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Provectus Biopharmaceuticals Announces Acceptances of PV-10 Poster Presentations at American Society of Clinical Oncology (ASCO) Annual Meeting

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.

Actinium Pharmaceuticals, Inc. Announces Proposed Public Offering of Common Stock and Warrants

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.

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.

Celyad to Present Update on allogeneic and autologous NKG2D-based CAR-T Candidates in Refractory mCRC at ESMO 21st World GI Congress

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]).

"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.

Affimed Provides Regulatory Update on AFM11 Clinical Program

On April 17, 2019 Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company committed to giving patients back their innate ability to fight cancer, reported that it has submitted to the U.S. Food and Drug Administration (FDA) additional information to Affimed’s initial response document submitted in early March relating to the previously-announced clinical hold on AFM11 (Press release, Affimed, APR 17, 2019, View Source [SID1234535196]). The additional information addresses the request from the FDA for the clinical trial protocol for the study of AFM11 for treatment of acute lymphocytic leukemia (ALL). Affimed anticipates receiving a response from the FDA regarding the status of the AFM11 clinical program in the second quarter of 2019.

Moleculin Announces Significant Discovery in Lung Cancer Models

On April 17, 2019 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, reported that its ongoing sponsored research at The University of Texas MD Anderson Cancer Center has now demonstrated that Annamycin is able to significantly improve survival in an aggressive form of triple negative breast cancer metastasized to the lungs in animal models (Press release, Moleculin, APR 17, 2019, View Source [SID1234535193]).

"We know that Annamycin was previously shown to be significantly more potent than doxorubicin in both Lewis lung carcinoma in vivo and small cell lung cancer in vitro models," commented Walter Klemp, Moleculin’s Chairman and CEO. "Now we are seeing significant activity against triple negative breast cancer that has metastasized to the lungs. This particular animal model used in our testing is considered to represent a very aggressive form of cancer. We believe our success in increasing the survival rate in mice with this tumor model in combination with the previously observed high uptake of Annamycin by the lungs is a promising indication that supports additional clinical research in lung and metastatic lung cancers."