MATEON THERAPEUTICS TEAM PUBLISHES A NEW PEER-REVIEWED ONCOLOGY ARTICLE ON THE POSITIVE CLINICAL STUDY RESULTS FOR OT-101 AGAINST RECALCITRANT RESISTANT ANAPLASTIC ASTROCYTOMA – A RARE FORM OF MALIGNANT BRAIN TUMOR

On April 2, 2020 Mateon Therapeutics Inc. (OTCQB:MATN) reported the publication of a peer-reviewed research article co-authored by Fatih Uckun MD PhD, Sanjive Qazi PhD, and Vuong Trieu, PhD in the oncology journal Cancer Reports and Reviews (Press release, Mateon Therapeutics, APR 2, 2020, View Source [SID1234556167]).

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We previously reported the preliminary findings of a Phase II study (NCT00431561) confirmed its favorable safety profile and showed that OT101 can offer early disease control to R/R high-grade glioma patients at 6 months at a rate comparable to that achieved with the standard alkylating chemotherapy drug temozolomide. We are now reporting our analysis of the long-term follow-up data on the recalcitrant/resistant anaplastic astrocytoma (R/RR AA) patient subpopulation treated in the NCT00431561 study as proof of concept for the clinical utility of the Convection Enhanced Delivery of OT-101 platform (CEDOT). Notably, OT101 administered intratumorally via the CEDOT platform exhibited clinically meaningful single-agent activity and induced durable complete response (CR), partial response (PR) in more than half of the treated R/R AA patients. The median overall survival of patients receiving the CEDOT-delivered experimental therapy 1136 (95% CI:811 – 1743) days which was significantly better than the 590 (95% CI:287 – NA) days median OS (Log Rank χ2=6.5, P-value=0.011) of the TMZ-treated patient population.

"This work demonstrates superiority of OT-101 against an approved chemotherapeutic agent against AA and emphasizes our commitment to find effective new therapies for difficult-to-treat cancers," stated Dr. Vuong Trieu, Chairman and Chief Executive Officer of Mateon Therapeutics.

OT-101 has received orphan drug designation for glioblastoma, melanoma, and pancreatic cancer. Furthermore, FDA recently granted Rare Pediatric Designation for OT-101 against diffuse intrinsic pontine glioma (DIPG). OT-101 is also effective against coronavirus including COVID-19 and being deployed against the COVID-19 epidemic.

Kite Licenses Antibodies and Establishes Collaboration With Teneobio in Multiple Myeloma

On April 2, 2020 Kite, a Gilead Company (Nasdaq: GILD), and Teneobio, Inc. reported the companies have entered into a license and collaboration agreement through which Kite will receive exclusive rights to certain antibodies directed to B-cell maturation antigen (BCMA) (Press release, Kite Pharma, APR 2, 2020, View Source [SID1234556098]). The fully human variable heavy chain of one such antibody is currently undergoing clinical evaluation in a chimeric antigen receptor (CAR) format for the treatment of patients with multiple myeloma in a Phase 1 clinical trial at the National Cancer Institute. Kite and Teneobio will also collaborate on the discovery of antibodies directed to four additional targets, using Teneobio’s proprietary Human Heavy-Chain Antibodies (UniAb) platform, to be used in CAR T cell therapies for multiple myeloma and other cancers.

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This press release features multimedia. View the full release here: View Source

CARs traditionally utilize an antigen-recognition domain made up of a single chain variable fragment (scFv). The binding domain derived from Teneobio’s BCMA antibody has key potential benefits, including minimal potential for immunogenicity due to its lack of murine elements, and its small size, which may allow for the creation of dual-targeting CAR T therapies.

"Kite is committed to pursuing novel CAR T therapies that have the potential to be meaningfully differentiated treatment options for people living with multiple myeloma," said Peter Emtage, PhD, Senior Vice President of Research at Kite. "Based on encouraging early clinical signals and unique attributes of the binding domain from Teneobio, this exciting collaboration will be central to our strategy of developing next-generation CAR T therapies with the potential to overcome the tumor microenvironment."

"We are pleased that Kite, a leader in cell therapy, has recognized the potential of Teneobio’s UniAb platform to enable differentiated CAR T cell therapies in treating multiple myeloma and other cancers," said Roland Buelow, PhD, CEO of Teneobio. "We look forward to working with Kite to advance our uniquely differentiated cancer-targeting UniAbs on behalf of patients in need of novel therapies."

Under the terms of the agreement, Teneobio will receive an upfront payment and will be eligible to receive additional payments based on achievement of certain clinical and regulatory milestones, as well as royalties on future potential sales.

The Anti-BCMA CAR T cell therapy using Teneobio’s UniAb platform is investigational and not yet approved by any regulatory authority. Its efficacy and safety have not been established.

Nevro Announces Pricing of Public Offerings of Common Stock and Convertible Senior Notes

On April 2, 2020 Nevro Corp. ("Nevro") (NYSE: NVRO), a global medical device company that is providing innovative, evidence-based solutions for the treatment of chronic pain, reported the pricing of concurrent underwritten public offerings of (a) 1,625,000 shares of its common stock at a public offering price of $84.00 per share for gross proceeds, before deducting underwriting discounts and commissions and estimated offering costs, of approximately $136,500,000 (the "common stock offering") and (b) $165,000,000 aggregate amount of its 2.75% convertible senior notes due 2025 (the "notes") (the "notes offering") (Press release, Nevro, APR 2, 2020, View Source [SID1234556114]). Nevro has granted the underwriters of the offerings a 30-day option to purchase an additional (a) 243,750 shares of common stock at the public offering price, less underwriting discounts and commissions and (b) $24,750,000 aggregate amount of notes, less underwriting discounts and commissions and solely to cover over-allotments with respect to the notes offering. All of the shares of common stock to be sold in the common stock offering are being offered by Nevro. The offerings of the shares and the notes are expected to close on April 6, 2020, subject to customary closing conditions.

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The notes will be senior, unsecured obligations of Nevro, and will bear interest at a rate of 2.75% per year. Interest will be payable semi-annually in arrears on April 1 and October 1 of each year, beginning on October 1, 2020. The notes will mature on April 1, 2025, unless earlier repurchased or converted. Nevro may not redeem the notes, and no sinking fund is provided for the notes. Holders of the notes will have the right to require Nevro to repurchase all or a portion of their notes upon the occurrence of a fundamental change (as defined in the indenture governing the notes) at a cash purchase price of 100% of their principal amount plus any accrued and unpaid interest to, but excluding, the fundamental change repurchase date.

The notes may be converted at an initial conversion rate of 9.5238 shares of Nevro’s common stock per $1,000 principal amount of notes (which is equivalent to an initial conversion price of approximately $105.00 per share and represents a conversion premium of 25.0% to the public offering price of Nevro’s common stock in the common stock offering). Prior to the close of business on the business day immediately preceding October 1, 2024, the notes will be convertible at the option of the holders of the notes only upon the satisfaction of specified conditions and during certain periods. On or after October 1, 2024 until the close of business on the second scheduled trading day preceding the maturity date, the notes will be convertible at the option of the holders of notes at any time regardless of these conditions. Conversions of the notes will be settled in cash, shares of Nevro’s common stock or a combination thereof, at Nevro’s election.

In connection with the pricing of the notes, Nevro entered into privately-negotiated convertible note hedge transactions with one or more of the underwriters and/or their respective affiliates and/or other financial institutions (the "option counterparties"). These transactions cover, subject to customary anti-dilution adjustments, the number of shares of Nevro’s common stock that will initially underlie the notes, and are expected generally to reduce the potential equity dilution, and/or offset any cash payments in excess of the principal amount due, as the case may be, upon conversion of the notes. Nevro entered into separate, privately-negotiated warrant transactions with the option counterparties at a higher strike price relating to the same number of shares of Nevro’s common stock, subject to customary anti-dilution adjustments, pursuant to which Nevro will sell warrants to the option counterparties. The warrants could have a dilutive effect on Nevro’s outstanding common stock to the extent that the price of Nevro’s common stock exceeds the strike price of those warrants. The strike price of the warrants will initially be $147.00 per share, which represents a premium of approximately 75% over the public offering price of Nevro’s common stock in the common stock offering and is subject to certain adjustments under the terms of the warrant transactions.

If the underwriters exercise their option to purchase additional notes, Nevro expects to enter into additional convertible note hedge transactions and additional warrant transactions with the option counterparties, which will initially cover the number of shares of Nevro’s common stock that will initially underlie the additional notes sold to the underwriters.

Morgan Stanley is acting as bookrunning manager for the offerings.

Nevro has been advised that in connection with establishing their initial hedges of the convertible note hedge and warrant transactions, the option counterparties or their respective affiliates expect to enter into various derivative transactions with respect to Nevro’s common stock concurrently with or shortly after the pricing of the notes. This activity could increase (or reduce the size of any decrease in) the market price of Nevro’s common stock or the notes at that time. The option counterparties or their respective affiliates may modify their hedge positions by entering into or unwinding various derivatives with respect to Nevro’s common stock and/or purchasing or selling Nevro’s common stock or other securities of Nevro in secondary market transactions from time to time following the pricing of the notes and prior to maturity of the notes (and are likely to do so during any observation period related to a conversion of the notes).

The potential effect, if any, of these transactions and activities on the market price of Nevro’s common stock or the notes will depend in part on market conditions and cannot be ascertained at this time, but any of these activities could adversely affect the value of Nevro’s common stock, which could affect the ability to convert the notes, the value of the notes and the amount of cash, if any, and the number of and value of the shares of Nevro’s common stock, if any, holders would receive upon conversion of the notes.

Nevro intends to use a portion of the net proceeds from the common stock offering and the notes offering to pay the cost of the convertible note hedge transactions (after such cost is partially offset by the proceeds to Nevro from the sale of the warrants). Nevro expects to use the remainder of the net proceeds from the common stock offering for general corporate purposes, including the repayment of its 1.75% Convertible Senior Notes due 2021 (the "existing convertible notes") at maturity and Nevro may use a portion of the remaining net proceeds to repurchase a portion of the existing convertible notes prior to their maturity. If the underwriters exercise their option to purchase additional notes, then Nevro intends to use a portion of the net proceeds from the sale of additional notes, together with the proceeds from the sale of additional warrants, to enter into additional convertible note hedge transactions with the option counterparties and Nevro intends to use the remaining net proceeds from the sale of such additional notes as set forth above.

A shelf registration statement on Form S-3 (including a base prospectus) relating to the common stock offering and the notes offering was automatically declared effective by the Securities and Exchange Commission ("SEC"). Preliminary prospectus supplements related to each of the common stock offering and the notes offering (together with such base prospectus, each a "prospectus"), have been filed with the SEC and are available on the SEC’s website located at www.sec.gov. Copies of the prospectus relating to the common stock offering and the notes offering may be obtained, when available, from: Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014.

This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, nor shall there be any sale, of these securities in any state or 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 jurisdiction.

Helix Biopharma Corp. Provides Corporate Update

On April 2, 2020-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 a corporate update (Press release, Helix BioPharma, APR 2, 2020, View Source [SID1234556099]).

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COVID-19
As countries across the globe face an unprecedented public health crisis due to COVID-19, Helix has taken various measures to protect the health and well-being of our staff while maintaining business continuity.

The office and laboratory of Helix in Canada have been following the recommendations of federal, provincial and regional authorities. This includes operating a safe and clean working environment, providing work at home facility and observing latest public health guidance such as ‘social distancing’. Except for a limited number of staff at the laboratory to maintain critical infrastructure operation, all Helix personnel are working from remote locations.

Clinical Development initiatives The Company’s U.S. Phase I L-DOS47 lung cancer study in combination with pemetrexed and carboplatin (LDOS001) has completed patient recruitment. Study reports are being compiled and an abstract has been submitted to a conference. As previously reported in the Company’s recently filed Q2 fiscal 2020 filings, the Company’s European Phase II L-DOS47 lung cancer study in Poland and Ukraine (LDOS003) no longer requires patient enrollment. The Company indicated that the first stage of the study related to dose escalation would be concluded and progression to the second stage of the study would only proceed if a third-party was willing to partner with the Company on the study and upon a confirmatory medical review.

The Company’s U.S. Phase 1b/II pancreatic study of L-DOS47 in combination with doxorubicin (LDOS006) continues to enroll patients and has dosed two patients. Given the COVID-19 crisis however, the Company expects patient enrollment will be impacted. Helix is working closely with the clinical trial site and the hospital to ensure best care is being provided to patients while ensuring Helix complies with their COVID-19 protocols.

Corporate initiatives COVID-19 has created significant uncertainty and has materially impacted equity markets globally at a time when the Company was in the planning process of up-listing to the U.S. and raising additional capital. Nevertheless, the Company continues to engage both U.S. and Canadian investment bankers and is preparing for a capital raise in combination with an up-listing on the NASDAQ. Though the Company previously expected to conduct road shows and face-to-face meetings with potential investors during the month of April 2020, COVID-19 has made it impossible to do so. Instead, the Company expects to conduct online meetings and conference calls.

The Company recently closed a $6,000,000 private placement which included the disposition of a 15.5% stake in the Company’s Polish subsidiary, Helix Immuno-oncology S.A. ("HIO"). As previously disclosed, the Company intends to fully divest its remaining 51.0% interest in HIO to raise additional capital to further fund the Company’s clinical development programs while retaining a licensing arrangement for future royalties and milestone payments.

As a result of the recent private placement the Company is in a sound financial position allowing management to operate as normally as possible, in light of COVID-19. Given that the duration and magnitude of the impact on the economy and the Company’s business from COVID-19 is unknown, the Company has implemented a review of 2 operations in order to reduce or defer spending where possible, while maintaining key clinical and business program priorities.

The Company thanks all its staff who responded quickly and professionally as well as all our stakeholders who continue to support our Company during these challenging times.

I-Mab Announces First Patient Dosed in Phase 1/2a Clinical Trial of Anti-CD47 Antibody, TJC4, in China

On April 2, 2020 I-Mab (the "Company") (Nasdaq: IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel or highly differentiated biologics to treat diseases with significant unmet medical needs, particularly cancers and autoimmune disorders, reported that the first patient was dosed with TJC4 in a Phase 1/2a clinical trial evaluating its use in treating patients with relapsed or refractory acute myeloid leukemia (r/r AML) or myelodysplastic syndrome (MDS) in China (Press release, I-Mab Biopharma, APR 2, 2020, View Source [SID1234556100]). TJC4, also known as TJ011133, is an internally developed differentiated anti-CD47 monoclonal antibody that is designed to minimize inherent binding to normal red blood cells while preserving its strong anti-tumor activity.

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The clinical trial in China is a multi-center, open-label, single-arm study to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics and preliminary efficacy of TJC4 as a monotherapy in patients with r/r AML and MDS (CXSL1900039; NCT04202003;). I-Mab is also conducting a Phase 1 trial (NCT Number: NCT03934814) in the U.S. in patients with advanced solid tumors and lymphoma, with complete data from the dose escalation portion expected in the third quarter of 2020.

"We have been at full speed conducting clinical development of TJC4 in both U.S. and China," said Dr. Joan Shen, CEO of I-Mab. "Dosing the first patient in China represents another important milestone, both for our TJC4 program and for patients, as TJC4 stands out as a globally competitive, highly differentiated anti-CD47 asset for cancer treatment. Together with the Phase 1 dose escalation study of TJC4 in the U.S., we continue to leverage our clinical development capabilities and expertise to facilitate clinical validation of TJC4 in China and the U.S."

About CD47 and TJC4

CD47 is a glycoprotein over-expressed in a wide variety of cancers and delivers a "don’t eat me" signal to tumor-engulfing macrophages through its ligand SIRPα, and is one of the most promising immuno-oncology targets after PD-1 and PDL1.

TJC4 is a differentiated anti-CD47 monoclonal antibody and designed to minimize inherent binding to normal red blood cells by this class of monoclonal antibodies yet preserve its strong anti-tumor activities. Blockade of CD47 by TJC4 enables macrophages to engulf cancer cells. TJC4 recognizes a unique epitope on CD47 and exhibits minimal binding to red blood cells. The hematologic safety advantage of TJC4 has been demonstrated in a series of robust pre-clinical and toxicological studies including those in cynomolgus monkeys, while it maintains superb anti-tumor activities.