On February 10, 2020 Myovant Sciences (NYSE: MYOV), a healthcare company focused on developing innovative treatments for women’s health and prostate cancer, reported recent corporate updates and reported financial results for the third fiscal quarter ended December 31, 2019 (Press release, Myovant Sciences, FEB 10, 2020, View Source [SID1234554089]).

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"The next six months promise to be an inflection point for Myovant as we expect to submit NDAs for prostate cancer and uterine fibroids in the U.S. and announce data from two Phase 3 studies in endometriosis," said Lynn Seely, M.D., CEO of Myovant. "We are preparing to potentially bring two distinct one pill, once a day treatments to the many women and men who suffer from these common diseases. The low-interest loan facility from Sumitomo Dainippon Pharma strengthens our financial position and further supports this vision."
Third Fiscal Quarter 2019 and Recent Business Highlights
Relugolix Phase 3 Clinical Programs

In November 2019, Myovant announced that the Phase 3 HERO study evaluating the safety and efficacy of once-daily, oral relugolix monotherapy (120 mg) over 48 weeks in 934 men with advanced prostate cancer met its primary efficacy endpoint with a 96.7% response rate and all tested key secondary endpoints, while demonstrating 54% fewer major cardiovascular events as compared with leuprolide injections administered every 3 months. Myovant anticipates submitting its NDA for relugolix monotherapy tablet for men with advanced prostate cancer in the second quarter of calendar year 2020.

In February 2020, Myovant announced positive one-year safety and efficacy data from the LIBERTY open-label extension study with an 87.7% response rate and, on average, an 89.9% reduction in menstrual blood loss from baseline, while demonstrating maintenance of bone mineral density through one year consistent with LIBERTY 1 and 2. Myovant expects to submit its NDA for relugolix combination tablet for women with heavy menstrual bleeding associated with uterine fibroids in April 2020. The NDA submission, for which Myovant no longer expects to use a priority review voucher, will include complete one-year safety and efficacy data from the LIBERTY open-label extension study, key data that may positively impact the labeled duration of use of the relugolix combination tablet. Myovant also anticipates submitting a Marketing Authorization Application (MAA) to the European Medicines Agency in the first quarter of calendar year 2020.

Myovant completed patient recruitment in SPIRIT 2 in August 2019 and in SPIRIT 1 in October 2019, enrolling 623 women and 638 women, respectively. The SPIRIT 1 and 2 are replicate Phase 3 studies evaluating the safety and efficacy of relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) in women with pain associated with endometriosis. Myovant expects to report top-line results from SPIRIT 2 and SPIRIT 1 in the first and second quarters of calendar year 2020, respectively.

In December 2019, Myovant successfully completed one-year stability studies for the relugolix combination tablet in support of potential commercialization.
Corporate

In December 2019, Roivant Sciences transferred a majority of Myovant’s outstanding common shares to Sumitovant Biopharma Ltd. (Sumitovant), a subsidiary of Sumitomo Dainippon Pharma. Concurrent with the transfer of these shares, Myovant entered into a low interest (3-month LIBOR plus 3%) revolving loan facility of up to $400 million with Sumitomo Dainippon Pharma. In addition, Hiroshi Nomura, Representative Director, President and CEO of Sumitomo Dainippon Pharma, and Adele Gulfo, Chief Business and Commercial Development Officer at Sumitovant, joined Myovant’s Board of Directors.

In December 2019, Myovant used initial proceeds of $113.7 million from the Sumitomo Dainippon Pharma loan facility to repay all of Myovant’s outstanding obligations to NovaQuest Capital Management (NovaQuest) and Hercules Capital, Inc. (Hercules).

In December 2019, Myovant announced the promotion of Frank Karbe to President and Chief Financial Officer and Matthew Lang to Chief Administrative and Legal Officer.
Third Fiscal Quarter 2019 Financial Summary
Research and development (R&D) expenses for the quarter ended December 31, 2019, were $48.9 million compared to $58.4 million for the comparable prior year period. R&D expenses in both periods primarily include expenses related to Myovant’s Phase 3 clinical programs, manufacturing expenses, as well as personnel-related expenses for employees engaged in R&D activities. R&D expenses related to Myovant’s clinical programs have continued to decline, driven primarily by the wind down of Myovant’s Phase 3 studies. The decrease in study costs were partially offset by increases in other R&D expenses related predominantly to Myovant’s manufacturing activities in connection with preparations for Myovant’s anticipated commercial launches and regulatory submissions for relugolix combination tablet and relugolix monotherapy tablet in multiple indications and jurisdictions, as well as increases in personnel expenses, share-based compensation expense, and other R&D expenses. For the quarter ended December 31, 2019, R&D expenses include $1.8 million of share-based compensation related to the accelerated vesting of certain equity awards as a result of a change in control in Myovant in connection with the closing of the transaction between Roivant and Sumitomo Dainippon Pharma.
General and administrative (G&A) expenses for the quarter ended December 31, 2019, were $29.1 million compared to $10.7 million for the comparable prior year period. The increase primarily reflects a one-off increase in share-based compensation, as well as increases in personnel-related expenses, professional service fees, expenses related to commercial operations activities in advance of potential regulatory approvals of relugolix combination tablet and relugolix monotherapy tablet, other general overhead and administrative expenses to support Myovant’s headcount growth and expanding operations and the assumption of activities previously provided by Myovant’s former majority shareholder, Roivant. For the quarter ended December 31, 2019, G&A expenses include $14.4 million of share-based compensation, of which $10.2 million are related to the accelerated vesting of certain equity awards as a result of a change in control in Myovant.
Interest expense for the quarter ended December 31, 2019, was $3.6 million compared to $1.6 million in the comparable prior year period. The increase for the quarter was primarily the result of higher outstanding debt balances under Myovant’s financing arrangements with NovaQuest and Hercules. On December 31, 2019, Myovant repaid all of its outstanding obligations to NovaQuest and Hercules.
Loss on extinguishment of debt for the quarter ended December 31, 2019, was $4.9 million, which resulted from the early retirement of Myovant’s outstanding obligations to NovaQuest and Hercules. There were no such amounts in the comparable prior year period.

Interest income for the quarter ended December 31, 2019, was $0.6 million. There was no interest income for the quarter ended December 31, 2018. During the quarter ended December 31, 2019, a portion of Myovant’s cash was invested in a combination of money market funds, commercial paper, and short-term corporate bonds. There were no such investments during the comparable prior year period.
Net loss for the quarter ended December 31, 2019, was $85.6 million, compared to $70.6 million for the comparable prior year period. The increase in the net loss for the quarter was driven primarily by the increase in expenses outlined above. On a per common share basis, net loss was $0.96 and $1.04 for the quarters ended December 31, 2019, and 2018, respectively. The decrease in the net loss per common share for the quarter was due to an increase in the weighted-average common shares outstanding primarily as a result of Myovant’s underwritten public equity offering in June 2019.
Capital resources: Cash, cash equivalents, and marketable securities totaled $98.9 million as of December 31, 2019. As of December 31, 2019, Myovant had $286.3 million of available borrowing capacity under the loan facility from Sumitomo Dainippon Pharma. Additional funds may be drawn down by Myovant no more than once any calendar quarter, subject to certain terms and conditions, including consent of Myovant’s Board of Directors.
About Relugolix
Relugolix is a once-daily, oral gonadotropin-releasing hormone (GnRH) receptor antagonist that reduces ovarian estradiol production, a hormone known to stimulate the growth of uterine fibroids and endometriosis, and testicular testosterone production, a hormone known to stimulate the growth of prostate cancer. Myovant is developing a relugolix combination tablet (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) for women with heavy menstrual bleeding associated with uterine fibroids and for women with pain associated with endometriosis. Myovant is also developing a relugolix monotherapy tablet (120 mg once daily) for men with advanced prostate cancer.
About MVT-602
MVT-602 is an oligopeptide kisspeptin-1 receptor agonist. Kisspeptin, the ligand, is a naturally-occurring peptide that stimulates GnRH release and is required for puberty and maintenance of normal reproductive function, including production of sperm, follicular maturation and ovulation, and production of estrogen and progesterone in women and testosterone in men. A Phase 2a clinical study in healthy female volunteers to characterize the dose-response curve in a minimal controlled ovarian stimulation setting has been completed.

On February 10, 2020 Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, reported that Brian M. Culley, Chief Executive Officer, will be presenting at NobleCon16 – Noble Capital Markets’ Sixteenth Annual Investor Conference on February 18, 2020 at 2:30pm Eastern Time at the Hard Rock Hotel & Casino, Hollywood, Florida in Terrace Ballroom B (Press release, Lineage Cell Therapeutics, FEB 10, 2020, View Source [SID1234554088]).

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A video webcast of the presentation will be available the day following the presentation on the Events and Presentations section of Lineage’s website and an archived presentation will be available for 30 days. Additional videos are available on the Media page of the Lineage website, located at www.lineagecell.com/media/. Lineage’s presentation will also be available as part of a complete catalog of presentations on Noble Capital Markets’ Conference website: www.nobleconference.com and on Channelchek, www.channelchek.com the investor portal created by Noble Capital Markets.

On February 10, 2020 Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading genome editing company focused on developing curative therapeutics using CRISPR/Cas9 technology both in vivo and ex vivo, reported that it is presenting new data from two of its development programs at Keystone Symposia’s Engineering the Genome Conference, a joint meeting with the Emerging Cellular Therapies: Cancer and Beyond Conference, taking place Feb. 8-12, 2020, in Banff, Canada (Press release, Intellia Therapeutics, FEB 10, 2020, View Source [SID1234554087]). Intellia researchers are presenting data in support of the company’s lead engineered cell therapy development candidate, NTLA-5001 for the treatment of the hematological cancer, acute myeloid leukemia (AML). Intellia also is sharing preclinical results for its hereditary angioedema (HAE) program, which is Intellia’s third CRISPR/Cas9 development program, announced in January 2020.

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"Intellia continues to demonstrate strong progress across both our engineered cell therapy and in vivo pipelines," said Intellia President and Chief Executive Officer John Leonard, M.D. "We are observing very favorable preclinical data with our engineered T cells, and we are moving ahead with IND-enabling studies and manufacturing for NTLA-5001, to enable a regulatory submission in the first half of 2021.

"On the in vivo side, the data from our HAE development program reinforce the modularity of Intellia’s non-viral delivery genome editing platform and how it is enabling independent, single-dose therapies for multiple monogenic diseases. For HAE, we expect to nominate a development candidate in the first half of this year," continued Dr. Leonard.

New Data from Intellia’s Engineered Cell Therapy Development Program for AML

NTLA-5001, which is Intellia’s first engineered T cell therapy development candidate and is wholly owned, utilizes a T cell receptor (TCR)-directed approach to target the Wilms’ Tumor 1 (WT1) intracellular antigen for the treatment of AML. The company’s WT1-TCR T cell approach aims to develop a broadly applicable treatment for AML patients, regardless of mutational background of a patient’s leukemia.

The company is presenting data demonstrating that the selection of a natural, high-affinity TCR, in combination with CRISPR-enabled engineering and targeted insertion, results in an engineered T cell capable of specific and potent killing of primary AML blasts. Today’s presentation at Keystone builds on data previously presented last fall at the Annual Congress of the European Society of Gene and Cell Therapy (ESGCT).

The data being presented at the Keystone conference substantiate the advantages that a homogeneous T cell product developed through CRISPR engineering, like NTLA-5001, may have over traditional T cell engineering approaches. In particular, traditional T cell engineering methods typically result in a T cell product that carries two different TCRs, one endogenous and one transferred, which can pair in various combinations of alpha and beta chains and form mixed TCRs with unknown specificities. Intellia researchers are sharing today that the precise replacement of the endogenous TCR with the transgenic TCR (tgTCR) resulted in T cells with improved tgTCR expression levels and in 95% of edited T cells carrying exclusively the desired pairs of the tgTCR alpha and beta chains. This therapeutic TCR profile is expected to yield improved T cell product homogeneity, as researchers showed that Intellia’s T cell editing approach results in superior function of the engineered T cells toward WT1-positive targets in vitro. This therapeutic TCR profile is also expected to result in lower reactivity against unwanted targets on normal tissues that could lead to toxicities, including graft-versus-host disease (GvHD).

Researchers identified that the selected lead WT1 TCR exhibits high avidity (in the nM range) to its target epitope and shows tight epitope specificity. Being a natural TCR isolated from a healthy donor, it may have a lower cross-reactivity risk than many affinity-matured TCRs. Cells engineered with Intellia’s lead WT1 TCR also demonstrated no detectable cytotoxicity toward bone marrow CD34+ cells, which express WT1 at low levels. This is an advantage over current CAR-T cell approaches targeting CD33 or CD123 in AML, which have been shown to induce severe bone marrow toxicity.

Furthermore, the data demonstrate that specific and potent killing of WT1-positive primary AML blasts result from T cells expressing Intellia’s lead WT1 TCR when cocultured in vitro. This outcome was observed across multiple patient samples that harbor the frequent HLA-A*02:01 allele and that express different WT1 levels as well as AML characteristics. These data validate that the epitope targeted by the lead WT1 TCR, which is distinct from a previously evaluated RMF epitope, is presented efficiently and broadly by AML tumor cells that carry the correct human leukocyte antigen (HLA) restriction. Intellia’s lead WT1 TCR also has the potential to target WT1-positive solid tumors, such as ovarian cancer, glioblastoma, lung cancer and mesothelioma.

The company plans to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) in the first half of 2021 for NTLA-5001 for the treatment of AML. Details on today’s presentations on WT1 TCR T cells, including data from ongoing collaborations with researchers at IRCCS Ospedale San Raffaele, Milan, at Keystone are as follows:

"Developing Next-Generation Engineered TCR-T Cells with CRISPR"
Presenter: Birgit Schultes, Ph.D., vice president, cell therapy, Intellia
Session: "Genome Editing as a Biology Discovery Tool"
Presentation date/time: Mon., Feb. 10, 2020, 8-11:15 a.m. MT
Location: Van Horne C

"Multiple Genome Editing of Early Differentiated T Cells for Cancer Immunotherapy"
Presenter: Chiara Bonini, M.D., Ph.D., deputy director of the Division of Immunology, Transplantation and Infectious Diseases at IRCCS Ospedale San Raffaele
Session: "Next Generation Immune Cell Engineering"
Presentation date/time: Mon., Feb. 10, 2020, 8-11:15 a.m. MT
Location: Van Horne A/B
First Data Presented on Potential CRISPR/Cas9-Based Therapy for HAE, Intellia’s Third Development Program

Researchers presented yesterday at the Keystone conference the company’s first dataset in support of Intellia’s development program for HAE. HAE is a rare genetic disorder characterized by recurring and unpredictable severe swelling attacks in various parts of the body, and is significantly debilitating or even fatal in certain cases. The disease is caused by increased levels of the bradykinin protein. Most patients with HAE have a C1 esterase inhibitor (C1-INH) protein deficiency, which normally prevents the unregulated release and buildup of bradykinin.

Intellia’s HAE treatment hypothesis involves knocking out the kallikrein B1 (KLKB1) gene to reduce kallikrein activity, which is involved in the biological pathway for release of bradykinin. Intellia expects this reduction to correlate with a decrease in bradykinin activity, thus, preventing the activation of endothelial cells that causes vascular leakage and angioedema in HAE patients. The data presented at the Keystone conference showed that the knockout of KLKB1 produces in non-human primates (NHPs) a 90% reduction in kallikrein activity, a level that translates to a therapeutically meaningful impact on HAE attack rates (Source: Banerji et al., NEJM, 2017). This kallikrein activity reduction was sustained for at least five months in an ongoing NHP study, in a highly reproducible manner observed across both rodent and NHP studies.

Similar to its lead in vivo program, for the treatment of transthyretin amyloidosis (ATTR), Intellia’s potential HAE therapy utilizes the company’s modular non-viral lipid nanoparticle (LNP) system to deliver CRISPR/Cas9. Intellia’s proprietary LNP-based delivery system includes two basic components: Cas9 messenger RNA (mRNA) and a guide RNA (gRNA). The gRNA is the only variable portion of the LNP delivery system and is the sole component that needs to be changed from the LNP-based delivery system that forms the foundation of NTLA-2001, Intellia’s development candidate for the treatment of ATTR for which the company intends to submit an IND application in mid-2020.

Intellia continues to evaluate several potential guide RNAs and expects to nominate a development candidate for HAE in the first half of 2020. Intellia’s KLKB1 HAE program is subject to an option by Regeneron to enter into a Co/Co agreement, in which Intellia would remain the lead party.

Yesterday’s short talk, titled "In Vivo Delivery of CRISPR/Cas9 to the Liver Using Lipid Nanoparticles Enables Gene Knockout Across Multiple Targets in Rodent and Non-Human Primates," was made by Jessica Seitzer, director, genomics, Intellia. These data included results from ongoing collaborations with researchers at Regeneron.

On February 10, 2019 Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading genome editing company focused on developing curative therapeutics using CRISPR/Cas9 technology both in vivo and ex vivo, is presenting new data from two of its development programs at Keystone Symposia’s Engineering the Genome Conference, a joint meeting with the Emerging Cellular Therapies: Cancer and Beyond Conference, taking place Feb. 8-12, 2020, in Banff, Canada (Press release, Intellia Therapeutics, FEB 10, 2020, View Source [SID1234554086]). Intellia researchers are presenting data in support of the company’s lead engineered cell therapy development candidate, NTLA-5001 for the treatment of the hematological cancer, acute myeloid leukemia (AML). Intellia also is sharing preclinical results for its hereditary angioedema (HAE) program, which is Intellia’s third CRISPR/Cas9 development program, announced in January 2020.

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"Intellia continues to demonstrate strong progress across both our engineered cell therapy and in vivo pipelines," said Intellia President and Chief Executive Officer John Leonard, M.D. "We are observing very favorable preclinical data with our engineered T cells, and we are moving ahead with IND-enabling studies and manufacturing for NTLA-5001, to enable a regulatory submission in the first half of 2021.

"On the in vivo side, the data from our HAE development program reinforce the modularity of Intellia’s non-viral delivery genome editing platform and how it is enabling independent, single-dose therapies for multiple monogenic diseases. For HAE, we expect to nominate a development candidate in the first half of this year," continued Dr. Leonard.

New Data from Intellia’s Engineered Cell Therapy Development Program for AML

NTLA-5001, which is Intellia’s first engineered T cell therapy development candidate and is wholly owned, utilizes a T cell receptor (TCR)-directed approach to target the Wilms’ Tumor 1 (WT1) intracellular antigen for the treatment of AML. The company’s WT1-TCR T cell approach aims to develop a broadly applicable treatment for AML patients, regardless of mutational background of a patient’s leukemia.

The company is presenting data demonstrating that the selection of a natural, high-affinity TCR, in combination with CRISPR-enabled engineering and targeted insertion, results in an engineered T cell capable of specific and potent killing of primary AML blasts. Today’s presentation at Keystone builds on data previously presented last fall at the Annual Congress of the European Society of Gene and Cell Therapy (ESGCT).

The data being presented at the Keystone conference substantiate the advantages that a homogeneous T cell product developed through CRISPR engineering, like NTLA-5001, may have over traditional T cell engineering approaches. In particular, traditional T cell engineering methods typically result in a T cell product that carries two different TCRs, one endogenous and one transferred, which can pair in various combinations of alpha and beta chains and form mixed TCRs with unknown specificities. Intellia researchers are sharing today that the precise replacement of the endogenous TCR with the transgenic TCR (tgTCR) resulted in T cells with improved tgTCR expression levels and in 95% of edited T cells carrying exclusively the desired pairs of the tgTCR alpha and beta chains. This therapeutic TCR profile is expected to yield improved T cell product homogeneity, as researchers showed that Intellia’s T cell editing approach results in superior function of the engineered T cells toward WT1-positive targets in vitro. This therapeutic TCR profile is also expected to result in lower reactivity against unwanted targets on normal tissues that could lead to toxicities, including graft-versus-host disease (GvHD).

Researchers identified that the selected lead WT1 TCR exhibits high avidity (in the nM range) to its target epitope and shows tight epitope specificity. Being a natural TCR isolated from a healthy donor, it may have a lower cross-reactivity risk than many affinity-matured TCRs. Cells engineered with Intellia’s lead WT1 TCR also demonstrated no detectable cytotoxicity toward bone marrow CD34+ cells, which express WT1 at low levels. This is an advantage over current CAR-T cell approaches targeting CD33 or CD123 in AML, which have been shown to induce severe bone marrow toxicity.

Furthermore, the data demonstrate that specific and potent killing of WT1-positive primary AML blasts result from T cells expressing Intellia’s lead WT1 TCR when cocultured in vitro. This outcome was observed across multiple patient samples that harbor the frequent HLA-A*02:01 allele and that express different WT1 levels as well as AML characteristics. These data validate that the epitope targeted by the lead WT1 TCR, which is distinct from a previously evaluated RMF epitope, is presented efficiently and broadly by AML tumor cells that carry the correct human leukocyte antigen (HLA) restriction. Intellia’s lead WT1 TCR also has the potential to target WT1-positive solid tumors, such as ovarian cancer, glioblastoma, lung cancer and mesothelioma.

The company plans to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) in the first half of 2021 for NTLA-5001 for the treatment of AML. Details on today’s presentations on WT1 TCR T cells, including data from ongoing collaborations with researchers at IRCCS Ospedale San Raffaele, Milan, at Keystone are as follows:

"Developing Next-Generation Engineered TCR-T Cells with CRISPR"
Presenter: Birgit Schultes, Ph.D., vice president, cell therapy, Intellia
Session: "Genome Editing as a Biology Discovery Tool"
Presentation date/time: Mon., Feb. 10, 2020, 8-11:15 a.m. MT
Location: Van Horne C

"Multiple Genome Editing of Early Differentiated T Cells for Cancer Immunotherapy"
Presenter: Chiara Bonini, M.D., Ph.D., deputy director of the Division of Immunology, Transplantation and Infectious Diseases at IRCCS Ospedale San Raffaele
Session: "Next Generation Immune Cell Engineering"
Presentation date/time: Mon., Feb. 10, 2020, 8-11:15 a.m. MT
Location: Van Horne A/B
First Data Presented on Potential CRISPR/Cas9-Based Therapy for HAE, Intellia’s Third Development Program

Researchers presented yesterday at the Keystone conference the company’s first dataset in support of Intellia’s development program for HAE. HAE is a rare genetic disorder characterized by recurring and unpredictable severe swelling attacks in various parts of the body, and is significantly debilitating or even fatal in certain cases. The disease is caused by increased levels of the bradykinin protein. Most patients with HAE have a C1 esterase inhibitor (C1-INH) protein deficiency, which normally prevents the unregulated release and buildup of bradykinin.

Intellia’s HAE treatment hypothesis involves knocking out the kallikrein B1 (KLKB1) gene to reduce kallikrein activity, which is involved in the biological pathway for release of bradykinin. Intellia expects this reduction to correlate with a decrease in bradykinin activity, thus, preventing the activation of endothelial cells that causes vascular leakage and angioedema in HAE patients. The data presented at the Keystone conference showed that the knockout of KLKB1 produces in non-human primates (NHPs) a 90% reduction in kallikrein activity, a level that translates to a therapeutically meaningful impact on HAE attack rates (Source: Banerji et al., NEJM, 2017). This kallikrein activity reduction was sustained for at least five months in an ongoing NHP study, in a highly reproducible manner observed across both rodent and NHP studies.

Similar to its lead in vivo program, for the treatment of transthyretin amyloidosis (ATTR), Intellia’s potential HAE therapy utilizes the company’s modular non-viral lipid nanoparticle (LNP) system to deliver CRISPR/Cas9. Intellia’s proprietary LNP-based delivery system includes two basic components: Cas9 messenger RNA (mRNA) and a guide RNA (gRNA). The gRNA is the only variable portion of the LNP delivery system and is the sole component that needs to be changed from the LNP-based delivery system that forms the foundation of NTLA-2001, Intellia’s development candidate for the treatment of ATTR for which the company intends to submit an IND application in mid-2020.

Intellia continues to evaluate several potential guide RNAs and expects to nominate a development candidate for HAE in the first half of 2020. Intellia’s KLKB1 HAE program is subject to an option by Regeneron to enter into a Co/Co agreement, in which Intellia would remain the lead party.

Yesterday’s short talk, titled "In Vivo Delivery of CRISPR/Cas9 to the Liver Using Lipid Nanoparticles Enables Gene Knockout Across Multiple Targets in Rodent and Non-Human Primates," was made by Jessica Seitzer, director, genomics, Intellia. These data included results from ongoing collaborations with researchers at Regeneron.

On February 10, 2020 I-Mab (the "Company") (Nasdaq: IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel or highly differentiated biologics to treat diseases with significant unmet medical needs, particularly cancers and autoimmune disorders, reported that the underwriters of the Company’s initial public offering (the "IPO") have exercised in part their over-allotment option to purchase an additional 768,350 American Depositary Shares ("ADSs") of the Company at the IPO price of US$14.00 per ADS (Press release, I-Mab Biopharma, FEB 10, 2020, View Source [SID1234554085]). Each ten (10) ADSs represent twenty-three (23) ordinary shares of the Company.

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After giving effect to the exercise of the over-allotment option, I-Mab has issued and sold a total of 8,175,750 ADSs in the IPO, for total gross proceeds of US$114,460,500.

Jefferies LLC and China International Capital Corporation Hong Kong Securities Limited acted as joint book-runners. China Renaissance Securities (Hong Kong) and Huatai Securities (USA) acted as lead managers for the offering.

A registration statement related to the offering has been filed with the U.S. Securities and Exchange Commission (the "SEC") was declared effective on January 16, 2020. The offering is made only by means of a prospectus forming a part of the effective registration statement. Copies of the final prospectus relating to this offering , when available, may be obtained from (i) Jefferies LLC, Attn: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, New York 10022, by telephone at (877) 821-7388 or by email at [email protected] or (ii) China International Capital Corporation Hong Kong Securities Limited, Attn: Rita Li, 29th One International Finance Center, One Harbour View Street, Central, Hong Kong, by telephone at (852) 2872-2000 or by e-mail at [email protected].

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