On October 30, 2017 Five Prime Therapeutics, Inc. (Nasdaq:FPRX), a clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics, reported that new preclinical data demonstrating potent anti-tumor activity with FPT155, its novel therapeutic CD80-Fc fusion protein, were featured in a poster presentation yesterday during the 2017 AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) (Press release, Five Prime Therapeutics, OCT 30, 2017, View Source [SID1234521297]). The conference is being held October 26-30, 2017, in Philadelphia. A PDF of the poster, “FPT155, a novel therapeutic CD80-Fc fusion protein, with potent anti-tumor activity in preclinical models,” will be made available on the Publications page of the Five Prime website.

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“The work done in preclinical models with FPT155 suggests that it has the potential to be a potent T cell co-stimulator with strong antitumor activity, and it may have a synergistic effect when combined with anti-PD1 therapy,” said Bryan Irving, Ph.D., Senior Vice President of Research at Five Prime. “These results are very encouraging, and we are working to complete IND-enabling studies in anticipation of an IND filing for FPT155 in mid 2018.”

Five Prime has developed FPT155, a novel CD80 (B7.1) extracellular domain (ECD)-Fc fusion protein, as a co-stimulatory molecule designed to stimulate T cell activation and break tumor immune tolerance. In vitro studies show that FPT155 induces T cell activation and cytokine production via CD28, but is dependent on co-engagement of the T cell antigen receptor, differentiating it from a CD28 “superagonist.” A murine FPT155 was generated to investigate FPT155’s impact in preclinical models and was found to be well tolerated with potent efficacy in syngeneic tumor models, including the induction of complete tumor regression in the CT26 model. mFPT155 promotes the infiltration of T cells into the tumor core and increases the ratio of effector T cells to regulatory T cells, thus inducing a favorable microenvironment for an effective antitumor immune response. Furthermore, in preclinical studies combination of mFPT155 and anti-PD1 therapy leads to stronger antitumor efficacy compared to either therapy alone.

On October 30, 2017 Heat Biologics, Inc. ("Heat") (NASDAQ: HTBX), a biopharmaceutical company developing drugs designed to activate a patient’s immune system against cancer, reported that its subsidiary, Pelican Therapeutics, Inc. ("Pelican"), received the second tranche in the amount of $6.5 million of its $15.2 million Cancer Prevention and Research Institute of Texas (CPRIT) grant award (Press release, Heat Biologics, OCT 30, 2017, View Source [SID1234521298]). To-date, Pelican has received an aggregate of $8.3 million in grants from CPRIT.

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The CPRIT award supports the pre-clinical development, manufacturing and clinical development of a 70-patient Phase 1 clinical trial for PTX-35, the company’s lead asset. PTX-35 is a novel co-stimulatory monoclonal antibody against TNFRSF25, an emerging co-stimulatory receptor on T-cells. PTX-35, in combination with checkpoint inhibitors and other immunotherapy agents, has the potential to improve clinical responses for a broad range of patients by expanding the population of antigen-specific "memory" CD8+ T-cells – the immune cells critical in tumor eradication.

"We believe these funds will enable us to progress our manufacturing efforts and advance our pipeline, with the goal of addressing the unmet need for patients who don’t respond well to current cancer therapy," said Rahul Jasuja, Ph.D., CEO of Pelican.

On October 30, 2017 Aviragen Therapeutics, Inc. (NASDAQ:AVIR), a company focused on the discovery and development of direct-acting antivirals to treat infections that have limited therapeutic options, and Vaxart, Inc., a privately-held, clinical-stage company focused on developing oral recombinant vaccines based on its proprietary delivery platform that allows for administration by tablet rather than by injection, reported that the companies have entered into a definitive merger agreement (Press release, Aviragen Therapeutics, OCT 30, 2017, View Source [SID1234639795]). The merger will result in a combined company, Vaxart, Inc., focused on developing orally-delivered therapeutics and prophylactics to address a variety of viral infections.

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"We are thrilled with the prospect of combining forces with Aviragen, which will create a deep pipeline of antiviral products and allow Vaxart to accelerate development of the promising vaccine candidates that are based on our proprietary oral delivery platform," said Wouter Latour, M.D., Chief Executive Officer of Vaxart. "This transaction gives us the opportunity to build on the positive Phase 2 challenge study results we announced recently for our influenza oral tablet vaccine, as well as the excellent results we obtained in the safety and immunogenicity studies with our norovirus vaccine. Additionally, it will provide us access to Aviragen’s antiviral assets, including their BTA074 Phase 2 program for the treatment of condyloma caused by HPV, which is on track to complete enrollment this quarter and to report top-line safety and efficacy data in the second quarter of 2018."

"We believe our oral vaccine programs are significantly de-risked based on the positive clinical outcome of the BARDA-funded H1N1 influenza Phase 2 challenge study which serves as proof of concept for our technology platform as a whole," continued Latour, "and we look forward to taking our norovirus vaccine into a Phase 2 challenge study next. Norovirus is the leading cause of acute viral gastroenteritis in the United States, causing frequent outbreaks across the population, and we believe our oral tablet vaccine would be the optimal approach to address this unmet medical need."

The Vaxart technology platform has been engineered for the delivery of a wide range of oral vaccines, initially targeting norovirus, human papilloma virus (HPV), respiratory syncytial virus, and influenza, using a convenient and room temperature-stable tablet, which eliminates the need for injection. In clinical studies to date, Vaxart vaccines consistently generated broad systemic and local immune responses that could provide important advantages in preventing infection, as well as robust T cell responses that we believe are essential to obtain a therapeutic benefit in chronic viral infection and cancer.

"After a comprehensive review of strategic alternatives, we are delighted to announce this transaction with Vaxart, which will complement Aviragen’s focus on infectious diseases and position us to create both near and long-term value for our stockholders," said Joseph M. Patti, Ph.D., President and Chief Executive Officer of Aviragen Therapeutics. "Vaxart is well-funded to advance its norovirus and HPV antiviral vaccine programs, and together with BTA074, the combined companies are poised to provide meaningful value-creating data readouts."

Today, Vaxart will be announcing positive results from the company’s Phase 1b open-label, dose-ranging study assessing the safety and immunogenicity of VXA-G1.1-NN, Vaxart’s norovirus oral tablet vaccine, in 60 healthy adult volunteers. VXA-G1.1-NN met both the primary and secondary endpoints for safety and immunogenicity in the clinical trial. Based on the favorable clinical data, a Phase 2 norovirus challenge study is expected to begin in the second half of 2018. To date, Vaxart has dosed more than 300 adult volunteers with its vaccines for norovirus, respiratory syncytial virus and influenza.

About the Transaction

The exchange ratio in the merger agreement was determined by assigning $60 million in value to Aviragen for its financial and clinical assets and $90 million in value for Vaxart’s assets. On a pro forma basis, after giving effect to the number of shares of Aviragen common stock issued in the merger, Vaxart’s securityholders will own approximately 60% of the combined company and Aviragen securityholders will own approximately 40% of the combined company, subject to certain potential adjustments as described in the merger agreement. The transaction has been approved by the board of directors of both companies. The merger is expected to close in the first quarter of 2018, subject to the approval of the stockholders of each company as well as other customary conditions. Wouter Latour, M.D., will serve as Chief Executive Officer of the combined company.

Upon the closing of the transaction, the name of the combined company will become Vaxart, Inc. and shares of the combined are expected to continue trading on NASDAQ under the proposed ticker symbol "VXRT."

Stifel, Nicolaus & Company, Incorporated is acting as financial advisor to Aviragen, and Dechert LLP is serving as legal counsel to Aviragen. Cooley LLP is serving as legal counsel to Vaxart.

Aviragen will reduce its workforce by six to a total of 10 full-time employees, who will remain on board to complete the BTA074 Phase 2 clinical trial and assist with the transition of duties to the Vaxart management team.

Aviragen and Vaxart management will host a conference call this morning, Monday, October 30, 2017 at 8:30 a.m. EDT to discuss the planned merger. To participate in the conference call, please dial (877) 312-5422 (United States) or (253) 237-1122 (international) and refer to conference ID number 6295889. A replay of the conference call can be accessed under the Investors section of Aviragen’s website at www.aviragentherapeutics.com and on the Vaxart website at www.vaxart.com.

New data show that switching patients with Crohn’s disease (CD) to INFLECTRA (infliximab CT-P13) from REMICADE (infliximab) led to comparable efficacy, safety and tolerability to treatment with REMICADE over a 24 week period (Press release, Pfizer, OCT 30, 2017, View Source [SID1234521318]). The full 54-week results of the randomized controlled trial comparing INFLECTRA and REMICADE in biologic-naïve patients with active CD support the long-term effectiveness of treatment with INFLECTRA.1 The results also show that INFLECTRA was well-tolerated, with a similar safety profile to REMICADE.1 Pfizer Inc. (NYSE:PFE) and Celltrion Healthcare jointly announced the secondary outcomes from the phase III trial of INFLECTRA in CD at the 25th United European Gastroenterology (UEG) Week.

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*INFLECTRA is marketed as INFLECTRA (infliximab-dyyb) in the United States (U.S.) and under other brand names in some countries. In the EU, INFLECTRA is marketed as INFLECTRA (infliximab CT-P13)
**REMICADE is a U.S. registered trademark of Janssen Biotech, Inc.

"The data announced today show that 24 weeks (six months) after switching from REMICADE to the Infliximab biosimilar CT-P13, patients with Crohn’s disease continue to experience similar efficacy, safety and tolerability compared to staying on REMICADE," said Stephen B Hanauer, M.D., Professor of Medicine-Gastroenterology and Hepatology, Feinberg School of Medicine, Northwestern University, US. "These data support previous findings which demonstrate the importance of CT-P13 as a treatment option for patients with Crohn’s disease, providing healthcare professionals further confidence when stable patients switch to CT-P13 from REMICADE."

"These new data add to the considerable body of evidence, including real-world studies and the NOR-SWITCH trial, for the switching of stable patients to INFLECTRA," said Sam Azoulay, M.D., Senior Vice President, Chief Medical Officer, Pfizer Essential Health. "Today’s announcement further highlights Pfizer’s commitment to biosimilars and provides additional evidence supporting use of INFLECTRA in Crohn’s disease."

The study previously reported its primary endpoint at six weeks, demonstrating non-inferiority of INFLECTRA compared to REMICADE in the treatment of CD.2

More than 50 real-world studies in IBD have been conducted with INFLECTRA, evaluating over 7,500 IBD patients in real-world settings.2,3,4,5,6,7,8,9,10,11,12,13,14 There is an important and growing body of evidence for the switching of stable REMICADE patients to INFLECTRA. Clinical studies supporting this switch include NOR-SWITCH,15 BIO-SWITCH,16 PROSIT-BIO3 and now CT-P13 3.4.1,2,17 For example, the NOR-SWITCH study published earlier this year showed that switching from REMICADE to INFLECTRA was not inferior to continued treatment with REMICADE when measured across all adult indications.15

About the trial

This is a randomized, double-blind, parallel-group, phase III study conducted over 54 weeks in 220 patients with active CD to compare overall safety and efficacy between INFLECTRA and REMICADE as determined by the Crohn’s Disease Activity Index (CDAI)-70 response rates†.1 The primary endpoint of the 54 week study was collected at week 6 to demonstrate that INFLECTRA is non-inferior to REMICADE in the treatment of CD.2 From Week 30, patients on REMICADE were randomized to either continue on the same treatment or switch to INFLECTRA while patients on INFLECTRA were randomized to either continue on the same treatment or switch to REMICADE.1 Final study results were collected at 54-weeks.1

The pre-specified secondary endpoints reported today include CDAI-70 response rates after week 6, clinical remission,[1] Short Inflammatory Bowel Disease Questionnaire (SIBDQ)[2] results, and safety endpoints including adverse events and immunogenicity. While not powered to draw definitive conclusions, these new data add to the body of evidence supporting use of INFLECTRA in the Crohn’s Disease indication, including switch to INFLECTRA from REMICADE.1 Comparable efficacy, as measured by CDAI-70 response and clinical remission after week 6 was observed, and these response rates were maintained and observed to be similar in all study arms at week 54.1 One-year data including adverse drug reactions, serious adverse events and infections were observed to be similar among all treatment groups.1 There were no clinically meaningful differences in immunogenicity results throughout the study period among treatment groups up to week 54.1

† CDAI: Crohn’s Disease Activity Index, a recognised measure for the evaluation of disease activity. A response to treatment is measured as a decrease of 70 points or greater (CDAI-70).
[1] Clinical remission: decrease in CDAI >150 points
[2] Short Inflammatory Bowel Disease Questionnaire, a health-related quality of life tool measuring physical, social, and emotional status, and has been predominantly used in trials for Crohn’s disease.

ABOUT INFLECTRA: IMPORTANT SAFETY INFORMATION AND INDICATIONS FROM THE U.S. PRESCRIBING INFORMATION

Only your doctor can recommend a course of treatment after checking your health condition. INFLECTRA (infliximab-dyyb) can cause serious side effects such as lowering your ability to fight infections. Some patients, especially those 65 years and older, have had serious infections caused by viruses, fungi or bacteria that have spread throughout the body, including tuberculosis (TB) and histoplasmosis. Some of these infections have been fatal. Your doctor should monitor you closely for signs and symptoms of TB during treatment with INFLECTRA.

Unusual cancers have been reported in children and teenage patients taking TNF-blocker medicines. Hepatosplenic T-cell lymphoma, a rare form of fatal lymphoma, has occurred mostly in teenage or young adult males with Crohn’s disease or ulcerative colitis who were taking infliximab products and azathioprine or 6-mercaptopurine. For children and adults taking TNF blockers, including INFLECTRA, the chances of getting lymphoma or other cancers may increase.

You should discuss any concerns about your health and medical care with your doctor.

What should I tell my doctor before I take INFLECTRA?

You should let your doctor know if you have or ever had any of the following:

Tuberculosis (TB) or have been near someone who has TB. Your doctor will check you for TB with a skin test. If you have latent (inactive) TB, you will begin TB treatment before you start INFLECTRA.
Lived in a region where certain fungal infections like histoplasmosis or coccidioidomycosis are common.
Infections that keep coming back, diabetes, or an immune system problem.
Any type of cancer or a risk factor for developing cancer, for example, chronic obstructive pulmonary disease (COPD) or had phototherapy for psoriasis.
Heart failure or any heart condition. Many people with heart failure should not take INFLECTRA.
Hepatitis B virus (HBV) infection or think you may be a carrier of HBV. Your doctor will test you for HBV.
Nervous system disorders (like multiple sclerosis or Guillain-Barré syndrome).
Also tell your doctor if you:

Use the medicines Kineret (anakinra), Orencia (abatacept), or Actemra (tocilizumab) or other medicines called biologics used to treat the same problems as INFLECTRA.
Are pregnant, plan to become pregnant, are breast-feeding, or have a baby and were using INFLECTRA during your pregnancy. Tell your baby’s doctor about your INFLECTRA use. If your baby receives a live vaccine within 6 months after birth, your baby may develop infections with serious complications that can lead to death.
Recently received or are scheduled to receive a vaccine. Adults and children taking INFLECTRA should not receive live vaccines or treatment with a weakened bacteria (such as BCG for bladder cancer) while taking INFLECTRA.
What should I watch for and talk to my doctor about before or while taking INFLECTRA?

The following serious (sometimes fatal) side effects have been reported in people taking INFLECTRA.

You should tell your doctor right away if you have any of the signs listed below:

Infections (like TB, blood infections, pneumonia)—fever, tiredness, cough, flu, or warm, red, or painful skin or any open sores. INFLECTRA can make you more likely to get an infection or make any infection that you have worse.
Lymphoma or any other cancers in adults and children.
Skin cancer—any changes in or growths on your skin.
Heart failure—new or worsening symptoms, such as shortness of breath, swelling of your ankles or feet, or sudden weight gain.
Reactivation of HBV—feeling unwell, poor appetite, tiredness, fever, skin rash, and/or joint pain.
Liver injury—jaundice (yellow skin and eyes), dark brown urine, right-sided abdominal pain, fever, or severe tiredness.
Blood disorders—fever that doesn’t go away, bruising, bleeding, or severe paleness.
Nervous system disorders—numbness, weakness, tingling, changes in your vision, or seizures.
Allergic reactions during or after the infusion—hives, difficulty breathing, chest pain, high or low blood pressure, swelling of face and hands, and fever or chills.
Lupus-like syndrome—chest discomfort or pain that does not go away, shortness of breath, joint pain, rash on the cheeks or arms that gets worse in the sun.
Psoriasis—new or worsening psoriasis such as red scaly patches or raised bumps on the skin that are filled with pus.
The more common side effects with infliximab products are respiratory infections (that may include sinus infections and sore throat), headache, rash, coughing, and stomach pain.

INFLECTRA is a prescription medication used to treat:

Crohn’s Disease

Can reduce signs and symptoms and induce and maintain remission in adult patients with moderately to severely active Crohn’s disease who haven’t responded well to other therapies
Paediatric Crohn’s Disease

Can reduce signs and symptoms and induce and maintain remission in children (ages 6-17) with moderately to severely active Crohn’s disease who haven’t responded well to other therapies
Ulcerative Colitis

Can reduce signs and symptoms, induce and maintain remission, promote intestinal healing, and reduce or stop the need for steroids in adult patients with moderately to severely active ulcerative colitis who haven’t responded well to other therapies
Rheumatoid Arthritis

Can reduce signs and symptoms, help stop further joint damage, and improve physical function in patients with moderately to severely active rheumatoid arthritis, in combination with methotrexate
Ankylosing Spondylitis

Can reduce signs and symptoms in patients with active ankylosing spondylitis
Psoriatic Arthritis

Can reduce signs and symptoms of active arthritis, help stop further joint damage, and improve physical function in patients with psoriatic arthritis
Plaque Psoriasis

Approved for the treatment of adult patients with chronic severe (extensive and/or disabling) plaque psoriasis under the care of a physician who will determine if INFLECTRA is appropriate considering other available therapies
Please see full Prescribing Information for INFLECTRA (infliximab-dyyb).

On October 30, 2017 NewLink Genetics Corporation (NASDAQ:NLNK) reported that indoximod, its leading drug development candidate, was granted orphan-drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with Stage IIb-IV melanoma (Press release, NewLink Genetics, OCT 30, 2017, View Source [SID1234521301]).

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“We are pleased to receive this orphan drug designation from the FDA,” said Charles J. Link, Jr., MD, Chairman, Chief Executive Officer and Chief Scientific Officer. “This decision supports our ongoing clinical development plans for indoximod as we continue to pursue innovative treatments for patients with cancer.”

The FDA grants orphan drug designation to investigational drugs and biologics that are intended for the treatment of rare diseases that affect fewer than 200,000 people in the U.S. Incentives may include tax credits related to clinical trial expenses, an exemption from the FDA user fee, FDA assistance in clinical trial design and potential market exclusivity for seven years following approval.