On May 18, 2021 Hummingbird Bioscience, an innovative clinical-stage biotech company focused on developing precision therapies against hard-to-drug targets to improve treatment outcomes, reported the close of its US$125 million Series C financing round (Press release, Hummingbird Bioscience, MAY 18, 2021, View Source [SID1234580198]). The financing was led by Novo Holdings, with significant participation from new investors including Frazier Healthcare Partners, Octagon Capital, EDBI, AMGEN Ventures, DROIA Ventures, Morningside Ventures, Pureos Bioventures, Polaris Partners, Affinity Asset Advisors, Ally Bridge Group and Altium Capital Management. Existing investors including SK Inc, Heritas Capital, SEEDS Capital and Mirae Asset Venture Capital also joined the round.

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"We are delighted to have the support and confidence of leading global healthcare investors to advance the development of our unique pipeline of precision therapies against important, yet hard-to-drug targets. We have made tremendous progress since closing our Series B in 2019 and this financing reflects strong support for our platform, people, and development strategy," said Piers Ingram, Chief Executive Officer and co-founder, Hummingbird Bioscience. "With our world-class team of researchers and proprietary technologies, Hummingbird is at the cutting-edge of scientific discovery. These new funds give us further resources to invest in our early stage pipeline, as well as supporting the clinical development of our two lead programs that we believe can deliver very meaningful benefit for patients."

Proceeds from the financing will be used to advance the clinical development of Hummingbird’s lead assets including, HMBD-001, a best-in-class HER3 antibody for NRG1-fusion and HER3-driven tumors, and HMBD-002, a first-in-class anti-VISTA neutralizing antibody for advanced solid tumors. The funds will also be used to expand the capabilities of Hummingbird’s proprietary Rational Antibody Discovery platform and progress the development of its next-generation pipeline of precision therapeutics including HMBD-009, a BCMA-TACI dual-specific T cell engager.

"We are delighted to lead this financing in Hummingbird and pleased to have attracted a syndicate of sophisticated investors to enable the acceleration of the company’s clinical development activities. We believe that Hummingbird’s novel data-driven, systems biology approach brings new precision to the field of antibody drug discovery and development, and we are proud to support the team in realizing their vision," said Kenneth Harrison, Partner, Novo Ventures.

Kenneth Harrison along with Dan Estes, General Partner, Frazier Healthcare Partners, and Kiel Kim, Vice President, SK Inc., will join Hummingbird’s board of directors.

"Hummingbird is at an exciting point, on the cusp of starting clinical studies for both HMBD-001 and HMBD-002. I look forward to working with the Hummingbird team in developing and building out its portfolio of drug candidates that have transformative potential for patients with cancer and autoimmune diseases," said Dan Estes.

Kiel Kim said: "There is significant potential for novel antibody-based therapeutics and through Hummingbird’s Rational Antibody Discovery platform, we can now discover high value antibodies for challenging targets. We look forward to continuing our partnership with Hummingbird to solve complex challenges in antibody development, and deliver highly differentiated therapies to patients in need."

On May 18, 2021 Enveric Biosciences, Inc. (NASDAQ: ENVB) ("Enveric" or the "Company"), a patient-first biotechnology company developing novel cannabinoid (CBD) medicines to improve quality of life for cancer patients, reported its financial results for the three months ended March 31, 2021 (Press release, Enveric Biosciences, MAY 18, 2021, View Source [SID1234580230]).

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David Johnson, Chairman and Chief Executive Officer, said, "Thus far in 2021, we continued to focus on making progress on our pipeline of support care therapies, bolster our management team and Scientific Advisory Board with talented industry experts and maintain a healthy balance sheet, which as of March 31, 2021 had approximately $23 million in cash. As we approach the second half of this year, we expect to receive approval and initiate two critical Phase I/II trials in Glioblastoma Multiforme and Radiation Dermatitis. In parallel, we opportunistically continue to evaluate strategic investments similar to our Diverse Biotech license for five molecules, exclusive supply agreement with PureForm and other undervalued synergistic investments."

Corporate Updates:

Appointed Arash Asher M.D., Director of Cancer Rehabilitation and Survivorship to Cedars-Sinai Cancer Center, to Enveric’s Scientific Advisory Board. Enveric Biosciences held its first Scientific Advisory Board meeting on April 25, 2021, during which the Board discussed and reviewed Enveric’s radiodermatitis and glioblastoma clinical development plans in detail.
Appointed Carter Ward as Chief Financial Officer, effective May 15, 2021. Mr. Ward brings extensive public company leadership experience in life sciences, SEC reporting and the capital markets. Mr. Ward is replacing John Van Buiten, who is expected to remain in a consulting role with the company, supporting Mr. Ward both during the transition and moving forward.
Enhanced Board of Directors with the appointment of Dr. Douglas D. Lind. Dr. Lind’s extensive and diverse background, working in both healthcare and finance, will add tremendous value in helping Enveric bring better treatment options to cancer patients in need.
On March 10, 2021, the Company also received $3,267,245 from the exercise of warrants to purchase 851,099 shares of common stock.
Financial Results for the Three Months Ended March 31, 2021:

Net cash used in operating activities was $3,162,278 during the three months ended March 31, 2021, which consisted primarily of a net loss of $3,250,711, offset by amortization of intangibles of $136,640, other income from the change in fair value of warrant liability of $3,813,000, stock-based compensation expense of $3,591,565, inducement expense related to conversion of warrants of $298,714, increases in prepaid expenses and other current assets for $66,208, offset by increases in accounts payable and accrued liabilities of $59,278.

Enveric’s operating expenses increased to $6,764,997 for the quarter ending March 31, 2021 from $836,702 for the three months ended March 31, 2020. This change was primarily driven by an increase in general and administrative fees of $5,770,343 and an increase in research and development costs of $157,952. The increase in general and administrative fees was primarily driven by stock-based compensation of $3,591,565, stock option modification expense of $298,714, and an increase in public company compliance costs of $582,667.

Net cash provided by financing activities was $24,881,733 during the three months ended March 31, 2021, which included $21,614,488 in proceeds from the sale of common stock, net of offering costs, and $3,267,245 in proceeds from warrant exercises. Cash as of March 31, 2021 totaled $22,657,150 and the Company currently has no debt.

As of May 13, 2021, the Company had 21,390,290 shares of common stock outstanding.

On May 18, 2021 Almac Discovery, the independent research driven drug discovery company dedicated to the development of novel and innovative therapeutics, reported that it is delighted to share ground-breaking new research which has identified nearly thousands of gene pairs that represent ‘Achilles Heels’ or cancer vulnerabilities in analysis of more than 700 different cancer models (Press release, Almac, MAY 18, 2021, View Source [SID1234580179]). In the future, this could lead to new ways to stop cancer cells in their tracks by using existing drugs, as well as proposing new targets for drug development. These drugs could even be used to combat cancers that do not respond to the current standard treatments.

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The research was led by Mark Wappett, Head of Bioinformatics at Almac Discovery and Honorary Lecturer at Queen’s University Belfast, in collaboration with the Overton and McDade groups in the Patrick G Johnston Centre for Cancer Research (PGJCCR) at Queen’s University Belfast and the Department of Biochemistry at Vanderbilt University, USA.

Pivotal to the research is a completely new computational method for discovering cancer synthetic lethality from clustered regularly interspaced short palindromic repeats (CRISPR) and gene expression data using a website called ‘SynLeGG’. This site analyses large and complex datasets to identify changes in genes that occur in certain cancers that may make them more addicted to other similar genes and therefore susceptible to treatments targeting these partners. It was published today (17 May) in the journal Nucleic Acids Research and can be accessed here.

Study lead Mark Wappett, Almac Discovery, commented "Synthetic Lethality with Genetics and Genomics, or SynLeGG for short, provides the wider scientific community access to key datasets generated by cutting edge molecular biology technologies, such as CRISPR, and a toolkit with which to analyse this data. Ultimately we hope that by increasing the reach of this data we can expedite more targeted and effective cancer treatments."

Dr Ian Overton, Senior Lecturer at the PGJCCR explains: "Understanding the molecular fingerprints of cancer can pinpoint ways to target drugs precisely to those patients where they will be most effective. Our work makes a step towards more effective and personalised cancer treatments, ultimately saving lives.

"We make our results available on the SynLeGG web server, opening a window to share these rich resources with researchers across the scientific community – in order to accelerate progress in cancer research."

Dr Simon McDade, Senior Lecturer from the PGJCCR said: "We anticipate that this resource will seed detailed investigation of a number of specific vulnerabilities we have identified, ultimately identifying novel treatment strategies that will translate into significant benefits for cancer patients in the long term."

On May 18, 2021 CNS Pharmaceuticals presented the corporate Presentation (Presentation, CNS Pharmaceuticals, MAY 18, 2021, View Source [SID1234580199]).

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On May 18, 2021 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, and City of Hope, a world-renowned independent cancer research and treatment center, reported that the first patient has been dosed in a clinical trial to establish the safety and feasibility of administering MB-101 (autologous IL13Rα2-CAR T cells) to patients with leptomeningeal brain tumors (e.g., glioblastoma, ependymoma or medulloblastoma) (Press release, Mustang Bio, MAY 18, 2021, View Source [SID1234580215]). The trial will enroll up to 30 patients and is taking place at City of Hope, where this chimeric antigen receptor T ("CAR T") cell therapy was initially developed. Even though it is a single center clinical trial, Mustang and City of Hope will facilitate patient transfers from other centers, as needed.

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All subjects enrolled in the Phase 1 single-center, two-arm clinical trial will undergo surgery for the placement of an intraventricular (ICV) Rickham catheter for CAR T cell delivery. The Phase 1 trial will determine the safety and feasibility of administering MB-101 through the ICV Rickham catheter over four weekly cycles in patients with glioblastoma (Arm 1) and ependymoma or medulloblastoma (Arm 2). The primary endpoints that will be evaluated are toxicity and survival at three months. Secondary endpoints include overall survival, CAR T and endogenous T cell levels, cytokine levels and phenotype detection in peripheral blood, tumor cyst fluid and cerebrospinal fluid.

Lisa Feldman, M.D., Ph.D., a neurosurgeon and assistant clinical professor in the Division of Neurosurgery at City of Hope and principal investigator of the clinical trial, commented, "Based on our research to date, including a previous clinical trial at City of Hope, further evaluation is warranted for this CAR T cell therapy. The prior clinical trial demonstrated encouraging potential of administering autologous IL13Rα2-CAR T cells intraventricularly to help treat patients with leptomeningeal brain tumors, a form of metastatic brain cancer that is difficult to treat. We continue to work closely with the Mustang team to potentially bring a safe, effective treatment option to patients suffering with this life-threatening disease."

Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, "The successful dosing of the first patient in this clinical trial of MB-101 is an important milestone in Mustang’s development program. We are pleased to support City of Hope to further study MB-101 in leptomeningeal brain tumors to potentially bring hope to patients suffering from this devastating and fatal disease. MB-101 has already demonstrated therapeutic potential when infused into the ventricular system, including delivering a complete response in a patient with leptomeningeal glioblastoma that was published in the New England Journal of Medicine. We aim to generate additional data that supports the advancement of this program."

Additional information about the trial can be found on clinicaltrials.gov using the identifier NCT04661384.

About MB‐101 (IL13Rα2‐specific CAR T cells)
IL13Rα2 is an attractive target for CAR T therapy as it has limited expression in normal tissue but is overexpressed on the surface of the majority of malignant glioma cells, including glioblastoma multiforme, ependymoma and medulloblastoma. CAR T cells are designed to express a membrane‐tethered IL‐13 receptor ligand (IL‐13) incorporating a single‐point mutation that provides high affinity for IL13Rα2 and reduces binding to IL13Rα1 in order to reduce healthy tissue targeting. Mustang is developing MB‐101 as an optimized CAR T product incorporating enhancements in CAR design and T cell engineering to improve antitumor potency and T cell persistence. MB‐101 includes a second‐generation hinge optimized CAR containing mutations in the IgG4 linker to reduce off‐target Fc interactions, the 4-1BB (CD137) co‐stimulatory signaling domain for improved persistence of CAR T cells and the extracellular domain of CD19 as a selection/safety marker. To further improve persistence, central memory T cells are enriched and genetically engineered using a manufacturing process that limits ex vivo expansion to reduce T cell exhaustion and maintain a memory T cell phenotype.