On March 19, 2019 Context Therapeutics, a clinical-stage biotechnology company focused on hormone driven cancers, reported it will present at the following upcoming investor conferences (Press release, Context Therapeutics, MAR 19, 2019, View Source [SID1234534482]).

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Needham and Company 18th Annual Health Care Conference in New York City on Tuesday, April 9, 2019 at 2:30 p.m. ET.

On March 19, 2019 VBL Therapeutics (Nasdaq: VBLT), reported the presentation of human data indicating that the viral anti-cancer investigational therapy VB-111 has potential to stimulate the immune system to induce a strong and durable response against ovarian tumors (Press release, VBL Therapeutics, MAR 19, 2019, View Source [SID1234534461]). Administration of VB-111 was associated with an infiltration of immune cells within the tumor, which was followed by tumor necrosis and sustained clinical response. VBL’s study entitled "VB-111, an anti-cancer gene therapy, induces immunotherapeutic effect in platinum resistant ovarian cancer" was presented last evening at the SGO 50th Annual Meeting on Women’s Cancer at the Hawaii Convention Center in Honolulu, Hawaii. The presentation was delivered by Dr. Ronnie Shapira-Frommer from Sheba Medical Center, Tel Aviv and Dr. Richard Penson from Massachusetts General Hospital, Boston.

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Ofranergene obadenovec (VB-111) is a targeted anti-cancer investigational gene therapy with a dual mechanism: disruption of the tumor vasculature and induction of an anti-tumor directed immune response. In a Phase 2 clinical trial, VB-111 in combination with chemotherapy (paclitaxel) prolonged survival in patients with recurrent platinum resistant ovarian cancer (median OS 498 days for therapeutic dose VB-111 + paclitaxel combination therapy, compared to 172 days for low dose VB-111 + paclitaxel (p=0.03)). OVAL, VBL’s ongoing pivotal Phase 3 trial, is designed to repeat the successful Phase 2 protocol, with the primary endpoint of improvement in overall survival. An interim analysis of the OVAL study is expected at year-end 2019.

"Cancer cells utilize various mechanisms to proliferate and survive, including silencing of, and escape from, the immune system. We believe that treatment strategies should therefore aim both to target the cancer cells and to stimulate the immune system to attack the tumor," said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. "While we initially designed VB-111 as anti-tumor therapy targeting tumor blood supply, it is now evident that VB-111 can also drive immune cells into immunologically `cold` tumors turning the tumors ‘hot,` enabling the immune system to fight the tumor. These clinical findings provide encouraging evidence of the therapeutic potential of VB-111, as we continue to advance our clinical program in ovarian cancer and additional indications."

For a link to VBL’s poster at the SGO 50th Annual Meeting on Women’s Cancer refer to: SGO Poster

About Ofranergene Obadenovec (VB-111)
VB-111, a potential first-in-class anticancer therapeutic candidate, is the Company’s lead oncology product currently being studied in the OVAL potential-registration Phase 3 pivotal trial for ovarian cancer (ClinicalTrials.gov Identifier: NCT03398655). VB-111 has received orphan drug designation in both the US and Europe, and fast track designation in the US for prolongation of survival in patients with rGBM. In addition, VB-111 successfully demonstrated proof-of-concept and survival benefit in Phase 2 clinical trials in radioiodine-refractory thyroid cancer and recurrent platinum-resistant ovarian cancer (NCT01711970). VB-111 has received an Orphan Designation for the treatment of ovarian cancer from the European Commission.

On March 19, 2019 Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP) ("Aurinia" or the "Company") reported its financial results for the fourth quarter and year ended December 31, 2018 (Press release, Aurinia Pharmaceuticals, MAR 19, 2019, View Source [SID1234534506]). Amounts, unless specified otherwise, are expressed in U.S. dollars.

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2018 and Recent Highlights

Notice of Allowance from the United States Patent and Trademark Office ("USPTO") for claims which have the potential to cover voclosporin’s method of use and dosing protocol for lupus nephritis ("LN’) until December 2037.
Phase 2a Dry Eye Study results released in January 2019 demonstrating statistically superior efficacy of voclosporin ophthalmic solution ("VOS") versus Restasis.
AURORA Phase 3 trial in LN completed patient enrollment, ahead of schedule, in September 2018 – on track for top-line data in late 2019.
Phase 2 FSGS study with voclosporin initiated in June 2018 with patient recruitment ongoing.
Cash, cash equivalents, and short-term investments of $125.9 million as of December 31, 2018.
Balance sheet strengthened with additional $30 million raised through ATM facility during Q1 2019.
"The team at Aurinia has made extraordinary progress throughout 2018 by achieving a number of significant clinical milestones with voclosporin, and we are excited for what lies ahead in 2019. In addition to completing enrollment in the AURORA Phase 3 trial ahead of schedule last September, we also released Phase 2a dry eye study results with VOS that we believe further demonstrate the potential of voclosporin", commented Richard M. Glickman, Chief Executive Officer and Chairman of the Board of Aurinia Pharmaceuticals."

Dr. Glickman further commented, "With the recent Notice of Allowance we received from the USPTO for claims covering voclosporin’s method of use and dosing protocol for the treatment of proteinuric kidney diseases including LN, we are very pleased with the additional exclusivity that could extend to December 2037 which I believe provides additional value creating opportunities for our shareholders.

Highlights

USPTO Notice of Allowance

On February 25, 2019, Aurinia announced that it received a Notice of Allowance from the USPTO for claims directed at its novel voclosporin dosing protocol for LN (U.S. patent application 15/835,219, entitled "PROTOCOL FOR TREATMENT OF LUPUS NEPHRITIS").

The allowed claims broadly cover the novel voclosporin individualized flat-dosed pharmacodynamic treatment protocol adhered to and required in both the previously reported Phase 2 AURA-LV trial and the Company’s ongoing Phase 3 confirmatory AURORA trial. Notably, the allowed claims cover a method of modifying the dose of voclosporin in patients with LN based on patient specific pharmacodynamic parameters.

This Notice of Allowance concludes a substantive examination of the patent application at the USPTO, and after administrative processes are completed and fees are paid, is expected to result in the issuance of a U.S. patent with a term extending to December 2037. If the FDA approves the use of voclosporin for LN and the label for such use follows the dosing protocol under the Notice of Allowance, the issuance of this patent will expand the scope of intellectual property protection for voclosporin, which already includes robust manufacturing, formulation, synthesis and composition of matter patents.

AURORA LN Clinical Trials

Aurinia’s Phase 3 clinical trial ("AURORA") is evaluating voclosporin for the treatment of LN, which was initiated in May of 2017, completed enrollment in September 2018. The target enrolment of 324 patients was surpassed due to high patient and investigator demand with 358 LN patients randomized in sites across 27 countries. Top-line data is expected to be available in Q4 2019.

A significant percentage of patients who have completed the AURORA trial are rolling over into the AURORA blinded extension trial ("AURORA 2"). The purpose of AURORA 2 is to assess the long-term benefit/risk of voclosporin in patients with LN; this trial is not a requirement for potential regulatory approval of voclosporin.

Dry Eye Syndrome ("DES")

In July 2018, Aurinia initiated a Phase 2a head-to-head study of voclosporin ophthalmic solution ("VOS") versus Restasis (cyclosporine ophthalmic emulsion) 0.05% for the treatment of moderate to severe DES. This four-week study enrolled a total of 100 patients.

In January 2019 the Company announced results from this study. The study evaluated efficacy, safety and tolerability head to head with Restasis.

VOS showed statistical superiority to Restasis on FDA-accepted objective signs of DES
42.9% of VOS subjects vs 18.4% of Restasis subjects (p=0.0055) demonstrated ≥ 10mm improvement in Schirmer Tear Test ("STT") at Week 4
VOS showed statistical superiority to Restasis in Fluorescein Corneal Staining ("FCS") (p=0.0003)
The primary endpoint of drop discomfort at 1-minute on the first day of therapy showed no statistical difference between the treatment groups, as both groups exhibited low drop discomfort scores
With respect to the primary endpoint of drop discomfort, VOS did not meet the primary endpoint as both drugs were well tolerated and demonstrated less than anticipated drop discomfort. However, secondary outcome measures on efficacy, namely the STT and FCS, demonstrated statistically superior results over Restasis.

Focal Segmental Glomerulosclerosis ("FSGS")

Aurinia initiated a Phase 2 proof-of-concept study for FSGS in June 2018 and is currently in the process of enrolling patients with this disease. This proof-of-concept Phase 2 open-label study aims to enroll approximately 20 treatment-naïve patients diagnosed with primary FSGS.

Financial Liquidity at December 31, 2018

At December 31, 2018, Aurinia had cash, cash equivalents and short-term investments of $125.9 million compared to $173.5 million of cash and short-term investments at December 31, 2017. Net cash used in operating activities was $51.6 million for the year ended December 31, 2018, compared to $41.2 million for the year ended December 31, 2017.

At-The-Market ("ATM") Facility

On November 30, 2018, Aurinia entered into an open market sale agreement with Jefferies LLC pursuant to which the Company could from time to time sell, through ATM offerings, common shares that would have an aggregate offering amount of up to $30 million. Subsequent to year-end, the ATM was fully utilized. Aurinia received gross proceeds of $30 million and issued 4.6 million common shares. The Company incurred share issue costs of $1.2 million including a 3% commission and professional and filing fees related to the ATM offering.

February 14, 2014 Warrant Exercises

The derivative warrants outstanding related to the February 14, 2014 private placement offering were exercised subsequent to December 31, 2018. Certain holders of these warrants elected the cashless exercise option and the Company issued 687,000 common shares on the cashless exercise of 1.3 million warrants. Three holders of 464,000 warrants exercised these warrants for cash, at a price of $3.2204. We received cash proceeds of $1.5 million and issued 464,000 common shares.

The Company believes, based on its current plans that Aurinia has sufficient financial resources to fund the existing LN program, including the AURORA trial and the AURORA 2 extension trial, complete the NDA submission to the FDA, conduct the ongoing Phase 2 study for FSGS, commence additional DES studies and fund operations into mid-2020.

Financial Results for the Fourth Quarter Ended December 31, 2018

The Company reported a consolidated net loss of $14.6 million or $0.17 per common share for the fourth quarter ended December 31, 2018, as compared to a consolidated net loss of $3.3 million or $0.04 per common share for the fourth quarter ended December 31, 2017.

The loss for the fourth quarter ended December 31, 2018 reflected an increase of $593,000 in the estimated fair value of derivative warrant liabilities compared to a reduction of $9.0 million in the estimated fair value of derivative warrant liabilities for the fourth quarter ended December 31, 2017.

The net loss before this non-cash change in estimated fair value of derivative warrant liabilities was $13.9 million for the fourth quarter ended December 31, 2018 compared to $12.3 million for the same period in 2017.

Research and development ("R&D") expenses increased to $10.8 million in the fourth quarter of 2018, compared to $8.7 million in the fourth quarter of 2017. The increase in these expenses primarily reflected costs incurred for the AURORA 2 extension trial, the DDI study and the FSGS and DES Phase 2 studies which were newly enrolled studies in 2018.

Corporate, administration and business development expenses increased to $3.5 million for the fourth quarter of 2018, compared to $3.1 million for the fourth quarter of 2017, reflecting higher professional fees incurred during the fourth quarter of 2018.

Financial Results for the Year Ended December 31, 2018

For the year ended December 31, 2018, Aurinia recorded a consolidated net loss of $64.1 million or $0.76 per common share, which included a non-cash increase of $10.0 million related to the estimated fair value annual adjustment of derivative warrant liabilities at December 31, 2018. After adjusting for this non-cash impact, the net loss before this change in estimated fair value of derivative warrant liabilities was $54.1 million.

This compared to a consolidated net loss of $70.8 million or $0.92 per common share in 2017, which included a non-cash increase of $23.9 million in the estimated fair value of derivative warrant liabilities for the year ended December 31, 2017. After adjusting for this non-cash impact for 2017, the net loss before this change in estimated fair value of derivative warrant liabilities was $46.9 million.

The change in the revaluation of the derivative warrant liabilities is primarily driven by the change in our share price. Our share price of $6.82 was significantly higher at December 31, 2018, compared to our share price of $4.53 at December 31, 2017. This increase in our share price resulted in large increases in the estimated fair value of derivative warrant liabilities for each of 2018 and 2017. The derivative warrant liabilities will ultimately be eliminated on the exercise or forfeiture of the warrants and will not result in any cash outlay by Aurinia.

We incurred R&D expenses of $41.4 million for the year ended December 31, 2018, as compared to $33.9 million for the year ended December 31, 2017. The increase in R&D expenses in 2018 primarily reflected costs related to the AURORA 2 extension trial, the DDI study and the FSGS and DES Phase 2 studies.

We incurred corporate, administration and business development expenses of $13.7 million for the year ended December 31, 2018, as compared with $12.1 million for the same period in fiscal 2017. The increase in these expenses reflected higher corporate activity levels overall, and higher personnel compensation costs which included a non-cash stock compensation expense of $4.2 million for the year ended December 31, 2018, compared to $3.2 million for the year ended December 31, 2017.

The audited financial statements and the Management’s Discussion and Analysis for the year ended December 31, 2018, are accessible on Aurinia’s website at www.auriniapharma.com, on SEDAR at www.sedar.com or on EDGAR at www.sec.gov/edgar.

Aurinia will host a conference call and webcast to discuss the fourth quarter and year ended December 31, 2018 financial results today, Tuesday, March 19, 2019 at 4:30 p.m. ET. This event can be accessed on the investor section of the Aurinia website at www.auriniapharma.com.

On March 19, 2019 DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for kidney diseases and neurological disorders, reported its financial results for the year ended December 31, 2018 (Press release, DiaMedica, MAR 19, 2019, View Source [SID1234534492]).

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Business Highlights

"In the past year, DiaMedica has achieved important development goals for our two lead programs, DM199 for chronic kidney disease and acute ischemic stroke. We expect to build upon this success in 2019 as we work toward advancing our pipeline of clinical programs, which hold the potential to have significant impact on patients suffering from chronic kidney disease and acute ischemic stroke," stated Rick Pauls, DiaMedica’s President and CEO. "After our successful Nasdaq IPO in December, we have sufficient capital to obtain Phase II read-outs in our two lead programs. We are well positioned to execute on our clinical development plans to achieve meaningful milestones in the next year, and we look forward to sharing our progress."

U.S. IPO, Nasdaq Uplisting and U.S. Reporting Company

On December 6, 2018, DiaMedica completed an initial public offering ("IPO") of its common shares in the United States and uplisted to the Nasdaq Capital Market, raising $16.4 million in gross proceeds and $14.7 million in net proceeds. This was an important milestone for DiaMedica that expanded its investor base, adding several U.S. institutional investors, and strengthened its balance sheet. The IPO also provided the capital to complete Phase II clinical trials for DM199 in patients suffering acute ischemic strokes ("AIS") and chronic kidney disease ("CKD").

License of DM199 with Ahon Pharma, subsidiary of Fosun Pharma.

In September 2018, DiaMedica signed a license and collaboration agreement with Fosun Pharma’s Ahon Pharma subsidiary for acute ischemic stroke in China. Fosun is one of the largest Chinese pharmaceutical firms with an extensive hospital sales force. The agreement provides exclusive rights to clinically develop and commercialize DM199 solely for acute ischemic stroke in China, Taiwan, Hong Kong and Macau. Under the terms of the agreement, DiaMedica may receive approximately $32 million in milestone payments, plus sales-based royalties of up to approximately 10%. In addition, DiaMedica has retained full control over the manufacturing of DM199. Ahon Pharma is currently preparing an application for an investigational new drug application to the China National Medical Products Administration. In China, a form of the KLK1 protein extracted from human urine, known as u-KLK1 or Kailikang, has been approved and is considered a standard of care for AIS patients.

Clinical Developments

DM199 for the Treatment of Chronic Kidney Disease

Enrolling Patients in Phase Ib Clinical Study in Patients with CKD

In December 2018, the United States Food & Drug Administration ("FDA") accepted DiaMedica’s investigational new drug ("IND") application to study DM199 in patients with CKD. In February 2019, the Company began enrolling patients in its Phase Ib clinical study, which is being conducted at 3 sites in the U.S. and all sites are actively enrolling patients. The open label clinical trial is evaluating three dose levels of DM199, administered in a single subcutaneous ("SC") dose, in 32 patients with moderate or severe CKD. Primary endpoints include safety, tolerability, pharmacokinetics, change in KLK1 levels, albumin to creatine ratios and kidney biomarkers measured over a 12-day period. This study is intended to assist in identifying dose levels for use in subsequent Phase II trials. The Company expects a readout on the results of the CKD study in mid-2019.

Released Chronic Kidney Disease White Paper

Today, DiaMedica also released a white paper that further details the potential of KLK1/DM199 to treat patients with chronic kidney disease. The paper can be accessed at www.diamedica.com/product-candidates/chronic-kidney-disease.

DiaMedica is currently planning a randomized Phase II study in patients with rare forms of chronic kidney disease to be initiated in the second half of 2019. The Company will have updates on the rare forms to be targeted in this study and other details to follow.

DM199 for the Treatment of Acute Ischemic Stroke

DM199 Acute Ischemic Stroke Phase II "REMEDY" Trial Update.

In 2018, the Company initiated treatment of patients in its Phase II randomized, double-blind, placebo-controlled multi-center evaluation to assess the safety, tolerability and markers of DM199 in acute ischemic stroke patients, the REMEDY trial. With the success of its IPO, DiaMedica raised its target enrollment in the REMEDY trial from 60 to approximately 100 patients to provide additional data to support the design of a robust and efficient Phase III study. In this trial, the study drug (DM199 or placebo) is administered as an intravenous ("IV") infusion within 24 hours of stroke symptom onset, followed by SC injections later that day and once every 3 days for 21 days (8 SC doses). Multiple plasma-based biomarkers (e.g. C-reactive protein), the Modified Rankin Scale, National Institutes of Health Stroke Scale and the Barthel Index will be assessed at multiple points throughout the study, including 90 days post-stroke. This study will also include multiple tests to investigate DM199’s therapeutic potential. With the increase in the enrollment target, the Company expects to complete this trial in the fourth quarter of 2019 or first quarter of 2020.

AIS Review Paper Supporting the Use of DM199 for AIS Published in Peer-Reviewed Journal

On January 22, 2019, DiaMedica announced that a manuscript titled "Human Tissue Kallikrein in the Treatment of Acute Ischemic Stroke" was published in the peer-reviewed medical journal "Therapeutic Advances in Neurological Disorders (TAND)." The paper reviews the scientific literature covering the biochemical role of KLK1 and presents the mechanistic rationale for using KLK1 as an additional pharmacological treatment for AIS. In addition to the biochemical mechanism of KLK1, the paper highlights supporting results from human genetics and preclinical animal models of brain ischemia. It also reviews published clinical results for treatment of AIS by a form of KLK1 that is isolated from human urine. This form has been approved for post-infarct treatment of AIS in China and data has been published on clinical trials involving over 4,000 patients. The paper offers a series of testable therapeutic hypotheses for demonstrating the long-term beneficial effect of KLK1 treatment in AIS patients and the reasons for this action.

Financial Results

License revenue for 2018 was comprised of the initial $500,000 license payment DiaMedica received in connection with the license and collaboration agreement with Ahon Pharma.

Research and development expenses were $4.5 million for the year ended December 31, 2018 compared to $3.2 million for the year ended December 31, 2017, an increase of $1.3 million. The increase was primarily due to the additional preclinical testing and related costs required to support an application for an investigational new drug application in the United States, higher study costs for the REMEDY Phase II stroke study as compared with the DM199 bridging study which was substantially completed in 2017, and increased personnel and non-cash stock-based compensation costs.

General and administrative expenses were $2.7 million for the year ended December 31, 2018 compared to $1.3 million for the year ended December 31, 2017. General and administrative costs increased due to one-time costs incurred associated with the Company’s planned IPO in the United States, primarily the Nasdaq listing process and related legal and accounting fees. Higher salaries, fees and short-term benefits due to the addition of staff and higher share-based compensation also contributed to the increase during 2018.

Other income, net, was $1.1 million for the year ended December 31, 2018 compared to $259,000 for 2017. The increase resulted primarily from the recognition of the research and development incentive from the Australia Government paid for qualifying research work performed by DiaMedica Australia. This increase was partially offset by increased foreign currency transaction losses.

Balance Sheet and Cash Flow

Total cash resources were $16.8 million as of December 31, 2018, compared to $1.4 million as of December 31, 2017. Total current assets were $18.0 million and $1.5 million as of December 31, 2018 and December 31, 2017, respectively. These increases resulted primarily from net proceeds of $20.6 million received from the sale of common shares and warrants during 2018, partially offset by the use of cash to fund operations in the current year,

Current liabilities increased to $1.3 million as of December 31, 2018, compared to $1.0 million as of December 31, 2017. The increase in current liabilities resulted primarily from the increase in costs accrued related to clinical trials.

Net cash used in operating activities was $5.7 million for the year ended December 31, 2018, up from $3.9 million for the year ended December 31, 2017. The net cash used in each of these periods primarily reflects the net loss for these periods, and was partially offset by non-cash charges for stock-based compensation and the net effects of changes in operating assets and liabilities.

Conference Call Information

DiaMedica management will host a conference call to discuss these results on Wednesday March 20, 2019, at 8:00 a.m. Central Time:

Date:

Wednesday, March 20, 2019

Time:

8:00 AM CT

Web access:

View Source

Dial In:

(866) 962-3583 (domestic)

(630) 652-5857 (international)

Conference ID:

6773627

Listeners should log on to the website or dial in 15 minutes prior to the call. The webcast will remain available for play back on our website, under investor events and presentations, following the earnings call and for 12 months thereafter. A telephonic replay of the conference call will be available until March 28, 2019, by dialing 1(855) 859-2056 (US Toll Free Dial In), (404) 537-3406 (international), replay passcode 6773627.

About DM199

DM199 is a recombinant (synthetic) form of the human serine protease, KLK1. The KLK1 protein plays an important role in the regulation of diverse physiological processes including blood flow, inflammation, fibrosis, oxidative stress and neurogenesis via a molecular mechanism that increases production of nitric oxide and prostacyclin. KLK1 deficiency may play a role in multiple vascular and fibrotic diseases such as chronic kidney disease, retinopathy, stroke, vascular dementia, and resistant hypertension where current treatment options are limited or ineffective. DiaMedica is the first company to have developed a recombinant form of the KLK1 protein. The KLK1 protein, produced from porcine pancreas and human urine, has been used to treat patients in Japan, China and Korea for decades. DM199 is currently being studied in patients with acute ischemic stroke and patients with chronic kidney disease.

On March 18, 2019 Leap Therapeutics, Inc. (Nasdaq:LPTX) reported the presentation of clinical data from its ongoing Phase 2 clinical trial of DKN-01 in patients with advanced gynecological malignancies at the Society of Gynecologic Oncology 50th Annual Meeting on Women’s Cancer (Press release, Leap Therapeutics, MAR 18, 2019, View Source [SID1234534414]). Patients, including those with carcinosarcoma and Wnt pathway alterations, have experienced partial responses and durable clinical benefit in both the monotherapy and combination arms of the study. The complete data set will become available in the coming months as the most recently enrolled patients have yet to be evaluated. The complete poster is available on Leap’s website at View Source

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"We are very pleased with the single agent and combination activity of DKN-01 in this heavily pre-treated population. Allowing patients to achieve partial responses and durable stable disease with a favorable safety profile reflects meaningful clinical benefit," commented Rebecca C. Arend, M.D., Ph.D., Department of Obstetrics and Gynecology at the University of Alabama at Birmingham School of Medicine. "With the rapid enrollment of this study since the beginning of the year, we are looking forward to robust data maturing during the year."

"It is encouraging to see the mechanism-based strategy of enriching the study with patients with Wnt pathway alterations lead to impressive clinical outcomes," commented Michael Birrer, M.D., Ph.D., Director of the Comprehensive Cancer Center at the University of Alabama at Birmingham. "We are also particularly interested in the early activity in carcinosarcoma patients, who are in need of new and better treatment options."

· DKN-01 single agent partial response: Twenty-one patients (who had previously received one to ten lines of therapy) have been enrolled in two monotherapy arms of the study. Twelve patients are currently evaluable. One patient has experienced a partial response (PR), and six patients have had stable disease (SD) for greater than six weeks. Seven patients have been recently enrolled and have not yet had their first imaging assessment. This study marks the third different tumor type where DKN-01 has had single agent activity.

·Partial response and tumor reductions in DKN-01/Paclitaxel combination: Forty-one patients (who had previously received one to nine lines of prior therapy) have been enrolled in two combination arms of the study. Twenty-one patients are currently evaluable. One patient has experienced a PR, and fifteen patients have had SD for greater than six weeks. Thirteen patients have been recently enrolled and have not yet had their first imaging assessment.

·Patients whose tumors had confirmed Wnt pathway alterations experienced a greater duration of clinical benefit: In eight evaluable monotherapy patients with confirmed Wnt pathway alterations, one patient has experienced a PR and four have had SD. In the fourteen evaluable combination therapy patients, one patient has experienced a PR and seven have had SD. The patient with a partial response on DKN-01 combination therapy has a tumor with a CTNNB1 mutation. Tumor CTNNB1 mutations stabilize the transcription factor beta-catenin and are correlated with increased levels of DKK1 and poor clinical outcomes. In this study, eight CTNNB1 patients are evaluable, and six experienced clinical benefit.

· Carcinosarcoma partial response leads to new expansion cohort at higher dose: Carcinosarcoma is a rare and difficult-to-treat form of uterine cancer. Four carcinosarcoma patients have been enrolled, and the three evaluable patients had tumor reductions and one experienced a PR. To explore a new treatment option for these patients, the Company will expand the study and provide a higher dose of DKN-01 as a monotherapy and in combination with paclitaxel.

About P204

The P204 study is a Phase 2 basket study evaluating DKN-01 as a monotherapy and in combination with paclitaxel in patients with relapsed/refractory endometrioid endometrial cancer (EEC) or endometrioid ovarian cancer (EOC). The study contains four groups and is designed to evaluate the efficacy, safety, and pharmacodynamics of DKN-01 monotherapy and combination therapy in both EEC and EOC, with each group following a 2-stage Simon Minimax design. The study will enroll approximately 94 patients, of which approximately 50% will be required to have documented activating mutations of beta-catenin or other Wnt signaling alterations.

About DKN-01

DKN-01 is a humanized monoclonal antibody that binds to and blocks the activity of the Dickkopf-1 (DKK1) protein, a modulator of Wnt/Beta-catenin signaling, a signaling pathway frequently implicated in tumorigenesis and suppressing the immune system. DKK1 has an important role in tumor cell signaling and in mediating an immuno-suppressive tumor microenvironment through enhancing the activity of myeloid-derived suppressor cells and downregulating NK ligands on tumor cells.