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.

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 Diplomat Pharmacy, Inc. (NYSE: DPLO), reported that executives will present at this year’s J.P. Morgan Healthcare Conference in San Francisco (Press release, Diplomat Speciality Pharmacy, DEC 19, 2018, View Source [SID1234532136]).

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!

Diplomat’s Brian Griffin, chairman and CEO, and Atul Kavthekar, chief financial officer, are scheduled to present at 8 a.m. PT Monday, Jan. 7. Joel Saban, president, will also attend the conference.

A live audio webcast of the presentation and related presentation materials will be available on the investor relations section of Diplomat’s website at ir.diplomat.is. An audio recording and related presentation materials will be available online for approximately 90 days.

On December 19, 2018 Genomic Health, Inc. (NASDAQ: GHDX) reported that the National Institute for Health and Care Excellence (NICE) in the United Kingdom has issued its updated guidance again recommending the Oncotype DX Breast Recurrence Score test for use in clinical practice to guide adjuvant chemotherapy treatment decisions for certain patients with early-stage breast cancer (Press release, Genomic Health, DEC 19, 2018, View Source [SID1234532154]). Further, NICE expanded its recommendation to include patients with micrometastases, indicating that some cancer cells have spread to the lymph nodes.

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!

"Oncotype DX is the only test that provides specific information about an individual patient’s response to chemotherapy, correctly identifying the important minority of patients who will receive substantial treatment benefit and the majority of patients who will not benefit from chemotherapy," said Simon D H Holt, Honorary Consultant Surgical Oncologist, Peony Breast Care Unit at Prince Philip Hospital in Llanelli, UK. "This test allows us to target treatment much more effectively and should be routinely used for all eligible patients."

The recommendation of the Oncotype DX Breast Recurrence Score test in NICE’s updated guidance is based on the test’s unique ability to predict who will benefit from chemotherapy and who will not. Importantly, NICE acknowledges Oncotype DX as the only test that reduces the overall number of patients who receive chemotherapy, as well as the only test supported by long-term patient outcomes evidence, including the recently published landmark TAILORx study. Further, NICE also found the Oncotype DX test to be the most cost-effective tool in guiding chemotherapy treatment.

"We believe this positive endorsement from NICE reflects the growing global recognition of the unique value Oncotype DX provides," said Torsten Hoof, senior vice president, international, Genomic Health. "As we continue to experience an increasing impact of the TAILORx study results on clinical practice, we believe we are one step closer to broadening Oncotype DX access through increased reimbursement in Western Europe and around the world."

The predictive value of the Oncotype DX Breast Recurrence Score test was also recently acknowledged by Germany’s health technology assessment body, the Institute for Quality and Efficiency in Health Care (IQWiG), which concluded that only the Oncotype DX test has sufficient evidence to guide breast cancer adjuvant chemotherapy decisions based on the TAILORx study results.

Additionally, the U.S. National Comprehensive Cancer Network (NCCN) categorized Oncotype DX as the only "preferred" test for chemotherapy treatment decision-making for node-negative, early-stage breast cancer patients in its 2018 updated treatment guidelines.

About Oncotype DX

The Oncotype DX portfolio of breast, colon and prostate cancer tests applies advanced genomic science to reveal the unique biology of a tumor in order to optimize cancer treatment decisions. The company’s flagship product, the Oncotype DX Breast Recurrence Score test, is the only test that has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer. Additionally, the Oncotype DX Breast DCIS Score test predicts the likelihood of recurrence in a pre-invasive form of breast cancer called DCIS. In prostate cancer, the Oncotype DX Genomic Prostate Score test predicts disease aggressiveness and further clarifies the current and future risk of the cancer prior to treatment intervention. With more than 950,000 patients tested in more than 90 countries, the Oncotype DX tests have redefined personalized medicine by making genomics a critical part of cancer diagnosis and treatment. To learn more about Oncotype DX tests, visit www.OncotypeIQ.com, www.MyBreastCancerTreatment.org or www.MyProstateCancerTreatment.org.