On May 29, 2019 Moffitt Cancer Center reported a licensing agreement with TuHURA Biopharma, Inc., a start-up biotechnology company in Seattle, to develop new immunotherapy treatments for cancer that will apply to a greater number of cancers and a larger patient population (Press release, Moffitt Cancer Ctr, MAY 29, 2019, View Source [SID1234556959]). This agreement will provide TuHURA the exclusive rights to develop Moffitt’s first-in-class bifunctional immunoconjugates that are cancer cell binding agents linked to immune system activators. These agents help target the immune system activators to the tumor microenvironment and cancer cells focusing an immune attack on the tumor while avoiding normal, non-cancer cells. The novel bifunctional immunoconjugates could increase a tumor’s susceptibility to immune attack, with the promise of increasing the effectiveness of immunotherapy among more patients with less toxicity and severity of side-effects.

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"With this agreement, Moffitt can build on the incredible advancements we have seen in immuno-oncology, bringing novel treatments to patients, while delivering a safer and more effective approach," said Alan F. List, M.D., president and CEO of Moffitt. "The potential of this effort is enormous, and we are pleased to work with TuHURA to help drive research and development of the next critical breakthroughs in cancer care."

Researchers at Moffitt have identified a cellular target which, when blocked, decreases the immune suppressing capabilities of the tumor microenvironment—the immediate area surrounding a tumor, including blood vessels, supporting cells and immune cells. By impacting the tumor’s microenvironment, tumors become more vulnerable to attack by a patient’s immune system. This creates an advantageous opportunity for immunotherapies to be more effective among a larger population of patients. The technology’s dual mode of action increases tumor microenvironment susceptibility to immune attack while targeting immunotherapy directly to the cancer cells, focusing immune attack to where the tumor lives potentially avoiding attack on healthy cells in the body. This approach has the potential to help in increasing effectiveness, minimizing toxicity and expanding the population of patients who could benefit from current immunotherapies.

"Having reviewed more than 100 new technologies among 40 leading academic institutions and cancer research centers across the United States, the technology developed at Moffitt has the greatest potential to advance the field of cancer immunotherapy. Decreasing the immune suppression caused by the tumor microenvironment is an area of intense research among both academic and pharmaceutical research," said James A. Bianco, M.D., TuHURA’s principal founder and executive chairman. "This technology has the potential to address major limitations of existing immune therapies."

Moffitt and TuHURA’s work will seek to create first-in-class bifunctional immunoconjugates for both solid tumors and blood related cancers. The approach builds upon key progress immunotherapy has yielded in cancer care, specifically with checkpoint inhibitors.

"Moving forward with Moffitt’s technology, TuHURA could exponentially expand access for cancer patients to novel, cutting-edge treatments not currently available," added List. "Our goal is to build a new model that can treat myriad more individuals facing cancer successfully."

TuHURA will first focus on lung and head and neck cancer. The company will see the new bifunctional immunoconjugates through the clinical development process to United States Food and Drug Administration approval.

On May 29, 2019 GT Biopharma, Inc. (OTCQB: GTBP) (OTC: GTBP.PA) an immuno-oncology company focused on innovative treatments based on the Company’s proprietary NK cell engager (TriKE) platform and Multi-Target Directed Bispecific Drug Conjugate (MTBDC) platform, reported that the results of its second Phase I-II trial (NCT02370160) for GTB-1550 (DT2219), an MTBDC targeting CD22 and CD19 for treatment of refractory B-cell malignancies, will be published (J Clin Oncology 37, 2019 suppl; abstract e19066) on-line in conjunction with the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in Chicago from May 31 – June 4 (Press release, GT Biopharma , MAY 29, 2019, View Source [SID1234539514]).

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Top Line Results Summary:

Treatment was well tolerated at 60 mcg/kg x 8 doses and the most common adverse events included capillary leak syndrome, elevated AST/ALT, low albumin, weight gain and leukopenia. All were Grade 1-2 and resolved after 3-5 days allowing day 15 GTB-1550 administration.
There were no neutropenic fever or immune mediated adverse events. Four patients experienced dose limiting toxicity (DLT) at dose 80 μg/kg/day: Grade 4 capillary leak syndrome (n=1), Grade 3 liver function test (LFT) abnormalities (n=2) and Grade 4 thrombocytopenia >7 days duration (n=1).
Thirteen patients were evaluable for response, and 3 experienced objective clinical benefit. One patient with primary refractory pre-B acute lymphoblastic leukemia achieved complete remission after 1st cycle. Two patients with transformed lymphoma demonstrated transient tumor shrinkage, however, GTB-1550 therapy was discontinued due to DLT and increased neutralizing antibody titer after 1st cycle (pre C1 28%, pre C2 108%).
Correlative studies showed a low incidence of neutralizing antibody in Non-Hodgkin Lymphoma (NHL) patients recently exposed to Rituximab.
Mr. Anthony Cataldo, the Chairman and Chief Executive Officer of GT Biopharma commented, "­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­We are pleased with the results GTB-1550 has shown in the current Phase I-II clinical trial and in our earlier Phase I-II clinical trial. This now positions us to move forward with the FDA phase II clinical trial."

Dr. Veronika Bachanova, Associate Professor of Medicine, Division of Hematology, Oncology and Transplantation at the University of Minnesota and the Principal Investigator for both clinical trials commented, "We are excited about the progress GTB-1550 is making in the clinic, and look forward to the possibility of exploring additional monotherapy and synergistic combination studies against various B-cell malignancies." Both clinical studies were conducted at the University of Minnesota’s Masonic Cancer Center in Minneapolis.

About GTB-1550 Multi-Target Directed Bispecific Therapy

GTB-1550 targets cancer cells expressing the CD19 receptor or CD22 receptor or both receptors thereby maximizing cancer cell recognition by binding to CD19+, CD22+ and CD19+/CD22+ cancer cells. When GTB-1550 binds to cancer cells, the cancer cells internalize GTB-1550, and are killed due to the action of drug’s cytotoxic diphtheria toxin payload. GTB-1550 has previously demonstrated success in a Phase I-II human clinical trial in patients with relapsed/refractory B-cell lymphoma or leukemia. At the time of the interim review, 13 patients met the evaluation criteria, including nine NHL and four ALL patients. More than 50% of patients (seven of 13) exhibited a clinical benefit, defined as stable disease, partial remission or complete remission at Day 29. Of the seven patients, one demonstrated a complete remission (CR), one demonstrated a partial remission (PR) and five demonstrated stable disease (SD).

About the TriKE Platform

The Company’s TriKE product candidates are single-chain, tri-specific scFv recombinant fusion proteins composed of the variable regions of the heavy and light chains (or heavy chain only) of anti-CD16 antibodies, wild-type or a modified form of IL-15 and the variable regions of the heavy and light chains of an antibody designed to precisely target a specific tumor antigen. GT Biopharma utilizes the NK stimulating cytokine human IL-15 as a cross linker between the two scFvs which is designed to provide a self-sustaining signal leading to the proliferation and activation of NK cells thus enhancing their ability to kill cancer cells mediated by antibody-dependent cell-mediated cytotoxicity (ADCC). GT Biopharma has an exclusive worldwide license agreement with the University of Minnesota to further develop and commercialize cancer therapies using proprietary TriKE technology developed by researchers at the university to target NK cells to cancer.

On May 29, 2019, Spherix Incorporated, a Delaware corporation (the "Company"), reported that its entered into a Securities Purchase Agreement (the "Purchase Agreement") with a single accredited investor (the "Purchaser") for the sale by the Company of 221,000 shares (the "Shares") of the Company’s common stock, par value $0.0001 per share (the "Common Stock") at a purchase price of $2.60 per share, and pre-funded common stock purchase warrants to purchase up to 86,692 shares of Common Stock (the "Warrants") at a purchase price of $2.5999 per Warrant, which represents the per Share purchase price, less a $0.0001 per share exercise price for each of the Warrants (Filing, 8-K, Spherix, MAY 29, 2019, View Source [SID1234539016]). The Company sold the Shares and Warrants for aggregate gross proceeds of approximately $799,991 which transaction closed on May 31, 2019.

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The Purchase Agreement contains customary representations and warranties of the Company, termination rights of the parties and certain covenants of the Company.

The Warrants are immediately exercisable for $0.0001 per share until exercised in full, except that a holder will not have the right to exercise any portion of the Warrant if the holder (together with its affiliates) would beneficially own in excess of 9.99% of the number of shares of Common Stock outstanding immediately after giving effect to the exercise, as such percentage ownership is determined in accordance with the terms of the Warrants. However, any holder may increase or decrease such percentage to any other percentage upon notice to the Company, but in no event in excess of 9.99%, provided that any increase in such percentage shall not be effective until 61 days after such notice. The Warrants may also be exercisable on a "cashless" basis.

The Company received net proceeds of approximately $799,991 from the sale of the Shares and Warrants. The net proceeds will be used for working capital purposes.

The Shares, Warrants and shares of Common Stock underlying the Warrants (the "Warrant Shares") were, or in the case of the Warrant Shares, will be, offered and sold by the Company pursuant to an effective shelf registration statement on Form S-3, which was filed with the Securities and Exchange Commission (the "SEC") on January 9, 2018 and subsequently declared effective on January 19, 2018 (File No. 333-222488) (the "Registration Statement"), and the base prospectus contained therein. The Company filed a prospectus supplement with the SEC on May 31, 2019 in connection with the sale of the Shares, Warrants and Warrant Shares.

A copy of the opinion of Ellenoff Grossman & Schole LLP relating to the legality of the Shares, Warrants and Warrant Shares offered by us is attached as Exhibit 5.1 hereto.

This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy securities, nor shall there be any sale of securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.

The foregoing is only a brief description of the Purchase Agreement and the Warrant and does not purport to be a complete description thereof. Such descriptions are qualified in their entirety by reference to the forms of the Purchase Agreement and the Warrant, copies of which are filed as Exhibits 10.1 and 4.1, respectively, to this Current Report on Form 8-K and are incorporated by reference herein.

On May 29, 2019 MaxCyte reported that Doug Doerfler, Chief Executive Officer, will provide a company overview at the 2019 BIO International Convention on Wednesday, June 5, at 1:15 p.m. ET at the Pennsylvania Convention Center in Philadelphia (Press release, MaxCyte, MAY 29, 2019, View Source [SID1234537619]).

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In his presentation, Mr. Doerfler will discuss:

The status of MaxCyte’s Phase I dose-escalation clinical trial with MCY-M11, a wholly-owned non-viral mRNA-based therapeutic candidate from MaxCyte’s CARMA platform. Investigators recently began dosing in the trial’s second cohort of individuals with relapsed/refractory ovarian cancer and peritoneal mesothelioma. MaxCyte is one of a small number of companies with a cell therapy for solid tumours in the clinic, and successful dosing represents MaxCyte’s unique approach to chimeric antigen receptor ("CAR") therapy, including its rapid manufacturing process.
MaxCyte’s commercial momentum including new multi-drug commercial agreements signed with CRISPR Therapeutics, Precision BioSciences and with Kite, a Gilead Company. All programs enable non-viral cell engineering for development of multiple CAR-T drug candidates. MaxCyte’s total number of cell therapy partnered program licenses total more than 70 including more than 35 partnered program licensed for clinical development.
MaxCyte’s newly launched next generation of commercially-oriented instruments and consumables, under the ExPERT brand. This includes three instrument formats with enhanced design and functionality, coupled with a wider range of consumables that offer expanded utility from early research to clinical and commercial use.

For more information about the conference, please visit: //convention.bio.org/

On May 29, 2019 Innate Pharma SA (the "Company" – Euronext Paris: FR0010331421 – IPH) reported the publication of data demonstrating the potential of multifunctional NKp46 NKCEs in cancer immunotherapy (Press release, Innate Pharma, MAY 29, 2019, View Source [SID1234536717]). These findings, led by Professor Eric Vivier and the Innate Pharma teams in collaboration with Aix−Marseille University and the Marseille Immunopole cluster, were released in an article entitled "Multifunctional natural killer cell engagers targeting NKp46 trigger protective tumor immunity" in the online issue of Cell yesterday.

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"Our multifunctional NKp46 NKCE technology provides a versatile platform to generate formats with the potential to co-engage up to three activating receptors on NK cells and two different tumor antigens on cancer cells," explains Eric Vivier, Chief Scientific Officer of Innate Pharma, Professor at Aix-Marseille University and lead author of this publication. "These preclinical observations demonstrate the potential of NKp46 NKCEs, which were stable and had promising chemistry and manufacturing profiles compatible with industrial development. Together with a stronger anti-tumor activity in preclinical models than traditional standard therapeutic antibodies, these results support the clinical development of NKCEs for cancer immunotherapy".

Most attempts in anti-tumor therapy to date have focused on manipulating effector T cells. T cell engager formats are in clinical development, but their use has so far been limited mostly to hematological diseases because of their potential toxicity. In this paper, the authors describe the manipulation of NK cells in cancer via NKCEs based on their anti-tumor effector potential and favorable toxicity profile as compared to T cells.

NKp46 NKCEs binds to one or two antigens at the surface of tumor cells, and engage both CD16 and NKp46 activating receptors on NK cells. The co-engagement of NKp46 synergizes with CD16 to induce full NK cell activation and tumor cell lysis. Further, NKp46 expression is often conserved on infiltrating NK cells in most solid tumors.

In the scope of the expanded oncology R&D collaboration announced in October 2018, AstraZeneca has recently acquired an option to exclusively license a multi-specific NKp46 NK cell engager from Innate Pharma preclinical portfolio.

Innate Pharma is eligible for up to $855 million in opt-in payments, development and commercial milestones and high-single to double-digit tiered royalties on net sales for this molecule if the option is exercised prior to the molecule reaching clinical development. After opt-in and up to the start of a Phase III clinical trial, AstraZeneca will incur all the development costs. Innate retains the right to participate in cost sharing for Phase III clinical trials in order to receive 50% profit and loss sharing within the EU.

In addition, Innate Pharma has a research collaboration and licensing agreement with Sanofi for the generation and evaluation of up to two bispecific NK cell engagers (one of which is now the IPH61 program), using Innate Pharma’s technology and Sanofi’s technology and tumor targets. Under the terms of this license agreement, Sanofi is responsible for the development, manufacturing and commercialization of products resulting from the research collaboration. Innate Pharma is eligible to receive up to €400m in development and commercial milestone payments as well as royalties on net sales.