Tyra Biosciences raises $106M in Series B financing to advance novel pipeline of therapies targeting acquired resistance in oncology

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."

Cannabics Pharmaceuticals to Initiate in-vivo Dose Response Study on Proprietary Colorectal Cancer Drug Candidate RCC-33

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."

Affimed and NKMax America Announce FDA Clearance of IND Application to Study the Combination of AFM24, an EGFR Targeted Innate Cell Engager, with SNK-01 Natural Killer Cell Therapy in Solid Tumors

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.

Hemispherian is delighted to announce its first granted patent

On March 31, 2021 Hemispherian AS ("Hemispherian" or the "Company"), a Norwegian preclinical pharmaceutical company focused on epigenetic therapeutics for the treatment of cancer, reported that the United Kingdom Intellectual Property Office (UKIPO) has granted the company’s first patent, which covers a family of small molecule drugs effective against a broad range of cancers (Press release, Hemispherian, MAR 31, 2021, View Source [SID1234578117]).

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The patent covers the use of compounds from the GLIX family in cancer treatment or prevention alone or in combination with one or more further anticancer agents. It was filed in February 2019 and it will therefore offer exclusivity until February 2039. This new patent is owned by Hemispherian and all the inventors are now part of the executive team of the Company.

"We are extremely pleased that the UKIPO has granted the patent. This is the culmination of a decade of academic research and development. This newly granted patent is a cornerstone in Hemispherian’s IP strategy aiming to produce a range of cancer drugs targeting an entirely new mechanism of action."

Entry into a Material Definitive Agreement

On March 31, 2021, CTI BioPharma Corp. (the "Company") reported that entered into an underwriting agreement (the "Underwriting Agreement") with Stifel Nicolaus & Company, Incorporated and JMP Securities LLC (the "Representatives"), as representatives of the underwriters named therein (the "Underwriters"), relating to the offer and sale (the "Offering") of 14,260,800 shares of the Company’s common stock, par value $0.001 per share (the "Common Stock"), at a public offering price of $2.50 per share , and 600 shares of the Company’s Series X1 convertible preferred stock, par value $0.001 per share (the "Series X1 Preferred Stock"), at a public offering price of $25,000 per share (Filing, 8-K, CTI BioPharma, MAR 31, 2021, View Source [SID1234577615]). In addition, the Company granted the Underwriters a 30-day option to purchase up to an additional 2,139,120 shares of its Common Stock on the same terms and conditions (the "Option"). On April 5, 2021, the Underwriters exercised the Option in full.

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The aggregate gross proceeds to the Company from the Offering and the Option are approximately $56.0 million, before deducting underwriting discounts and estimated offering expenses.

The securities described above were issued pursuant to the Company’s effective shelf registration statement on Form S-3 (File No. 333-251161) (the "Registration Statement"), filed with the Securities and Exchange Commission (the "SEC") on December 7, 2020 and declared effective on December 15, 2020. On March 31, 2021, the Company filed a prospectus supplement with the SEC in connection with the Offering. The Offering and the Option closed on April 6, 2021.

In the Underwriting Agreement, the Company agreed to indemnify the Underwriters against certain liabilities, including liabilities under the Securities Act of 1933, as amended, or to contribute payments that the Underwriters may be required to make because of such liabilities. The foregoing description of the Underwriting Agreement is not complete and is qualified in its entirety by references to its full text, a copy of which is filed as Exhibit 1.1 to this Current Report on Form 8-K and incorporated by reference herein.