On May 15, 2019 Sutro Biopharma, Inc. (NASDAQ: STRO), a clinical-stage drug discovery, development and manufacturing company focused on the application of precise protein engineering and rational design to create next-generation oncology therapeutics, reported its financial results for the quarter ended March 31, 2019 (Press release, Sutro Biopharma, MAY 15, 2019, View Source [SID1234536335]).

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"During the first quarter of 2019, we initiated a Phase 1 clinical trial for our second wholly-owned product candidate, STRO-002, for the treatment of ovarian and endometrial cancers. We will present initial safety data for STRO-001, for the treatment of multiple myeloma and non-Hodgkin lymphoma on June 15, 2019 at the EHA (Free EHA Whitepaper) Congress," said Bill Newell, Sutro’s Chief Executive Officer. "Further, the investigational new drug ("IND") clearance received by our partner Celgene for our BCMA ADC represents another significant moment for antibody drug conjugates ("ADCs") as important therapeutic modalities in fighting cancer.

Recent Business Highlights and Developments

STRO-001 Clinical Program

Potential first-in-class and best-in-class ADC directed against CD74, which is highly expressed in many B cell malignancies
Phase 1 dose-escalation, with dose expansion, clinical trial enrolling patients with multiple myeloma and non-Hodgkin lymphoma, with initial safety data to be presented at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress on June 15, 2019 and initial efficacy data expected by year end 2019
STRO-001 granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of multiple myeloma
STRO-002 Clinical Program

Potential best-in-class ADC directed against folate receptor-alpha, which is highly expressed in ovarian cancer
Phase 1 dose-escalation, with dose expansion, clinical trial enrolling women with advanced ovarian and endometrial cancers, with initial safety data expected by year end 2019

BCMA ADC Clinical Program and Celgene Collaboration

Third product candidate to originate from Sutro’s proprietary discovery and manufacturing platform to enter clinical development since early 2018

Existing pipeline bolstered with three bispecific assets from Sutro’s collaboration with Celgene, for which Sutro holds U.S. rights, targeting BCMA-CD3, PD1-LAG3 and PD1-TIM3.

Celgene receives FDA clearance on its IND application for an ADC targeting B-cell maturation antigen ("BCMA") for the treatment of multiple myeloma, for which product candidate Celgene has worldwide development and commercialization rights. Sutro is entitled to development and regulatory milestone payments and tiered royalties from Celgene for this BCMA ADC.

Under the Celgene collaboration, U.S. clinical development and commercialization rights to three collaboration programs (BCMA-CD3, PD1-LAG3 and PD1-TIM3) are now fully owned by Sutro, as Celgene elected not to pay the option fee to continue to have rights for these programs following IND clearance of the first collaboration program. For any products resulting from these three programs, Celgene will own ex-U.S. development and commercialization rights and will be obligated to pay Sutro development and regulatory milestone payments and tiered royalties.

Quarter 2019 Financial Highlights

Cash, Cash Equivalents and Marketable Securities

As of March 31, 2019, Sutro had cash, cash equivalents and marketable securities of $184.3 million.

Revenue

Revenue was $8.6 million for the quarter ended March 31, 2019, which included collaboration revenue from Celgene, Merck and EMD Serono. On January 1, 2019, Sutro adopted Accounting Standards Update No. 2014-09 Revenue from Contracts with Customers (Accounting Standards Codification Topic 606). For more information on the impact of the adoption of the new revenue standard, see "Notes to Unaudited Interim Condensed Financial Statements" contained in Part I, Item 1 of Sutro’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 15, 2019. Future collaboration revenue from Celgene, Merck and EMD Serono, and from any future collaboration partners, will fluctuate as a result of the amount and timing of revenue recognition of upfront, milestones and other collaboration agreement payments.

Operating Expenses

Total operating expenses for the quarter ended March 31, 2019, were $22.9 million compared with $17.5 million for the same period in 2018, including non-cash stock-based compensation of $2.3 million and $0.3 million, and depreciation and amortization expense of $1.1 million and $1.2 million, in the 2019 and 2018 quarters, respectively. Total operating expenses for the 2019 quarter were comprised of research and development expenses of $15.2 million and general and administrative expenses of $7.7 million, with both expense types expected to increase in 2019 as Sutro’s internal product candidates advance in clinical development and additional general and administrative expenses are incurred as a public company following its IPO that closed on October 1, 2018.

On May 15, 2019 AVEO Oncology (NASDAQ: AVEO) reported two poster presentations at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held May 31-June 4, 2019 in Chicago, Illinois (Press release, AVEO, MAY 15, 2019, View Source [SID1234536352]).

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Presentation Details

Title: Efficacy and safety of tivozanib in recurrent, platinum-resistant ovarian, fallopian tube or primary peritoneal cancer
First Author: Wendy M. Swetzig, PhD, Northwestern University Feinberg School of Medicine
Abstract Number: 5538
Poster Session: Gynecologic Cancer
Poster Board: 361
Date and Time: Saturday, June 1, 2019, 1:15-4:15 PM CT
Location: Hall A

Title: TIVO-3: Subgroup analysis of progression-free survival of tivozanib compared to sorafenib in subjects with refractory advanced renal cell carcinoma (RCC)
First Author: Camillo Porta, MD, Associate Professor, Department of Internal Medicine, University of Pavia and Division of Translational Oncology, IRCCS Maugeri, Italy
Abstract Number: 4572
Poster Session: Genitourinary (Nonprostate) Cancer
Poster Board: 398
Date and Time: Monday, June 3, 2019, 1:15-4:15 PM CT
Location: Hall A

About Tivozanib (FOTIVDA)

Tivozanib (FOTIVDA) is an oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) discovered by Kyowa Hakko Kirin and approved for the treatment of adult patients with advanced renal cell carcinoma (RCC) in the European Union plus Norway and Iceland. It is a potent, selective and long half-life inhibitor of all three VEGF receptors and is designed to optimize VEGF blockade while minimizing off-target toxicities, potentially resulting in improved efficacy and minimal dose modifications.1,2 Tivozanib has been shown to significantly reduce regulatory T-cell production in preclinical models3 and has demonstrated synergy in combination with nivolumab (anti PD-1) in a Phase 1/2 study in RCC. Tivozanib has been investigated in several tumor types, including renal cell, hepatocellular, colorectal and breast cancers. In addition, a new formulation of tivozanib is in pre-clinical development for the treatment of age-related macular degeneration.

On May 15, 2019 Mylan N.V. (NASDAQ: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) reported that final data from the HERITAGE study will be presented at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago (Press release, Mylan, MAY 15, 2019, View Source [SID1234536368]). The HERITAGE study compared Ogivri to the reference product, Herceptin, in patients with HER2+ metastatic breast cancer in combination with taxanes for the first 24 weeks and then as a monotherapy until progression. Safety and overall survival, cumulative through 36 months of follow-up, will be presented as part of the Breast Cancer – Metastatic session, "HER2-Positive Disease: How Far Have We Come?," on June 2.

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Mylan Head of Global Biologics, R&D, Arnd Annweiler, commented: "We’re pleased with the final results of the landmark HERITAGE study which further validate the safety and efficacy profile of Ogivri and confirm that no clinically meaningful differences exist between the biosimilar product and Herceptin in terms of safety, purity and potency. We have long been committed to the science and clinical data behind this important treatment and are proud to reach this milestone. Today, we continue on our mission to increase access to Ogivri and the additional biosimilars in our pipeline for patients around the world. We’re grateful for ASCO (Free ASCO Whitepaper)’s recognition of this critical study over the past years and the important role they have played in educating and instilling confidence in healthcare providers and patients about the safety, efficacy and value of biosimilars."

Christiane Hamacher, CEO, Biocon Biologics, said: "The final safety and overall survival data from the HERITAGE study for our biosimilar trastuzumab, Ogivri, cumulative through 36 months of follow up, reconfirms that efficacy and safety is very similar to the reference product, Herceptin. The presentation of this data at ASCO (Free ASCO Whitepaper) will enable a wider adoption of our biosimilar trastuzumab which has so far benefited thousands of patients across the globe. Biocon Biologics is committed to enable access to this high quality affordable therapy for HER2-positive breast and gastric cancer patients as we strive to co-create a healthy future."

Following are the session details:

Abstract 1021: Biosimilar trastuzumab-dkst monotherapy versus trastuzumab monotherapy after combination therapy: Final overall survival (OS) from the phase III HERITAGE Trial
Date: June 2, 2019
Poster display: #102, 8-11 a.m. CDT, Hall A
Poster discussion: 11:15 a.m.-12:45 p.m. CDT, Hall D2
Session: Breast Cancer – Metastatic
Presenter: Dr. Cornelius Waller, Department of Haematology, Oncology and Stem Cell Transplantation, University Medical Centre Freiburg and Faculty of Medicine, University of Freiburg, Freiburg, Germany
Mylan and Biocon’s biosimilar for Herceptin has received regulatory approval in more than 65 countries worldwide.

About the HERITAGE Study
HERITAGE is a double-blind, randomized clinical trial designed to evaluate comparative efficacy and safety of the trastuzumab biosimilar trastuzumab-dkst (formerly known as MYL-1401O) versus branded trastuzumab. Eligible patients had centrally confirmed, measurable HER2-positive metastatic breast cancer without prior chemotherapy or trastuzumab for metastatic disease. Patients were randomized to receive either trastuzumab-dkst or branded trastuzumab with docetaxel or paclitaxel for a minimum of eight cycles. Trastuzumab was continued until progression. The primary endpoint is overall response at week 24 by blinded central evaluation using RECIST 1.1. Secondary endpoints include progression free survival, overall survival, and safety. A sample size of 456 patients was calculated to demonstrate equivalence in overall response at week 24 for trastuzumab-dkst versus branded trastuzumab, defined as a 90% confidence interval for the ratio of best overall response within the equivalence margin (0.81, 1.24).The primary endpoint has previously been reported: the overall response rate in patients with HER2-positive metastatic breast cancer at week 24 was equivalent between the trastuzumab-dkst and trastuzumab groups (Rugo et al. JAMA. 2017;317:37-47).

On May 15, 2019 AnHeart Therapeutics (Hangzhou) Co., Ltd.. (hereinafter referred to as AnHeart) reported the completion of the series A round of financing raising about 100 million Chinese yuan (Press release, AnHeart Therapeutics, MAY 15, 2019, View Source [SID1234555758]). The financing was exclusively provided by Decheng Capital, an internationally known venture capital institution specializing in the biomedical industry. This round of financing will be used to establish the AnHeart team to carry out Phase 2 clinical trials of its leading asset AB-106 and to further enrich the company’s product pipeline.

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AnHeart is a clinical stage company, specialized in acquisition, development and commercializing innovative drugs that improve human health and quality of life. Its leading asset is AB-106, an oral, highly selective ROS1/NTRK small molecule inhibitor. This new anticancer drug was acquired from Japan’s Daiichi Sankyo Co., Ltd. in December 2018.

Early clinical trials have shown that AB-106 had satisfactory safety and efficacy and exhibits long progression-free survival in patients with non-small cell lung cancer with ROS1 fusion mutations. Currently, AB-106 has completed phase 1 clinical trials in the United States and Japan for the treatment of patients with solid tumors and neuroendocrine tumors containing ROS1 or NTRK fusion genes. The latest Phase 1 clinical trial results are expected to be reported in detail at the China Clinical Oncology Association Annual Meeting (CSCO) in September 2019.

"AnHeart is committed to the development of innovative drugs with unmet clinical needs," said Dr. Wang Yuyuan, co-founder and CEO of AnHeart. "With the strong support from Decheng Capital, we successfully acquired worldwide global rights for AB-106 from Japan Daiichi Sankyo and took over the long-term follow-up of the product in the US IND and Phase 1 clinical trials." Strategic collaborations are one of the strategies of Anheart. The company plans to establish and enhance clinically innovative product pipelines with near key value inflection points by working with large and medium-sized biopharmaceutical companies."

Dr. Yan Bing, Co-Founder and CMO of Anheart added: "Our team has very rich clinical development experience, and successful drug approval experience in Asia Pacific, Europe and America. We also have long term collaboration with top industry leaders as well. In fact, leveraging our global clinical development capabilities and interdisciplinary expert networks to optimize the clinical commercial value of assets is another strategy of AnHeart."

"Besides acquiring clinical assets by cooperation with large and medium-sized biopharmaceutical projects, we also consider introducing and developing assets that have not entered the clinical phase but have demonstrated good potential in animal experiments in order to build and consolidate an innovative product pipeline", Dr. Zheng Lihua, Co-Founder and CBO of AnHeart added.

"We are very glad we have the opportunity to support Anheart", said Dr. Cui Xiangmin, Managing Partner of Decheng Capital. "AnHeart has built a very successful clinical development team. We believe that AnHeart can use its strength in clinical development to bring a variety of innovative drugs to the market to meet the clinical needs of patients."

On May 15, 2019 VBL Therapeutics (Nasdaq: VBLT) reported financial results for the first quarter ended March 31, 2019, and provided a corporate update (Press release, VBL Therapeutics, MAY 15, 2019, View Source [SID1234536306]).

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"As we continue to advance development of VB-111, we are getting a better understanding of its mechanism of action and how best to incorporate it into oncology treatment regimens," said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. "We expect two additional VB-111 clinical trials to begin this year, a Phase 2 trial in colon cancer in combination with a checkpoint inhibitor (in collaboration with the National Cancer Institute) and an investigator-sponsored study in recurrent glioblastoma which will be conducted by a group of top US neuro-oncology centers. Therefore, together with the ongoing Phase 3 OVAL pivotal study in ovarian cancer, there will be a total of three VB-111 clinical trials up and running in the second half of 2019.

We are also pleased to announce that there will be two presentations on VB-111 at the upcoming 2019 ASCO (Free ASCO Whitepaper) Annual Meeting in early June, by Dr. Richard Penson from Massachusetts General Hospital on the final Phase 2 results in ovarian cancer, and by Dr. Benjamin Ellingson from UCLA on VB-111 Phase 2 and Phase 3 MRI data in recurrent GBM.

In addition to advancing VB-111, we are also moving forward with two parallel development programs targeting MOSPD2, which has significant potential as a therapeutic target for both inflammatory diseases and cancer."

"We had $47.7 million in cash and cash equivalents at March 31, 2019, which we believe is sufficient to continue development of VB-111 and other product candidates and to fund our operating expenses and capital expenditure requirements through 2021," said Amos Ron, Chief Financial Officer of VBL Therapeutics.

First Quarter and Recent Corporate Highlights:

Executed a strategic exclusive option license agreement with one of the world-leading European animal health companies, for the development of VBL’s proprietary anti-inflammatory molecule, VB-201, for veterinary use. VBL received an undisclosed up-front payment and upon exercising the option to license, VBL expects to receive additional milestones and royalties, which may exceed €50 million. VBL retains worldwide rights for the use of VB-201 for the treatment of humans.

Awarded a non-dilutive grant of over 10 million New Israeli Shekels (approximately $2.9 million) by the Israel Innovation Authority (IIA), to support continued development of VB-111 for 2019.

Presented new data indicating that VB-111 has potential to stimulate the immune system to induce a strong and durable response against ovarian tumors at the Society for Gynecologic Oncology 50th Annual Meeting on Women’s Cancer. The Company’s ongoing potential registration OVAL pivotal trial in platinum resistant ovarian cancer continues to enroll patients as planned.

MOSPD2 program for inflammation: Presented new data at the Keystone Symposia on the role of MOSPD2 in the migration of certain inflammatory cells, the myeloid cells. VBL is developing the VB-600 platform of antibodies targeting MOSPD2 for treatment of various inflammatory indications.

MOSPD2 oncology program: VBL is currently developing bi-specific antibodies that bring together tumor cells, via MOSPD2, and T cells, via CD3, to recruit the immune system to fight tumor cells.

First Quarter ended March 31, 2019 Financial Results:

Cash Position: At March 31, 2019, the Company had cash, cash equivalents and short-term bank deposits totaling $47.7 million and working capital of $43.1 million. The Company expects that its cash, cash equivalents and short-term bank deposits will enable it to fund operating expenses and capital expenditure requirements through 2021.

Revenues: Revenues related to VBL’s collaborations were $0.2 million in the first quarter of 2019.

R&D Expenses: Research and development expenses, net, after government grants, for the quarter ended March 31, 2019, were approximately $3.3 million, compared to approximately $5.8 million in the same period in 2018.

G&A Expenses: General and administrative expenses for the quarter ended March 31, 2019 were $1.3 million, compared to $1.4 million for the same period in 2018.

Comprehensive Loss: VBL reported a net loss for first quarter ended March 31, 2019, of $4.2 million, or ($0.12) per share, compared to a net loss of $7.2 million, or ($0.24) per share, in the quarter ended March 31, 2018.

For further details on VBL’s financials, please refer to Form 6-K filed with the SEC.

Conference Call:

Wednesday, May 15th @ 8:30am Eastern Time

From the US: 877-407-9208

International: 201-493-6784

Conference ID: 13690495

Webcast: View Source