On January 18, 2018 Cytovation AS, a privately held biotech company developing CyPep-H1 for the treatment of cutaneous warts, reported that it has raised NOK 10m in a private funding round, completing the second stage of fundraising, having raised NOK 20m in June 2017 (Press release, Cytovation, JAN 18, 2018, View Source [SID1234561560]). Both financings were led by a group of private investors in Norway and the Company will now use these funds to advance lead product CyPep-H1 through the final stages of pre-clinical development and into and through a Phase I/IIa clinical trial in patients with warts caused by the human papilloma virus (HPV).

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Cytovation is developing CyPep-H1 as a topical formulation of its proprietary lytic peptide, CyPep. CyPep is a highly-stable, purpose-engineered peptide, consisting of 27 amino acids, that selectively targets transformed or infected cells, destroying the cell membrane and killing the cells. The release of antigens from the lysed cells also triggers an immune response against the diseased cells, providing the possibility of long-term protection against warts.

The mode-of-action of CyPep presents a completely novel strategy to treat this common and potentially debilitating condition. Based on this mechanism, the Company believes that CyPep can have a number of applications in dermatological diseases, with CyPep-H1, for the treatment of cutaneous warts, being the first candidate under development. The Company is also investigating the potential of CyPep-derived peptides for the treatment of certain cancers.

Cytovation’s CEO, Kjell Inge Arnevig, commented on the financing: "The completion of this final tranche of fundraising now enables Cytovation to move through toxicology studies and formulation and into our planned Phase I/IIa clinical trial for CyPep-H1. We expect initial results from this study late 2018 and are confident that they will confirm the potential of this novel treatment approach for the many largely unsatisfied patients globally, who suffer from cutaneous warts."

On January 18, 2018 Sandoz, a Novartis division and the global leader in biosimilars, reported a global partnership with Asia’s premier biopharmaceuticals company, Biocon, to develop, manufacture and commercialize multiple biosimilars in immunology and oncology for patients worldwide (Press release, Novartis, JAN 18, 2018, View Source [SID1234523277]).

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Under the terms of the agreement, both companies will share responsibility for end-to-end development, manufacturing and global regulatory approvals for a number of products, and will have a cost and profit share arrangement globally. Worldwide commercialization responsibilities will be divided and each company’s strengths will be leveraged within specific geographies. Sandoz will lead commercialization in North America* and the EU,** while Biocon will lead commercialization in Rest of the World.***

"Today’s announcement bolsters our leadership position in biosimilars and positions us to continue to lead well into the future," said Richard Francis, CEO, Sandoz. "Biocon is a great complement to our proven biosimilar capabilities at Sandoz. Through this collaboration, we are reinforcing our long-term commitment to increase patient access to biologics."

"Together, we will be able to realize benefits at every stage of the value chain, from development, through manufacturing to commercialization," said Carol Lynch, Global Head, Biopharmaceuticals, Sandoz. "This collaboration further strengthens our ability to deliver next-generation biosimilar medicines to patients."

Sandoz is committed to increasing patient access to high-quality biosimilars. We are the global leader in biosimilars, with five biosimilars currently marketed worldwide, as well as a leading global pipeline. Sandoz is well-positioned to continue leading the biosimilars industry based on our experience and capabilities in development, manufacturing and commercialization. As a division of Novartis, the first global healthcare company to establish a leading position in both innovative and off-patent medicines, we benefit strongly from this unique blend of experience and expertise in many different market environments.

As an innovation-led biopharmaceutical company, Biocon has successfully developed and taken a range of novel biologics, biosimilar antibodies, rh-insulin and insulin analogs from ‘lab to market’. The collaboration with Sandoz builds upon Biocon’s successful progress in its existing global biosimilars program. An early mover in the biosimilars space, Biocon has successfully launched its insulin glargine in Japan, trastuzumab and bevacizumab biosimilars in India and rh-insulin, insulin glargine and biosimilar trastuzumab in a few emerging markets; and it was the first Indian company to have a biosimilar approved by the US Food and Drug Administration.

Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "to develop," "to commercialize," "potential," "can," "will," "plan," "expect," "anticipate," "look forward," "believe," "committed," "investigational," "pipeline," "launch," "expansion," "portfolio," "collaboration," "partnership," or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved biosimilar products described in this press release, or regarding potential future revenues from such products or the collaboration and partnership with Biocon. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Neither can there be any guarantee that, if approved, such biosimilar products will be approved for all indications included in the reference product’s label. Nor can there be any guarantee that such products will be commercially successful in the future. Neither can there be any guarantee that the collaboration and partnership with Biocon will achieve any or all of its intended goals and objectives, or be commercially successful. In particular, our expectations regarding such products, and the collaboration and partnership with Biocon, could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; the particular prescribing preferences of physicians and patients; competition in general, including potential approval of additional biosimilar versions of such products; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures; litigation outcomes, including intellectual property disputes or other legal efforts to prevent or limit Sandoz or Biocon from selling the products developed, manufactured and commercialized under the collaboration and partnership; general economic and industry conditions, including the effects of the persistently weak economic and financial environment in many countries; potential or actual data security and data privacy issues; safety, quality or manufacturing issues, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

On January 18, 2018 Celsion Corporation (NASDAQ:CLSN), an oncology drug development company, reported a year-end 2017 corporate review and clinical progress for two of its development programs: ThermoDox, a proprietary, heat-activated liposomal encapsulation of doxorubicin, which is in Phase III development for treatment of primary liver cancer; and GEN-1, an IL-12 DNA plasmid vector encased in a nanoparticle delivery system, which enables cell transfection followed by persistent, local secretion of the IL-12 protein, and which is in Phase I development for the localized treatment of ovarian cancer (Press release, Celsion, JAN 18, 2018, View Source [SID1234523278]).

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"In 2017, Celsion achieved our key development goals for our two lead programs, ThermoDox and GEN-1. We expect to build upon this success in 2018 as we work toward advancing our pipeline of clinical and preclinical development programs, which hold the potential to enhance the power of proven chemotherapy and immunotherapy platforms," stated Michael H. Tardugno, Celsion’s chairman, president and chief executive officer. "After successful and highly efficient financings in the second half of 2017, we have capital sufficient to complete enrollment of our Phase III OPTIMA Study and advance development through the first pre-planned efficacy analysis, which is expected in the first quarter of 2019. We further expect that our current cash position will allow us to make meaningful progress in our open-label, randomized, 86-patient Phase I/II study of GEN-1 in newly diagnosed patients with stage III and IV ovarian cancer. We are well positioned to execute on our clinical development plans to achieve meaningful milestones in the next year, and I look forward to sharing our progress."

On January 18, 2018 OncoSec Medical Incorporated ("OncoSec" or the "Company") (NASDAQ:ONCS), a company developing intratumoral cancer immunotherapies, reported preliminary clinical observations related to its pilot biomarker OMS-I140 clinical trial of ImmunoPulse IL-12 in patients with metastatic Triple Negative Breast Cancer (TNBC) (Press release, OncoSec Medical, JAN 18, 2018, View Source [SID1234523279]). The study is designed to assess whether a single cycle of ImmunoPulse IL-12 increases TNBC tumor immunogenicity by driving a pro-inflammatory cascade of events including activation of cytotoxic tumor-infiltrating lymphocytes (TILs).

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To date, five patients with TNBC have been treated with a single cycle of ImmunoPulse IL-12 (intratumoral pIL-12 [tavokinogene telseplasmid or "tavo"] with electroporation). Two of these five patients were subsequently treated with single agent nivolumab (Opdivo) – an anti-PD-1 checkpoint inhibitor treatment – as their immediate next therapy. Both of these patients, who were heavily pretreated metastatic TNBC patients with chemotherapy refractory disease, experienced robust objective responses in both ImmunoPulse IL-12 treated and untreated lesions. These clinical observations have prompted the Company to further commit to a more definitive evaluation of the combined therapies.

"Metastatic TNBC is a heterogeneous cancer with a poor prognosis where less than five percent of pre-treated patients achieve an objective response to PD-1/PD-L1 checkpoint treatments," explained Sharron Gargosky, Chief Clinical and Regulatory Officer of OncoSec. "The marked synergy shown in these patients strongly suggests that IL-12 may have primed the tumor microenvironment, impacting the clinical result. The combination of ImmunoPulse IL-12 and checkpoint inhibition represents a highly promising new therapeutic approach for TNBC and warrants a formal evaluation given the extremely low response rate in women who have failed multiple prior therapies."

Previous studies have demonstrated that breast cancer patients whose tumors are associated with markers of inflammation, such as the presence of TILs, achieve better clinical outcomes. In addition, the density of TILs is a key requirement for the anti-tumor activity of immune checkpoint inhibitors like anti-PD-1/PD-L1 antibodies. By augmenting the expansion of CD8+ tumor infilatrating T cells, ImmunoPulse IL-12 may be an ideal candidate to combine with checkpoint inhibitors, which has demonstrated low and variable activity as a monotherapy in TNBC.

Immunological examination of samples from all patients are currently being analyzed. These data, along with the full information regarding clinical observations and safety data, will be submitted for presentation at an upcoming medical meeting in 2018.

To learn more about the trial, visit www.oncosec.com. Additional details can also be found at www.clinicaltrials.gov via NCT02531425.

OPDIVO is a registered trademark of Bristol-Myers Squibb Company.

ImmunoPulse is a registered trademark of OncoSec Medical Incorporated, San Diego, CA, USA.

About Triple Negative Breast Cancer (TNBC)
Breast cancer cells that test negative for estrogen receptors (ER-), progesterone receptors (PR-), and HER2 (HER2-) means the cancer is triple negative.1 Approximately 15-20 percent of US breast cancer cases are triple negative breast cancer (TNBC),2 which disproportionately affects younger women as well as African-American women, followed by Hispanic women.3

TNBC remains a poor-prognosis breast cancer subtype, with limited treatment options for patients with advanced, recurrent disease. In the recurrent disease setting, chemotherapy remains the standard of care, and median survival is approximately 13 months from the time of disease recurrence.4 Emerging evidence shows immunotherapy options may play an important role in the treatment paradigm for TNBC. Preliminary data demonstrated the anti-PD-1 antibody, pembrolizumab, led to an objective response in approximately 18 percent of TNBC patients;5 and in the heavily pretreated population led to an objective overall response in approximately 4-8% of patients; 6 the anti-PD-L1 antibody, MPDL3280A, achieved an objective response in 33 percent of patients.7 There is increasing evidence that tumors need TILs for anti-PD-1/PD-L1 therapies to be most effective. Data also show TILs promote better responses to chemotherapy and improve clinical outcomes in breast cancer, including TNBC.8-13

On January 18, 2018 DXC Technology (NYSE: DXC), the world’s leading independent, end-to-end IT services company, reported that it will release financial results for the third quarter of fiscal year 2018 on Thursday, February 8, 2018, at approximately 4:15 p.m. Eastern Standard Time (EST) (Press release, DynPort Vaccine Company, JAN 18, 2018, View Source [SID1234523292]).

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DXC Technology senior management will host a conference call and webcast on the same day at 5 p.m. EST. The dial-in number for domestic callers is (888) 394-8218. Callers who reside outside of the United States should dial +1 (323) 794-2149. The passcode for all participants is 5950692. The webcast audio and any presentation slides will be available on DXC Technology’s Investor Relations website.

A replay of the conference call will be available from approximately two hours after the conclusion of the call until February 15, 2018. Replay numbers can be found at the following link. The replay passcode is also 5950692.