Adaptimmune to Provide Update on Study of NY-ESO SPEAR® T-cell Therapy in Synovial Sarcoma at the European Society for Medical Oncology (ESMO) 2016 Congress

On October 5, 2016 Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, reported that it will present a poster presentation of updated data on its lead clinical program, an NY-ESO SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell therapy, in patients with synovial sarcoma at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2016 Congress (Press release, Adaptimmune, OCT 5, 2016, View Source;p=RssLanding&cat=news&id=2209585 [SID:SID1234515615]). This meeting will take place at the Bella Center exhibition center in Copenhagen, Denmark on October 7 through 11, 2016.

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Sunday, October 9, 2016
Poster Presentation
Abstract number: 1075P
Title: "Open Label Non-Randomized Multi-Cohort Pilot Study of Genetically Engineered NY-ESO-1 Specific NY-ESO SPEAR T-cells in HLA-A*02+ Patients with Synovial Sarcoma"
Presentation Time: 13:00-14:00
Location: Hall E

The following synovial sarcoma cohorts will be reviewed in this poster presentation:

Cohort 1: Subjects with high NY-ESO-1 antigen expression and lymphodepletion with cyclophosphamide and fludarabine;
Cohort 2: Subjects with low NY-ESO-1 antigen expression and lymphodepletion with cyclophosphamide and fludarabine;
Cohort 3: Subjects with high NY-ESO-1 antigen expression and lymphodepletion with cyclophosphamide alone (no fludarabine);
Cohort 4: Subjects with high NY-ESO-1 antigen expression and lymphodepletion with a modified (lower) dose than Cohort 1 of cyclophosphamide and fludarabine.
These data follow presentations at the 2016 Annual American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Meeting, where we reported robust clinical responses in solid and hematologic tumors; durable persistence without the requirement for IL-2 support in vivo with cells detectable for up to three years; data showing that the incidence of cytokine release syndrome (CRS) appeared to be of lower frequency and severity compared to that reported with CD19 CAR-T therapy; and that our NY-ESO SPEAR T-cells have been generally well tolerated with common side effects including diarrhea, pyrexia, and fatigue. One fatal SAE of bone marrow failure was reported at ASCO (Free ASCO Whitepaper) in cohort 2 of our synovial sarcoma trial. Internal investigations have not identified a mechanism by which NY-ESO SPEAR T-cells may have caused bone marrow failure.

At ESMO (Free ESMO Whitepaper), the company will provide additional tolerability data of our NY-ESO SPEAR T-cells in patients with synovial sarcoma and an update on the benefit:risk profile in patients treated to date.

Adaptimmune’s SPEAR T-cell candidates are novel cancer immunotherapies that have been engineered to target and destroy cancer cells by strengthening a patient’s natural T-cell response. T-cells are a type of white blood cell that play a central role in a person’s immune response. Adaptimmune’s goal is to harness the power of the T-cell and, through its multiple therapeutic candidate, significantly impact cancer treatment and clinical outcomes of patients with solid and hematologic cancers.

Hercules’ Portfolio Update for Q3 2016 Highlights Continued Execution of Its Portfolio and Earnings Growth Strategy

On October 5, 2016 Hercules Capital, Inc. (NYSE:HTGC) ("Hercules" or the "Company"), the leading specialty financing provider to innovative venture growth, pre-IPO and M&A stage companies backed by leading venture capital firms, reported its portfolio update for Q3 2016 (Press release, Hercules, OCT 5, 2016, View Source [SID:SID1234515612]).

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"Hercules Capital achieved another solid quarter of new originations and fundings as we continue to build our debt investment portfolio to our desired target of $1.35 billion," stated Manuel A. Henriquez, chairman and chief executive officer of Hercules. "While Q3 is normally our seasonally softest calendar quarter, our team continued to execute our ‘slow and steady’ growth and origination strategy achieving nearly $180 million of new commitments, including five new innovative venture growth stage technology and life sciences companies, backed by some of the leading venture capital firms in the U.S. The success of our origination team is a reflection of our strong brand and reputation within the venture capital and entrepreneurial communities."

Henriquez continued, "During the quarter, we also witnessed a healthy pick up in M&A activities with four companies announcing or completing M&A events, further bolstering our growing earnings spillover, as we look to harvest those capital gains for potential future distributions to our shareholders. We were also excited to see one of our portfolio companies, TPI Composites (NASDAQ:TPIC), successfully complete its IPO and become part of the Russell 2000 Index as it had nearly doubled its market capitalization prior to that event. During the quarter we were also able to bolster our liquidity and strengthen our balance sheet, positioning us well for the fourth quarter as we work to convert this strong liquidity into new interest-earning investments in a methodical fashion across our key investment markets driving additional growth in our debt investment portfolio."

New Debt and Equity Commitments for Q3 2016

As of September 30, 2016, Hercules has originated $178.0 million of debt and equity commitments to new and existing portfolio companies.

Five (5) new commitments to innovative venture growth stage companies:

Technology Portfolio – $45.0 Million

$25.0 million to a technology developer of enterprise analytics focused on customer and employee interactions and behaviors
$20.0 million to a software developer that designs a leading application for note taking, organizing and archiving
Life Sciences Portfolio – $85.0 Million

$35.0 million to a pharmaceuticals sales and distribution company
$30.0 million to a physician management and technology company that provides physician practice management and population health technology
$20.0 million to a biopharmaceutical company dedicated to developing therapeutics that address important unmet medical needs in otolaryngology
New Commitments to Existing Portfolio Companies – $48.0 Million

Unscheduled Principal Repayments "Early Pay-Offs:"

As of September 30, 2016, Hercules received $84.2 million in unscheduled principal repayments "early pay-offs."

Portfolio Company IPO and M&A Activity in Q3 2016:

IPO Activities

1. TPI Composites, Inc., (NASDAQ:TPIC) the largest U.S.-based independent manufacturer of composite wind blades for the wind energy market, raised $69.0 million by offering 6.25 million shares of its common stock at $11.00 per share in July 2016. Hercules committed a total of $20.0 million in two (2) venture debt financings to TPI Composites beginning in June 2013. Hercules held warrants for 160 shares of Preferred Series B stock as of June 30, 2016, which represents an unrealized gain of approximately $1.2 million as of the closing price of $18.47 for TPI Composites on September 14, 2016.

2. As of September 30, 2016, Hercules held warrant and equity positions in four (4) portfolio companies that had filed Registration Statements in contemplation of a potential IPO, including:

Four companies filed confidentially under the JOBS Act
There can be no assurances that companies that have yet to complete their IPOs will do so.

M&A Activities

1. Celator Pharmaceuticals, Inc. (NASDAQ:CPXX), a pharmaceutical company developing new and more effective therapies to treat cancer, was acquired by Jazz Pharmaceuticals, Inc. (NASDAQ:JAZZ), an international biopharmaceutical company focused on improving patients’ lives by identifying, developing and commercializing meaningful products that address unmet medical needs, for $30.25 per share. The transaction closed on July 12, 2016. Hercules initially committed $15.0 million in venture debt financing to Celator Pharmaceuticals in May 2014. The Company recognized a net realized gain of approximately $1.5 million from the sale of shares, generating a fully realized internal rate of return ("IRR") of approximately 19.8% from its loan repayments and equity/warrant gains.

2. ReachLocal, Inc. (NASDAQ:RLOC), a leader in powering online marketing, helping local businesses grow and operate their business better with leading technology and expert service, was acquired by Gannett Co., Inc., (NYSE:GCI), a next-generation media company committed to strengthening communities across the company’s network, for $4.60 per share in cash, via a tender offer. The transaction closed on August 9, 2016. Hercules initially committed $25.0 million in venture debt financing to ReachLocal in April 2015. The Company recognized a net realized gain of $610,000 from the transaction, generating a fully realized IRR of approximately 24.1% from its loan repayments and equity/warrant gains.

3. TouchCommerce, a technology partner and leader in digital customer service and engagement solutions, was acquired by Nuance Communications, Inc. (NASDAQ:NUAN), a leading provider of voice and language solutions for businesses and consumers around the world, for $215.0 million in total consideration. The transaction closed on August 16, 2016. Hercules committed a total of $18.0 million in three (3) venture debt financings to TouchCommerce beginning in June 2013. Hercules held warrants for 2.3 million shares of Preferred Series E stock, as of June 30, 2016, which represents a realized gain of approximately $698,000 and an unrealized gain of approximately $770,000 as of the closing price of $14.46 for Nuance Communications on September 14, 2016.

4. IronPlanet, a leading online marketplace for used heavy equipment and other durable assets, announced that it had entered into a definitive agreement on August 29, 2016 under which Ritchie Bros. Auctioneers Incorporated (NYSE & TSX: RBA), the world’s largest industrial auctioneer and a leading equipment distributor, will acquire IronPlanet for approximately US $758.5 million, subject to customary closing adjustments. Hercules initially committed $37.5 million in venture debt financing to IronPlanet in October 2014. Hercules currently holds warrants for 1.2 million shares of Preferred Series D stock, as of June 30, 2016.

Innocrin Pharmaceuticals, Inc. Appoints Edwina BaskinBey, MD as Chief Medical Officer and Expands the Ongoing Phase 2 Study of Seviteronel in Women with
Estrogen Receptor-positive or Triple-negative Breast Cancer (TNBC)

On September 5, 2016 Innocrin Pharmaceuticals, Inc., a clinical-stage pharmaceutical company developing the oral, dual-mechanism, selective CYP17 lyase and androgen receptor (AR) inhibitor, seviteronel, for the treatment of breast and prostate cancers resistant to recently-approved hormonal therapies, reported the appointment of Edwina Baskin-Bey, MD as Chief Medical Officer, effective August 30, 2016 (Press release, Innocrin Pharmaceutical, OCT 5, 2016, View Source [SID:SID1234515611]).

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William Moore, PhD, Innocrin Chief Executive Officer stated, "I’m very pleased to welcome Edwina to the senior management team. Her strong development experience with AR pathway-targeted therapies such as abiraterone, enzalutamide, and apalutamide will serve Innocrin well as we move into later-stage Phase 2 breast and prostate cancer clinical studies."

Dr. Baskin-Bey has extensive oncology research and drug development experience. Immediately prior to joining Innocrin, she led several prostate cancer development programs at Janssen as Global Director of Oncology Development. Prior to Janssen, she was Global Director of Oncology Development at Astellas Pharma, with responsibility for the development of various (Phase 0-4) oncology products, including enzalutamide. Following receipt of a Doctorate in Medicine degree from Mount Sinai/NYU, Dr. Baskin–Bey trained as a general surgeon at the Mayo Clinic, performing basic scientific and clinical research through the National Institutes of Health.

Said Dr. Baskin-Bey, "I am excited to join Innocrin as the company expands its Phase 2 breast and castration-resistant prostate cancer development programs. Seviteronel holds great promise for late-stage breast and prostate cancer patients whose disease has progressed while on currently available therapies."

Innocrin also announced that once-daily oral seviteronel has advanced to Stage 2 in both the ER+ and AR+ triple-negative breast cancer (TNBC) groups in its ongoing open- label Phase 2 study (NCT02580448). Phase 2 oncology studies typically employ early ‘stopping rules’ that prevent large numbers of patients from being exposed to inactive drugs. Seviteronel has advanced to Stage 2 in both the ER+ and TNBC populations based upon early signs of significant therapeutic activity.

Dr. Baskin-Bey commented, "It is encouraging to see early signs of single-agent seviteronel clinical benefit in these two breast cancer patient populations which are in need of new treatment options. The combined inhibition of CYP17 lyase and the AR is a novel approach for the treatment of TNBC and ER+ disease. Seviteronel potentially addresses an unmet medical need for women whose breast cancer has progressed despite treatment with traditional ER-targeting agents or chemotherapy."

Innocrin will present updated Phase 2 clinical study results from 7:30-9:00 AM on December 8, 2016 at the San Antonio Breast Cancer Symposium (poster P2-08-04).

About Seviteronel (VT-464) Seviteronel is a once-daily oral therapeutic that can be given without prednisone. Seviteronel selectively inhibits CYP17 lyase, an enzyme needed for the synthesis of androgens and estrogens, and also directly blocks the AR.

It is thought that the AR may stimulate disease progression of breast cancer tumors that no longer are ER+ (e.g., are triple-negative) or are ER+ but have become resistant to ER-directed therapies such as aromatase inhibitors or tamoxifen. Preclinical study results, presented at the 2015 San Antonio Breast Cancer Symposium, confirmed that seviteronel blocks the growth of resistant ER+ and AR+ breast cancer cells more potently than enzalutamide.

A growing body of preclinical and clinical evidence shows that seviteronel blocks the growth of deadly, castration-resistant prostate cancer that is resistant to abiraterone (a CYP17 hydroxylase inhibitor) or enzalutamide (an AR antagonist). CRPC disease progression following treatment with abiraterone, enzalutamide or both represents a major unmet medical need due to the widespread and growing use of both agents, as well as the high cross-resistance between these agents (e.g., cancers that are resistant to abiraterone are typically resistant to enzalutamide and vice versa).

About Breast Cancer Each year over 230,000 women are diagnosed with breast cancer in the United States, with almost 40,000 deaths attributable to the disease. While estrogen deprivation is currently the standard of care for postmenopausal women with ER+ BCa, the majority of patients eventually develop resistance. ER+ patients comprise ~75% of all metastatic breast cancer cases, and TNBC accounts for ~15-20%. TNBC has a more aggressive course than ER+ BCa does but both have poor survival rates post-failure of endocrine and/or chemotherapy.

About Prostate Cancer Prostate cancer is the second most common form of cancer affecting men in the United States: an estimated one in six will be diagnosed with prostate cancer in his lifetime. Prostate cancer afflicts nearly 240,000 men each year in the US and approximately 36,000 men die due to metastatic CRPC.

Cellectar Biosciences Announces USPTO Issues Formal Patent Allowance for CLR 1603

On October 4, 2016 Cellectar Biosciences, Inc. (Nasdaq: CLRB) (the "company"), an oncology-focused clinical stage biotechnology company, reported that the United States Patent and Trademark Office ("USPTO") has issued a formal patent allowance for CLR 1603, which covers method of use for the treatment of a variety of solid tumors and associated cancer stem cells using the company’s phospholipid drug conjugate ("PDC") delivery platform technology with paclitaxel (Filing, 8-K, Cellectar Biosciences, OCT 5, 2016, View Source [SID:SID1234515593]). This patent allowance follows the May 2016 issuance of the composition of matter patent for the same compound.

CLR 1603 is a form of paclitaxel conjugated to the company’s patented phospholipid drug conjugate delivery platform using a simple compound linker. The USPTO patent allowance covers method of use for breast, pancreatic, lung, colorectal and prostate cancers. The company expects the full patent to be granted by the end of 2016.

"The receipt of this formal patent allowance represents the fourth time Cellectar has secured a positive USPTO action since May 2016. These actions have expanded and strengthened our intellectual property portfolio for PDC delivery platform assets, including our lead therapeutic product candidate CLR 131 and our chemotherapeutic conjugate program assets," said Jim Caruso, president and CEO of Cellectar. "While we continue to aggressively protect our products through strategic intellectual property achievements, we remain committed to advancing an intelligent research and development program to further optimize asset valuation."

About Phospholipid Drug Conjugates (PDCs)
Cellectar’s product candidates are built upon its patented cancer cell-targeting delivery and retention platform of optimized phospholipid ether-drug conjugates (PDCs). Its phospholipid ether (PLE) carrier platform was deliberately designed to be coupled with a variety of payloads to facilitate both therapeutic and diagnostic applications. The basis for selective tumor targeting of our PDC compounds lies in the differences between the plasma membranes of cancer cells compared to those of normal cells. Cancer cell membranes are highly enriched in lipid rafts, which are glycolipoprotein microdomains of the plasma membrane of cells that contain high concentrations of cholesterol and sphingolipids, and serve to organize cell surface and intracellular signaling molecules. PDCs have been tested in over 70 different xenograft models of cancer.

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BioLineRx Announces Acceptance of BL-8040 Abstracts for
Oral and Poster Presentations at 58th American Society of
Hematology (ASH) Annual Meeting

On October 5, 2016 BioLineRx Ltd. (NASDAQ/TASE: BLRX), a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, reported that data on BL-8040, the Company’s leading oncology platform, have been accepted for presentations at the 58th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exhibition in San Diego, California, taking place December 3-6, 2016 (Filing, 6-K, BioLineRx, OCT 5, 2016, View Source [SID:SID1234515592]).

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Information on the BL-8040 abstracts presented at ASH (Free ASH Whitepaper) is included below:

· (Abstract #767) Oral Presentation: The High Affinity CXCR4 Inhibitor, BL-8040, Induces Apoptosis of AML Blasts and their Terminal Differentiation by Blocking AKT/ERK Survival Signals and Downregulating BCL-2, MCL-1 and Cyclin-D1 through Regulation of Mir-15a/16-1 Expression; Monday, December 5, 2016, 11:30 am PST; Marriott Marquis San Diego Marina Hotel, San Diego, Ballroom AB

· (Abstract #2745) Poster Presentation: The Selective Anti-Leukemic Effect of BL-8040, a Peptidic CXCR4 Antagonist, is Mediated by Induction of Leukemic Blast Mobilization, Differentiation and Apoptosis: Results of Correlative Studies from a Ph2a Trial in Acute Myeloid Leukemia; Sunday, December 4, 2016, 6:00-8:00 pm PST; San Diego Convention Center, Hall GH.

About BL-8040
BL-8040 is a short peptide for the treatment of acute myeloid leukemia, solid tumors, and certain hematological indications. It functions as a high-affinity antagonist for CXCR4, a chemokine receptor that is directly involved in tumor progression, angiogenesis, metastasis and cell survival. CXCR4 is over-expressed in more than 70% of human cancers and its expression often correlates with disease severity. In a number of clinical and pre-clinical studies, BL-8040 has shown robust mobilization of cancer cells from the bone marrow, thereby sensitizing these cells to chemo- and bio-based anti-cancer therapy, as well as a direct anti-cancer effect by inducing apoptosis. In addition, BL-8040 has also demonstrated robust stem-cell mobilization, including the mobilization of colony-forming cells, and T, B and NK cells. BL-8040 was licensed by BioLineRx from Biokine Therapeutics and was previously developed under the name BKT-140.