On March 31, 2021 Outpace Bio, a biotechnology company building a platform to create next-generation smart cell therapies, reported the closing of a $30 million Series A financing round (Press release, Outpace Bio, MAR 31, 2021, View Source [SID1234637769]). The oversubscribed financing was led by ARTIS Ventures and Lyell Immunopharma, Inc., with additional participation from Abstract Ventures, Civilization Ventures, Mubadala Capital (the asset management arm of Mubadala Investment Company), Playground Global, Sahsen Ventures, and WRF Capital. Funding will be used to demonstrate proof of principle for Outpace’s platform. In addition to closing the financing round, Outpace has entered into a collaboration with Lyell Immunopharma for joint research and subsequent development and commercialization by Lyell of a potential immune cell therapy for the treatment of cancer.

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Creating next-generation smart cell therapies

Certain diseases have remained incurable despite decades of effort because they are too complex for any single molecule to solve. Outpace is building a platform to improve the safety and efficacy of cell and gene-based therapies.

"Diseases like cancer and autoimmunity happen when cells default to the wrong decisions. A biological activity that is beneficial in one context can drive dysfunction or toxicity in another. Outpace is working to overcome this by reprogramming cells to make the right decisions in the right context," said Marc Lajoie, CEO and co-founder of Outpace. "We believe that cures will require the full power of cells to intervene in complex biology in ways that small molecule drugs and biologics cannot."

Just as custom-designed software and hardware have enabled modern smartphones to revolutionize how people interact with information, Outpace custom-designs biological software and hardware to revolutionize how cells interact with disease. Outpace’s built-for-purpose proteins unlock biological functions that off-the-shelf parts cannot. Initial proof points are focused on creating highly functional, ultra-specific T cell therapies that will be effective against solid tumors, while also laying the groundwork to solve similar problems across the cell and gene therapy field.

"Outpace creates a unique opportunity to drive efficacy in cell and gene therapies without compromising on safety. The way to do that is by engineering new biology that can’t be achieved by repurposing nature – custom-designed proteins provide a unique opportunity to address specific therapeutic needs," said Vasudev Bailey, PhD, senior partner at ARTIS Ventures. "We believe the Outpace team has the knowledge and passion to revolutionize this field in close collaboration with other pharma and biotech leaders."

Outpace and Lyell to supercharge anticancer T cell therapies

Under the collaboration agreement, Outpace and Lyell will use Outpace’s technologies in an effort to unlock the biology of a cytokine that the companies believe has the potential to dramatically improve efficacy in treating patients with cancer, but would require careful control to avoid systemic toxicity.

"Outpace’s technology holds promise to enable the efficacy of this cytokine without the toxicity," said Rick Klausner, founder and executive chairman of Lyell. "Outpace’s approach is unique in its ability to directly modulate this biology, and we look forward to working with them."

The collaboration enables Outpace to combine its mechanism-driven approach to reprogramming biological function with Lyell’s translation expertise and deep mechanistic understanding of biology. Outpace plans to forge additional partnerships with other industry leaders to bring cell and gene therapies to the clinic, leveraging its platform to accelerate the development of new cures.

On March 31, 2021 Takeda Pharmaceutical Company Limited (TOKYO:4502) (NYSE:TAK) ("Takeda") reported the completion of its previously-announced sale of Takeda Consumer Healthcare Company Limited ("TCHC") to Oscar A-Co KK, a company controlled by funds managed by The Blackstone Group Inc. and its affiliates (collectively "Blackstone") for a total value of JPY 242.0 billion1 (Press release, Takeda, MAR 31, 2021, View Source [SID1234577384]). This divestment agreement was first announced in August 2020.

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Following the transfer of shares, TCHC will be excluded from the scope of consolidation of Takeda2, and operates as Alinamin Pharmaceutical Co., Ltd ("Alinamin Pharmaceuticals").

The divested portfolio included a variety of over-the-counter ("OTC") medicines and health products that generated total revenues of over JPY 60.0 billion in fiscal year 2019. TCHC’s strong regional brands included Alinamin, its top selling product and Japan’s first vitamin B1 preparation, and Benza, a cold remedy. Takeda is confident that under Blackstone, Alinamin Pharmaceuticals will be well-positioned to continue growing and developing its product offerings in the years to come to address the evolving needs of consumers.

Takeda intends to use the proceeds from the sale to reduce its debt and accelerate deleveraging towards its target of 2x net debt/adjusted EBITDA within FY2021 – FY2023.

Takeda has sustained momentum in its divestiture strategy and has exceeded its $10 billion non-core asset divestiture target. Takeda has announced 12 deals since January 2019, for a total aggregate value of up to approximately $12.9 billion.

The sales price is currently anticipated to be approximately JPY 230.0 billion, subject to certain adjustments, including net debt and working capital of TCHC and Takeda Healthcare Products Company Limited as of March 31, 2021. With the completion of the transfer of shares, a pre-tax gain of approximately JPY 140.0 billion on the sale of shares of a subsidiary will be recognized, and Takeda anticipates Reported Net Profit attributable to owners of the Company to increase by approximately the same amount in the fiscal year ending March 31, 2021 (FY2020). Since the gain on the sale of shares of the subsidiary relates to the divestiture of a non-core business, there will be no impact on Core Operating Profit or Core Net Profit.

1 Enterprise value. Actual sales price will be determined after adjustment for items including net debt and working capital of TCHC and Takeda Healthcare Products Company Limited ("THP").
2 As a result of the share transfer, a wholly owned subsidiary of TCHC, THP, will also be excluded from the scope of consolidation of Takeda.

On March 31, 2021 NexImmune, Inc. (Nasdaq: NEXI), a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to orchestrate a targeted immune response by directing the function of antigen-specific T cells, reported its financial results for 2020 and highlighted recent corporate accomplishments (Press release, NexImmune, MAR 31, 2021, View Source [SID1234577438]).

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"2020 was a transformational year for NexImmune," said Scott Carmer, Chief Executive Officer. "Our first two programs, NEXI-001 and NEXI-002, entered Phase 1/2 clinical trials and successfully enrolled patients throughout the year despite the COVID-19 pandemic. We were very pleased to have initial data from our first cohort of patients in the NEXI-001 trial accepted for oral presentation at the ASH (Free ASH Whitepaper) annual meeting in December. In addition, we strengthened our management team, scientific advisory board and Board of Directors with the addition of several industry-leading scientists and executives. All of these advancements contributed to our successful IPO in February, 2021."

Mr. Carmer added, "With a strong cash position from the completion of our IPO, we are focused on driving our current clinical trials toward completion, and to accelerating ongoing development of our AIM ACT product pipeline and platform technology. This work will concentrate on clinical programs targeting solid tumors and IND-enabling pre-clinical experiments to support the initial application of our ‘AIM Injectable’ formulation, respectively. In developing our proprietary AIM nanoparticle technology, our mission is to transform cell-mediated immunotherapy for the benefit of patients facing a number of difficult-to-treat diseases."

Select corporate highlights

On February 17, 2021, NexImmune completed a successful IPO and raised gross proceeds of $126M. The IPO was oversubscribed and priced at the top of the range.

During January 2021, NexImmune announced the appointments of Robert Knight, MD as Chief Medical Officer; Jerome Zeldis, MD, PhD as Executive Vice President, Research and Devopment; Jeffery Weber, MD, PhD as Chief Scientific Advisor and Scientific Advisory Board Chair; and Grant Verstandig as a member of the Board of Directors.

On December 7, 2020, lead investigators for the Company’s ongoing Phase 1/2 clinical trial evaluating NEXI-001 provided an oral presentation at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition that highlighted initial results from the first five patients treated. Initial data demonstrated early signs of safety, tolerability and robust immune responses in acute myeloid leukemia (AML) patients with relapsed disease after allogeneic hematopoietic stem cell transplantation (allo-HSCT).

On October 6, 2020, NexImmmune announced dosing of the first patient in its Phase 1/2 trial of NEXI-002 for the treatment of patients with relapsed and/or refractory multiple myeloma that had failed at least three lines of prior therapy.

NEXI-001 and NEXI-002 are both in Phase 1/2 clincal trials. The company expects to share preliminary data from the initial safety cohorts of each trial at a conference in Q2 2021, with more complete results for each trial at the end of Q4 2021.

Select financial highlights

Cash and cash equivalents for the company as of December 31, 2020 were $5.0M, compared to $9.1M at December 31, 2019. Based upon its current operating plans and cash and cash equivalents, including the net proceeds from the IPO, the Company expects to have sufficient capital to fund its operating expenses and capital expenditure requirements through the second quarter of 2022.

Research and development expenses were $17.8M in 2020, compared to $15.2M in 2019. The increase in R&D expenses were mainly attributable to costs for the two clinical trials as well as personnel-related expenses driven by increased headcount, offset partially by reduced preclinical and regulatory-related spending.

General and administrative expenses were $10.0M and $5.7M in 2020 and 2019, respectively. The increase was due primarily to increases in headcount and fees related to professional and consulting services.

Net loss in 2020 was $29.9M, compared to $20.5M in 2019.

On March 31, 2021 Kiromic BioPharma (NASDAQ: KRBP), a pre-clinical stage biotechnology company using its proprietary DIAMOND artificial intelligence ("A.I.") platform to improve drug discovery and development with a therapeutic focus on immune-oncology, reported its financial results for the year ended December 31, 2020, and provided an update on its corporate developments (Press release, Kiromic, MAR 31, 2021, View Source [SID1234577456]).

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"Kiromic BioPharma achieved important scientific and operational milestones during the year that we believe have us well positioned for preparing our staff and our facilities for the first in-human dosing in Q3 2021," said Dr. Maurizio Chiriva-Internati, CEO and President of Kiromic BioPharma. "We are thankful to our employees and collaborators who have maintained this high level of execution in the middle of the hard challenges posed by the COVID-19 pandemic."

Our approach and goal is to defeat cancer by developing immunotherapies that rely on improving target discovery and validation. With better targets, we believe our therapies will be more effective than the current array of immunotherapies using older targets.

Corporate and Scientific Highlights

Initial Public Offering Completion – On October 20, 2020, we completed our IPO, raising $15 million of gross proceeds, significantly strengthening the Company’s balance sheet to support the continued development of our promising pipeline of targeted cancer therapies.

Two IND Application Filings – On December 17, 2020 we filed two applications with the U.S. Food and Drug Administration ("FDA"). The first IND was for a Phase 1 clinical trial of intravenously ("IV") administered allogeneic CAR-T for epithelial ovarian carcinoma ("EOC") and malignant pleural mesothelioma ("MPM"). The second IND was for a Phase 1 clinical trial of an intrapleural/intraperitoneal (IP) administered allogeneic CAR-T for EOC and MPM.

Since filing the original INDs in December 2020, the Company has had communications with the FDA, and numerous consults with scientific board and clinical advisors regarding resubmission. In March 2021, we announced that we planned to resubmit the two INDs.

The revised INDs will be for first in-human dosing of our Off-the-Shelf, Allogeneic Gamma-Delta T cell therapy for metastatic and progressive locally advanced solid malignancies.

The revised INDs have protocols which retain approximately 80% of the original INDs.

Longwood University Licensing Agreement – On November 30, 2020, we executed a licensing agreement for chPD1 with Longwood University. This marks a major milestone for Kiromic CAR-T development. With chPD1, we believe our chimeric PD1 CAR-T will be able to overcome the challenging tumor micro-environment (TME) which has plagued other CAR-T programs, while making Kiromic the only CAR-T development program with a built-in capability to meet other CAR-T programs head-on who do not have a bundled chPD1 CAR-T.

GMP Facility Completion – As of September 30, 2020, the key features of the GMP facility have been completed, clearing the path for the production of off-the-shelf Gamma-Delta-T cells, a novel approach to CAR-T cell therapy, which will be evaluated in the upcoming clinical trials.
FY 2020 Financial Highlights

Cash Position: Cash and cash equivalents were $10,150,500 as of December 31, 2020, compared to $1,929,100 as of December 31, 2019. The increase was primarily due to cash inflows of $15,805,600 attributable to financing activities related to the issuance of common stock from the initial public offering, issuance of Series B Preferred Stock and proceeds net of repayments from the Paycheck Protection Program loan. These inflows were offset by outflows of $6,126,600 and $1,457,600 attributable to operating activities and investing activities, respectively.

R&D Expenses: Research and development expenses were $5,052,900 for the year ended December 31, 2020, compared to $1,201,700 for the year ended December 31, 2019. The increase was primarily attributable to augmented headcount, increased square footage to our Houston, TX leased facilities, in-vitro experimentation costs, and intellectual property costs.

G&A Expenses: General and administrative expenses were $14,144,000 for the year ended December 31, 2020, compared to $2,503,700 for the year ended December 31, 2019. This increase was primarily due to increased stock compensation expenses and personnel expenses.

Net Loss: Net loss was $19,200,200 for the year ended December 31, 2020, compared to a net loss of $3,727,900 for the year ended December 31, 2019.

Dr. Chiriva-Internati continued, "Developing live-cell therapies by leveraging artificial intelligence is central to transforming the cost and efficiency of the immune-oncology field and improving the potential for off-the-shelf therapies for cancer patients. We believe our approach will help us design more efficient pre-clinical validation studies and more targeted clinical trials, thereby accelerating our drug candidates’ time to approval and eventually to market. DIAMOND is central to our process in achieving this outcome rapidly and with reduced costs," concluded Dr. Chiriva-Internati.

On March 31, 2021 Cannabics Pharmaceuticals Inc. (OTCQB: CNBX), a global leader in the development of cancer related cannabinoid-based medicine, reported it is initiating a Dose Response in-vivo Study in mice; results to be included as part of the Product Package to be submitted to the U.S. Food and Drug Administration along with a Pre-IND meeting request (Press release, Cannabics Pharmaceuticals, MAR 31, 2021, View Source [SID1234578706]).

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The Dose Response Study comes in light of previously reported results indicating a 33% reduction in tumor volume and a 35% prolonged survival rate in mice inoculated with human colorectal cancer cells and exposed to Cannabics RCC-33.

Eyal Barad Cannabics Pharmaceuticals co-founder and CEO said: "the entire Cannabics team is filled with enthusiasm as we see our own formula having such promising results on animals. Our priority and attention is in advancing RCC-33 down the clinical and regulatory pathway in a timely and efficient manner to be potentially become a part of the standard of care and treatment regimen for colorectal cancer patients."