Novocure Announces Recipients of 3rd Annual AACR-Novocure Grants for Tumor Treating Fields Research Program

On July 15, 2021 Novocure (NASDAQ: NVCR) reported the recipients of the 3rd Annual AACR (Free AACR Whitepaper)-Novocure Grants for Tumor Treating Fields Research program (Press release, NovoCure, JUL 15, 2021, View Source [SID1234584899]). The program represents a joint effort between Novocure and the American Association for Cancer Research (AACR) (Free AACR Whitepaper) to promote and support innovative research on Tumor Treating Fields (TTFields). The AACR (Free AACR Whitepaper) is the world’s first and largest professional organization dedicated to advancing cancer research and its mission to prevent and cure cancer.

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Such collaborations help to deepen the understanding of TTFields’ mechanism of action and to identify its optimal use. Extensive preclinical and clinical evidence provides the foundation upon which Novocure executes its strategy to advance TTFields through additional clinical research studies across multiple solid tumor types.

Professor Maurizio D’Incalci, M.D., of Humanitas University in Italy is one of the grant recipients. He and his team’s hypothesis is that the sensitivity of malignant pleural mesothelioma (MPM) cells to TTFields is related to the modulation of genes and pathways involved in cell proliferation and survival. Their research will investigate the potential synergism of TTFields with selected anticancer drugs in MPM based on the mechanistic insights.

"While great progress has been made regarding the research and development of Tumor Treating Fields, there is still more to learn and understand to continue deepening the science," Professor D’Incalci said. "We are excited to have begun our research and look forward to sharing the results."

The program includes research grants and career development awards totaling more than $2 million over the next three years. The research grants include six AACR (Free AACR Whitepaper)-Novocure Tumor Treating Fields Research Grants and two AACR (Free AACR Whitepaper)-Novocure Career Development Awards for Tumor Treating Fields Research. Recipients of the research grants will receive a total of $100,000 to $250,000 over one to two years. Recipients of the career development awards will receive a total of $225,000 over three years.

"We are so proud of this year’s recipients of the AACR (Free AACR Whitepaper)-Novocure Grants for Tumor Treating Fields Research," said Asaf Danziger, Novocure’s Chief Executive Officer. "We are honored to collaborate with the AACR (Free AACR Whitepaper) as we continue to deepen our understanding of the mechanism of action of Tumor Treating Fields. We wish great success to the recipients as they conduct this important work."

2021 AACR (Free AACR Whitepaper)-Novocure Tumor Treating Fields Research Grants

Spencer J. Collis, Ph.D.; University of Sheffield (United Kingdom); TTFields-based DDRi combinations to overcome spatiofunctional heterogeneity
Maurizio D’Incalci, M.D.; Humanitas University (Italy); TTFields in mesothelioma: mechanisms and novel rational drug combinations
Chang-Young Jang, Ph.D.; Sookmyung Women’s University (South Korea); Identification of new target of TTFs in mitosis for therapeutic application
Sara G.M. Piccirillo, Ph.D.; University of New Mexico; The impact of Tumor-Treating Fields on residual disease in glioblastoma
Claudio E. Tatsui, M.D.; University of Texas MD Anderson Cancer Center; Tumor Treating Fields in the therapy of spinal metastases
Suhe Wang, M.D., Ph.D.; University of Michigan; Natural electrical fields treatment to induce immune modulation in NSCLC
2021 AACR (Free AACR Whitepaper)-Novocure Career Development Awards for Tumor Treating Fields Research

Gerben Borst, M.D., Ph.D.; University of Manchester (United Kingdom); Unraveling the cell cycle effect of TTFields towards synergistic strategies
Jared A. Weis, Ph.D.; Wake Forest University; Characterizing effects of TTFields on cell-extracellular matrix biophysics
About Tumor Treating Fields

Tumor Treating Fields, or TTFields, are electric fields that disrupt cancer cell division.

When cancer develops, rapid and uncontrolled division of unhealthy cells occurs. Electrically charged proteins within the cell are critical for cell division, making the rapidly dividing cancer cells vulnerable to electrical interference. All cells are surrounded by a bilipid membrane, which separates the interior of the cell, or cytoplasm, from the space around it. This membrane prevents low frequency electric fields from entering the cell. TTFields, however, have a unique frequency range, between 100 to 500 kHz, enabling the electric fields to penetrate the cancer cell membrane. As healthy cells differ from cancer cells in their division rate, geometry and electric properties, the frequency of TTFields can be tuned to specifically affect the cancer cells while leaving healthy cells mostly unaffected.

Whether cells are healthy or cancerous, cell division, or mitosis, is the same. When mitosis starts, charged proteins within the cell, or microtubules, form the mitotic spindle. The spindle is built on electric interaction between its building blocks. During division, the mitotic spindle segregates the chromosomes, pulling them in opposite directions. As the daughter cells begin to form, electrically polarized molecules migrate towards the midline to make up the mitotic cleavage furrow. The furrow contracts and the two daughter cells separate. TTFields can interfere with these conditions. When TTFields are present in a dividing cancer cell, they cause the electrically charged proteins to align with the directional forces applied by the field, thus preventing the mitotic spindle from forming. Electrical forces also interrupt the migration of key proteins to the cell midline, disrupting the formation of the mitotic cleavage furrow. Interfering with these key processes disrupts mitosis and can lead to cell death.

TTFields is intended principally for use together with other standard-of-care cancer treatments. There is a growing body of evidence that supports TTFields’ broad applicability with certain other cancer therapies, including radiation therapy, certain chemotherapies and certain immunotherapies. In clinical research and commercial experience to date, TTFields has exhibited no systemic toxicity, with mild to moderate skin irritation being the most common side effect.

Fundamental scientific research extends across two decades and, in all preclinical research to date, TTFields has demonstrated a consistent anti-mitotic effect. The TTFields global development program includes a network of preclinical collaborators and a broad range of clinical trials across all phases, included four phase 3 pivotal trials in a variety of tumor types. To date, more than 18,000 patients have been treated with TTFields.

ERASCA ANNOUNCES PRICING OF UPSIZED INITIAL PUBLIC OFFERING

On July 15, 2021 Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, reported the pricing of its upsized initial public offering of 18,750,000 shares of common stock at an initial public offering price of $16.00 per share (Press release, Erasca, JUL 15, 2021, View Source [SID1234584916]). All of the shares are being offered by Erasca. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Erasca, are expected to be $300.0 million. The shares are expected to begin trading on the Nasdaq Global Select Market on July 16, 2021 under the ticker symbol "ERAS." The offering is expected to close on July 20, 2021, subject to the satisfaction of customary closing conditions. In addition, Erasca has granted the underwriters a 30-day option to purchase up to an additional 2,812,500 shares of common stock at the initial public offering price, less underwriting discounts and commissions.

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J.P. Morgan, Morgan Stanley, BofA Securities, Evercore ISI and Guggenheim Securities are acting as joint book-running managers for the offering.

Registration statements relating to the offering have been filed with the Securities and Exchange Commission and became effective on July 15, 2021. The offering will be made only by means of a prospectus. When available, copies of the final prospectus may be obtained from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, by telephone at (866) 803-9204, or by email at [email protected]; from Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014, or by email at [email protected]; from BofA Securities, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, North Carolina 28255-0001, Attention: Prospectus Department, or by email at [email protected]; from Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, New York 10055, by telephone at (888) 474-0200, or by email at [email protected]; or from Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, New York 10017, by telephone at (212) 518-9544, or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any offer or sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

Entry into a Material Definitive Agreement.

On July 15, 2021, Royalty Pharma plc (the "Issuer") reported that it entered into an underwriting agreement (the "Underwriting Agreement"), by and among the Issuer, Royalty Pharma Holdings Limited (the "Guarantor"), RP Management, LLC (the "Manager") and BofA Securities, Inc., Citigroup Global Markets Inc., Goldman Sachs & Co. LLC, J.P. Morgan Securities LLC and Morgan Stanley & Co. LLC, as representatives of the several underwriters listed on Schedule I thereto (the "Underwriters"), pursuant to which the Issuer has agreed to issue and sell to the Underwriters $600 million aggregate principal amount of its 2.150% Senior Notes due 2031 and $700 million aggregate principal amount of its 3.350% Senior Notes due 2051 (the "Notes") in a registered public offering pursuant to an effective shelf registration statement on Form S-3 (Registration File No. 333- 257883) (Filing, 8-K, Royalty Pharma , JUL 15, 2021, View Source [SID1234584917]). The Notes will be guaranteed on a senior unsecured basis by Royalty Pharma Holdings Ltd. The offering is expected to close on July 26, 2021, subject to the satisfaction of customary closing conditions. The description of the Underwriting Agreement contained herein is qualified in its entirety by reference to the Underwriting Agreement, a copy of which is included as Exhibit 1.1 to this Current Report on Form 8-K and is incorporated herein by reference.

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Lilly Announces Acquisition of Protomer Technologies

On July 14, 2021 Eli Lilly and Company (NYSE: LLY) reported the acquisition of Protomer Technologies ("Protomer"), a private biotech company (Press release, Eli Lilly, JUL 14, 2021, View Source [SID1234584832]). Protomer’s proprietary peptide- and protein-engineering platform is used to identify and synthesize molecules that can sense glucose or other endogenous modulators of protein activity.

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The potential value of the transaction is over $1 billion, with successful achievement of future development and commercial milestones. Lilly previously led an equity investment in Protomer alongside the JDRF T1D Fund, providing Lilly with 14 percent ownership of the company. Lilly is acquiring the remainder of the stock of Protomer beyond its initial investment.

Founded in 2015 and based in Pasadena, California, Protomer is engineering next-generation protein therapeutics that can sense molecular activators in the body. The company’s proprietary chemical biology-based platform enables the development of therapeutic peptides and proteins with tunable activity that can be controlled using small molecules. Protomer has used this approach toward advancing a portfolio of therapeutic candidates, including glucose-responsive insulins that can sense sugar levels in the blood and automatically activate as needed throughout the day.

"Lilly has long strived to make life better for people living with diabetes and we have a continued determination to provide real solutions, including innovation in insulin therapy. Glucose-sensing insulin is the next frontier and has the potential to revolutionize the treatment and quality of life of people with diabetes by dramatically improving both therapeutic efficacy and safety of insulin therapy," said Ruth Gimeno, vice president, diabetes research and clinical investigation at Lilly. "Protomer’s glucose-sensing insulin program, based on its proprietary molecular engineering of protein sensors (MEPS) platform, is showing significant promise and Lilly is excited to enhance our diabetes pipeline with the company’s innovative technology."

"We are excited to join Lilly, a leader in diabetes therapies, and advance our science with their support to better serve the needs of patients. This transaction validates our team’s accomplishments, and we look forward to continuing our important work together with Lilly," said Alborz Mahdavi, CEO and founder of Protomer. "We have been supported by JDRF since our inception and working closely with one of the leading organizations in type 1 diabetes research has been invaluable for us. The Protomer team is excited to embark on the next chapter of our work at Lilly as we focus our efforts on advancing glucose-responsive insulins and accelerating the development of these next-generation protein therapeutics."

"This is a significant milestone for the T1D community and a key step to bring the promise of Protomer’s game-changing technology one step closer to the clinic," said Katie Ellias, managing director at the JDRF T1D Fund. "Our early support and investment in Protomer is emblematic of our Fund’s mission to help companies with novel science accelerate next generation life-changing therapies for people living with T1D. We are thrilled Protomer has found a home at Lilly, a company that shares our commitment to delivering solutions to the diabetes community."

This transaction will be reflected in Lilly’s reported results and financial guidance according to Generally Accepted Accounting Principles (GAAP). There will be no change to Lilly’s 2021 non-GAAP earnings per share guidance as a result of this transaction.

Aquilo Partners, L.P. is acting as financial advisor and Morrison & Foerster LLP as legal advisor to Protomer. Kirkland & Ellis LLP is serving as Lilly’s legal counsel.

Celldex Therapeutics Announces Pricing of Upsized $250 Million Public Offering of Common Stock

On July 14, 2021 Celldex Therapeutics, Inc. ("Celldex" or the "Company") (Nasdaq: CLDX) reported the pricing of an underwritten public offering of 5,952,381 shares of its common stock at a public offering price of $42.00 per share (Press release, Celldex Therapeutics, JUL 14, 2021, View Source [SID1234584852]). In connection with the offering, Celldex has granted the underwriters a 30-day option to purchase up to an additional 892,857 shares of common stock at the public offering price, less underwriting discounts and commissions.

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Jefferies, SVB Leerink, Guggenheim Securities and Cantor are acting as the joint book-running managers for the offering. LifeSci Capital LLC and H.C. Wainwright & Co. are acting as co-lead managers for the offering.

The Company expects to receive gross proceeds from the offering, excluding the exercise of the underwriters’ option, if any, of approximately $250 million, excluding underwriting discounts and commissions and other offering-related expenses.

Celldex intends to use the net proceeds from the offering to continue clinical and preclinical development of its product candidates, including current and future development of CDX-0159, growing its bispecific antibody platform and clinical candidates, funding ongoing efforts to develop additional clinical pipeline products and for general corporate purposes.

The offering is expected to close on July 16, 2021, subject to customary closing conditions.

The securities described above are being offered pursuant to a prospectus supplement and an accompanying base prospectus forming part of a shelf registration statement on Form S-3 (File No. 333-249917), which was previously filed with the Securities and Exchange Commission ("SEC") and deemed effective on November 6, 2020. A final prospectus supplement relating to the offering will be filed with the SEC and will be available on the SEC’s website located at View Source When available, copies of the final prospectus supplement and the accompanying base prospectus may be obtained for free by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388 or by e-mail at [email protected]; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6105, or by e-mail at [email protected]; or Guggenheim Securities, LLC Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017 or by telephone at (212) 518-9544, or by email at [email protected]; or Cantor Fitzgerald & Co., Attn: Capital Markets, 499 Park Avenue, 4th Floor, New York, New York 10022 or by email at [email protected].

The offering will be made only by means of a prospectus. This press release does not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.