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Inflection Biosciences Announces Publication of Positive Data for PIM/PI3K/mTOR Inhibitor In Neuroblastoma

On August 7th 2019 Inflection Biosciences Ltd, a company developing innovative therapeutics for the treatment of cancer, announced the publication of pre-clinical data showing the company’s PIM/PI3K/mTOR, AUM302 (formerly IBL-302), has promise as a treatment for neuroblastoma (Press release, Inflection Biosciences, AUG 7, 2019, View Source [SID1234538591]). This research has recently been published in the medical journal EMBO Molecular Medicine.

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This publication is the result of a collaboration between Inflection Biosciences and two research teams at the Lund University Cancer Centre, Sweden, led by Associate Professors Sofie Mohlin and Daniel Bexell. Inflection Biosciences recently announced that global development and commercialisation rights to AUM302 were granted to AUM Biosciences, Singapore.

Neuroblastoma is an extracranial childhood malignancy of the nervous system that accounts for 15% of all paediatric cancer fatalities. Despite advances in treatment, children with high‐risk disease have poor survival rates, with up to 40% 5‐year mortality. It has previously been shown that targeting the PI3K/mTOR pathway could be a viable treatment for aggressive neuroblastoma. Furthermore, in neuroblastoma cell lines and patient derived xenograft (PDX) derived cell cultures, high levels of PIM were also significantly associated with adverse neuroblastoma patient outcomes.

These published results show that from a panel of 707 cell lines across 47 tumour types, neuroblastoma was the most sensitive tumour type to AUM302 treatment, and out of 16 neuroblastoma cell lines, AUM302 was generally more effective than PI3K inhibitors alone. AUM302 improved the effect of three clinically used chemotherapeutic agents in vitro. AUM302 treatment alone reduced tumour growth in a neuroblastoma xenograft and inhibited neuroblastoma PDX growth in combination with low‐dose cisplatin.

Dr. Bexell, one of the lead authors on the publication, commented: "Adding AUM302 to current treatments to lower administered doses of highly toxic chemotherapy could decrease complications later in life and improve outcomes in these young neuroblastoma patients."

The publication titled ‘Anti‐tumor effects of PIM/PI3K/mTOR triple kinase inhibitor IBL‐302 in neuroblastoma’ can be accessed here.

The research was funded by the Swedish Cancer Society and the Swedish Childhood Cancer Foundation.

Entry into a Material Definitive Agreement

On August 7, 2019, Phio Pharmaceuticals Corp. ("we" or the "Company") reported that it has entered into a purchase agreement (the "Purchase Agreement") and a registration rights agreement (the "Registration Rights Agreement") with Lincoln Park Capital Fund, LLC ("LPC"), pursuant to which the Company has the right to sell to LPC up to $10,000,000 in shares of the Company’s common stock, $0.0001 par value per share (the "Common Stock"), subject to certain limitations and conditions set forth in the Purchase Agreement (Filing, 8-K, Phio Pharmaceuticals, AUG 7, 2019, View Source [SID1234538542]).

Under the Purchase Agreement, the Company has the right, from time to time at its sole discretion and subject to certain conditions, to direct LPC to purchase up to 200,000 shares of Common Stock on any business day (or $50,000 worth of common stock, whichever is greater) (the "Regular Purchase Amount"). The Company may increase the amount which it directs LPC to purchase, up to a maximum of 500,000 shares of Common Stock, if on the date of the purchase the closing sale price of the Common Stock is not below certain threshold prices, as set forth in the Purchase Agreement, subject in each case to $1,000,000 in total purchase proceeds per purchase date. The purchase price of shares of Common Stock will be based on the market prices of the Common Stock at the time of such purchases. Such sales of Common Stock by the Company, if any, may occur from time to time, at the Company’s option, over the 30-month period commencing on the date that a registration statement, which the Company agreed to file with the Securities and Exchange Commission (the "SEC") pursuant to the Registration Rights Agreement, is declared effective by the SEC and a final prospectus in connection therewith is filed and the other terms and conditions of the Purchase Agreement are satisfied.

In addition to regular purchases, the Company may also direct LPC to purchase additional amounts as accelerated purchases or as additional purchases if the Company has utilized the Regular Purchase Amount in full and if the closing sale price of the Common Stock exceeds certain threshold prices, as set forth in the Purchase Agreement. In all instances, the Company may not sell shares of its Common Stock to LPC under the Purchase Agreement if it would result in LPC beneficially owning more than 9.99% of the Common Stock.

The Purchase Agreement also limits the Company’s issuance of shares of Common Stock to Lincoln Park thereunder to 5,015,730 shares of Common Stock, representing 19.99% of the shares of Common Stock outstanding on the date of the Purchase Agreement unless (a) stockholder approval is obtained to issue more than such amount or (b) the average price of all applicable sales of our common stock to Lincoln Park under the Purchase Agreement equals or exceeds the lower of (i) the closing price of our common stock on the Nasdaq Capital Market immediately preceding August 7, 2019 or (ii) the average of the closing price of our common stock on the Nasdaq Capital Market for the five Business Days immediately preceding August 7, 2019.

LPC represented to the Company, among other things, that it was an "accredited investor" (as such term is defined in Rule 501(a)(3) of Regulation D under the Securities Act of 1933, as amended (the "Act")), and the Company sold the securities in reliance upon private placement exemptions from the registration requirements under Section 4(a)(2) of the Act, as well as Rule 506 under Regulation D under the Act. The Company has agreed with Lincoln Park that it will not enter into any "variable rate" transactions with any third party for a period defined in the Purchase Agreement.

The Purchase Agreement and the Registration Rights Agreement contain customary representations, warranties, agreements and conditions to completing future sale transactions, indemnification rights and obligations of the parties. The Company has the right to terminate the Purchase Agreement at any time, at no cost or penalty. During any "event of default" under the Purchase Agreement, all of which are outside of LPC’s control, LPC does not have the right to terminate the Purchase Agreement; however, the Company may not initiate any regular or other purchase of shares by LPC, until such event of default is cured.

Actual sales of shares of Common Stock to LPC under the Purchase Agreement will depend on a variety of factors to be determined by the Company from time to time, including, among others, market conditions, the trading price of the Common Stock and determinations by the Company as to the appropriate sources of funding for the Company and its operations. As a commitment fee for entering into the Purchase Agreement, the Company has agreed to issue to LPC 500,000 shares of Common Stock (the "Commitment Shares"). The Company will not receive any cash proceeds from the issuance of the Commitment Shares.

The net proceeds under the Purchase Agreement to the Company will depend on the frequency and prices at which the Company sells shares of its stock to LPC. The Company expects that any proceeds received by the Company from such sales to LPC will be used for working capital and general corporate purposes.

This current report on Form 8-K shall not constitute an offer to sell or a solicitation of an offer to buy any shares of Common Stock, nor shall there be any sale of shares of Common Stock in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

The foregoing descriptions of the Purchase Agreement and the Registration Rights Agreement are qualified in their entirety by reference to the full text of such agreements, copies of which are attached hereto as Exhibit 10.1 and 10.2, respectively, and each of which is incorporated herein in its entirety by reference. The representations, warranties and covenants contained in such agreements were made only for purposes of such agreements and as of specific dates, were solely for the benefit of the parties to such agreements, and may be subject to limitations agreed upon by the contracting parties.

Helix BioPharma Corps. Receives U.S. FDA Approval For Phase Ib/II Pancreatic Trial

On August 7, 2019 Helix BioPharma Corp. (TSX: HBP), ("Helix" or the "Company"), an immuno-oncology company developing innovative drug candidates for the prevention and treatment of cancer, reported that it has received approval from the U.S. Food and Drug Administration ("FDA"), to initiate a Phase Ib/II study of L-DOS47 and doxorubicin in advanced metastatic pancreatic cancer (Press release, Helix BioPharma, AUG 7, 2019, View Source [SID1234538499]).

This is an open label, non-randomized study designed to evaluate the safety, tolerability and preliminary activity of L-DOS47 in combination with doxorubicin in patients with metastatic pancreatic cancer who have progressed on at least two prior treatment regimens.

Phase Ib will involve a dose escalation safety run-in to determine the appropriate dose to be used in combination with doxorubicin for Phase II. Phase II will evaluate preliminary anti-tumor activity and safety of the Maximum Tolerated Dose of L-DOS47 given in combination with doxorubicin.

"We are very pleased to gain this approval from the FDA," said Dr. Herman Chao, Helix’s Chief Executive Officer. "This represents an expansion of the L-DOS47 application from treating lung cancer to potentially benefiting pancreatic patients. The team is already hard at work to begin all the necessary preparatory activities to move the trial forward. We look forward to be ready to dose patients at the earliest opportunity."

Y-mAbs to Announce Second Quarter 2019 Financial and Operating Results on August 14

On August 7, 2019 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) reported that it will report its second quarter 2019 financial and operating results on Wednesday, August 14, 2019, after the close of the U.S. financial markets (Press release, Y-mAbs Therapeutics, AUG 7, 2019, View Source [SID1234538450]). The announcement will be followed by a conference call and webcast with the investment community at 4:30 p.m. ET. Participating on the call from Y-mAbs will be Thomas Gad, Founder, Chairman and President; Dr. Claus Moller, Chief Executive Officer; and Bo Kruse, Chief Financial Officer.

Conference call and webcast details:

Investors (domestic): 877-407-0792
Investors (international): 201-689-8263
Conference ID: 13693605

To access a live webcast of the update, please use the following link:
View Source

SCYNEXIS Reports Second Quarter 2019 Financial Results and Provides Company Update

On August 7, 2019 SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company delivering innovative therapies for difficult-to-treat and often life-threatening infections, reported financial results for the quarter ended June 30, 2019, and provided an update on recent clinical developments (Press release, Scynexis, AUG 7, 2019, View Source [SID1234538449]).

"We are pleased with the rapid enrollment observed in our Phase 3 VANISH program for vulvovaginal candidiasis (VVC), which underscores the significant unmet need in this patient population," said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. "We look forward to sharing top-line data from the U.S. study in the first quarter of 2020, and from the global study in the second quarter of 2020. We are making great progress toward our goal of a planned New Drug Application (NDA) submission for VVC in the second half of 2020."

Dr. Taglietti continued, "We are committed to maximizing the full value of ibrexafungerp in multiple settings. As we approach important milestones for our VVC registration program, we are also excited by the promising data supporting the potential role of oral ibrexafungerp as a treatment for a broad range of life-threatening, hospital-based, fungal infections, including Candida auris and other multidrug-resistant pathogens for which few existing treatment options are available."

Ibrexafungerp (formerly SCY-078), the first representative of a novel family of antifungal compounds referred to as triterpenoids, is being developed for oral and intravenous (IV) administration and is in clinical development for the treatment of both serious outpatient fungal infections, including VVC, and hospital-based life-threatening fungal infections, including invasive candidiasis (IC), invasive aspergillosis (IA) and refractory invasive fungal infections. If approved, ibrexafungerp could potentially address significant unmet medical needs as the only oral non-azole antifungal therapy.

Ibrexafungerp Update

Significant progress made in Phase 3 VANISH program evaluating the safety and efficacy of oral ibrexafungerp (300mg BID for one day) versus placebo for the treatment of VVC
The VANISH Phase 3 program is comprised of two Phase 3, randomized, double-blind, placebo-controlled, multicenter studies:
The VANISH 303 study is being conducted in U.S. centers and is expected to enroll approximately 350 patients; enrollment in the study is exceeding expectations and SCYNEXIS anticipates top-line data in the first quarter of 2020. More information about this study can be found at: View Source
The global VANISH 306 study is being conducted in U.S. and European centers and is expected to enroll approximately 350 patients; enrollment is progressing as planned, and the Company anticipates top-line data in the second quarter of 2020. More information about this study can be found at: View Source
All NDA preparatory activities remain on track to support a planned NDA submission in the second half of 2020.
Phase 3 CANDLE study evaluating the safety and efficacy of oral ibrexafungerp versus placebo for the prevention of recurrent VVC is on track to start enrollment this quarter following the Special Protocol Assessment (SPA) agreement received from the U.S. Food and Drug Administration (FDA) in July 2019
The Company recently announced an agreement with the FDA under a SPA, on the design, trial population, endpoints and statistical analysis of the CANDLE study, a pivotal Phase 3 clinical trial of oral ibrexafungerp for the prevention of recurrent VVC. This SPA provides agreement with the FDA that the Phase 3 protocol design adequately addresses efficacy objectives that, if met, would form the primary basis of a regulatory submission for approval of oral ibrexafungerp for the prevention of recurrent VVC, an indication with no FDA-approved therapies.
The CANDLE study is a global Phase 3, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of oral ibrexafungerp (300mg BID for one day, given once per month for a total of six treatment days) compared to placebo in female patients with recurrent VVC (defined as three or more episodes of VVC in the past 12 months, including the episode at screening). The study is being conducted at approximately 50 sites and is expected to enroll approximately 320 patients. Enrollment is expected to commence this quarter with an expected supplemental NDA submission in 2021.
More information about the CANDLE study can be found at: View Source
An open-label sub-study within CANDLE will evaluate the efficacy of oral ibrexafungerp in fluconazole-failure VVC patients
All patients in the CANDLE study will initially receive three doses of oral fluconazole to treat their acute episode of VVC present at screening before progressing to the prevention phase of the study.
Patients who fail to sufficiently respond to fluconazole treatment for their acute episode will be included in the sub-study, in which they will be offered one day of oral ibrexafungerp treatment (300mg BID) for their unresolved acute episode.
More information about the sub-study within the CANDLE study can be found at: View Source
Continued advancement of oral ibrexafungerp for hospital-based invasive fungal infections with two Phase 3 studies (FURI in refractory infections and CARES in Candida auris infections) and one Phase 2 study in invasive aspergillosis (SCYNERGIA)
Enrollment is ongoing in the Company’s refractory invasive fungal infection (rIFI) program, which comprises two open-label Phase 3 studies (FURI and CARES) designed to support a potential future NDA submission through the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD). Positive clinical findings from these studies have so far reinforced the potential role of oral ibrexafungerp as a novel therapy to combat severe and difficult-to-treat fungal infections, including multidrug-resistant Candida auris. More information about these studies can be found at:
View Source
View Source
Enrollment continues in the Phase 2 SCYNERGIA study, a randomized, double-blind clinical trial assessing the safety and efficacy of oral ibrexafungerp in combination with voriconazole, compared to voriconazole alone. More information about this study can be found at: View Source
Data presented at the American Society for Microbiology (ASM) Microbe 2019 Meeting demonstrates broad potential utility of ibrexafungerp for the treatment and prevention of multiple severe fungal infections
A total of nine presentations revealed data further demonstrating the potential of ibrexafungerp as a treatment for invasive fungal infections (visit scynexis.com/science to view the presentations). The data presented highlighted the potent activity of ibrexafungerp against difficult-to-treat and/or multidrug-resistant pathogens, including Candida auris, Candida glabrata, and Pneumocystis pneumonia. The activity of ibrexafungerp was tested against many Candida strains resistant to echinocandins, the current standard of care for these infections, and potent activity of ibrexafungerp was observed.
In vivo chronic toxicology studies further support the safety profile of ibrexafungerp, allowing for patients suffering from invasive fungal infections to use oral ibrexafungerp for an extended period of time and enabling its potential development as a prophylactic agent and as a treatment for chronic fungal infections.
Corporate Highlight

Management Team strengthened with appointment of Dr. Nkechi Azie as Vice President of Clinical Development.
SCYNEXIS announced the appointment of Nkechi Azie, MD, MBA, FIDSA, as Vice President of Clinical Development. Dr. Azie will lead clinical development activities and strengthen medical affairs efforts in anticipation of ibrexafungerp’s potential approval and commercial launch. She joins SCYNEXIS with over 25 years of experience in drug development and medical affairs, having worked in therapeutic areas including infectious disease, women’s health and immunology.
Second Quarter 2019 Financial Results

Cash, cash equivalents and short-term investments totaled $35.2 million as of June 30, 2019, with net working capital of $28.9 million. Based upon its existing operating plan, SCYNEXIS believes its existing cash, cash equivalents, short-term investments, and the sale of a portion of its New Jersey net operating losses (NOLs), will be sufficient to fund operations beyond the planned NDA submission for acute VVC in the second half of 2020.

Research and development expenses increased to $8.5 million for the quarter ended June 30, 2019, compared to $5.6 million in the second quarter of 2018. The increase of $2.9 million, or 51%, was primarily driven by an increase of $3.2 million in clinical development costs, an increase of $0.4 million in chemistry, manufacturing, and controls (CMC) costs, a net increase in other research and development costs of $0.6 million, offset in part by a decrease of $1.3 million in preclinical development expense.

Selling, general and administrative expenses in the second quarter of 2019 increased to $2.8 million, compared with $2.1 million in the second quarter of 2018. The increase of $0.7 million, or 31%, was primarily driven by a $0.4 million increase in business development costs.

Total other income increased to $2.8 million in the second quarter of 2019, compared to a $3.1 million loss in the second quarter of 2018. The increase in other income is attributable to the non-cash gains recognized during the second quarter of 2019 of $2.0 million and $1.3 million associated with the fair value adjustments for warrant liabilities and derivative liability, respectively.

Net loss for the second quarter of 2019 was $8.4 million, or $0.16 per share. This compares with a net loss for the second quarter of 2018 of $10.8 million, or $0.23 per share.

About Ibrexafungerp
Ibrexafungerp [pronounced eye-BREX-ah-FUN-jerp] is an investigational antifungal agent and the first representative of a novel class of structurally-distinct glucan synthase inhibitors, triterpenoids. This agent combines the well-established activity of glucan synthase inhibitors with the potential flexibility of having oral and intravenous (IV) formulations. Ibrexafungerp is currently in development for the treatment of fungal infections caused primarily by Candida (including C. auris) and Aspergillus species. It has demonstrated broad spectrum antifungal activity, in vitro and in vivo, against multidrug-resistant pathogens, including azole- and echinocandin-resistant strains. The FDA has granted Qualified Infectious Disease Product (QIDP) and Fast Track designations for the formulations of ibrexafungerp for the indications of invasive candidiasis (IC) (including candidemia), invasive aspergillosis (IA) and VVC (including prevention of recurrent VVC), and has granted Orphan Drug Designation for the IC and IA indications. Ibrexafungerp is formerly known as SCY-078.