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BioNTech und Genmab starten klinische Entwicklung von bi-spezifischem Duo-Body®-PD-L1x4-1BB mit Phase I/IIa Studie in soliden Tumoren

On June 17, 2019 2019 BioNTech SE, a biotechnology company focused on the clinical development of patient-specific immunotherapy for the treatment of cancer and other serious diseases, reported the launch of DuoBody PD-L1x4-1BB product candidate clinical development (Press release, BioNTech, JUN 17, 2019, View Source [SID1234539089]). PD-L1x4-1BB is a bi-specific antibody developed in collaboration with Genmab A / S. The Phase I / IIa trial will test the bi-specific antibody in patients with metastatic or surgically non-removable solid tumors that can not be treated with standard care. The DuoBody PD-L1x4-1BB is the first co-developed product candidate to reach the clinical phase. The costs and profits of the partnership are shared 50 to 50 times.

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"The launch of the Phase I / IIa clinical trial with a product candidate that was developed in just four years confirms our highly productive partnership with Genmab," said Prof. Dr. med. Ugur Sahin, CEO of BioNTech . "The dual-immunostimulatory mechanism of action of the DuoBody PD-L1x4-1BB can address a variety of cancers, as well as providing an additional level of treatment options in our cancer therapy portfolio. We also strengthen BioNTech’s strategy of using new targets and mechanisms to unlock the full potential of the immune system for cancer immunotherapy. "

The DuoBody PD-L1x4-1BB is a novel bi-specific antibody that combines the checkpoint blockade of the inhibitory PD-1: PD-L1 signaling axis with the conditional stimulation of T cells by activating the 4-1BB receptor and thereby increase the proliferation of activated T cells for the efficient control of cancer cells. The original idea and the concept of combining the two mechanisms are based on scientific studies conducted by BioNTech. The unblinded study with the DuoBody PD-L1x4-1BB (ClinicalTrials.gov Identification Number NCT03917381) is carried out at several sites and consists of two parts: a dose-escalation study (Phase I, First-in-Human) and a dose-expansion study (Phase IIa). Primary endpoints include, above all, safety assessment, including the review of dose-limiting toxicity and adverse events.

CASI Pharmaceuticals Acquires Worldwide Rights To Commercialize anti-CD19 T-cell Therapy

On June 17, 2019 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company that is focusing on developing and accelerating the launch of innovative therapeutics and pharmaceutical products in China, the U.S., and throughout the world, reported the signing of a license agreement for exclusive worldwide license and commercialization rights to an autologous anti-CD19 T-cell therapy product (CNCT19) from Juventas Cell Therapy Ltd., a China-based domestic company located in Tianjin City, China (Press release, CASI Pharmaceuticals, JUN 17, 2019, View Source [SID1234537128]). Juventas will continue to develop CNCT19 with CASI’s participation on the program’s steering committee. CASI will be responsible for payment of certain future development milestones and sales royalties.

In connection with the license, CASI Pharmaceuticals (Wuxi) Co., Ltd., a joint venture in which CASI owns 80% of the registered capital, will invest RMB 80 million (approximately 11.6 million) in Juventas through a wholly owned Chinese subsidiary in lieu of the upfront payment for the license.

CNCT19 targets CD19, a B-cell surface protein widely expressed during all phases of B-cell development and a validated target for B-cell driven hematological malignancies. CD19-targeted CAR constructs from several different institutions have demonstrated consistently high antitumor efficacy in children and adults with relapsed B-cell acute lymphoblastic leukemia (B-ALL), chronic lymphocytic leukemia (CLL), and B-cell non-Hodgkin lymphoma (B-NHL). CD19 antigen is the most frequently used biomarker in the CAR-T cell therapy clinical trials for hematological malignant diseases such as leukemia and lymphoma. Juventas has previously submitted two INDs to the NMPA for Acute Lymphoblastic Leukemia (ALL) and Non-Hodgkin Lymphoma (NHL) indications; approvals of which are expected in late 2019.

Larry Zhang, President of CASI (Beijing) Pharmaceuticals Co., Ltd., a wholly owned subsidiary of CASI, commented, "We are extremely excited by this partnership and are encouraged by the preliminary data which showed promising results that may offer the potential to be the best in class anti-CD19 CAR-T product for Non-Hodgkin lymphoma (NHL) and B-cell acute lymphoblastic leukemia (B-ALL). We are excited about our role to help drive innovation in this exciting therapeutic area and remain committed to providing a range of solutions to patients with hematological malignancies. We look forward to working with Juventas to advance the clinical development of this therapy and for CASI to begin commercial planning."

Alexander Zukiwski, M.D., CASI’s Chief Medical Officer commented, "Juventas has made significant strides thus far with regulatory filings in two treatment areas, B-cell acute lymphoblastic leukemia (B-ALL) and Non-Hodgkin lymphoma (NHL), and have identified sites for both Phase 1 and Phase 2 studies in China. We look forward to reviewing the data from the Phase 1 and 2 studies once they are available."

Data Presented At 24ᵗʰ Congress of the European Hematology Association Demonstrates Clinical Safety, Early Efficacy of Imago BioSciences’ IMG-7289 in Myelofibrosis Patients

On June 17, 2019 Imago BioSciences, Inc., a clinical-stage biotechnology company developing innovative treatments for myeloid diseases, reported that positive safety and early efficacy clinical data regarding its lysine-specific demethylase (LSD1) inhibitor, IMG-7289, were presented at the 24th Congress of the European Hematology Association (EHA) (Free EHA Whitepaper). Based on the findings, Imago has expanded the study into a Phase 2b trial and is evaluating clinical investigations in additional myeloid diseases (Press release, Imago BioSciences, JUN 17, 2019, View Source [SID1234537127]).

The data, from the ongoing IMG-7289-CTP-102 Phase 1/2a clinical trial, showed that IMG-7289 was well-tolerated in patients with high or intermediate-2 risk myelofibrosis resistant to or intolerant of approved therapy. In addition, the therapy was effective in reducing spleen volumes and substantially improved symptom scores in a majority of evaluable patients. The expanded Phase 2b study, expected to enroll 35 additional patients, will utilize a modified dosing schedule of IMG-7289 that safely optimizes efficacy. Additional trial sites have been added in the US, EU and UK (see clinicaltrials.gov NCT03136185).

"IMG-7289 has shown tremendous promise to be a meaningful treatment option for myelofibrosis patients, and these data support our clinical program," said Hugh Young Rienhoff, Jr. M.D., chief executive officer of Imago BioSciences. "These data, particularly the strong safety and efficacy signals, have informed our Phase 2b dosing strategy and encourage us to explore additional indications in myeloproliferative diseases."

The data presented is from a cohort of 16 enrolled patients, 15 of whom had received one or more prior treatments including ruxolitinib. All patients began treatment with a sub-therapeutic dose of 0.25 mg per kg, with doses increasing until platelet count rested between 50 and 100K/μL. Twelve patients (75%) sustained a platelet count within this target zone at a dose of 0.81 mg/kg, with 14 patients (88%) completing the 85-day study. Nine patients were evaluable for efficacy, with six (66%) showing a reduction of spleen volume via imaging and five (56%) recording a greater than 50% reduction in total symptom score (TSS) and two (22%) recording an improved bone marrow fibrosis score at 12 weeks.

The study has not shown safety signals, dose-limiting toxicities, or patient deaths with a median duration of treatment at 156 days. Fourteen patients in the study reported a total of 239 adverse events.

"LSD-1 inhibition has shown positive preclinical potential for treating myelofibrosis. This first report of clinical data suggesting that IMG-7289 is safe and tolerable in patients is cause for optimism in this terrible disease," said Kristen Pettit, M.D., Assistant Professor of Medicine at the University of Michigan and a principle investigator of the study. "Even with a conservative dosing approach to evaluate safety, we saw encouraging improvements in patients’ symptoms and spleen sizes. Continued evaluation of this therapeutic candidate under the modified clinical trial design with a more aggressive dosing approach will be a critical next step."

A summary of the presentation is available in the "News" section of Imago’s website.

About IMG-7289

IMG-7289 is a small molecule discovered by Imago BioSciences that inhibits lysine-specific demethylase 1 (LSD1 or KDM1A), an enzyme regulating cytokine expression, myeloid differentiation and sustaining self-renewal in malignant hematopoietic stem/progenitor cells. In non-clinical studies, IMG-7289 demonstrated robust in vivo efficacy as a single agent and in combination with other therapeutic agents across a range of myeloid malignancies models including the myeloproliferative neoplasms which encompass myelofibrosis, essential thrombocythemia and polycythemia vera. IMG-7289 also shows activity against solid tumors in combination with checkpoint inhibitor agents in non-clinical models. IMG-7289 is under evaluation for the treatment of acute myeloid leukemia (see clinicaltrials.gov NCT02842827), with additional clinical studies in myeloid diseases under evaluation.

Ampio Pharmaceuticals Announces Pricing of Public Offering

On June 17, 2019 Ampio Pharmaceuticals, Inc. (NYSE American: AMPE) reported that it will offer up to $12 Million of its common stock in public offering (Press release, Ampio, JUN 17, 2019, View Source [SID1234537126]). Ampio has entered into purchase agreements for the purchase of an aggregate 25,320,000 common shares of the Company at an offering price of $0.40 per Common Share for aggregate gross proceeds of $10.1 million, before placement agent fees and other offering expenses. Ampio anticipates an additional 4,680,000 shares of its Common Stock will be sold at the same price at the close of the offering. The offering is expected to close on or about June 19, 2019.

The Company intends to use the net proceeds from this offering for the full cost of its AP-013 clinical trial pursuant to its recently announced Special Protocol Assessment and other general corporate purposes.

ThinkEquity, a division of Fordham Financial Management, Inc., is acting as the exclusive placement agent for this transaction.

All of the common stock in this offering were offered on a reasonable best efforts, any and all basis pursuant to an effective shelf registration statement. A prospectus supplement relating to the offering was filed by the Company with the SEC and is available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and accompanying prospectus may also be obtained from ThinkEquity, 17 State Street, 22nd Floor, New York, NY 10004 (646) 968-9355, Email: [email protected].

This press release shall not constitute an offer to sell or a 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 registration or qualification under the securities laws of any such state or jurisdiction.

Immunotherapy Study for Prostate Cancer Active Surveillance Completes Enrollment

On June 17, 2019 Candel Therapeutics (a.k.a. Advantagene, Inc.) reported that it has completed enrollment of the "ULYSSES" trial, a Phase 2 study of ProstAtak for prostate cancer patients choosing Active Surveillance (PrTK04- NCT02768363) (Press release, Candel Therapeutics, JUN 17, 2019, View Source [SID1234537124]). Enrollment is still open for prostate cancer patients choosing radiation therapy as their primary treatment (PrTK03- NCT01436968). ProstAtak is Gene Mediated Cytotoxic Immunotherapy (GMCI – aglatimagene besadenovec (AdV-tk) plus oral valacyclovir) for treatment of prostate cancer. GMCI is an "off the shelf", low-toxicity immunotherapy that stimulates a patient’s own immune system to generate a robust and precise response against their cancer.

In the USA, about 175,000 men are diagnosed with localized prostate cancer each year. Approximately one third of these patients choose Active Surveillance (AS), a strategy to monitor rather than radically treat their disease. If the disease progresses, radical surgery or radiation are still options. AS is chosen primarily to avoid or postpone the significant risk of urinary incontinence and sexual dysfunction often associated with radical treatments. The number of patients on AS has been steadily increasing over the past 5 years.

The ULYSSES study enrolled 190 patients at 22 clinical sites. The size of the study was expanded from an originally planned 156 patients due to investigator and patient demand. The primary endpoint for the trial is change in tumor-risk markers such as tumor grade and extent of disease. Other endpoints of interest include time to radical treatment and safety. Topline data is expected late next year.

"Men with low-risk prostate cancer benefit from active surveillance but a significant proportion have cancer progression and ultimately require surgery or radiation therapy," said Dr. Scott Eggener, Professor of Surgery and Radiology and Director of the Prostate Cancer Program at University of Chicago and a lead investigator in the Ulysses study. "It would be very exciting if there was an easily delivered and safe intervention that significantly lowers the likelihood of these men ever requiring surgery or radiation."

Candel is also conducting PrTK03, a registration trial with ProstAtak for the treatment of intermediate-high risk localized prostate cancer patients undergoing radiation under a Special Protocol Assessment approved by the U.S. Food and Drug Administration. If proven efficacious, ProstAtak will be the first and only therapeutic pharmaceutical available for newly diagnosed prostate cancer. The company is conducting additional GMCI clinical studies in pancreas, lung, and brain cancers with impressive clinical results to date.

"We are thrilled with the progress of the Ulysses study," stated Dr. Estuardo Aguilar-Cordova, Chief Executive Officer of Candel, "we are grateful to the patients and doctors that are participating and are very hopeful that their efforts will result in better outcomes for future cancer patients. With side effects similar to those of a flu shot, ProstAtak could one day become a first-line ‘Pro-Active Surveillance’ option for the thousands of men diagnosed with low-risk prostate cancer every year."