News from Katan Assocaites

Seth to Present at Sachs Cancer Bio Partnering Forum

Tue, 21 May 2013 00:00:00 GMT

Sachs Cancer Bio Partnering Forum
Promoting Public & Private Sector
Collaboration & Investment in Drug Development
21st – 22nd May 2013 • Westin Copley Place, Boston

The Sachs Cancer Bio Partnering Forum is designed to bring together thought leaders from cancer research institutes, patient advocacy groups, pharma and biotech to facilitate partnering and funding/investment. We expect around 300 delegates and there is an online meeting system and meeting facilities to make the event transactional. There will also be a track of presentations by research institutes, patient advocacy groups, pharmaceutical companies on partnering and biotech’s seeking licensing/investment.

Invion, Ltd. announces Investigational New Drug Application (IND) for INV103 (ala-Cpn10)

Wed, 24 Apr 2013 00:00:00 GMT

Clinical-stage drug development company Invion Limited (ASX:IVX) today announced the submission of an Investigational New Drug application (IND) to the U.S. Food & Drug Administration (FDA) for INV103 (ala-Cpn10), a modified version of the naturally occurring human protein, chaperonin10.

If accepted, the IND will enable Invion to begin phase II clinical studies in patients with systemic lupus erythematosus (SLE or lupus).

The submission follows the company’s pre-IND meeting with the FDA on 14 December 2012.

“The submission of this IND with the FDA is a major milestone for the company and a testament to our team’s determined efforts to progress this program. Led by Dr Mitchell Glass, the Invion team has moved swiftly to pre-IND and then IND stage, and are now focussed on the next step in the development path for this drug,” said Dr William Garner, Chief Executive Officer.

“If granted, the lupus IND will be the second IND that Invion is working under to develop its assets. This is a significant achievement for a company of our size and operational leanness”, he said.

The submission of the lupus IND is the 50th IND submission for Chief Medical Officer, Dr Mitchell Glass, who has received marketing authorisation for 5 New Drug Application (NDA) submissions with the FDA.

“We believe the data to date clearly demonstrates that the investigation of INV103 as a therapy for lupus is warranted, and we look forward to continuing our work to elucidate clinically meaningful results for this drug,” Dr Glass said.

About INV103 (ala-Cpn10): Target Product Profile

INV103 (ala-Cpn10) is a modified version of the natural human protein, chaperonin10, which has biological activity ideally suited to the treatment of inflammation associated with autoimmune disease. IL-6 is a marker of vascular inflammation, and with INV103 clinical data to date that includes a significant reduction in biomarkers of inflammation including serum IL-6, INV103 is targeted as a potential new therapy in the under-serviced lupus market.

About Lupus

Lupus is a vascular inflammatory disease that leads to chronic inflammation, antibody production, and tissue damage. The disease occurs more commonly in women and increases risk of other health problems including heart disease, kidney disease and osteoporosis. In March 2011, the FDA approved the first new drug for lupus in more than 50 years which is both a reflection of the complexity of the disease and a clear indication of a major unmet clinical need. The lupus drug market is predicted to reach sales of over $4B in the US and five major EU markets by 2020.

About the Clinical Trial Protocol

The Protocol as submitted is entitled a “Double-blinded, randomized, placebo-controlled study to investigate the safety, tolerability, pharmacokinetics, and biochemical activity of intravenous ala-Cpn10 administration in subjects with SLE.” The Protocol Number is IVXCpn001. The primary objective is to evaluate the safety, tolerability and efficacy of four-week treatment with Cpn10 in subjects with mild SLE. The adverse event profile and safety laboratory parameters will be monitored throughout the study. The primary outcome measure is the reduction from baseline serum IL-6 levels at the end of active dosing, comparing treatment to placebo cohort. Secondary outcome measures include safety and toxicity, pharmacokinetics (PK) and an assessment of anti-drug antibodies (ADAs). Exploratory endpoints include Safety of Estrogens in the Lupus Erythematosus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) score; pharmacodynamics (PD) (serum biomarkers correlated with disease activity and the inflammatory response of patient immune cells); and changes in other serologic measures including autoantibodies and indicators of systemic inflammation and vascular damage. Details of this clinical trial can be found at www.clinicaltrials.gov with the identifier: NCT01838694.

About the Clinical Trial site and Principal Investigator

The Altoona Center for Clinical Research (ACCR) is a privately owned, 40,000 square foot state-of-the-art research and group private practice facility located in Duncansville, Philadelphia. ACCR is dedicated to providing quality clinical research with the highest standards of patient safety. Over 740 studies have been completed at the center for at least 100 different Sponsors and CRO’s. The Center was founded in 1991 by Alan J. Kivitz, MD, CPI. Dr. Kivitz is a Certified Physician Investigator and a member of the Osteoporosis & Arthritis Investigator Networks. Dr Kivitz and his team of rheumatologists have a combined 48 years of clinical research experience. All four physicians are Board Certified in Rheumatology and Internal Medicine.

About Invion Limited

Invion is a clinical-stage drug development company focussed on the development of treatments for major opportunities in the inflammatory diseases market including asthma and COPD ($34B) and lupus (to $4B)i. The Company’s strategy is for the cost-effective development of its assets to late phase II before negotiating commercial partnerships. Invion has two phase II proprietary therapeutic candidates: INV102 (nadolol), a beta blocker being repurposed to treat inflammatory lung conditions; and, INV103 (ala-Cpn10), a modified human protein being targeted to the treatment of autoimmune inflammation. These assets are in phase II clinical programs in chronic bronchitis (smoking cessation), asthma and systemic lupus erythematosus (lupus). Medical, regulatory and commercial precedent, as well as existing phase II data, supports Invion’s development strategy which is being carried out under an experienced management team including Dr Mitchell Glass who has filed five 50 INDS and 5 NDAs with the FDA. Invion’s strategic partners include the United States National Institutes of Health (NIH) which is funding the phase II asthma program in excess of $4 million (non-dilutive). This is an exciting validation by one of the most prominent medical research bodies in the world.

Seth to Present at BIO 2013 Panel Discussion

Tue, 23 Apr 2013 00:00:00 GMT

Survival Strategies for Companies Under $100M Market Cap: Routes to Equity and Exits for Micro-Cap Companies

Description

Micro-cap biotech companies, those with market capitalizations of less than $100 million, are considered speculative and risky at best for investors and prospective partners. However, these companies today account for the majority of public and private companies operating globally. While raising cash is either close to impossible or impossibly dilutive, M&A between these industry have-nots presents opportunities for survival by strategically combining resources and assets to create more viable entities. With the right assets, management team and operating platform, non-crippling equity may return, along with willing suitors and deals that will satisfy investors. Industry analysts predict that takeover plays are only going to increase for smaller biotechs in 2013. Why? Recent data from Thomson Reuters shows that biotech M&A activity is at a four-year high as large pharma faces major patent cliffs. As of December 2012, biotech M&A dollars exceeded $30.6 billion, compared to roughly $15 billion in the same period of 2011. While larger financings and M&A transactions have high visibility, what about the trends for smaller companies? Expect speculative and lively discussion as this panel takes a frank look at successful and unsuccessful financings and M&A strategies for smaller companies. Don’t miss the opportunity to ask this group of experts for feedback and ideas that may guide your company along the path towards survival and/or exit.

Learning Objectives:

Review lessons and strategies for M&A activity among smaller companies
Learn how to structure smaller M&A transactions that merge public and private companies
Outline how smaller M&A deals occur between domestic and international companies

Advaxis and FusionVax Sign a Memorandum of Understanding for the License of Advaxis’ ADXS-HPV in Asia

Mon, 22 Apr 2013 00:00:00 GMT

Advaxis and FusionVax Sign a Memorandum of Understanding for the License of Advaxis’ ADXS-HPV in Asia

Advaxis’ First Commercial Licensing Opportunity for its Lead Product Candidate ADXS-HPV

Advaxis, Inc., (OTCBB: ADXS) (“Advaxis” or the “Company”), a leader in developing the next generation of immunotherapies for cancer and infectious diseases, announced that it has entered into a Memorandum of Understanding (MoU) with FusionVax, Inc. (“FusionVax”) setting forth the main terms under which Advaxis will, subject to the entry of a definitive agreement, exclusively license its lead clinical stage product candidate, ADXS-HPV, to FusionVax for Asia.

FusionVax is a private Taiwan-based biopharmaceutical company developing immunotherapies for the treatment of HPV-associated cancers. It is committed to in-licensing and developing early to late phase product candidates with primary disease targets of cervical cancer and lung cancer with a secondary focus on treatments for CIN, oropharyngeal cancers, and genital warts. FusionVax develops its licensed technologies through collaborations with top academic leaders at prestigious medical centers in Asia including: National Taiwan University, Taipei Medical University, and Mackay Memorial Hospital Medical Center.

Dr. HunChi Lin, Chief Executive Officer of FusionVax, commented, "We are very pleased to have the opportunity to collaborate with Advaxis to develop vaccines for the treatment of cervical cancer, a cancer that is the leading cause of the death of Chinese women."

Under the terms of the MoU, Advaxis will exclusively license the rights to ADXS-HPV to FusionVax for the Asia territory, exclusive of India, for all indications. In exchange, FusionVax will pay Advaxis an up-front payment, certain event-based financial milestones, an annual exclusive licensing fee, and an annual net sales royalty in countries with issued patents. In exchange for the up-front payment, Advaxis will provide FusionVax an equal amount of Advaxis common stock. FusionVax will be responsible for conducting clinical trials and pursuing commercialization of ADXS-HPV in Asia and, in exchange, Advaxis will pay FusionVax net sales annual royalty on ADXS-HPV in the U.S. of less than 1%. The companies will share all data generated from their respective clinical trials.

Under the terms of the MoU, Advaxis and FusionVax will work together over the next six months to enter into a definitive exclusive licensing agreement based upon these terms. FusionVax has agreed to place into escrow a portion of the first event-based milestone pending the execution of a definitive licensing agreement.

“FusionVax is well-positioned to further develop ADXS-HPV clinically and to realize its commercial value in Asia across multiple HPV-associated cancers,” commented Daniel J. O’Connor, Senior Vice President, Chief Legal and Business Development Officer of Advaxis.

“With five studies currently in the field in four indications, we continue to broaden our data. This MoU is the first milestone on Advaxis’ path to future licensing opportunities,” commented Thomas A. Moore, Chairman and Chief Executive Officer of Advaxis.

About Advaxis, Inc.

Advaxis is a clinical-stage biotechnology company developing the next generation of immunotherapies for cancer and infectious diseases. Advaxis immunotherapies are based on a novel platform technology using live, attenuated bacteria that are bio-engineered to secrete antigen/adjuvant fusion protein(s) designed to redirect the powerful immune response all human beings have to the bacterium to the cancer itself.

ADXS-HPV is being evaluated in 5 clinical trials for HPV-associated diseases: recurrent/refractory cervical cancer (Phase 2, India), locally advanced cervical cancer (Phase 2, GOG/NCI US study, Clinical Trials.gov Identifier NCT01266460), CIN 2/3 (Phase 2, US study, Clinical Trials.gov Identifier NCT01116245), head & neck cancer (Phase 1/2, CRUK study, Clinical Trials.gov Identifier NCT01598792), and anal cancer (Phase 1/2, BrUOG study, Clinical Trial.gov Identifier NCT01671488). Over fifteen (15) distinct constructs are in various stages of development, developed directly by the Company and through strategic collaborations with recognized centers of excellence such as: the National Cancer Institute, Cancer Research – UK, the Wistar Institute, the University of Pennsylvania, the University of British Columbia, the Karolinska Institute, Brown University Oncology Group, and others. For more information please visit: advaxis.com | Facebook | twitter | LinkedIn

Forward-Looking Statements

This news release contains forward-looking statements, including, but not limited to: statements regarding ADXS-HPV, its clinical stage product candidate, and immunotherapies, as well as statements regarding the entry into a definitive licensing agreement with FusionVax, as well as Advaxis’ ability to develop ADXS-HPV further clinically and realize its commercial value in Asia, the generation of additional data regarding ADXS-HPV, and future licensing opportunities. Such forward-looking statements are subject to a number of risks and uncertainties, such as those described in the “Risk Factors” section in Advaxis’ Annual Report on Form 10-K for the fiscal year ended October 31, 2012, which is available at www.sec.gov, as well as its other filings with the Securities and Exchange Commission. Advaxis undertakes no obligation to revise these forward-looking statements to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. You are cautioned not to place undue reliance on any forward-looking statements.

Contacts

Advaxis, Inc.
Diana Moore, 609-452-9814
Director, Investor Relations & Business Development
ir@advaxis.com

Therakine, Lt.d. Announces Transaction with Rainbow Coral Corp. (OTCBB: RBCC)

Wed, 20 Mar 2013 00:00:00 GMT

NOKOMIS, Fla.--(BUSINESS WIRE)--

In a bid to expand the market for its biotech innovations beyond North America, Rainbow Coral Corp. (RBCC) is seeking out new overseas targets that stand to benefit from adding licenses for the drug delivery protocols that its joint venture partner, TheraKine, has developed.

Some experts believe that the worldwide market for the 10 most popular drug delivery technologies (DDTs) alone could grow to $81.5 billion by 2015. TheraKine is a leader in this marketplace, having developed and patented novel, tunable technologies with the potential to enable selective, site-specific drug delivery that allow for lower drug concentrations and significantly reduced risk of drug toxicity.

In order to build market share in this fast-growing sector, RBCC is looking for overseas healthcare providers for whom TheraKine’s advanced sustained-release delivery system could yield significant returns for their clients.

“Licensing is the key to making this a successful partnership with TheraKine,” said RBCC CEO Patrick Brown. “Together, we can spread this revolutionary technology around the globe to the doctors and patients who need it most.”

For more information on Rainbow BioSciences’ personalized medicine initiatives, please visit www.rainbowbiosciences.com/investors.html.

Rainbow BioSciences will develop new medical and research technology innovations to compete alongside companies such as Bristol Myers Squibb Co. (NYSE: BMY), Biogen Idec Inc. (NASDAQ: BIIB), Abbott Laboratories (NYSE: ABT) and Amgen Inc. (NASDAQ: AMGN).

About Rainbow BioSciences

Rainbow BioSciences, LLC, is a wholly owned subsidiary of Rainbow Coral Corp. (OTCBB: RBCC). The Company continually seeks out new partnerships with biotechnology developers to deliver profitable new medical technologies and innovations. For more information on our growth-oriented business initiatives, please visit www.RainbowBioSciences.com. For investment information and performance data on the Company, please visit www.RainbowBioSciences.com/investors.html.

Notice Regarding Forward-Looking Statements

Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: This news release contains forward-looking information within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements that include the words "believes," "expects," "anticipate" or similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of the Company to differ materially from those expressed or implied by such forward-looking statements. In addition, description of anyone's past success, either financial or strategic, is no guarantee of future success. This news release speaks as of the date first set forth above and the Company assumes no responsibility to update the information included herein for events occurring after the date hereof.

Contact:
Rainbow Coral Corp.
Patrick Brown, 850-269-7230
President and CEO
info@rainbowcoral.com

Biotech: Outlook 2013 Published Micro-Cap Review Magazine

Mon, 14 Jan 2013 00:00:00 GMT

Seth & Stan wrote a featured article entitled "Biotech: Outlook 2013" which was published in the Micro-Cap Review Magazine.