On December 19, 2018 Ziopharm Oncology, Inc. (Nasdaq:ZIOP) and TriArm Therapeutics, Ltd, reported they will launch Eden BioCell, Ltd. to lead clinical development and commercialization of Sleeping Beauty-generated CAR-T therapies in the People’s Republic of China (including Macau and Hong Kong), Taiwan and Korea (Press release, Ziopharm, DEC 19, 2018, View Source [SID1234573334]). TriArm is a cell therapy company with operations in Germany, China and the United States that was formed by Panacea Venture Healthcare, a fund co-founded and managed by James Huang, Managing Partner of Kleiner Perkins Caufield & Byers China (KPCB China).

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!

For the territory of China, Taiwan and Korea, Ziopharm will license the rights to Eden BioCell for third-generation Sleeping Beauty-generated CAR-T therapies targeting the CD19 antigen. Eden BioCell will be owned 50-50 by Ziopharm and TriArm. TriArm has committed up to $35 million to this joint venture. Under the terms of the agreement, Eden BioCell has rights in the region to CAR-T cells very rapidly manufactured in two days or less using the Sleeping Beauty platform to express a CD19-specific CAR and membrane-bound interleukin-15, or mbIL15, along with a kill switch. Ziopharm CEO Laurence Cooper, M.D., Ph.D., and Panacea Venture Healthcare Managing Director James Huang will serve on Eden BioCell’s Board of Directors and each party will share decision-making authority.

"Since 2017, we have been doing diligence on ways to address the many obstacles that exist in the production and commercialization of CAR-T immunotherapy. Viral-based CAR-T therapies already are facing cost constraints and limited commercial success in U.S. and EU markets due to the expense and complexity in manufacturing, and this problem will be exacerbated in China, with its healthcare system, reimbursement structure and large patient population," said Mr. Huang. "I am excited to be working with Ziopharm’s Sleeping Beauty platform, which, as the most clinically-advanced non-viral approach to genetical modification of T cells, offers the best chance to simplify manufacturing, reduce costs, and most importantly, help the many patients who need access to these T-cell therapies."

"Advancing our Sleeping Beauty platform in the China region is a key part of both our business development and clinical development strategies," said Dr. Cooper. "James Huang has an outstanding track record of creating value in China, and he and the team at TriArm are ideal partners because they have entrenched relationships with front-line physicians and officials at leading hospitals and regulatory bodies, a commitment to conduct high-quality trials, and state-of-the-art facilities with good manufacturing practices."

TriArm will manage all clinical development to execute trials in China for Eden BioCell. The TriArm team has considerable experience in all areas of drug development, including scientific research, clinical and regulatory areas, as well as significant laboratory and manufacturing know-how regarding T-cell therapies.

Griffin Securities, Inc. acted as the financial advisor for Ziopharm for this licensing agreement.

Conference Call
Ziopharm will host a webcast and conference call on Wednesday, Dec. 19, at 8 a.m. ET to discuss this new joint venture. The call can be accessed by dialing 1-844-309-0618 (U.S. and Canada) or 1-661-378-9465 (international). The passcode for the conference call is 3272014. To access live webcast or the subsequent archived recording, visit the "Investors Events and Presentations" section of the Ziopharm website at www.ziopharm.com. The webcast will be recorded and available for replay on the Company’s website for two weeks.

On December 19, 2018 An obscure sliver of RNA with a grim-sounding name is unexpectedly taking center stage as a linchpin in transforming pre-leukemic cells into full-blown leukemia (Press release, Apexian Pharmaceuticals, DEC 19, 2018, View Source [SID1234532135]). Apexian Pharmaceuticals’ reported that latest studies in collaboration with Indiana University’s Simon Cancer Center investigator Dr. Reuben Kapur show promise for halting that transformation.

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!

These results, published December 6, 2018, in Cell Stem Cell, explain how a long noncoding RNA called Morrbid becomes hyperactivated after an acute inflammatory insult. Morrbid’s overzealous signaling functionally alters the bone marrow’s myeloid cells (precursors to white blood cells) when those cells are deficient in a tumor-suppressor gene called TET2. The cells mature rapidly, increase in absolute numbers, become resistant to programmed cell death, and churn out high levels of inflammatory proteins in a sustained, self-perpetuating response.

Inflammation has long been suspected of contributing to cancer, but these results establish a causative link. Dr. Kapur’s and Apexian’s results also support others’ findings that Morrbid controls myeloid cell lifespan.

Using a mouse model that mimics human acute myeloid leukemia, Dr. Kapur and Apexian’s Chief Science Officer, Mark Kelley, PhD demonstrated that Apexian’s flagship compound APX3330 could reduce Morrbid’s activity. Blocking both the precancerous cells’ growth and the cells’ production of inflammatory proteins.

Such anti-inflammatory therapy could be of clinical value in people carrying TET2 mutations.

"Our ongoing pre-clinical research continues to identify the role that APX3330 plays in impacting disease including hematological disorders, said Dr. Mark Kelley, Chief Scientific Officer. "Inflammation plays a critical role in the growth and survival of blood stem cells with pre-leukemia mutations such as TET2 and increases the risk of blood related cancers. APX3330 blocked this change from pre-leukemia to leukemia in the mouse models

On December 19, 2018 Aurinia Pharmaceuticals Inc., (NASDAQ:AUPH)(TSX:AUP) reported its Chairman and Chief Executive Officer, Richard M. Glickman, will present a company overview at the 37th Annual J.P. Morgan Healthcare Conference in San Francisco, CA on Thursday, January 10, 2019 at 10:00am PST, 1pm EST (Press release, Aurinia Pharmaceuticals, DEC 19, 2018, View Source [SID1234532153]).

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!

The presentation will be webcast live and can be accessed via the investor section of the Aurinia website, www.auriniapharma.com. A replay of will also be archived on the site following the event.

On December 19, 2018 INmune Bio Inc., an immunotherapy company developing treatments to reprogram the innate immune system to fight disease, reported that it has been granted Clinical Trial Authorization (CTA) by the United Kingdom (UK) regulatory authority, Medicines and Healthcare products Regulatory Agency (MHRA), for a Phase I clinical trial of its lead therapeutic candidate INKmune (Press release, INmune Bio, DEC 19, 2018, View Source [SID1234532170]). The innate immune drug will be used to treat relapsed and refractory ovarian cancer in a UK based trial.

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!

"The CTA approval for the first clinical trial of INKmune is a major milestone for the company," said RJ Tesi, M.D, chief executive officer and co-founder of INmune Bio. "INKmune is our second cancer program to enter the clinic and will be tested in women with relapsed and refractory ovarian cancer, which accounts for more deaths than any other cancer of the female reproductive system."

Modern cancer therapy strives to harness the patient’s immune system to help control the cancer. Natural killer (NK) cells of the innate immune system must function normally to eliminate residual disease – the cancer left over after traditional cancer therapy that is the cause of cancer relapse. INKmune is a novel cancer therapy that may switch on the patient’s NK cells to attack residual disease that can be the cause of treatment failure.

"This approval represents external validation of our pre-clinical data set using Tumor Primed NK cells against a range of cancer cells which are insensitive to NK killing," says Dr. Mark Lowdell, chief scientific officer and co-founder of INmune Bio. "The way that INKmune activates the patient’s own immune system means that it could be used for many types of cancer; women with ovarian cancer are just the first of many patients we hope to treat with INKmune."

Today, ovarian cancer ranks fifth in cancer deaths among women. In 2018 alone, the American Cancer Society estimated 22,240 new cases in the US. Unfortunately, when ovarian cancer relapse occurs, the average survival is between 12 to 18 months, and fewer than 1 in 10 patients survive beyond five years following standard chemotherapy treatment.

On December 19, 2018 MannKind Corporation (Nasdaq: MNKD) (MannKind) reported the pricing of an underwritten public offering of 26,666,667 shares of its common stock and warrants to purchase up to an aggregate of 26,666,667 shares of its common stock (Press release, Mannkind, DEC 19, 2018, View Source [SID1234532189]). Each share of common stock is being sold together with a warrant to purchase one share of common stock for a combined purchase price of $1.50, for a gross deal size of $40.0 million, not including any future proceeds from the exercise of the warrants and before deducting the underwriting discounts and commissions and offering expenses. Each warrant will have an exercise price of $1.60 per share, will be exercisable immediately and will expire on the 12-month anniversary of the date of issuance. The shares of common stock and warrants can only be purchased together but will be issued separately and will be immediately separable upon issuance. The offering is expected to close on December 26, 2018, subject to customary closing conditions.

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!

Leerink Partners is acting as sole book-running manager for the offering. BTIG, LLC and Oppenheimer & Co. Inc. are acting as co-lead managers for the offering. H.C. Wainwright & Co., LLC acted as a financial advisor to MannKind in connection with the offering.

The securities described above are being offered by MannKind pursuant to a shelf registration statement on Form S-3 (No. 333-210792) previously filed by MannKind with the Securities and Exchange Commission (SEC) on April 18, 2016 and declared effective on April 27, 2016. The offering will be made only by means of a written prospectus and prospectus supplement that form part of the registration statement. A preliminary prospectus supplement related to the offering and accompanying prospectus has been filed with the SEC and is available on the SEC website located at View Source Copies of the final prospectus supplement and the accompanying prospectus related to the offering, when available, may be obtained from Leerink Partners LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, telephone: (800) 808-7525, ext. 6132, or by email at [email protected].

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