On May 9, 2019 Synlogic, Inc. (Nasdaq: SYBX), a clinical stage company applying synthetic biology to beneficial microbes to develop novel, living medicines, reported its financial results for the first quarter ended March 31, 2019 (Press release, Synlogic, MAY 9, 2019, View Source [SID1234536066]).

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"We made significant progress on our 2019 goals in the first quarter of the year providing a strong foundation for the continued development of our Synthetic Biotic platform and clinical pipeline," said Aoife Brennan, M.B., Ch.B. Synlogic’s president and chief executive officer. "We strengthened our scientific leadership with the appointment of two experienced drug developers, Dr. Scott Plevy, as Chief Scientific Officer, and Dr. Patricia Hurter, who joined our board of directors and brings additional relevant experience in manufacturing. In addition, we have manufactured clinical trial material in-house for our IO program and made significant advances in developing processes to reliably and reproducibly manufacture solid formulations of our orally administered Synthetic Biotic medicines. The new formulation has a more patient-friendly stability profile and provides a path to longer out-patient studies and eventual commercialization."

Recent Highlights

Corporate

Appointment of Scott Plevy, M.D., as Synlogic’s Chief Scientific Officer. Dr. Plevy has responsibility for Synlogic’s research organization. He most recently served as Vice President, Gastroenterology Disease Area Leader and IL-23 Pathway Leader at Janssen Research & Development, LLC, after a successful career in academia. He has served as the lead investigator on multiple early-phase clinical trials, published on a breadth of topics from disease-specific targets to basic immunology and molecular biology, and performed translational research to advance the understanding of novel immunologic interventions in inflammatory bowel disease, other inflammatory conditions, and microbiome-related diseases.
Appointment of Patricia N. Hurter, Ph.D., to Synlogic’s board of directors. Dr. Hurter served as Senior Vice President at Vertex from 2011 to 2019, during which time her responsibilities grew to include all CMC and preclinical development activities of Vertex’s R&D portfolio, as well as the internal GMP manufacturing facility that provides drug substance and product for clinical development and commercial supply. Dr. Hurter also served as Interim Head of Global Regulatory Affairs at Vertex and played a leadership role in the development and commercialization of four transformative therapies for Vertex. Prior to joining Vertex, Dr. Hurter was Director, Formulation Design and Characterization for Merck.
Pipeline

Presentation of data at the Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) demonstrating the development of a robust and reproducible process to generate a solid oral formulation of Synlogic’s Synthetic Bioticmedicine for future studies and potential commercial use. The ASGCT (Free ASGCT Whitepaper) presentation focused on preparation and characteristics of a solid oral preparation of SYNB1618, Synlogic’s Synthetic Biotic medicine for the treatment of phenylketonuria (PKU). The data demonstrate that Synlogic has developed a robust and reproducible process to generate a solid formulation of SYNB1618 with minimal impact on cell viability and phenylalanine consuming activity compared to a liquid formulation that is currently being evaluated in an ongoing Phase 1 /2a clinical study in patients with PKU. Synlogic expects to have data from the Phase 1 /2a study in patients in the third quarter of 2019.
Publication in Science Translational Medicine of first in human clinical data and supporting preclinical data from investigational Synthetic Biotic candidate, SYNB1020. The data support the continued development of SYNB1020 which is currently being evaluated in a Phase 1b/2a clinical trial in patients with cirrhosis and elevated blood ammonia with data expected in the third quarter of 2019.
In-house manufacturing of clinical trial material for Synlogic’s first immuno-oncology program, SYNB1891, a dual innate immune activator. Synlogic expects to file an investigational new drug (IND) application for SYNB1891 in the second half of 2019.
Advancement of investigational Synthetic Biotic medicines to lead optimization stage in AbbVie collaboration. Synlogic and AbbVieare developing an oral treatment for inflammatory bowel disease (IBD).
First Quarter 2019 Financial Results

For the three months ended March 31, 2019, Synlogic reported a consolidated net loss of $12.9 million, or $0.51 per share, compared to a consolidated net loss of $11.2 million, or $0.55 per share, for the corresponding period in 2018. The increase in net loss was primarily due to increases in compensation-related expenses due to increased headcount, as well as increases in research and development expenses to support Synlogic’s advancing clinical programs.

Research and development expenses were $10.4 million for the three months ended March 31, 2019 compared to $8.4 million for the corresponding period in 2018. The increase was primarily due to an increase in compensation-related expenses associated with increased headcount and increased expenses associated with manufacturing and pre-clinical and clinical studies of Synlogic’s Synthetic Biotic programs.

General and administrative expenses for the three months ended March 31, 2019 were $3.7 million compared to $3.6 million for the corresponding period in 2018.

Revenue was $0.3 million for the three months ended March 31, 2019 compared to $0.4 million for the same period in 2018. Revenue for both periods is associated with services performed under Synlogic’s collaboration with AbbVie to develop a Synthetic Biotic medicine for the treatment of IBD.

As of March 31, 2019, Synlogic had cash, cash equivalents, and short-term investments of $109.8 million.

Conference Call & Webcast Information

Synlogic will host a conference call and live webcast today at 5:00 pm ET today, Thursday, May 9, 2019. To access the live webcast, please visit the "Event Calendar" page within the Investors and Media section of the Synlogic website. Alternatively, investors may listen to the call by dialing +1 (844) 815-2882 from locations in the United States or +1 (213) 660-0926 from outside the United States. The conference ID number is 2154739. For those unable to participate in the conference call or webcast, a replay will be available for 30 days on the Investors and Media section of the Synlogic website.

On May 9, 2019 Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ: CKPT), a clinical-stage, immuno-oncology biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers, reported financial results and recent corporate highlights for the first quarter ended March 31, 2019 (Press release, Checkpoint Therapeutics, MAY 9, 2019, View Source [SID1234536065]).

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James F. Oliviero, President and Chief Executive Officer of Checkpoint, said, "We continue to make substantial progress with our lead clinical programs, both of which have recently produced data demonstrating unequivocal activity in patients with multiple forms of cancer, including lung cancer and skin cancer. We presented data late last year in an oral presentation at the World Conference on Lung Cancer demonstrating that CK-101, our novel, oral, third-generation EGFR inhibitor, was active in patients with treatment-naïve and relapsed/refractory EGFR mutation-positive lung cancer. EGFR mutation-positive lung cancer represents approximately 20% of the 228,000 newly-diagnosed lung cancer patients in the US, and there is currently only one third-generation EGFR inhibitor approved for these patients. Our plan is to commence a phase 3 trial in first-line EGFR mutation-positive non-small cell lung cancer later this year."

Mr. Oliviero continued, "We are also excited by our progress with our anti-PD-L1 program. We announced earlier this year that we advanced cosibelimab ("cosi", formerly CK-301), our high affinity, fully-human anti-PD-L1 antibody, into potentially pivotal cohorts in several solid tumor indications. This was supported by the positive interim clinical results we announced earlier this month showing anti-tumor activity across multiple advanced cancers. We believe the early data for cosi are very exciting and may show differentiation from other drugs in this class as a result of cosi’s dual mechanism of action through the engagement of both T-cells and NK cells."

Financial Results:

Cash Position: As of March 31, 2019, Checkpoint’s cash and cash equivalents totaled $14.1 million. The Company believes its cash and cash equivalents and projected licensing revenue will be sufficient to fund its anticipated operating cash requirements for at least 12 months.
R&D Expenses: Research and development expenses for the first quarter of 2019 were $4.6 million, compared to $6.9 million for the first quarter of 2018, a decrease of $2.3 million. Research and development expenses for the first quarter of 2019 included $0.2 million of non-cash stock expenses, compared to $0.7 million for the first quarter of 2018. The Company expects research and development expenses throughout the rest of 2019 to continue to remain lower than the comparable periods in 2018.
G&A Expenses: General and administrative expenses for the first quarter of 2019 were $1.7 million, compared to $2.2 million for the first quarter of 2018, a decrease of $0.5 million. General and administrative expenses for the first quarter of 2019 included $0.6 million of non-cash stock expenses, compared to $1.1 million for the first quarter of 2018.
Net Loss: Net loss attributable to common stockholders for the first quarter of 2019 was $5.9 million, or $0.18 per share, compared to a net loss of $8.8 million, or $0.35 per share, for the first quarter of 2018. The net loss for the first quarter of 2019 included $0.8 million of non-cash stock expenses, compared to $1.8 million for the first quarter of 2018.
Recent Corporate Highlights:

In January 2019, Checkpoint announced that the ongoing multi-center clinical trial of anti-PD-L1 antibody cosibelimab was expanded to enroll patients in three endometrial and colorectal cohorts intended to support potential requests for accelerated approval and Biologics License Application ("BLA") submissions to the U.S. Food and Drug Administration ("FDA"). The ongoing trial is also enrolling cohorts of patients with non-small cell lung cancer ("NSCLC") and cutaneous squamous cell carcinoma.
In March 2019, Checkpoint announced two new patent issuances by the U.S. Patent and Trademark Office and the European Patent Office for CK-101. The patents cover CK-101 in the U.S. and Europe through at least August 2034, not including any potential patent term extensions.
In May 2019, Checkpoint announced positive interim safety and efficacy data from its ongoing multicenter Phase 1 clinical trial of cosibelimab. Cosibelimab is a high affinity, fully-human IgG1 monoclonal antibody that directly binds to programmed death ligand-1 ("PD-L1") and blocks the PD-L1 interaction with the programmed death receptor-1 ("PD-1") and B7.1 receptors. Cosibelimab is potentially differentiated from currently marketed PD-1 and PD-L1 antibodies with a half-life that supports sustained >99% tumor target occupancy and the additional benefit of a functional Fc domain capable of inducing antibody-dependent cell-mediated cytotoxicity ("ADCC") for potential enhanced efficacy in certain tumor types. Cosibelimab appeared to be safe and well-tolerated with no dose-limiting toxicities. Objective responses and target lesion reductions were observed across diverse tumor types, particularly in NSCLC and cutaneous squamous cell carcinoma.

On May 9, 2019 Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company focused on the development and commercialization of precisely targeted oncology therapies, reported financial results for the first quarter ended March 31, 2019 (Press release, Corvus Pharmaceuticals, MAY 9, 2019, View Source [SID1234536064]).

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"With the initiation of patient enrollment in our Phase1/1b trial of CPI-818, Corvus now has three agents with novel mechanisms of action in clinical trials for a wide range of cancers," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "Looking forward, we have several important milestones for each of our programs in 2019."

"For the adenosine pathway, we continue to be in a leadership position with ciforadenant (CPI-444), our small molecule inhibitor of the A2A receptor, and CPI-006, our anti-CD73 antibody. We are enrolling patients in two ciforadenant Phase 1b/2 trials and we have discovered a potentially predictive genetic biomarker, the Adenosine Signature, that may provide clinicians with the ability to select patients most likely to benefit from therapy. This positions us to potentially initiate a molecularly defined, late stage study of ciforadenant in patients with renal cell cancer around the end of the year. For CPI-006, the initial clinical data from both the monotherapy and combination arms of our Phase 1/1b clinical trial will be presented in an oral presentation at the ASCO (Free ASCO Whitepaper) annual meeting in June. In addition, we expect incremental data updates on these programs at major medical meetings over the course of the year."

"Turning to CPI-818, we are very excited to be investigating it in patients with T-cell lymphomas, a patient group that often has limited treatment options and poor clinical outcomes," continued Dr. Miller. "We believe that CPI-818 represents a novel approach for these patients and the Phase 1/1b study is designed to evaluate both anti-tumor activity and its effect on normal T-cells, which could provide valuable information for future trials of CPI-818 in other types of cancer and autoimmune diseases. We currently anticipate that initial data from the study will be presented in late 2019, providing another potential catalyst for the Company."

CPI-818, an oral, covalent, selective interleukin-2-inducible kinase (ITK) inhibitor, is based on a similar targeting strategy to that of Bruton’s tyrosine kinase (BTK) inhibitors. Key members of the scientific team at Corvus led the development of the first BTK inhibitor, ibrutinib, which is approved for the treatment of several types of B-cell lymphomas. ITK, the T-cell homologue of BTK, has many biochemical and functional similarities with BTK. T-cell lymphomas are often incurable, especially after relapse. As ITK is frequently overexpressed in T-cell lymphoma, we believe the selective inhibition of ITK may represent a new treatment strategy for this type of cancer, possibly analogous to the effects of BTK inhibition with ibrutinib in B-cell lymphomas. Unlike other ITK inhibitors, the selectivity of CPI-818 has been shown in preclinical studies to shift immune responses to a T-cytotoxic type 1 (Th1) phenotype. We believe CPI-818 has the potential to display a dual mechanism of action: direct cytotoxicity to T-cell lymphoma and enhancement of the immune system by increasing the Th1 immune response.

Recent Achievements
Ciforadenant (CPI-444): A2A Receptor Antagonist of Adenosine

Continued enrolling patients with renal cell cancer (RCC) in an amended Phase 1b/2 clinical trial evaluating ciforadenant in combination with Genentech’s Tecentriq (atezolizumab), an anti-PD-L1 antibody. The RCC patients in the trial have failed treatments with anti-PD-(L)1 antibodies and tyrosine kinase inhibitors.
Continued enrollment of up to 65 patients with non-small cell lung cancer (NSCLC) in a Phase 1b/2 trial being conducted by Genentech as part of their MORPHEUS platform. The study is evaluating ciforadenant and Tecentriq in patients who have failed no more than two prior regimens.
Presented updated data on the Adenosine Gene Signature (AdenoSig) highlighting its potential to enable patient selection for treatment with ciforadenant based on a molecularly defined gene signature, that may predict which patients may be more responsive to the adenosine blockade.
CPI-006: Anti-CD73 Antibody

Continued enrollment of up to 350 patients with advanced cancer in a Phase 1/1b clinical trial evaluating CPI-006 as a single agent and in combination with either ciforadenant or pembrolizumab. The trial is currently enrolling patients in the dose escalation phase for CPI-006 administered as a monotherapy and in combination with ciforadenant.
Initial clinical data from the Phase 1/1b study will be delivered in an oral presentation at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June 2019. This will build upon data presented in February that demonstrated early signs of immunologic activity across multiple pathways that may be important in cancer therapy.
CPI-818: A small molecule ITK inhibitor

Initiated enrollment of CPI-818, an ITK inhibitor, in a Phase 1/1b study in patients with several types of T-cell lymphomas, including peripheral T-cell lymphoma (PTCL), cutaneous T-cell lymphoma (CTCL) and others.
Presented preclinical and biochemical studies with CPI-818 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in March highlighting the selectivity and immunologic activity of CPI-818 and its anti-tumor activity in spontaneous canine T-cell lymphoma.
Financial Results

At March 31, 2019, Corvus had cash, cash equivalents and marketable securities totaling $105.8 million, as compared to cash, cash equivalents and marketable securities of $114.6 million at December 31, 2018.

Research and development expenses for the three months ended March 31, 2019 totaled $9.4 million compared to $12.1 million for the same period in 2018. The decrease of $2.7 million was primarily due to a decrease in ciforadenant program costs.

The net loss for the three months ended March 31, 2019 was $11.6 million, compared to a net loss of $14.3 million for the same period in 2018. Total stock compensation expense for the three months ended March 31, 2019 was $2.0 million compared to $1.8 million of total stock compensation expense for the same period in 2018.

Conference Call Details
Corvus will host a conference call and webcast today, Thursday, May 9, 2019, at 4:30 p.m. ET (1:30 p.m. PT), during which time management will provide a business update and discuss the first quarter 2019 financial results. The conference call can be accessed by dialing 1-800-479-1004 (toll-free domestic) or 1-720-543-0206 (international) and using the conference ID 5606517. The live webcast may be accessed via the investor relations section of the Corvus website. A replay of the webcast will be available on Corvus’ website for 90 days.

On May 9, 2019 Kitov Pharma Ltd. (the "Company" or "Kitov") (NASDAQ/TASE: KTOV), a pharmaceutical company focused on advancing first-in-class combination oncology therapies to overcome tumor drug resistance, increase treatment response rate, and slow tumor progression, reported that its CEO, Isaac Israel, will present at 18th MIXiii-BIOMED Conference and Exhibition, the leading annual international healthcare industry meeting in Israel, to be held on May 14-16, 2019 in Tel Aviv, Israel (Press release, Kitov Pharmaceuticals , MAY 9, 2019, View Source [SID1234536063]). The oral presentation will give an overview of Kitov’s clinical development plans for its oncology candidate NT-219, including disclosing its first indication for a phase 1/2 clinical trial and trial design.

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NT-219 is a first-in-class small molecule dual inhibitor of STAT3 and IRS1/2, with the potential to prevent and overcome drug resistance in various cancer types when used in combination with existing agents.

Presentation Details:

Title: "NT-219, a First-in-class Dual Inhibitor of STAT3 and IRS1/2 is Overcoming Drug Resistance"
Session: Transformative Cancer Therapies
Presenter: Isaac Israel, chief executive officer
Date: Thursday, May 16, 2019
Time: 1:05-1:20 p.m. IST
Location: Hall A, David Intercontinental Hotel

About the MIXiii Biomed Conference

MIXiii-Biomed Conference and Exhibition is the leading annual international healthcare industry meeting in Israel. The conference serves as a meeting point for local and multinational companies, investors, technology transfer experts, university, research scientists, and government representatives. This year, the focus of the conference is expanding to the full spectrum of healthcare: from prevention to rehabilitation and everything in between. Presentations will address diagnosis, monitoring, and treatment domains, and will explore trends and innovations that are shaping the future of the healthcare system to its full extent. Fields to be included are gene editing and gene therapy, transforming medicine, personalized medicine and digital health, transformative cancer therapies, prevention and rehabilitation, new modalities of cell therapies, disruptive and advanced medical devices, and cannabis therapeutics. 18th MIXiii-Biomed will take place May 14-16, 2019, at the David Intercontinental Hotel in Tel Aviv. More information can be found at View Source

On May 9, 2019 Harpoon Therapeutics, Inc. (Nasdaq: HARP), a clinical-stage immunotherapy company developing a novel class of T cell engagers, reported financial results for the first quarter ended March 31, 2019 and provided a corporate update (Press release, Harpoon Therapeutics, MAY 9, 2019, View Source [SID1234536062]).

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"Harpoon has continued to progress in 2019, both in the clinic and in its development as a company. We are pleased to now have two T cell engagers in the clinic, with dosing of the first patient with our second product candidate HPN536 in April. We continue to develop additional candidates, with IND submissions expected this year and next," said Gerald McMahon, Ph.D., President and Chief Executive Officer of Harpoon Therapeutics. "We believe TriTACs provide unique benefits in the exciting field of T cell engagers and we look forward to achieving a number of development milestones in 2019 across the TriTAC platform, including presentation of a maturing HPN424 dataset by the end of this year at a medical conference."

First Quarter 2019 Business Highlights and Other Recent Developments

In February, Harpoon successfully completed its initial public offering, raising net proceeds of approximately $71 million.

In March, Harpoon designated its fourth Tri-specific T cell Activating Construct (TriTAC) in development, HPN328, for the treatment of small cell lung cancer (SCLC). HPN328 targets delta-like 3 (DLL3), a protein highly expressed in a majority of SCLC tumors, but not in normal tissue. This selective expression makes DLL3 an attractive drug target for T cell engagers. Harpoon is currently conducting IND-enabling studies and expects to initiate a Phase 1 clinical trial of HPN328 in 2020.

In April, Harpoon dosed the first patient with HPN536, a mesothelin-targeting T cell engager, in a Phase 1/2a clinical trial for ovarian and other mesothelin-expressing solid tumors. This represents the second TriTAC that Harpoon has brought into the clinic. The study consists of two phases, an initial dose escalation phase of approximately 20 ovarian cancer patients followed by an expansion phase of up to three additional parallel cohorts of 20 patients each with ovarian, pancreatic and mesothelioma cancer. The study is designed to evaluate the safety, tolerability, pharmacokinetics and activity of HPN536. For additional information about the trial, please visit clinicaltrials.gov using the identifier NCT03872206.

Anticipated Milestones

Harpoon plans to have three TriTAC product candidates in the clinic by the end of 2019, with a fourth expected in 2020. All of Harpoon’s anticipated milestones for 2019 remain on track, as follows:

HPN424 – present additional Phase 1 data in the second half of 2019 at a medical conference

HPN536 – initiated Phase 1/2a trial in April 2019

HPN217 – initiate Phase 1 trial in the second half of 2019

HPN328 – initiate Phase 1 trial in 2020

First Quarter Financial Results

Harpoon Therapeutics ended the first quarter of 2019 with $147.6 million in cash, cash equivalents, and marketable securities compared to $89.5 million as of December 31, 2018. The increase was due to approximately $71 million in net proceeds from Harpoon’s initial public offering, completed in February 2019, partially offset by cash used in operations.

Net loss for the first quarter ended March 31, 2019 was $13.6 million compared to $4.9 million for the first quarter ended March 31, 2018.

Revenue for the first quarter of 2019 was $1.1 million compared to $1.6 million for the first quarter of 2018. The decrease was due to an upfront payment of $0.5 million recognized in the first quarter of 2018 related to our license agreement with Werewolf Therapeutics, Inc. During both periods, revenue primarily consisted of the amortized portion of the deferred $17.0 million upfront payment received in October 2017 under our collaboration agreement with AbbVie.

Research and development expense for the first quarter of 2019 was $9.4 million compared to $5.5 million for the first quarter of 2018. The increase primarily arose from clinical development expenses and an increase in personnel-related expenses, including conducting preclinical studies, continuation of the first clinical trial for lead product candidate, HPN424, and manufacturing activities for four TriTAC product candidates in various stages of development.

General and administrative expense for the first quarter of 2019 was $5.8 million compared to $1.0 million for the first quarter of 2018. The increase was primarily due to an increase in legal fees, consulting and accounting services related to our 2018 year-end audit, and an increase in headcount.