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Tocagen to Present Preclinical Data on Anti-PD-L1 Product Candidate Toca 521 at the 2018 Annual Meeting of The American Society of Gene & Cell Therapy (ASGCT)

On May 14, 2018 Tocagen Inc. (Nasdaq: TOCA), a clinical-stage, cancer-selective gene therapy company, reported preclinical data on Toca 521, a retroviral replicating vector (RRV) expressing a single-chain variable fragment targeting PD-L1, will be presented at the 2018 Annual Meeting of The American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper), held May 16-19 in Chicago (Press release, Tocagen, MAY 14, 2018, View Source;p=RssLanding&cat=news&id=2348847 [SID1234526566]).

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In a preclinical study, Toca 521 reversed PD-1/PD-L1 mediated immune suppression, resulting in robust, durable and highly selective anti-tumor activity that was superior to systemically administered anti-PD-1 or anti-PD-L1 monoclonal antibodies. Tocagen expects to advance Toca 521 into investigational new drug application (IND) enabling studies this year.

In addition, previously disclosed clinical data and new preclinical results from an ovarian cancer model will be presented.

Summaries are provided below for new data sets, for which full posters will be placed on Tocagen’s website following the presentation.

Presentation Type: Poster (Abstract: 111)
Title: PD-L1 Checkpoint Blockade Using a Single-Chain Variable Fragment Targeting PD-L1 Delivered by Retroviral Replicating Vector Enhances Anti-Tumor Effect in Cancer Models
Presenter: Amy Lin, Ph.D., associate director of experimental virology at Tocagen
Date and Time: Wednesday, May 16, 5:30 p.m. CT
Summary:

A RRV expressing a single-chain variable fragment targeting PD-L1, called Toca 521, was developed using Tocagen’s proprietary cancer-selective gene therapy platform technology.
Preclinical results demonstrated Toca 521 reversed PD-1/PD-L1 mediated immune suppression in a human in vitro cell culture system, and conferred robust, durable and highly selective anti-tumor activity compared to systemically administered anti-PD-1 or anti-PD-L1 monoclonal antibodies.
These results indicate further development of Toca 521 is warranted to investigate the potential for improved safety and efficacy profiles compared to systemic monoclonal antibodies against the same checkpoint target. Toca 521 could also be useful in combination with other agents, including immuno-oncology therapies.
Presentation Type: Oral presentation (Abstract: 344)
Title: Treatment of Recurrent HGG Patients with the Retroviral Replicating Vector Toca 511 and Toca FC Resulted in Durable Responses and Survival Lasting 3 Years or Longer: Immune Mechanisms and Molecular Analyses of Tumors
Presenter: Douglas Jolly, Ph.D., executive vice president of research and pharmaceutical development at Tocagen
Date and Time: Thursday, May 17, 9:20-9:40 a.m. CT

Presentation Type: Poster (Abstract: 428)
Title: Toca 511-Mediated Prodrug Activator Gene Therapy: A Promising Therapeutic Strategy for Ovarian Cancer
Presenter: Sara Collins, Ph.D., assistant scientist in the department of cell biology at the University of Miami Miller School of Medicine. These studies were performed in the laboratory of Noriyuki Kasahara, M.D., Ph.D., professor of cell biology and pathology at the University of Miami.
Date and Time: Thursday, May 17, 5:15 p.m. CT
Summary:

Preclinical studies evaluating Toca 511 and 5-FC in a mouse model of ovarian cancer were conducted.
Increased survival and reduced tumor burden was observed in mice with pre-existing tumors receiving Toca 511 followed by 5-FC, as compared to untreated controls.
About Toca 511 & Toca FC

Tocagen’s lead product candidate is a two-part cancer-selective immunotherapy comprised of an investigational biologic, Toca 511 and an investigational small molecule, Toca FC. Toca 511 (vocimagene amiretrorepvec) 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, infected cancer cells carry the CD gene and produce CD. Toca FC is an orally administered, extended-release formulation of the 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 in the tumor microenvironment resulting in anti-cancer immune activation and subsequent tumor killing.

Mateon Therapeutics Reports First Quarter 2018 Financial Results

On May 14, 2018 Mateon Therapeutics, Inc. (OTCQX:MATN), a biopharmaceutical company developing investigational drugs for the treatment of orphan oncology indications, reported first quarter 2018 financial results (Press release, Mateon Therapeutics, MAY 14, 2018, View Source [SID1234526565]).

For the three months ended March 31, 2018, Mateon reported a net loss of $0.8 million, a decrease of $3.2 million from the net loss of $4.0 million reported for the three months ended March 31, 2017. R&D expenses decreased to $0.2 million for the first three months of 2018 compared to $2.8 million for the same period in 2017, while general and administrative expenses decreased to $0.6 million for the first three months of 2018 compared to $1.1 million for the same period in 2017.

At March 31, 2018, Mateon had cash and cash equivalents of $0.2 million. In April 2018, Mateon raised net proceeds of approximately $2.4 million in a private placement financing transaction.

"During the first quarter of 2018 our efforts were focused on obtaining capital so that we could advance our product candidates," said William D. Schwieterman, M.D., Chief Executive Officer of Mateon Therapeutics. "After receiving the initial funds from our April financing transaction, we authorized our clinical investigators to resume screening new patients into our clinical study of OXi4503 in relapsed/refractory acute myeloid leukemia and myelodysplastic syndromes. Based on our encouraging preclinical data, we are also planning for a new clinical study of CA4P as an immuno-oncology agent in combination with Opdivo – initially evaluating the combination in advanced melanoma patients who have not responded to currently approved treatments."

Celgene Corporation to Webcast at Upcoming Investor Conferences and Events

On May 14, 2018 Celgene Corporation (NASDAQ: CELG) reported to present at four upcoming investor conferences and events where Celgene management will provide an overview of the Company (Press release, Celgene, MAY 14, 2018, View Source [SID1234526564]). The events will be webcast live and will be available in the Investor Relations section of the Company’s website at www.celgene.com.

Thursday, May 24, 2018, Celgene will host an R&D Deep Dive on Multiple Myeloma at 1:30pm ET

Wednesday, May 30, 2018, Celgene will present at the Sanford C. Bernstein Strategic Decisions Conference at 3:00 pm ET

Sunday, June 3, 2018, Celgene will host an Analyst & Investor Event at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting at 7:30 pm ET

Wednesday, June 6, 2018, Celgene will present at the Jefferies 2018 Global Healthcare Conference at 1:30 pm ET

Unum Therapeutics Reports First Quarter 2018 Financial Results and Provides Business Update

On May 14, 2018 Unum Therapeutics Inc. (NASDAQ: UMRX), a clinical-stage biopharmaceutical company focused on the development of cellular immunotherapies based on its novel, universal Antibody-Coupled T-cell Receptor (ACTR) technology platform, reported financial results and provided a corporate update for the first quarter ended March 31, 2018 and recent activities (Press release, Unum Therapeutics, MAY 14, 2018, View Source [SID1234526563]).

"Following our successful initial public offering in April 2018 and concurrent private placement, we are in a strong financial position to continue developing our proprietary, universal ACTR technology platform and rapidly advancing our pipeline of cellular immunotherapies through clinical development," said Chuck Wilson, CEO of Unum. "We are currently evaluating the potential of ACTR in combination with different tumor-targeting antibodies, in three ongoing multi-center Phase I trials, ATTCK-20-2 and ATTCK-20-03 evaluating ACTR087 and ACTR707, respectively, in combination with rituximab in patients with CD20+ r/r Non-Hodgkin Lymphoma (NHL), and ATTCK-17-01 evaluating ACTR087 in combination with SEA-BCMA in patients with r/r multiple myeloma. We expect to report preliminary data from these three trials late this year. In the second half of 2018 we also look forward to filing an IND and initiating clinical development of ACTR707 in combination with trastuzumab for the treatment of patients with HER2+ advanced cancers, our first solid tumor product candidate."

Recent Business Highlights and Outlook

Successfully Completed IPO and Concurrent Private Placement: In April, 2018, Unum successfully completed an initial public offering (IPO) of 5,985,000 shares of common stock at a public offering price of $12.00 per share, including the exercise by the underwriters of 215,000 shares of their overallotment option, raising $66.8 million in net proceeds. In addition, with a private placement concurrent with the IPO, Seattle Genetics, Inc. purchased $5.0 million shares of common stock at the initial public offering price. The proceeds from the IPO and the concurrent private placement will be used primarily to advance Unum’s four lead ACTR development candidates.

Initiated Cohort Expansion Phase of ATTCK-20-2 Phase I trial; Plans to Expand Clinical Development: In May 2018, Unum initiated the cohort expansion phase of the ATTCK-20-2 trial evaluating safety and anti-lymphoma activity of ACTR087 at the preliminary recommended phase 2 dose (RP2D) level used in combination with rituximab in patients with CD20+ r/r NHL. Unum expects to report updated data, including preliminary data from this phase of the ATTCK-20-2 trial, in the fourth quarter of 2018.

These data will also inform the strategy for a planned multi-center Phase II clinical trial exploring ACTR T cells used in combination with rituximab in patients with CD20+ r/r NHL who received prior CD19 CAR T cell therapy.

In addition, Unum intends to file a protocol amendment to the ATTCK-20-2 trial in the second half of 2018 to explore ACTR087 in combination with an alternative rituximab dosing regimen from that currently being studied. Preclinical experiments have shown that the level of ACTR T cell activity depends upon the amount of the co-administered antibody. As such, ACTR087 safety and anti-tumor activity in combination with rituximab in CD20+ r/r NHL may be even further optimized by an alternative rituximab regimen. Testing the alternative regimen will complement the clinical data being generated to support additional clinical trials with the combination.

Initiated Patient Enrollment and Dosing in ATTCK-17-01 Phase I trial: In the first quarter, Unum initiated patient enrollment ATTCK-17-01, a Phase I, multi-center, open-label clinical trial designed to test the safety, tolerability, and anti-myeloma activity of ACTR087 used in combination with SEA-BCMA in patients with r/r multiple myeloma. Unum is currently enrolling and dosing patients in this trial and expects to report preliminary data in the fourth quarter of 2018.

Continued Enrollment in ATTCK-20-03 Phase I trial: In the fourth quarter of 2017, Unum initiated patient enrollment in a Phase I, multi-center, open-label clinical trial called ATTCK-20-03, evaluating the safety, tolerability, and anti-lymphoma activity of ACTR707 used in combination with rituximab in patients with CD20+ r/r NHL. Unum has completed enrollment in the first dose level of this ongoing dose escalation study and expects to report preliminary data from the trial in the fourth quarter of 2018.

On Track to File IND for First Solid Tumor ACTR Product Candidate in the Second Half of 2018: Unum is on track to file an IND in the second half of 2018 for ACTR707 in combination with trastuzumab for the treatment of patients with HER2+ advanced cancers.
First Quarter 2018 Financial Results

Collaboration Revenue: Collaboration revenue recognized during the three months ended March 31, 2018 and 2017 of $2.2 million and $1.8 million, respectively, reflects the recognition of a portion of the $25.0 million upfront payment received from Seattle Genetics under Unum’s collaboration agreement as well as reimbursements of research and development costs by Seattle Genetics. Effective January 1, 2018, Unum adopted the new revenue recognition standard, ASC 606, which changed the manner in which the Company recognizes revenue from this collaboration agreement.

R&D Expenses: Research and development expenses were $8.1 million for the three months ended March 31, 2018, compared to $7.0 million for the same period last year. The increase reflects higher clinical trial costs for the three active Phase I clinical trials, as well as increased personnel-related costs, materials and facility-related costs related to scaling manufacturing processes, and increased consultant costs. This was partially offset primarily by a decrease in consulting and manufacturing costs incurred for the Phase I clinical trial of ACTR087 in combination with rituximab as there was no production activity in the first quarter of 2018.

G&A Expenses: General and administrative expenses for the three months ended March 31, 2018 were $1.1 million, compared to $0.9 million for the prior year period.

Net Loss: Net loss attributable to common stockholders was $6.8 million, or $0.66 per share, for the three months ended March 31, 2018, and $6.0 million, or $0.58 per share, for the three months ended March 31, 2017.

Cash, Cash Equivalents and Marketable Securities: As of March 31, 2018, Unum had cash, cash equivalents, and marketable securities of $32.4 million. This amount does not include the approximately $66.8 million in net proceeds from its IPO in April 2018, $5.0 million from the concurrent private placement, and available borrowings under its loan and security agreement of $15.0 million. The Company believes that the net proceeds from the IPO and concurrent private placement, together with its existing cash, cash equivalents, and marketable securities, will fund operating expenses and capital expenditure requirements through at least December 2019, without considering available borrowings under its loan and security agreement.

Intrexon to Participate in the Bank of America Merrill Lynch 2018 Healthcare Conference

On May 14, 2018 Intrexon Corporation (NYSE: XON), a leader in the engineering and industrialization of biology to improve the quality of life and health of the planet, reported Lt. General (Ret.) Thomas P. Bostick, PhD, PE, Dist.M. ASCE, NAE, Intrexon’s Chief Operating Officer, and Thomas E. Shrader, PhD, CFA, Vice President, Communications and Strategy, will participate in a fireside chat session at the Bank of America Merrill Lynch 2018 Healthcare Conference at Encore at the Wynn, Las Vegas, Nevada on Tuesday, May 15th, at 5:00 p.m. Pacific Time (Press release, Intrexon, MAY 14, 2018, View Source [SID1234526562]).