On March 12, 2019 Synlogic, Inc. (Nasdaq: SYBX), a clinical stage company applying synthetic biology to probiotics to develop novel, living medicines, reported its financial results for the fourth quarter and full year ended December 31, 2018 (Press release, Synlogic, MAR 12, 2019, View Source [SID1234534234]).

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"2019 is an exciting year for Synlogic as we continue to advance out platform and programs," said Aoife Brennan, M.B., Ch.B. Synlogic’s president and chief executive officer. "Data expected mid-year from clinical trials of SYNB1020 and SYNB1618, in patients with hyperammonemia and phenylketonuria, respectively, will guide our plans for future development of our Synthetic Biotic medicines in these areas and additional rare metabolic diseases. We are also exploring new applications of our platform as we advance our first immuno-oncology program toward submission of an Investigational New Drug (IND) application and into clinical studies. Furthermore, with our increased capability to manufacture clinical trial material, we are now in a position to advance our programs through development as expeditiously as possible."

2019 Priorities
Pipeline

Presentation of top-line data from Phase 1b/2a study of SYNB1020 in patients with cirrhosis and elevated blood ammonia expected by mid-year. The double-blind, placebo-controlled study is designed to assess safety and tolerability, the ability of orally administered SYNB1020 to lower blood ammonia as well as its effect on several exploratory measures associated with hyperammonemia in this population. These data will provide valuable information for both platform development and the development path for Synlogic’s hyperammonemia program.
Presentation of top-line data from study to evaluate SYNB1618 in patients with PKU expectedby mid-year. The second part of this double-blind, placebo-controlled study is designed to assess safety and tolerability of orally administered SYNB1618 in a single dose (N=4) and multiple dose cohort (N=10) of patients with phenylketonuria (PKU). Additional endpoints of the study will explore the production of biomarkers of SYNB1618 activity that are expected to provide information as to the differences in pharmacodynamics of the Synthetic Biotic medicine in patients versus healthy volunteers.
Advancement of SYNB1891 immuno-oncology program candidate to enable filing of an IND application in the second half of the year. SYNB1891 is an intra-tumorally administered Synthetic Biotic medicine engineered to produce cyclic di-AMP (CDA), an agonist of the STING pathway, that is designed to serve as a dual innate activator of the immune system as a potential treatment for solid tumors.
Continued progress and refinement of manufacturing and process development. Synlogic is developing and manufacturing solid oral Synthetic Biotic formulations suitable for Phase 2 clinical trials and beyond.
Advancement of new research programs to expand product pipeline.
Presentation and publication of data at major scientific and medical meetings.Synlogic is committed to publishing and presenting data that demonstrate the breadth of Synlogic’s Synthetic Biotic platform.
Advancement of collaboration. On March 6, 2019, Synlogic announcedthat its collaboration with AbbVie to develop a Synthetic Biotic medicine for the treatment of inflammatory bowel disease (IBD) had advanced into lead optimization triggering a milestone payment to Synlogic. The two companies will work together to develop and enable the selection of a suitable candidate for entry into IND-enabling studies.
Corporate

Continued strengthening of Synlogic’s leadership. In February 2019, Synlogic announced the appointment of Patricia N. Hurter, Ph.D.,Senior Vice President of Pharmaceutical and Preclinical Sciences at Vertex Pharmaceuticals, Inc.,to its board of directors. Synlogic is also conducting a search to fill the position of Chief Medical Officer vacated by Dr. Brennan.
Continued exploration of additional strategic opportunities. Synlogic expects to develop additional strategic collaborations to expand the reach of the Synthetic Biotic platform.
Fourth Quarter 2018 Financial Results
For the three months ended December 31, 2018, Synlogic reported a consolidated net loss of $11.9 million, or $0.47 per share, compared to a net loss of $11.7 million, or $0.74 per share, for the corresponding period in 2017.

Research and development expenses were $8.9 million for the three months ended December 31, 2018 compared to $7.7 million for the corresponding period in 2017. The increase was primarily due to an increase in compensation-related expenses associated with increased headcount and increases in expenses related to the lease of a larger facility at 301 Binney Street in Cambridge, Massachusetts, which Synlogic occupied in January 2018.

General and administrative expenses for the three months ended December 31, 2018 were $4.0 million compared to $4.3 million for the corresponding period in 2017. The decrease was primarily due to decreases in professional fees such as audit, legal and tax services, partially offset by increases in compensation-related expenses associated with increased headcount and increases in expenses related to the lease of Synlogic’s facility at 301 Binney Street.

Revenue was $0.1 million for the three months ended December 31, 2018 and December 31, 2017. Revenue is associated with the payments received for services performed under the Synlogic’s collaboration with AbbVie to develop a Synthetic Biotic medicine for the treatment of IBD.

As of December 31, 2018, Synlogic had cash, cash equivalents, and short-term investments of $122.7 million.

Full Year 2018 Financial Results
For the year ended December 31, 2018, consolidated net loss was $48.4 million, or $2.03 per share, compared to a consolidated net loss of $40.4 million, or $6.00 per share, for the year ended December 31, 2017. Revenues were $2.5 million for the year ended December 31, 2018, compared to $2.4 million for the same period in 2017. Total operating expenses were $53.8 million for the year ended December 31, 2018, compared to $43.3 million for the same period in 2017. The increase in operating expenses was primarily due to compensation-related expenses associated with increased headcount, increased expenses related to the lease of Synlogic’s facility at 301 Binney Street and increased external costs associated with development of Synlogic’s Synthetic Biotic programs, including process and formulation development, pre-clinical and clinical studies.

Conference Call & Webcast Information
Synlogic will host a conference call and live webcast today at 8:00 a.m. ET today, Tuesday, March 12, 2019. To access the live webcast, please visit the "Event Calendar" page within the Investors and Media section of the Synlogic website. Alternatively, investors may listen to the call by dialing +1 (844) 815-2882 from locations in the United States or +1 (213) 660-0926 from outside the United States. The conference ID number is 2181868. For those unable to participate in the conference call or webcast, a replay will be available for 30 days on the Investors and Media section of the Synlogic website.

On March 12, 2019 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage immunotherapeutics company, reported the closing of the previously announced registered direct offering of common units and pre-funded units receiving gross proceeds of $14 million (Press release, Altimmune, MAR 12, 2019, View Source [SID1234534252]).

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On March 8, 2019, the Company disclosed approximately $34.4 million in cash, cash equivalents and restricted cash as of December 31, 2018. Altimmune intends to use the cash on hand together with the net proceeds of approximately $12.7 million from this offering for the continued advancement and development activities for its product pipeline, strategic growth opportunities (including potential acquisitions and/or licensing transactions), and general working capital purposes.

Roth Capital Partners acted as sole placement agent for the offering.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

The securities described above were offered by Altimmune pursuant to a registration statement on Form S-3 (File No. 333-217034) that was declared effective by the Securities and Exchange Commission (SEC) on April 6, 2017. A final prospectus supplement and an accompanying prospectus relating to the offering were filed with the SEC on March 11, 2019 and are available on the SEC’s web site at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained by contacting Roth Capital Partners, LLC, Attention: Equity Capital Markets, 888 San Clemente Drive, Suite 400, Newport Beach, California 92660, by telephone at (800) 678-9147 or e-mail at [email protected].

On March, 12 2019 Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO – FR0010095596), ("Onxeo" or "the Company"), a clinical-stage biotechnology company specializing in the development of innovative drugs targeting tumor DNA Damage response (DDR) in oncology, in particular against rare or resistant cancers, reported its consolidated full-year financials, as of December 31, 2018, and provided a business update (Press release, Onxeo, MAR 12, 2019, View Source [SID1234534275]).

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On March 12, 2019 Vect-Horus and RadioMedix reported the signing of a Letter of Intent (LOI) to establish an agreement for the co-development of a Vect-Horus theranostic agent for the diagnostic and radiotherapy of Glioblastoma Multiforme (GBM) of the brain (Press release, RadioMedix, MAR 12, 2019, View Source [SID1234534235]).

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This partnership will marry the expertise of Vect-Horus in targeting tumors with its technology VECTrans and the know-how of RadioMedix in developing and conducting pre-clinical evaluation and clinical trials with radiopharmaceuticals.

GBM is the most common and most aggressive malignant type of primary brain tumors and is a serious and life-threatening condition. The theranostic agent targets the Low-Density Lipoprotein Receptor (LDLR), which is highly expressed on many cancer cells, including glioblastoma. Positron Emission Tomography (PET) imaging and biodistribution studies in human glioblastoma xenograft and orthotopic models have shown a significant accumulation of the agent within the tumor.

"We are pleased that our technology, VECTrans in combination with expertise of RadioMedix will serve to advance an innovative and promising approach for glioblastoma treatment." said Alexandre Tokay, CEO of Vect-Horus "This co-development project is fully aligned with our strategy to expand the use of our technology in cancer indications with high unmet medical needs."
"We look forward to very compelling outcomes from our co-development project, as we seek to create new technologies for the benefit of cancer patients, by giving doctors and hospitals more imaging and treatment options." Said D.r Jamal Temsamani, Director of Drug Development of Vect-Horus.

"Development of a highly sensitive and effective theranostic approach for GBM has always been among our top priorities. Our initial evaluation of VECTrans technology appears to be extremely promising." said D.r Ebrahim Delpassand, CEO of RadioMedix. "Our plan is to utilize VECTrans technology to initially develop an accurate molecular diagnostic PET/CT probe to precisely map the tumor involvement in the brain. This will significantly improvethe precision of the surgical resection of the tumor. The treatment will then be followed by targeted alpha-emitter or beta-emitter radionuclide therapy using the same technology to eradicate any residual malignant cells at the molecular level" added Dr. Delpassand.

"RadioMedix has strong interests and all expertise needed to develop the VECTrans–based radio-theranostic agents for GBM", said Izabela Tworowska, Ph.D., CSO of RadioMedix. "Targeting LDLR can improve the blood-brain barrier (BBB) permeability of the drug and selectively deliver the isotope payload to GBM cancer cells."

On March 12, 2019 Eli Lilly and Company (NYSE: LLY) reported that its Phase 3 RELAY study of CYRAMZA (ramucirumab) met its primary endpoint of progression-free survival (PFS), demonstrating a statistically significant improvement in the time patients lived without their cancer growing or spreading after starting treatment (Press release, Eli Lilly, MAR 12, 2019, View Source [SID1234534255]). The Phase 3 global, randomized, double-blind trial is evaluating CYRAMZA in combination with erlotinib, compared to placebo in combination with erlotinib, as a first-line treatment in patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have activating EGFR mutations.

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The safety profile observed in the RELAY study was consistent with what has been previously observed for CYRAMZA in Phase 3 clinical trials and the established safety profile of erlotinib. The most common (>5% incidence) Grade ≥3 adverse events occurring at a higher rate (≥5% difference) on the CYRAMZA-plus-erlotinib arm compared to the placebo-plus-erlotinib arm were hypertension, dermatitis acneiform (an acne-like rash), and diarrhea. Detailed efficacy and safety results will be submitted for presentation at a medical meeting in 2019.

"Despite recent treatment advances in metastatic EGFR-mutated non-small cell lung cancer, prognosis remains poor and there is an ongoing need for additional first-line treatment options to help patients with this deadly disease," said Maura Dickler, M.D., vice president of late phase development, Lilly Oncology.

There is no cure for people with metastatic lung cancer. The disease is associated with low survival rates and disease progression following acquired resistance remains a challenge. Most patients receive several lines of treatment and the therapeutic regimen prescribed for first-line treatment can impact a person’s options for later lines of treatment. Tyrosine kinase inhibitors (TKIs) are the current standard treatment option for EGFR-mutated NSCLC. Erlotinib, the TKI included in the RELAY trial regimen, is a globally recognized standard of care for this type of lung cancer.

"We are excited about these results, which show CYRAMZA plus erlotinib significantly delayed disease progression in this patient population. The RELAY trial is another example of Lilly’s deep commitment to providing new treatment options to patients with lung cancer," said Dr. Dickler. "We would like to thank the patients, investigators and clinical trial sites that are participating in the RELAY study, and we look forward to working with regulatory authorities globally on our submissions."

Lilly intends to initiate global regulatory submissions in mid-2019.

RELAY is the second positive Phase 3 study of CYRAMZA in metastatic NSCLC. In the positive Phase 3 REVEL study, CYRAMZA plus docetaxel was compared to placebo plus docetaxel in people with metastatic NSCLC whose cancer had progressed on or after prior platinum-based chemotherapy for locally advanced or metastatic disease. The primary endpoint of overall survival was met, as well as key secondary endpoints of PFS and response rate. The REVEL results supported CYRAMZA’s current indication in second-line NSCLC.

Results of previously completed Phase 3 studies of CYRAMZA have also supported approvals in second-line gastric and colorectal cancer. Based on the REACH-2 results, Lilly has made regulatory submissions in the U.S., EU and Japan for the use of CYRAMZA in second-line treatment of patients with hepatocellular carcinoma.

About the RELAY Trial
RELAY is a global randomized, double-blind, placebo-controlled Phase 3 study of CYRAMZA in combination with erlotinib, compared to placebo in combination with erlotinib, as a first-line treatment in previously untreated patients with metastatic NSCLC whose tumors have EGFR (epidermal growth factor receptor) exon 19 deletions or exon 21 (L858R) substitution mutations. Initiated in 2015, the study randomized 449 patients across North America, Europe and Asia. The primary endpoint of the RELAY trial is progression-free survival; key secondary endpoints include safety, response rate, overall survival, and patient-reported outcomes.

About Lung Cancer and EGFR Mutations
Lung cancer is the leading cause of cancer death in the U.S. and most other countries, killing nearly 1.7 million people worldwide each year.1 In the U.S., lung cancer is responsible for approximately 25 percent of all cancer deaths, more than those from breast, colon and prostate cancers combined.2 Non-small cell lung cancer (NSCLC) is much more common than other types of lung cancer and accounts for about 80 to 85 percent of all lung cancer cases.3 Stage IV NSCLC is a very difficult-to-treat cancer and the prognosis is poor for metastatic NSCLC.4

EGFR is a protein that helps cells grow and divide. When the EGFR gene is mutated it can cause the protein to be overactive, resulting in the formation of cancer cells. EGFR mutations may occur in 10 to 35 percent of NSCLC tumors globally.5 Activating EGFR mutations are found in about 10 to 20 percent of Caucasian patients with lung adenocarcinomas and in up to 40 to 60 percent of Asian patients.6,7,8 Regardless of ethnicity, these mutations are commonly found in females, non-smokers and those with adenocarcinoma histology.9,10 The most common EGFR mutations are activating exon 19 deletion and exon 21 (L858R) substitution mutations, which are present in over 90 percent of EGFR-mutated tumors.7,8

About CYRAMZA (ramucirumab)
In the U.S., CYRAMZA (ramucirumab) is approved for use as a single agent or in combination with paclitaxel as a treatment for people with advanced or metastatic gastric (stomach) or gastroesophageal junction (GEJ) adenocarcinoma whose cancer has progressed on or after prior fluoropyrimidine- or platinum-containing chemotherapy. It is also approved in combination with docetaxel as a treatment for people with metastatic non-small cell lung cancer (NSCLC) whose cancer has progressed on or after platinum-based chemotherapy. Additionally, it is approved with FOLFIRI as a treatment for people with metastatic colorectal cancer (mCRC) whose cancer has progressed on or after therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine.

CYRAMZA is being investigated in a broad global development program that has enrolled more than 14,000 patients across more than 100 trials worldwide. These include several studies investigating CYRAMZA in combination with other anti-cancer therapies for the treatment of multiple tumor types.

Ramucirumab is an antiangiogenic therapy. It is a vascular endothelial growth factor (VEGF) Receptor 2 antagonist that specifically binds and blocks activation of VEGF Receptor 2 by blocking the binding of VEGF receptor ligands VEGF-A, VEGF-C, and VEGF-D. Ramucirumab inhibited angiogenesis in an in vivo animal model.

About Angiogenesis and VEGF Protein
Angiogenesis is the process of making new blood vessels. In a person with cancer, angiogenesis creates new blood vessels that give a tumor its own blood supply, allowing it to grow and spread.

Some tumors create proteins called VEGF. These proteins attach to the VEGF receptors of blood vessel cells causing new blood vessels to form around the tumors, enabling growth. Blocking the VEGF protein from linking to the blood vessels helps to inhibit tumor growth by slowing angiogenesis and the blood supply that feeds tumors. Of the three known VEGF receptors, VEGF Receptor 2 is linked most closely to VEGF-induced tumor angiogenesis.

INDICATIONS
Gastric Cancer
CYRAMZA, as a single agent or in combination with paclitaxel, is indicated for the treatment of patients with advanced or metastatic, gastric or gastroesophageal junction (GEJ) adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy.

Non-Small Cell Lung Cancer
CYRAMZA, in combination with docetaxel, is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with disease progression on or after platinum-based chemotherapy. Patients with epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving CYRAMZA.

Colorectal Cancer
CYRAMZA, in combination with FOLFIRI (irinotecan, folinic acid, and 5-fluorouracil), is indicated for the treatment of patients with metastatic colorectal cancer (mCRC) with disease progression on or after prior therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine.