On February 27, 2019 NewLink Genetics Corporation (NASDAQ:NLNK) reported consolidated financial results for the fourth quarter and year ended 2018, as well as progress in its clinical development programs (Press release, NewLink Genetics, FEB 27, 2019, View Source [SID1234533736]). The Company also outlined key 2019 priorities related to its clinical pipeline.

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"In 2018, we published further clinical results on indoximod that suggest it has significant activity in combination therapy for a variety of cancer indications," said Charles J. Link, Jr, MD, Chairman and Chief Executive Officer. "As we enter 2019 with a strong cash position, our intention is to focus on developing the best potential registration strategy for bringing indoximod forward and further developing our pipeline assets, especially NLG207. We would like to thank the investigators and patients who support our clinical trials year after year, and we remain committed to your care."

Anticipated 2019 Outlook

Updated results on the cohort of patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG), from the efficacy portion of a Phase 1b study of indoximod for the treatment of pediatric patients with recurrent malignant brain tumors, are anticipated in 2019

Results from a Phase 2 study of NLG207 (formerly CRLX101), a nanoparticle formulation of the topoisomerase 1 inhibitor, camptothecin, conducted by the Gynecological Oncology Group (GOG) for patients with recurrent ovarian cancer, has been accepted for presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019, at the Georgia World Conference Center, in Atlanta, March 29 – April 3, 2019

Updated results from a Phase 1 study of NLG802, a prodrug of indoximod with enhanced pharmacokinetic properties, are anticipated in 2019

Updated results from a Phase 1b study of indoximod for pediatric patients with recurrent malignant brain tumors are anticipated in 2019

Completion by Merck of the rolling Biologics License Application (BLA) filing for V920 (rVSV∆G-ZEBOV-GP), our partnered Ebola vaccine candidate, is expected in 2019
2018 Highlights

Presented Phase 1 results of indoximod plus front-line radiation and maintenance chemotherapy for the treatment of pediatric patients with newly diagnosed DIPG at the American Association of Clinical Research (AACR) (Free AACR Whitepaper) Annual Meeting, April 2018, and updated Phase 1 results at the International Symposium of Pediatric Neuro-Oncology (ISPNO) Annual Meeting, July 2018, showing symptomatic improvement and marked radiographic improvement in DIPG patients.

Presented updated Phase 1 results for indoximod plus standard of care chemotherapy for younger, healthy patients with newly diagnosed acute myeloid leukemia (AML) in an oral session at the 60thAmerican Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, December 2018

Presented final results from two Phase 2 studies of indoximod at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting with results for indoximod plus checkpoint inhibition in advanced melanoma which we believe showed encouraging overall and complete response rates which compared favorably to historical PD-1 monotherapy results and results for indoximod plus gemcitabine / nab-paclitaxel in metastatic pancreatic cancer demonstrating potentially promising activity that correlated with a measurable immune response

At the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2018 Annual Meeting, we presented correlative immunologic assay results from biopsies obtained during both the advanced melanoma and the metastatic pancreatic cancer trials previously presented at ASCO (Free ASCO Whitepaper) 2018, illustrating indoximod’s impact on the tumor microenvironment as well as first-in-human results showing significantly enhanced pharmacokinetic properties of our indoximod prodrug, NLG802

November 13, 2018, our partner, Merck, announced that it had begun the rolling submission of licensure application for Ebola vaccine, V920 (rVSV∆G-ZEBOV-GP), to the FDA
Financial Results

Cash Position: NewLink Genetics ended the year on December 31, 2018, with cash and cash equivalents totaling $120.7 million compared to $158.7 million for the year ending December 31, 2017. The Company projects its cash position is sufficient to fund planned operations through the end of 2021.

R&D Expenses: Research and development expenses were $5.7 million and $45.7 million in the fourth quarter and year ended December 31, 2018 compared to $17.5 million and $69.9 million during the comparable periods in 2017. The decrease year-over-year was due primarily to a $15.2 million reduction in contract research and manufacturing expense, $3.0 million in personnel-related expense, $3.3 million in supplies and equipment, $1.8 million in clinical trial costs, $1.3 million in technology and licensing, and reduction in restructuring expenses of $100,000, offset by a $500,000 increase in consulting and other costs.

G&A Expenses: General and administrative expenses in the fourth quarter and year ended December 31, 2018 were $5.4 million and $29.2 million compared to $6.7 million and $31.7 million during the comparable periods in 2017. The year-over-year decrease of $2.5 million was due to a reduction of $2.5 million in personnel-related spending, $550,000 reduction in consulting and other costs, reduction in restructuring expenses of $300,000, offset by an $850,000 increase in supplies and other expenses.

Net Loss: NewLink Genetics reported a net loss of $10.6 million or a loss of $0.28 per diluted share for the fourth quarter of 2018 and a net loss of $53.6 million or a loss of $1.44 per diluted share for the year ended December 31, 2018, compared to a net loss of $13.7 million or $0.37 per diluted share for the fourth quarter of 2017 and a net loss of $72.0 million or $2.30 per diluted share for the year ended December 31, 2017.

NewLink Genetics ended 2018 with 37,251,220 shares outstanding.

Conference Call and Webcast Details

The Company has scheduled a conference call and webcast for 4:30 p.m. ET today to discuss the results and to give an update on clinical and business development activities. NewLink Genetics’ senior management team will host the call, which will be open to all listeners. There will also be a question and answer session following the prepared remarks.

Access to the live conference call is available by dialing (855) 469-0612 (U.S.) or (484) 756-4268 (international) five minutes prior to the start of the call. The conference call will be webcast live and a link to the webcast can be accessed through the NewLink Genetics website at www.NewLinkGenetics.com in the "Investors & Media" section under "Events and Presentations," or through this link View Source To ensure a timely connection, it is recommended that users register at least 15 minutes prior to the scheduled webcast. A replay of the call will be available approximately two hours after the completion of the call and can be accessed by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and using the passcode 1279102. The replay will be available for two weeks from the date of the call.

About Indoximod

Indoximod is an investigational, orally available small molecule targeting the IDO pathway. The IDO pathway is a key immuno-oncology target, suppressing immune response and allowing for immune escape by degrading tryptophan with the resultant production of kynurenine. Indoximod reverses the immunosuppressive effects of low tryptophan and high kynurenine through mechanisms that include modulation of the AhR-driven transcription of genes that control immune function. This results in increased proliferation of effector T cells, increased differentiation into helper T cells rather than regulatory T cells, and downregulation of IDO expression in dendritic cells. Indoximod is being evaluated in combination with treatment regimens including chemotherapy, radiation, checkpoint blockade and cancer vaccines across multiple indications including recurrent pediatric brain tumors, DIPG, and AML.

About NLG207

NLG207 (formerly CRLX101) is an investigational nanoparticle-drug conjugate (NDC) composed of a cyclodextrin-based polymer backbone conjugated to camptothecin, a topoisomerase-1 inhibitor. NDCs enhance drug delivery to tumors where gradual payload release inside cancer cells augments antitumor activity while reducing toxicity. Topoisomerase 1 inhibitors are a class of drugs that modify DNA damage responses in cancer cells. NewLink Genetics is evaluating NLG207 in a series of clinical trials in advanced refractory ovarian cancer patients.

On February 27, 2019 Syros Pharmaceuticals (NASDAQ: SYRS), a leader in the development of medicines that control the expression of genes, reported that it will present new preclinical data on SY-1365, its first-in-class selective cyclin-dependent kinase 7 (CDK7) inhibitor currently in a Phase 1 clinical trial focused on ovarian and breast cancers, and on SY-5609, its selective oral CDK7 inhibitor that the company has named as its next development candidate, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting taking place March 29-April 3 in Atlanta (Press release, Syros Pharmaceuticals, FEB 27, 2019, View Source [SID1234533752]).

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The presentation on SY-1365 will highlight data showing that alterations in the RB pathway are predictive of response to SY-1365 in patient-derived xenograft models of high-grade serous ovarian cancer, supporting exploration of RB alterations as potential biomarkers of response to SY-1365. The presentation on SY-5609 will describe in vitro and in vivo data on the selectivity, potency and anti-tumor activity of SY-5609 that supported its advancement into investigational new drug application (IND)-enabling preclinical studies.

The abstracts for these presentation are now available online on the AACR (Free AACR Whitepaper) website at View Source

Details on the presentation are as follows:

Presentation Title: Prospective identification of RB pathway alterations predict response to SY-1365, a selective CDK7 inhibitor, in a panel of high-grade serous ovarian cancer (HGSOC) patient derived xenograft (PDX) models
Date & Time: Tuesday April 2, 1:00 – 5:00 p.m. ET
Session Title: Targeting the Cell Cycle: Development of Preclinical Models and Therapeutic Targets
Session Category: Molecular and Cellular Biology/Genetics
Presenter: Nan Ke, Syros
Abstract Number: 4409
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 37

Presentation Title: SY-5609, an orally available selective CDK7 inhibitor, demonstrates broad anti-tumor activity in vivo
Date & Time: Tuesday April 2, 1:00 – 5:00 p.m. ET
Session Title: Targeting the Cell Cycle: Development of Preclinical Models and Therapeutic Targets
Session Category: Molecular and Cellular Biology/Genetics
Presenter: Shanhu Hu, Ph.D., Syros
Abstract Number: 4421
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 37

On February 27, 2019 ImmunoGen, Inc., (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that 11 posters highlighting continued innovation in the field of ADCs will be presented at the upcoming American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting to be held March 29 – April 3, 2019 in Atlanta, Georgia (Press release, ImmunoGen, FEB 27, 2019, View Source [SID1234533737]).

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"ImmunoGen remains at the forefront of ADC innovation and the data to be presented at AACR (Free AACR Whitepaper) further demonstrate the value of our productive research platform," said Richard Gregory, Ph.D., ImmunoGen’s chief scientific officer.

The schedule of ImmunoGen’s presentations at AACR (Free AACR Whitepaper) is as follows:

IGN Payload Innovation

Title: Antibody-drug conjugates (ADCs) of a new class of N-10 amino linked DNA alkylating indolino-benzodiazepines (IGNs) – abstract #224
Date: March 31, 2019
Time: 1:00-5:00 PM ET

In an ongoing effort to further explore the structure-activity relationship of DNA alkylating effector molecules for ADCs, a new class of IGNs has been developed that possesses a self-immolative peptide linker attached at the N-10 amine of the imine-reduced IGN monomer subunit. ADCs with this class of payload displayed potent, antigen-specific in vitro activity across a panel of folate receptor α (FRα)-expressing cell lines.
Title: Antibody-drug conjugates (ADCs) with indolinobenzodiazepine dimer (IGN) payloads: DNA-binding mechanism of IGN catabolites in target cancer cells – abstract #1886
Date: March 31, 2019
Time: 1:00-5:00 PM ET

Investigation of the mechanism of binding of IGN catabolites with DNA in target cancer cells and with model duplex DNA or hairpin oligonucleotides. Both mono-and-di-imine IGN molecules remained bound to genomic DNA even at two days, suggesting a potent interaction with cellular DNA.
Advancement in Platform Linkers and Payloads

Title: Optimizing lysosomal activation of antibody-drug conjugates (ADCs) by incorporation of novel cleavable dipeptide linkers – abstract #0231
Date: March 31, 2019
Time: 1:00-5:00 PM ET

Based on screens of a panel of dipeptide linkers for efficient lysosomal proteolysis, several novel, previously unreported peptide linker designs were identified and incorporated into ADCs bearing a DNA-alkylating IGN payload. Several dipeptide linker designs were superior in rates of lysosomal processing compared to a reference standard L-Ala-L-Ala dipeptide linker.
Title: LC-MS based catabolite identification study of an ADC with DM21-C, a novel maytansinoid linker-payload – abstract #538
Date: March 31, 2019
Time: 1:00-5:00 PM ET

ImmunoGen’s newest ADC design uses the novel maytansinoid linker-payload, DM21-C that bears a peptidase/protease-cleavable linker. The goal of this study was to identify the catabolites generated upon incubation in antigen-positive cancer cells (both cell pellet and media), in mouse plasma, as well as in in vitro catabolic systems. DM51 (the thiol- resulting from self-immolation of the cleaved linker-payload) was identified as a major catabolite of the DM21-C ADC.
Title: Preclinical evaluation of DM21, a next‐generation maytansinoid payload with a stable peptide linker – abstract #3898
Date: April 2, 2019
Time: 1:00-5:00 PM ET

To evaluate the toxicity of DM21 as an ADC, it was conjugated to the non‐targeting, chimeric anti‐soybean trypsin inhibitor antibody (chKTI), and administered to cynomolgus monkeys in two groups with separate dose levels. chKTI‐DM21 was well-tolerated at both doses.
Novel Approaches to ADC Development

Title: Generation of site-specific DARPin drug conjugates using EGFR as a model system – abstract #215
Date: March 31, 2019
Time: 1:00-5:00 PM ET

DARPin molecules are small engineered proteins, derived from natural ankyrin repeat proteins that are selected to bind to specific targets with high affinity. DARPin drug conjugates (DDCs) were developed using a model EGFR multi-specific DARPin molecule, consisting of four DARPin domains linked together. Biophysical characterization showed the DDCs to be well behaved in stability and solubility assays.
Title: Development of a Probody-Drug Conjugate (PDC) targeting EpCAM for the treatment of solid tumors- abstract #1439
Date: March 31, 2019
Time: 1:00-5:00 PM ET

EpCAM is an attractive target for ADC development due to its overexpression on a variety of tumors of epithelial origin; however, EpCAM is also expressed on a variety of normal epithelia, thus limiting its utility as an ADC target due to potential toxicity. We aim to overcome this limitation by developing an EpCAM-targeting Probody drug conjugate (PDC). EpCAM-targeting PDCs were better tolerated than the corresponding EpCAM-targeting ADC even at higher dose levels and displayed longer half-lives and greater exposure.
Title: IMGC936, a first-in-class ADAM9-targeting antibody-drug conjugate, demonstrates promising anti-tumor activity – abstract #5136
Date: April 1, 2019
Time: 8:00 AM-12:00 PM ET

Under a co-development agreement with MacroGenics, it has been shown that ADAM9 is overexpressed in multiple solid tumor indications and that anti-ADAM9 antibodies are efficiently internalized and degraded by tumor cell lines, making ADAM9 an attractive target for ADC development. IMGC936 is the first ADAM9-targeting ADC to enter preclinical development. In vitro studies have demonstrated targeted cytotoxicity of IMGC936 across a panel of ADAM9-positve tumor cell lines with activity at least 2 logs greater than a non-targeting conjugate. Consistent with the activity observed in vitro, an anti-ADAM9-DM21 conjugate displayed compelling anti-tumor activity in multiple xenograft models representing non-small cell lung, gastric and colorectal cancers.
Title: Preclinical evaluation of a new, non-agonist ADC targeting MET-amplified tumors with a peptide-linked maytansinoid – abstract #4817
Date: April 3, 2019
Time: 8:00 AM-12:00 PM ET

cMet is an attractive target for ADCs, which may address the unmet treatment need for patients with tumors harboring MET amplification. To assess potential toxicity due to normal tissue expression, binding of our antibody to normal hepatocytes from humans and cynos was measured. Very low expression and binding versus tumor cell lines were found and demonstrated that the cytotoxic activity of disulfide-cleavable maytansinoid ADCs prepared from the hinge-variant cMet antibody was equivalent to the parental form in in vivo models. These data merit further exploration of this ADC as a novel treatment option for patients with MET-amplified tumors.
Optimizing ADC Dosing

Title: The potential benefit of lower drug-antibody ratio (DAR) on antibody-maytansinoid conjugate in vivo efficacy – abstract #219
Date: March 31, 2019
Time: 1:00-5:00 PM

Describes development of a cross-reactive model system that utilizes a chimeric anti-murine FRα antibody that binds with similar affinity to mouse and human FRα. Using this cross-reactive system, where the target is also expressed in normal tissues, 2.0 DAR conjugates were more efficacious than 3.5 DAR conjugates when dosed at matched payload concentrations in multiple xenograft models, suggesting that lower DAR can be an effective strategy to compensate for target-mediated drug disposition (TMDD).
Title: Utilizing a mouse cross-reactive model system to better understand antibody-drug conjugate pharmacokinetics, biodistribution and efficacy – abstract #229
Date: March 31, 2019
Time: 1:00-5:00 PM ET

Generation of a cross-reactive model system that utilized a chimeric anti-murine FRα antibody that binds both mouse and human FRα and can be conjugated to either maytansinoid or IGN payloads. This model system was predicted to have substantial TMDD due to normal tissue expression of FRα. The results showed that TMDD significantly affected the pharmacokinetics, biodistribution, and activity of the conjugate relative to a non-cross-reactive ADC, with lower ADC doses being more severely impacted than higher doses.
Additional information and full abstracts can be found at www.aacr.org.

On February 27, 2019 Celularity, Inc., a clinical-stage cell therapeutics company developing allogeneic cellular therapies harnessed from human placentas, reported it will present first-ever clinical and pre-clinical results from its comprehensive placental hematopoietic stem cell derived natural killer (PNK) cells oncology program at the 2019 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting being held from March 29 – April 3, 2019 in Atlanta, Georgia (Press release, Celularity, FEB 27, 2019, View Source [SID1234533753]). Investigational PNK-007 is a fully allogeneic, off-the-shelf cell therapy product developed as a potential treatment option for various hematological cancers and solid tumors.

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"Combining the unique biologic properties of placental-derived cells with our proprietary IMPACT cell therapy development platform, Celularity is working to develop next-generation, off-the-shelf immunotherapies that could be safer, more accessible, and more affordable than currently available approaches," said Robert J. Hariri, M.D., Ph.D., Celularity’s Founder, Chairman and CEO. "These data are an important and validating milestone of our IMPACT platform. We believe the emergent positive profile marks the unveiling of a potential new immuno-oncology option, one capable of turning cells from this abundant, highly scalable and versatile source—the placenta leftover after a healthy birth—into meaningful therapies for patients with cancer and other serious diseases."

Data highlights at AACR (Free AACR Whitepaper) include:

Presentation (Abstract #CT108): A Phase I study of PNK‐007, allogeneic, off the shelf NK cell, post autologous transplant in multiple myeloma. Monday, April 1, 1:00pm – 5:00pm EST. Location: Georgia World Congress Center, Exhibit Hall B, Poster Board Number 7.

Presentation (Abstract #CT079): A Phase 1 Study of PNK-007, Allogeneic, Off the Shelf NK Cell in Relapsed/Refractory AML. Monday, April 1, 1:00pm – 5:00pm EST. Location: Georgia World Congress Center, Exhibit Hall B, Poster Board Number 3.

Poster Presentation (Abstract #LB-070): Immune monitoring of PNK-007, an allogeneic, off the shelf NK cell in a Phase I study of acute myeloid leukemia. W. van der Touw, Ph.D. Monday, April 1, 8:00am – 12:00pm EST. Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 41, Poster Board Number 15.

Oral Presentation (Abstract #5318): Genetic modification potentiates the anti-tumor activity of human placental CD34+ cells-derived NK cells. J. Li, Ph.D. Sunday, March 31, 3:00pm – 5:00pm EST. Location: Georgia World Congress Center, Room B405.

About PNK-007

PNK‐007 is the only allogeneic, off-the-shelf NK cell therapy being developed from placental hematopoietic stem cells as a potential treatment option for various hematological cancers and solid tumors. NK cells are a unique class of immune cells, innately capable of targeting cancer cells and interacting with adaptive immunity. When derived from the placenta, these cells offer intrinsic safety and versatility, allowing potential use across a range of organs and tissues. PNK cells are currently being investigated for patients with acute myeloid leukemia (AML) and multiple myeloma (MM).

On February 27, 2019 ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically-targeted therapies for cardiovascular diseases, reported financial results for the year ended December 31, 2018 and provided a corporate update (Press release, Arca biopharma, FEB 27, 2019, View Source [SID1234533785]).

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"During 2018, we continued to make progress on our lead development program as we: reported Phase 2B results for the GENETIC-AF trial; designed a Phase 3 development plan based on learnings from those results; identified a clear regulatory path; and, began discussions with the FDA to confirm agreement on future development of Gencaro, potentially the first genetically-targeted cardiovascular therapeutic," commented Dr. Michael Bristow, ARCA’s President and Chief Executive Officer. "With the Gencaro FDA SPA agreement now in place, 2019 will be an important year for ARCA as we work towards the initiation of the Phase 3 clinical trial and expand development activities for AB171, a potential genetically-targeted treatment for heart failure and peripheral arterial disease."

Pipeline Update

GencaroTM (bucindolol hydrochloride) – a pharmacologically unique beta-blocker and mild vasodilator being developed as a potential genetically-targeted treatment for atrial fibrillation (AF) in patients with heart failure (HF).

In February 2019, ARCA received a Special Protocol – Agreement Letter from the U.S. Food and Drug Administration (FDA) on its Special Protocol Assessment (SPA) application for the Phase 3 PRECISION-AF clinical trial.

– PRECISION-AF is designed as a double-blind, active-controlled, multicenter, international study comparing Gencaro with Toprol-XL (metoprolol succinate) for the prevention of AF recurrence or all-cause mortality (ACM) in HF patients with mid-range ejection fraction (HFmrEF).

– Subject to securing additional financing, ARCA anticipates initiating PRECISION-AF in the fourth quarter of 2019.
AB171 – a thiol-substituted isosorbide mononitrate being developed as a potential genetically-targeted treatment for heart failure (HF) and peripheral arterial disease (PAD).

Chemistry, manufacturing and controls (CMC) activities were continued in the fourth quarter.
IND-enabling non-clinical studies are anticipated to begin in the second half of 2019.
IND submission anticipated in the first quarter of 2020.
2018 Summary Financial Results

Cash, cash equivalents and marketable securities were $6.6 million as of December 31, 2018, compared to $11.8 million as of December 31, 2017. ARCA believes that its current cash, cash equivalents and marketable securities will be sufficient to fund its operations, at its projected cost structure, through the end of the third quarter of 2019.

Research and development (R&D) expenses for the year ended December 31, 2018 were $4.2 million compared to $14.1 million for 2017. The $9.8 million decrease in R&D expenses in 2018 as compared to 2017 was primarily due to decreased clinical expenses following the completion of the GENETIC-AF clinical trial in 2017.

General and administrative (G&A) expenses for the year ended December 31, 2018 were $3.9 million compared to $4.6 million in 2017. The Company expects G&A expenses in 2019 to be consistent with those in 2018 as it maintains administrative activities to support our ongoing operations.

Total operating expenses for 2018 were $8.1 million compared to $18.7 million during 2017. The decrease in total operating expenses in 2018 was primarily due to the decrease in R&D expense due to the completion of the GENETIC-AF clinical trial.

Net loss was $7.9 million, or $0.57 per share, for 2018 compared to $18.5 million, or $1.77 per share, for 2017.