Maverick Therapeutics Reveals Preclinical Data from COBRA™ Program, MVC-280, at Virtual Cell Engager Summit 2020

On August 19, 2020 Maverick Therapeutics, Inc., a private biopharmaceutical company pioneering conditionally active bispecific T cell targeted immunotherapies, reported the presentation of preclinical data from its lead COBRA programs, MVC-101 and MVC-280, at the 2nd Annual Cell Engager Summit taking place virtually from August 18 to August 20, 2020 (Press release, Maverick Therapeutics, AUG 19, 2020, View Source [SID1234563878]).

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Chad May Ph.D., Senior Vice President, Research & Development, Maverick Therapeutics, will reveal new preclinical data characterizing the conditional and potent activity of its second program candidate, MVC-280, a COBRA that targets B7H3, during a presentation titled "Protease Dependent COBRATM Activity Regresses Established Tumors in Mice." The preclinical data demonstrate that MVC-280 regresses established solid tumors in mice and increases tolerability relative to inherently active T cell engagers. Dr. May is also scheduled to participate in a panel discussion on the opportunities within the tumor microenvironment to widen the therapeutic index.

"The preclinical data from MVC-280 are extremely encouraging and highlight the therapeutic potential for COBRAs to pursue more broadly expressed and validated targets," said Chad May, Ph.D., Senior Vice President, Research & Development, Maverick Therapeutics. "The binding kinetics of the MVC-280 COBRA also gave us a unique opportunity to assess tolerability and efficacy within the same in vivo model and enabled the calculation of a therapeutic index, which we consider to be 30 to 100x greater than that of an inherently active T cell engager."

Highlights of the presentation include:

MVC-101 regressed established solid tumors expressing EGFR in mice
MVC-280 regressed established solid tumors expressing B7H3 in mice
Half-life extended COBRAs are cleared more rapidly after proteolytic activation
Regression of established solid tumors is dependent on tumor mediated linker cleavage and COBRA activation
The COBRA design increases the therapeutic window
Presentation Schedule

Panel Discussion:

Title: Exploiting the High Protease Concentration in the Tumor Microenvironment to Reduce Toxicity
Date & Time: Wednesday, August 19, 2020 at 11:30AM ET
Presentation:

Title: Protease Dependent COBRA Activity Regresses Established Tumors in Mice
Session: Analyzing Tumor Target Selection to Maximize Efficacy Whilst Minimizing Toxicity
Date & Time: Thursday, August 20, 2020 at 9:30AM ET
About the COBRA Platform

Maverick Therapeutics’ COBRA platform is the most mature conditionally active bispecific T cell engaging platform designed to safely target a broad range of solid tumors with highly specific and potent activity while limiting on-target toxicities in normal tissues. By nature of its highly innovative design, the COBRA platform reflects a novel approach to T cell engaging immunotherapies where T cell activation and resulting cell killing only take place where it is needed – in tumors. This unique design delivers the long sought trifecta in cancer care; high specificity, high potency and reduced toxicity.

About MVC-101

Maverick Therapeutics’ lead program candidate, MVC-101, is a proprietary COBRA molecule designed to target the Epidermal Growth Factor Receptor (EGFR), a protein expressed on both malignant and healthy tissues. MVC-101 regressed established human tumors in several preclinical models. Exposures of MVC-101 at efficacious relative to tolerated doses in safety studies demonstrates an increased therapeutic index compared to standard T cell engagers. MVC-101 is designed to be a universal solution for patients with EGFR expressing solid tumor cancers. EGFR is expressed on a wide range of solid tumor cancers, including but not limited to colorectal, head & neck, renal, pancreatic, cervical and non-small cell lung cancers. Maverick expects to initiate a Phase 1/2, Open Label, Dose Escalation Study of MVC-101 in Q1 2021.

About MVC-280

Maverick Therapeutics’ second program candidate, MVC-280, is a proprietary COBRA molecule designed to target B7H3 (CD276). B7H3 is expressed in a broad range of malignant and healthy tissues, similar to EGFR. MVC-280 regressed established tumors in several preclinical models. It is cross-reactive to its target protein expressed on mouse tissues, creating an opportunity to measure both efficacy and relative safety in the same preclinical model and use that data to calculate a therapeutic index. MVC-280 is designed to be a universal solution for patients with B7H3 expressing solid tumor cancers. B7H3 is expressed on a wide range of solid tumor cancers, including but not limited to prostate, renal, triple negative breast, head & neck, ovarian and urothelial cancers. Maverick expects to initiate a Phase 1/2, Open Label, Dose Escalation Study of MVC-280 in H2 2021.

EDAP TMS SA to Announce Second Quarter 2020 Financial Results on August 26, 2020

On August 19, 2020 EDAP TMS SA (Nasdaq: EDAP), the global leader in therapeutic ultrasound, reported that it will release its financial results for the second quarter ended June 30, 2020 after the markets close on Wednesday, August 26, 2020 (Press release, EDAP TMS, AUG 19, 2020, View Source [SID1234563877]).

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An accompanying conference call and webcast will be conducted by Marc Oczachowski, Chairman of the Board and Chief Executive Officer, and François Dietsch, Chief Financial Officer. The call will be held at 8:30am EDT on Thursday, August 27, 2020. Please refer to the information below for conference call dial-in information and webcast registration.

Conference Call & Webcast
Thursday, August 27th @ 8:30am Eastern Time
Domestic: 877-451-6152
International: 201-389-0879
Passcode: 13707833
Webcast: View Source

Alkermes Initiates Phase 2 Study Designed to Evaluate Clinical and Immunologic Activity of ALKS 4230 on Tumor Microenvironment in Patients with Advanced Solid Tumors

On August 19, 2020 Alkermes plc (Nasdaq: ALKS) reported the initiation of ARTISTRY-3, a new phase 2 study to evaluate the clinical and immunologic effects of ALKS 4230 monotherapy on the tumor microenvironment of a variety of advanced, malignant solid tumors (Press release, Alkermes, AUG 19, 2020, View Source [SID1234563875]). ALKS 4230, a novel cytokine, is an investigational, engineered fusion protein designed to selectively expand tumor-killing immune cells while avoiding the interleukin-2 (IL-2)-induced activation of immunosuppressive cells by preferentially binding to the intermediate-affinity IL-2 receptor complex.

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"Early clinical data from our ARTISTRY program showed that ALKS 4230 selectively expanded cancer-fighting immune cells in the periphery, with negligible effects on regulatory T cells (Tregs)," said Craig Hopkinson, M.D., Chief Medical Officer and Executive Vice President of Research & Development at Alkermes. "Data from the ARTISTRY-3 clinical trial will provide a deeper understanding of the effects of ALKS 4230 on immunologic activity in the tumor microenvironment across a variety of tumor types. Findings from this trial may help us answer important mechanistic questions and identify the tumor types for which ALKS 4230 could offer the most clinical benefit, thereby helping to inform a potential registration strategy."

This single-center, open-label study will evaluate treatment-emergent changes in the tumor microenvironment and peripheral blood immunophenotypes, as well as the safety, tolerability, and pharmacokinetic profile of ALKS 4230 (6µg/kg) dosed intravenously, as lead-in monotherapy followed by combination with the anti-PD-1 therapy KEYTRUDA (pembrolizumab), in patients with select advanced malignant solid tumors. Paired tumor biopsies will be collected pre–treatment and following the monotherapy and combination phases to evaluate the effects of ALKS 4230 on the immune cell repertoire, including changes in density and ratio of immune cells, within the tumor microenvironment. The study will also assess clinical anti-tumor activity (overall response rate and duration of response) of ALKS 4230 as one of its secondary objectives.

ARTISTRY-3 is the fourth clinical trial evaluating ALKS 4230 as a novel immuno-oncology candidate. ARTISTRY-1 and ARTISTRY-2 are ongoing, phase 1/2 studies evaluating ALKS 4230 as a monotherapy and in combination with pembrolizumab. ARTISTRY-1 and ARTISTRY-2 are evaluating intravenous and subcutaneous administration of ALKS 4230, respectively. ION-01 is an ongoing, phase 2 multi-site trial, designed to estimate the response rate to ALKS 4230 in combination with pembrolizumab in patients with advanced or recurrent head and neck squamous cell cancer who did not achieve complete remission with an anti-PD-(L)1 antibody treatment.

About ALKS 4230
ALKS 4230 is an investigational, novel, engineered fusion protein comprised of modified interleukin-2 (IL-2) and the high affinity IL-2 alpha receptor chain, designed to selectively expand tumor-killing immune cells while avoiding the activation of immunosuppressive cells by preferentially binding to the intermediate-affinity IL-2 receptor complex. The selectivity of ALKS 4230 is designed to leverage the proven anti-tumor effects of existing IL-2 therapy while mitigating certain limitations.

About the ARTISTRY Clinical Development Program
ARTISTRY is an Alkermes-sponsored clinical development program evaluating ALKS 4230 in patients with advanced solid tumors.

ARTISTRY-1 and ARTISTRY-2 are phase 1/2 studies evaluating the safety, tolerability, efficacy and pharmacokinetic and pharmacodynamic effects of ALKS 4230 in patients with refractory advanced solid tumors, in both monotherapy and combination settings with the PD-1 inhibitor KEYTRUDA (pembrolizumab). In ARTISTRY-1, ALKS 4230 is administered as an intravenous infusion daily for five consecutive days. In ARTISTRY-2, ALKS 4230 is administered subcutaneously and is being evaluated with once-weekly and once-every-three-week dosing schedules.

ARTISTRY-3 will evaluate the clinical and immunologic activity of intravenous ALKS 4230 monotherapy on tumor microenvironment in advanced solid tumor patients.

Rakuten Medical Announces Acquisition of Medlight SA

On August 19, 2020 Rakuten Medical, Inc. reported the acquisition of Medlight SA (Press release, Rakuten Medical, AUG 19, 2020, View Source [SID1234563869]). Medlight produces and commercializes a large range of catheters and diffusers for optical light delivery. The terms of the deal were not disclosed.

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The acquisition of Medlight provides Rakuten Medical with a strategic partner, including resources and its network of well-qualified subcontractors to facilitate rapid development of new optical devices under the European and US medical regulatory standards. This acquisition also ensures Rakuten Medical has access to and more comprehensive oversight of a supply chain vital to the development of the company’s diagnostics and therapeutic light technologies.

Previously Medlight served as a contract manufacturer for Rakuten Medical’s device finishing facility in Germany. Medlight was also a labeler for clinical trial materials and provided QA oversight for upstream manufacturing activities.

Founded in 1997, Medlight technologies have been used by more than 35 biotech companies in over 70 different diagnostic and therapeutic applications. Though cancer is the primary therapeutic indication, Medlight’s technologies have also been applied to treat cardiovascular diseases, Parkinson’s disease, ophthalmic, dermatologic, and dental diseases.

Medlight has a strong track record of working cooperatively with health care professionals, industrial partners, academic institutions, and pharmaceutical companies to develop specific medical devices for therapeutic light delivery. Headquartered just outside of Lausanne, Switzerland, Medlight’s proximity to Rakuten Medical’s device development group in Sinn-Fleisbach, Germany provides additional logistic benefits.

"Medlight is an ideal acquisition, as they are global leaders in the development of light dosimetry technologies for a variety of diseases," said Hiroshi Mikitani, Chairman and CEO of Rakuten Medical. "This acquisition secures our supply chain, ensuring the needs of patients are met by optimizing and managing continuous improvement of our delivery system."

Founder and CEO, Medlight SA, Roland Bays commented, "Our agreement with Rakuten Medical is a strategic and operational fit. We are very excited to combine our innovative technologies to yield the maximum benefit to the medical community, the patients, and families that are battling cancer."

BioLineRx Achieves Enrollment Target in Phase 3 GENESIS Trial for Planned Interim Analysis

On August 19, 2020 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, reported that a sufficient number of patients (~65% of the original planned sample size) have been enrolled in the ongoing GENESIS Phase 3 trial to allow for an interim efficacy analysis to take place in the second half of 2020 (Press release, BioLineRx, AUG 19, 2020, View Source [SID1234563853]). This ongoing registrational study is investigating motixafortide (BL-8040) for the mobilization of hematopoietic stem cells (HSCs) for autologous transplantation in patients with multiple myeloma. If the primary endpoint is met at the time of the interim analysis, the Company plans to immediately announce the cessation of further recruitment, without the need to enroll the full planned sample size. In this case, top-line results are expected in the first half of 2021, in order to maintain study blinding for all study endpoints, including those related to engraftment, for a period of 100 days subsequent to transplantation. If the primary endpoint is not reached in the interim analysis, the Company expects recruitment will continue until the originally planned sample size is met.

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"A significantly lower than anticipated patient dropout rate in the GENESIS trial triggered our decision to conduct an interim efficacy analysis, for which we have now enrolled a sufficient number of patients," said Philip Serlin, Chief Executive Officer of BioLineRx. "Once this analysis is complete, we will have enough information to decide whether to cease further enrollment or continue until completion of the original target enrollment of 177 patients. We expect the interim analysis to be completed within the next few months."

The GENESIS trial was initiated in December 2017. GENESIS is a randomized, placebo-controlled, multicenter study, evaluating the safety, tolerability and efficacy of motixafortide and G-CSF, compared to placebo and G-CSF, for the mobilization of HSCs for autologous transplantation in multiple myeloma patients. The primary objective of the study is to demonstrate that motixafortide on top of G-CSF is superior to G-CSF alone in the ability of mobilize ≥ 6×106 CD34+ cells in up to two apheresis sessions. Secondary objectives include time to engraftment of neutrophils and platelets and durability of engraftment, as well as other efficacy and safety parameters