On August 15, 2018 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology (I-O) company with a pipeline of immune checkpoint antibodies, cancer vaccines and adoptive cell therapies1, reported that Merck, known as MSD outside the United States and Canada, initiated a Phase I clinical trial of an undisclosed antibody candidate discovered by Agenus, under the two companies license and research collaboration (Press release, Agenus, AUG 15, 2018, View Source [SID1234528898]). Based on this milestone and under the terms of the agreement, Agenus received a $4 million milestone payment and is entitled to receive up to an additional $95 million in success milestones from Merck.

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"We continue to deliver on all milestones with our existing partners." said Garo H. Armen, Ph.D., Chairman and CEO of Agenus. "This is yet another validation of our antibody discovery platform and expertise in the field and adds to our successes in delivering first in class discoveries to patients. Notably, besides this, we also have two other partnered programs advancing to the clinic this year, each triggering additional milestone payments to Agenus."

This milestone is the second under the collaboration, originally announced in April 2014. According to the terms of the agreement, Merck is responsible for all product development expenses for the antibody candidate, and Agenus is eligible to receive up to an additional $95 million in milestone payments, as well as royalties on worldwide product sales.

On August 15, 2018 Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, reported a favorable review of safety data from the second dose cohort of patients who received one billion transduced SPEAR T‑cells targeting MAGE-A4 in the ongoing basket study in nine solid tumor indications (Press release, Adaptimmune, AUG 15, 2018, View Source;p=RssLanding&cat=news&id=2363723 [SID1234528864]). Based on these data, the Safety Review Committee (SRC) has endorsed dose escalation to the third dose cohort of 1.2 to 6 billion cells.

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To date, three patients have received 100 million transduced MAGE‑A4 SPEAR T-cells in the first dose cohort, and three patients received one billion cells in the second cohort. No evidence of toxicity related to off-target binding or alloreactivity has been reported. Most adverse events were consistent with those typically experienced by cancer patients undergoing cytotoxic chemotherapy or other cancer immunotherapies.

"In Cohorts 1 and 2, we have observed cell expansion consistent with the doses administered. We are initiating dosing with 1.2 to 6 billion cells in the MAGE-A10 and MAGE-A4 studies. We have a number of patients whose cell products have been manufactured and these cells can be used when patients are ready for therapy. We remain on track to deliver initial data on response assessments from these cohorts during the second half of 2018," said Rafael Amado, Adaptimmune’s President of Research & Development.

Overview of Study Design MAGE-A4 Pilot Study

This is a first-in-human, open-label study utilizing a modified 3+3 design in up to 36 patients with escalating doses of 100 million (Cohort 1), 1 billion (Cohort 2), and 1.2‑6 billion (Cohort 3) transduced SPEAR T-cells to evaluate safety, including dose limiting toxicities (DLTs) followed by a possible expansion phase with doses of up to 10 billion SPEAR T-cells
This active trial is being evaluated across nine solid tumor indications including urothelial, melanoma, head and neck, ovarian, NSCLC, esophageal, and gastric cancers; as well as synovial sarcoma and myxoid/round cell liposarcoma (MRCLS)
Patients are screened under a separate protocol (Screening Protocol: NCT02636855) to identify those who have the relevant HLA-A*02 alleles and MAGE-A4 tumor expression
There was a 21-day stagger between patients in Cohort 1, with this stagger dropping to 7 days in Cohorts 2, and 3. There is no pre-determined stagger in the potential expansion phase
Cohorts 1-3 were intended to enroll 3 patients each with an expansion to 6 patients if DLTs were observed
The expansion phase can enroll up to 30 patients
The lymphodepletion regimen are:
Cohorts 1 and 2 – fludarabine (flu) (30mg/m2/day) and cyclophosphamide (cy) (600 mg/m2/day) for 3 days
Cohorts 3 and expansion phase – flu (30mg/m2/day) for 4 days and cy (600 mg/m2/day) for 3 days
Efficacy is assessed by overall response rate, time to response, duration of response, progression-free survival, and overall survival at weeks 4, 8, and 12, month 6, and then every 3 months until confirmation of disease progression
Adaptimmune’s Pipeline
Adaptimmune’s proprietary technology enables the Company to consistently generate affinity enhanced T-cell receptors (TCRs) that address intracellular targets on solid tumors that may not be accessible to certain other immunotherapy treatment modalities. Adaptimmune has three wholly owned SPEAR T‑cells in active clinical trials, with additional first and next generation SPEAR T‑cells being evaluated by means of Adaptimmune’s proprietary preclinical testing platform in advance of proceeding to the clinic.

Adaptimmune’s wholly owned SPEAR T-cells targeting MAGE‑A10, MAGE‑A4, and AFP are being evaluated in four active clinical trials across ten solid tumor indications:

MAGE-A10: Two active trials, one in NSCLC, and a triple tumor study in urothelial (bladder), melanoma, and head & neck cancers
MAGE-A4: One active trial across nine solid tumor indications including urothelial, melanoma, head and neck, ovarian, NSCLC, esophageal, and gastric cancers; as well as synovial sarcoma and myxoid/round cell liposarcoma (MRCLS)
AFP: One active study in hepatocellular (liver) cancer
Patients are receiving doses of 1.2-6 billion SPEAR T-cells across all the MAGE-A4 and MAGE‑A10 trials as there has been no evidence of off-target toxicity, to date, which has supported dose escalation

On August 14, 2018 GT Biopharma Inc. (OTCQB: GTBP) and (Euronext Paris: GTBP.PA), an immuno-oncology biotechnology company focused on innovative treatments based on the company’s proprietary platforms, reported the Chief Executive Officer, Dr. Raymond W. Urbanski, will present at the Wedbush PacGrow Healthcare Conference on Wednesday, August 15, at 1:50pm (Press release, GT Biopharma , AUG 14, 2018, View Source [SID1234539525]).

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Dr. Urbanski’s presentation will provide a corporate overview and highlight the company’s proprietary technology platforms. These innovative platforms include the tri- and tetra-specific natural killer cell engagers (TriKEs and TetraKEs) as well as their bi-specific antibody drug conjugates. In addition, Dr. Urbanski will provide an update to their current clinical and preclinical programs.

Dr. Urbanski said, "We are very excited to present at the Wedbush PacGrow Healthcare Conference. Conferences such as this gives us the opportunity to engage with leading institutional investors and interact with other global companies. It also allows us to further demonstrate that GT Biopharma is at the forefront of immune-oncology therapeutics."

A webcast of the conference presentation will be available on the company website at gtbiopharma.com after the conference.

On August 14, 2018 AIVITA Biomedical, a biotech company specializing in innovative stem cell applications, announced today the initiation of its first clinical site for the Company’s ROOT OF CANCER Phase 2 trial in patients with newly diagnosed glioblastoma (GBM) (Press release, AIVITA Biomedical, AUG 14, 2018, View Source [SID1234528865]). The University of California, Irvine (UCI)’s Comprehensive Brain Tumor Program and the UCLA-UCI Alpha Stem Cell Clinic (ASCC) have received IRB approval to begin recruiting patients to receive AIVITA’s platform ROOT OF CANCER treatment. Patients will receive autologous dendritic cells loaded with autologous tumor antigens derived from self-renewing tumor cells as an adjunctive therapy following primary surgery plus concurrent chemoradiation.

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AIVITA’s single-arm, open-label GBM trial calls for approximately 55 patients with newly diagnosed glioblastoma to be enrolled with the intent to receive the Company’s ROOT OF CANCER treatment. Under the direction of UCI neuro-oncologist and Principal Investigator Daniela Bota, MD, PhD, the treatment will be administered in a series of injections along with standard care, which may include surgery, chemotherapy and radiation.

"We are honored to be launching this trial with Dr. Bota and her very capable team," said Dr. Bob Dillman, AIVITA’s Chief Medical Officer. "With a 100% product manufacturing success rate and a world-class team, we are fully enabled to supply multiple clinical trial sites and get to definitive data quickly."

Dr. Daniela Bota said, "I am delighted to have the opportunity to offer my patients a new treatment that has already demonstrated remarkable improvements in survival rates during previous trials treating other cancer types."

AIVITA’s ROOT OF CANCER technology is also currently the subject of a Phase 2 clinical trial in ovarian cancer in the USA and a commercialization effort in melanoma in Japan. Of the 10 patient tumor samples received thus far in AIVITA’s ROOT OF CANCER ovarian trial, short-term tumor cell lines have been successfully established for all 10.

About Glioblastoma

Glioblastoma (GBM) is the most aggressive and most common form of malignant brain tumor. Median survival is only nine months, rising to 15–16 months for those able to receive aggressive standard of care surgery and adjuvant chemoradiation.1 The cause of most cases is unclear. The National Cancer Institute estimates there will be 23,880 new cases of brain and nervous system cancer in 2018.

[1] Bi, Wenya Linda, and Rameen Beroukhim. "Beating the Odds: Extreme Long-Term Survival with Glioblastoma." Neuro-Oncology 16.9 (2014): 1159–1160. PMC. Web. 18 June 2018.

About the ROOT OF CANCER GBM trial

AIVITA’s treatment is a platform technology applicable to any solid tumor type and consists of autologous dendritic cells loaded with autologous tumor antigens from autologous self-renewing tumor-initiating cells, which means the cells have to be self-renewing as a cell line.

Patients eligible for treatment will be those (1) who have recovered from surgery such that they are about to begin concurrent chemotherapy and radiation therapy (CT/RT), (2) for whom an autologous tumor cell line has been established, (3) have a Karnofsky Performance Status of > 70 and (4) have undergone successful leukapheresis from which peripheral blood mononuclear cells (PBMC) were obtained that can be used to generate dendritic cells (DC).

On August 14, 2018 Surface Oncology (NASDAQ:SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported financial results and corporate highlights for the second quarter of 2018 (Press release, Surface Oncology, AUG 14, 2018, View Source [SID1234528881]).

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"Since the completion of our IPO, we have made significant progress across the company, including continued progress of our SRF231 Phase I trial, with initial data expected in the first half of 2019, and the advancement of a second program, NZV930, into clinical development by our partner, Novartis. The speed with which these programs have advanced from discovery to clinical stage is truly remarkable, and I congratulate the entire team on a job well done," said Jeff Goater, chief executive officer of Surface Oncology. "We remain focused on execution in all aspects of the company, including IND-enabling studies for our SRF617 and SRF388 programs."

Selected Highlights:

SRF231, a fully human monoclonal antibody targeting CD47: In February 2018, Surface initiated a Phase I trial of SRF231. The multi-center, open-label Phase I trial will evaluate the safety and tolerability of SRF231 in multiple ascending doses with the goal of establishing a recommended dose for further study. Following the dose escalation phase, the Company intends to evaluate the safety and efficacy of SRF231 in a targeted set of solid and hematologic malignancies. The trial plan calls for enrollment of up to ~150 patients with initial clinical results from this trial expected in the first half of 2019. Surface holds worldwide rights to SRF231. In July, the FDA granted SRF231 Orphan Drug Designation for the treatment of multiple myeloma.

NZV930 (formerly SRF373), a fully human monoclonal antibody targeting CD73: Surface’s collaborator, Novartis, initiated a Phase I clinical trial for NZV930 in June 2018. The study will assess the safety, tolerability, and preliminary anti-tumor activity of NZV930 alone and when combined with PDR001 (anti-PD-1) and/or NIR178 (A2AR antagonist), in patients with advanced cancers. The trial is designed to enroll up to 344 patients across multiple solid tumor indications, including non-small cell lung cancer, triple negative breast cancer, pancreatic ductal adenocarcinoma, microsatellite stable colorectal cancer, ovarian cancer and renal cell carcinoma. NZV930 has been licensed on a worldwide basis by Novartis.

In June, Surface Oncology was recognized as one of the Best Places to Work in 2018 by the Boston Business Journal.

In July, Liisa Nogelo-Kerr joined Surface as General Counsel. She brings nearly 20 years of corporate, transactional, R&D and commercial legal experience in the biotechnology industry. Prior to Surface, Liisa served as the General Counsel of the Broad Institute of MIT and Harvard. In this role, she was responsible for the Broad’s legal operations, including support of research initiatives and the negotiation of major transactions with pharma and tech companies. Prior to the Broad Institute, Liisa held senior positions on the R&D and corporate legal teams at Biogen and served as lead attorney and member of the executive committee for three late-stage drug development programs in ALS and hemophilia. Earlier in her career, Liisa practiced at Bingham McCutchen, an international law firm, where she advised private equity, medical device, biotechnology and other emerging technology company clients on a broad range of corporate and transactional matters.

Also in July, Seth Lewis joined Surface as Vice President, Investor Relations and Corporate Communications. Most recently Seth was Vice President, Investor Relations and Corporate Communications at Bavarian Nordic, an international biotech focused on live virus vaccine R&D and manufacturing. Prior to his time at Bavarian Nordic, Seth was a Senior Vice President of The Trout Group, LLC, a leading investor relations and advisory firm, focused on life sciences companies.
Financial Results
As of June 30, 2018, cash, cash equivalents and marketable securities were $185.6 million, compared to $63.3 million on December 31, 2017. This increase was primarily related to $108.7 million in net proceeds from the Company’s IPO and concurrent private placement completed in April 2018.

Research and development (R&D) expenses were $15.1 million for the second quarter ended June 30, 2018, compared to $10.7 million for the same period in 2017. The increase was largely due to expenditures associated with Surface’s advancing product pipeline, including increased R&D personnel costs associated with the growth of the Company. R&D expenses included $0.8 million in stock-based compensation expenses for the second quarter of 2018.

General and administrative (G&A) expenses were $3.9 million for the second quarter ended June 30, 2018, compared to $2.0 million for the same period in 2017. The increase was largely due to increased G&A personnel associated with the growth of the company and increased professional fees. G&A expenses included $0.7 million in stock-based compensation expenses for the second quarter of 2018.

For the second quarter ended June 30, 2018, net loss was $15.9 million, or basic and diluted net loss per share attributable to common stockholders of $0.73. Net loss was $6.6 million for the same period in 2017, or basic and diluted net loss per share attributable to common stockholders of $2.73. The decrease in net loss per share attributable to common shareholders is primarily due to the completion of the IPO in April 2018, which resulted in the sale of 7,200,000 shares of common stock and automatic conversion of 16,863,624 shares of convertible preferred stock into shares of common stock. In addition to the shares sold in the public offering, the Company completed a concurrent sale of an additional 766,666 shares at the initial offering price of $15.00 per share.

Cautionary Note Regarding Forward-Looking Statements:
Certain statements set forth in this press release constitute "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements can be identified by terms such as "believes," "expects," "plans," "potential," "would" or similar expressions and the negative of those terms. These forward-looking statements are based on our management’s current beliefs and assumptions about future events and on information currently available to management.

Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks include, but are not limited to, risks and uncertainties related to: our limited operating history and historical losses, our liquidity to fund the development of SRF231 and our other product candidates through current and future milestones, our ability to raise additional funding to complete the development and any commercialization of our product candidates, our dependence on the success of our lead product candidates, SRF231 and NZV930, results from preclinical studies or early clinical trials may not be representative of larger clinical trials, results from the clinical trials and preclinical studies of third parties working in immuno-oncology and our dependence on third parties in connection with our manufacturing, clinical trials and pre-clinical studies. Additional risks and uncertainties that could affect our future results are included in the section titled "Risk Factors" and "Management’s Discussion and Analysis of Financial Condition and Results of Operations" in our Prospectus dated April 18, 2018, which is available on the SEC’s website at www.sec.gov and our website at www.surfaceoncology.com. Additional information on potential risks will be made available in other filings that we make from time to time with the SEC. In addition, any forward-looking statements contained in this press release are based on assumptions that we believe to be reasonable as of this date. Except as required by law, we assume no obligation to update these forward-looking statements, or to update the reasons if actual results differ materially from those anticipated in the forward-looking statements.