On March 23, 2021 Charles River Laboratories International, Inc. (NYSE: CRL) reported that it has closed its previously announced offering of $500 million in aggregate principal amount of its 3.750% senior notes due 2029 (the "2029 notes") and $500 million in aggregate principal amount of its 4.000% senior notes due 2031 (the "2031 notes" and, together with the 2029 notes, the "notes") in an unregistered offering (Press release, Charles River Laboratories, MAR 23, 2021, View Source [SID1234577028]).

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Charles River will use the gross proceeds of the offering of the notes to redeem its 5.5% senior notes due 2026 (the "2026 notes"), to fund, along with borrowings under its senior credit facilities, a portion of the purchase price for its proposed acquisition of Cognate BioServices, Inc., and to pay fees and expenses in connection with the offering, the redemption of the 2026 notes, and the amendment of its senior credit facilities.

The notes have not been, and will not be, registered under the Securities Act of 1933, as amended (the "Securities Act"), or under the securities laws of any other jurisdiction. Unless they are registered, the notes may be offered only in transactions that are exempt from registration under the Securities Act and applicable state securities laws. The notes were offered only to persons reasonably believed to be qualified institutional buyers under Rule 144A under the Securities Act and to non-U.S. persons outside the United States under Regulation S of the Securities Act.

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

On March 23, 2021 Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, reported the four recipients of its Forward for Health Equity grants (Press release, Myovant Sciences, MAR 23, 2021, https://investors.myovant.com/news-releases/news-release-details/myovant-sciences-announces-recipients-forward-health-equity [SID1234577044]). The grant program provides funding to nonprofit healthcare organizations with innovative projects focused on improving healthcare access, with an initial focus on reducing racial disparities in prostate cancer and uterine fibroids in the U.S. The recipients will receive up to $50,000 each.

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"Now more than ever, it is critical to address inequities in healthcare – so we are incredibly excited to announce the inaugural recipients of our Forward for Health Equity grants," said Jarrad Aguirre, M.D., Head of Corporate Strategy and Advocacy at Myovant Sciences, Inc. "The recipients have all proposed innovative initiatives that have great potential to address the unacceptable inequities that too many patients with prostate cancer and uterine fibroids face. We are proud to support these important organizations and build on our commitment to improving healthcare access and redefining care."

The 2021 Forward for Health Equity grant recipients are:

Prostate Cancer:

Emmanual Health Education, Inc. for "The Black Walnut: Sowing Roots for Health Equity and Health Access," to promote prostate cancer screening and health education around The Black Walnut, a documentary film that examines barriers to care for Black men.
University of California, San Francisco for "Leveraging Technology to Achieve Equity for Men with Prostate Cancer on Androgen Deprivation Therapy," to develop and test a multilingual, digital personalized lifestyle program to improve care for men with advanced prostate cancer receiving androgen deprivation therapy.
Uterine Fibroids:

The Center for Black Health & Equity for "S.I.P. and Share: Women Supporting Women," to establish a culturally appropriate outreach initiative that addresses knowledge gaps around uterine fibroids, medical mistrust and bias, and access to healthcare.
Boston Medical Center for "Center of Excellence for Patients with Uterine Fibroids in a Safety-Net Setting," to create a Fibroid Center to provide multidisciplinary care and implement an innovative, community-partnered patient engagement model at Boston Medical Center.
"Prostate cancer and uterine fibroids disproportionately impact Black Americans, and inequities in healthcare access exacerbate these disparities," said Reggie Ware, Chief Executive Officer of BlackDoctor.org and member of the grant review committee. "The recipients of the Forward for Health Equity grants have a demonstrated commitment to reducing racial disparities, and I look forward to seeing the impact they achieve in their communities through these innovative initiatives."

Myovant Sciences launched the Forward for Health Equity grant program in September 2020 to reduce disparities in healthcare and support innovative projects focused on improving access to care. Applications were reviewed by a grant review committee of Myovant employees and external leaders, including Reggie Ware (BlackDoctor.org), Jessica Shepherd, M.D. (Baylor University Medical Center), and Kelvin Moses, M.D., Ph.D. (Vanderbilt University Medical Center). The committee chose grant recipients based on their potential to improve health equity, degree of innovation, and focus on healthcare access.

On March 23, 2021 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it obtained approval from the Ministry of Health, Labour and Welfare (MHLW) for the anticancer agent/antimicrotubule binding anti-CD79b monoclonal antibody Polivy intravenous infusion 30mg and 140mg [generic name: polatuzumab vedotin (genetical recombination)] in combination with bendamustine (freeze-dried formulation) and rituximab (BR therapy) for the treatment of relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) (Press release, Chugai, MAR 23, 2021, View Source [SID1234577005]).

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"I am very pleased that Polivy in combination with BR therapy now can be offered to patients as a new treatment option for R/R DLBCL, a disease with high unmet medical needs, in the hematologic cancer field following Rituxan and Gazyva," said Chugai’s President and CEO Dr. Osamu Okuda. "We are preparing to bring this first-in-class anti-CD79b antibody-drug conjugate (ADC) to patients so that we may contribute to realize a better treatment."

The approval is based on data including the results from a multicenter overseas phase Ib/II clinical study (GO29365) that evaluated the efficacy and safety of Polivy in combination with BR therapy compared to BR therapy alone, and a multicenter, single-arm Japanese phase II study (JO40762/P-DRIVE study) that evaluated the efficacy and safety of the combination therapy in R/R DLBCL.

The efficacy and safety of Polivy and BR therapy (40 patients) compared with BR therapy alone (40 patients) was studied in the randomized phase II part of the GO29365 study in 80 patients with R/R DLBCL not eligible for autologous stem cell transplantation (ASCT). The primary endpoint of the complete response rate (CRR) at the time point of primary response assessment (PRA; 6 to 8 weeks after last dose of Polivy) as evaluated by an independent assessment committee using positron emission tomography-computed tomography (PET-CT) was 40% (16/40 patients; 95% CI: 24.9-56.7%) in the Polivy + BR therapy group, and 17.5% (7/40 patients; 95% CI: 7.3-32.8%) in the BR therapy group (data cut-off: April 30, 2018). Adverse reactions occurred in 36 (92.3%) patients out of 39 patients who received Polivy. The most common adverse reactions were neutropenia 53.8% (21/39 patients), thrombocytopenia 41.0% (16/39 patients), diarrhea and anemia 33.3% (13/39 patients) each, fatigue and nausea 23.1% (9/39 patients) each, and pyrexia and peripheral neuropathy 20.5% (8/39 patients) each.

In the P-DRIVE study, the efficacy and safety of Polivy + BR therapy were studied in 35 patients with R/R DLBCL not eligible for ASCT. The primary endpoint of the CRR at the PRA as assessed by the principal investigator using PET-CT was 34.3% (12/35 patients), (95% CI: 19.1-52.2%) (data cut-off: December 24, 2019). Adverse reactions occurred in 33 (94.3%) patients out of 35 patients who received Polivy. The most common adverse reactions were anemia 37.1% (13/35 patients), nausea 31.4% (11/35 patients), thrombocytopenia and neutropenia 25.7% (9/35 patients) each, constipation, decreased platelet count and decreased neutrophil count 22.9% (8/35 patients) each, and malaise and decreased appetite 20.0% (7/35 patients) each.

A double-blind, placebo-controlled global phase III study (GO39942/POLARIX study) is ongoing for untreated DLBCL to compare the efficacy and safety of Polivy in combination with rituximab plus cyclophosphamide, doxorubicin, prednisolone (R-CHP) to rituximab plus cyclophosphamide, doxorubicin, vincristine, prednisolone (R-CHOP).

[Reference information]
Polatuzumab Vedotin Achieved Primary Endpoint in the Japanese Phase II study for Relapsed or Refractory Diffuse Large B-cell Lymphoma (Press release issued by Chugai on February 13, 2020)
View Source

European Commission approves Roche’s Polivy for people with previously treated aggressive lymphoma (Press release issued by Roche on January 21, 2020)
View Source

Approval information

Product name: Polivy Intravenous Infusion 30mg, Polivy Intravenous Infusion 140mg

Generic name: polatuzumab vedotin (genetical recombination)

Intended uses or indications: Relapsed or refractory diffuse large B-cell lymphoma

Dosage and administration:
The usual adult dosage is 1.8mg/kg (body weight) polatuzumab vedotin (genetical recombination) administered by intravenous infusion every 3 weeks for 6 doses, in combination with bendamustine hydrochloride and rituximab (genetical recombination). If the first infusion is well tolerated after 90 minutes, subsequent infusions may be administered over a shorter time of at least 30 minutes. Reduce the dose as necessary in accordance with the patient’s condition.

About GO29365 study1)
GO29365 is a global, phase Ib/II study evaluating the safety and tolerability of Polivy in combination with bendamustine and rituximab (BR therapy) or obinutuzumab (BG therapy) in R/R follicular lymphoma or DLBCL. In the phase II randomized part of the study with 80 DLBCL patients, the efficacy and safety of Polivy in combination with BR therapy were studied compared to BR therapy alone. The primary endpoint was complete response at the point of primary response assessment as evaluated by an independent assessment committee using PET-CT. Patients received six cycles of treatment, spaced three weeks apart.

About JO40762 (P-DRIVE) study
JO40762 (P-DRIVE) is an open label, single-arm study investigating Polivy in combination with BR therapy in 35 patients with R/R DLBCL. Primary endpoint is investigator’s assessment of CRR by PET-CT at the timing of primary response assessment. Patients received six cycles of treatment, spaced three weeks apart.

About polatuzumab vedotin
Polatuzumab vedotin was developed by Roche using Seattle Genetics’ ADC technology. It is a first-in-class anti-CD79b antibody-drug conjugate (ADC), comprising the anti-CD79b humanized monoclonal antibody and a tubulin polymerization inhibitor attached together using a linker. The CD79b protein is expressed specifically in the majority of B-cells, making it a promising target for the development of new therapies2,3). Polatuzumab vedotin binds to CD79b and destroys these B-cells through the delivery of an anti-cancer agent, which is thought to suppress the effects on normal cells4,5). Polatuzumab vedotin was granted accelerated approval in the US in June 2019 and conditional marketing authorization in the EU in January 2020, respectively.

About diffuse large B-cell lymphoma (DLBCL)
DLBCL is one of the histologic subtypes of non-Hodgkin’s lymphoma (NHL), which is categorized as an aggressive disease that progresses on a monthly basis. DLBCL is the most common form of NHL, accounting for 30-40 percent of NHL6-8). DLBCL frequently occurs in middle-aged and older people, mainly in their 60’s9). The median age at diagnosis has been reported to be 6410).

The combination of rituximab and chemotherapy is the standard therapy for untreated DLBCL; however, recurrence has been observed in about 40% of patients due to insufficient therapeutic effect11). In addition, although autologous stem cell transplantation (ASCT) is recommended for eligible patients with recurrent or refractory DLBCL, ASCT cannot be performed in about half of these patients due to failure of salvage chemotherapy prior to ASCT12). Furthermore, no standard therapy has been established for patients ineligible for ASCT due to reasons including age or complications13). Therefore, more useful new treatment options for relapsed or refractory DLBCL are in great need.

Salvage chemotherapy: Salvage chemotherapy or salvage therapy is used to treat patients with hematologic malignancy who experienced no therapeutic effects (refractory), or recurrence/relapse of the disease. Applicable treatment may vary depending on the type of cancer. Combination therapies of multiple drugs including anticancer agents14) are generally used.

Trademarks used or mentioned in this release are protected by law.

On March 23, 2021 Seneca Biopharma, Inc. (Nasdaq: SNCA), a biopharmaceutical company focused on developing novel treatments for diseases of high unmet medical need, reported its financial results for the year ended December 31, 2020 (Press release, Neuralstem, MAR 23, 2021, View Source [SID1234577029]).

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Business Highlights for 2020 to date.

During 2020, the Company achieved the following business milestones:

Entered into a definitive Merger Agreement with Leading BioSciences, Inc. (LBS), a privately held company focused on developing novel therapeutics to improve human health through therapeutic protection of the gastrointestinal mucosal barrier.
Completed offerings resulting in net proceeds of over $14.7 million.
Continued progress on the Company’s out-licensing effort to partner NSI-566 and reached an agreement to license NSI-189.
Announced the completion of the last subject’s follow-up assessment in the Company’s non-GCP Phase II trial evaluating NSI-566, for the treatment of chronic ischemic stroke.
Financial Results for the Year Ended December 31, 2020

Cash Position and Liquidity: At December 31, 2020, cash was approximately $10.5 million as compared to approximately $5.1 million at December 31, 2019.

Operating Loss: Operating loss for the year ended December 30, 2020 was $10.7 million compared to a loss of $8.6 million for the comparable 2019 period. The increase in operating loss for 2020 was due to an increase in G&A expenses which reflects an enhanced management structure to support corporate objectives as well as professional fees in connection with the proposed merger, when compared to the same period of 2019.

Net Loss: Net loss for the year ended December 31, 2020 was $16.3 million, or $1.17 per share, compared to a loss of $8.4 million, or $3.80 per share on a post-reverse stock-split basis, for the same period in 2019. The 2020 increase in net loss was primarily attributed to an increase in G&A, as noted above, and a non-cash expense of $5.6 million related to the January 2020 warrant inducement offering.

On March 23, 2021 Universal Diagnostics (UDX), an in-vitro diagnostics company developing minimally-invasive, blood-based solutions for detecting cancer early, reported that it has started a prospective, multi-center observational study in the US for its investigational advanced adenoma (precursor lesions) and colorectal cancer (CRC) detection blood test (Press release, Universal Diagnostics, MAR 23, 2021, View Source [SID1234577045]). UDX is performing this study to evaluate the performance of a preliminary panel of biomarkers for detecting colorectal cancer and advanced adenomas in the US population and to provide supporting data for the development of the final assay.

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The study, called USOPTIVAL, has been designed to collect blood samples and clinical data from 1,100 subjects, aged 45-84, who have a suspected advanced adenoma or have newly diagnosed with CRC scheduled for resection surgery. A second cohort of subjects who are at average-risk of CRC and are scheduled for routine colonoscopy examination will also be included. This prospective study will be performed at approximately 17 clinical sites. Further details about USOPTIVAL can be found here.

"The start of USOPTIVAL is our first in the US, so is an important milestone in the development of our blood test for adenomas and early-stage colorectal cancer. In addition, the study will enable us to build our clinical/medical network in preparation of our pivotal clinical study later," said Juan Martínez-Barea, Co-Founder and President of Universal Diagnostics. "USOPTIVAL is scheduled to be completed by the end of 2021, enabling us to conduct the pivotal study of our CRC/AA test."

About the Colorectal Cancer and Advanced Adenoma Test

UDX’s first product is a simple, non-invasive and accurate blood-based screening test that allows early-stage colorectal cancer detection and cancer prevention through advanced adenoma detection. Using profiling of DNA methylation changes in large number of tissue and plasma samples using next-generation sequencing (NGS) approach, UDX has identified and quantified a proprietary panel of biomarkers that has been combined into targeted assays that have shown 77% sensitivity for colorectal cancer, 62.5% sensitivity of adenomas and 88-90% specificity and tissue of origin accuracy across different verification studies.