On October 19, 2020 Recombinetics Inc., a leading gene editing company with platform technology applied to biomedicine and animal agriculture, reported that it has partnered with American Preclinical Services in a first of its kind study to improve Glioblastoma outcomes (Press release, Recombinetics, OCT 19, 2020, View Source [SID1234568633]).

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Surrogen, a subsidiary of Recombinetics Inc., is focused on developing large animal models of human disease for use in medical research. In September, Surrogen displayed the world’s first genetically engineered large animal model of Glioblastoma, which develops in a predictable and reproducible timeframe. This important scientific advancement was achieved through somatic cell gene editing to engineer the precise genetic changes seen in human tumors.

Glioblastoma, or GBM, is a devastating disease which results in a cancerous tumor that develops in the brain. GBM is the most common and aggressive of all brain tumors, with few effective treatment options available, and a five-year survival rate of less than 5%.

One of the most significant challenges for the development of new therapies or treatments is the lack of reliable and reproducible animal models of the disease for use in pre-clinical studies. With this breakthrough, that is no longer the case. This technology presents a unique opportunity to impact the lives of those diagnosed with Glioblastoma and to give families hope.

According to Dr. Adrienne Watson, Recombinetics’ Vice President of Research and Development, "This new model of glioblastoma gives us the opportunity to better understand this disease and improve patient outcomes by identifying tumor biomarkers, developing new surgical and imaging technologies, and most importantly, creating new therapeutic techniques to treat these tumors."

"The goal is to improve the therapeutic development landscape by being able to reproduce the effects of therapies effective in animals, in human patients, as well as improve dose selection prior to entering clinical trials. Overall, the technology may speed up the process of bringing viable therapies to market," says CEO, Mark Platt.

"One of the most difficult tasks in preclinical research today is developing models of human disease in animals that can then be dependably used to test the effectiveness of novel methods for treatment. These new large-animal disease models will introduce a new paradigm for evaluating new medical devices, new surgical techniques, new drugs or drug delivery systems with substantially higher degree of translatability to clinical outcomes. These models have the potential to reduce both the development times for new therapies and the risk of failure of a new modality in very expensive clinical trials," states Jim Pomonis, CSO, American Preclinical Services.

On October 19, 2020 AbbVie reported the commencement of its offers to exchange (the "Registered Exchange Offers") any and all of its outstanding (i) $30,000,000,000 aggregate principal amount of senior unsecured notes previously issued on November 21, 2019 (the "2019 USD Notes"), (ii) $13,251,781,000 aggregate principal amount of senior unsecured notes previously issued on May 14, 2020 (the "2020 USD Notes" and, together with the 2019 USD Notes, the "USD Notes") and (iii) €2,517,066,000 aggregate principal amount of senior unsecured notes previously issued on May 14, 2020 (the "Euro Notes" and, together with the USD Notes, the "Original Notes"), each issued pursuant to an exemption from the registration requirements of the Securities Act of 1933, as amended (the "Securities Act"), for an equal principal amount of new notes in a transaction registered under the Securities Act (the "Registered Notes") (Press release, AbbVie, OCT 19, 2020, View Source [SID1234568630]).

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The 2019 USD Notes were issued in a private offering to fund a portion of the aggregate cash consideration payable in connection with AbbVie’s acquisition of Allergan plc ("Allergan") and to pay related fees and expenses. The 2020 USD Notes and the Euro Notes were issued in a private offering upon the completion of AbbVie’s offers to exchange (the "prior exchange offers") any and all outstanding notes issued by certain of Allergan’s subsidiaries.

AbbVie is offering to issue the Registered Notes to satisfy its obligations under the registration rights agreement entered into with the initial purchasers of the 2019 USD Notes and the registration rights agreement entered into with the dealer managers for the prior exchange offers. The Registered Exchange Offers do not represent a new financing transaction.

The terms of the Registered Notes to be issued in the Registered Exchange Offers are substantially identical to the terms of the corresponding series of Original Notes, except that the offering of the Registered Notes will be registered under the Securities Act and the transfer restrictions, registration rights and additional interest provisions applicable to the Original Notes will not apply to the Registered Notes. AbbVie will issue the Registered Notes under the same indentures that govern the applicable series of Original Notes.

The following table sets forth the outstanding aggregate principal amount of each series of Original Notes. The Registered Exchange Offers consist of offers to exchange up to the entire aggregate principal amount of each series of Original Notes for an equal principal amount of the corresponding series of Registered Notes.

Title of Series of Original Notes

Amount
Outstanding

Senior Floating Rate Notes due May 2021

$750,000,000

Senior Floating Rate Notes due November 2021

$750,000,000

2.150% Senior Notes due 2021

$1,750,000,000

5.000% Senior Notes due 2021

$1,175,701,000

3.450% Senior Notes due 2022

$2,627,036,000

3.250% Senior Notes due 2022

$1,462,358,000

Senior Floating Rate Notes due 2022

$750,000,000

2.300% Senior Notes due 2022

$3,000,000,000

2.800% Senior Notes due 2023

$244,575,000

3.850% Senior Notes due 2024

$945,394,000

2.600% Senior Notes due 2024

$3,750,000,000

3.800% Senior Notes due 2025

$2,890,467,000

2.950% Senior Notes due 2026

$4,000,000,000

3.200% Senior Notes due 2029

$5,500,000,000

4.550% Senior Notes due 2035

$1,681,354,000

4.050% Senior Notes due 2039

$4,000,000,000

4.625% Senior Notes due 2042

$389,217,000

4.850% Senior Notes due 2044

$1,008,583,000

4.750% Senior Notes due 2045

$827,096,000

4.250% Senior Notes due 2049

$5,750,000,000

0.500% Senior Notes due 2021

€539,018,000

1.500% Senior Notes due 2023

€433,228,000

1.250% Senior Notes due 2024

€603,389,000

2.625% Senior Notes due 2028

€427,893,000

2.125% Senior Notes due 2029

€513,538,000

AbbVie will accept for exchange any and all Original Notes validly tendered and not validly withdrawn prior to 5:00 p.m., New York City time, on November 17, 2020 (as the same may be extended by AbbVie with respect to one or more series of Original Notes, the "Expiration Date"). Prior to the Expiration Date, tenders of Original Notes may be withdrawn according to the procedures described in the Prospectus (as defined below). Promptly after the Expiration Date, AbbVie will settle the Registered Exchange Offers by issuing Registered Notes pursuant to the terms of the Registered Exchange Offers.

A Registration Statement on Form S-4 (File No. 333-249277) (the "Registration Statement") relating to the Registered Exchange Offers was filed with the Securities and Exchange Commission on October 2, 2020 and was declared effective on October 16, 2020. The Registered Exchange Offers are being made pursuant to the terms and subject to the conditions set forth in a prospectus dated October 19, 2020 (as the same may be amended or supplemented, the "Prospectus"), which has been filed with the Securities and Exchange Commission and forms a part of the Registration Statement. The complete terms and conditions of the Registered Exchange Offers, including instructions regarding procedures for tendering Original Notes, are described in the Prospectus, the Registration Statement and related letter of transmittal, copies of which may be obtained by contacting (i) U.S Bank National Association, the exchange agent in connection with the Registered Exchange Offers for the USD Notes, at (800) 934-6802 or (ii) Elavon Financial Services DAC, the exchange agent in connection with the Registered Exchange Offers for the Euro Notes, at +44 (0) 207 330 2000.

This press release is not an offer to sell or exchange or a solicitation of an offer to buy or exchange any of the securities described herein. The Registered Exchange Offers are being made solely pursuant to the terms and conditions of the Prospectus, the Registration Statement, the related letter of transmittal and the other related materials.

On October 19, 2020 Cerus Corporation (Nasdaq:CERS) reported that its third quarter 2020 financial results will be released on Thursday, October 29, 2020, after the close of the stock market (Press release, Cerus, OCT 19, 2020, View Source [SID1234568626]). The Company will host a conference call and webcast at 4:30 P.M. ET that afternoon, during which management will discuss the Company’s financial results and provide a general business overview and outlook.

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To listen to the live webcast and view the presentation slides, please visit the Investor Relations page of the Cerus website at View Source Alternatively, you may access the live conference call by dialing (866) 235-9006 (U.S.) or (631) 291-4549 (international).

A replay will be available on Cerus’ website, or by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and entering conference ID number 7249794. The replay will be available approximately three hours after the call through November 12, 2020.

On October 19, 2020 Mereo BioPharma Group plc (NASDAQ: MREO, AIM: MPH) ("Mereo" or "the Company"), a clinical stage biopharmaceutical company focused on oncology and rare diseases, reported that the U.S. Food and Drug Administration has cleared an investigational new drug (IND) application to proceed with a Phase 1b/2 study for the Company’s lead oncology product candidate etigilimab (Press release, Mereo BioPharma, OCT 19, 2020, View Source [SID1234568624]). Etigilimab is a novel IgG1 monoclonal antibody against TIGIT (T-cell immunoreceptor with Ig and ITIM domains), a next generation checkpoint receptor shown to block T-cell activation and the body’s natural anti-cancer immune response.

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Mereo is on track to initiate the Phase 1b/2 basket study in the fourth quarter of 2020. The study will evaluate etigilimab in combination with an anti-PD-1 initially in approximately 100 patients with a defined series of tumor types, including biomarker enriched and rare tumor cohorts. The study will incorporate flat dosing (for patients 50 kg and higher) which is based on data from Mereo’s previous Phase 1a and Phase 1b combination studies with etigilimab.

Dr. John Lewicki, Chief Scientific Officer of Mereo, said: "Recent clinical data regarding anti-TIGIT therapies in combination with PDL-1/PD-1 inhibition have been promising. We designed etigilimab as a novel IgG1 which blocks TIGIT signalling while retaining an intact effector function and we believe our development approach is differentiated. We have selected the tumor types for our planned Phase 1b/2 basket combination study based on biomarker screening of large collections of different tumor samples and correlating these with suboptimal responses to anti- PDL-1/PD-1. We’ve also included tumor types where we saw evidence of activity in our previous Phase 1a/1b study. We look forward to initiating the study this quarter and providing additional details during our planned virtual R&D day."

In November 2020, Mereo plans to host a virtual R&D day featuring external experts to review the etigilimab development program, including the design and biomarker strategy of the Phase 1b/2 basket combination study. Mereo also plans to provide an overview of its rare disease product pipeline. Further information including the date/time of the virtual R&D day will be announced in the coming weeks.

About Etigilimab

Etigilimab is an antibody against TIGIT (T-cell immunoreceptor with Ig and ITIM domains). TIGIT is a next generation checkpoint receptor shown to block T-cell activation and the body’s natural anti-cancer immune response. Etigilimab is an IgG1 monoclonal antibody which binds to the human TIGIT receptor on immune cells with a goal of improving the activation and effectiveness of T-cell and NK cell anti-tumor activity. Mereo completed a Phase 1a dose escalation clinical trial with etigilimab in patients with advanced solid tumors and enrolled patients in a Phase 1b study in combination with nivolumab in selected tumor types.

23 patients were treated in the Phase 1a dose escalation study with doses up to 20 mg/kg Q2W. Tumor types included colorectal cancer, endometrial cancer, pancreatic cancer and other tumors. No dose limiting toxicities were observed. In the Phase 1b combination study, a total of ten patients, nine of whom had progressed on prior anti-PD-1/PD-L1 therapies were enrolled at doses of 3, 10, and 20 mg/kg. Eight patients were evaluable for tumor growth assessment, and all of these patients had progressed on PD-1/PD-L1 therapies with best responses including one patient with a partial response another with stable disease. These patients remained on study for up to 224 days. No dose limiting toxicities (DLTs) were observed and the most common related adverse events included fatigue, rash, and pruritis.

Mereo plans to initiate a Phase 1b/2 study of etigilimab in combination with an anti-PD-1 in a series of tumor types in Q4 2020.

On October 19, 2020 Scholar Rock(NASDAQ: SRRK), a clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, reported the closing of a $50 million debt facility with Silicon Valley Bank and Oxford Finance LLC, of which the first $25 million was funded at closing (Press release, Scholar Rock, OCT 19, 2020, View Source [SID1234568623]). Scholar Rock intends to use the proceeds for general corporate purposes, including the advancement of the Company’s pipeline and for pre-commercialization preparations.

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"This non-dilutive financing strengthens Scholar Rock’s balance sheet as we advance our clinical programs and overall platform for patients affected by a wide range of serious diseases, including neuromuscular disorders, cancer, fibrosis, and anemia," said Ted Myles, CFO & Head of Business Operations of Scholar Rock. "Importantly, this facility provides added financial and operational flexibility as we head into important clinical read-outs for SRK-015 in spinal muscular atrophy and SRK-181 in immuno-oncology."

Scholar Rock’s approach to discovering and developing growth factor targeted drugs is fundamentally new and different from traditional approaches," stated Christopher A. Herr, Senior Managing Director at Oxford Finance. "As the company looks towards potential late-stage development with upcoming clinical data, we are pleased to provide capital to support their vision of developing novel medicines."

"Scholar Rock is an innovative biopharma company that is developing treatments for an array of diseases with high unmet medical needs and we are excited to expand our relationship to support their next phase of growth," said Kate Walsh, Director of Life Science and Healthcare at Silicon Valley Bank.

Under the terms of the debt facility, the second $25 million tranche is available through December 31, 2021 upon dosing of the first patient in a Phase 3 trial for SRK-015 and dosing of the first patient in Part B of the DRAGON Phase 1 trial for SRK-181. The debt facility will mature on May 1, 2025 and requires interest only payments for the first two years.