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Kite Highlights Durable Complete Remissions Up to 56+ Months in Patients with Chemorefractory Aggressive Non-Hodgkin Lymphoma (NHL) after Anti-CD19 CAR T-Cell Therapy at the National Cancer Institute

On July 20, 2017 Kite Pharma, Inc. (Nasdaq:KITE), a leading cell therapy company, reported the recent online publication of results in Molecular Therapy from a National Cancer Institute (NCI) study of anti-CD19 chimeric antigen receptor (CAR) T-cell therapy in patients with aggressive NHL including diffuse large B-cell lymphoma (DLBCL) (Press release, Kite Pharma, JUL 20, 2017, View Source [SID1234519835]). The research, led by James N. Kochenderfer, M.D., an Investigator in the Experimental Transplantation and Immunology Branch of the NCI Center for Cancer Research, and Steven A. Rosenberg, M.D., Ph.D., Chief of the Surgery Branch at NCI’s Center for Cancer Research, was performed pursuant to a Cooperative Research and Development Agreement (CRADA) between NCI and Kite.

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This work follows previously published data in the February 2015 issue of the Journal of Clinical Oncology in which nine patients with chemorefractory aggressive NHL were treated with a single dose of anti-CD19 CAR T cells with a CD28 co-stimulatory domain. Seven of the 9 patients were evaluable for response. Complete remissions (CR) were observed in 5 of the 7 evaluable patients. Four of the 5 CRs are ongoing from 38 to 56+ months after treatment. There were no chronic toxicities attributable to CAR T cells except B-cell aplasia and hypogammaglobulinemia. Importantly, 3 of 4 patients in ongoing CR had recovery of normal polyclonal B cells, showing that durable CRs can be maintained in the absence of continued activity of anti-CD19 CAR T cells.

"We are encouraged to see durable CRs ongoing for more than 3 years, which raises a possibility of cure, from a single infusion of anti-CD19 CAR T cells in patients with chemorefractory DLBCL, a population that previously had no curative treatment options. This study helps us to understand the long-term potential for this anti-CD19 CAR T cell therapy (axicabtagene ciloleucel) in the larger aggressive NHL patient population," said David Chang, M.D., Ph.D., Executive Vice President of Research and Development and Chief Medical Officer of Kite.

Spherix Announces Pricing of Public Offering of Common Stock

On July 19, 2017 Spherix Incorporated ("Spherix" or the "Company") (NASDAQ: SPEX), an intellectual property development company committed to fostering of technology and monetization of intellectual property, reported that it has priced a firm commitment underwritten public offering of 1,250,000 shares of its common stock at a price to the public of $2.00 per share (Press release, Spherix, JUL 19, 2017, View Source [SID1234538990]). In addition, Spherix has granted the underwriter a 45-day option to purchase up to 187,500 additional shares of common stock to cover over-allotments, if any. The offering is expected to close on or about July 24, 2017, subject to satisfaction of closing conditions.

The total gross proceeds of the offering are expected to be approximately $2.5 million. After deducting the underwriter’s discount and other estimated offering expenses payable by Spherix, the net proceeds to the Company are expected to be approximately $2.1 million. These amounts assume no exercise of the underwriter’s over-allotment option.

Laidlaw & Company (UK) Ltd. acted as the sole underwriter for the offering.

The shares are being offered pursuant to a registration statement on Form S-1 (File No. 333-218216) that was declared effective by the Securities and Exchange Commission (SEC) on July 18, 2017. The securities may be offered only by means of a prospectus. A final prospectus supplement related to the offering will be filed with the SEC, and will be available on the SEC’s website at www.sec.gov and may also be obtained from Laidlaw & Company (UK) Ltd., Attention: Syndicate Department, 546 Fifth Avenue, 5th Floor, New York, New York 10036, telephone (212) 953-4900, email: [email protected].

This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, nor may there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Bio-Path Holdings Receives Notice of Allowance for Key U.S. Composition of Matter Patent

On July 19, 2017 Bio-Path Holdings, Inc., (NASDAQ: BPTH), a biotechnology company leveraging its proprietary DNAbilize liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, reported that the United States Patent and Trademark Office has issued a notice of allowance for claims related to the Company’s proprietary liposomal delivery and antisense technology, DNAbilize, including its use in the treatment of cancers, autoimmune diseases and infectious diseases (Press release, Bio-Path Holdings, JUL 19, 2017, View Source [SID1234519839]).

"We are particularly encouraged by the expanding role of our proprietary liposomal delivery and antisense technology as a treatment for a variety of cancers, autoimmune diseases and infectious diseases. This patent further bolsters our intellectual property position and provides us with additional opportunities to build upon this important technology," said Peter H. Nielsen, Chief Executive Officer of Bio-Path Holdings.

The new patent, titled "P-Ethoxy Nucleic Acids for Liposomal Formulation," (based on Application No. 15/294,223) will provide broad protection for application of the DNAbilize technology in the treatment of a variety of cancers, as well as autoimmune and infectious diseases. DNAbilize is a proprietary liposomal delivery and antisense technology, designed to systemically distribute nucleic acid drugs throughout the human body with a simple intravenous transfusion.

Tiziana Life Sciences Announces Initiation of a Phase IIa Clinical Trial with Milciclib in Patients with Hepatocellular Carcinoma

On July 19, 2017 Tiziana Life Sciences plc (AIM: TILS), a clinical stage biotechnology company developing targeted drugs for cancer and inflammatory diseases, reported the enrolment of the first patient in its phase IIa clinical trial with milciclib, a novel inhibitor of cyclin-dependent kinases (CDKs), in patients with refractory hepatocellular carcinoma ("HCC") (Press release, Tiziana Life Sciences, JUL 19, 2017, View Source [SID1234519833]). Top line data from this trial, being conducted in Italy, Israel, Greece and Turkey, is expected in Q4 2018. The primary objective of this multi-centre, multi-country and dose-ranging phase IIa clinical study is to evaluate the safety of milciclib in HCC patients who fail to respond to or are intolerant to the existing standard of care treatment. Subsequently, a phase IIb is planned with the combination of milciclib with the standard of care treatment sorafenib in HCC patients.

Milciclib is an inhibitor of several cyclin-dependent kinases (CDKs), which are commonly overexpressed in tumours resistant to chemotherapy. Accordingly, the investigational therapy will be tested in patients who have failed to respond to the standard of care treatment, sorafenib (NexavarÒ). Preclinical studies conducted strongly suggest that milciclib acts primarily through downregulation of microRNA (miR) 221 and 222, which are known to be associated with hepatocarcinogenesis and overexpression of these miRs is also believed to be associated with development of resistance to sorafenib in HCC patients.

In previous phase I clinical studies, oral treatment with milciclib was found to be safe and well-tolerated in patients with advanced solid tumours such as thymoma and thymic carcinoma, pancreatic carcinoma and colon cancer.1 The combination of milciclib with gemcitabine, a well-known nucleoside analogue, in a phase I dose-escalation study showed favourable clinical responses in approximately 36% of patients with advanced/metastatic tumours, including patients previously considered to be resistant to gemcitabine.2

Gabriele Cerrone, Chairman of Tiziana Life Sciences, commented: "HCC is a real unmet medical need due to its growing incidence and lack of effective therapy. It is the fifth most common cancer worldwide and the second most common cause of death from cancer worldwide."

Kunwar Shailubhai, CEO & CSO of Tiziana Life Sciences, commented: "Oral treatment with milciclib has been well-tolerated in previous studies with cancer patients. We strongly believe, based on its unique mechanism of action, that the drug may have potential to be developed either as a monotherapy or combo-therapy with sorafenib for treatment of HCC."

Dr. Ilan Yaron, Director of the Department of Medicine at Hebrew University Hadassah Medical Center, Israel and Chief Medical Officer of Tiziana Life Sciences, added: "The prognosis for liver cancer is very poor due to lack of effective therapy. We believe that milciclib holds promise as an effective anti-cancer treatment with a high safety profile."

About HCC
Hepatocellular carcinoma is the fifth most common cancer in men and the ninth in women. Additionally, it is the fifth most common cancer worldwide and the second most common cause of death from cancer worldwide.3 The tumour is associated with chronic hepatitis B and chronic hepatitis C infections, as well as with nonalcoholic steatohepatitis. The prognosis for liver cancer is very poor due to lack of effective therapy.

About Milciclib
Milciclib (PHA-848125AC) is a small molecule inhibitor of several cyclin dependent kinases (CDKs) such as CDK1, CDK4, CDK5 and CDK7. CDKs are serine threonine kinases that play crucial roles in progression of the cell cycle from G1 to S phase. Overexpression of CDKs and other downstream signalling pathways that regulate cell cycles have been frequently found to be associated with development of resistance towards chemotherapies. Oral treatment with milciclib was found to be effective in reducing tumour growth in animal models of HCC, possibly through downregulation of miR-221 and miR-222. In a phase I study, oral treatment with milciclib was found to be well-tolerated and the drug showed promising clinical responses in patients with advanced solid malignancies such as in thymic carcinoma, pancreatic carcinoma and colon cancer.

Invenra Enters Collaboration Agreement with Merck to Identify Therapeutic Antibodies Against Challen

On July 18, 2017 Invenra reported a collaboration with Merck, known as MSD outside the United States and Canada, to discover fully human therapeutic antibodies against an unnamed target of interest to Merck (Press release, Invenra, JUL 18, 2017, View Source [SID1234570588]). Financial details of the deal were not disclosed.

"We are excited to be working with this first rate team in Merck," said Dr. Roland Green, CEO of Invenra. "Invenra’s ability to test antibodies for a functional phenotype early in the screening process combined with Merck’s established role as a leader in this field will advance the science regarding difficult to address targets. This collaboration marks a significant milestone for Invenra in its mission to advance the field of antibody discovery through its ultra-high throughput mAbSeqTM technology."

About mAbSeq and B-Body Technologies

Invenra’s proprietary platform is based on ultra-high throughput technology allowing function forward screening of full-length antibodies using Invenra’s mAbSeqTM technology, where antibodies can be directly and quickly interrogated in a multi-plexed fashion with a diverse set of immunotypic and biologically relevant assays. The Invenra technology allows rapid identification of high affinity mAbs with broad epitope coverage while simultaneously performing direct phenotypic screening to isolate those mAbs with the most relevant biological activity. B-Body is a novel bispecific format that can also be screened in large numbers using mAbSeq for bispecific combinations with desired phenotypic characteristics.