On August 28, 2020 NRG Oncology reported that A practice-changing study, NRG Oncology clinical trial NRG-RTOG 9802, has demonstrated, for the first time, a survival benefit of adjuvant chemotherapy following radiotherapy over radiotherapy alone in certain subgroups of patients with high-risk, low-grade glioma (WHO classification: LGG, grade II), a type of brain tumor that originates from glial cells (Press release, NRG Oncology, AUG 28, 2020, https://www.nrgoncology.org/Home/News/Post/comprehensive-genomic-analysis-in-NRG-Oncology-RTOG-9802 [SID1234564209]).

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The study results, published in a recent issue of the Journal of Clinical Oncology, sought to determine the prognostic and predictive impact of WHO-defined molecular subgroups and corresponding molecular alterations, known as IDH1/2 mutations, in people with the disease. LGG patients display highly variable survival outcomes depending on which molecular subgroup they are in. These subgroups are: IDH-wild type, IDH-mutant/1p19q non-codeleted, and IDH-mutant/1p19q codeleted. Genetic mutations were determined by testing patients’ tissue samples through immunohistochemistry and/or deep sequencing.

A total of 116 of 251(46%) enrolled "high-risk" patients with LGG from the two treatment arms had adequate tissues available for genomic analyses using multiple platforms. After neuropathology review, representative areas (70% tumor) were selected for DNA isolation. Of the eligible patients successfully profiled for the WHO-defined molecular groups, 26 of them (24%) were IDH-wild type, 43 (41%) were IDH-mutant/non-codeleted, and 37 (35%) were IDH-mutant/codeleted. Treatment with postradiation chemotherapy (PCV; procarbazine, lomustine (CCNU), and vincristine) was associated with longer progression-free survival (HR, 0.32; P =.003; HR, 0.13; P < .001) and overall survival (HR, 0.38; P = .013; HR, 0.21; P = .029) in the IDH-mutant/non-codeleted and IDH-mutant/codeleted subgroups, respectively. In contrast, no significant difference in either progression-free survival or overall survival was observed with the addition of PCV in the IDH-wild-type subgroup.

"Our study is the first to our knowledge to demonstrate the predictive value of the WHO-defined molecular subgroups in a practice-changing phase III clinical trial of high-risk grade II glioma in correlation to overall survival with long-term follow-up data," said the study’s lead author Arnab Chakravarti, MD, professor and chair of the Department of Radiation Oncology at The Ohio State University Comprehensive Cancer Center, the Klotz Family Chair of Cancer Research, and Director of the Brain Tumor Program. "Our evidence suggests that IDH mutation status could serve as the primary predictor of response to PCV in addition to radiotherapy in high-risk LGGs and is a more accurate predictor of response than historical histopathological classifications."

Importantly, the analysis supports the notion that patients with IDH-mutant high risk LGG, regardless of codeletion status, receive benefit from the addition of PCV. "This study can now help clinicians interpret the results within the context of the altered molecular landscape and serve as a basis for survival times for the design of future high-risk LGG clinical trials," added Dr. Chakravarti.

NRG-RTOG 9802 was supported by National Cancer Institute (NCI) Grants No. U10CA21661, U10CA180868, U10CA180822, UG1CA189867, and U10CA37422 (NRG Oncology/RTOG); NCI Grant No. P30 CA016058; NCI Grants No.R01CA108633, R01CA169368, RC2CA148190, and U10CA180850-01 (A.C.); a Brain Tumor Funders Collaborative Grant (A.C.); The Ohio State University Comprehensive Cancer Center (A.C.); and Cancer Therapy Evaluation Program of the NCI Grant No. NRG-BN-TS002 (A.C.and E.H.B.).

On August 28, 2020 CohBar, Inc. (NASDAQ: CWBR) (the "Company"), a clinical stage biotechnology company developing mitochondria based therapeutics to treat chronic diseases and extend healthy lifespan, reported the closing of its previously announced underwritten public offering of 12,300,000 units at a price to the public of $1.22 per unit (Press release, CohBar, AUG 28, 2020, View Source [SID1234564156]). Each unit consists of one share of the Company’s common stock and one warrant to purchase 0.75 of a share of common stock at a per share exercise price of $1.44. In addition, the underwriters partially exercised the over-allotment option for warrants to purchase an additional 1,383,750 shares. The warrants are exercisable for five years from the closing date of the offering. The aggregate gross proceeds from this offering were approximately $15.0 million, before deducting underwriting discounts and commissions and estimated offering expenses.

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Roth Capital Partners acted as sole book-running manager for the offering and Brookline Capital Markets, a division of Arcadia Securities, LLC, and WBB Securities acted as co-managers.

The securities were issued pursuant to an effective shelf registration statement filed with the Securities and Exchange Commission (SEC) on November 22, 2017. A final prospectus supplement and accompanying prospectus relating to the offering were filed with the SEC and are available on the SEC’s website at www.sec.gov. Copies of the prospectus supplement, together with the accompanying prospectus, can be obtained at the SEC’s website at www.sec.gov or from Roth Capital Partners, 888 San Clemente, Newport Beach, CA 92660, Attn: Prospectus Department, telephone: 800-678-9147.

This press release does not and shall not constitute an offer to sell or the solicitation of an offer to buy any securities, 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 registration or qualification under the securities laws of any such state or other jurisdiction.

On August 28, 2020 University of Illinois Chicago reported that a new type of breast cancer drug developed by researchers can help halt progression of disease and is not toxic, according to phase 1 clinical trials (Press release, University of Illinois , AUG 28, 2020, View Source [SID1234564152]). The drug is specifically designed for women whose cancer has stopped responding to hormone therapy.

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The results are published in the journal Breast Cancer Research and Treatment.

Breast cancer affects one in eight women in the United States, and while there are many types of breast cancer, around 80% are categorized as estrogen receptor-positive, or ER-positive. This means the cancer cells have receptors—molecules that can receive signals from chemicals in the body—that are sensitive to and react to the hormone estrogen.

In the case of ER-positive breast cancer, this means that estrogen fuels cancer growth. To treat this type of breast cancer, doctors prescribe medication to block hormone production in the body or interfere with the effect hormones have on cancer cells. This type of treatment is called hormone therapy. However, nearly half of women treated with hormone therapy become resistant, leaving traditional chemotherapy and its side effects as the only option for treatment.

"While there are many treatments for breast cancer, about half of women with ER-positive cancers become resistant to hormone therapy, leaving them with few treatments other than chemotherapy, with its well-known toxic side effects," said Debra Tonetti, professor of pharmacology at the UIC College of Pharmacy and an author on the paper.

Tonetti, together with Gregory Thatcher, the Hans W. Vahlteich Chair of medicinal chemistry at UIC and co-author on the paper, developed the new drug, called TTC-352. Preclinical studies showed that TTC-352, which is a selective human estrogen receptor partial agonist, causes complete tumor regression, but unlike tamoxifen, may pose a reduced risk of uterine cancer development.

In the phase 1 clinical trial, 15 women who had metastatic breast cancer and previously were treated with several rounds of hormone therapy and, in some cases, chemotherapy including a CDK4/6 inhibitor, were enrolled. The researchers found that there were no toxic side effects, even at the highest doses.

In total, six patients experienced stable disease with a lack of disease progression: two for 6 months and four for 3 months.

"This is very encouraging because these participants were at an advanced stage of their disease, and we saw that their cancers stopped growing for a significant amount of time," said Tonetti, who is also a member of the University of Illinois Cancer Center.

The doses given to participants were in line with what the researchers believe are therapeutic levels—in other words, participants received doses equivalent with what patients would be given to treat their disease.

"The results of the phase 1 trial indicate that TTC-352 is a safe and tolerable alternative to chemotherapy—therefore, without the side effects of chemotherapy—for patients who have already been treated with hormone therapy," Thatcher said.

On August 28, 2020 The TARGIT Collaborative Group (TCG) reported that publication of the long-term results of the Targeted Intraoperative Radiotherapy Trial (TARGIT-A Trial) comparing partial breast single fraction targeted intraoperative radiotherapy (TARGIT-IORT) to 3-6 week post-operative whole breast radiotherapy, demonstrating equivalent long-term outcomes between the two treatments (Press release, TARGIT Collaborative Group, AUG 28, 2020, View Source [SID1234564150]). The results of the trial were published on August 19, 2020 in the British Medical Journal (www.bmj.com/content/370/bmj.m2836).

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The TARGIT-A Trial was a 2,298-patient multicenter, international, randomized controlled trial evaluating the use of TARGIT-IORT using the Intrabeam System (Carl Zeiss Meditec, Inc.) as a method of delivering IORT. TARGIT-IORT is typically administered in less than 30 minutes at the time of lumpectomy. TARGIT-IORT is the only method of delivering IORT widely available in the U.S. for which effectiveness has been proven in a randomized control trial.

Dr. Valery Uhl, Radiation Oncologist and President of the TCG, stated: "We now have long-term proof that TARGIT-IORT is not only an effective—but in many ways superior—treatment for early-stage breast cancer. Every hospital where breast cancer surgery is performed should offer this form of radiation treatment to their breast cancer patients. Not only are long-term local control and cancer survival outcomes similar to whole breast radiotherapy, but mortality from other causes was lower in the IORT arm. TARGIT-IORT should be considered the new standard of treatment for early-stage breast cancer based on this large, multi-institutional, prospective, randomized controlled trial."

The TARGIT-A trial is largely responsible for the widespread adoption of IORT as a treatment option for early-stage breast cancer in the U.S. IORT is now covered by Medicare and most health plans. According to Breast Surgeon, Dr. Dennis Holmes, a TCG Founder and TARGIT-A Trial publication co-author, "in addition to being efficacious, separate publications have shown TARGIT-IORT to be associated with fewer side effects, improved quality of life, and reduced healthcare cost compared to whole breast radiotherapy."

Dr. Barry Rosen, Breast Surgeon and Secretary/Treasurer of TCG noted: "TARGIT-IORT is a safe, convenient, cost-effective alternative to WBRT that has virtually no side-effects and better cosmetic outcomes by virtue of its targeted therapy. I believe this establishes a new standard for patient-centered, precision oncology and should be offered to all breast cancer patients that meet eligibility requirements. Furthermore, the lower non-cancer mortality rates associated with IORT warrants further study."

On August 28, 2020 Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, reported financial results for the quarter ended June 30, 2020 (Press release, Legend Biotech, AUG 28, 2020, View Source [SID1234564149]).

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"Legend Biotech continues to execute on our corporate strategy, advancing the development of our lead product candidate, ciltacabtagene autoleucel (cilta-cel), in collaboration with Janssen Biotech, Inc. as well as our other pipeline programs," said Frank Zhang, Ph.D., Chief Executive Officer and Chairman of the Board of Legend Biotech. "We look forward to presenting data from the CARTITUDE-1 study at a major medical conference in the second half of 2020."

Second Quarter 2020 & Recent Highlights

Collaborative Research and License Agreement with Noile-Immune Biotech. On April 27, 2020, Legend Biotech entered into a collaborative research and license agreement with Noile-Immune Biotech Inc. pursuant to which Legend Biotech obtained a license to develop and commercialize next-generation CAR-T and/or TCR-T cell therapies incorporating Noile-Immune’s PRIME (proliferation-inducing and migration-enhancing) technology for up to two targets for all indications.
Updated Results from Janssen sponsored Phase 1b/2 CARTITUDE-1 study. On May 13, 2020, Legend Biotech announced positive follow up data (median of 11.5 months) from the Phase 1b portion of the CARTITUDE-1 study evaluating cilta-cel1 (JNJ-4528) in heavily pretreated patients with relapsed or refractory multiple myeloma (RRMM).
Appointment of Three New Directors. In May 2020, Dr. Corazon (Corsee) Dating Sanders, Dr. Darren Ji, and Mr. Philip Yau joined Legend Biotech’s Board of Directors.
Successful Initial Public Offering. On June 9, 2020, Legend Biotech successfully completed its initial public offering for total gross proceeds of approximately $487.3 million.
Appointment of Dr. Frank Zhang as CEO. On August 1, 2020, the Board of Directors of Legend Biotech appointed Dr. Frank Zhang to serve as Chief Executive Officer, succeeding Dr. Yuan Xu upon her resignation.
First Breakthrough Therapy Designation from China CDE. On August 5, 2020, Legend Biotech announced that the China Center for Drug Evaluation ("CDE"), National Medical Products Administration recommended Breakthrough Therapy Designation ("BTD") for cilta-cel for the treatment of adults with relapsed/refractory multiple myeloma. The designation was granted on August 13, 2020, making cilta-cel the first investigational product to obtain BTD in China.
Key Upcoming Milestones

Legend Biotech, in collaboration with Janssen Biotech, Inc., anticipates the presentation of data from the CARTITUDE-1 study at a major medical conference in the second half of 2020.
Janssen Biotech, Inc., Legend Biotech’s collaboration partner, expects to initiate the BLA filing for cilta-cel to the U.S. FDA by the end of 2020 and also expects that a marketing authorization application will be submitted to the European Medicines Agency ("EMA") in early 2021.
Legend Biotech expects to use the data from CARTIFAN-1 in support of a regulatory submission for approval in China in 2021.
Legend Biotech intends to submit an IND application for LB1901 in relapsed or refractory T cell Lymphoma ("TCL") in the second half of 2020.
The extent to which the COVID-19 may impact our business and clinical trials is highly uncertain and cannot be predicted with confidence, such as the ultimate geographic spread of the disease, the duration of the outbreak and social distancing regulations, travel restrictions, business closures or business disruptions and the effectiveness of actions taken in the United States and other countries to contain and treat the disease.

Financial Results for the Quarter Ended June 30, 2020

Cash and Cash Equivalents:

As of June 30, 2020, Legend Biotech had approximately $562.4 million of cash and cash equivalents and approximately $75.6 million in time deposits.

Revenue

Revenue for the three months ended June 30, 2020 was $11.6 million compared to $10.1 million for the three months ended June 30, 2019. This increase of $1.5 million was primarily due to additional milestone payments from Janssen Biotech, Inc. that were achieved in late 2019, which resulted in additional consideration being allocated to steering committee service for the three month ended June 30, 2020. Revenue for the three months ended June 30, 2020 and June 30, 2019 consisted of recognition of upfront and milestone payments allocated to steering committee service pursuant to the license and collaboration agreement with Janssen Biotech, Inc. Legend Biotech has not generated any revenue from product sales to date.

Research and Development Expenses

Research and development expenses for the three months ended June 30, 2020 were $53.6 million compared to $32.6 million for the three months ended June 30, 2019. This increase of $21.0 million was primarily due to a higher number of clinical trials, a higher number of patients enrolled in those trials and a higher number of research and development product candidates in the three months ended June 30, 2020.

Administrative Expenses

Administrative expenses for the three months ended June 30, 2020 were $4.5 million compared to $1.6 million for the three months ended June 30, 2019. This increase of $2.9 million was primarily due to Legend Biotech’s expansion of supporting administrative functions to aid continued research and development activities.

Selling and Distribution Expenses

Selling and distribution expenses for the three months ended June 30, 2020 were $9.6 million compared to $5.0 million for the three months ended June 30, 2019. This increase of $4.6 million was primarily due to increased costs associated with commercial preparation activities for cilta-cel.

Other Income and Gains

Other income and gains for the three months ended June 30, 2020 was $1.3 million compared to $1.2 million for the three months ended June 30, 2019.

Fair Value Loss of Convertible Redeemable Preferred Shares

For the three months ended June 30, 2020, Legend Biotech reported a one-time non-cash charge of $80.0 million caused by changes of fair value of Series A convertible redeemable preferred shares (Series A Preferred Shares). Upon listing on the Nasdaq Global Market, all outstanding Series A Preferred Shares were converted into ordinary shares of Legend Biotech and all accrued but unpaid dividends were settled in the form of ordinary shares of Legend Biotech.

Loss for the Period

For the three months ended June 30, 2020, net loss was $134.9 million, or $0.63 per share, compared to a net loss of $28.8 million, or $0.14 per share, for the three months ended June 30, 2019.