platform. It integrates NEC’s Artificial Intelligence technologies. These technologies are used to select the most relevant mutations (neoantigens) that are integrated into the TG4050 vaccine. These AI technologies will also contribute to the in-depth analysis of the patient’s immune characteristics, in order to determine the profiles of those who responded to the vaccine.
Data validating the vaccine design principle behind TG4050 are being actively promoted and will be presented at several specialized international congresses.
The first clinical trials assessing TG4050 are ongoing in Europe and in the United States. They are including patients with ovarian cancers and head and neck cancers. NEC is financing 50% of their cost.
The clinical trials are a central part of a broad program of translational research in collaboration with expert centers both in the US and Europe. This program will generate a significant body of data evaluating the activity of TG4050 from these initial clinical trials. The first data are expected in 1H 2021.
The Company has set up an in-house good manufacturing practice (GMP) unit dedicated to the manufacturing of the individualized batches of TG4050 needed for the current Phase 1 trials.
The myvac project is supported by Bpifrance, within the NEOVIVA program. The NEOVIVA project aims to strengthen the development of this highly innovative technology together with three partners: HalioDx, Traaser and Institut Curie. €2.6 million have been allocated to Transgene over five years. The NEOVIVA project is complimentary to the collaboration between Transgene and NEC.
Invir.IO platform

BT-001 is the first oncolytic virus from the Invir.IO platform. It is based on Transgene’s patented viral vector VVcopTK-RR- which has been designed to encode BioInvent’s anti-CTLA4 antibody (an immune checkpoint inhibitor) as well as the cytokine GM-CSF.
Preclinical results with BT-001 have been extremely promising, with treatment leading to the eradication of tumors in several murine models known for their low sensitivity to immune checkpoint inhibitors. These data will be presented at scientific congresses in the coming months. A first-in-human trial is being prepared and BT-001 is expected to enter the clinic before the end of 2020.
The collaboration with AstraZeneca is highly productive with Transgene already delivering the first multi-armed oncolytic viruses to its partner. As a result, Transgene has received $10 million at the time the collaboration was signed and booked €1.3 million related to the achievement of certain preclinical milestones. In 2020, Transgene will continue to design further oncolytic viruses for this collaboration. AstraZeneca can exercise an option to further develop each of these novel drug candidates.
Transgene’s patented viral vector, which underpins the Invir.IO platform, allows the development of a wide range of multifunctional oncolytic viruses. Transgene has already designed a number of proprietary oncolytic viruses that are being evaluated in preclinical models. A candidate is expected to be selected with the aim of submitting a clinical trial application in 2H 2020 ahead of starting a clinical trial in 2021.
Summary of key ongoing clinical trials

TG4001
+ Bavencio

(avelumab)
Phase 2

Targets: HPV16 E6 and E7 oncoproteins

HPV-positive cancers including oropharyngeal head and neck cancer – 2nd line

✓ Clinical collaboration with Merck KGaA and Pfizer, for the supply of avelumab

✓ Publication of the results of a Phase 2b trial of TG4001 in Gynecologic Oncology (April 2019), demonstrating the biological activity of this immunotherapeutic in CIN 2/3 lesions; editorial in The Lancet Oncology (April 2019)

✓ Positive results of the Phase 1b part of the trial presented at ESMO (Free ESMO Whitepaper) (Sept. 2019) Three of the six patients who received the recommended dose responded to the treatment. The observed responses were durable.

→ Interim Phase 2 results expected in 2Q 2020

myvac
TG4050
Phase 1

Targets: tumor neoantigens

Ovarian cancer – after first-line surgery and adjuvant therapy

✓ Trial authorized in the United States (May 2019) and in France (Sept. 2019)

✓ Principal investigator: Matthew Block (Mayo Clinic)

✓ First patient enrolled in January 2020

→ First data expected in 1H 2021

myvac
TG4050
Phase 1

HPV-negative head and neck cancer – after surgery and adjuvant therapy

✓ Trial authorized in the United Kingdom (July 2019) and in France (Sept. 2019)

✓ Principal investigator: Christian Ottensmeier (Southampton University)

✓ First patient enrolled in January 2020

→ First data expected in 1H 2021

TG6002
Phase 1/2a

Payload: FCU1 for the local production of a chemotherapy agent

Gastro-intestinal adenocarcinoma (colorectal cancer for Phase 2) – Intravenous (IV) route

✓ Publication in Molecular Therapy Oncolytics (March 2019) highlighting the promising activity of TG6002 in preclinical colorectal carcinoma models

✓ Multicenter trial ongoing in Belgium, France and Spain

✓ Last dose levels currently being evaluated (Phase 1 part)

→ First results of the Phase 1 part expected in 2Q 2020

TG6002
Phase 1/2a

Colorectal cancer with liver metastasis – Intrahepatic artery (IHA) route

✓ Multicenter trial authorized in the United Kingdom (July 2019)

✓ First patient treated in February 2020

→ First results expected in 1H 2021 (Phase 1 part)

Invir.IO
BT-001
Phase 1/2

Payload: anti-CTLA4 antibody and GM-CSF cytokine

Solid tumors

✓ Collaboration with BioInvent

✓ First clinical trial application submitted

→ Presentation of very encouraging preclinical results at upcoming scientific congresses

→ First clinical trial expected to start before the end of 2020

Key financials for 2019

Operating income of €13.7 million in 2019, compared to € 42.9 million in 2018.
R&D services for third parties amounted to €6.7 million in 2019 (€1.3 million in 2018). This significant increase is mainly due to the collaboration signed with AstraZeneca in 2019. This generated €5.3 million in revenue in 2019. The research tax credit amounted to €6.5 million in 2019 (€5.7 million euros in 2018). As a reminder, the much higher operating income figure in 2018 was mainly the result of the €35.6 million income generated by the transaction with Tasly Biopharmaceuticals Co, Ltd.
Net operating expenses of €39.2 million in 2019, compared to €35.5 million in 2018.
R&D expenses increased to €31.4 million in 2019 (from €27.3 million in 2018), due to the acceleration of external expenses for clinical projects and the setup of manufacturing unit dedicated to small clinical batches. General and administrative expenses stood at €7.1 million in 2019 versus €7.0 million in 2018.
Financial income of €6.7 million in 2019 versus a loss of €2.0 million in 2018.
The decision taken at the end of 2019 to stop the clinical development of TG4010 has led to a downward reassessment of the financial debt related to the repayable advances of the ADNA program of €8.7 million. This has been recognized as financial income.
Net loss of €18.8 million in 2019, compared to a net profit of €8.0 million in 2018.
Cash burn reduced to €20.5 million in 2019 (excluding the proceeds of the rights issue), versus €24.5 million in 2018.

Transgene received €8.9 million in June 2019, following the signing of the contract with AstraZeneca. This contributed to the reduced net cash burn compared to 2018 despite an increase in operating expenses during the period.
Cash available at year-end 2019: €43.3 million, compared to €16.9 million at the end of 2018, due to the successful €48.7 million rights issue completed in July 2019.
Transgene expects its cash burn for 2020 to be around €25 million.
The financial statements for 2019 as well as management’s discussion and analysis are attached to this press release (Appendices A and B).

The Board of Directors of Transgene met on March 11, 2020, under the chairmanship of Philippe Archinard and closed the 2019 financial statements. Audit procedures have been performed by the statutory auditors and the delivery of the auditors’ report is ongoing.

The Company’s universal registration document, which includes the annual financial report, will be available early April 2020 on Transgene’s website, www.transgene.fr.

A conference call in English is scheduled today, March 11, 2020, at 6:00 p.m. CET.

On March 11, 2020 Biocare Medical ("Biocare"), a leading developer of world class immunohistochemistry ("IHC") and molecular reagents and instrumentation, is reported that Luis de Luzuriaga has joined the company as Chief Executive Officer (Press release, Biocare Medical, MAR 11, 2020, View Source [SID1234555424]).

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Mr. de Luzuriaga has spent his entire career in commercial and executive leadership roles within the life sciences tools and diagnostics sector. Notably, Mr. de Luzuriaga spent six years leading Global Commercial Operations at Leica Biosystems and also served as the Divisional Vice President and General Manager of Abbott Hematology. Most recently, Mr. de Luzuriaga was the CEO of BIT Group (subsidiary of Messer Group), a leading product development and contract manufacturer for high performance clinical, medical and life science devices.

Mr. de Luzuriaga’s proven ability to drive extraordinary growth and industry leadership within the life sciences tools sector aligns well with Biocare’s strong growth trajectory and reputation for quality diagnostic tools focused on the oncology and immunotherapy markets. "Since our first interaction with Luis, it was clear that he had the experience, capabilities and expertise to propel Biocare to the forefront of the industry," said Ryan Glaws, Partner at Excellere Partners. "His extensive experience and impressive track record at Leica, Abbott and BIT make him the ideal partner to guide Biocare through this exciting and transformational period in the company’s history."

"I am excited to join Biocare and work with what I know to be both a dynamic and talented team. Having previously competed against Biocare, I know first-hand about the quality of the products and reputation in the marketplace. It is an honor and a privilege to lead this organization, and I am very excited about the future of Biocare," said Mr. de Luzuriaga.

On March 11, 2020 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported an interim clinical data update for cirmtuzumab, a ROR1-targeted monoclonal antibody, combined with ibrutinib, in patients with relapsed/refractory mantle cell lymphoma (MCL) as part of the ongoing Phase 1/2 CIRLL (Cirmtuzumab and Ibrutinib targeting ROR1 for Leukemia and Lymphoma) clinical trial (data cutoff as of March 6, 2020) (Press release, Oncternal Therapeutics, MAR 11, 2020, View Source [SID1234555423]):

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50% Complete Response (CR) rate (6 of 12 evaluable patients), determined by Cheson criteria. One of the six patients had a complete metabolic response (CMR) by PET scan, with a bone marrow biopsy pending. All six CRs are ongoing, including one patient who has remained in CR at over 21 months on study. Four of the six patients achieved CRs within four months on the combination of cirmtuzumab and ibrutinib
33% Partial Response (PR) rate (4 of 12)
17% Stable Disease (SD) rate (2 of 12)
83% best Objective Response (CR or PR) rate (ORR)
100% Clinical Benefit (CR, PR or SD) rate
Median follow-up 6.4 months
Patients had received a median of two prior therapies before participating in this study including chemotherapy; autologous stem cell transplant (SCT); autologous SCT and CAR-T therapy; autologous SCT and allogeneic SCT; and ibrutinib with rituximab
The combination of cirmtuzumab plus ibrutinib has been well tolerated in this study, with adverse events consistent with those reported for ibrutinib alone. There were no dose-limiting toxicities, no discontinuations and no serious adverse events attributed to cirmtuzumab alone.

"The reported complete response rate for patients with MCL treated with cirmtuzumab and ibrutinib is highly encouraging and is higher than previously reported for ibrutinib alone, particularly considering that some of these patients were heavily pre-treated. Patients with relapsed MCL remain in dire need of well-tolerated treatment options that provide deeper and more durable responses," said Hun Ju Lee, M.D., Associate Professor of Medicine in the Department of Lymphoma & Myeloma at the University of Texas MD Anderson Cancer Center, who is an investigator on the CIRLL clinical trial.

The CIRLL clinical trial is supported by a grant from the California Institute for Regenerative Medicine (CIRM) and is being conducted in collaboration with the University of California San Diego (UC San Diego).

"We are encouraged by the complete response rate for patients with MCL reported in the ongoing CIRLL clinical trial, and look forward to further developing cirmtuzumab in the ongoing clinical trials for patients with MCL, chronic lymphocytic leukemia (CLL) and breast cancer, as well as potentially for other ROR1-expressing solid tumors and hematological malignancies," said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO.

About the CIRLL Clinical Trial

The CIRLL clinical trial (CIRM-0001) is a Phase 1/2 trial evaluating cirmtuzumab in combination with ibrutinib in separate groups of patients with CLL or MCL. Enrollment of the dose-finding cohorts in CLL and MCL and dose-expansion cohort in CLL has been completed. Enrollment of the dose-expansion cohort in MCL and randomized Phase 2 cohort in CLL is ongoing. Based on the data from the dose-finding cohorts, the recommended dosing regimen was determined to be 600 mg of cirmtuzumab administered intravenously every two weeks for three doses, followed by dosing every four weeks, in combination with 420 mg of ibrutinib administered once daily for patients with CLL, or 560 mg of ibrutinib once daily for patients with MCL, which are the FDA-approved doses of ibrutinib in these indications. Additional information about the CIRM-0001 clinical trial and other clinical trials of cirmtuzumab may be accessed at ClinicalTrials.gov.

About Cirmtuzumab

Cirmtuzumab is an investigational, potentially first-in-class monoclonal antibody targeting ROR1, or Receptor tyrosine kinase-like Orphan Receptor 1. Cirmtuzumab is currently being evaluated in a Phase 1/2 clinical trial in combination with ibrutinib for the treatment of CLL or MCL, in a collaboration with the UC San Diego School of Medicine and the California Institute for Regenerative Medicine (CIRM). In addition, an investigator-initiated Phase 1 clinical trial of cirmtuzumab in combination with paclitaxel for women with metastatic breast cancer is being conducted at the UC San Diego School of Medicine.

ROR1 is a potentially attractive target for cancer therapy because it is an onco-embryonic antigen – not usually expressed on adult cells, and its expression confers a survival and fitness advantage when reactivated and expressed by tumor cells. Researchers at the UC San Diego School of Medicine discovered that targeting a critical epitope on ROR1 was key to specifically targeting ROR1 expressing tumors. This led to the development of cirmtuzumab, that binds this critical epitope of ROR1, which is highly expressed on many different cancers but not on normal tissues. Preclinical data showed that when cirmtuzumab bound to ROR1, it blocked Wnt5a signaling, inhibited tumor cell proliferation, migration and survival, and induced differentiation of the tumor cells. Cirmtuzumab is in clinical development and has not been approved by the U.S. Food and Drug Administration for any indication.