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Geneos Therapeutics Secures $10.5 Million in Series A Financing to Develop the Next Generation of Neoantigen-Targeting Cancer Immunotherapies

On February 21, 2019 Geneos Therapeutics reported that it has closed its Series A round raising $10.5 Million in financing (Press release, Geneos Therapeutics, FEB 21, 2019, View Source [SID1234535369]). This funding will launch its operations as a standalone entity to develop the next generation of neoantigen-targeting cancer immunotherapies. Geneos, created as a spinout of Inovio Pharmaceuticals, Inc. (NASDAQ: INO) will leverage a proven immunotherapy platform ("Geneos Platform") under an exclusive license from Inovio in the field of personalized treatments for cancer. The Series A Financing, which includes a committed initial investment and a milestone driven option, is led by Santé Ventures and joined by Inovio.

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Cancer neoantigens – the mutations and genomic changes that accumulate as tumors develop – have been recognized as important targets in the development of immune mediated treatments for cancer. These are recognized by the immune system as being foreign and generate immune responses directed at the cancer. The Geneos Platform allows the company to develop exquisitely personalized therapies tailored to each patient’s own tumor mutations. The Geneos Platform is poised to deliver the following key advantages: ability to drive potent and broad T cell immune responses, capability to target an unprecedented number of neoantigens in a single formulation, and a rapid manufacturing turnaround time. Geneos, along with its collaborators at The Wistar Institute, recently published preclinical, proof-of-concept animal model data in the prestigious journal, Cancer Immunology Research, demonstrating the advantages of the Geneos Platform.

Dr. Niranjan Y. Sardesai, Chief Operating Officer of Inovio Pharmaceuticals, co-founded Geneos and has served as the company’s Chief Executive Officer. "Geneos holds the potential to become the leader in the development of personalized cancer immunotherapies to provide patients the chance for a cure" said Dr. Sardesai. "My confidence in this start-up, based on industry leading technology, rests on the fact that Geneos can create neoantigen-targeting immunotherapies against any cancer. Our immunotherapies can activate – in vivo – strong T cell responses (both CD4+ and CD8+). In addition, Geneos cancer fighting treatments can be designed in days instead of months or years. This funding will allow us to demonstrate clinical proof-of-concept for treating cancer at an individual patient level. I invite you to learn more about Geneos by visiting www.geneostx.com." Concurrently with the Series A financing, Dr. Sardesai resigned as Inovio COO and will dedicate all his efforts as Geneos’ CEO.

The Series A financing will enable the company to establish its operations and complete IND enabling activities towards the initiation of first-in-human clinical trials. As part of the new financing, Geneos will no longer be a wholly-owned subsidiary of Inovio Pharmaceuticals.

Geneos’ leaders begin operations with a track record of success in building immunotherapy-based companies. Backed by an extensive portfolio of globally issued or filed patents and regulatory experience in Phase I-III clinical development, Geneos takes an exclusive license of Inovio’s DNA-based immunotherapy platform for personalized cancer immunotherapy; while Inovio will continue to develop and commercialize population based (non-personalized) cancer immunotherapies and infectious disease vaccines based on its proprietary SynCon design. To date, the platform technology has demonstrated in multiple clinical trials, animal models, and peer-reviewed publications the ability to elicit a potent and tumor-specific immune response to fight cancer.

Dr. J. Joseph Kim, CEO, Inovio Pharmaceuticals, said, "Establishing Geneos with a patient-specific direction allows Inovio to focus on executing our strategies to develop and commercialize DNA-based vaccines and immunotherapies to attack the major cancer types and challenging infectious diseases affecting global populations. Geneos will build on Inovio’s technology offering patient-specific, tumor-targeted immunotherapies to the world, one patient at a time."

Dr. Sam Broder (former Director of the National Cancer Institute), joins Geneos’ founding Board of Directors alongside Dr. Sardesai, Dr. Kim, Dr. Casey Cunningham (CSO, Santé Ventures) and Dr. James Eadie (Partner, Santé Ventures). Leading the Series A investment, Dr. Eadie said, "We are pleased to be in at the start of Geneos as a standalone company. Neoantigens are increasingly recognized as an important area for therapeutic development and the Geneos platform addresses many of the current limitations to this approach. Niranjan and his team bring a wealth of experience in this area and we look forward to working with them as they build upon Inovio’s great work."

In addition to Dr. Broder, Geneos is advised by a world-leading group of inter-disciplinary experts spanning oncology basic research, clinical development, and commercialization who believe in the potential of the Geneos Platform to impact personalized cancer treatment. Joining the company on its Advisory Board are:

Dr. David B. Weiner, W. W. Smith Endowed Chair in Cancer Research, The Wistar Institute. Dr. Weiner will serve as the Chair of the company’s Advisory Board.
Dr. Chi Van Dang, Scientific Director, Ludwig Institute for Cancer Research and Professor, The Wistar Institute; and
Ms. Shawn Tomasello, former Chief Commercial Officer of Kite Pharmaceuticals and Pharmacyclics; and former President of the Americas, Hematology and Oncology, for Celgene

Bexion Pharmaceuticals, Inc. Announces the Opening of a Pediatric Phase I Safety Study Using BXQ-350 in the Treatment of Rare CNS and Solid Tumors

On April 18 2019 Bexion Pharmaceuticals, Inc., a clinical stage oncology company, reported the initiation of an open-label Phase 1 Safety Study of BXQ-350 (Press release, Bexion, APR 18, 2019, View Source [SID1234535542]). The first US site is Cincinnati Children’s Hospital Medical Center. This clinical trial will evaluate the safety of BXQ-350 and determine the maximum tolerated dose (MTD) in the pediatric population with recurrent solid tumors, brain tumors and diffuse intrinsic pontine gliomas (DIPG).

Phase 1 Adult Dose Ranging Study
In a Phase 1 Part 1 Adult Dose Ranging Study, BXQ-350 was well tolerated at all five doses tested with no dose limiting toxicities observed and no serious adverse events attributed to the therapy. Preliminary data in Part 2 of the Phase 1 support a safe and tolerable drug profile. Information about the Phase 1 Study of BXQ-350 in Adult Patients with Advanced Solid Tumors trial can be found at View Source

Phase I Pediatric Protocol
In December 2018, the FDA cleared a Phase I Pediatric Protocol as part of Bexion’s current IND to move BXQ-350 into the pediatric population.

"With this initiation of Pediatric Phase 1 studies, we are confirming our commitment to the pediatric patient community," stated Dr. Ray Takigiku, Founder and CEO of Bexion. "It is our goal to develop BXQ-350 as quickly as possible for both adult and pediatric cancer patients, particularly those with difficult to treat tumors including high grade gliomas and other brain tumors. We are very grateful to the patients, participating clinical trial sites, and our partners for their engagement and their support."

Technology supporting BXQ-350 was discovered over 15 years ago
The technology supporting BXQ-350 was discovered over 15 years ago by Dr. Xiaoyang Qi, a then faculty member at Cincinnati Children’s. CancerFree KIDS, a non-profit focused on eradicating cancer a life-threatening disease in children, provided the first grant that supported this discovery. Cincinnati Children’s licensed the technology to Bexion to continue development and ultimately commercialize the discovery.

"The very first research grant CancerFree KIDS ever awarded was to Dr. Qi in 2004", explained Ellen Flannery, Founder and Executive Director of CancerFree KIDS. "It was for the study that eventually led to the formation of Bexion Pharmaceuticals. We have followed this research and Bexion since that time, waiting for this pivotal moment of the initiation of a Pediatric Phase I trial. It is rare for a pediatric trial to happen so early in the development of a new treatment. CancerFree KIDS is grateful to Bexion, Cincinnati Children’s and CTI Clinical Trial and Consulting Services, Bexion’s Clinical Research Organization for initiating this trial as quickly as feasibly possible. This means we have an opportunity to get this extremely promising new treatment approved for the children who need it as quickly as possible."

Additional Sites Are Planned
Additional sites are planned, including Nationwide Children’s Hospital in Columbus, Ohio and several children’s hospitals in the western United States.

Soligenix Achieves Significant Enrollment Milestone for its Pivotal Phase 3 Clinical Trial of SGX942 in the Treatment of Oral Mucositis in Head and Neck Cancer

On April 18, 2019 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported that it has reached a significant milestone in the Phase 3 clinical study (the "DOM-INNATE" study) for SGX942 (dusquetide) in the treatment of oral mucositis in patients with head and neck cancer (HNC) (Press release, Soligenix, APR 18, 2019, View Source [SID1234535258]). Patient enrollment is sufficient to support the planned interim efficacy analysis by the independent Data Monitoring Committee (DMC).

In accordance with the clinical protocol, approximately 90 subjects have been enrolled into the study as required for the planned interim efficacy analysis. In the coming weeks, subjects that are currently enrolled will have their protocol assessments completed at participating study centers, including the primary endpoint assessment. The blinded data will be verified for accuracy by the Soligenix clinical team and the data set will be provided to an independent statistical analysis center that interacts directly with the DMC for the interim efficacy analysis. All participating subjects and study centers, as well as the Company, will remain blinded at all times.

The DMC is a group, independent of the Company, charged with safety oversight of the clinical study as well as the conduct of one, pre-specified interim efficacy analysis. One DMC member is a statistician, with the remainder consisting of clinicians knowledgeable and experienced in the disease indication being studied. The DMC convenes at pre-determined intervals (in accordance with a pre-defined charter) to review unblinded safety and efficacy data. The DMC has the power to recommend continuation or termination of the study based on the evaluation of these data. Specific recommendations include stopping the study for overwhelming efficacy, stopping the study for serious safety concern, stopping the study for futility, continuing enrollment in the study at the pre-specified sample size of approximately 190 subjects, or re-estimating sample size up or down to maintain the study’s statistical power.

"Completing the required enrollment to support the DMC interim analysis is a significant milestone for the SGX942 program," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "We must now wait for the last enrolled subject to reach the study’s primary endpoint measure, which will occur up to 16 weeks after entering the study. During this time, we will continue enrolling patients from the US and Europe into the trial, while looking forward to receiving the formal DMC recommendation in the September timeframe."

Soligenix has been working with leading oncology centers internationally, a number of which participated in the Phase 2 study, to advance this Phase 3 clinical trial referred to as the "DOM–INNATE" study (Dusquetide treatment in Oral Mucositis – by modulating INNATE immunity).

Based on the positive and previously published Phase 2 results (Study IDR-OM-01), the pivotal Phase 3 clinical trial (Study IDR-OM-02) is designed to be a highly powered, double-blind, randomized, placebo-controlled, multinational trial that seeks to enroll approximately 190 subjects with squamous cell carcinoma of the oral cavity and oropharynx who are scheduled to receive a minimum total cumulative radiation dose of 55 Gy fractionated as 2.0-2.2 Gy per day with concomitant cisplatin chemotherapy given as a dose of 80-100 mg/m2 every third week. Subjects are randomized to receive either 1.5 mg/kg SGX942 or placebo given twice a week during and for two weeks following completion of CRT. The primary endpoint for the study is the median duration of severe oral mucositis, assessed by oral examination at each treatment visit and then through six weeks following completion of CRT. Oral mucositis is evaluated using the WHO (World Health Organisation) Grading system. Severe oral mucositis is defined as a WHO Grade of ≥3. Subjects are followed for an additional 12 months after the completion of treatment.

Patient recruitment is anticipated to be completed 2019 with top-line results available in the first half of 2020, pending the outcome of the interim analysis.

About Oral Mucositis

Mucositis is the clinical term for damage done to the mucosa by anticancer therapies. It can occur in any mucosal region, but is most commonly associated with the mouth, followed by the small intestine. It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of mucositis, that mucositis affects approximately 500,000 people in the US per year and occurs in 40% of patients receiving chemotherapy. Mucositis can be severely debilitating and can lead to infection, sepsis, the need for parenteral nutrition and narcotic analgesia. The gastrointestinal damage causes severe diarrhea. These symptoms can limit the doses and duration of cancer treatment, leading to sub-optimal treatment outcomes.

The mechanisms of mucositis have been extensively studied and have been recently linked to the interaction of chemotherapy and/or radiation therapy with the innate defense system. Bacterial infection of the ulcerative lesions is now regarded as a secondary consequence of dysregulated local inflammation triggered by therapy-induced cell death, rather than as the primary cause of the lesions.

It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of oral mucositis, that oral mucositis in HNC is a subpopulation of approximately 90,000 patients in the US, with a comparable number in Europe. Oral mucositis almost always occurs in patients with HNC treated with CRT and is severe, causing inability to eat and/or drink, in >80% of patients. It is common (40-100% incidence) in patients undergoing high dose chemotherapy and hematopoietic cell transplantation, where the incidence and severity of oral mucositis depends greatly on the nature of the conditioning regimen used for myeloablation.

Oral mucositis in HNC remains an area of unmet medical need where there are currently no approved drug therapies.

About Dusquetide

Dusquetide (the active ingredient in SGX942) is an IDR, a new class of short, synthetic peptides. It has a novel mechanism of action whereby it modulates the body’s reaction to both injury and infection towards an anti-inflammatory, anti-infective and tissue healing response. IDRs have no direct antibiotic activity but, by modulating the host’s innate immune system responses, increase survival after infections caused by a broad range of bacterial Gram-negative and Gram-positive pathogens. It also accelerates resolution of tissue damage following exposure to a variety of agents including bacterial pathogens, trauma and chemo- and/or radiation therapy. Preclinical efficacy and safety has been demonstrated in numerous animal disease models including mucositis, colitis, macrophage activation syndrome (MAS) as well as bacterial infections, including melioidosis.

SGX942 has demonstrated safety in a Phase 1 clinical study in 84 healthy human volunteers. Positive efficacy results were demonstrated in an exploratory Phase 2 clinical study in 111 patients with oral mucositis due to CRT for HNC. Soligenix is working with leading oncology centers in the US and Europe to advance SGX942 in oral mucositis with the conduct of a pivotal Phase 3 clinical trial referred to as the "DOM–INNATE" study (Dusquetide treatment in Oral Mucositis – by modulating INNATE immunity).

SGX942 has received Fast Track Designation from the FDA for the treatment of oral mucositis as a result of radiation and/or chemotherapy treatment in HNC patients, as well as Promising Innovative Medicine designation in the United Kingdom by the Medicines and Healthcare Products Regulatory Agency for the treatment of severe oral mucositis in HNC patients receiving CRT. In addition, products containing the same active ingredient, dusquetide, have been granted Fast Track Designation as an adjunctive therapy with other antibacterial drugs, for the treatment of melioidosis and Orphan Drug Designations in the treatment of MAS and the treatment of acute radiation syndrome.

Soligenix has a strong intellectual property position in the IDR technology platform, including composition of matter for dusquetide and related analogs. Dusquetide was developed pursuant to discoveries made by Professors B. Brett Finlay, PhD and Robert Hancock, PhD of the University of British Columbia, Canada. Soligenix has received partial funding from NIH for its oral mucositis clinical studies. The Phase 2 study was supported with a Phase I SBIR grant (#R43DE024032) award, with the Phase 3 study being supported by a Phase II SBIR grant (#R44DE024032) award.

Key nonclinical and clinical findings from the dusquetide program can be found in the following publications:

"Targeting Innate Immunity to Treat Disease: Potential Therapeutic Applications" at View Source
"A novel approach for emerging and antibiotic resistant infections: Innate defense regulators as an agnostic therapy" at View Source
"Dusquetide: A Novel Innate Defense Regulator Demonstrating a Significant and Consistent Reduction in the Duration of Oral Mucositis in Preclinical Data and a Randomized, Placebo-Controlled Phase 2 Clinical Study" at View Source
"Dusquetide: Reduction in Oral Mucositis associated with Enduring Ancillary Benefits in Tumor Resolution and Decreased Mortality in Head and Neck Cancer Patients" at View Source

Gilead Sciences to Release First Quarter 2019 Financial Results on Thursday, May 2, 2019

On April 18, 2019 Gilead Sciences, Inc. (Nasdaq: GILD) reported that its first quarter 2019 financial results will be released on Thursday, May 2, after the market closes (Press release, Gilead Sciences, APR 18, 2019, View Source [SID1234535248]). At 4:30 p.m. Eastern Time, Gilead’s management will host a conference call to discuss the company’s financial results for the first quarter 2019 and provide a business update.

The live webcast of the call can be accessed at the company’s Investors page at View Source Please connect to the company’s website at least 15 minutes prior to the start of the call to ensure adequate time for any software download that may be required to listen to the webcast. Alternatively, please call 877-359-9508 (U.S.) or 224-357-2393 (international) and dial the conference ID 5259422 to access the call. Telephone replay will be available approximately two hours after the call through 8:00 p.m. Eastern Time, May 4, 2019. To access the replay, please call 855-859-2056 (U.S.) or 404-537-3406 (international) and dial the conference ID 5259422. The webcast will be archived on www.gilead.com for one year.

Heat Biologics CEO to Present at the ThinkEquity Conference in New York City

On April 18, 2019 Heat Biologics, Inc. (NASDAQ: HTBX), a biopharmaceutical company developing immunotherapies designed to activate a patient’s immune system against cancer, reported that Jeff Wolf, Chief Executive Officer, is scheduled to present at the ThinkEquity Conference on Thursday, May 2nd, at 8:00 AM Eastern Time, which is being held at The Mandarin Oriental Hotel in New York City (Press release, Heat Biologics, APR 18, 2019, View Source [SID1234535223]).

Additional information on the conference is available at, View Source