On April 3, 2019 Rgenix, Inc., a clinical stage biopharmaceutical company developing first-in-class small molecule and antibody cancer therapeutics, reported it is presenting pre-clinical data from ongoing research of RGX-019, a monoclonal antibody that targets MERTK, for the treatment of advanced cancer (Press release, Rgenix, APR 3, 2019, View Source [SID1234534968]). In a presentation of a late-breaking abstract, "Characterization of the anti-cancer and immunologic activity of RGX-019, a novel pre-clinical stage humanized monoclonal antibody targeting the MERTK receptor," which was accepted for the 2019 American Association of Cancer Research Annual Meeting, Isabel Kurth Ph.D., Rgenix VP of Research, discussed data showing RGX-019 to be a potent and selective inhibitor of MERTK signaling, resulting in suppression of cancer growth and activation of the innate immune response.

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RGX-019 is a humanized monoclonal antibody that selectively targets MERTK, a receptor tyrosine kinase of the TYRO3/AXL/MERTK (TAM) family. MERTK is expressed in immune cells such as macrophages, dendritic cells and NK cells, and is also overexpressed in a wide variety of liquid and solid cancers.

Activation of MERTK on cancer cells via ligand binding activates several tumor-promoting signaling pathways, stimulating tumor proliferation, migration and angiogenesis, and decreasing apoptosis and chemosensitivity. When activated on macrophages, MERTK promotes an immune-suppressive M2 phenotype.

RGX-019 binds to human MERTK with high affinity and selectivity, without detectible binding to other related TAM kinases. RGX-019 has a unique mechanism of action that not only leads to blockade of ligand binding, but also to MERTK degradation via receptor internalization.

This novel mechanism of action leads to inhibition of cancer growth in vitro and in vivo as well as activation of M1 (pro-inflammatory) cytokine release from immune-suppressive M2 macrophages.

Masoud Tavazoie, MD, PhD, and Chief Executive Officer of Rgenix, said, "We are excited to have an opportunity to reveal the pre-clinical data that demonstrates the positive progress we are making with the development of RGX-019, our third proprietary program. The ability of RGX-019 to selectivity degrade MERTK in cancers cells and M2 macrophages provides a distinct advantages over current small-molecule approaches to targeting MERTK which are hampered by off-target binding to other related kinases. This data provides a strong foundation for IND enabling studies."

Sohail Tavazoie, MD, PhD, and Chair of Rgenix’s Scientific Advisory Board, said, "RGX-019 shows great potential as a cancer therapeutic and its ability to selectively modulate both cancer growth and innate immune activation is illustrative of that possibility. We look forward to continuing our research on this antibody and its impact on various MERTK expressing cancers."

On April 3, 2019 Aileron Therapeutics (NASDAQ: ALRN), the clinical-stage leader in the field of stabilized cell-permeating peptides to treat cancer and other diseases, reported the closing of its previously announced private placement of Aileron common stock and warrants, resulting in gross proceeds of $26 million, before deducting placement agent fees and offering expenses, and excluding the exercise of any warrants (Press release, Aileron Therapeutics, APR 3, 2019, View Source [SID1234535002]).

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The private placement was led by Satter Medical Technology Partners, L.P. Additional participants included Jennison Associates (on behalf of certain clients) and an undisclosed institutional investor, in addition to other new and existing investors.

In connection with this financing, Aileron also announced that Dr. Nolan Sigal, a Partner at Satter, has joined Aileron’s Board of Directors.

Dr. Sigal has served as a partner at Satter Management, a private investment firm, since January 2018. From March 2008 to December 2017, Dr. Sigal was the president and chief executive officer of Tunitas Therapeutics, Inc., a private biopharmaceutical company. Prior to 2008, Dr. Sigal held various leadership positions with several public and private pharmaceutical and biotechnology companies, including Merck & Company, Trellis, Cytokinetics, and Pharmacopeia. Dr. Sigal received an A.B. from Princeton University and an M.D. and Ph.D. from the University of Pennsylvania School of Medicine.

"I believe that the application of Aileron’s proprietary peptide drug, ALRN-6924, in the indications of MDM2-amplified tumors (with Pfizer’s Ibrance) and myelopreservation represent compelling opportunities. As a member of the Board of Directors, I look forward to helping the Company as it seeks to create value for its shareholders through the advancement of these programs," stated Nolan Sigal, M.D., Ph.D.

"We expect that the proceeds from this closing will enable Aileron to achieve key clinical data readouts" said Dr. Manuel Aivado, M.D, Ph.D., CEO & President of Aileron. "We expect the addition of Dr. Sigal to our Board of Directors to play an important role in our success. His extensive research experience as an executive in the biotech industry makes him a welcome addition to the Aileron team."

In the private placement the Company sold 11,838,582 units, consisting of 11,838,582 shares of common stock and associated warrants to purchase 11,838,582 shares of common stock, for a combined price of $2.01 per unit. In addition, the Company also sold 1,096,741 units, consisting of pre-funded warrants to purchase 1,096,741 shares of common stock and associated warrants to purchase 1,096,741 shares of common stock, for a combined price of $2.01 per unit.

William Blair & Company, L.L.C. acted as sole placement agent in connection with the financing.

Aileron expects to use the net proceeds from the financing to fund the further advancement of its ALRN-6924 clinical trials and research programs, including its ongoing clinical trial collaboration with Pfizer testing ALRN-6924 in combination with palbociclib in MDM2-amplified cancers and its planned Phase 1b/2 clinical trial to evaluate ALRN-6924 as a myelopreservative agent to protect against chemotherapy-induced toxicity. This use of proceeds reflects Aileron’s decision to cease enrollment and clinical development in AML/MDS in light of the Company’s resources and its re-assessment of the commercial opportunities in AML/MDS considering the rapidly evolving competitive landscape in this field.

The securities sold in the private placement have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or applicable state securities laws, and accordingly may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. Aileron has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the shares of common stock issued in the private placement and the shares of common stock issuable upon the exercise of the warrants issued in the private placement.

This release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state. Any offering of the securities under the resale registration statement will only be by means of a prospectus.

On April 3, 2019 Veracyte, Inc. (Nasdaq: VCYT) reported that it will release its financial results for the first quarter 2019 after the close of market on Tuesday, April 30, 2019 (Press release, Veracyte, APR 3, 2019, View Source [SID1234534969]). Company management will host a conference call and webcast to discuss its financial results and provide a general business update at 5:00 p.m. Eastern time on the same day.

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The conference call will be webcast live from the company’s website and will be available via the following link View Source The webcast should be accessed 10 minutes prior to the conference call start time. A replay of the webcast will be available for one year following the conclusion of the live broadcast and will be accessible on the company’s website at View Source

The conference call can be accessed as follows:

U.S./Canada participant dial-in number (toll-free): (855) 541-0980
International participant dial-in number: (970) 315-0440
Conference I.D.: 9289499

On March 28, 2019, Applied DNA Sciences, Inc. and its wholly-owned subsidiary, APDN (B.V.I.), Inc., (collectively, the "Company"), reported that it has entered into a Patent and Know-How License and Cooperation Agreement (the "Agreement") with ETCH BioTrace S.A. ("ETCH"), a wholly-owned subsidiary of TheraCann International Benchmark Corporation ("TheraCann"), a legal cannabis and hemp consultancy (Press release, Applied DNA Sciences, APR 3, 2019, View Source [SID1234534988]). The Agreement grants ETCH the exclusive right and license, with rights to sublicense, to use, offer to sell, sell and import the Company’s proprietary or patented DNA tagging, DNA tag application and DNA tag authentication technologies marketed under SigNature and/or CertainT (the "Technology") within the global cannabis sativa L and cannabis sativa L derivative product markets, excluding use in textiles. The Agreement further grants ETCH the non-exclusive right and license, with rights to sublicense, to use, offer to sell, sell and import the Technology within the global cannabis sativa L market and cannabis sativa L derivative product markets for use in textiles. The Agreement also grants ETCH the limited use of trademarks owned by the Company solely for the purpose of promoting, marketing and disclosing the Technology, with all goodwill and benefit arising from such use inuring to the exclusive benefit of the Company.

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Under the Agreement, a $5,000,000 non-refundable up-front licensing fee is payable to the Company over a four-month period, with $1,000,000 due on or before April 15, 2019, $2,000,000 due on or before June 30, 2019 and $2,000,000 due on or before August 15, 2019. The Company and ETCH will jointly market and sell the Technology, with profits to be shared between the parties after specified gross profit minimums are reached. The Agreement also provides for specified annual cash payment minimums to the Company, scaling from $2,000,000 in year two, $7,000,000 in year three, $10,000,000 in year four, $12,000,000 in years five through ten, $16,000,000 in years ten through fifteen, to $20,000,000 in year fifteen, which TheraCann must pay to the Company to maintain its license exclusivity. Such annual cash payment minimums may be comprised of any cash payments from ETCH or any sublicensee for DNA taggant, profit share, DNA authentication devices/reagents, DNA authentication services, project fees, other service or product fees, and/or other cash payments. In lieu of the annual cash payment minimums for years one and two, the parties agree to create a mutually agreeable development plan for TheraCann’s commercialization of the Technology which will contain commercialization milestones that can be met by TheraCann in lieu of annual cash payment minimums.

The term of the license granted with respect to any licensed patent will continue until any valid claim with respect to such patent has expired, and the term of the license granted with respect to any licensed know-how (such as trade secrets and methods) is twenty years. Either party may terminate the Agreement on written notice to the other party if the other party materially breaches the Agreement and such breach is incapable of cure or being capable of cure, remains uncured sixty business days after written notice. The Company may immediately terminate the Agreement if ETCH, its affiliates, or sublicensee institutes or participates in a challenge to the licensed patents. Either party may terminate the Agreement effective immediately in the event the other party dissolves, becomes insolvent, or is subject to bankruptcy proceedings. Should the Company dissolve, become insolvent, become subject to bankruptcy proceedings, cease its business operations generally, cease manufacture of the Technology, or fail to provide ETCH with the Technology for twenty business days, among other things, ETCH and its affiliates are granted licenses to enable ETCH to manufacture and/or practice the Technology to the extent required to comply with ETCH’s ongoing commercial obligations, and the Company has agreed to place into escrow the know-how pertaining to the Technology in connection with such backup license.

During the term, any improvements to any licensed patent shall remain the sole property of the Company if conceived, made or reduced to practice in whole or in part by the Company or be jointly owned by the Company and ETCH where conceived, made, or reduced to practice in whole or in part by ETCH. The Company and ETCH shall agree on a filing strategy for each country where patent protection is sought, and the Company shall be obligated to prepare, file, and prosecute any patent applications, maintain all patents, and notify ETCH of any changes in status or deadlines. ETCH’s consent is required to abandon any patents, and the Company shall assign such abandoned patent to ETCH upon request.

The Agreement also contains mutual confidentiality and indemnification obligations for the Company and ETCH. The Company may not assign the Agreement without ETCH’s prior written consent, not to be unreasonably withheld. Due to an acknowledged level of uncertainty relating to contracts for the provision of services to the legal cannabis industry, both ETCH and the Company expressly waived any defense based on illegality.

The foregoing description of the Agreement does not purport to be complete and is subject to, and qualified in its entirety by, the full text of such agreement.

On April 3, 2019 NeoImmuneTech, Inc. (NIT), a T cell-based therapeutics company, reported the presentation of new research at the AACR (Free AACR Whitepaper) Annual Meeting, being held March 29 – April 3, 2019 in Atlanta, GA (Press release, NeoImmuneTech, APR 3, 2019, View Source [SID1234534970]). Study results regarding Hyleukin-7 (Interleukin-7-hyFc), developed jointly with Korean affiliate company Genexine, Inc. (Genexine), will be presented in two posters.

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Presentation Details:

Title: CT045. Hyleukin-7, a long-acting interleukin-7, increased absolute lymphocyte counts after subcutaneous and intramuscular administration in healthy subjects
Date: April 1, 2019

This poster details Hyleukin-7’s safety profile and T cell boosting effects from the first-in-human study in healthy subjects. Hyleukin-7 administration was well-tolerated, exhibited dose-dependent increases in T cells, and significantly increased killer and memory T cells, which are crucial for effective anti-tumor response. Additionally, the poster reports that dose escalation of Hyleukin-7 in multiple ongoing clinical trials in cancer patients has shown similar safety profiles to the first-in-human study, and also demonstrated dose-dependent increases of killer T cells. The study was led by professor Howard Lee of Seoul National University Hospital (SNUH).

Title: 4991. Hyleukin-7, the Fc-fused interleukin-7, generates anti-tumor activity by modulating both adaptive and innate immune cells in the tumor microenvironment
Date: April 3, 2019

Data shown here focuses on the anti-cancer mechanism of Hyleukin-7 from preclinical studies. Hyleukin-7 affected the immune cells not only in the peripheral blood but also in the tumor microenvironment (TME). This study, led by professor Seung-Woo Lee of Pohang University of Science and Technology (POSTECH), Korea, demonstrated that administration of Hyleukin-7 in an animal cancer model significantly increased the quantity of killer T cells. Most importantly, within the TME killer T cells drastically increased while regulatory T cells and myeloid lineage cells (immune suppressor cells) such as myeloid-derived suppressor cells (MDSC) substantially decreased, resulting in significant anti-tumor activity.

"This research is the first to demonstrate that a long-acting IL-7 effectively modulates the TME, significantly amplifying anti-tumor T cells and reducing immune-suppressive cells such as MDSCs in the tumor," said professor Seung-Woo Lee. "These data allow us to envision Hyleukin-7 as a potential next-generation cancer immunotherapy with a differentiated function."

"Having recently raised $92 million in Series D funding round, we aim to use the funds to continue confirming the anti-tumor effects and mode of action of Hyleukin-7 through multiple monotherapy and combination therapy clinical trials in various tumor types," added Se Hwan Yang, Ph.D., Chief Executive Officer of NIT.

NIT and Genexine are currently conducting dose-escalation studies to identify an optimal Hyleukin-7 dosing regimen in advanced solid tumors and brain cancer (glioblastoma) patients. NIT and Genexine are also collaborating with global pharmaceutical companies to combine Hyleukin-7 with anti-PD-1/anti-PD-L1 therapies in clinical trials in high-risk skin cancers and triple-negative breast cancer patients in the United States and Korea, respectively.

About Hyleukin-7
Hyleukin-7 (rhIL-7-hyFc, NT-I7), an immuno-oncology agent, is a T cell growth factor composed of a covalently linked homodimer of engineered Interleukin-7 (IL-7) molecule, biologically fused with the proprietary long-acting platform – hyFc. IL-7 is known to be a critical factor for T cells homeostasis, acting to increase both the number and functionality of T cells. Hyleukin-7 amplifies and reinvigorates persistent T cell immunity in the treatment of patients with cancer and lymphopenia, thus providing unique opportunities for immuno-oncology (IO) combination strategies. Hyleukin-7 is being developed as an "IO enabling" therapy to harness T cell immunity in combination with current cancer treatments such as anti-PD-(L)1 agents or chemo/radiotherapy as well as next generation IO therapeutics.