On November 8, 2018 Sesen Bio, Inc. (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of people with cancer, reported operating results for the third quarter ended September 30, 2018 and recent highlights from its development program for Vicinium for patients with high-grade non-muscle invasive bladder cancer (NMIBC) (Press release, Sesen Bio, NOV 8, 2018, View Source [SID1234530922]).

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"2018 has been a year of focused execution for Sesen Bio, led by the advancement of the Phase 3 program for Vicinium for patients with NMIBC," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "NMIBC is a devastating disease and there remains just one recommendation for patients who do not respond or become refractory to today’s standard-of-care treatment: complete bladder removal. Our goal is to help save this essential organ and provide a meaningful treatment option for patients with BCG-unresponsive NMIBC. Our Phase 3 registration clinical trial is well-designed and preliminary data reported earlier this year suggest that Vicinium is active and has a favorable safety profile, consistent with our Phase 2 experience. We look forward to assessing six-month data from the trial next month and twelve-month data in mid-2019. If the VISTA Trial is successful, we believe Viciniumcould change the treatment outlook for patients with NMIBC, bringing us closer to achieving our mission of saving and renewing the lives of patients with cancer."

Recent Highlights

In September 2018, at the Global Congress on Bladder Cancer 2018, Sesen Bio presented a biomarker update from its Phase 3 VISTA Trial data showing that all screened patient samples expressed EpCAM, the molecular target of Vicinium.
In October 2018, the company entered into an agreement with FUJIFILM Diosynth Biotechnologies U.S.A., Inc. to provide supply services in support of the manufacturing of Vicinium for the treatment of high-grade NMIBC. The Agreement facilitates a transfer of manufacturing technology from Sesen Bio to Fujifilm.
Upcoming Events

Sesen Bio anticipates reporting six-month data from the ongoing Phase 3 VISTA Trial in December 2018. A conference call will be held to review the data, with details to follow.
Third Quarter 2018 Financial Results

Cash Position: Cash and cash equivalents were $57.9 million as of September 30, 2018, compared to $11.3 million as of September 30, 2017.
Revenue: There was no revenue for the three-month periods ended September 30, 2018 and 2017, respectively, as no revenue triggering milestones were achieved during either period under the company’s license agreement with F. Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc. (Roche).
R&D Expenses: Research and development expenses were $3.4 million for the three months ended September 30, 2018, compared to $3.6 million for the same period in 2017. The decrease was due primarily to a reduction in Vicinium-related development expenses.
G&A Expenses: General and administrative expenses were $3.8 million for the three months ended September 30, 2018, compared to $1.6 million for the same period in 2017. The increase was due primarily to an increase in professional fees as well as higher personnel-related expenses.
Net Loss: Net loss was $14.0 million, or $0.18 per share, for the three months ended September 30, 2018, compared to net loss of $9.1 million, or $0.37 per share, for the same period in 2017. The increase was due primarily to the change in the fair value of contingent consideration and increased general and administrative expenses.
Financial Guidance: Based on current operating plans, Sesen Bio believes it will have capital sufficient to fund its current operating plans into 2020.

On November 8, 2018 Bio-Thera Solutions, a clinical-stage biopharmaceutical company developing a pipeline of innovative therapies and a pipeline of biosimilars, reported the company will present one poster at the 2018 EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium taking place November 13 – 16, 2018 in Dublin, Ireland.

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The poster, entitled "BAT8001, a potent anti-HER2 antibody-drug conjugate with a novel stable linker for the treatment of HER2-positive gastric cancer," will present preclinical data that highlight advantages of BAT8001 as a potential treatment for breast cancer patients. An abstract of the presentation is currently available on EORTC website.

Presentation details are as follows:

Poster Session: Molecular Targeted Agents – PART I
Session Date and Time: Tuesday, November 13, 2018, 12:00 – 18:30
Location: Poster Area/Exhibition Hall

Poster Board Number: PB-084

Abstract Number 133

About BAT8001

BAT8001 is an investigational HER2-ADC being evaluated in multiple tumor types. HER2 is a naturally occurring receptor that is overexpressed in many types of cancer, including breast cancer and gastric cancer. BAT8001 is being developed for use as a single agent and in combination with other agents for the treatment of multiple cancers. BAT8001 is currently being evaluated in a Phase 3 clinical trial for the treatment of metastatic breast cancer patients (more information on the trial is available at View Source (CTR20180157)). The BAT8001 clinical study program will be expanded beyond metastatic breast cancer to other HER2-positive cancers, including gastric cancer, over the next 12 months.

About Antibody-Drug Conjugates

Antibody-drug Conjugates or ADCs are designed to harness the targeting ability of monoclonal antibodies (mAbs) to deliver cytotoxic agents selectively to tumor cells by linking the monoclonal antibody and cytotoxic agent through a chemical linker. An ideal ADC consists of: 1) a highly selective mAb for a tumor-associated antigen that has little or no expression on normal cells, 2) a potent cytotoxic agent designed to induce target cell death after being internalized in the tumor cell and released and 3) a chemical linker that is stable in circulation but releases the cytotoxic agent in target cells. By selectively delivering a cytotoxic agent directly inside a tumor cell, ADCs increase the safety and tolerability of the cytotoxic agent relative to giving the cytotoxic agent systemically to the patient.

On November 8, 2018 Selecta Biosciences, Inc. (Nasdaq: SELB), a clinical-stage biopharmaceutical company focused on unlocking the full potential of biologic therapies by mitigating unwanted immune responses, reported financial results for the third quarter ended September 30, 2018 and provided a corporate update (Press release, Selecta Biosciences, NOV 8, 2018, View Source [SID1234531037]).

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"We believe that our lead program, SEL-212, has the potential to fulfill several unmet needs in chronic severe gout patients including sustained serum uric acid reduction, reduced painful flares and once monthly dosing. We have recently presented interim data from our Phase 2 trial at ACR showing sustained SUA control over a five-month combination period. Based on these data, we are planning the initiation of a six-month head-to-head superiority clinical trial against Krystexxa with interim data readouts expected in 2019 and full data presentation anticipated in first quarter of 2020," said Werner Cautreels, Ph.D., President and CEO of Selecta. "We believe our SVP technology has the potential to induce antigen specific tolerance allowing for the full benefit of biologics, including the possible re-dosing of AAV gene therapy programs. As Selecta enters the next stage of its growth, we look forward to the portfolio development strategy under the leadership of new CEO, Carsten Brunn, Ph.D."

Recent Highlights and Anticipated Upcoming Milestones

SEL-212 6-Month Head-to-Head Trial vs. Krystexxa Expected to Begin in 1Q 2019:Selecta plans to start a head-to-head superiority trial of SEL-212 compared to the current FDA-approved uricase therapy, Krystexxa, in the first quarter of 2019. Selecta expects to report interim data at the 3-month and 6-month timepoints in 2019 with full data anticipated in the first quarter of 2020.

Presented New Interim Phase 2 Clinical Data from Patients Receiving 5-Monthly Doses of SEL-212 at ACR 2018: At the 2018 American College of Rheumatology (ACR)/Association for Rheumatology Health Professionals (ARHP) Annual Meeting in Chicago, Selecta presented interim data from new cohorts of patients that received five monthly doses of SEL-212 for the treatment of chronic severe gout. These interim data continue to show that SEL-212 is generally well-tolerated at clinically active doses following repeated administrations in the trial and the serum uric acid (SUA) control rates observed for patients who completed the 5-month treatment period support the 6-month dosing strategy the company plans to pursue in the head-to-head trial and Phase 3 clinical program.

Announced Collaboration with CureCN for the Exploration of Clinical Use of SVP-Rapamycin in Combination with AAV Gene Therapy for Treatment of Crigler-Najjar Syndrome (CN): The company announced its exploration of a new collaboration with CureCN, a European consortium, for the use of Selecta’s SVP-Rapamycin technology in combination with an AAV gene therapy in CN, a rare genetic disorder characterized by an inability to properly convert and clear bilirubin from the body. Preclinical toxicology studies will need to be completed and then the combination product candidate is projected to enter the clinic in the second half of 2019 with the goal of potentially re-dosing gene therapy. This opportunity builds upon preclinical work that was published together with Genethon in Nature Communications in October 2018.

Appointed Carsten Brunn, Ph.D. as President and Chief Executive Officer: In September 2018, the company announced that Carsten Brunn, Ph.D., had been appointed President and Chief Executive Officer of Selecta Biosciences, effective December 1, 2018. He will also serve on the company’s Board of Directors. Current President and CEO, Werner Cautreels, Ph.D., will continue to lead the company until December, will assist Dr. Brunn during the transition and will remain a member of the Board through December 31, 2018. Dr. Cautreels is expected to serve as an advisor to the company following his retirement. Dr. Brunn joins Selecta from Bayer, where he was most recently the President of Pharmaceuticals for the Americas Region and a member of the Global Pharmaceutical Executive Committee.
Third Quarter 2018 Financial Results:

Revenue: For the third quarter of 2018, the company recognized no revenue, which compares to less than $0.1 million for the third quarter of 2017. The decline is the result of reduced revenue recognized from the company’s grants and collaborations.

Research and Development Expenses: Research and development expenses for the third quarter of 2018 were $11.9 million, which compares to $9.5 million for the third quarter of 2017. The increase is primarily the result of higher clinical costs related to the company’s Phase 2 trial of SEL-212, preparation for the start of the planned SEL-212 Phase 3 program and head-to-head clinical trial, and incremental headcount-related expenses.

General and Administrative Expenses: General and administrative expenses for the third quarter of 2018 were $4.1 million, which compares with $4.4 million for the third quarter of 2017. The reduction in costs is primarily the result of reduced employee salaries and benefits and patent related costs.

Net Loss: For the third quarter of 2018, Selecta reported a net loss of $(16.0) million, or $(0.71) per share, compared to a net loss of $(14.7) million, or $(0.66) per share, for the same period in 2017.

Cash Position: Selecta had $50.5 million in cash and cash equivalents as of September 30, 2018, which compares to cash, cash equivalents and short-term investments of $66.2 million at June 30, 2018. The current operating plan accounts for funding in preparation for the planned Phase 3 clinical program for SEL-212. However, prior to beginning the Phase 3 clinical program, the company expects to conduct the planned head-to-head trial against Krystexxa. The company will require an additional equity offering or other external sources of capital to conduct the planned head-to-head trial against Krystexxa.
Conference Call Reminder
Selecta management will host a conference call at 8:30 a.m. ET today to provide a corporate update and review the company’s third quarter 2018 financial results. Investors and the public can access a live and archived webcast of this call via the Investors & Media section of the company’s website, View Source Individuals may also participate in the live call via telephone by dialing (844) 845-4170 (domestic) or (412) 717-9621 (international) and may access a teleconference replay for one week by dialing (877) 344-7529 (domestic) or (412) 317-0088 (international) and using confirmation code 10124090.

On November 8, 2018 Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company focused on delivering innovative therapies to patients with kidney disease through the biology of hypoxia-inducible factor (HIF), reported financial results for the third quarter ended September 30, 2018 (Press release, Akebia, NOV 8, 2018, View Source [SID1234531054]).

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"In the third quarter, we continued to drive our vadadustat Phase 3 development program, while working diligently to close our proposed merger transaction with Keryx Biopharmaceuticals by the end of 2018. The combination is expected to create a fully-integrated kidney disease therapeutics company, with a strengthened financial profile, positioned to deliver substantial long-term value to shareholders," said John P. Butler, President and Chief Executive Officer of Akebia Therapeutics. "In addition, we look forward to the Phase 3 clinical trial readouts in Japan from our collaboration partner, Mitsubishi Tanabe Pharma Corporation, expected next year. This will be the first time Phase 3 data has been reported for our product candidate, vadadustat, which is an important milestone."

Third Quarter 2018 and Recent Corporate Highlights

Merger Integration Planning:

Following the definitive merger agreement with Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) announced June 28, 2018, Akebia has been actively engaged in integration planning and expects to close the transaction by the end of 2018;
The combination offers potential operating and product portfolio synergies and the opportunity to create significant value and accelerate the growth potential beyond what either company would achieve separately;
The combined company will have an expanded and highly complementary nephrology portfolio, with Auryxia (ferric citrate), a U.S. Food and Drug Administration (FDA)-approved product in two indications with significant growth opportunity, and vadadustat, an investigational late-stage hypoxia-inducible factor prolyl hydroxylase inhibitor, which has the potential to provide a new oral standard of care to patients with anemia due to chronic kidney disease (CKD);
The combined company will have an established renal development, manufacturing and commercial organization, positioning it as a partner of choice for the renal community and for companies developing renal products; and
The combined company plans to leverage its leadership’s extensive expertise in the commercial renal market with the goal of maximizing sales of Auryxia while driving launch momentum for vadadustat in the United States, subject to FDA approval.
Clinical Development:

Akebia continued to enroll subjects in its Phase 3 INNO2VATE program, with top-line results expected in the first quarter of 2020, subject to the accrual of major adverse cardiovascular events (MACE). U.S. enrollment in the Phase 3 INNO2VATE Conversion study completed last quarter, as announced in Akebia’s second quarter 2018 earnings press release;
Akebia continued to enroll subjects in its Phase 3 PRO2TECT program, with top-line results anticipated in mid-2020, subject to the accrual of MACE; and
Akebia received a recommendation from the Independent Data Monitoring Committee, which held another meeting in the quarter, for Akebia’s global Phase 3 PRO2TECT and INNO2VATE programs to continue without modification.
Other Business:

This past quarter, Akebia appointed Cynthia Smith to its Board of Directors. With more than 20 years of broad leadership experience within the healthcare industry, including serving as a Chief Commercial Officer, Cynthia brings expertise that is particularly relevant to Akebia as it prepares for the commercialization of vadadustat, subject to regulatory approval, and works to maximize the value of Auryxia, subject to the consummation of Akebia’s merger with Keryx Biopharmaceuticals.
Financial Results

Akebia reported a net loss of $26.0 million, or ($0.46) per share, for the third quarter of 2018 as compared to a net loss for the third quarter of 2017 of $23.1 million or ($0.49) per share.

Collaboration revenue was $53.2 million for the third quarter of 2018 compared to $41.3 million for the third quarter of 2017. Collaboration revenue recognized in the third quarter of 2018 related primarily to revenue recognized under both the U.S. collaboration agreement with Otsuka Pharmaceutical Co. Ltd., or Otsuka, and the collaboration agreement with Otsuka related to Europe, China and certain other regions, or the Otsuka International Agreement. Collaboration revenue recognized in the third quarter of 2017 also related to the Otsuka U.S. Agreement and the Otsuka International Agreement, which were consummated in December 2016 and April 2017, respectively.

Research and development expenses were $70.6 million for the third quarter of 2018 compared to $58.7 million for the third quarter of 2017. The increase was primarily attributable to external costs related to the global PRO2TECT and INNO2VATE Phase 3 programs. Research and development expenses were further increased by headcount and compensation-related costs.

General and administrative expenses were $10.4 million for the third quarter of 2018 compared to $6.7 million for the third quarter of 2017. The increase was primarily attributable to an increase in legal and other professional fees related to our proposed merger with Keryx Biopharmaceuticals, and an increase in costs to support the company’s research and development programs, including headcount and compensation-related costs.

Akebia ended the third quarter of 2018 with cash, cash equivalents and available for sale securities of $390.1 million. The company also generally receives cost-share funding from its collaboration agreements with Otsuka on a prepaid quarterly basis. Akebia expects its existing cash resources, including the prepaid quarterly committed cost-share funding from its collaborators, to fund its current operating plan through the first quarter of 2020.

On November 8, 2018 Veracyte, Inc. (Nasdaq: VCYT) reported the publication of "real world" data showing that the Afirma Genomic Sequencing Classifier (GSC) enables even more patients to avoid unnecessary surgery in thyroid cancer diagnosis compared to the company’s flagship, original Afirma Gene Expression Classifier (GEC) (Press release, Veracyte, AUG 8, 2018, View Source [SID1234531100]). The findings are published online in Endocrine Practice, the journal of the American Association of Clinical Endocrinologists"

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In the study, researchers from Memorial Healthcare System in Hollywood, Fla., reviewed data from all patients in their practice whose thyroid nodules were deemed indeterminate (i.e., not clearly benign or cancerous) by cytopathology review and who subsequently received results from genomic testing with the Afirma GSC (n=139) or the Afirma GEC (n=481). They found that the Afirma GSC identified 47 percent more thyroid nodules as benign than the first-generation test (61.2 percent vs. 41.6 percent). Use of the next-generation test also reduced overall surgery rates among all patients with indeterminate thyroid nodules by 45 percent. The researchers determined that sensitivity for the Afirma GSC in their practice was 97 percent.

The RNA sequencing-based Afirma GSC demonstrated especially strong performance in distinguishing benign from cancerous Hürthle cells – a category of thyroid cell that has historically been challenging to diagnose by cytopathology or molecular methods. The Afirma GSC identified 64.7 percent of Hürthle cell dominant biopsies as benign compared to 17.3 percent with the original test and dramatically reduced overall surgery referrals in this group by 57.3 percent.

"Our data suggest that the Afirma GSC is helping us to further reduce unnecessary surgeries among our patients with indeterminate thyroid nodules by enhancing the original test’s specificity while maintaining its high sensitivity," said R. Mack Harrell, M.D., cofounder of the Memorial Center for Integrative Endocrine Surgery and lead author of the new study. "A key reason for this change is the Afirma GSC’s ability to rule out cancer in Hürthle-dominant thyroid nodules. This is important because Hürthle-dominant cases comprise 22 percent of the indeterminate thyroid nodules we evaluate."

Dr. Harrell’s practice began using the Afirma GEC when it was introduced in January 2011. They have been offering patients the Afirma GSC since it became available in August 2017.

"This new publication adds to the growing body of real-world data confirming the utility and consistent performance of the Afirma GSC across a variety of clinical settings," said Bonnie Anderson, Veracyte’s chairman and chief executive officer. "Developed using a novel combination of RNA sequencing and machine learning technology, the Afirma GSC helps even more patients with benign thyroid nodules get clearer answers and avoid unnecessary surgery, further benefitting them, their physicians and the healthcare system."

About Afirma

Veracyte’s Afirma solution provides a comprehensive offering in thyroid cancer diagnosis for physicians evaluating patients with thyroid nodules. The Afirma Genomic Sequencing Classifier combines RNA sequencing data with machine learning to identify patients with benign thyroid nodules among those with indeterminate cytopathology results in order to avoid unnecessary surgery and preserve the thyroid. Since the commercial introduction of Afirma in 2011, Veracyte has performed over 100,000 genomic tests, and estimates it has saved more than 40,000 patients from unnecessary thyroid surgery and removed an estimated $800 million in surgery costs from the healthcare system. The Afirma classifier is proven in over 20 published clinical studies, is included in most leading clinical guidelines and is covered as medically necessary by Medicare and all major U.S. health plans. The company’s Afirma Xpression Atlas platform, introduced in May 2018, provides extensive genomic data that may inform surgery strategy and treatment options for patients with thyroid nodules that are suspicious for cancer or cancerous. The RNA sequencing-based platform measures 761 DNA variants and 130 RNA fusions in over 500 genes shown to be associated with thyroid cancer on thyroid nodule fine needle aspiration samples.