On March 31, 2021 Curve Therapeutics (Curve) a private biotechnology company pioneering a potentially game-changing, functional drug discovery platform, reported the grant of US Patent 10,962,549 describing novel Microcycles that inhibit both HIF-1 and HIF-2 (Press release, Curve Therapeutics, MAR 31, 2021, View Source [SID1234640610]).

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Curve originated from world-leading Microcycle research conducted by Professor Tavassoli’s group in the Department of Chemistry at the University of Southampton, UK. The company is pioneering a game-changing, functional, drug discovery engine to generate higher quality functional hits and leads with the aim of discovering first-in-class therapeutics against challenging therapeutic targets.

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 Tyra Biosciences, a biotech company targeting acquired resistance in oncology with purpose-built drugs, reported the closing of a $106 million Series B financing to accelerate and expand its in-house drug discovery platform, SNÅP, and to advance its pipeline of novel, small molecule therapies into the clinic (Press release, Tyra Biosciences, MAR 31, 2021, View Source [SID1234586908]).

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The financing is led by new investor Nextech Invest and includes participation from Cormorant Asset Management, BVF Partners, L.P., Janus Henderson Investors, and Logos, as well as returning investors Alta Partners, RA Capital, Boxer Capital of Tavistock Group, and Canaan. Melissa McCracken, Ph.D. from Nextech Invest will join the TYRA Board of Directors.

"We warmly welcome Melissa to our Board of Directors, and the addition of top-tier crossover investors to our strong financing syndicate," said Todd Harris, Founder and Chief Executive Officer of Tyra Biosciences. "At Tyra, we are driven to overcome the desperation faced by patients in the moment their therapy stops working. This financing enables the acceleration and expansion of our mission to deliver therapies that are purpose-built for each new acquired resistance, so that for patients living with cancer, there is always a new hope."

With this raise, TYRA also announces the expansion of its executive leadership team, including:
— Hiroomi Tada, MD, Ph.D., Chief Medical Officer
— Piyush Patel, Ph.D., Chief Development Officer; and
— Robert L. Hudkins, Ph.D., promoted to Chief Technology Officer.

"Tyra has assembled a dynamic and experienced team that is bringing unprecedented speed, clarity, and focus to structure-based drug discovery through purposeful process optimization and prioritization of real-world, empirical data," said Dr. McCracken, Principal at Nextech Invest. "I am pleased to join the Board of Directors at Tyra, which is well positioned to deliver on their vision of accelerating the development of new therapies targeting acquired resistance in oncology."

TYRA’s in-house discovery engine, SNÅP, enhances traditional structure-based drug discovery through the generation of rapid and sequential "structural SNÅPshots" that enable the empirical (observational) evaluation of atomic-level interactions between drug and target.

"At Tyra, we’ve built in-house tools and expertise to shorten the timeline for generating crystal structures, deep cellular profiles, and data from in vivo models to days rather than weeks," said Robert Hudkins, Ph.D., Chief Technology Officer at Tyra Biosciences. "This vast amount of empirical data forms comprehensive ‘structural SNÅPshots’ that we use to refine molecular designs down to the tenth of an angstrom on a weekly cycle."

The first drug candidates developed using the SNÅP platform are expected to be nominated for development in 2021 and advance to the clinic in 2022.

"The rigor, fidelity, and speed of the SNÅP platform drives rapid discovery cycles towards novel drug candidates differentiated through achieving precise structural fit to their targets," said Hiroomi Tada, MD, Ph.D., Chief Medical Officer at Tyra Biosciences. "I am excited to join Tyra at this early stage to ensure that this ethos is extended to our approach to clinical development as we relentlessly advance new therapies for patients."

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."

On March 31, 2021 Affimed N.V. (NASDAQ: AFMD), a clinical-stage immuno-oncology company, and NKMax America Inc., a clinical stage biotech company, reported that the U.S. Food and Drug Administration (FDA) cleared an investigational new drug application (IND) for an Affimed and NKMax America co-sponsored Phase 1/2a dose escalation and expansion study in which the two companies will investigate the combination of AFM24, an EGFR/CD16A innate cell engager (ICE), and SNK-01, an autologous NK-cell product, in patients suffering from tumors known to express EGFR (Press release, NKGEN Biotech, MAR 31, 2021, View Source [SID1234578705]). The combination represents a novel approach to exploring innate immunity-based therapeutics to treat patients with solid tumors who failed conventional therapy with the aim to improve outcomes for high-medical need patient populations.

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"This combination is part of our overall development strategy for AFM24, the first and only innate cell engager in clinical development for solid tumors. In addition to NK cell-based combinations, we are also developing AFM24 as single agent and in combination with atezolizumab in several tumor indications," said Dr. Andreas Harstrick, Affimed’s Chief Medical Officer. "The mechanism of action of the two compounds could be highly synergistic as AFM24 has strong binding affinity to NK cells, directing them to kill tumor cells. Moreover, this combination approach represents an opportunity to supplement patients with dysregulated innate immune systems with targeted cellular therapy."

"The FDA clearance of our IND application for SNK-01 in combination with AFM24 is an important milestone for our Natural Killer cell therapy development program," said Stephen Chen, Chief Operating Officer and Chief Technical Officer of NKMax America. "We look forward to investigating this combination as part of our comprehensive strategy aimed at producing a cell therapy for patients with advanced/metastatic EGFR-expressing cancers."

Further Information About the AFM24/SNK-01 Phase 1/2a study

The Phase 1/2a study is based on preclinical in vitro testing, combining Affimed’s ICE AFM24 with NKMax America autologous NK-cell product SNK-01, which showed enhanced activity of NK cell induced target cell killing. The Phase 1/2a study will be an open-label, non-randomized, multi-center, US only, dose escalation trial to evaluate the combination in adult patients with EGFR-expressing tumors. The primary objective of the phase 1 study part will be to establish the safety and the recommended phase 2 dose of AFM24/SNK-01 combination, as well as to evaluate pharmacokinetics, pharmacodynamics, and preliminary activity in patients with advanced cancers expressing EGFR. The phase 2a portion of the study will evaluate the preliminary efficacy of AFM24 in patients with select solid tumor subtypes.