On September 15, 2020 Cue Biopharma, Inc. (NASDAQ: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells within the body, reported the peer-reviewed publication of preclinical data focused on the in vivo detection of tumor antigen-specific T cells in a paper published in Nature Methods titled, "In vivo detection of antigen-specific CD8 T cells by immuno-positron emission tomography (Press release, Cue Biopharma, SEP 15, 2020, View Source [SID1234608295])." The study was co-authored by Steven C. Almo, Ph.D., co-founder of Cue Biopharma, professor and chair of biochemistry, professor of physiology & biophysics and the Wollowick Family Foundation chair in multiple sclerosis and immunology at Albert Einstein College of Medicine and Hidde Ploegh, Ph.D., a renowned expert in molecular immunology and a member of the program in cellular and molecular medicine at Boston Children’s Hospital.

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In this work, researchers employed dimeric protein scaffolds to develop a novel immuno-positron emission tomography (immunoPET) imaging approach. These protein scaffolds, known as synTacs, consist of Fc-based covalent peptide-major histocompatibility complex (pMHC) dimers, which form the core structure of Cue Biopharma’s Immuno-STAT (Selective Targeting and Alteration of T cells) platform. By targeting synTacs labelled with positron emitting isotopes against specified tumor antigens, researchers were able to specifically and non-invasively detect tumor antigen-specific T cells in murine solid tumor models. In the same study, similar application of synTacs deploying viral antigens could detect and engage virus-specific T cells in the lung tissue.

"These studies demonstrate the remarkable breadth of applications supported by the Immuno-STAT platform, as it enables clinical applications for highly selective targeted treatments of cancer, autoimmune diseases and infectious diseases, but, also as demonstrated in the Nature Methods paper, the potential to serve as prognostics and diagnostics for mechanism-of-action and treatment efficacy by revealing the in vivo distribution of the biologic and its target T cells in diseased tissue," said Dr. Almo.

"This work highlights the power of the Sortase A coupling technology developed in our lab, as it readily allowed the site-specific, stoichiometric and highly reproducible installation of PET imaging tags (64Cu2+ and 89Zr4+ and 18F) for the in vivo tracking of antigen-specific T cells targeting tumor cells and virally infected cells in the disease tissue. These advances highlight the strength of modular biologic platforms, like the Immuno-STAT platform, that can be deployed for targeting and tracking antigen-specific effector lymphocytes in the patients to gain predictive insights into pharmacodynamic and clinical responses," elaborated Dr. Ploegh.

Specific detection of intratumoral T cells by this newly developed immunoPET approach provides further support that the core component of the Immuno-STAT scaffold can penetrate into the tumors and directly engage tumor-resident T cells. These data highlight the modular nature and the broad applicability of the Immuno-STAT platform to selectively deliver cargoes, such as imaging agents or immunomodulatory signals to tumor-resident T cells.

Anish Suri, Ph.D., president and chief scientific officer of Cue Biopharma, commented, "We are highly encouraged by these results, as they highlight the inherent advantages of our engineered biologics platforms. Data showing the efficient penetration of the HPV16 E7 targeted synTac into solid tumors are particularly noteworthy, as similar technologies are unable to deliver cargoes past the tumor periphery. Further, this synTac is analogous to our lead asset, CUE-101, which carries a covalently linked IL-2 variant and is currently being evaluated in a Phase 1 trial in HPV16 driven head and neck squamous cell carcinoma."

Albert Einstein College of Medicine and its faculty members acknowledge the following relationships with Cue Biopharma, Inc.: Dr. Almo holds equity in Cue Biopharma, Inc., receives royalties from existing license agreements between Einstein and Cue, and is a member of its Science Advisory Board. Albert Einstein College of Medicine holds equity in Cue and receives royalties from existing licensing agreements.

On September 15, 2020 Strand Therapeutics reported that it is positioned to reshape the future of oncology (Press release, Strand Therapeutics, SEP 15, 2020, View Source [SID1234573056]). The company is genetically programming RNA not just to deliver a gene of interest, but to control the location, timing and intensity of therapeutic protein expression using mRNA-encoded logic circuits.

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That controllability is an important feature, and one that’s been lacking for mRNA gene therapies. With it, mRNA gene therapy has the potential to supplant traditional DNA-based gene therapy, offering a gene delivery technology that is easier and safer.

The idea to program mRNA was developed at Massachusetts Institute of Technology’s Synthetic Biology Center and spun out of the labs scientific co-founders Darrell Irvine, Ph.D. and Ron Weiss, Ph.D., where co-founders Tasuku Kitada, Ph.D., now president and head of R&D, and Jacob Becraft, Ph.D., CEO, worked as researchers.

Kitada and Becraft were the first to create synthetic gene circuits using synthetic mRNA, showing that post-transcriptional circuits could be "wired" to create a variety of networks that enabled cell type-specific expression and small molecule-based control of gene expression from synthetic mRNA.

In the MIT research lab of Ron Weiss, the pair led the team that developed the world’s first synesthetic biology programming language for mRNA.

"You can make it so that rather than DNA or RNA just expressing a protein, it can respond to inputs. Our body is filled with natural genetic circuits," Becraft told BioSpace.

Traditional DNA-based gene therapy uses viral vectors or nanoparticles to deliver a gene to the nucleus of a cell, where it is transcribed into mRNA. The mRNA then carries those instructions outside the nucleus and into the cytoplasm where protein is produced. Once the gene is in place, its expression can be up- or down-regulated. The challenge is that, "The cells protect their nucleus," Becraft noted. That makes it difficult for a gene to enter.

mRNA, however, doesn’t access the nucleus. Instead it accesses the cytoplasm. This approach to gene therapy is easier from a drug delivery perspective, and safer, because "it doesn’t run the risk of DNA mutating the genome," Becraft explained.

"We take the approach that the mRNA molecule doesn’t need to be changed structurally. We make regular, non-modified RNA, but make that mRNA smarter, able to operate autonomously and sense its surroundings," he said.

Strand Therapeutics does that by engineering the sequences of the nucleotides rather than changing the biochemical makeup of the RNA. In 2018, researchers showed that mRNA can deliver RNA therapeutic proteins, alongside those that encode for RNA-binding proteins in their genetic circuits.

In August, Irvine and Weiss published a paper in Nature Cancer showing the technology can simulate multiple mechanisms in known orders to stimulate multiple targets at once, creating a full-fledged immune response. Working in mice, they used multifunctional oncolytic nanoparticles to deliver self-replicating IL-12 RNA that was encapsulated in lipids.

The system promoted immunogenic cancer cell death, stimulated danger sensors in transfected cells, and modulated the immune cells for a greater anti-tumor immune response. In several of the mouse models, a single injection to the tumor eradiated those tumors, caused uninjected tumors to regress, and induced a protective immune memory.

"What we’ve done is use our programming technology to simulate multiple mechanisms in known order to kill multiple targets at once, to create a full-fledged immune response. You need to take a holistic approach and hit targets in the correct order," Becraft stressed. The platform is entering IND-enabling studies in humanized mouse models now.

"What’s different about synthetic biology is that we’re building therapies that recapitulate how biological systems work," Becraft said. "The mRNA enters into a cell and will respond to what’s happening in the cell with a feedback loop. For example, if it sees markers of a cancer cell, you build a system to recognize those inputs – like a computer program – and actuate a response. With programmable mRNA, we can stimulate multiple mechanisms and deliver multiple different cargos at once."

Strand Therapeutics’ MIT pedigree lends it immediate academic validation, but to succeed, the company also needed industry validation that the approach was not only scientifically interesting but promising to other healthcare leaders.

"It’s always good to have pharma interest, to recognize the technology’s potential," Becraft said. That’s a key tipping point."

That validation arrived in the form of multiple industry awards.

From a business development standpoint, "One of the first big awards was the Bristol-Myers Squibb 2018 Golden Ticket, recognizing Strand as an innovative startup. I say that not because of the free lab space and mentorship but because, through it, I met a member of the BMS team who was a very experienced executive in the biopharma world. She left BMS and joined another company, but we stayed in touch. Eventually, we hired her as our COO." Becraft makes a point of stressing that she wasn’t poached. "She worked at another company before joining Strand Therapeutics."

Just over a year ago, the company received $6 million in seed funding from Playground Global, Alexandria Venture Investments, ANRI and private investors. That allowed it to hire key personnel and further develop its synthetic biology platform. With that boost, it has attracted pharmaceutical partners and is pursuing multiple partnership strategies. Now, Becraft said, "We’re set to enter clinical trials in early 2022."

On September 15, 2020 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), reported that the U.S. Food and Drug Administration (FDA) has granted the Company Fast Track designation for its lead investigational drug, Rhenium NanoLiposomes (RNL), for the treatment of patients with recurrent glioblastoma (Press release, PLUS THERAPEUTICS, SEP 15, 2020, View Source [SID1234572289]). As previously reported, the Company also received orphan drug designation from the FDA for RNL for the treatment of patients with glioblastoma.

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Fast Track designation confers several benefits to the drug development program including 1) more frequent meetings with FDA to discuss the drug’s development plan, 2) more frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers, 3) eligibility for Accelerated Approval and Priority Review, if relevant criteria are met, and 4) Rolling Review, which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. NDA review usually does not begin until the drug company has submitted the entire application to the FDA.

"Fast Track designation validates the potential importance of this novel radiotherapeutic for patients with recurrent glioblastoma who currently have no good treatment options," said Dr. Marc Hedrick, President and Chief Executive Officer of Plus Therapeutics. "With this designation in hand, we intend to move into Cohort 6 of the trial, one key step closer to bringing forth a novel therapy for these patients."

RNL is being evaluated in the NIH/NCI-supported, multi-center ReSPECT Phase 1 dose-finding clinical trial (NCT01906385). As reported last week, the ReSPECT trials’ Data and Safety Monitoring Board (DSMB) approved the Company to proceed to Cohort 6 of the trial, which includes increasing both the drug volume and radiation dose to 8.8 milliliters (mL) and 22.3 millicuries (mCi), respectively.

RNL is designed to safely, effectively, and conveniently deliver a very high dose of radiation, of up to 25 times greater concentration than currently used external beam radiation therapy, directly into the brain tumor for maximum effect.

About Glioblastoma

Glioblastoma (Grade IV astrocytoma) is the most common and most aggressive of the primary malignant brain tumors in adults. According to the most recent Central Brain Tumor Registry of the United States (CBTRUS) Statistical Report, on average there are nearly 12,0000 cases of glioblastoma diagnosed annually in the U.S., with historical 1-year and 5-year median survival rates of 40.8% and 6.8%, respectively.

On September 15, 2020 CNS Pharmaceuticals, Inc. (the "Company") reported that it entered into a purchase agreement (the "Purchase Agreement"), and a registration rights agreement (the "Registration Rights Agreement"), with Lincoln Park Capital Fund, LLC ("Lincoln Park"), pursuant to which Lincoln Park has committed to purchase up to $15.0 million worth of the Company’s common stock, $0.001 par value per share (the "Common Stock") (Filing, 8-K, CNS Pharmaceuticals, SEP 15, 2020, View Source [SID1234565417]).

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Under the terms and subject to the conditions of the Purchase Agreement, the Company has the right, but not the obligation, to sell to Lincoln Park, and Lincoln Park is obligated to purchase up to $15.0 million worth of shares of the Company’s Common Stock. Such sales of Common Stock by the Company, if any, will be subject to certain limitations, and may occur from time to time, at the Company’s sole discretion, over the 36-month period commencing on the date that a registration statement covering the resale of shares of Common Stock that have been and may be issued under the Purchase Agreement, which the Company agreed to file with the Securities and Exchange Commission (the "SEC") pursuant to the Registration Rights Agreement, is declared effective by the SEC and a final prospectus in connection therewith is filed and the other conditions set forth in the purchase agreement are satisfied, all of which are outside the control of Lincoln Park (such date on which all of such conditions are satisfied, the "Commencement Date").

Thereafter, under the Purchase Agreement, on any business day selected by the Company that the closing sale price of the Common Stock equals or exceeds the threshold price set forth in the Purchase Agreement, the Company may direct LPC to purchase up to 30,000 shares of Company Common Stock on such business day (each, a "Regular Purchase"), provided, however, that (i) the Regular Purchase may be increased to up to 50,000 shares, provided that the closing sale price of the Common Stock is not below $2.00 on the purchase date; (ii) the Regular Purchase may be increased to up to 75,000 shares, provided that the closing sale price of the Common Stock is not below $2.50 on the purchase date; (iii) the Regular Purchase may be increased to up to 100,000 shares, provided that the closing sale price of the Common Stock is not below $3.00 on the purchase date; and (iv) the Regular Purchase may be increased to up to 150,000 shares, provided that the closing sale price of the Common Stock is not below $4.00 on the purchase date. In each case, Lincoln Park’s maximum commitment in any single Regular Purchase may not exceed $1,000,000. In addition, after the Commencement Date, the Company may direct Lincoln Park to purchase, on two separate occasions that must be at least 30 business days apart, $1,000,000 worth of Common Stock per such purchase (each, a "Tranche Purchase"). The purchase price per share for each Regular Purchase and each Tranche Purchase will be based on prevailing market prices of the Common Stock immediately preceding the time of sale. There are no upper limits on the price per share that Lincoln Park must pay for shares of Common Stock under the Purchase Agreement. In addition to Regular Purchases and Tranche Purchases, the Company may also direct Lincoln Park to purchase other amounts as accelerated purchases or as additional accelerated purchases if the closing sale price of the Common Stock equals or exceeds the threshold price at the times set forth in the Purchase Agreement. The above-referenced share amount limitations and closing sale price thresholds are subject to adjustment for any reorganization, recapitalization, non-cash dividend, stock split, reverse stock split or other similar transaction as provided in the Purchase Agreement.

Lincoln Park has no right to require the Company to sell any shares of Common Stock to Lincoln Park, but Lincoln Park is obligated to make purchases as the Company directs, subject to satisfaction of the conditions set forth in the Purchase Agreement. Actual sales of shares of Common Stock to Lincoln Park will depend on a variety of factors to be determined by the Company from time to time, including, among others, market conditions, the trading price of the Common Stock and determinations by the Company as to the appropriate sources of funding for the Company and its operations.

The net proceeds under the purchase agreement to the Company will depend on the frequency and prices at which the Company sells shares of its stock to Lincoln Park. The Company expects that any proceeds received by the Company from such sales to Lincoln Park will be used for working capital and general corporate purposes.

The aggregate number of shares that the Company can sell to Lincoln Park under the Purchase Agreement may in no case exceed 19.99% of the shares of the Common Stock outstanding immediately prior to the execution of the Purchase Agreement) (the "Exchange Cap"), unless (i) stockholder approval is obtained to issue shares above the Exchange Cap, in which case the Exchange Cap will no longer apply, or (ii) the average price of all applicable sales of our Common Stock to Lincoln Park under the Purchase Agreement equals or exceeds the lower of (A) the official closing price of the Company’s Common Stock on Nasdaq on the trading day immediately preceding the date of the Purchase Agreement and (B) the average official closing price of our Common Stock on Nasdaq for the five consecutive trading days ending on the trading day immediately preceding the date of the Purchase Agreement, adjusted such that the transactions contemplated by the Purchase Agreement are exempt from the Exchange Cap limitation under applicable Nasdaq rules.

In all instances, the Company may not sell shares of its Common Stock to Lincoln Park under the purchase agreement if it would result in Lincoln Park beneficially owning more than 4.99% of its Common Stock.

The Company has agreed with Lincoln Park that it will not enter into any "variable rate" transactions as defined in the Purchase Agreement with any third party for a period set forth in the Purchase Agreement. Lincoln Park has covenanted not to cause or engage in any manner whatsoever, any direct or indirect short selling or hedging of the Common Stock.

As consideration for Lincoln Park’s irrevocable commitment to purchase Common Stock upon the terms of and subject to satisfaction of the conditions set forth in the Purchase Agreement, upon execution of the Purchase Agreement, the Company issued 201,991 shares of Common Stock to Lincoln Park as commitment shares.

Lincoln Park has represented to the Company, among other things, that it is an "accredited investor" (as such term is defined in Rule 501(a) of Regulation D under the Securities Act of 1933, as amended (the "Securities Act")). The securities referred to in this current report on Form 8-K are being issued and sold by the Company to Lincoln Park in reliance upon the exemptions from the registration requirements of the Securities Act afforded by Section 4(a)(2) of the Securities Act and Rule 506(b) of Regulation D promulgated thereunder.

The Purchase Agreement and the Registration Rights Agreement contain customary representations, warranties, agreements and conditions to completing future sale transactions, indemnification rights and obligations of the parties. The Company has the right to terminate the Purchase Agreement at any time, at no cost or penalty. During any "event of default" under the Purchase Agreement, all of which are outside of Lincoln Park’s control. The Company may not initiate any regular or other purchase of shares by Lincoln Park, until an event of default is cured. In addition, in the event of bankruptcy proceedings by or against the Company, the purchase agreement will automatically terminate.

This current report on Form 8-K shall not constitute an offer to sell or a solicitation of an offer to buy any shares of Common Stock, nor shall there be any sale of shares of Common Stock in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

The foregoing descriptions of the Purchase Agreement and the Registration Rights Agreement are qualified in their entirety by reference to the full text of such agreements, copies of which are attached hereto as Exhibit 10.1 and 10.2, respectively, and each of which is incorporated herein in its entirety by reference. The representations, warranties and covenants contained in such agreements were made only for purposes of such agreements and as of specific dates, were solely for the benefit of the parties to such agreements, and may be subject to limitations agreed upon by the contracting parties.

On September 15, 2020 Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) ("Takeda") reported the expansion of its cell therapy manufacturing capabilities with the opening of a new 24,000 square-foot R&D cell therapy manufacturing facility at its R&D headquarters in Boston, Massachusetts (Press release, Takeda, SEP 15, 2020, View Source [SID1234565253]). The facility provides end-to-end research and development capabilities and will accelerate Takeda’s efforts to develop next-generation cell therapies, initially focused on oncology with potential to expand into other therapeutic areas.

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"We are collaborating with some of the best scientists and innovators around the world establishing a highly differentiated immuno-oncology pipeline leapfrogging into new modalities and mechanisms with curative potential," said Chris Arendt, Ph.D., Head of Takeda’s Oncology Therapeutic Area Unit. "With three oncology cell therapy programs in the clinic and two more targeted to enter the clinic in fiscal year 2021, we are working with urgency and purpose for patients. This new facility helps us rapidly scale our manufacturing capabilities so we can simultaneously advance multiple highly differentiated cell therapy programs."

Oncology cell therapy is a type of immunotherapy that uses genetically modified immune cells to find and kill cancer cells. Because cell therapies are engineered from living cells, they need to be manufactured in a highly regulated environment to maintain cleanliness, consistency and contamination control. Each oncology cell therapy platform has unique process requirements for how they are formulated, manufactured, transported and ultimately administered to patients. Next-generation cell therapy is one of the multiple investigational platforms that Takeda is researching in oncology as part of its focus on redirected immunity. Takeda’s pipeline of diverse immuno-oncology programs harnesses innate immunity, including through innovative cell therapies, immune engager platforms, innate immuno-modulation, novel-scaffold immune check point platforms and oncolytic viruses.

A Purpose-Built Facility to Rapidly Advance Cell Therapy Research & Development

The R&D cell therapy manufacturing facility will produce cell therapies for clinical evaluation from discovery through pivotal Phase 2b trials. The current Good Manufacturing Practices (cGMP) facility is designed to meet all U.S., E.U. and Japanese regulatory requirements for cell therapy manufacturing to support Takeda clinical trials around the world. It will be instrumental in building Takeda’s cell therapy capabilities and capacity to advance multiple next-generation oncology cell therapy platforms and programs with world-class collaborators including Nobel Laureate Shinya Yamanaka, M.D., Ph.D., Kyoto University (induced pluripotent stem cells), Adrian Hayday, Ph.D., Gamma Delta Therapeutics (gamma delta T-cells), Koji Tamada, M.D., Ph.D., Noile-Immune Biotech (armored CAR-Ts), Michel Sadelain, M.D., Ph.D., Memorial Sloan Kettering Cancer Center (next-generation CARs), and Katy Rezvani, M.D., Ph.D., The University of Texas MD Anderson Cancer Center (CAR-NK).

Takeda and MD Anderson are developing a potential best-in-class allogeneic cell therapy product (TAK-007), a Phase 1/2 CD19-targeted chimeric antigen receptor-directed natural killer (CAR-NK) cell therapy with potential for off-the-shelf use being studied in patients with relapsed or refractory non-Hodgkin’s lymphoma (NHL) and chronic lymphocytic leukemia (CLL). Two additional Phase 1 studies of Takeda cell therapy programs were also recently initiated: 19(T2)28z1xx CAR T cells (TAK-940), a next-generation CAR-T signaling domain developed in partnership with Memorial Sloan Kettering Cancer Center (MSK) to treat relapsed/refractory B-cell cancers, and a cytokine and chemokine armored CAR-T (TAK-102) developed in partnership with Noile-Immune Biotech to treat GPC3-expressing previously treated solid tumors. Dr. Sadelain and MSK have intellectual property rights and associated interests related to the content of this release by virtue of licensing agreements between MSK and Takeda.

Harnessing the Power of Takeda’s Cell Therapy Translational Engine

Proactive and deep collaboration between research and development and commercial manufacturing is critical to developing and delivering next-generation cell therapies. Takeda’s Cell Therapy Translational Engine (CTTE) connects clinical translational science, product design, development, and manufacturing through each phase of research, development and commercialization. It provides bioengineering, chemistry, manufacturing and control (CMC), data management, analytical and clinical and translational capabilities in a single footprint to overcome many of the manufacturing challenges experienced in cell therapy development.

"The proximity and structure of our cell therapy teams allow us to quickly apply what we learn across a diverse portfolio of next-generation cell therapies including CAR NKs, armored CAR-Ts and gamma delta T cells, among others," said Stefan Wildt, Ph.D., Head of Pharmaceutical Sciences and Translational Engine, Cell Therapies at Takeda. "Insights gained in manufacturing and clinical development can be quickly shared across our global research, manufacturing and quality teams, a critical ability in our effort to deliver potentially transformative treatments to patients as fast as we can."