On March 6, 2019 LIDDS AB reported that the last patient has been enrolled in LIDDS Phase IIb study for the localized treatment of prostate cancer (Press release, Lidds, MAR 6, 2019, View Source [SID1234555910]). The Phase IIb study will identify the optimal dose for Phase III and test the safety of Liproca Depot and its effectiveness in stopping cancer progression. Liproca Depot is based on LIDDS unique NanoZolid drug delivery technology.

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-We are very pleased that patient recruitment is now finalized and we look forward to concluding the study and receiving the results in third quarter this year, says Monica Wallter, CEO.

-We expect this study to show that by injecting Liproca Depot directly into the tumor, prostate cancer progression can be stopped and patients can avoid radical surgery and radiation therapy which are associated with side effects such as sexual dysfunction and incontinence, says Monica Wallter.

-A large prostate cancer patient group is currently not receiving any treatment and Liproca Depot has the potential to provide a new treatment regimen that will benefit healthcare providers and prostate cancer sufferers in a market worth over USD 9 billion annually, says Monica Wallter.

The Phase IIb study for Liproca Depot includes 60 patients and is being conducted at major urology clinics in Canada, Finland and Lithuania.

LIDDS has already signed an exclusive licensing agreement for Liproca Depot in China with the Puheng Jiangxi pharmaceutical company. Preparations are ongoing in China for a Phase III clinical study that will be fully funded by the Chinese licensee. Prostate cancer is a very common disease in China and around 500 000 patients are diagnosed each year.

-We look forward to continuing our dialogue with major pharmaceutical companies on out-licensing Liproca Depot in the US, Europe and the rest of the world. With more than USD 3 billion currently being spent each year on localized prostate cancer treatment, Liproca Depot can offer a new regimen that benefits patients, healthcare providers and pharmaceutical companies, says Monica Wallter.

About the study:
The study (LPC-004) consists of two parts. The first part of the study is evaluating the tolerability and safety of substantially higher doses of the anti-androgen 2-HOF (2-hydroxyflutamide) compared to earlier Phase II studies with Liproca Depot. In the second part, consisting of 40 patients, LIDDS will receive efficacy results measured with the biomarker PSA, prostate volume, MRI data and Quality of Life reports.

In the study, patients diagnosed with a localized non-aggressive prostate cancer received intra-prostatic injections of Liproca Depot containing NanoZolid and the anti-androgen drug 2-HOF. All participating subjects were defined as "Active Surveillance" patients, not chosen for surgery or radiation therapy. Patients are being followed for six months to assess the anti-androgen response and cancer control.

On March 6, 2019 Castle Biosciences, Inc., a skin cancer diagnostics company providing personalized genomic information to improve cancer management decisions, reported publication of an independent, prospective study of patients with Stage IB and II cutaneous melanoma showing that the DecisionDx-Melanoma gene expression profile (GEP) test accurately identifies risk of melanoma recurrence (Press release, Castle Biosciences, MAR 6, 2019, View Source [SID1234535089]). The study was published in the Journal of the European Academy of Dermatology and Venereology. Results are consistent with the eight previously published prospective and retrospective performance studies showing the clinical value of the DecisionDx-Melanoma test to predict patient outcomes, which can help inform management decisions.

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Study Details:

A total of 86 patients diagnosed with cutaneous melanoma between April 2015 and December 2016 were prospectively enrolled across five tertiary melanoma referral centers in Spain.
Patients received the DecisionDx-Melanoma test as part of their initial work-up.
Median age was 59.2 years, mean tumor Breslow thickness was 2.5 mm and 70% of patients did not have ulcerated tumors.
62 patients (72%) had American Joint Committee on Cancer (AJCC 7th edition) Stage IB/IIA melanoma (considered "low risk"), and 24 patients (28%) had Stage IIB/C melanoma. Patients who had a positive sentinel lymph node biopsy result were excluded.
Overall median follow-up time was 26 months.
Key Results:

53 patients had a Class 1 (low risk) DecisionDx-Melanoma test result; 33 patients were Class 2 (high risk).
All 7 patients who experienced a recurrence were Class 2; no Class 1 patients experienced a recurrence (p<0.001). Two of the patients who experienced a recurrence were classified as low risk by AJCC staging but high risk (Class 2) by their DecisionDx-Melanoma test result.
Disease-free survival rate was significantly higher for patients with a Class 1 test result compared to those with a Class 2 result based on Kaplan-Meier survival curve analysis (p<0.001).
When AJCC staging was combined with the DecisionDx-Melanoma test result, the significant difference in disease-free survival between Class 1 and Class 2 results was maintained (p=0.001).
Multivariate analysis that included age and AJCC staging showed the DecisionDx-Melanoma test result to be an independent predictor of recurrence (Class 2 hazard ratio=18.82, p=0.01).
"For patients with early stage melanoma, this prospective, multicenter study shows that the DecisionDx-Melanoma test can accurately predict risk of recurrence both independently and when combined with traditional AJCC staging factors," commented Sebastian Podlipnik, M.D., Hospital Clinic of Barcelona, University of Barcelona, Spain. "These results are consistent with previous retrospective and prospective studies, and show that the DecisionDx-Melanoma test can improve identification of high-risk patients and inform decisions on surveillance and follow-up strategies."

The full published study results can be accessed at the journal’s website.

About DecisionDx-Melanoma

DecisionDx-Melanoma is a gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node positivity, independent of traditional staging factors and has been studied in over 2,900 patients. Using tissue from the primary melanoma, the test measures the expression of 31 genes. The test has been validated in three multicenter studies that have included 690 patients and have demonstrated consistent results. Performance has also been confirmed in five prospective studies including over 780 patients. The consistent high performance and accuracy demonstrated in these studies, which combined have included over 1,470 patients, provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results.

Prediction of the likelihood of sentinel lymph node positivity has also been validated in two prospective multicenter studies that included over 1,400 patients. Impact on patient management plans for one of every two patients tested has been demonstrated in multicenter and single-center studies. More information about the test and disease can be found at www.SkinMelanoma.com.

On March 6, 2019 Exact Sciences Corporation (NASDAQ: EXAS) reported that it has priced its underwritten public offering of 0.3750% convertible senior notes due 2027 (the "Notes") and upsized the offering from $600 million to $650 million aggregate principal amount (Press release, Exact Sciences, MAR 6, 2019, View Source [SID1234534175]). The Company has granted the underwriter a 30-day option to purchase up to an additional $97.5 million aggregate principal amount of the Notes solely to cover over-allotments, if any.

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The Notes will be senior unsecured obligations of the Company and will bear interest at a rate of 0.3750% per annum. Interest on the Notes will be payable semi-annually in arrears on March 15 and September 15 of each year, beginning September 15, 2019. The Notes will be convertible into cash, shares of the Company’s common stock (and, if applicable, cash in lieu of any fractional share), or a combination thereof, at the Company’s election. The initial conversion rate will be 8.9554 shares of the Company’s common stock per $1,000 principal amount of Notes, which is equivalent to an initial conversion price of approximately $111.6645 per share. The Notes will mature on March 15, 2027, unless earlier converted or repurchased in accordance with their terms prior to such date, and may not be redeemed by the Company prior to maturity. Prior to September 15, 2026, the Notes will be convertible only upon the occurrence of certain events and during certain periods, and thereafter, until the close of business on the second scheduled trading day immediately preceding the maturity date.

The offering is expected to close on March 8, 2019, subject to customary closing conditions. Concurrently with this offering, in separate transactions, the Company expects to enter into agreements with certain holders of its 1.0% Convertible Senior Notes due 2025 (the "2025 Notes") to exchange an aggregate of approximately $493.4 million of the outstanding principal amount of the 2025 Notes for consideration consisting of (1) an aggregate amount of approximately $493.3 million in cash and (2) an aggregate amount of approximately 2.16 million shares of the Company’s common stock. The terms of such agreements have been or will be individually negotiated and will depend on the market price of the Company’s common stock and the trading price of the 2025 Notes at the time such agreements are entered into. The cash portion of such consideration will be funded from net proceeds from this offering. The Company may also exchange or induce conversions of the 2025 Notes following completion of this offering and may fund such exchanges or conversions with the proceeds of this offering. The Company intends to use the remaining net proceeds of this offering for general corporate and working capital purposes.

BofA Merrill Lynch is acting as the sole book-running manager for the Notes offering.

An automatically effective shelf registration statement relating to the Notes was filed with the SEC on June 6, 2017. A copy of the prospectus supplement and prospectus relating to the Notes offering may be obtained free of charge on the SEC’s website at View Source or by sending a request to BofA Merrill Lynch, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, Attention: Prospectus Department (or by e-mail at [email protected]).

This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of these securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state. The offering of the Notes will be made only by means of the prospectus and related prospectus supplement.

On March 6, 2019 Immutep Limited (ASX: IMM; NASDAQ: IMMP) (Immutep or the Company), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, reported positive, more mature data from its ongoing TACTI-mel phase I clinical study of the Company’s lead product candidate, eftilagimod alpha ("efti" or "IMP321") (Press release, Immutep, MAR 6, 2019, View Source [SID1234534115]). The data will be presented at the World Immunotherapy Congress 2019 in San Diego USA, by Dr. Frédéric Triebel, Immutep’s Chief Scientific Officer and Chief Medical Officer at 3:00 PM Pacific Standard Time on 5th March 2019.

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The TACTI-mel study is evaluating the combination of efti with anti-PD-1 therapy KEYTRUDA (pembrolizumab) in 24 patients with unresectable or metastatic melanoma. It is a multi-center, open-label clinical trial that involves four cohorts of six patients, each cohort testing different dosages of efti, including 1 milligram (mg), 6 mg and 30 mg, in combination with pembrolizumab.

Part A of the study is starting the combination therapy at cycle 5 of the pembrolizumab treatment in three cohorts with a treatment duration of 6 months. Part B of the study includes a cohort of 6 patients at 30 mg of efti in combination with pembrolizumab, starting at cycle 1, day 1 and with a treatment duration of 12 months.

*Exploratory ORR when tumour size is measured according to irRC from day 1 of cycle 1 of pembrolizumab and following combination therapy (which starts at cycle 5 of prembrolizumab treatment).

Safety results (total n=24):

Efti has very favorable safety profile in doses up to 30 mg administered s.c. every 2 weeks;

Combination with PD-1 antagonists is feasible without dose limiting toxicity (DLTs) or reaching MTD; and

No DLT or new safety signal have been observed in either part of the study.

Notes to the results

Part B

All patients high risk with 100% M1c status, 83% elevated LDH and 50% ECOG 1;

Very deep responses with 1 patient having complete disappearance of target lesions at 3 months already; and

Treatment is ongoing (6+ months) in 4 patients.

Part A

Late stage (78 % M1C stage, 38 % elevated LDH) patients sub-optimally responding to pembrolizumab monotherapy;

Long lasting and durable responses (up to 30 months) continue to be observed in a subset of patients, 4 patients still in PFS follow-up; and

Tumor shrinkage in 56% of patients incl. 2 patients with complete disappearance of all target lesions.

The full presentation slides from this event can be accessed via Immutep’s website.

Immutep CSO and CMO, Frédéric Triebel, CEO, Marc Voigt and Director of Clinical Development, Christian Mueller will discuss the data, along with the clinical development program for IMP321, including other trials, on a global webcast in the coming weeks. Details of the webcast will be announced separately.

About the TACTI-mel clinical trial

The ongoing TACTI-mel (Two ACTive Immunotherapies in melanoma) Phase I clinical trial is a multi-center, open-label study evaluating the combination of eftilagimod alpha ("efti") with pembrolizumab, in unresectable or metastatic melanoma patients that have had either a suboptimal response or had disease progression with pembrolizumab monotherapy (clinicaltrials.gov identifier NCT 02676869).

On March 6, 2019 Idera Pharmaceuticals, Inc. ("Idera") (NASDAQ: IDRA), a clinical-stage biopharmaceutical company focused on the development, and ultimately the commercialization, of therapeutic drug candidates for both oncology and rare disease indications characterized by small, well-defined patient populations with serious unmet medical needs, reported its financial and operational results for the fourth quarter and year ended December 31, 2018 (Press release, Idera Pharmaceuticals, MAR 6, 2019, View Source [SID1234534076]).

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"2018 ended with incredibly positive momentum for tilsotolimod which carried into 2019 and continues today," stated Vincent Milano, Idera’s chief executive officer. "Despite the challenges we faced in the first half of 2018, we emerged as a tightly focused organization with a clear understanding of our mission to bring tilsotolimod to the market in our initial indication of anti-PD-1 refractory metastatic melanoma. We also are exploring tilsotolimod as an investigational therapy for patients with other tumor types that have not been well-served by available immunotherapies to date," continued Milano. "The ILLUMINATE development program is making excellent progress across the board and I am incredibly proud of our team for their continued dedication and execution."

"As it pertains to Idera overall, we will continue business development efforts to identify and pursue assets and opportunities with the purpose of further growing our company for long-term success and value creation for our loyal shareholders. However, I cannot be any clearer that the advancement and future success of tilsotolimod is our highest priority, passion and focus."

ILLUMINATE (tilsotolimod) Clinical Development Update

ILLUMINATE 301 – Randomized phase 3 trial of tilsotolimod in combination with ipilimumab versus ipilimumab alone in patients with PD-1 refractory metastatic melanoma:

• Overall Response Rate (ORR) and Overall Survival (OS) as primary endpoints;

• Trial initiated in the first quarter of 2018;

• Sites planned in 12 countries: 78 sites activated;

• Planned enrollment of approximately 300 patients; and

• Completion of enrollment expected during the fourth quarter of 2019.

ILLUMINATE 206 – Phase 2, multi-center trial to test the safety and effectiveness of tilsotolimod in combination with ipilimumab and nivolumab in treating patients with Squamous Cell Carcinoma of the Head and Neck (SCCHN) and Microsatellite Stable Colorectal Cancer (MSS-CRC).

• Received notice from the U.S. Food and Drug Administration that the company can proceed to implement the ILLUMINATE-206 clinical trial under a new Investigational New Drug (IND) application; and

• Both trial cohorts of SCCHN and MSS-CRC expected to initiate in the second quarter of 2019.

ILLUMINATE 204 – Phase 1/2 trial of tilsotolimod in combination with ipilimumab or pembrolizumab in patients with PD-1 refractory metastatic melanoma:

• Completed enrollment with 52 patients in Phase 2 expansion at 8 mg (RP2D) dose with ipilimumab;

• Completed target enrollment of at least 40 patients in the primary enrollment population constituting patients who are naïve to prior ipilimumab treatment in the metastatic setting;

• Presented an interim data update in December 2018 which showed:

32.4% ORR of the first 34 patients evaluable for efficacy including 9% (N=3) achieve Complete Response (CR); 24% (N=8) achieving Partial Response (PR); and 76.5% (N=26) achieving disease control (CR, PR or Stable Disease [SD]); and
• Data from ILLUMINATE-204 expected in the fourth quarter of 2019.

ILLUMINATE 101 – Phase 1b trial of tilsotolimod monotherapy in patients with refractory solid tumors:

• Completed enrollment in all dose cohorts of the trial; and

• Abstract accepted for presentation of translational data from this trial at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2019 Annual Meeting, being held March 29 – April 3, 2019 in Atlanta, GA.

Corporate Updates:
The company today is announcing the planned retirement of Senior Vice President and Chief Medical Officer Joanna Horobin, M.B. Ch.B, given the consolidation of Idera’s business operations and team in Pennsylvania. The retirement will be effective July 31, 2019. Dr. Horobin joined Idera in November 2015 and notably has led the advancement of the tilsotolimod ILLUMINATE program, advancing the program from pre-clinical into exploratory early phase clinical and translational evaluation through to the ongoing ILLUMINATE 301 phase 3 trial in anti-PD-1 refractory metastatic melanoma and most recently expanding into a study in patients SCCHN and MSS-CRC.

Dr. Horobin will assist Idera in the search to fill the role of Chief Medical Officer and will remain with the company in an advisory capacity following her July 31 retirement.

"I’m incredibly appreciative to Joanna for the critical role she has played as we transitioned Idera to a focused clinical development organization with a clear eye towards ultimate commercialization of products for patients suffering from life-threatening rare diseases," offered Milano. "We all wish Joanna the utmost happiness as she transitions to the next phase of her life following a tremendously productive and rewarding 35-year career developing critical medicines that have made a positive impact on countless patients’ lives."

"I am tremendously proud of the progress we’ve made at Idera over the past several years. We have shown clinical proof-of-concept of tilsotolimod to prime the immune system to better respond to checkpoint inhibition which may enable tilsotolimod to benefit more patients," stated Dr. Horobin. "It’s been a great honor to work with so many talented individuals during my time at Idera and I look forward to continuing to assist in an advisory capacity as the opportunities for tilsotolimod expand."

Additionally, since September 30, 2018, the following corporate updates were announced:

• The company entered into an at the market offering (ATM) agreement with JMP Securities LLC under which the company may elect to sell shares of its common stock having an aggregate offering price of up to $50 million;

• The company entered into a common stock purchase agreement and registration rights agreement with Lincoln Park Capital (LPC) Fund, LLC, under which the company has the right to sell an aggregate of up to $35 million of its common stock at the company’s discretion; and

• Carol A. Schafer was appointed to Idera’s Board of Directors on December 18, 2018, filling the seat of Mr. William Reardon, who will be resigning from the Board effective March 10, 2019.

Upcoming Investor Conference:
The company will participate in the 2019 Barclays Global Healthcare Conference on Tuesday, March 12, 2019 at 11:15 a.m. Eastern Time at the Loews Miami Beach Hotel in Florida.

Live audio webcast of Idera’s presentations will be accessible in the Investors and Media section of Idera’s website at View Source Archived versions will also be available on the Company’s website after the event for 90 days.

Financial Results
Fourth Quarter Results
Net loss applicable to common stockholders for the three months ended December 31, 2018 was $12.2 million, or $0.45 per basic and diluted share, compared to net loss applicable to common stockholders of $14.9 million, or $0.66 per basic and diluted share, for the same period in 2017. Revenue in the fourth quarter of 2018 was nominal. Research and development expenses for the three months ended December 31, 2018 totaled $8.9 million compared to $10.4 million for the same period in 2017. General and administrative expense for the three months ended December 31, 2018 totaled $3.6 million compared to $3.7 million for the same period in 2017.

Full Year Results
Net loss applicable to common stockholders for the year ended December 31, 2018 was $59.9 million or $2.25 per basic and diluted share, compared to net loss applicable to common stockholders of $66.0 million, or $3.35 per basic and diluted share, for the same period in 2017. Revenue for the year ended December 31, 2018 was $0.7 million compared to revenue of $0.9 million for the same period in 2017. Research and development expenses for the year ended December 31, 2018 totaled $41.8 million compared to $50.7 million for the same period in 2017. General and administrative expenses for the year ended December 31, 2018 totaled $15.4 million compared to $15.6 million for the same period in 2017. Merger-related costs, net for the year ended December 31, 2018 totaled $1.2 million compared to $1.1 million for the same period in 2017. Restructuring costs for the year ended December 31, 2018 totaled $3.1 million and related to our decision in July 2018 to wind-down our discovery operations. No such costs were incurred in 2017.

As of December 31, 2018, our cash and cash equivalents totaled $71.4 million compared to $112.6 million as of December 31, 2017. We currently anticipate that, based on our current operating plan, our existing cash, cash equivalents and investments will fund our operations into the first quarter of 2020.