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

On August 31, 2020 Avid Bioservices, Inc. (NASDAQ:CDMO) (NASDAQ:CDMOP), a dedicated biologics contract development and manufacturing organization (CDMO) working to improve patient lives by providing high quality development and manufacturing services to biotechnology and pharmaceutical companies, reported that its Board of Directors has declared a quarterly cash dividend payment on the Company’s 10.50% Series E Convertible Preferred Stock (the "Series E Preferred Stock") (Press release, Avid Bioservices, AUG 31, 2020, View Source [SID1234564181]).

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The quarterly dividend on the Series E Preferred Stock is payable on October 1, 2020 to holders of record at the close of business on September 14, 2020.

The quarterly dividend payment on the Series E Preferred Stock will be $0.65625 per share, which is equivalent to an annualized 10.50% per share, based on the $25.00 per share stated liquidation preference, accruing from July 1, 2020 through September 30, 2020. The Series E Preferred Stock is listed on the NASDAQ Capital Market and trades under the ticker symbol "CDMOP".

On August 31, 2020 Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, reported it received $24.6 million in cash from Juvenescence Ltd., representing principal and interest due under a convertible promissory note (Press release, Lineage Cell Therapeutics, AUG 31, 2020, View Source [SID1234564180]). The note was issued in August 2018 as partial payment for the sale by Lineage to Juvenescence of 14.4 million shares of common stock of AgeX Therapeutics, Inc.

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"Lineage has been tremendously successful at monetizing its extensive patent and technology portfolio, most notably through the creation and sale of businesses like AgeX and OncoCyte, and the license or sale of non-core assets. It is worth highlighting that we have not conducted a traditional equity financing in nearly three years, and with an additional $24 million just received from Juvenescence, we believe we have over two years of cash runway based on our current business plan. This cash runway extends well past the expected timing of several major clinical milestones. We are best known for our promising cell therapy programs that are advancing through clinical trials, but I believe our broad technology platform, our financial strategy, and our responsible spending approach are equally notable and likely under-appreciated, particularly in a capital-intensive industry," stated Brian M. Culley, Lineage CEO. "Our core technology continues to be highly productive, not least of all by providing the foundation for three unique cell therapy programs, each with emerging safety and efficacy data and significant commercial opportunities. Furthermore, the VAC program we recently reacquired from Cancer Research UK includes a platform capable of generating numerous new programs, which may unlock exciting opportunities for us or for partnerships with other companies. Our mission is to convert the power of our directed cell differentiation platform into novel products and provide our shareholders with long-term growth and sustainability."

Importantly, Lineage has the following plans and objectives for the remainder of 2020:

– Meet with BARDA as part of the BARDA CoronaWatch Meeting Program, to discuss the use of dendritic cells for vaccine development (revised to September).

– Report initial VAC2 clinical data from patients treated in the ongoing Phase 1 trial in NSCLC (non-small cell lung cancer) run by Cancer Research UK.

– Present new and accumulated OpRegen data from the ongoing Phase 1/2a clinical trial at the American Academy of Ophthalmology (AAO) Annual 2020 Meeting the second week of November.

– Complete patient enrollment in the U.S. with the Gyroscope Orbit SDS and new thaw-and-inject formulation in the ongoing Phase 1/2a clinical trial of OpRegen for the treatment of dry AMD.

– Update U.S. Food and Drug Administration (FDA) on our recent progress and discuss further development of the OPC1 program.