On May 15, 2019 Amgen (NASDAQ: AMGN) reported that data from its oncology pipeline will be presented at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in Chicago, May 31-June 4, 2019 (Press release, Amgen, MAY 15, 2019, View Source [SID1234536367]). Seven investigational assets will be featured across a range of hematologic malignancies and solid tumors.

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"Biology and human genetics have been the foundation of Amgen’s innovation for the last four decades," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "Based on the fundamentals of our science and the speed at which we are moving, I believe Amgen will have a profound effect on how certain cancers are treated in the future. We are committed to bringing novel cancer therapies more quickly than ever before to the patients who need them."

Notable data from the Company’s oncology pipeline include first-in-human data for investigational AMG 510, the first KRASG12C inhibitor to reach the clinical stage in patients with locally-advanced or metastatic KRASG12C mutant solid tumors. Additional early-stage pipeline data will showcase Amgen’s bispecific T cell engager (BiTE) platform across hematologic malignancies and solid tumors, including for the first time, in prostate cancer. BiTE molecules are designed to engage patients’ T cells to tumor-specific antigens, activating the cytotoxic potential of T cells with the goal of eliminating detectable cancer. Updated results will also be presented from a Phase 1 dose escalation study evaluating investigational AMG 420, a B-cell maturation antigen (BCMA) targeting BiTE molecule, in patients with relapsed or refractory multiple myeloma.

A complete listing of Amgen’s abstracts is available on the ASCO (Free ASCO Whitepaper) website. Notable abstracts include:

Clinical Data Abstracts

Phase 1 Study of Pasotuxizumab (BAY 2010112), a PSMA-Targeting Bispecific T cell Engager (BiTE) Immunotherapy for Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Abstract #5034, Poster Presentation, Saturday, June 1 from 1:15-4:15 p.m. CT in McCormick Place, Hall A
Evaluation of AMG 420, an anti-BCMA Bispecific T-cell Engager (BiTE) Immunotherapy, in R/R Multiple Myeloma (MM) Patients: Updated Results of a First-in-Human (FIH) Phase 1 Dose Escalation Study
Abstract #8007, Oral Presentation, Sunday, June 2 from 11:57 a.m.–12:09 p.m. CT in McCormick Place, Room E451
Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics (PK), and Efficacy of AMG 510, a Novel Small Molecule KRASG12C Inhibitor, in Advanced Solid Tumors
Abstract #3003, Oral Presentation, Monday, June 3 from 9–9:12 a.m. CT in McCormick Place, Room S406
Trials-in-Progress Abstracts

Phase 1 Study of AMG 757, a Half-Life Extended Bi-Specific T Cell Engager (BiTE) Antibody Construct Targeting DLL3, in Patients with Small Cell Lung Cancer (SCLC)
Abstract #TPS8577, Poster Presentation, Sunday, June 2 from 8–11 a.m. CT in McCormick Place, Hall A
Phase 1 Study of AMG 119, a Chimeric Antigen Receptor (CAR) T Cell Therapy Targeting DLL3, in Patients with Relapsed/Refractory Small Cell Lung Cancer (SCLC)
Abstract #TPS8576, Poster Presentation, Sunday, June 2 from 8–11 a.m. CT in McCormick Place, Hall A
Novel anti-EGFRvIII Bispecific T Cell Engager (BiTE) Antibody Construct in Glioblastoma (GBM): Trial in Progress of AMG 596 in Patients with Recurrent or Newly Diagnosed Disease
Abstract #TPS2071, Poster Presentation, Sunday, June 2 from 8–11 a.m. CT in McCormick Place, Hall A
Amgen Webcast Investor Meeting
Amgen will host a webcast investor meeting at ASCO (Free ASCO Whitepaper) 2019 on Monday, June 3 at 6:30 p.m. CT. David M. Reese, M.D., executive vice president of Research and Development at Amgen, along with members of Amgen’s clinical development team and clinical investigators, will participate at the investor meeting to discuss Amgen’s oncology program and data presented at ASCO (Free ASCO Whitepaper) 2019.

Live audio of the conference call will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

The webcast, as with other selected presentations regarding developments in Amgen’s business given at certain investor and medical conferences, can be accessed on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

About KRAS
The subject of more than three decades of research, RAS proteins make up the most frequently mutated gene family in human cancers.1,2 Within this family, KRAS is the most prevalent variant and is particularly common in solid tumors.2 A specific mutation known as KRASG12C accounts for approximately 12 percent of all KRAS mutations across tumor types.3 Amgen is exploring the potential of KRASG12C inhibition across a broad variety of tumor types.

About BiTE Technology
Bispecific T cell engager (BiTE) technology is a targeted immuno-oncology platform that is designed to engage patients’ own T cells to any tumor-specific antigen, activating the cytotoxic potential of T cells to eliminate detectable cancer. The BiTE immuno-oncology platform has the potential to treat different tumor types through tumor-specific antigens. The BiTE platform leads to off-the-shelf solutions, which have the potential to make innovative T cell treatment available to all providers when their patients need it. Amgen is advancing more than a dozen BiTE molecules across a broad range of hematologic malignancies and solid tumors, further investigating BiTE technology with the goal of enhancing patient experience and therapeutic potential.

On May 15, 2019 Rubius Therapeutics, Inc. (Nasdaq:RUBY), a clinical-stage biopharmaceutical company that is generating red blood cells and bioengineering them into an entirely new class of cellular medicine reported first quarter 2019 financial results and provided an overview of operational progress (Press release, Rubius Therapeutics, MAY 15, 2019, View Source [SID1234536305]). In addition, Rubius announced that company president, Torben Straight Nissen, Ph.D., will be leaving the Company at the end of July 2019, to join Flagship Pioneering where he has held a venture partner role since joining Rubius in 2016.

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"Rubius has made significant progress this year, including the clearance of our first Investigational New Drug application for RTX-134 for the treatment of patients with phenylketonuria," said Pablo J. Cagnoni, M.D., chief executive officer of Rubius Therapeutics. "We plan to begin enrolling patients in the Phase 1b trial during the second quarter with initial clinical data expected during the second half of the year. We presented important preclinical data from our emerging oncology portfolio at AACR (Free AACR Whitepaper), demonstrating promising anti-tumor activity with no observed toxicities for our lead product candidates, RTX-240 and RTX-224, for the treatment of solid tumors and RTX-aAPC for the treatment of HPV-positive tumors. The year is off to a great start as we continue to advance our Red Cell Therapeutics towards our ultimate goal of treating patients who are underserved by available therapies."

"We are grateful to Torben for all his contributions towards building a world-class organization and for remaining with Rubius since I joined the company to continue supporting the scale-up of our manufacturing capabilities," continued Dr. Cagnoni. "During his tenure, Torben also took part in executing key financings, made important leadership hires and helped drive the formation and advancement of our portfolio of programs that target rare diseases, cancer and autoimmune diseases. We wish him the best going forward."

"I am very proud of the hard work, dedication and innovative spirit of the Rubius team that has led the company to where it is today," said Dr. Straight Nissen. "I believe Rubius’ Red Cell Therapeutics approach has the potential to transform the future of cellular medicine, and I look forward to following the company as they work towards bringing these important therapies to patients. I wish all my talented colleagues at Rubius continued success as I transition to focus on earlier stage platform companies within the Flagship Pioneering ecosystem."

Dr. Straight Nissen will continue to provide consulting services to Rubius into 2020. With his departure, Spencer Fisk, senior vice president of technical operations, and Thomas Wickham, Ph.D., senior vice president of discovery, will report directly to Dr. Cagnoni.

First Quarter Program Highlights and Updates

In March 2019, Rubius received clearance from the U.S. Food and Drug Administration (FDA) of the Company’s Investigational New Drug (IND) application for RTX-134. RTX-134 is an allogeneic, off-the-shelf cellular therapy for the potential treatment of patients with phenylketonuria (PKU), a rare, inherited metabolic disorder that is characterized by the body’s inability to metabolize the essential dietary amino acid, phenylalanine.

oThe Company expects to enroll up to 10 adult patients with PKU in the Phase 1b trial, with enrollment expected to begin during the second quarter of 2019 and initial clinical data anticipated in the second half of 2019, including:

Preliminary safety;

Longevity of RTX-134 cells in circulation;

Proof-of-mechanism as measured by production of trans-cinammic acid, the metabolite of phenylalanine when degraded by phenylalanine ammonia lyase (PAL); and

Selection of a preliminary dose and schedule.

On April 2, 2019, Rubius presented preclinical data from its emerging oncology pipeline at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting.

oRTX-240 (4-1BBL and 1L-15TP) and RTX-224 (4-1BBL and IL-12) are allogeneic cellular therapy product candidates that are engineered to replicate the human immune system by stimulating the adaptive and innate immune systems to induce an immune response.

RTX-240 and RTX-224 each demonstrated potent activation of the immune system, anti-tumor activity and a potentially broad therapeutic window when compared to agonists antibodies or recombinant cytokines.

Additionally, RTX-224 in combination with an anti-PD-1 antibody demonstrated substantial tumor shrinkage in a difficult-to-treat MC38 colon cancer model.

oRed Cell Therapeutic (RCT) artificial antigen presenting cells, or RTX-aAPCs, are engineered to induce a tumor-specific response by expanding tumor-specific T cells against a target antigen.

RTX-aAPCs activated and significantly expanded antigen-specific T cells to promote substantial tumor regressions, leading to increased survival with no observed toxicity, in an OVA-positive murine model.

The Company continued to strengthen its leadership by appointing Natalie Holles to its board of directors and Greg Whitehead as senior vice president and chief quality officer, while bolstering internal capabilities in discovery, platform development and technical operations.

Rubius remains on track to submit a total of four to five INDs across 2019 and 2020, while continuing to progress additional pipeline programs in rare diseases, cancer and autoimmune diseases.

First Quarter Financial Results

Net loss for the first quarter of 2019 was $32.6 million or $0.42 per common share, compared to $14.4 million or $1.72 per common share in the first quarter of 2018.

In the first quarter of 2019, Rubius invested $20.9 million in research and development (R&D) related to its novel RED PLATFORM and towards expanding and advancing its product pipeline, compared to $9.5 million in the first quarter of 2018. The year-over-year increase was due to an additional $3.6 million of costs incurred in preparation for the Phase 1b clinical trial for RTX-134, and $9.3 million was associated with personnel costs, stock-based compensation, facility and laboratory costs driven by increases in R&D headcount and expanded research activities to support Rubius’ goal of delivering four to five IND’s across 2019 and 2020. These increases were offset by a decrease in external manufacturing and research costs that were not related to programs.

G&A expenses were $13.5 million during the first quarter of 2019, as compared to $5.1 million for the first quarter of 2018. The higher costs were primarily driven by a $7.4 million increase in personnel costs, stock-based compensation and facility costs, due to increased headcount in our general and administrative function, as well as increases in professional fees and infrastructure costs to support the Company’s growth and to operate as a public company.

Cash Position

As of March 31, 2019, cash, cash equivalents and investments were $378.9 million as compared to $404.1 million as of December 31, 2018, providing Rubius with a cash runway into 2021. During the quarter, the Company used $22.9 million of cash to fund operations and $4.2 million to fund capital expenditures.

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).