Bristol-Myers Squibb to Announce Results for Third Quarter 2019 on October 31, 2019

On September 12, 2019 Bristol-Myers Squibb Company (NYSE:BMY) reported that it will announce results for the third quarter of 2019 on Thursday, October 31, 2019 (Press release, Bristol-Myers Squibb, SEP 12, 2019, View Source [SID1234539464]). During a conference call at 8:30 a.m. ET on October 31, company executives will review financial information and will address inquiries from investors and analysts.

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Investors and the general public are invited to listen to a live webcast of the call at View Source or by dialing in the U.S. toll free 800-458-4212 or international 786-789-4772, confirmation code: 532230. Materials related to the call will be available at the same website prior to the conference call. A replay of the call will be available beginning at 11:45 a.m. ET on October 31 through 11:45 a.m. ET on November 4, 2019. The replay will also be available through View Source or by dialing in the U.S. toll free 888-203-1112 or international 719-457-0820, confirmation code: 532230.

Medicenna to Present Latest Data from the MDNA55 Clinical Trial in Recurrent Glioblastoma at the Targeting Innate Immunity Congress

On September 12, 2019 Medicenna Therapeutics Corp. ("Medicenna" or "the Company") (TSX: MDNA,OTCQB: MDNAF), a clinical stage immuno-oncology company, reported that it will present updated clinical results from the Phase 2b clinical trial of MDNA55 for the treatment of recurrent glioblastoma (rGBM) at the Inaugural Targeting Innate Immunity Congress to be held on September 24 and 25, 2019 in Cambridge, MA (Press release, Medicenna Therapeutics, SEP 12, 2019, View Source [SID1234539480]).

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The presentation will discuss recent clinical data on survival outcomes and therapeutic benefit from MDNA55 in rGBM patients, a uniformly fatal type of brain cancer. Medicenna’s lead candidate, MDNA55, simultaneously targets the interleukin-4 receptor (IL-4R), which is over-expressed by tumor cells and its supportive tumor microenvironment (TME) which hides the tumor from the immune system.

The details of the podium presentation are as follows:

Title:

Tipping the balance towards success in a Phase 2b recurrent GBM Trial: Overcoming the
tumor and its microenvironment by targeting the IL4R using MDNA55

Presenter:

Dr. Fahar Merchant, PhD

Date/Time:

Wednesday, September 25, 2019 at 10:00 am

Location:

Hyatt Regency Cambridge, 575 Memorial Drive, Cambridge, MA 02139

Crescendo Biologics to collaborate with world-leading oncology groups at the University of Oxford and the University of Surrey

On September 12, 2019 Crescendo Biologics Ltd (Crescendo), the drug developer of novel, targeted T cell enhancing therapeutics, reported that it has signed collaborations with worldrenowned oncology research groups at the University of Oxford and the University of Surrey (Press release, Crescendo Biologics, SEP 12, 2019, View Source [SID1234539465]). These collaborations will accelerate the development of CB307, Crescendo’s lead programme for PSMA positive tumours, and its follow-on pipeline of CD137-directed T cell enhancing programmes.

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The Department of Oncology at the University of Oxford is one of the world’s leading cancer research centres. Dr Kerry Fisher’s group within this department, focuses on deepening our understanding of the tumour microenvironment to develop innovative new therapies for cancer patients.

Professor Hardev Pandha is a clinician scientist and a medical oncologist at the University of Surrey. He is head of the University’s Targeted Cancer Therapy research group, Director of the Surrey Cancer Research Institute and an expert in the management of patients with urological cancers. Professor Pandha leads a highly respected team with key interests in early phase clinical trials with targeted agents and novel therapies in translational settings.

Theodora Harold, CEO of Crescendo Biologics, commented:

Professor Pandha and Dr Fisher each head up world-leading groups-it is a credit to the quality of our science to be able to collaborate with them. Their multidisciplinary and collaborative approaches to oncology research will allow Crescendo to gain a greater understanding of these difficult to treat cancers and support us to deliver first in class, targeted T cell therapies."

Dr Kerry Fisher, Department of Oncology, University of Oxford, commented: "We look forward to working with Crescendo to further explore and understand the mechanisms driving the development of cancers and applying our group’s translational expertise to advance Crescendo’s novel Humabody programmes."

Professor Hardev Pandha, University of Surrey, added:

"We are delighted to be exploring the potential of Crescendo’s novel, targeted, T cell co-stimulatory molecules to deliver therapeutic benefit to patients with high unmet medical need."

Tocagen Reports Results of Toca 5 Phase 3 Trial in Recurrent Brain Cancer

On September 12, 2019 Tocagen Inc. (Nasdaq: TOCA), a clinical-stage, cancer-selective gene therapy company, reported that the Toca 5 Phase 3, randomized, multi-center clinical trial evaluating Toca 511 & Toca FC in patients with recurrent high grade glioma (HGG) undergoing resection missed the primary endpoint of overall survival compared to standard of care treatment (11.1 months median compared to 12.2 months, HR=1.06, p=0.6154) (Press release, Tocagen, SEP 12, 2019, View Source [SID1234539481]). In addition, all secondary endpoints showed no meaningful difference between the arms of the trial. The safety, tolerability and adverse event profile of Toca 511 & Toca FC was as expected for this patient population.

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Further analysis of the Toca 5 trial data is currently underway and presentation of the results is planned at an upcoming medical conference.

"Recurrent brain cancer represents a very high unmet medical need and patients with this disease have very few treatment options," said Marty Duvall, chief executive officer of Tocagen. "While the Toca 5 trial results are disappointing, we will be conducting a thorough analysis of the data including molecular analyses and pre-planned subgroups. In addition, we will be conducting an operational review. We sincerely appreciate the exceptional support from patients and their families as well as patient advocates, physicians and our employees who have been committed to the rigorous study of Toca 511 & Toca FC in the Toca 5 trial."

Conference Call and Webcast
Tocagen will host a conference call today, September 12, at 8:30 a.m. Eastern (5:30 a.m. Pacific) to discuss the Toca 5 clinical trial. The live call may be accessed by dialing 1-877-270-2148 for domestic callers or 1-412-902-6510 for international callers. A live webcast of the conference call will be available online from the Investors section of Tocagen’s website at www.tocagen.com. The webcast will be archived on Tocagen’s website for 60 days.

About Toca 511 & Toca FC
Tocagen’s lead product candidate is a two-part cancer-selective immunotherapy comprising an investigational biologic, Toca 511, and an investigational small molecule, Toca FC. Toca 511 is a retroviral replicating vector (RRV) that selectively infects cancer cells and delivers a gene for the enzyme, cytosine deaminase (CD). Through this targeted delivery, only infected cancer cells carry the CD gene and produce CD. Toca FC is an orally administered prodrug, 5-fluorocytosine (5-FC), which is converted into an anti-cancer drug, 5-fluorouracil (5-FU), when it encounters CD. 5-FU kills cancer cells and immune-suppressive myeloid cells resulting in anti-cancer immune activation and subsequent tumor killing.

More information about the Toca 5 trial can be found on ClinicalTrials.gov using the clinical trial identifier NCT02414165. The Toca 5 trial was funded in part by a grant awarded by the FDA Office of Orphan Products (FD-R-5732).

Cotinga Pharmaceuticals Reports Fiscal 2019 Fourth Quarter and Full Year Financial and Operating Results

On April 5, 2019 Cotinga Pharmaceuticals Inc. (TSX Venture: COT; OTCQB: COTQF) ("Cotinga" or the "Company"), a clinical-stage pharmaceutical company advancing a pipeline of targeted therapies for the treatment of cancer, reported its financial and operating results today for the three and nine months ended January 31, 2019 (Press release, Cotinga, SEP 12, 2019, View Source [SID1234550033]). Recent highlights include:

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Advanced the clinical development of COTI-2:

Cotinga announced the initiation of dosing patients in the combination therapy trial at MD Anderson Cancer Center evaluating COTI-2 and cisplatin in a wide spectrum of cancers;
The Company announced that it has entered into a research partnership with St. Vincent’s University Hospital in Dublin, Ireland with the intent to evaluate COTI-2 in combination with eribulin in patients with triple negative metastatic breast cancer (TNBC).
"We were thrilled to announce this fiscal quarter the dosing of patients in our Phase 1b/2a trial at MD Anderson of COTI-2 plus cisplatin in patients with solid tumors, as well as announce our collaboration with St. Vincent’s Hospital to begin work in TNBC," said Alison Silva, President & Chief Executive Officer. "We look forward to continuing to provide updates at critical milestones as we advance COTI-2 through clinical development."

Upcoming Milestones

COTI-2:

Continue the dose escalation Phase 1b/2a combination therapy trial evaluating the effect of COTI-2 plus cisplatin in patients with solid tumors;
Contingent on the raising of necessary funds, initiate the TNBC trial with COTI-2 plus eribulin.
Corporate:

Strengthen the balance sheet;
Opportunistically pursue regional or co-development partnerships for COTI-2, pipeline programs and other technologies.
Financial Results

The Company’s operational activities during the quarter were primarily focused on advancing the Phase 1b/2a clinical trial of COTI-2.

For the three months ended January 31, 2019, the Company incurred a net loss of $0.280 million, or $0.01 per share, compared to a net loss of $1.278 million, or $0.08 per share, for the three months ended January 31, 2018. The decrease in net loss during the three-month period is primarily due to decreases in Research and Development (R&D) expense and General and Administrative (G&A) expense.

For the nine months ended January 31, 2019, the Company incurred a net loss of $1.756 million, or $0.08 per share, compared to a net loss of $3.301 million, or $0.21 per share, for the nine months ended January 31, 2018. The decrease in net loss during the period is primarily due to decreases in R&D, Sales and Marketing (S&M) expense and G&A expense, offset by changes in fair value warrant liability.

There was no revenue for the three and nine months ended January 31, 2019 or in the comparative periods in the prior year.

R&D expense in the three-month period ended January 31, 2019 decreased by $0.424 million over the same period in the prior year. The decrease in R&D expense in the three-month period is primarily due to a decrease in salaries and benefits due to lower headcount and preclinical testing as Cotinga continues to work to initiate an expanded protocol for its ongoing Phase 1b/2 clinical trial of COTI-2. For the nine months ended January 31, 2019, R&D expense decreased by $1.568 million over the same period in the year prior.

S&M expense in the three-month period ended January 31, 2019 decreased by $0.063 million over the same period in the year prior. The decrease in S&M expense in the three-month period is primarily due to rebranding undertaken during the three months ended January 31, 2018. For the nine months ended January 31, 2019, S&M expense decreased by $0.085 million over the same period in the prior year due to cost reductions implemented last financial year and rebranding undertaken during the Q3 2018.

G&A expense in the three-month period ended January 31, 2019 decreased by $0.496 million over the same period in the year prior. The decrease in G&A expense in the three-month period is primarily due to a decrease in salaries due to lower head count; streamlining of corporate operations and lower professional fees and share-based compensation. For the nine months ended January 31, 2019, G&A expense decreased by $1.174 million over the same period in the prior year.

Fair value of warrant liability for the nine months ended January 31, 2019, decreased by $1.389 million over the same period in the year prior.

Detailed operating and financial results can be found in the Company’s Unaudited Condensed Interim Financial Statements and Management Discussion and Analysis for the three and nine months ended January 31, 2019, which can be found on SEDAR at www.sedar.com or on the Company’s website at www.cotingapharma.com.