1stOncology™: Cancer Intelligence Service – Page 13119 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

LineaRx and Takis/Evvivax Anti-Cancer Vaccine Candidates Demonstrate Tumor Reduction

On September 19, 2019 Applied DNA Sciences Inc. (NASDAQ: APDN) ("Applied DNA"), a leader in large-scale PCR-based DNA manufacturing, reported that LineaRx, Inc. ("LineaRx"), its majority-owned subsidiary focused on next-generation biotherapeutics, and its collaborators Takis/Evvivax have completed pre-clinical animal studies of two vaccine candidates produced with linear DNA (Press release, Applied DNA Sciences, SEP 19, 2019, View Source [SID1234539640]). Tests of both vaccines in mouse models demonstrated their ability to eliminate tumors in vivo, and to potentially prevent initial occurrence.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

Evvivax S.R.L. designed a synthetic gene sequence to produce immunity in companion animals, directed against the protein telomerase (TERT), which is overexpressed in 85% of all mammalian cancers, whereas Takis S.R.L. designed a neoantigen-based cancer vaccine (TK), as a proof-of-concept of personalized immunology. For the studies, the TERT and TK based vaccines were produced in linear DNA form by LineaRx. Here is a summary of the recently completed studies performed in vivo:

Previous results from Phase 1 of the collaboration’s Joint Development Agreement (JDA) confirmed immunogenicity in mice that were vaccinated with linear DNA against the human protein telomerase. The results reported herein are from the Phase 2 of the JDA using mice implanted with murine colon cancer.
In the prophylactic use of the telomerase vaccine, wherein vaccination is done before addition of tumor cell lines to the mice, transplanted tumors were cleared within 10 days.
In the therapeutic application using either TERT or TK linear DNA vaccine application, cancer cells were introduced and allowed to grow before administration of the vaccine. The successful reduction of total tumor mass was accomplished in conjunction with antibodies that targeted PD-1 and CTLA4. These antibodies, known as Checkpoint Inhibitors, are commonly used in oncology strategies that rely upon immunotherapy. In this setting the tumor cells were reduced significantly within 30 days.
The strategy of the Takis TK neoantigen vaccine uses unique multiple-target antigenic epitopes that have been identified from the tumor of a human patient. The linear DNA can utilize the genes for several of the most effective universal antigens such as TERT, or neoantigens that are more personalized to the patient.
"We know that immune system has a key role in fighting cancer" said Dr. Luigi Aurisicchio, CEO of Takis/Evvivax. "Thanks to a deep knowledge of cancer immunobiology and cutting-edge vaccination technologies we have now the tools to provide new therapies to our pet friends and human patients."

"Our unique triumvirate of JDA partners is compelling, in that clinical data accumulated from linear DNA vaccines for companion animals can be used to accelerate translation to human therapies by Evvivax and Takis" said Dr. James Hayward, president and CEO of Applied DNA and LineaRx. "Cancer vaccines would extend the lives of many family pets, and the benefit we believe would rapidly enure to humans."

Linear DNA vaccines are being spearheaded by LineaRx to drive more efficient production methods and what are believed to be safer therapies for patients. Current production standards for human DNA vaccines use the circular DNA of plasmids that are grown in bacteria. However, this raises concerns regarding the risk of integration of bacterial genes including the antibiotic-resistance genes into the human genome or transfer into commensal bacteria, that are a normal part of the human bacterial flora.

Dr Aurisicchio concluded, "The advantages of linear DNA should improve the safety and efficacy of all gene therapies, both in animals as well as humans." The JDA partners expect to publish their results in the scientific literature soon and will initiate planned Phase 3 work in companion animals.

Anixa Biosciences Commences Collaboration with Potomac Urology Center on Cchek™ Prostate Cancer Study

On September 19, 2019 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on harnessing the body’s immune system to fight cancer, reported that Potomac Urology Center, PC ("PUC") has joined its Cchek early cancer detection study (Press release, Anixa Biosciences, SEP 19, 2019, View Source [SID1234539639]). PUC will provide patient samples for Anixa’s ongoing prostate cancer study, including support of clinical validation of Anixa’s Cchek Prostate Cancer Confirmation test.

Dr. Nilay M. Gandhi, who will serve as the Principal Investigator at PUC for the study, stated, "We’re excited to take part in the development of Anixa’s Cchek prostate cancer detection test and we look forward to the impact this test may have on improving patient care."

"We are pleased to have PUC join us as a key collaborator in the development of Cchek, our artificial intelligence driven liquid biopsy for early cancer detection," stated Dr. Amit Kumar, CEO of Anixa. "Further, we look forward to PUC’s participation as we prepare for the commercial launch of our Cchek Prostate Cancer Confirmation test later this year."

PUC is an expert urology practice committed to providing the highest quality care to patients throughout the Northern Virginia area in the diagnosis and treatment of urology related conditions.

Trobix Bio Secures Funding from the Israel Innovation Authority

On September 18, 2019 Trobix Bio, a newly established start-up with a unique set of proprietary phage-based antibiotic resistance sensitizing solutions, reported that the Israel Innovation Authority (IIA) recently approved a grant for Trobix Bio to receive funding through the IIA "Early Stage Companies Incentive Program" (Press release, Trobix Bio, SEP 18, 2019, View Source [SID1234644363]). This funding will support the continuing development of novel products that abolish bacterial antibiotic resistance.

The IIA, previously known as the Office of the Chief Scientist of Israel’s Ministry of Economy, is an independent publicly funded agency, which acts as the support arm of the Israeli government to help facilitate the development of industrial R&D within the State of Israel.

"Trobix Bio is pioneering the development of products to treat the global crisis of antimicrobial resistance, and the support of our program by the IIA is proof of their confidence in the potential of Trobix Bio to combat antibiotic resistance with our unique technology," said Dr. Adi Elkeles, Founder and CEO of Trobix Bio. "We are grateful for the financial support from the IIA, which complements our seed funding that was completed in March 2019, thus enabling us to spring board the development of our initial product pipeline."

STORM Therapeutics presents breakthrough data showing in vivo efficacy and therapeutic proof of concept for targeting RNA modifying enzymes

On September 18, 2019 STORM Therapeutics, the biotechnology company focused on the discovery of small molecule therapies modulating RNA epigenetics reported that Oliver Rausch, Chief Scientific Officer of STORM Therapeutics will present first of its kind data on targeting RNA modifying enzymes for cancer treatment at its inaugural "RNA Epigenetics in Human Disease Conference" taking place at St Catharine’s College, Cambridge, UK on 17-20 September 2019 (Press release, STORM Therapeutics, SEP 18, 2019, View Source [SID1234561039]). Attendees are from renowned academic research institutions and pharmaceutical and biotechnology companies worldwide.

The presentation will take place at 12:00 BST today, Wednesday 18th September and is entitled "Targeting RNA modifying enzymes for the treatment of cancer".

Oliver Rausch will present research encapsulating STORM’s ground-breaking work on targeting RNA modifying enzymes for cancer treatment. He will describe how it employs leading analytical and drug discovery capabilities to establish a comprehensive pharmacological audit trail linking therapeutic efficacy to METTL3 target and pathway inhibition. STORM has identified small molecule inhibitors of METTL3 that are orally bioavailable and show pronounced anti-tumour efficacy in physiologically relevant, proof of concept animal models of Acute Myeloid Leukaemia (AML). The talk will demonstrate that small molecule inhibition of METTL3 produces the same phenotype and effects previously described in one of STORM’s founder scientists publications using genetic models and validates METTL3 as a druggable target for cancer.

Keith Blundy, CEO of STORM Therapeutics, said: "STORM is the first Company in the world to demonstrate in vivo activity of an RNA methyltransferase inhibitor, showing proof of concept efficacy in animal models and is on course to enter the clinic in 2021. STORM is exploring the potential of its first-in-class inhibitors in various solid and haematological cancers and other therapeutic areas. We are excited to be leading the field as we look to develop these highly innovative new treatment options for cancer patients."

Tony Kouzarides, Founder of STORM Therapeutics, added: "We founded STORM Therapeutics to lead and accelerate development of drugs targeting RNA epigenetics. We are proud to be the first company making significant progress towards this aim, with multiple programmes in in vivo testing currently."

For more information on the RNA Epigenetics in Human Disease Conference and the programme please visit: https://stormtxconference2019.com/

Fate Therapeutics Announces Completion of Public Offering of Common Stock and Full Exercise of Underwriters’ Option to Purchase Additional Shares

On September 18, 2019 Fate Therapeutics, Inc. (the "Company" or "Fate Therapeutics") (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported the closing of an underwritten public offering of 9,890,000 shares of its common stock, which included 1,290,000 shares that were issued pursuant to the full exercise of the underwriters’ option to purchase additional shares, at a public offering price of $17.50 per share (Press release, Fate Therapeutics, SEP 18, 2019, View Source [SID1234539634]). Aggregate gross proceeds from this offering, including exercise of the option, were approximately $173.1 million, prior to deducting underwriting discounts and commissions and estimated offering expenses. Fate Therapeutics intends to use the net proceeds from the offering to fund clinical trials and nonclinical studies, the manufacture of its clinical product candidates, the expansion of its cGMP compliant manufacturing operations, the conduct of preclinical research and development, and for general corporate purposes.

Jefferies, Citigroup, SVB Leerink and Wells Fargo Securities acted as joint book-running managers for the offering. Wedbush PacGrow and Cantor Fitzgerald & Co. acted as co-managers for the offering.

The securities described above were offered by Fate Therapeutics pursuant to a shelf registration statement on Form S-3 (File No. 333-228513) previously filed with and declared effective by the Securities and Exchange Commission (the "SEC"). A final prospectus supplement related to the offering was filed with the SEC on September 13, 2019 and is available on the SEC’s website at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the securities offered may also be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by e-mail at [email protected] or by telephone at (877) 821-7388; Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (800) 831-9146; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525 ext. 6132 or by email at [email protected]; or Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 375 Park Avenue, New York, New York 10152, by email at [email protected] or by telephone at (800) 326-5897.

This press release does not constitute an offer to sell or the solicitation of an offer to buy, 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.