On October 8, 2019 Galera Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, reported final data from its two-year tumor outcomes follow up of patients with locally advanced squamous cell head and neck cancer treated with its lead product candidate, GC4419 (avasopasem manganese) (Press release, Galera Therapeutics, OCT 8, 2019, View Source [SID1234540954]).

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GC4419, a highly selective and potent small molecule dismutase mimetic, is being developed to reduce the incidence and severity of radiation-induced severe oral mucositis (SOM), its lead indication. SOM is a common, debilitating complication of radiotherapy in patients with head and neck cancer. There is currently no FDA-approved drug to treat SOM in patients with head and neck cancer.

As part of its Phase 2b clinical trial of GC4419 in patients with locally advanced head and neck cancer, Galera assessed tumor outcomes of the patients over a two-year period following radiotherapy. Patients in the trial received seven weeks of radiation therapy plus cisplatin, and were treated with either 30 mg or 90 mg of GC4419 or placebo by infusion on the days they received their radiation treatment. At both the one-year interim assessment and final two-year mark, tumor outcomes were maintained across all four measures – overall survival, progression-free survival, locoregional control and metastasis-free survival – in both GC4419 dose groups (30 mg and 90 mg) compared to placebo.

"We are pleased with these data, which demonstrated GC4419, when added to a standard radiotherapy regimen, maintained the efficacy of treatment for head and neck cancer and reduced debilitating radiation-induced oral mucositis," said Mel Sorensen, M.D., President and CEO of Galera Therapeutics. "GC4419 achieved meaningful reductions in the duration, incidence and severity of SOM in the completed Phase 2b trial. These two-year tumor data further reinforce the potential of GC4419 to be a promising treatment to reduce radiation toxicities and complement standard radiotherapy regimens in head and neck cancer."

Full results will be submitted for presentation at a future scientific meeting.

GC4419 is being evaluated in the ongoing pivotal ROMAN Phase 3 trial in patients with head and neck cancer, with topline data anticipated in the first half of 2021. GC4419 is also currently being studied in combination with stereotactic body radiation therapy for its anti-tumor effect in a pilot Phase 1b/2a trial of patients with locally advanced pancreatic cancer.

About GC4419 (Avasopasem Manganese)

Galera’s lead product candidate, GC4419 (avasopasem manganese), is a highly selective and potent small molecule dismutase mimetic that is being developed for the reduction of SOM in patients with head and neck cancer. GC4419 is designed to rapidly convert superoxide to hydrogen peroxide, reducing mucosal damage and thereby the incidence and severity of mucositis. Left untreated, elevated superoxide can damage noncancerous tissues and lead to debilitating side effects, including oral mucositis, which can limit the anti-tumor efficacy of radiation therapy.

GC4419 is being studied in the Phase 3 ROMAN clinical trial of patients with locally advanced head and neck cancer, its lead indication, for its ability to reduce the duration, incidence and severity of radiation-induced severe oral mucositis. In Galera’s 223-patient, double blind, randomized, placebo- controlled Phase 2b clinical trial, GC4419 demonstrated the ability to reduce the median duration of severe oral mucositis (SOM) from 19 days to 1.5 days (92 percent), the incidence of SOM through completion of radiation by 34 percent and the severity of patients’ OM by 47 percent, and GC4419 was well tolerated in the trial when added to a standard radiotherapy regimen. GC4419 is also currently being studied in combination with SBRT for its anti-tumor effect in a pilot Phase 1b/2a trial of patients with locally advanced pancreatic cancer. In addition, in multiple preclinical studies, GC4419 demonstrated an increased tumor response to radiation therapy while preventing toxicity in normal tissue.

The U.S. Food and Drug Administration granted Breakthrough Therapy and Fast Track designations to GC4419 for the reduction of the duration, incidence and severity of SOM induced by radiotherapy in patients with head and neck cancer.

On October 8, 2019 Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage oncology company targeting the epigenetic causes of cancers, reported that Memorial Sloan Kettering Cancer Center (MSKCC) in New York City and Nationwide Children’s Hospital (Nationwide Children’s) in Columbus, OH have been added as clinical trial sites in the ongoing Phase 1/2 clinical trial of Seclidemstat for the treatment of Ewing sarcoma (Press release, Flex Pharma, OCT 8, 2019, View Source [SID1234540949]). The addition of MSKCC and Nationwide Children’s brings the total number of active clinical trial sites to eight.

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The Phase 1/2 clinical trial of Seclidemstat in patients with relapsed or refractory Ewing sarcoma is an open-label dose escalation and dose expansion study to determine the maximum tolerated dose (MTD) and establish the initial safety profile of Seclidemstat. The dose expansion portion of the study, or phase 2 portion, may provide potential efficacy data. In September, the Safety Review Committee cleared the third dose level (300 mg Seclidemstat twice-daily), and the fourth dose level is currently enrolling (600 mg Seclidemstat twice-daily). Based on current projections, Salarius expects to reach MTD in early 2020 and report initial patient data later in the same year.

"We are excited to now be working with Memorial Sloan Kettering Cancer Center and Nationwide Children’s Hospital to further develop our lead cancer drug candidate Seclidemstat as a potential treatment for Ewing sarcoma," stated David Arthur, President and Chief Executive Officer of Salarius. "Ewing sarcoma is a rare and devastating pediatric bone and soft-tissue cancer for which there are no targeted treatments currently available. We believe Seclidemstat could have a meaningful impact in Ewing sarcoma as a potential new and less toxic treatment, benefitting patients and their families."

Study enrollment at Memorial Sloan Kettering will be led by Paul A. Meyers, M.D., Chief of Pediatric Sarcoma Service and Vice-Chair for Clinical Affairs. Study enrollment at Nationwide Children’s Hospital will be led by Bhuvana A. Setty, M.D., Nationwide Children’s principal investigator.

In addition to MSKCC and Nationwide Children’s, active clinical trial site locations include, Johns Hopkins All Children’s Hospital in St. Petersburg, FL; Children’s Hospital of Los Angeles in Los Angeles, CA; Moffitt Cancer Center in Tampa, FL; Dana-Farber Cancer Institute in Boston, MA; MD Anderson Cancer Center in Houston, TX; and the Sarcoma Oncology Center in Santa Monica, CA.

More information on the Phase 1/2 clinical trial of Seclidemstat in Ewing sarcoma is available at: View Source

On October 8, 2019 Propanc Biopharma, Inc., a Delaware corporation (the "Company"), reported that it has entered into a Securities Purchase Agreement (the "Securities Purchase Agreement") whereby an investor (the "Investor") purchased from the Company, for a purchase price of $125,000 (the "Purchase Price") a Convertible Redeemable Promissory Note, in the principal amount of $131,000 (the "Note") (Filing, 8-K, Propanc, OCT 8, 2019, View Source [SID1234540948]). The Purchase Price was funded on October 2, 2019.

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The Securities Purchase Agreement contains such representations, warranties and covenants as are typical for a transaction of this nature.

Convertible Redeemable Promissory Note

The Note is due and payable on October 1, 2020 (the "Maturity Date") and entitles the holder to 8% interest per annum (the "Interest Rate"). The Note may be converted into shares of the Company’s common stock equal to 40% discount of the lowest closing bid price of the Common Stock, for the ten trading days immediately prior to the delivery of a notice of conversion; provided, however, such conversion shall not be effected to the extent that the Investor together with any of its affiliates would beneficially own in excess of 4.99%, which may be increased up to 9.99% upon 60 days’ prior written notice by the Investor to the Company. The Company may redeem the Note prior to April 2, 2020, as follows: (i) if the redemption occurs within the first 60 days then an amount equal to 115% of the face amount of the Note plus any accrued interest, (ii) if the redemption occurs after the 61st day but on or before the 120th day following the issuance of the Note, then an amount equal to 125% of the face amount of the Note along with any accrued interest, (iii) if the redemption occurs after the 121st day but on or before the 180th day following the issuance of the Note, then an amount equal to 135% of the face amount of the Note along with any accrued interest.

In the event of a default, without demand, presentment or notice, the Note shall become immediately due and payable.

The foregoing provides only brief descriptions of the material terms of the Securities Purchase Agreement and the Note, and does not purport to be a complete description of the rights and obligations of the parties thereunder, and such descriptions are qualified in their entirety by reference to the full text of the forms of Securities Purchase Agreement and the Note, respectively, filed as exhibits to this Current Report on Form 8-K, and are incorporated herein by reference.

On October 8, 2019 INmune Bio, Inc. (NASDAQ: INMB), an immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, reported that RJ Tesi, M.D., Co-Founder and CEO, will present at the 2nd Annual Advances in Immuno-Oncology USA Congress in San Diego taking place on Oct. 8 and Oct. 9 (Press release, INmune Bio, OCT 8, 2019, View Source [SID1234540947]). Dr. Tesi and CJ Barnum, Ph.D., Director of Neuroscience, will also present at the World Immunotherapy Congress taking place in Basel, Switzerland from Oct. 15 through 17.

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"The immuno-oncology field is rapidly growing, and emerging new therapies are at the center of attention," said Dr. Tesi. "With 30% of breast cancer patients being HER2+, trastuzumab has made significant strides in the treatment of breast cancer. Yet, many HER2+ breast cancer patients have shown resistance to the drug. In my presentation during the Advances in Immuno-Oncology USA Congress, I will address one of the reasons for the resistance – specifically the presence of the MUC4 biomarker – and how we may be able to use a soluble TNF inhibitor, such as our drug candidate INB03, to increase the efficacy of trastuzumab in those women who have shown resistance."

Advances in Immuno-Oncology USA Congress brings together global pharmaceutical organizations, leading biotech companies and presents a unique chance to connect scientists on the latest innovations in immuno-oncology therapy development, research and more.

"Our approach to treating patients with Alzheimer’s disease is focused on targeting the root of the disease, chronic inflammation and how we can leverage biomarkers," said Dr. Barnum. "It’s an honor to have the opportunity to present alongside some of the most prominent leaders in the immunotherapy community to approach the field from a non-oncology perspective."

The World Immunotherapy Congress is one of four conferences coordinated by the Festival of Biologics. The vision of the World Immunotherapy Congress is to bring together the full community and provide a single meeting point for where science meets business to make immunotherapy the cornerstone of the fight against cancer and other diseases.

Details on each speaking engagement can be found below:

Advances in Immuno-Oncology USA Congress:
Tuesday, October 8 at 5:20 p.m.
"Targeting Soluble TNF To Reverse Trastuzumab Resistance"
Dr. Tesi will address trastuzumab resistance in breast cancer patients due to the presence of MUC4, and the role of soluble TNF in MUC4 expression in HER2+ breast cancer. He will discuss how using INB03 as part of combination therapy may have positive effects in reversing trastuzumab resistance.

Wednesday, October 9 at 8:00 a.m.
"Alternative Therapeutic Strategies Beyond Checkpoint Inhibitors"
Serving as a moderator, Dr. Tesi will lead a table discussion of notable company spokespeople, covering the latest advances in immunotherapy.

World Immunotherapy Congress:
Tuesday, October 15 at 3:10 p.m.
"Targeting Protector Cells of the TME to Improve Efficacy of Immunotherapy"
Dr. Tesi will lead a discussion around "protector cells" of the TME and how they promote resistance to immunotherapy, and how eliminating MDSC and TAM will improve response to therapy. He will also discuss how INmune’s drug, INB03 targets sTNF as an effective strategy for eliminating MDSC and TAM.

The "Tumor microenvironment" session of the conference will be chaired by Dr. Tesi.

Wednesday, October 16 at 4:40 p.m.
"Approaching Alzheimer’s disease as an immunological disease: role of biomarkers"
Dr. Barnum will discuss how innate immune regulation causes chronic inflammation and development of Alzheimer’s disease, and how approaching AD as an immunological disease changes the clinical strategy, especially when developing biomarkers.

Dr. Barnum will also chair the "Immunotherapy for non-oncology" session of the conference.

On October 3, 2019, Heron Therapeutics, Inc. (the "Company") reported that it has entered into an underwriting agreement (the "Underwriting Agreement") with Jefferies LLC, Cowen and Company, LLC and Evercore Group L.L.C., as representatives of the several underwriters identified in Schedule A thereto (the "Underwriters"), pursuant to which the Company (i) agreed to issue and sell an aggregate of 8,571,429 shares of its common stock (the "Shares") to the Underwriters and (ii) granted the Underwriters an option for 30 days to purchase up to an additional 1,285,714 shares of its common stock that may be sold upon the exercise of such option by the Underwriters (the "Offering") (Filing, Heron Therapeutics, OCT 8, 2019, View Source [SID1234540946]). The Shares were sold at a public offering price of $17.50 per Share and, except with respect to the Shares sold to Tang Capital Partners, LP ("TCP"), were purchased by the Underwriters from us at a price of $16.45 per Share. TCP, an affiliate of Kevin Tang, the Chairman of the Board of Directors of the Company, agreed to purchase 285,714 of the Shares in the Offering at the public offering price. The Underwriters did not receive any underwriting discounts or commissions with respect to the sale of Shares to TCP.

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We estimate that the net proceeds we will receive from the Offering, excluding the proceeds from the additional 1,285,714 shares of common stock that may be purchased by the Underwriters following the exercise of their option, will be approximately $141.1 million, after deducting the Underwriters’ discounts and commissions and estimated offering expenses payable by us.

The Offering was made pursuant to the Company’s automatically effective registration statement on Form S-3 (Registration No. 333-219172), which was previously filed with the Securities and Exchange Commission under the Securities Act of 1933, as amended (the "Securities Act").

The Offering closed on October 8, 2019. In the Underwriting Agreement, the Company agreed to indemnify the Underwriters against certain liabilities, including liabilities under the Securities Act, or to contribute to payments that the Underwriters may be required to make because of such liabilities. A copy of the Underwriting Agreement is attached as Exhibit 1.1 hereto and is incorporated herein by reference. The foregoing description of the Underwriting Agreement does not purport to be complete and is qualified in its entirety by reference to such exhibit.