On May 27, 2021 AIM ImmunoTech Inc. (NYSE American: AIM) reported that it has entered into a two-year extension of its Material Transfer and Research Agreement with Shenzhen Smoore Technology Limited (Smoore), a subsidiary of Smoore International Holdings Limited (HKEX: 6969), with the goal of developing Ampligen as a potential inhalation therapy for COVID-19 and potentially other respiratory viral diseases (Press release, AIM ImmunoTech, MAY 27, 2021, View Source [SID1234583284]).

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AIM entered into the agreement on April 1, 2020, to study the utilization of an innovative Smoore inhalation delivery device and Ampligen as a potential treatment approach for the SARS-CoV-2 pandemic. On parallel paths, over the past year, Smoore has focused on the development of a personal inhalation device designed to administer Ampligen, given temperature parameters of dsRNA. Contemporaneously, AIM has studied the safety and efficacy of Ampligen using an ex vivo 3D model in primary human respiratory epithelial cells at Utah State University, which showed that Ampligen was able to decrease SARS-CoV-2 infectious viral yields by 90% at clinically achievable intranasal Ampligen dosage levels, and conducted intranasal safety testing. AIM hopes to commence inhalation safety testing before year-end.

"With Smoore’s concept for an Ampligen inhalation delivery device ready to be developed, and Ampligen’s track record of both safety and efficacy, we believe AIM is well positioned to move forward with our goal of developing Ampligen as a potential inhalation therapy for COVID-19 and potentially other respiratory viral diseases," said AIM CEO Thomas K. Equels. "We are in the process of planning a Phase 1/2 inhalation clinical study on a parallel track with Smoore’s device development testing."

‘Application of vaping technology in healthcare and pharmaceutical fields is one of our R&D focus. We are really happy to partner with AIM to explore applications of advanced atomization technology in medical inhalation therapy," Dr. Zhiqiang Shi, Chief Scientist and Director of Global R&D of Smoore, commented. "We will coordinate our device development work along with our partner’s plan and the regulation needs to move into next phase testing on schedule.’

On May 27, 2021 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational conditionally activated therapeutics based on its Probody technology platform, reported that Amy Peterson, M.D., chief development officer, will participate in a virtual fireside chat at the Jefferies Virtual Healthcare Conference on June 3rd at 2:00 p.m. ET (Press release, CytomX Therapeutics, MAY 27, 2021, View Source [SID1234580669]). In addition, management will be available for one-on-one meetings with investors who are registered to attend the conference.

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A live webcast of the fireside chat will be available on the Events and Presentations page of CytomX’s website at www.cytomx.com. An archived replay will be available for 30 days following the event.

On May 27, 2021 IconOVir Bio, Inc. (IconOVir), a preclinical-stage biotechnology company pioneering the next generation of oncolytic virus (OV) therapy to improve the treatment of patients with cancer, reported that Mark McCamish, M.D., Ph.D., President and Chief Executive Officer of IconOVir, will present a corporate overview at the Jefferies Healthcare Conference on Thursday, June 3, 2021 at 3:00 p.m. ET (12:00 p.m. PT) (Press release, IconOVir Bio, MAY 27, 2021, View Source [SID1234580687]).

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On May 27, 2021 BioInvent International AB ("BioInvent") (Nasdaq Stockholm: BINV), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, and Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, announce that their Investigational New Drug (IND) application for BT-001 has been granted by the U.S. Food and Drug Administration (FDA) (Press release, BioInvent, MAY 27, 2021, View Source [SID1234580703]). This IND will allow patients in the U.S. to be enrolled into the ongoing Phase 1/2a clinical trial of this novel oncolytic virus BT-001. BT-001 is armed with both a differentiated Treg-depleting human recombinant anti-CTLA4 antibody and GM-CSF.

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The ongoing Phase 1/2a (NCT04725331) study is a multicenter, open label, dose-escalation trial evaluating BT-001 as a single agent and in combination with pembrolizumab (anti-PD-1 treatment). The Phase 1 part of the trial has already been initiated in Europe, where it is enrolling patients in several countries.

BT-001 is expected to elicit a strong and effective antitumoral response by selectively targeting and modulating the tumor microenvironment. In addition, delivering the anti-CTLA4 antibody directly to the tumor aims to induce local Treg depletion and strong therapeutic activity. As a consequence, the safety and tolerability profile of the anti-CTLA4 antibody is expected to be greatly improved due to reduced systemic exposure.

BT-001 is being codeveloped through a 50/50 collaboration between BioInvent and Transgene.

"We are pleased to receive IND approval for this Phase 1/2a clinical trial of BT-001, which is BioInvent’s fourth clinical program. This unique oncolytic virus has very exciting potential as it combines multiple mechanisms of action and anti-cancer properties, and we are looking forward to developing it further with our partners at Transgene," said Martin Welschof, CEO of BioInvent.

Hedi Ben Brahim, Chairman and CEO of Transgene, said: "We have designed BT-001 to significantly improve treatment for patients with solid tumors by restoring their immune response against cancer. Its capacity to induce long-lasting antitumor immune responses and abscopal effects has been demonstrated in several tumor models. Patient accrual in the ongoing Phase 1 clinical trial is in line with our plan and highlight clinicians’ interest in this novel and promising immunotherapy approach. We are pleased to prepare the next step in its clinical development with this IND clearance which will allow us to enroll U.S. patients in this exciting clinical trial."

The Phase 1 trial is divided into two parts. Part A will enroll up to 36 patients with metastatic/advanced solid tumors. Patients will receive single agent, intra-tumoral administrations of BT-001. Part B will explore the combination of intra-tumoral injections of BT-001 with the standard treatment regimen of pembrolizumab in 12 patients. The Phase 2a part of the trial will evaluate BT-001-based combination regimen in several patient cohorts with different tumor types. These expansion cohorts will offer the possibility of exploring the activity of this approach to treat other malignancies not traditionally addressed with this type of treatment.

About BT-001

BT-001 is a novel oncolytic virus developed with Transgene’s Invir.IO platform. Invir.IO’s viruses are based on the patented large capacity Vaccinia virus Copenhagen strain genetically modified with the double deletion TK-RR-. This optimization enhances the safety profile of the virus.

BT-001 is engineered to encode both a highly differentiated Treg depleting anti-CTLA4 antibody and the human GM-CSF cytokine. The recombinant antibody recognizing human CTLA4 was generated by BioInvent’s proprietary n-CoDeR/F.I.R.S.T platforms. The use of an oncolytic virus to deliver the anti-CTLA4 locally and selectively in the tumor microenvironment allows high intratumoral concentrations of both transgenes eliciting a stronger and more effective antitumor response, by reducing systemic exposure to a very low level.

Preclinical data have shown that BT-001 has potential for broad single agent activity, and that selective tumor-localized delivery of anti-CTLA4 may allow for a better tolerated, sustained and more effective combination therapy with antibodies targeting the PD-1/PDL1 axis.

The scientific and clinical development of the oncolytic virus candidate BT-001 is a 50/50 collaboration between BioInvent and Transgene.

On May 29, 2021 ANI Pharmaceuticals, Inc. ("ANI" or the "Company") (Nasdaq: ANIP) reported that Nikhil Lalwani, Chief Executive Officer, and Stephen Carey, Chief Financial Officer, will present at the Jefferies Virtual Healthcare Conference 2021 as follows (Press release, ANI Pharmaceuticals, MAY 27, 2021, View Source [SID1234583239]):

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Date:
Friday, June 4, 2021

Time:

10:00 a.m. ET

Webcast Link:

View Source

The presentation will be webcast live at the aforementioned time, and archived for 30 days thereafter, via the Company’s website at www.anipharmaceuticals.com, under the Investors section.