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.

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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]).

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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.

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"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.

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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 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]).

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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.