On August 21, 2015 Interim Reported for Kancera AB (publ) Q2 2015, January 1 – June 30, 2015 (Press release, Kancera, AUG 21, 2015, View Source [SID:1234507306]). Schedule your 30 min Free 1stOncology Demo! The period January to June 2014 and the second quarter 2015 in brief
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R&D expenses for the period amounted to SEK 8.8m (SEK 6.9m) of which the second quarter constituted SEK 4.6m (SEK 3.4m).
Operating income for the period amounted to SEK -10.3m (SEK -8.0m) of which the second quarter constituted SEK -5.5m (SEK -3.9m).
Income after financial items for the period amounted to SEK -10.3m (SEK -7.9m) of which the second quarter constituted SEK -5.4m (SEK -3.8m).
Earnings per share for the period were SEK -0.10 (SEK -0.10) of which the second quarter constituted SEK -0.05 (SEK -0.05).
Cash flow from operating activities for the period amounted to SEK -10.9m (SEK -7.2m) of which the second quarter constituted SEK -5.8m (SEK -4.0m).
Equity as of June 30, 2015 amounted to SEK 31.2m (SEK 33.8m) or SEK 0.30 (SEK 0.44) per share. The equity/assets ratio as of June 30, 2015 was 76 percent (77 percent).
Cash and cash equivalents as of June 30, 2015 amounted to SEK 25.4m (SEK 31.1m).
Significant events during the period
Kancera reported that a second efficacy study of the drug candidate KAN0439834 has been completed in an animal model of an advanced stage of chronic lymphocytic leukemia characterized by a genetic change which makes the disease more difficult to treat. The results show that KAN0439834 reduces the number of ROR expressing leukemia cells in the lymphatic system (spleen) after 14 days of treatment. Further, Kancera reported that a second patent application EP15153394.0 has been filed covering small-molecule ROR inhibitors, including the drug candidate KAN0439834.
Kancera reports that the patent WO 2011/079902 concerning monoclonal antibodies against ROR1 has been approved in China. Kancera has acquired partial rights to this patent from Bioinvent under an agreement that does not involve any financial burden for Kancera (except patent expenses) before revenues are generated. Kancera through the company’s co-founder Professor Håkan Mellstedt has been involved in the development of these antibodies. These antibodies have mainly been used to identify and validate new indications for a future ROR-inhibiting drug. Any further development of the ROR-targeted monoclonal antibodies for therapeutic purposes will only be done in a partnership that provides funding and access to expertise in development of antibody-based drugs.
Kancera reported an operational update of the cancer projects ROR, PFKFB3, and HDAC6.
The ROR project reported that that Kancera’s candidate drug KAN0439834 is effective against both leukemic cells circulating in the blood and leukemic cells that have invaded the lymph nodes in humans.
Recent studies of clinical samples from leukemia patients underscore that ROR inhibitors mainly target the white blood cells causing cancer while the healthy white blood cells, including T cells, are spared. These results are of significance for the possibility to combine ROR inhibitors with the new generation of immuno-stimulating cancer drugs that have been developed since the effect of those requires functional T-cells.
A new generation of ROR inhibitors is being developed against solid tumors.
The PFKFB3 project reported a new discovery showing that Kancera’s PFKFB3 inhibitor KAN0438757 kills cancer cells by preventing them to repair their DNA. The discovery indicates that KAN0438757 could be an efficient complement to radiation for the treatment of advanced cancer.
The HDAC6 project reported that Kancera’s HDAC6 inhibitors counteract the migration of cancer-associated fibroblast cells and that an international patent application has been filed in May.
Kancera’s Annual General Meeting on May 28, 2015 decided to re-elect the current Board of Directors and auditor (Ernst & Young). The General Meeting also decided to authorize the Board, on one or more occasions until the next Annual General Meeting, to issue new shares. A new share issue may be made with or without preferential rights and against cash payment and / or in kind or set-off. The purpose of the authorization and the reason for the deviation from shareholders’ preferential rights is to enable the acquisition of capital for corporate acquisitions and the company’s operation. If the share issue is made against cash payment and without preferential rights for the shareholders, the number of shares issued may not exceed ten percent of the total number of shares outstanding at the time the authorization is exercised.
Kancera announced that a new share issue, with the authorization of the Annual General Meeting in 2014, was closed on May 27, 2015. The issue comprised a maximum of 4,927,386 shares. In total 25,926,793 shares were signed, of which 4,644,304 with preferential rights (with the support of subscription rights) and 21,282,489 without preferential rights. The share issue was thus oversubscribed to about 500 percent. This issue raised Kancera AB approximately SEK 12.3m before issue costs.
Kancera announced that the first subscription period for the exercise of the employee warrants was closed in June 2015. In total 450,246 new shares were signed giving Kancera SEK 1.7m before issue costs. There remain 2,349,754 warrants, of which 560,000 are held by Kancera to cover social security costs that are part of the employee warrants program.
Kancera announced that the company’s HDAC6 project has been awarded a grant totaling SEK 2m from the Swedish innovation agency VINNOVA. The grant is directed to projects that can develop into new strong innovations in a range of common diseases, including cancer. The grant is paid on four occasions during the two-year project. The project will be implemented in collaboration with the Cancer Center Karolinska (CCK), and is also planned to involve Swedish companies such as SARomics Biostructures, MetaSafe and Adlego Biomedical.
Significant events after the end of the reporting period
No significant news have been reported after the end of the period.
Statement from the CEO
In May, Kancera reported progress in the ROR, HDAC6 and PFKFB3 projects in an operational update showing that we have taken significant steps toward our main objectives during the period. The objectives include to demonstrate efficacy of ROR inhibitors against solid cancers, improve the pharmaceutical properties of the HDAC6 inhibitors and to investigate how PFKFB3 inhibitors are best combined with existing cancer therapies. However, several steps remain before we reach our objectives. Kancera’s projects were presented at two international scientific conferences in June yielding a good scientific response. Kancera’s unique small-molecule ROR project was presented at the annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and the exciting discovery that Kancera’s PFKFB3 inhibitors prevent DNA repair in irradiated cancer cells was presented at the Tomas Lindahl Conference on DNA repair in Oslo.
American research groups have progressed the development of biological drugs directed against ROR during the last 12 months such as the MD Anderson Cancer Center in Texas (genetically modified T cells that express ROR receptors on the cell surface) and the University of Southern California in San Diego (monoclonal antibodies) while Kancera remains in the forefront when it comes to development of small-molecule drugs against ROR. The development of biological drugs against ROR we consider as positive since these can contribute to the understanding of how a ROR-targeted drug works in different patient groups and provide information on what is required of a small molecule drug against ROR to be competitive.
During May and June, Kancera’s working capital was strengthened through a fully subscribed share issue and also through the exercise of employee warrants which together brought in SEK 14m before issue costs. In addition, Vinnova announced that its strategic innovation program for common diseases (SWElife) allocates SEK 2m to Kancera’s HDAC6 project over a two year period. The interest in HDAC6 as a drug target remains strong, which e.g. is reflected in the "Discovery on Target" conference in Boston in September where attention is paid to the contribution of HDAC6 to control the immune system’s ability to attack cancer. In July, Kancera conducted a screening campaign as part of the EU-funded anti-parasite project which means that the company has delivered according to plan up to the midterm report. This report constitutes the basis for a possible approval of an additional payment of about € 285,000 from the European Union in the fourth quarter.
The focus of the autumn’s product development is the continued development of ROR inhibitors for the treatment of solid tumors, and enhancement of the pharmaceutical properties of the already highly potent HDAC6 inhibitors.
Author: [email protected]
Axelar and Cadila Pharmaceuticals Announce Co-Development Agreement for Non-Small Cell Lung Cancer Treatment
On August 20, 2015 Axelar AB (‘Axelar’) and Cadila Pharmaceuticals Sweden AB (‘Cadila Pharma’) reported that they have entered into a co-development agreement for further formulation development and clinical development of AXL1717 in patients with non-small cell lung cancer (NSCLC) (Press release, Axelar, AUG 20, 2015, View Source [SID1234571469]).
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AXL1717 is a first-in-class, orally available compound with potential in multiple cancers. Under the terms of the agreement, Cadila Pharmaceuticals will perform formulation development on AXL1717, as well conduct a multicentre randomized Phase II study in patients with non-small cell lung cancer in India. Cadila Pharma will co-invest a proportion of the projected costs for the formulation development and clinical trials and will in return, receive defined geographic market rights for AXL1717 and revenue sharing in future licence deals for AXL1717.
As part of our quest to develop and commercialize AXL1717, this is the most exciting, and perhaps the most important transition in the history of the company," said Jonas Ekblom, Chairman of Axelar. "With a new ownership configuration, a new leadership team, and with Cadila Pharmaceuticals as a powerful strategic ally, I strongly feel that we have optimized our chances for success."
Commenting on the development, Dr. Rajiv I Modi, Chairman and Managing Director, Cadila Pharmaceuticals Ltd.,said: "We are very excited to take forward the AXL1717 project for non-small cell lung cancer, which is one of our focus areas of research. This is also in line with our vision to make available effective therapeutic options for patients who have failed prior treatments of the disease. This partnership reaffirms Cadila Pharmaceuticals’ commitment to developing novel cutting edge medical products through innovative, co-development model which we believe, has the potential to generate significant value for all partners."
Non Small Cell Lung Cancer is a key focus area for Cadila Pharmaceuticals. In 2013, the company had launched a first-in-the-world, active immunotherapy treatment in the management of squamous cell NSCLC.
Navidea Reports Publication of Lymphoseek® Comparative Results in Injection Site Pain Study in Breast Cancer
On August 20, 2015 Navidea Biopharmaceuticals (NYSE MKT: NAVB), reported publication of the results from an investigator-initiated, comparative study of Lymphoseek (technetium Tc 99m tilmanocept) injection versus filtered Tc-99m Sulfur Colloid (fTcSC) measuring injection site pain in patients with breast cancer undergoing lymphoscintigraphy (Press release, Navidea Biopharmaceuticals, AUG 20, 2015, View Source;p=RssLanding&cat=news&id=2080893 [SID:1234507304]). The paper titled, "Comparison of Post-injection Site Pain Between Technetium Sulfur Colloid and Technetium Tilmanocept in Breast Cancer Patients Undergoing Sentinel Lymph Node Biopsy," was published online in the Annals of Surgical Oncology [DOI – 10.1245/s10434-015-4802-y] and indicated, with patient-reported data, a statistically significant reduction in the level of post-injection associated pain using Lymphoseek compared with use of an fTcSC tracer.
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"The publication of these investigator-initiated study findings affirms the value that surgeons place on minimizing pain and discomfort for their patients and continues to reinforce the clinical importance of Lymphoseek," said Michael Tomblyn, M.D., Navidea’s Chief Medical Officer. "We believe that these results will enhance the visibility and awareness of Lymphoseek with surgical oncologists and illustrate both the clinical utility and clear benefits for patients."
"As surgeons who perform sentinel lymph node (SLN) biopsy procedures in breast cancer patients, one of our key focuses is optimizing a patient’s overall experience," said Dr. Anne Wallace, M.D., professor of surgery, UC San Diego School of Medicine, director of the Comprehensive Breast Health Center at UC San Diego Moores Cancer Center and the study’s lead investigator. "We designed this study to understand if Lymphoseek injection is less painful and could improve the patient experience. The results demonstrated that Lymphoseek, in fact, minimizes patient discomfort while allowing for effective SLN mapping."
The publication included results of the randomized, double-blind clinical trial comparing post-injection site pain using fTcSC versus Lymphoseek in 52 [(27) fTcSC and (25) Lymphoseek] breast cancer patients undergoing lymphoscintigraphy. Pain was evaluated with a visual analogue scale and short form McGill Pain Questionnaire at 1, 2, 3, 4, 5, 15 and 30 minutes post-injection. Analysis of the data indicated baseline pain scores were similar between groups. At one minute post-injection, patients receiving fTcSC experienced a mean change in pain of 16.8mm (standard deviation (SD) 19.5) compared to 0.2mm (SD 7.3) in the Lymphoseek group (p =0.0002). Overall, patients receiving Lymphoseek experienced statistically significant less change in pain scores compared to patients receiving fTcSC at 1-3 minutes post-injection.
About Lymphoseek
Lymphoseek (technetium Tc 99m tilmanocept) injection is the first and only FDA-approved receptor-targeted lymphatic mapping agent. It is a novel, receptor-targeted, small-molecule radiopharmaceutical used in the evaluation of lymphatic basins that may have cancer involvement in patients. Lymphoseek is designed for the precise identification of lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer. Lymphoseek is approved by the U.S. Food and Drug Administration (FDA) for use in solid tumor cancers where lymphatic mapping is a component of surgical management and for guiding sentinel lymph node biopsy in patients with clinically node negative breast cancer, melanoma or squamous cell carcinoma of the oral cavity. Lymphoseek has also received European approval in imaging and intraoperative detection of sentinel lymph nodes in patients with melanoma, breast cancer or localized squamous cell carcinoma of the oral cavity.
Accurate diagnostic evaluation of cancer is critical, as it guides therapy decisions and determines patient prognosis and risk of recurrence. Overall in the U.S., solid tumor cancers may represent up to 1.2 million cases per year. The sentinel node label in the U.S. and Europe may address approximately 235,000 new cases of breast cancer, 76,000 new cases of melanoma and 45,000 new cases of head and neck/oral cancer in the U.S., and approximately 367,000 new cases of breast cancer, 83,000 new cases of melanoma and 55,000 new cases of head and neck/oral cancer diagnosed in Europe annually.
Lymphoseek Indication and Important Safety Information
Lymphoseek is a radioactive diagnostic agent indicated with or without scintigraphic imaging for:
Lymphatic mapping using a handheld gamma counter to locate lymph nodes draining a primary tumor site in patients with solid tumors for which this procedure is a component of intraoperative management.
Guiding sentinel lymph node biopsy using a handheld gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma.
Important Safety Information
In clinical trials with Lymphoseek, no serious hypersensitivity reactions were reported, however Lymphoseek may pose a risk of such reactions due to its chemical similarity to dextran. Serious hypersensitivity reactions have been associated with dextran and modified forms of dextran (such as iron dextran drugs).
Prior to the administration of Lymphoseek, patients should be asked about previous hypersensitivity reactions to drugs, in particular dextran and modified forms of dextran. Resuscitation equipment and trained personnel should be available at the time of Lymphoseek administration, and patients observed for signs or symptoms of hypersensitivity following injection.
Any radiation-emitting product may increase the risk for cancer. Adhere to dose recommendations and ensure safe handling to minimize the risk for excessive radiation exposure to patients or health care workers.
In clinical trials, no patients experienced serious adverse reactions and the most common adverse reactions were injection site irritation and/or pain (<1%).
FULL LYMPHOSEEK PRESCRIBING INFORMATION CAN BE FOUND AT: WWW.LYMPHOSEEK.COM.
DelMar Pharmaceuticals Completes $2.6 Million Registered Direct Offering
On August 20, 2015 DelMar Pharmaceuticals, Inc. (OTCQX: DMPI) ("DelMar" and the "Company"), a biopharmaceutical company focused on developing and commercializing proven cancer therapies in new orphan drug indications, reported the closing of a registered direct placement (Placement) with $2.6 million received from the offering (Press release, DelMar Pharmaceuticals, AUG 20, 2015, View Source [SID:1234507303]).
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The Company sold to institutional and accredited investors an aggregate of 4.3 million shares of common stock and 4.3 million common stock purchase warrants at a price of $0.60 per share. Each common stock purchase warrant entitles the holder to purchase an additional share of the Company’s common stock at a price of $0.75 per share for a period of five years.
"The successful closing of this financing provides us with funding to support our current operations for the next year and enables us to focus on rapidly advancing our lead product candidate VAL-083 into a registration-directed Phase II/III clinical trial for the treatment of refractory glioblastoma," said Jeffrey Bacha, DelMar’s President & CEO.
"It is important to note that in addition to the new investors that participated in this round, we continue to receive strong support from our existing shareholders as evidenced by notable participation in this Placement. With this round of financing behind us, we remain focused on our development and commercialization strategy for VAL-083 with the goal of creating significant shareholder value," added Mr. Bacha.
The securities described above have been offered pursuant to a registration statement (File No. 333-203357), which was declared effective by the United States Securities and Exchange Commission (SEC) on July 15, 2015.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Copies of the prospectus related to this offering may be obtained by clicking on the following link: View Source
BioLineRx Reports Second Quarter 2015 Financial Results
On August 20, 2015 BioLineRx Ltd. (NASDAQ: BLRX; TASE: BLRX), a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, reported its financial results for the second quarter ended June 30, 2015 (Press release, BioLineRx, AUG 20, 2015, View Source;p=RssLanding&cat=news&id=2080874 [SID:1234507302]).
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Kinneret Savitsky, Ph.D., CEO of BioLineRx, remarked, "We expect some very exciting milestones for our BL-8040 oncology platform in the coming few months. First, we expect to report top-line data, including response rates, from our Phase 2 clinical study for treating relapsed/refractory AML in the fourth quarter of 2015, following the highly encouraging results to date we reported from the dose escalation stage of this study. Additionally, we presented positive safety and efficacy results from our Phase 1 study of BL-8040 as a novel stem cell mobilization treatment at the European Hematology Association (EHA) (Free EHA Whitepaper) conference in June, which supported the use of BL-8040 as a single-agent, single-injection, one-day regimen for the collection and transplantation of stem cells. This is a major improvement over currently available procedures, and the superior composition of the collected cells may offer the potential for better quality grafts and improved transplant outcomes. We look forward to meeting with the FDA in October to discuss the next steps in the clinical development of this program. Based on the outcome of the meeting, we would expect to initiate a Phase 2 study as early as the first quarter of 2016."
"We are also expanding our BL-8040 platform into multiple hematological indications beyond our primary AML program, which allows us to pursue additional high-potential, unmet medical needs, while at the same time reducing the overall development risk of our platform. In this regard, we have just announced the initiation of a Phase 2 study as a novel consolidation treatment for AML. The Phase 2b study, which is conducted in collaboration with the German Study Alliance Leukemia Group, will examine BL-8040 as part of a second-stage treatment, termed consolidation therapy, to improve outcomes for AML patients who have achieved remission after the standard first-line treatment regimen, called induction therapy. The consolidation therapy is aimed at eliminating the minimal residual disease left in the bone marrow that can lead to relapse. In addition, we are in the final planning stages for additional studies in AML patients with the FLT3-ITD mutation, and for hypoplastic myelodysplastic syndrome and aplastic anemia, which we expect to initiate by the end of this year."
Dr. Savitsky continued, "In parallel, we have continued our ongoing dialogue with the EU regulatory authorities to confirm that our novel polymer BL-7010 for treating celiac disease can be developed on the medical device pathway in Europe. Following confirmation of the device pathway, we expect to initiate a pivotal CE Mark registration study for BL-7010 in the fourth quarter of 2015 or beginning of 2016. Currently, we are completing additional non-clinical studies and formulation work to further support advancing and potential approval of BL-7010 in Europe."
"In addition to our core programs, we were proud to publish the results of our clinical trial for BL-5010, a novel formulation for the non-surgical removal of skin lesions, in The British Journal of Dermatology. Our partner Omega Pharma, now part of Perrigo, plans to submit an application for CE marking for BL-5010 in the third quarter of 2015. Upon potential CE Marking, we would expect the first sales of BL-5010 in Europe to start in 2016."
Dr. Savitsky concluded, "We continue to pursue various collaboration agreements to maximize the value of our current pipeline assets, including discussions with additional partners for the purpose of monetizing some of our non-core programs. In parallel to our internal pipeline development, we continue to screen potential assets to develop under our strategic partnership with Novartis, and we will provide timely updates on therapeutic candidates selected by Novartis when these promising candidates emerge. Finally, we remain well capitalized to execute on our development program and to achieve significant milestones across our expanded therapeutic pipeline and we look forward to demonstrating our enhanced value proposition over the coming months."
Financial Results for Quarter Ended June 30, 2015
Research and development expenses for the three months ended June 30, 2015 were $2.9 million, an increase of $0.1 million, or 4%, compared to $2.8 million for the three months ended June 30, 2014. The small increase resulted primarily from increased spending on BL-8040 in the 2015 period, partially offset by decreased spending on BL-7010, BL-9020 and BL-5010. Research and development expenses for the six months ended June 30, 2015 were $6.1 million, an increase of $0.6 million, or 11%, compared to $5.5 million for the six months ended June 30, 2014. The reason for the increase is similar to the one discussed above in the three-month comparison.
Sales and marketing expenses for the three months ended June 30, 2015 were $0.3 million, substantially similar to the comparable period in 2014. Sales and marketing expenses for the six months ended June 30, 2015 were $0.6 million, a decrease of $0.1 million, or 14%, compared to $0.7 million for the six months ended June 30, 2014. The decrease resulted primarily from professional fees related to a number of significant business development activities carried out during the six-month period in 2014, which resulted in collaboration and outlicensing agreements later in the year.
General and administrative expenses for the three months ended June 30, 2015 were $1.0 million, an increase of $0.1 million, or 17%, compared to $0.8 million for the three months ended June 30, 2014. The small increase resulted primarily from an increase in salary-related payments. General and administrative expenses for the six months ended June 30, 2015 were $1.8 million, substantially similar to the comparable period in 2014.
The Company’s operating loss for the three months ended June 30, 2015 amounted to $4.2 million, compared with an operating loss of $3.9 million for the corresponding 2014 period. The Company’s operating loss for the six months ended June 30, 2015 amounted to $8.5 million, compared with an operating loss of $8.0 million for the corresponding 2014 period.
Net non-operating expenses amounted to $0.9 million for the three months ended June 30, 2015, a change of $1.1 million, compared to net non-operating income of $0.3 million for the three months ended June 30, 2014. Non-operating income (expenses) for both periods primarily relates to fair-value adjustments of liabilities on account of the warrants issued in the private and direct placements conducted in February 2012 and 2013. These fair-value adjustments were highly influenced by the Company’s share price at each period end (revaluation date). Net non-operating expenses amounted to $0.9 million for the six months ended June 30, 2015, a change of $2.9 million, compared to net non-operating income of $2.0 million for the corresponding 2014 period. The reason for the decrease is similar to the one discussed above in the three-month comparison.
Net financial income amounted to $0.2 million for the three months ended June 30, 2015, compared to net financial expense of $0.4 million for the corresponding 2014 period. Net financial income amounted to $0.3 million for the six months ended June 30, 2015, compared to net financial expense of $0.2 million for the corresponding 2014 period. Net financial income (expenses) for the 2015 period primarily relates to investment income earned on our bank deposits, as well as banking fees. The 2014 period also includes exchange rate differences primarily relating to changes in the USD/NIS exchange rate.
The Company’s net loss for the three months ended June 30, 2015 amounted to $4.8 million, compared with a net loss of $4.1 million for the corresponding 2014 period. The Company’s net loss for the six months ended June 30, 2015 amounted to $9.1 million, compared with a net loss of $6.2 million for the corresponding 2014 period.
The Company held $54.8 million in cash, cash equivalents and short-term bank deposits as of June 30, 2015.
Net cash used in operating activities was $7.2 million for the six months ended June 30, 2015, compared to net cash used in operating activities of $7.7 million for the corresponding 2014 period. The $0.5 million decrease in net cash used in operating activities during the six-month period in 2015, compared to the six-month period in 2014, was primarily the result of an increase in trade payables and accruals.
Net cash used in investing activities for the six months ended June 30, 2015 was $17.9 million, compared to net cash used in investing activities of $15.5 million for the corresponding 2014 period. The changes in cash flows from investing activities relate primarily to investments in, and maturities of, short-term bank deposits and other investments during the respective periods.
Net cash provided by financing activities for the six months ended June 30, 2015 was $28.6 million, compared to net cash provided by financing activities of $22.6 million for the corresponding 2014 period. The cash flows from financing activities primarily reflect the underwritten public offerings of our ADSs in March 2015 and 2014.