On August 31, 2020 Seneca Therapeutics, Inc., a clinical-stage biopharmaceutical company dedicated to the development of oncolytic immune-therapeutics based on Seneca Valley Virus (SVV-001), reported the company has licensed TEM 8 intellectual property from Memorial Sloan Kettering Cancer Center (MSK) (Press release, Seneca Therapeutics, AUG 31, 2020, View Source [SID1234564188]). TEM8 may enable pre-screening of solid tumors to determine if SVV-001 might be effective in that patient. This discovery is based on research from Charles Rudin, MD., Ph.D. and colleagues at MSK. Researchers at MSK discovered that a protein called TEM 8 is the receptor of SVV. This discovery supports other work in the scientific field that TEM 8 is very selectively expressed on the surface of tumor cells in many solid cancer indications. Dr. Rudin and his laboratory demonstrated that the level of expression of TEM 8 and genes in the innate immune system could predict with a high degree of certainty what type of cancer cells would support SVV replication in and killing of the tumor cells. This research, originally published in 2017, will be utilized in upcoming SVV-001 clinical trials to pre-select patients that might best respond to SVV–mediated cancer therapy.

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Dr. Rudin is the Sylvia Hassenfeld Professor and Chief of Thoracic Oncology at Memorial Sloan Kettering Cancer Center. Dr. Rudin and his colleagues have been investigating SVV as a novel and promising cancer immunotherapeutic since 2005. Dr. Rudin said, "I couldn’t be more pleased to see this new exciting enabling technology head toward POC Phase II trials to demonstrate that SVV is efficacious and synergistic with checkpoint inhibitors."

Dr. Paul Hallenbeck, Founder, President, and Chief Scientific Officer at Seneca Therapeutics added, "Unlike most other oncolytic viruses SVV only replicates and kills cells that express TEM 8, namely solid tumor cells. MSK’s technology should also enable the wise selection of cancer indications best able to benefit from SVV therapy and enhance the number of patients that should respond."

On August 31, 2020 TRACON Pharmaceuticals (NASDAQ: TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., reported that following the closing of the private placement announced on August 27, 2020, it has entered into an additional definitive securities purchase agreement with multiple institutional health care focused funds to raise aggregate gross proceeds of approximately $5.0 million through a private placement of its common stock and pre-funded warrants (Press release, Tracon Pharmaceuticals, AUG 31, 2020, View Source [SID1234564187]). The closing of the private placement is expected to occur on or about August 31, 2020.

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TRACON will sell approximately 3.0 million shares of common stock, or in lieu of common stock, pre-funded warrants to purchase common stock, for aggregate gross proceeds of approximately $5.0 million. The purchase price of each share of common stock (or pre-funded warrant) is approximately $1.67. The pre-funded warrants will have a per share exercise price of $0.01 and will expire seven years from the date of issuance.

TRACON intends to use the net proceeds from the private placement to conduct the ENVASARC pivotal study of envafolimab in sarcoma and for working capital and general corporate purposes. As previously announced, the ENVASARC trial was cleared by the U.S. Food and Drug Administration on August 14, 2020.

The securities being sold in the private placement have not been registered under the Securities Act of 1933, as amended, or state securities laws and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission ("SEC") or an applicable exemption from such registration requirements. TRACON has agreed to file a registration statement with the SEC covering the resale of the shares of common stock issuable in connection with the private placement, including upon exercise of the pre-funded warrants.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

On August 31, 2020 Unum Therapeutics Inc. (Nasdaq: UMRX), a biopharmaceutical company focused on developing novel, best-in-class precision kinase inhibitors for a range of patients living with cancer and other unmet medical needs, reported the sale of its cell-based BOXR programs to SOTIO, a clinical stage immuno-oncology company owned by PPF Group (Press release, Unum Therapeutics, AUG 31, 2020, View Source [SID1234564184]). Under the terms of the agreement, SOTIO will make an upfront payment of $8.1 million for the BOXR technology and will assume development of Unum’s lead candidate, BOXR1030, which is on track for near-term entry into the clinic. In addition, Unum will be eligible to receive downstream milestones of up to $3.4 million. The sale to SOTIO will enable it to further advance its goal to develop the next generation of potent immunotherapies for patients with cancer. Unum will retain its antibody coupled T cell receptor (ACTR) technology and continues to explore strategic opportunities for the technology and assets. The sale is final as of August 28, 2020.

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"Within the past year, we have explored a range of strategic opportunities for our BOXR technology and programs, and we believe SOTIO has the clinical expertise to accelerate the development of this program, including BOXR1030, in multiple clinical trials for the benefit of patients," said Chuck Wilson, Ph.D., President and CEO of Unum. "We are extremely proud of the BOXR technology and programs and would like to thank all of our employees, and investors for not only supporting our vision, but advancing it as well. We look forward to SOTIO’s progress on the BOXR programs in the future."

SOTIO will assume responsibility for a portion of Unum’s facilities in Cambridge, MA to advance the BOXR programs, and certain Unum staff associated with the BOXR programs will transition to SOTIO to continue their work on the programs. Unum will retain certain staff and space in its Cambridge facilities as it refocuses on the development of small molecule precision kinase inhibitors, including its lead program PLX9486.

On July 6, 2020, Unum announced the completion of the acquisition of Kiq LLC, as part of a strategic pivot to focus on precision kinase inhibitors. Certain Unum stockholders of record at the time of the acquisition were granted a non-tradeable contingent value right (CVR). Holders of the CVR will be entitled to receive certain stock and/or cash payments from net proceeds received by Unum related to the disposition of Unum’s cell therapy assets for a period of three years following the closing of the transaction.

Net proceeds from the sale of BOXR will be reinvested into the development of PLX9486 as part of Unum’s focus on the development of small molecule precision kinase inhibitors to treat a range of genetically driven diseases. Additional operational updates will be provided in the upcoming months.

In addition, Unum appointed Peter Harwin, Co-founder and Managing Member, Fairmount Funds Management LLC as Board Chair. Harwin played an integral role in the recent acquisition of Kiq and will help guide the future vision of the company in delivering best-in-class therapies for patients with genetically defined diseases. Prior to founding Fairmount in 2016, Harwin served as a member of the investment team at Boxer Capital, a biotechnology unit of the Tavistock Group, and he currently serves as a strategic advisor to Quellis Biosciences Inc. and Dianthus Therapeutics, Inc. Harwin also serves on the board of directors of Viridian Therapeutics, Inc.

About BOXR and BOXR1030

Unum Therapeutics’ novel cell therapy programs address the major scientific obstacles in traditional T cell therapies. Scientists have discovered that the solid tumor microenvironment is highly immunosuppressive, blocking T cells from functioning as they should. The BOXR technology (Bolt-on Chimeric Receptor) addresses this issue by incorporating "bolt-on" transgenes to enhance intrinsic T cell functionality and overcome multiple mechanisms of immunosuppression in the solid tumor microenvironment. BOXR transgenes can then be engineered with therapeutic T cells, such as CAR T cells, to improve the functionality of T cell therapies, particularly in the solid tumor microenvironment. BOXR1030, the first product candidate from BOXR, contains the novel "bolt-on" enzyme called glutamic-oxaloacetic transaminase 2 (GOT2) that aims to improve intrinsic T cell function in the solid tumor microenvironment through enhanced metabolism. GOT2 plays a central metabolic role by linking multiple pathways involved in biosynthesis and cellular energy production.

On August 31, 2020 Astex Pharmaceuticals, Inc., a wholly owned subsidiary of Otsuka Pharmaceutical Co., Ltd., based in Tokyo, Japan, reported that the US Food & Drug Administration (FDA) has granted orphan drug designation for the company’s novel, orally administered non-peptidomimetic antagonist of the cellular and X-linked inhibitors of apoptosis proteins (cIAP1/2 and XIAP), tolinapant (formerly known as ASTX660), for the treatment of T-cell lymphoma (Press release, Astex Pharmaceuticals, AUG 31, 2020, View Source [SID1234564183]). Orphan drug designation is granted to drugs intended to treat a rare disease or condition. In the US an orphan disease is defined as one affecting fewer than 200,000 people. The designation provides for seven years of marketing exclusivity in the US following product approval, as well as certain tax incentives and grants.

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"T-cell lymphoma remains a challenging disease area with poor prognosis and high unmet medical need," said Mohammad Azab, MD, Astex Pharmaceuticals’ president and chief medical officer. "Astex’s development of tolinapant is aimed at bringing a new therapeutic option for patients with this type of cancer. We are delighted that the FDA has granted the orphan drug designation which recognizes the continued need for development of new treatments for patients with rare diseases such as peripheral T-cell lymphoma and cutaneous T-cell lymphoma."

ASTX660 is an investigational compound and is not currently approved in any country.

About Tolinapant (ASTX660)

Tolinapant is a novel, orally administered, non-peptidomimetic antagonist of the cellular and X-linked inhibitors of apoptosis proteins (cIAP1/2 and XIAP). Inhibitors of apoptosis proteins (IAPs) are frequently overexpressed in tumor cells and contribute to tumor cell survival and chemo-resistance. By inhibiting IAPs, tolinapant promotes cell death. Tolinapant also acts via a newly described immunomodulatory mechanism which works to enhance an anti-tumor immune response in T-cell lymphomas. Tolinapant was designed using Astex’s fragment-based drug design technology.

Tolinapant is being evaluated in a phase 1/2 clinical study for the treatment of advanced solid tumors and lymphomas (see View Source NCT02503423)

About T-Cell Lymphomas

T-cell lymphomas are a rare and heterogeneous group of blood cancers arising from abnormal T-lymphocytes. Approximately 6-10% of non-Hodgkin’s lymphomas (NHL) are T-cell lymphomas. The American Cancer Society estimates there will be 77,240 new cases of NHL diagnosed in the U.S. in 2020. Tumors of mature T-cell origin are usually referred to as peripheral T-cell lymphomas (PTCL). The World Health Organization’s 2016 classification describes 29 discrete subtypes of peripheral T-cell lymphoma. T-cell lymphomas generally affect people aged 60 or older, and are more common in men than in women. While some T-cell lymphomas follow an indolent course, many are aggressive and have poor prognosis.

On August 31, 2020 Dynavax Technologies Corporation (Nasdaq: DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, reported that Ryan Spencer, Chief Executive Officer, will participate in a virtual fireside chat at the H.C. Wainwright Virtual 22ND Annual Global Investment Conference on Monday, September 14, at 10:00 a.m. ET (Press release, Dynavax Technologies, AUG 31, 2020, View Source [SID1234564182]).

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The presentation will be webcast and may be accessed through the "Events & Presentations" page on the "Investors" section of the Company’s website at View Source