On August 4, 2020 Transgene (Paris:TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, reported that it has raised $22.2 million (€ 19 million) from the sale of 10.3 million shares of its minority stake in Tasly BioPharmaceuticals to a Chinese investment fund (Press release, Transgene, AUG 4, 2020, View Source [SID1234562842]). The shares that have been sold represent 38% of Transgene’s total holding in Tasly BioPharmaceuticals. The transaction enhances the Company’s cash position and strengthens its financial visibility until 2022.

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Following this share sale, Transgene holds 17.1 million shares in Tasly BioPharmaceuticals, equivalent to 1.58% of the Chinese company’s capital. Transgene’s remaining shareholding in Tasly BioPharmaceuticals would be valued at approximately $36.9 million based on the price of the current share sale.

In May 2020, Tasly Pharmaceuticals announced its plan to list its subsidiary Tasly Biopharmaceuticals on the Shanghai Stock Exchange’s Star Market.

Transgene has been a shareholder in Tasly BioPharmaceuticals since August 2018 when it received 27.4 million shares of Tasly Biopharmaceuticals in exchange for the sale of the Greater China rights of T101 and T601, two products respectively incorporating Transgene’s TG6002 and TG1050 patented technologies. At the time, these shares were valued at $48 million based on the pricing of a funding round conducted by Tasly concurrently with Transgene’s share subscription compared to the pre-IPO value of $59 million implied by the current operation.

On August 4, 2020 Immune-Onc Therapeutics, Inc. ("Immune-Onc"), a clinical-stage cancer immunotherapy company, reported it has been awarded a Small Business Innovation Research (SBIR) Direct to Phase II grant from the National Cancer Institute (NCI) of the National Institutes of Health (NIH) (Press release, Immune-Onc Therapeutics, AUG 4, 2020, View Source [SID1234562841]). The grant, in the amount of $2.14 million over two years, will support development of IO-202, a first-in-class antibody targeting leukocyte immunoglobulin-like receptor B4 (LILRB4), for acute myeloid leukemia (AML), the most common acute leukemia in adults, and for chronic myelomonocytic leukemia (CMML), a rare form of leukemia. The highly competitive SBIR programs enable small businesses to explore technological potential and pursue commercialization of innovations.

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"We are honored to receive financial support and scientific endorsement from the National Cancer Institute," said Charlene Liao, Ph.D., chief executive officer of Immune-Onc. "This Direct to Phase II SBIR award will help us advance our lead clinical program. We look forward to working with our investigators to initiate the first-in-human trial of IO-202 in two forms of leukemia: AML and CMML. We also plan to evaluate IO-202 in other blood cancers and solid tumors in the future."

In May, Immune-Onc’s IO-202 Investigational New Drug (IND) application received clearance from the U.S. Food and Drug Administration (FDA). In preclinical studies, IO-202 has shown evidence of activating T cell cytotoxicity against leukemia cells and blocking tumor infiltration. Immune-Onc’s first Phase I trial with IO-202 will evaluate its safety, tolerability, pharmacokinetics, pharmacodynamics and clinical activity in AML patients with monocytic differentiation and in CMML patients.

ABOUT AML and CMML

AML, the most common acute leukemia (blood and bone marrow cancer) in adults, is characterized by the proliferation of abnormal myeloblasts (a type of white blood cell) in the bone marrow. Nearly 20,000 new cases are expected in the U.S. in 2020. Despite advances in treatment, less than 30 percent of acute myeloid leukemia patients are alive five years after initial diagnosis.

CMML is a cancer that starts in blood-forming cells in the bone marrow and invades the blood. The condition is rare, with about 1,100 cases in the U.S. each year.

ABOUT IO-202

IO-202 is a first-in-class monoclonal antibody that blocks signaling of leukocyte immunoglobulin-like receptor B4 (LILRB4), an immune inhibitory receptor, with high binding affinity and specificity. In October 2018, Immune-Onc and The University of Texas announced the publication of pioneering research in Nature (DOI: 10.1038/s41586-018-0615-z) illuminating the roles of LILRB4 in immune suppression and tumor infiltration in AML. IO-202 is the first T-cell activator for AML. Preclinical studies showed that IO-202 can convert a "don’t kill me" to "kill me" signal by activating T cell killing of AML cells and a "don’t find me" to "find me" signal by inhibiting leukemia infiltration. IO-202 will be evaluated in AML and CMML in a Phase I trial, and Immune-Onc plans to explore its potential in other hematologic malignancies and solid tumors in future trials.

On August 4, 2020 BryoLogyx, Inc. reported that it has entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), to conduct a Phase I clinical trial with bryostatin-1 in pediatric and young adult patients with relapsing or refractory CD22 expressing acute lymphoblastic leukemia (ALL) and lymphoma (Press release, BryoLogyx, AUG 4, 2020, View Source [SID1234562840]). The study, expected to start later this year, will be the first in patients to evaluate the ability of bryostatin-1 to upregulate expression of CD22, a cancer immunotherapy target often downregulated following antibody drug conjugate or CAR T adoptive therapies. The Company is planning future clinical trials with bryostatin-1 to evaluate its ability to upregulate other antigen targets associated with B cell hematological malignancies.

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"This CRADA provides an accelerated path to demonstrating clinical proof-of-concept for our innovative approach that enhancing the response to cancer immunotherapy can be achieved by increasing expression of antigen targets," said Thomas M. Loarie, CEO of BryoLogyx. "Our collaboration builds on NCI’s pioneering work showing that relapse in patients undergoing ALL treatment with a CD22-directed CAR T therapy is associated with reduced CD22 antigen expression; and that in preclinical studies, bryostatin-1 upregulates CD22 density on the cancer cell, improves CAR T functionality, duration of response, and survival in CAR T-treated human xenograft models."

Under the CRADA, NCI researchers will test bryostatin-1 to evaluate its ability to modulate CD22 in patients with relapsed/refractory CD22+ ALL and lymphoma, while specifically evaluating its safety, defining the optimal biologic dose required to lead to an increase in CD22 site density, and anti-leukemic properties.

Mr. Loarie noted that BryoLogyx plans to follow this CRADA study with additional trials to expand the understanding of how bryostatin-1 increases tumor antigen expression and amplifies the immune response to several immune-oncology therapies in a variety of hematologic cancers.

The CRADA follows recent agreements entered into by BryoLogyx with Neurotrope to acquire a preclinical data package for a BryoLogyx-sponsored IND, along with study drug for the clinical trial.

On August 4, 2020 Tarveda Therapeutics, Inc., a clinical stage biopharmaceutical company developing a new class of potent and selective precision oncology medicines, which it refers to as Pentarin miniature drug conjugates, reported the publication of its preclinical study evaluating its HSP90 binding miniature drug conjugate with a pan-PI3K payload, T-2143, in solid tumors (Press release, Tarveda Therapeutics, AUG 4, 2020, View Source [SID1234562839]). The publication, titled "Novel Miniaturized Drug Conjugate Leverages HSP90 Driven Tumor Accumulation to Overcome PI3K Inhibitor Delivery Challenges to Solid Tumors," was published in Molecular Cancer Therapeutics, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper).

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"The PI3K pathway is one of the most frequently dysregulated signaling cascades in cancer and is implicated in a wide range of tumor types. Successful drug development of PI3K inhibitors has been very limited however, due to toxicity observed across numerous programs," said Mark Bilodeau, Ph.D., Chief Scientific Officer of Tarveda. "We have been able to leverage our HSP90 binding miniature drug conjugate platform to develop T-2143, designed to target a pan-PI3K inhibitor selectively to the activated HSP90 in solid tumors, and to mask the activity of the pan-PI3K inhibitor until it is released preferentially in the tumor, which further enhances the systemic tolerability of the payload. The results of the study published today confirm that T-2143 had superior efficacy to a non-targeted pan-PI3K inhibitor alone in a pre-clinical xenograft model, and that the tumor targeting and payload masking successfully reduced hyperglycemia, one of the most common dose-limiting toxicities in this class."

"The T-2143 conjugate design sets the stage for a potentially differentiated pan-PI3K inhibitor, with an improved efficacy and safety profile over existing pan-PI3K inhibitors alone," said Kapil Dhingra, M.D., a leading oncology therapeutics expert and member of the Tarveda Scientific Advisory Board. "The encouraging results of this preclinical study show that T-2143 was able to significantly inhibit tumor growth without the hyperglycemia commonly seen as a dose-limiting toxicity of inhibitors of PI3Ka including the pan-PI3K inhibitor class. If proven in human clinical trials, this approach has the potential to deliver improved efficacy of this important class of inhibitors, with applicability across a wide range of tumor types. As the second drug candidate from this novel platform, this data further supports the notion that HSP90 binding miniature conjugates can allow tumor specific accumulation and retention of a variety of payloads that may address unmet medical needs across a broad spectrum of tumor types, without the usual limitations encountered by antibody-drug conjugates."

The results of the study detail how our HSP90 targeted pan-PI3K inhibitor drug conjugate, T-2143, demonstrates rapid and sustained tumor accumulation of the conjugate, deep pathway inhibition, and superior efficacy in tumor xenograft models than the marketed pan-PI3K inhibitor, copanlisib, on its own. Data from the study show that by leveraging the preferential accumulation of HSP90 targeted conjugates and its payload in tumors, T-2143 can selectively target a pan-PI3K inhibitor, leading to efficacy in multiple xenograft tumor models. The selective targeting of T-2143 and the masking of the inhibitor active site enabled mitigation of hyperglycemia, a dose limiting side effect seen in pan-PI3K inhibitors, while driving higher tumor exposure and enhanced efficacy. The targeted drug conjugate strategy employed in the design of T-2143 is based on Tarveda’s HSP90 binding drug conjugate platform and shows the potential to provide new treatment options to patients with solid tumor malignancies through specific tumor targeting of anticancer payloads and the reduction of toxicity through selective tumor targeting as well as payload masking.

On August 5, 2020 Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) reported that senior management will be presenting and hosting 1×1 meetings at the following virtual investor conferences in August (Press release, Aldeyra Therapeutics, AUG 4, 2020, View Source [SID1234562838]):

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BTIG Virtual Biotechnology Conference 2020
Presentation Date: Tuesday, August 11, 2020
Time: 11:30 a.m. ET
2020 Wedbush PacGrow Healthcare Virtual Conference
Presentation Date: Wednesday, August 12, 2020
Time: 12:35 p.m. ET
A live webcast of these presentations will be available on the investor relations page of the company’s corporate website at View Source After the live webcast, the events will remain archived on the Aldeyra Therapeutics website for 90 days.