On April 18, 2019 Acorda Therapeutics, Inc. (NASDAQ: ACOR) reported that it will host a conference call and webcast to report its first quarter 2019 update and financial results on Thursday, May 2 at 8:30 a.m. ET (Press release, Acorda Therapeutics, APR 18, 2019, View Source [SID1234535190]).

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To participate in the conference call, please dial (866) 393-4306 (domestic) or (734) 385-2616 (international) and reference the access code 4783943. The presentation will be available on the Investors section of www.acorda.com.

A replay of the call will be available from 11:30 a.m. ET on May 2, 2019 until 11:59 p.m. ET on June 2, 2019. To access the replay, please dial (855) 859-2056 (domestic) or (404) 537-3406 (international); reference code 4783943. The archived webcast will be available in the Investor Relations section of the Acorda website at www.acorda.com.

On April 18, 2019 Inovio Pharmaceuticals, Inc. (NASDAQ: INO) reported the company’s novel DNA-encoded Bi-specific T Cell Engagers (dBiTEs) generated potent anti-tumor activities and cleared established tumors in preclinical studies (Press release, Inovio, APR 18, 2019, View Source [SID1234535189]). Inovio’s dBiTE results were published in a JCI Insight article entitled, "DNA-encoded bi-specific T cell engagers and antibodies present long-term antitumor activity," by Inovio and its collaborators at The Wistar Institute. JCI Insight is a peer-reviewed journal published by the American Society for Clinical Investigation dedicated to well-executed preclinical and clinical research studies.

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For this study, Inovio developed a novel dBiTE targeting the HER2 molecule which was tested in therapeutic models for the treatment of ovarian and breast cancers. Importantly, just a single dose of Inovio’s HER2 dBiTE resulted in high levels of corresponding BiTE in mice for up to four months, exceeding what is typically displayed with the currently approved BiTE’s short half-life of only a few hours. The HER2 dBiTE treatment effectively killed HER2-expressing tumor cells resulting in a near-complete tumor clearance.

Dr. J. Joseph Kim, Inovio’s President and CEO, said, "Inovio’s dBiTEs represent game-changing advancements in immuno-oncology. Leveraging Inovio’s in vivo synthetic nucleic expression platform, we have shown that just one dose of Inovio’s dBiTE could generate corresponding BiTEs at high levels for several months, demonstrating a dramatic advantage over conventional BiTEs. Our dBiTE technology could be utilized to overcome the greatest shortcomings of traditional BiTEs, particularly its incredibly short half-life. Based on these promising preclinical results, we plan to rapidly advance our first dBiTE candidate into clinical testing, as well as develop more cancer tumor-targeting dBiTEs as partnering candidates."

BiTEs are a class of artificial bi-specific monoclonal antibodies that has the potential to transform the immunotherapy landscape for cancer. They direct a host’s immune system, more specifically the T cells’ cytotoxic activity, against cancer cells. In layman’s terms, BiTEs are like a double-sided tape that binds to a tumor and to a cancer-killing T cell. One domain of the BiTE binds to the targeted tumor (like HER2 or CD19 expressing cells) while the other engages the immune system by binding directly to CD3 molecules on T cells. This double-binding activity drives T cell activation directly at the tumor resulting in a killing function and tumor destruction.

The biggest drawback of conventional protein-based BiTEs is their short half-life. The BiTEs have a half-life of only two hours, which requires patients to undergo continuous intravenous infusion for several weeks to maintain therapeutic levels, making treatment adherence more difficult and resulting in high levels of infusion-associated adverse events. In addition, just like other traditional monoclonal antibodies, conventional BiTEs are also manufactured in bioreactors, typically requiring costly large-scale manufacturing facility development and laborious production as well as having to deal with improper product folding and stability. They must also be kept and distributed frozen at all times. These difficulties collectively have limited the development and commercialization of conventional BiTEs as only one licensed product is currently on the market (BLINCYTO (blinatumomab)).

Inovio’s dBiTE is a new transformative application of Inovio’s dMAb platform. The dBiTEs share many advantages of Inovio’s dMAbs as they both are composed of engineered DNA sequences which encode antibody fragments. When administered by Inovio’s CELLECTRA delivery device, the patient’s own cells become the factory to manufacture functional BiTES encoded by the delivered dBiTE sequences. Inovio’s dBiTEs are developed with novel syntheic nucleics design using plasmid vectors and unique formulations allowing for rapidity of development, long-term product stability at refrigeration, ease of validated and scalable manufacturing and deployability.

About Inovio’s dBiTE program

Inovio’s dBiTEs are able to target the cytotoxic T cells to tumors by engaging proteins expressed in the tumor surface. The current preclinical models have shown proof that DNA technologies are in an advantageous position to launch a more ambitious BiTE program. The tumor-binding domain can be modified to engage multiple targets, of which preclinical data targeting HER2 and CD19 has been presented. Of these, the CD19dBiTE can be used to target B cell cancers and the HER2dBiTE can be used to treat advanced breast, ovarian, gastric, esophageal and endometrioid cancers.

On April 17, 2019 Provectus (OTCQB: PVCT) reported that data from clinical trials of lead investigational cancer agent PV-10 will be presented on two poster presentations at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, held in Chicago, IL from May 31-June 4, 2019 (Press release, Provectus Biopharmaceuticals, APR 17, 2019, View Source [SID1234535201]). Intratumoral injection of small molecule oncolytic immunotherapy PV-10 can yield immunogenic cell death in solid tumor cancers, stimulating tumor-specific reactivity in circulating T cells1-4 that may lead to a functional recruitment of the immune system.

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Abstract #1:

Presentation: A Phase 1 Study of Oncolytic Immunotherapy of Metastatic Neuroendocrine Tumours using Intralesional Rose Bengal Disodium: Cohort 1 results
Poster session: Gastrointestinal (Noncolorectal) Cancer (Monday, June 3, 9-11 AM)
Abstract number: 4102
Abstract #2:

Presentation: Phase 1b Study of PV-10 and PD-1 Blockade in Advanced Cutaneous Melanoma
Poster session: Melanoma/Skin Cancers (Monday, June 3, 1:15-4:15 PM)
Abstract number: 9559
About PV-10

PV-10 causes acute oncolytic destruction of injected tumors, releasing damage associated molecular pattern molecules (DAMPs) and tumor antigens that initiate an immunologic cascade where local response by the innate immune system facilitates systemic anti-tumor immunity by the adaptive immune system. The DAMP release-mediated adaptive immune response activates lymphocytes, including CD8+ T cells, CD4+ T cells, and NKT cells, based on clinical and preclinical experience in multiple tumor types. T cell function can be further augmented by combining PV-10 with immune checkpoint inhibition.

PV-10 is undergoing clinical study for adult solid tumor cancers like melanoma and cancers of the liver (including metastatic symptomatic neuroendocrine tumors and metastatic uveal melanoma) and preclinical study for pediatric cancers like neuroblastoma5, Ewing sarcoma, rhabdomyosarcoma, and osteosarcoma.

Orphan drug designation status has been granted to PV-10 by the U.S. Food and Drug Administration for the treatments of metastatic melanoma in 2006, hepatocellular carcinoma in 2011, neuroblastoma in 2018, and ocular melanoma (including uveal melanoma) in 2019.

PV-10’s active pharmaceutical ingredient is rose bengal disodium (RB) (4,5,6,7-tetrachloro-2’,4’,5’,7’-tetraiodofluorescein disodium salt), a small molecule halogenated xanthene. PV-10 drug product is a bright rose red solution containing 10% w/v RB in 0.9% saline for injection, which is supplied in single-use glass vials containing 5 mL (to deliver) of solution and administered without dilution to solid tumors via intratumoral injection.

Provectus’ intellectual property includes a family of US and international patents that protect the process by which pharmaceutical grade RB and related xanthenes are produced, reducing the formation of previously unknown transhalogenated impurities that exist in commercial grade RB in uncontrolled amounts. The requirement to identify and control these substances is in accordance with International Conference on Harmonisation (ICH) guidelines for the manufacturing of active pharmaceutical ingredient that is suitable for clinical trial and commercial pharmaceutical use. US patent numbers are 8,530,675, 9,273,022, and 9,422,260; patent expirations range from 2030 to 2031.

On April 17, 2019 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium") reported that it intends to offer and sell, subject to market and other conditions, shares of its common stock and warrants to purchase additional shares of its common stock in an underwritten public offering (Press release, Actinium Pharmaceuticals, APR 17, 2019, View Source [SID1234535200]). There can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. Actinium intends to use the net proceeds from the sale of the common stock and warrants to fund its ongoing pivotal, Phase 3 SIERRA trial for its lead product candidate Iomab-B and progress Phase 1 trials from its refocused CD33 program to the proof of concept stage. Actinium will also use the proceeds to support its Antibody Warhead Enabling technology platform, including its Iomab-ACT program, research and development and general working capital needs.

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William Blair & Company, L.L.C. is acting as sole bookrunner for the offering.

The shares and warrants are being offered pursuant to an effective shelf registration statement (including a prospectus) on Form S-3 (File No. 333-216748) filed with the U.S. Securities Exchange Commission (the "SEC"). A preliminary prospectus supplement, dated April 17, 2019 and accompanying prospectus, dated October 24, 2017, relating to the offering have been filed with the SEC. To obtain a copy of the preliminary prospectus supplement, dated April 17, 2019, and the final prospectus supplement (when available) for this offering, please contact William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, IL 60606, or by calling (800) 621-0687, or emailing [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, 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 such state or jurisdiction.

On April 17, 2019 Celyad (Euronext Brussels and Paris, and Nasdaq: CYAD), a clinical-stage biopharmaceutical company focused on the development of CAR-T cell-based therapies, reported that clinical data from the SHRINK and alloSHRINK Phase 1 trials, evaluating the safety of NKG2D-based autologous and allogeneic CAR-T candidates, CYAD-01 and CYAD-101, respectively, will be presented at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 21st World Congress on Gastrointestinal Cancer (WCGIC) to be held on July 3-6, 2019, in Barcelona, Spain (Press release, Celyad, APR 17, 2019, View Source [SID1234535199]).

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"We are delighted for the opportunity to present updated data at the upcoming WCGIC from both our autologous and allogeneic NKG2D-based clinical candidates for the treatment of refractory metastatic colorectal cancer" noted Frédéric Lehmann, Head of Global Clinical Development and Medical Affairs at Celyad. "We continue to build upon our clinical experience in the treatment of solid tumors with these novel immunotherapies and the oral presentation at WCGIC represents a special milestone to highlight preliminary data from the industry’s first trial investigating an ‘off-the-shelf ‘ CAR-T candidate for the treatment of solid tumors. In addition, the comparable trial designs between SHRINK and alloSHRINK as well as the similar CAR constructs provide insight into autologous and allogeneic approaches in an advanced solid tumor indication."

Presentation Details:

Abstract #631: Phase 1 studies assessing the safety and clinical activity of autologous and allogeneic NKG2D-based CAR-T therapy in metastatic colorectal cancer

Session: Short Oral Presentation

Background on CYAD-01 and CYAD-101

CYAD-01 is an investigational CAR-T therapy in which a patient’s T cells are engineered to express a chimeric antigen receptor (CAR) based on NKG2D, a receptor expressed on natural killer (NK) cells that binds to eight stress-induced ligands expressed on tumor cells. CYAD-101 is an investigational, non-gene edited, allogeneic (donor derived) CAR-T therapy that co-expresses the NKG2D CAR of CYAD-01 and the novel inhibitory peptide TIM (T cell receptor [TCR] Inhibiting Molecule). The expression of TIM reduces signalling of the TCR complex which is responsible for Graft versus Host Disease (GvHD).

Background on SHRINK and alloSHRINK Trials

SHRINK is an open-label, dose-escalation Phase 1 trial assessing the safety and activity of CYAD-01 administered concurrently with FOLFOX (combination of 5-fluorouracil, leucovorin and oxaliplatin) chemotherapy in patients with metastatic colorectal cancer (mCRC). Patients will receive six cycles of FOLFOX chemotherapy every two weeks and three administrations of CYAD-01 every two weeks.

alloSHRINK is an open-label, dose-escalation Phase 1 trial assessing the safety and clinical activity of CYAD-101 administered concurrently with FOLFOX chemotherapy in patients with refractory mCRC. Similar to the SHRINK trial for CYAD-01, patients will receive six cycles of FOLFOX chemotherapy every two weeks and three administrations of CYAD-101 every two weeks.