On May 13, 2019 Novigenix SA, a leading ImmunoTranscriptomics company that develops and commercializes products for early cancer detection and precision medicine reported the appointment of Dr. Jan Groen to the position of Chief Executive Officer and member of the Board of Directors (Press release, Novigenix, MAY 13, 2019, View Source [SID1234536230]).

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"Following the successful commercialization of its first product for early colon cancer detection, Novigenix is ready to expand its product offering based on its unique ImmunoTranscriptomics technology platform. I very much look forward to working with its dynamic team to build on this initial success"

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Dr. Jan Groen has many years of experience in the life science industry with a focus on emerging technologies, product development and commercialization. Dr. Groen was previously the President and CEO of MDxHealth SA (Euronext), an epigenetic diagnostic company focusing on urological cancers. During his 9 years at MDxHealth, Dr. Groen oversaw growth of total cumulative revenue to over US$100 million, the raising of more than US$80 million in equity financing, the establishment of a CLIA service laboratory in the United States and an ISO service laboratory in Europe, and the team expansion to over 220 staff to sell their prostate and other cancer diagnostic tests. Dr. Groen is co-founder of ViroClinics, founder CEO of DxOrange and has held numerous international executive management and board mandates in international diagnostic companies. He currently serves on the board of Angle Plc and Destina Genomics. He holds a Ph.D. degree in Medical Microbiology from the Erasmus University Rotterdam, a BSc in Clinical Laboratory Studies, and has published more than 125 papers in international scientific journals in the field of clinical diagnostics

"We are delighted to welcome Jan as the CEO of Novigenix. Jan’s decision to join Novigenix is testament to the potential and leadership position of our ImmunoTranscriptomics-based cancer diagnostic and precision medicine pipeline," said Dr. Brian Hashemi, Executive Chairman of the Board of Directors at Novigenix. "Jan’s leadership and considerable experience will contribute to making Colox the new colorectal cancer screening standard, while further developing our technology into other indications."

Novigenix is committed to unravel a new understanding of the human host response against cancer. The company was founded on the vision that ImmunoTranscriptomics will bring unprecedented advances in diagnosing and treating cancer patients leading to significant improvement in healthcare. Novigenix’s unique ImmunoTranscriptomics technology enables an accelerated identification of disease specific mRNA signatures of circulating immune cells, which combined with machine learning and predictive algorithms, can predict onset and progression of disease. The Company has established a valuable multicultural biobank and database of over 1,400 patients at risk of colorectal cancer (CRC) and has launched its first blood-based molecular diagnostic product, Colox, for the early detection of colon cancer. Colox is currently being distributed in Switzerland by Unilabs and Dr. Risch laboratory.

"Following the successful commercialization of its first product for early colon cancer detection, Novigenix is ready to expand its product offering based on its unique ImmunoTranscriptomics technology platform. I very much look forward to working with its dynamic team to build on this initial success," said Dr. Jan Groen.

About ImmunoTranscriptomics

ImmunoTranscriptomics consists of analyzing gene expression modifications (mRNA signatures) induced by the immune response to various triggers, such as the onset of cancer. The company has developed state-of-the-art bioinformatics capabilities, in particular deep neural network and machine learning, to generate mathematical models based on these mRNA signature analyses to predict the onset and progression of disease. Machine learning enables the continuous improvement of test performances with collection of new data through the development of predictive and adaptive analytics algorithms.

About Colox for colorectal cancer

Colox is the first liquid biopsy molecular diagnostic CRC test based on ImmunoTranscriptomics signature. It has the highest performance for non-invasive detection of pre-cancerous lesions. Worldwide each year, more than one million new cases of CRC are diagnosed and 500,000 people die from the disease. Current standard of care for CRC screening is cumbersome and invasive. As a result, the majority of individuals at average risk resist testing. Colox is a blood test designed to screen adults aged 50 or older, who have an average-risk for CRC. Since the launch Colox on the Swiss self-pay market, over 4,000 patients have benefited from the test.

On May 13, 2019 Trillium Therapeutics Inc. (NASDAQ/TSX: TRIL), a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported financial results for the three months ended March 31, 2019 (Press release, Trillium Therapeutics, MAY 13, 2019, View Source [SID1234536228]).

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"We are continuing to make progress toward achieving our 2019 milestones," said Robert L. Kirkman, M.D., Executive Chairman of Trillium Therapeutics. "We have treated the first patient under our amended TTI-621 intravenous protocol that will allow us to dose cutaneous T-cell lymphoma patients beyond 0.5 mg/kg, one quarter ahead of schedule. We remain focused on our plan to seek FDA guidance in mid-2019 on a proposed pivotal trial of intratumoral TTI-621 in patients with cutaneous T-cell lymphoma. We also took steps to reduce our expenses and extend our cash runway without impacting the expected timing of our clinical milestones."

First Quarter 2019 Financial Results:

As of March 31, 2019, Trillium had cash and cash equivalents and marketable securities, and working capital of $52.4 million and $42.3 million, respectively, compared to $45.4 million and $34.2 million, respectively at December 31, 2018. The increase in cash and cash equivalents and marketable securities, and the increase in working capital was due mainly to an equity financing in February 2019.

Net loss for the three months ended March 31, 2019 of $10.7 million was higher than the loss of $8.6 million for the three months ended March 31, 2018. The net loss was higher due mainly to a net foreign currency loss of $557 for the three months ended March 31, 2019 compared to a net foreign currency gain of $1,553 in the prior year comparable quarter, and higher manufacturing costs, partially offset by lower clinical trial expenses.

On May 13, 2019 Neon Therapeutics, Inc. (Nasdaq: NTGN), a clinical-stage immuno-oncology company developing neoantigen-based therapeutics, reported financial results for the first quarter ended March 31, 2019 and provided a business update (Press release, Neon Therapeutics, MAY 13, 2019, View Source [SID1234536227]).

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"The field of cancer immunotherapy has advanced considerably in recent years, but there remains a significant need for new approaches that could extend the benefits of immunotherapy and lead to improved patient outcomes. Neoantigen-based therapies hold the promise to transform the treatment of cancer and we are proud of our leadership in pursuing these untapped targets," said Hugh O’Dowd, Neon’s Chief Executive Officer. "We continue to make important progress across the Company, including our efforts to establish RECON as the best-in-class neoantigen bioinformatic prediction engine with our machine learning and proteomics expertise. We intend to further strengthen our position as a class-leader in neoantigen selection by continuing to leverage proprietary immunogenicity data from our ongoing clinical studies. We remain excited about numerous upcoming clinical milestones, including the top-line results from our NT-001 study of NEO-PV-01, which we expect to be the first clinical dataset ever reported with 12-month follow-up for a personal neoantigen vaccine in metastatic melanoma, non-small cell lung and bladder cancers."

Pipeline Updates
Neon is developing neoantigen-targeting therapies across multiple treatment modalities, including vaccines, adoptive T cell therapies and TCR-based T cell therapies to bring benefit to a broad set of patients across tumor types and stages of disease. This approach requires effectively identifying and selecting the optimal neoantigen targets for the unique mutational fingerprint of each individual patient’s tumor. Neon is pioneering a proprietary neoantigen platform to identify and harness the most therapeutically relevant neoantigens, including through its RECON bioinformatic neoantigen prediction engine, deep capabilities in peptide chemistry and manufacturing, and NEO-STIM T cell biology and immune-monitoring expertise.
Neon is using two distinct neoantigen therapeutic approaches across this platform: personal therapies that target individualized mutations (NEON / ONE), and off-the-shelf precision therapies (NEON / SELECT) that target shared mutations present in sub-populations of cancer patients.
"Neon is pursuing novel therapeutic approaches at the frontiers of immuno-oncology. We designed our R&D strategy to enable us to determine how our neoantigen-targeted platform and product candidates could improve patient outcomes beyond the limitations of current standard of care treatment. Our near-term R&D strategy is focused on leveraging Phase 1b clinical trials to determine the optimal patient selection, rational combinations and trial designs to inform subsequent Phase 2 and later stage clinical trials," said Richard Gaynor, M.D., Neon’s President of Research and Development.
NEON / ONE is Neon’s personal medicine approach to neoantigen-targeted therapies that are tailored for the individual profile of each patient’s tumor. Neon’s initial clinical strategy has focused on solid tumor indications where checkpoint inhibitors have been approved, either in combination or in refractory settings.

NEO-PV-01: Personal Neoantigen Vaccine

NEO-PV-01: Neon is evaluating its lead product candidate, a personal neoantigen vaccine, in a variety of treatment settings in Phase 1b development to determine the optimal late-stage clinical trials.

NT-001 Trial: Neon’s ongoing Phase 1b open-label clinical trial is evaluating a combination of NEO-PV-01 with OPDIVO (nivolumab) in patients with metastatic melanoma, non-small cell lung cancer (NSCLC) or bladder cancer.

Neon recently presented updated data from NT-001 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, describing the immune and pathologic markers associated with study subjects remaining progression-free at nine months. The analysis both confirmed the mechanism of action of NEO-PV-01 and highlighted new data on the association between histology and epitope spread in patients who had not progressed at nine months in the melanoma cohort. In addition, multiple molecular markers were determined to correlate with lack of clinical progression, which may prove useful for patient selection in late-stage clinical trials.

Neon expects to report top-line clinical results, including 12-month follow-up, from NT-001 in July 2019. The results are expected to include data from an intention-to-treat (ITT) analysis from 82 enrolled patients, including median progression-free survival (PFS) and objective response rates (ORR), safety and baseline patient characteristics in each of the three tumor cohorts.

NT-002 Trial: Neon recently completed enrollment in NT-002, its Phase 1b clinical trial evaluating NEO-PV-01 in combination with the current standard of care, KEYTRUDA (pembrolizumab) and chemotherapy, in first-line patients with untreated advanced or metastatic NSCLC. This trial is evaluating the safety, tolerability and efficacy of NEO-PV-01 in the metastatic setting. Neon expects to report immune monitoring and clinical outcome data from this trial by the end of Q3 2020.

NT-003 Trial: This Phase 1b clinical trial of NEO-PV-01 in metastatic melanoma combinations is currently enrolling. NT-003 will evaluate NEO-PV-01 and OPDIVO in combination with other agents, including Apexigen’s CD40 agonist (APX005M) or a CTLA-4 antagonist, to further enhance any NEO-PV-01-induced neoantigen immune response and improve clinical outcomes. This trial will also evaluate alternative NEO-PV-01 dosing schedules. Neon plans to announce immune monitoring data from this study in 2H 2020.

NT-004 Trial: Neon is planning to explore NEO-PV-01 in a monotherapy approach in an earlier disease setting in this Phase 1b trial.

NEO-PTC-01: Personal Neoantigen T cell Therapy

NEO-PTC-01: Neon’s personal adoptive T cell therapy consists of multiple T cell populations targeting neoantigens that are predicted to be the most therapeutically relevant from each patient’s tumor. NEO-PTC-01 uses T cells from the periphery of each patient that are then primed, activated and expanded to generate a therapy that specifically targets that patient’s personal neoantigens, with the potential to drive a robust and persistent anti-tumor response.

CTA Filing: Building on success to date in generating both memory and de novo immune responses, Neon is completing process development, which supports its plan to file a Clinical Trial Application (CTA) in Europe in the second half of 2019 to evaluate NEO-PTC-01 in refractory solid tumor settings. This work is being performed in collaboration with the Netherlands Cancer Institute (NKI), a leading academic research and treatment center with expertise in T cell biology and treatments.
NEON / SELECT is Neon’s off-the-shelf precision approach to neoantigen-targeted therapies that seek to target prevalent neoantigens that are shared across subsets of patients or tumor types.

NEO-SV-01: Breast Neoantigen Vaccine

NEO-SV-01: Neon is planning to develop its off-the-shelf neoantigen vaccine for the treatment of a genetically-defined subset of hormone receptor-positive (HR+) breast cancer, potentially across disease stages in combination with hormonal, chemotherapy or targeted therapies.

IND Filing: Following the completion of target validation and preclinical product development work, Neon expects to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration for a Phase 1b clinical trial of NEO-SV-01 in Q2 2019.

TCR-based T cell Therapies

TCRs: Neon continues to advance its precision T cell approach and has assembled libraries of high-quality T-cell receptors (TCRs) against various shared neoantigens. Neon is leveraging its proprietary NEO-STIM

induction protocol to rapidly generate T cells specific to these targets where multiple TCRs can be sequenced and characterized.
Expected Milestones
Clinical Trial Results:

NEO-PV-01: Top-line clinical results, including 12-month follow-up, from NT-001 Phase 1b trial in metastatic melanoma, NSCLC and bladder cancers (July 2019)

NEO-PV-01: Clinical results and correlative immune data from NT-001 Phase 1b trial planned for presentation at a medical congress (2H 2019)

NEO-PV-01: Clinical results and correlative immune data, including 12-month follow-up, from NT-002 Phase 1b trial in first-line metastatic NSCLC (Q3 2020)

NEO-PV-01: Immune data from NT-003 Phase 1b trial in metastatic melanoma combinations (2H 2020)
Clinical Trial Applications/Initiations:

NEO-SV-01: U.S. IND filing to evaluate NEO-SV-01 in a genetically defined subset of HR+ breast cancer (Q2 2019)

NEO-PTC-01: European CTA filing to evaluate NEO-PTC-01 in a refractory solid tumor setting (2H 2019)
First Quarter 2019 Financial Results and Financial Guidance:

R&D Expenses: Research and development expenses were $16.2 million for the first quarter of 2019, compared to $13.2 million for the same period last year. The increase was primarily due to costs related to research and development of NEO-PV-01, NEO-PTC-01 and NEO-SV-01, as well as investments in R&D headcount to support the advancement of Neon’s pipeline.

G&A Expenses: General and administrative expenses were $5.4 million for the first quarter of 2019, compared to $3.6 million for the same period last year. The increase was primarily due to personnel-related expenses, professional fees to support expanding operations and costs associated with being a public company.

Net Loss: Net loss attributable to common stockholders was $21.0 million for the first quarter of 2019, compared to $19.7 million for the same period last year.

Cash Position: As of March 31, 2019, cash, cash equivalents and marketable securities were $81.3 million, as compared to cash, cash equivalents and marketable securities of $103.3 million as of December 31, 2018.

Financial Guidance: Based on its current operating plan, Neon expects that its existing cash, cash equivalents and marketable securities will enable the Company to fund its anticipated operating expenses and capital expenditure requirements into at least Q2 2020.
OPDIVO is a registered trademark of Bristol-Myers Squibb Company. KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

On May 13, 2019 Xenetic Biosciences, Inc. (NASDAQ: XBIO) ("Xenetic" or the "Company"), a clinical-stage biopharmaceutical company focused on the discovery, research and development of next-generation biologic drugs and novel orphan oncology therapeutics, reported its financial results for the quarter ended March 31, 2019 and provided a corporate update (Press release, Xenetic Biosciences, MAY 13, 2019, View Source [SID1234536226]).

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"We expect 2019 to be a transformative year for Xenetic. With the anticipated closing of our acquisition of XCART, our differentiated CAR T platform technology, on track for this quarter, I believe Xenetic will be well positioned to drive momentum in the innovation and development of new oncology therapeutics where there remains significant unmet need," commented Jeffrey Eisenberg, Chief Executive Officer of Xenetic. "We plan to focus our R&D efforts initially on leveraging the XCART platform to develop cell-based therapeutics for the treatment of B-cell Non-Hodgkin lymphomas. All of this marks a very important moment in the evolution of Xenetic, and I firmly believe the Company can become a significant player in the oncology space with this potentially transformative technology platform, providing therapeutic solutions for physicians and individuals fighting cancer and their families as well as driving value for our shareholders."

XCART Technology

On March 1, 2019, the Company entered into agreements to acquire a novel CAR T ("Chimeric Antigen Receptor T Cell") platform technology, called "XCART." XCART is a proximity-based screening platform capable of identifying CAR constructs that can target patient-specific tumor neoantigens, with a demonstrated proof of mechanism in B-cell Non-Hodgkin lymphomas. The XCART technology, developed by The Scripps Research Institute in collaboration with the Shemyakin-Ovchinnikov Institute of Bioorganic Chemistry, is believed to have the potential to significantly enhance the safety and efficacy of cell therapy for B-cell lymphomas by generating patient- and tumor-specific CAR T cells. The acquisition is subject to conditions typical for a transaction of this kind, including appropriate stockholder approvals, and is expected to close by the end of the second quarter.

The XCART technology platform was designed by its originators to utilize an established screening technique to identify peptide ligands that bind specifically to the unique B-cell receptor ("BCR") on the surface of an individual patient’s malignant tumor cells. The peptide is then inserted into the antigen-binding domain of a CAR, and a subsequent transduction/transfection process is used to engineer the patient’s T cells into a CAR T format which redirects the patient’s T cells to attack the tumor. Essentially, the XCART screening platform is the inverse of a typical CAR T screening protocol wherein libraries of highly specific antibody domains are screened against a given target. In the case of XCART screening, the target is itself an antibody domain, and hence highly specific by its nature. The XCART technology creates the possibility of personalized treatment of lymphomas utilizing a CAR with an antigen-binding domain that should only recognize, and only be recognized by, the unique BCR of a particular patient’s B-cell lymphoma.

An expected result for XCART is reduced off-tumor toxicities, such as B-cell aplasia. Xenetic’s clinical development program will seek to confirm the early preclinical results, and to demonstrate a more attractive safety profile than existing therapies.

Once the acquisition is consummated, the Company intends to pursue development efforts of the XCART technology as well as other development efforts in the area of CAR T therapy.

Summary of Financial Results for First Quarter 2019

Net loss for the three months ended March 31, 2019, was approximately $1.3 million compared to a net loss of approximately $1.8 million for the same period in 2018. Working capital (deficit) was approximately $1.2 million and $(0.4) million at March 31, 2019 and December 31, 2018, respectively. During the quarter ended March 31, 2019, the Company’s working capital increased by $1.6 million due to the issuance of common stock and warrants in our March 2019 offering resulting in $2.7 million of net proceeds to Xenetic. The Company ended the quarter with approximately $2.0 million of cash.

On May 13, 2019 Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, reported that it will participate in the Bank of America Merrill Lynch Health Care Conference 2019 in Las Vegas, NV (Press release, Halozyme, MAY 13, 2019, View Source [SID1234536225]). Laurie Stelzer, senior vice president and chief financial officer, will provide an overview of the company on Thursday, May 16 at 12:20 p.m. ET / 9:20 a.m. PT.

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A live webcast of the presentation can be accessed through the "Investors" section of www.halozyme.com, and a recording will be made available for 90 days following each event. To access a live webcast, please visit Halozyme’s website approximately 15 minutes prior to the presentation to register and download any necessary audio software.