On September 13, 2016 Cellceutix Corporation (OTCQB: CTIX) ("the Company"), a clinical stage biopharmaceutical company developing innovative therapies with dermatology, oncology, antibiotic, and anti-inflammatory applications, reported a fiscal year-end business update including a timeline of key upcoming milestones (Filing, Annual, CellCeutix, 2015, SEP 13, 2016, View Source [SID:SID1234515120]).

Leo Ehrlich, Chief Executive Officer, commented, "We are extremely pleased with the tremendous progress that we have made, especially within the last 12 months. We have assembled an attractive portfolio of three unique compounds, each of which addresses very large markets and is supported by strong IP protection. To date, we have met all of the primary endpoints in each of our clinical trials, and we have a number of very important milestones upcoming during the course of the next 12 to 18 months. Many of these milestones have the potential to create a substantial inflection (turning) point in our market cap."

Upcoming Milestones

Drug Candidate
Event
Description
Period
Year
Brilacidin
Kevetrin
Prurisol

Clinical Update
Ulcerative Proctitis- Interim analysis Ph2a trial
4Q
2016

Trial Progress
Ovarian Cancer- Initiation Ph2a trial
4Q
2016

Trial Progress
Psoriasis- Initiation Ph2b trial
4Q
2016

Clinical Update
Oral Mucositis- Interim analysis Ph2
1H
2017

Clinical Update
Psoriasis- Interim Analysis Ph2b
1H
2017

Clinical Update
Ulcerative Proctitis- Complete Ph2a trial
1H
2017

Clinical Update
Oral Mucositis- Complete analysis Ph2 trial
2H
2017

Clinical Update
Ovarian Cancer- PoC p53 modulation (Ph2a)
2H
2017

Trial Progress
ABSSSI- Start Ph3 trial
*
2017
____________
*Timetable dependent on reaching SPA agreement with FDA

Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Cellceutix, commented, "We are making progress advancing Prurisol through the clinical pathway. We completed a Phase 2a trial of Prurisol in patients with mild-to-moderate chronic plaque psoriasis in May 2016. The trial successfully achieved its primary endpoint, further validating Prurisol’s potential as a novel oral treatment for psoriasis. On the heels of these data, we are now planning our Phase 2b trial of Prurisol for patients with moderate-to-severe plaque psoriasis in order to better define appropriate dosing to achieve greatest clinical responses and we expect to have our interim analysis top-line results in the second quarter of 2017. We believe that the potential safety profile of Prurisol may make this an attractive alternative to Celgene’s OTEZLA, which is on its way to achieving $1 billion in sales within just three years of its launch."

"We are also making headway with our Kevetrin asset, which has shown potent anti-tumor activity. Following our Phase 1 clinical trial at Harvard Cancer Centers’ Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center, we are now preparing for a Phase 2a trial of Kevetrin for treating late stage ovarian cancer. We anticipate that this trial will start in the fourth quarter of this year. Our plan is to conduct a small trial that will provide the critical data necessary to forge a partnership with a large pharmaceutical company that could potentially fund development of Kevetrin through FDA approval. We are encouraged by the guidance and feedback that we have received from potential partners which are incorporated in our Phase 2a trial design."

"Lastly, we completed our Phase 2b trial of Brilacidin for Acute Bacterial Skin and Skin Structure Infections, or ABSSSI, and are moving forward with our Phase 2 clinical trial with Brilacidin-OM for the prevention of Oral Mucositis in patients with head and neck cancer. Brilacidin has a novel mechanism of action– robust anti-bacterial as well as anti-inflammatory properties. In fact, a single dose of Brilacidin has been shown to deliver comparable clinical outcomes to the FDA-approved seven-day dosing regimen of daptomycin. Moreover, we believe that it will demonstrate a broad spectrum of activity in infectious diseases, gastrointestinal and inflammatory diseases, and a variety of dermatological diseases."

Mr. Ehrlich concluded, "To wrap up, the consistent theme across all of our compounds is strong supporting clinical data and a clear path to delivering a meaningful return on investment. We had previously been largely under the radar of Wall Street and institutional investors, but given our success to-date, we are now engaging in a much more aggressive outreach effort. We have a number of important upcoming milestones, that if successful, we believe will drive meaningful value for shareholders."

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On September 2016 Oxford BioMedica plc (LSE: OXB), ("OXB" or "the Group") a leading gene and cell therapy group, reported interim results for the six months ended 30 June 2016 (Press release, Oxford BioMedica, SEP 13, 2016, View Source [SID:SID1234515125]).

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HIGHLIGHTS (including post-period end):

OPERATIONAL

State-of-the-art bioprocessing facilities
Capacity expansion of bioprocessing and laboratory facilities now complete and approved for GMP vector manufacture

Partnering activities continuing to build

Novartis contract progressing well, contributing to 184% growth in first half Group revenues – multiple confirmed purchase orders through to Q2 2017
Second CAR-T programme for undisclosed indication underway with Novartis
New IP licence and expanded collaboration agreement signed with Immune Design
R&D collaboration signed with Green Cross LabCell to identify and develop gene modified natural killer (NK) cell-based therapeutics

Good progress across product development programmes

OXB to capture value of clinical products via out-licensing or spin out approach
OXB-102 and OXB-202 will be ready to start Phase I/II studies within next 6-9 months, subject to successfully out-licensing or spinning out these products
OXB-302 pre-clinical studies expected to complete by end of 2016
SAR422459 (for Stargardt Disease), licensed to Sanofi, has entered Phase IIa development
Novartis still on course to file CTL019 BLA in early 2017, with approval expected mid-2017 due to Breakthrough Therapy designation

FINANCIAL

Revenue increased by 184% to £12.5 million (H1 2015: £4.4 million) due in large part to Novartis contract
R&D, bioprocessing and administrative costs of £16.1 million (H1 2015: £11.7 million)
Operating loss of £6.9 million (H1 2015: £8.3 million)
Capital expenditure £6.0 million (H1 2015: £4.6 million)
Cash of £11.9 million (31 December 2015: £9.4 million) which includes the $10 million (£7.6 million) ring-fenced under the Oberland loan agreement
Fundraising of £10.0 million net of expenses announced separately today. In February 2016, the Group also raised a net £7.5 million through a 5% placing

Commenting on today’s announcement, John Dawson, Chief Executive Officer at Oxford BioMedica, said: "With world-class facilities, expertise and a broad intellectual property position, Oxford BioMedica is a leading gene and cell therapy company. Our unrivalled expertise in the bioprocessing and production of lentiviral vector makes us an ideal partner for the increasing number of potential companies wishing to use this exciting technology in clinical studies and, in due course, commercial therapeutics.

"Oxford BioMedica’s wholly-owned priority product programmes have progressed well during the period. In order to advance the clinical assets as expeditiously as possible whilst still capturing value for shareholders, the Group has decided to employ an external funding approach, via spin outs or out-licensing partnerships. Based on this approach, the proceeds raised in today’s fundraising will enable us to build upon our strong position by furthering the development and enhancement of our proprietary lentiviral vector delivery platform technology as we look to maximise bioprocessing revenues."

Nabi Biopharmaceuticals has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Nabi Biopharmaceuticals, SEP 13, 2016, View Source [SID1234515123]).

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On September 13, 2016 Siamab Therapeutics, Inc., a biotechnology company developing novel cancer immunotherapies, reported new pre-clinical data that showed its novel ST1 antibody drug conjugates (ADCs) target chemoresistant ovarian cancer cells and demonstrate strong efficacy in ovarian cancer models (Press release, Siamab Therapeutics, SEP 13, 2016, View Source [SID:SID1234515130]). These data were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper)’s 11th Biennial Ovarian Cancer Research Symposium 2016 in Seattle, Wash., on Monday, Sept. 12, 2016.

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"The preclinical results are exciting and show the potential of our antibody approach to target chemoresistant tumors in ovarian cancer"

Siamab’s ST1 ADCs target the cancer associated antigen, sialyl-Tn (STn) with high specificity and affinity. STn is present on multiple solid tumors including ovarian, pancreatic, prostate and colon, while showing little normal tissue expression, and has been implicated in immune suppression, metastasis, and a cancer stem cell phenotype.

"The preclinical results are exciting and show the potential of our antibody approach to target chemoresistant tumors in ovarian cancer," said Jeff Behrens, president and chief executive officer of Siamab Therapeutics. "We have developed multiple anti-glycan antibodies and ADCs with unprecedented cancer specificity and efficacy in animal models. These findings hold promise for developing new cancer therapeutics for ovarian cancer patients with disease recurrence who have limited treatment options."

The preclinical data were presented in a poster titled "Targeting a chemoresistant ovarian cancer cell population via the carbohydrate antigen sialyl Tn." The findings showed that Siamab’s ST1 ADCs significantly reduce tumor volume in a sustained fashion in ovarian cancer models. In addition, Siamab’s ST1 target, STn, demarks a population of cells that display a cancer stem cell phenotype as demonstrated by colony- and sphere-forming assays. The findings also showed that following platinum- and taxane-based cytotoxic chemotherapy, STn+ cancer cells are significantly enriched, further supporting their cancer stem cell and chemoresistant phenotype.

Siamab collaborated with Bo Rueda, Ph.D., director of the Vincent Center for Reproductive Biology, in the Department of Obstetrics and Gynecology at Massachusetts General Hospital on this research, funded by a National Cancer Institute SBIR Phase I contract. The collaboration explored the potential of Siamab’s anti-glycan antibodies to target populations of chemoresistant cancer cells. This research also looked at the relationship between tumor associated carbohydrate antigens (TACAs) and chemoresistant cancer cells that demonstrate a cancer stem cell (CSC) phenotype.

"We know chemoresistant cancer cells play a central role in disease recurrence and are particularly challenging to target," said Dr. Rueda. "Siamab’s ADCs targeted STn positive cells, demarking a chemoresistant population, and were effective in shrinking ovarian tumors in animal models. I look forward to continuing to work closely with Siamab as they move this program toward clinical development."

On September 12, 2016 PRA Health Sciences, Inc. (NASDAQ: PRAH) and Takeda Pharmaceutical Company Limited (TSE: 4502) reported that the companies have entered into a new partnership agreement under which PRA Health Sciences (PRA) will serve as Takeda’s primary strategic partner to deliver on the company’s pipeline and marketed products clinical development and post-approval needs (Press release, Takeda, SEP 12, 2016, View Source [SID:SID1234515124]).

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"This partnership is a fundamental part of Takeda’s R&D transformation and represents a truly innovative approach to clinical development, unprecedented in our industry," said Andy Plump, M.D., Ph.D., Director, Chief Medical and Scientific Officer at Takeda. "PRA has a reputation for providing tailored sourcing solutions. We believe PRA will be an ideal partner as we focus, deliver and advance our current and future pipeline."

The innovative partnership provides a flexible operating model that combines operational expertise, transferred from Takeda to PRA, with PRA’s wide range of global capabilities. This model is aimed to improve operating efficiencies, drive globalization and reduce fixed infrastructure costs. This flexible approach will facilitate the development of new medicines by focusing resources, teams and activities where needed, an important requirement for an industry-leading, highly agile R&D organization focused on meeting patient needs.

"This partnership is an exciting opportunity for PRA and represents a significant milestone and transformational business opportunity for us," said PRA Chief Executive Officer Colin Shannon. "This is the first time that a pharmaceutical company and a clinical research organization (CRO) have come together to create such a comprehensive business and operational strategy. This partnership model redefines collaboration and is the first of its kind in the CRO industry."

The partnership will enable PRA to utilize its internal resources and expertise to manage an entire pipeline of studies for Takeda, across Phases I-IV and provide Regulatory, Pharmacovigilance and other operational services for both development and marketed product portfolios. The transformation is expected to result in approximately 300 Takeda employees supporting drug development and marketed products to be given the opportunity to transition to PRA in the United States and Europe, subject to appropriate information and consultation with works councils, unions, and employee representatives. Discussion regarding Japan employees is ongoing between Takeda and PRA.