On June 22, 2020 Aethlon Medical, Inc. (Nasdaq: AEMD), a therapeutic medical device and technology company focused on unmet needs in viral diseases, oncology and inflammation, reported positive ex vivo data demonstrating the ability of a laboratory version of the Company’s Hemopurifier to capture tumor-derived exosomes in several forms of cancer (Press release, Aethlon Medical, JUN 22, 2020, View Source [SID1234561366]). The data were presented in e-poster format by Dr. Annette Marleau, the Company’s Senior Director of Research, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting II, on June 22, 2020.

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Exosomes are subcellular particles that are shed from both normal and malignant cells and have been shown to mediate multiple mechanisms of tumor growth and spread. The e-poster, titled, "Targeting Tumor-Derived Exosomes using a Lectin Affinity Hemofiltration Device", highlights data from ex vivo studies which demonstrate that a laboratory version of the Hemopurifier effectively captures and removes substantial quantities of exosomes from fluid samples that are circulated through the device. The data show that the Hemopurifier can clear exosomes that originate from plasma from patients with diverse cancers, including head and neck cancer, melanoma, ovarian cancer, esophageal cancer and breast cancer. The e-poster is available online at View Source!/9045/presentation/7490.

"Despite abundant research on tumor-derived exosomes and their role in cancer growth and immunosuppression, a clinical strategy for influencing exosomes in oncology has been unavailable," said Timothy C. Rodell, M.D., Chief Executive Officer of Aethlon. "The ability to effectively target and capture exosomes that exhibit signatures of malignancy and immunosuppression offers a potentially powerful therapeutic strategy for cancer. By reducing the presence of tumor-derived exosomes in the circulation of cancer patients, we believe the Hemopurifier may have the potential to improve the benefits of existing cancer treatment regimens and emerging immuno-oncology drugs. Our recently announced Early Feasibility Study in patients with head and neck cancer being treated with pembrolizumab (KeytrudaÒ) may provide human clinical data to complement these in vitro studies."

On June 22, 2020 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology (I-O) company with an extensive pipeline of agents designed to activate immune response to cancers, reported that it has entered into an agreement with Betta Pharmaceuticals (SZ300558), a top Chinese pharmaceutical company focusing on the development of innovative oncology therapies, for an exclusive collaboration and license agreement for the development and commercialization of balstilimab and zalifrelimab in Greater China, including Mainland China, Hong Kong, Macau and Taiwan (Press release, Agenus, JUN 22, 2020, View Source [SID1234561275]).

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Under the terms of the agreement, Agenus will receive $35 million, which includes $15 million in upfront cash and a $20 million equity investment. The agreement also includes $100 million in potential milestones plus royalties on net sales. Betta receives exclusive rights for the development and commercialization of balstilimab and zalifrelimab to either as monotherapies or combination therapies, excluding intravesical delivery in greater China.

Agenus’ balstilimab (anti-PD-1) is advancing in trials planned for BLA filing this year as a monotherapy and in combination with zalifrelimab (anti-CTLA-4) for the treatment of refractory or metastatic cervical cancer. Agenus has recently reported positive results suggesting robust and durable responses of balstilimab and zalifrelimab in patients with relapsed or refractory metastatic cervical cancer. The US FDA recently granted Fast Track designation for balstilimab alone and in combination with zalifrelimab in this indication.

"Betta has a strong track record of advancing innovative products in China and a growing portfolio of complementary oncology therapies," said Garo Armen, Chairman and Chief Executive Officer of Agenus. "Betta is an ideal partner to enable us to address significant patient needs in China while also advancing global development of balstilimab and zalifrelimab."

"We are delighted to enter this collaboration with Agenus, a leader in the immuno-oncology field, as the first step in a long-term strategic partnership," said Lieming Ding, Chairman and Chief Executive Officer of Betta Pharmaceuticals. " Based on the compelling clinical data reported to date, we believe Agenus’ balstilimab and zalifrelimab hold great promise for Chinese patients with cervical cancer, with the potential to further expand in additional tumor types through synergistic combinations with Betta’s existing pipeline programs."

The equity purchase component of the transaction is subject to China regulatory approval and other customary closing conditions.

On June 22, 2020 Nimbus Therapeutics, a biotechnology company designing breakthrough medicines through structure-based drug discovery and development, reported a poster at the AACR (Free AACR Whitepaper) Virtual Annual Meeting II detailing promising preclinical findings from the company’s HPK1 pipeline program (Press release, Nimbus Therapeutics, JUN 22, 2020, View Source [SID1234561302]).

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Nimbus developed multiple selective small-molecule inhibitors of HPK1 using the company’s proven structure-based drug discovery engine. The lead compound, NMBS-1, displays very high selectivity against T cell-specific kinases and kinases in the MAP4K family and promising activity in in vitro and in vivo models. NMBS-1 enhanced IL-2 production from stimulated human T cells, alleviated PGE2-mediated immunosuppression of T cell activation, and enhanced IL-6 production, proliferation, and IgG secretion from B cells. In a mouse syngeneic tumor model, oral administration of NMBS-1 resulted in significant tumor growth inhibition, both as a monotherapy and in combination with anti-CTLA4.

"These data are further evidence that HPK1 inhibition is a potentially powerful approach to achieve anti-tumor immunity — and we’re very pleased that our small-molecule inhibitor displays the selectivity that has long been a challenge for drug makers in this space," said Peter Tummino, Ph.D., Chief Scientific Officer of Nimbus. "We will continue rapidly advancing our preclinical studies, with the goal of initiating a first-in-human trial next year."

The poster is titled "A Highly Selective and Potent HPK1 Inhibitor Enhances Immune Cell Activation and Induces Robust Tumor Growth Inhibition in a Syngeneic Tumor Model."

The company will be hosting a webcast to further discuss these data on Thursday, June 25, from 11 a.m. to 12 p.m. ET. If you wish to attend the live webcast, please pre-register at https://bit.ly/NimbusHPK1Seminar. A replay of the webcast will be available at this link after the event.

On June 22, 2020 ImmunSYS, Inc., a clinical stage biopharmaceutical company focused on the development of innovative cancer immunotherapy products, reported results from a proof of concept (PoC) study evaluating its proprietary technology platform, YourVaccx for the treatment of patients with metastatic cancers (Press release, ImmunSYS, JUN 22, 2020, View Source;utm_medium=rss&utm_campaign=50-complete-response-rate-observed-in-yourvaccxtm-study-for-patients-with-metastatic-prostate-cancer-was-presented-at-the-aacr-virtual-annual-meeting-ii [SID1234561319]).

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The retrospective, IRB approved case series was independently monitored by a contract research organization. A total of 27 patients were enrolled, including 21 with metastatic prostate cancer (mPCa), and 6 with metastatic cancers of varying types: 2 bladder, 1 pancreatic, 1 melanoma, 1 colon cancer and 1 unknown. A single treatment cycle consisted of in situ cryosurgical lysis of tumor tissue followed by a direct injection of a combination of anti CTLA-4 antibody, anti PD-1 antibody and GM-CSF into the target treatment zone, followed by 30 days of daily subcutaneous GM-CSF. The patients were assessed after the completion of therapy, which varied from between 1 and 3 cycles of treatment. All responses to therapy were assessed by RECIST v. 1.1 and metastatic prostate cancer patients were also assessed by serum PSA levels. 3 patients could not be evaluated due to a lack of follow-up imaging. For all evaluable patients, the PoC study data showed a 38% (9/24) complete response rate (CR) and a 4% (1/24) partial response rate (PR), for an objective response rate (ORR) of 42% (10/24). The combination therapy was
generally well tolerated.

Key findings in mPCa patients:

Among the 18 evaluable mPCa patients, there was a 50% (9/18) CR
50% (9/18) ORR
62% (13/21) of patients had post-therapy PSA reductions of ≥ 50%
The majority of responses have been durable, with 5 of 9 CRs persisting from 12 months to over 51 months to date
6 Grade 3-4 adverse events occurred in 14.3% (3/21), with no treatment-related deaths

"We are pleased to present these encouraging findings at the AACR (Free AACR Whitepaper) virtual annual meeting II," said Eamonn Hobbs, Chairman and Chief Executive Officer of ImmunSYS. "These results demonstrate longterm, durable responses, ranging from 1 to 4.5 years, and a favorable tolerability profile in tough-to-treat patient populations. There is an unmet need for effective treatment options for patients with metastatic cancers and these data demonstrate the potential that YourVaccx has to significantly improve the lives of patients."

Our poster #6540 entitled, "Regression of metastatic cancer and abscopal effects following in situ vaccination by cryosurgical tumor cell lysis and intratumoral immunotherapy: A case series" and accompanying audio clip narrated by Gary Onik, M.D. is now available at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2020 Virtual Annual Meeting II.

On June 22, 2020 Lantheus Holdings, Inc. (the "Company") (NASDAQ: LNTH), the parent company of Lantheus Medical Imaging, Inc. ("LMI"), a global leader in the development, manufacture and commercialization of innovative diagnostic imaging agents and products, reported that it has completed its previously announced merger with Progenics Pharmaceuticals, Inc. ("Progenics") (Nasdaq: PGNX), an oncology company developing innovative medicines and artificial intelligence to find, fight and follow cancer (Press release, Lantheus Medical Imaging, JUN 22, 2020, View Source [SID1234561335]). The merger agreement was first announced on October 2, 2019.

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"Today marks an important day for Lantheus and Progenics. This combination forms an innovative company with a diversified diagnostics and therapeutics portfolio," said Mary Anne Heino, Lantheus President and Chief Executive Officer. "The transaction leverages Lantheus’ long-standing expertise in complex manufacturing, supply chain and commercial excellence, with Progenics’ three leading FDA approved products, clinical pipeline and development capabilities. We’re excited to welcome the talented Progenics employees to the Lantheus organization to help build upon our solid foundation."

Upon completion of the merger, Progenics stockholders received, for each share of Progenics common stock, 0.31 of a share of Lantheus common stock and one non-tradeable contingent value right, which is payable in two contingent payments, subject to a cap, upon the achievement of certain milestones related to the financial performance of PyLTM (18F-DCFPyL), Progenics’ prostate-specific membrane antigen targeted imaging agent designed to visualize prostate cancer.

The Company will continue to trade on Nasdaq under the ticker symbol LNTH. Progenics is being delisted.