On November 7, 2018 Savara Inc. (Nasdaq: SVRA), an orphan lung disease company, reported financial results for the third quarter ending September 30, 2018 and provided a business update (Press release, Savara, NOV 7, 2018, View Source [SID1234530912]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are creating a differentiated orphan lung disease company through a portfolio of investigational programs addressing significant unmet need in rare respiratory diseases," said Rob Neville, Chief Executive Officer, Savara. "This past quarter’s achievements demonstrate considerable progress with our lead candidate, Molgradex, and in the coming year we look forward to numerous important data read-outs from our three clinical studies, two of which are pivotal. Additionally, we expect Savara’s pipeline, buoyed by indication expansion and product acquisitions, to facilitate sustainable growth now and in the future."

Recent Developments and Upcoming Highlights

Molgradex for autoimmune pulmonary alveolar proteinosis (aPAP)

Completed enrollment of 139 patients in the IMPALA study, a global, pivotal Phase 3 clinical study evaluating Molgradex, an inhaled formulation of granulocyte-macrophage colony-stimulating factory (GM-CSF) for the treatment of aPAP.
Expect top line results from the IMPALA study in Q2 2019. Positive results would facilitate the submission of a Biologic License Application in the first half of 2020, with an anticipated commercial launch in the U.S. and EU in 2020 or early 2021.
Continue active enrollment in IMPALA-X, an open-label, multicenter extension study to determine the long-term safety and utilization of Molgradex in patients with aPAP.
Announced a partnership with the PAP Foundation to support their efforts to unite, educate and assist the PAP patient community, including work to further expand the PAP patient registry.
Molgradex for nontuberculous mycobacterial (NTM) lung infection

Completed enrollment of 32 patients in the OPTIMA study, a Phase 2a clinical study evaluating Molgradex for the treatment of NTM lung infection.
Expect interim results from the OPTIMA study in Q4 2018.
Anticipate top line results from the OPTIMA study in Q2 2019.
The Investigational New Drug application for Molgradex in cystic fibrosis (CF)-affected individuals with chronic NTM lung infection has been accepted by the U.S. Food and Drug Administration. Savara expects to initiate a Phase 2a study of Molgradex in CF subjects with NTM lung infection in Q1 2019.
Completed license agreement with Mayo Clinic, enabling inclusion of Mayo clinical data in Savara’s patent applications related to NTM.
AeroVanc

Continue patient enrollment in the AVAIL study, a pivotal, global Phase 3 clinical study of AeroVanc, an inhaled vancomycin hydrochloride powder for the treatment of persistent methicillin resistant staphylococcus aureus, or MRSA, lung infection in CF. At the end of Q3, patient enrollment was at 126 out of a target of 200.
Continue to target completion of patient enrollment in the AVAIL study in Q1 2019, with top line data in H2 2019.
Exploratory Pipeline

Expect to announce the initial indication for the Phase 2-ready aerosolized amikacin/fosfomycin proprietary combination antibiotic early in 2019, with an anticipated study-start later in 2019.
Financials

Successfully closed a public offering at the end of July with net proceeds to Savara of approximately $45.8 million.
Third Quarter Financial Results
Savara’s net loss attributable to common stockholders for the three months ended September 30, 2018 was $12.6 million, or $(0.37) per share, compared with a net loss attributable to common stockholders of $6.8 million, or $(0.28) per share, for the three months ended September 30, 2017.

Research and development expenses were $9.5 million for the three months ended September 30, 2018, compared with $5.0 million for the three months ended September 30, 2017. This increase was primarily due $2.5 million in additional expenses associated with AeroVanc Phase 3 study activities and $2.5 million in development costs of Molgradex, including the expansion of the aPAP study in the U.S. and costs associated with the Phase 2 NTM study. Conversely, the total research and development costs for the three months ended September 30, 2017 included approximately $0.4 million related to the Aironite program, which was assumed in the merger with Mast Therapeutics, Inc. in April 2017 and subsequently terminated in the first quarter of 2018.

General and administrative expenses for the three months ended September 30, 2018 were $3.1 million, compared with $1.5 million for the three months ended September 30, 2017. This increase was primarily due to $1.5 million additional costs related to personnel. The remaining increase in expense was associated with continued legal and accounting requirements for a public company.

Other income of $0.1 million was recognized for the three months ended September 30, 2018 as compared to other expense of $0.4 million for the three months ended September 30, 2017. The change was primarily due to additional interest income attributable to an increased balance maintained in our short-term investments for the three months ended September 30, 2018, as compared to that for the three months ended September 30, 2017.

As of September 30, 2018, Savara had a debt balance of approximately $15.0 million and had cash, cash equivalents and short-term investments of approximately $112.0 million.

Conference Call and Webcast
Savara will hold a conference call today beginning at 5:30 PM Eastern Time/4:30 PM Central Time to provide a business update. Shareholders and other interested parties may access the conference call by dialing (855) 239-3120 from the U.S., (855) 669-9657 from Canada, and (412) 542-4127 from elsewhere outside the U.S. and request the "Savara Inc." call. A live webcast of the conference call will be available online in the Investors section of Savara’s website at View Source A replay of the webcast will be available on Savara’s website for 30 days, and a telephone replay will be available through November 12, 2018 by dialing (877) 344-7529 from the U.S., (855) 669-9658 from Canada and (412) 317-0088 from elsewhere outside the U.S. and entering the replay access code 10125683

On November 7, 2018 DURECT Corporation (Nasdaq: DRRX) reported financial results for the three months ended September 30, 2018 and provided a corporate update (Press release, DURECT, NOV 7, 2018, http://investors.durect.com/phoenix.zhtml?c=121590&p=irol-newsArticle&ID=2375965 [SID1234530911]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Total revenues were $8.0 million and net loss was $2.7 million for the three months ended September 30, 2018 as compared to total revenues of $20.7 million and net income of $6.1 million for the three months ended September 30, 2017. The third quarter of 2018 included a $5 million milestone payment from Indivior related to the FDA approval of PERSERIS (risperidone). The third quarter of 2017 included $12.5 million in revenues from the upfront payment related to a patent purchase agreement with Indivior.
At September 30, 2018, cash and investments were $41.5 million, compared to cash and investments of $36.9 million at December 31, 2017. Debt at September 30, 2018 was $19.9 million.
"During the third quarter, we benefited from two product approvals through corporate relationships, most notably U.S. FDA approval of Indivior’s PERSERIS to treat adults with schizophrenia, as well as the Taiwan Ministry of Health and Welfare’s approval of Orient Pharma’s Methydur Sustained Release Capsules to treat patients with ADHD," stated James E. Brown, D.V.M., President and CEO of DURECT. "We expect anticipated earn-outs and royalties from these approvals to begin providing cash flow, starting next year, that will help finance the development of our proprietary pipeline, including DUR-928, which we are currently evaluating in two Phase 2a clinical trials in alcoholic hepatitis (AH) and primary sclerosing cholangitis (PSC). We are planning to accelerate enrollment in the AH trial by enrolling both moderate and severe AH patients simultaneously going forward. In addition, we plan to initiate a Phase 2a clinical trial of topical DUR-928 in patients suffering from psoriasis in the first quarter of 2019, and a trial in nonalcoholic steatohepatitis (NASH) patients in the first half of 2019."

Update on Selected Programs:

Epigenetic Regulator Program. DUR-928, the lead product candidate in the Company’s Epigenetic Regulator Program, is an endogenous, first-in-class small molecule, which may have broad applicability in several hepatic and renal diseases such as NASH and PSC, in acute organ injuries such as AH and acute kidney injury (AKI), and in inflammatory skin disorders such as psoriasis and atopic dermatitis.

Ongoing Clinical Trials

Alcoholic Hepatitis (AH)

DURECT is conducting a Phase 2a clinical trial with intravenously administered DUR-928 in patients with AH. This is an open label, dose escalation, multi-center U.S. study, originally designed to be conducted in two sequential parts. Part A includes patients with moderate AH (as determined by the Model of End-Stage Liver Disease (MELD) scores, a common scoring system to assess the severity and prognosis of AH patients), and Part B includes patients with severe AH. Three dose levels (30, 90 and 150 mg) are planned for testing in Part A. Dose escalation occurs following review of safety and pharmacokinetic (PK) results of the prior dose level by a Dose Escalation Committee (DEC). The target number of patients for the study is 4-6 per dose group. The objectives of this study include safety, PK and pharmacodynamic (PD) signals, including liver biochemistry and biomarkers. Additional information on the trial design, including eligibility criteria and site locations, can be found at www.clinicaltrials.gov using the NCT Identifier NCT03432260.
The Company recently completed dosing for the low-dose 30 mg cohort (n=4) of Part A (moderate AH patients). After completing the safety and PK review by the DEC, DURECT plans to commence the 90 mg cohort in Part A.
The Company has amended the protocol so that after the DEC completes its review, DURECT can begin enrolling Part B (severe AH patients), starting with the low dose, while it simultaneously continues enrolling Part A (moderate AH patients). The Company believes enrolling Part A and B simultaneously will accelerate the overall timeline for the trial. Over the course of the trial, the clinical sites have encountered many severe AH patients who may have qualified for Part B but were deemed screen failures due to their MELD scores being too high for Part A.
AH is a syndrome of progressive inflammatory liver injury associated with long-term heavy intake of alcohol, and encompasses a spectrum that ranges from mild injury to severe, life threatening liver damage. The prevalence of AH is estimated to occur in 10-35% of heavy drinkers. According to an article in the Journal of Clinical Gastroenterology (2015 July; 49(6): 506-511), there were over 320,000 hospitalizations related to alcoholic hepatitis in 2010, resulting in hospitalization costs of nearly $50,000 per patient.
Primary Sclerosing Cholangitis (PSC)

The Company is currently conducting a Phase 2a clinical trial in PSC with orally administered DUR-928. This is a randomized, open label, multi-center study with two cohorts (10 mg and 50 mg), in which patients (n = 15-20 per cohort) receive daily oral dosing of DUR-928 for four weeks with follow-up for an additional four weeks. The objectives of this study include safety, PK and PD signals, including the percent change from baseline of serum alkaline phosphatase (ALP) and other biomarkers. Additional information on the trial design, including eligibility criteria and site locations, can be found at www.clinicaltrials.gov using the NCT Identifier NCT03394781. To date, five PSC patients have been dosed, and as such the Company is not able to provide meaningful interim data at this time. The Company plans to continue enrolling patients and will provide an update when enrollment has reached a critical mass for data analysis.
PSC is a chronic liver disease characterized by a progression of cholestasis (decrease in bile flow) with inflammation and fibrosis of bile ducts. DUR-928 has been awarded orphan drug designation for the PSC indication.
Planned Clinical Trials

Psoriasis

The Company is planning to conduct a Phase 2a proof-of-concept trial with topical DUR-928 in patients with mild to moderate plaque psoriasis beginning in the first quarter of 2019. This will be a multicenter, randomized, double-blind, vehicle-controlled clinical trial conducted in the U.S. Approximately 20 subjects will be enrolled to obtain about 15 evaluable subjects in the study. DUR-928 will be applied topically once-daily for four weeks. Patients will serve as their own controls, as each patient will have similar contralateral plaques. DUR-928 will be applied to one plaque and the vehicle control will be applied to the contralateral plaque daily for four weeks. Patients will be followed for an additional four weeks and the primary efficacy endpoint will be improvement in local psoriasis scores in the DUR-928-treated plaque compared to the vehicle-treated plaque.
The Company observed activity of DUR-928 in a previous exploratory Phase 1b trial utilizing intralesional injections of DUR-928 in psoriasis patients. In support of the upcoming study, it has completed multiple non-clinical safety studies for topically applied DUR-928.
Skin inflammatory disorders, such as psoriasis and atopic dermatitis, affect approximately 7.5 million and 32 million Americans, respectively. Most currently available topical treatments, typically as first line therapy, either slow down excessive skin cell proliferation or reduce inflammation. Steroids are the most commonly used topical anti-inflammatory agents because they reduce the swelling and redness of lesions.
Non-Alcoholic Steatohepatitis (NASH)

DURECT is planning to conduct a clinical trial in NASH patients with orally-administered DUR-928 beginning in the first half of 2019. Further details on study design and timing will be provided as the Company gets closer to initiation. In the Company’s previous Phase 1b NASH study, reported at the European Association for the Study of the Liver (EASL) in April 2017, a reduction of certain biomarkers after a single oral dose of DUR-928 was observed. Exploratory biomarker analysis indicated that a single oral dose of DUR-928 in NASH patients resulted in statistically significant reductions from baseline of both full-length and cleaved cytokeratin-18 (CK-18), bilirubin, hsCRP and IL-18.
Indivior Agreement and PERSERIS. In September 2017, the Company entered into a patent purchase agreement with an affiliate of Indivior PLC, whereby the Company assigned certain of its U.S. patent rights to Indivior. This assignment may provide further intellectual property protection for PERSERIS (risperidone) extended-release injectable suspension for the treatment of schizophrenia in adults.

Under the terms of the agreement, Indivior made an upfront non-refundable payment to the Company of $12.5 million. Indivior also agreed to make an additional $5 million payment to the Company based on NDA approval of PERSERIS, as well as quarterly earn-out payments that are based on a single digit percentage of U.S. net sales for certain products covered by the patent rights, including PERSERIS. The patent rights include granted patents extending through at least 2026. In July 2018, the FDA approved the NDA for PERSERIS and the Company received the $5 million milestone payment in August 2018. On November 1, 2018, Indivior stated that they are preparing a full promotional launch of PERSERIS with a field force of 40 to 60 representatives, contingent upon the preliminary injunction against Dr. Reddy’s Laboratories being upheld by the U.S. Court of Appeals for the Federal Circuit. Indivior further stated that they will be making PERSERIS available in the U.S. in Q4 2018 to begin generating product awareness and trial. For more information on PERSERIS, please see Indivior’s earnings press release dated November 1, 2018. U.S. sales of long acting injectables to treat schizophrenia were in excess of $3 billion in 2017.

POSIMIR (SABER-Bupivacaine) Post-Operative Pain Relief Depot. POSIMIR is the Company’s investigational post-operative pain relief depot that utilizes the Company’s patented SABER technology and is designed to deliver bupivacaine to provide up to 3 days of pain relief after surgery.

In October 2017, the Company reported that PERSIST, a Phase 3 clinical trial for POSIMIR did not meet its primary efficacy endpoint of reduction in pain on movement as compared to standard bupivacaine HCl over the first 48 hours after surgery. While the efficacy results trended in favor of POSIMIR versus the comparator, they did not achieve statistical significance. In May 2018, the Company amended its U.S. licensing agreement with Sandoz, pursuant to which DURECT is now eligible for up to $30 million in milestone payments based on NDA approval, and remains eligible for up to an additional $230 million in sales-based milestones. Each party, pursuant to the Amendment, is also permitted to develop or commercialize competing products. The Amendment also includes modifications to DURECT’s development obligations and to both parties’ termination provisions, including a right for DURECT to terminate for convenience prior to NDA approval. There is also a new termination fee payable to DURECT in the event that Sandoz terminates the agreement for convenience. The agreement between the two companies remains in full force and effect, except as expressly covered in the Amendment. DURECT continues to evaluate and consider potential next steps with the program.

Methydur Sustained Release Capsules (ORADUR-methylphenidate ER Capsules). In September 2018, Orient Pharma informed DURECT that it had obtained marketing authorization from the Ministry of Health and Welfare in Taiwan for Methydur Sustained Release Capsules. This product is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) and will be available in three strengths (22 mg, 33 mg and 44 mg) in Taiwan. Orient Pharma also has stated that it expects to make Methydur Sustained Release Capsules commercially available in Taiwan in 2019, while seeking a partner in China and pursuing regulatory approvals in selected other countries where it has commercialization rights and a commercial presence.

In August 2009, DURECT entered into a development and license agreement with Orient Pharma Co., Ltd., a diversified multinational pharmaceutical, healthcare and consumer products company with headquarters in Taiwan. In this agreement, DURECT granted to Orient Pharma the development and commercialization rights to ORADUR-Methylphenidate ER Capsules (Methydur Sustained Released Capsules) in certain defined Asian and South Pacific countries. DURECT retains rights to North America, Europe, Japan and all other countries not specifically licensed to Orient Pharma. DURECT is entitled to receive a royalty on sales of Methydur Sustained Release Capsules by Orient Pharma. Orient Pharma has also committed to supply a portion of the commercial requirements in territories other than the United States for Methydur Sustained Release Capsules.

Debt amendment. In November 2018, the Company amended its existing $20 million term loan with Oxford Finance such that principal payments now commence 18 months later than previously scheduled (i.e., commencing June 1, 2020 rather than December 1, 2018) and the final maturity date is moved back by 30 months (i.e., from August 1, 2020 to November 1, 2022). The interest rate and final payment remain unchanged, and the Company paid Oxford Finance an amendment fee of $900,000.

Upcoming investor conference. DURECT will be presenting at the Stifel 2018 Healthcare Conference at 11:45 am Eastern time on Wednesday, November 14. The conference is being held at the Lotte New York Palace Hotel. A live audio webcast of the presentation will be available by accessing View Source . A live audio webcast of these presentations will also be available by accessing DURECT’s homepage at www.durect.com and clicking "Investor Relations." If you are unable to participate during the live webcast, the call will be archived on DURECT’s website under Audio Archive in the "Investor Relations" section.

Earnings Conference Call
A live audio webcast of a conference call to discuss third quarter 2018 results and provide a corporate update will be broadcast live over the internet at 4:30 p.m. Eastern Time on November 7 and will be available by accessing DURECT’s homepage at www.durect.com and clicking "Investor Relations." If you are unable to participate in the live webcast, the call will be archived on DURECT’s website under Audio Archive in the "Investor Relations" section.

On November 7, 2018 Cytokinetics, Incorporated (Nasdaq: CYTK) reported that Robert I. Blum, President and Chief Executive Officer, is scheduled to present a corporate update at the Credit Suisse 27th Annual Healthcare Conference on Tuesday, November 13, 2018 at 10:20 AM MT at The Phoenician in Scottsdale, AZ, and to participate in a Fireside Chat at the 30th Annual Piper Jaffray Healthcare Conference on Tuesday, November 27, 2018 at 10:00 am ET at the Lotte New York Palace in New York (Press release, Cytokinetics, NOV 7, 2018, View Source [SID1234530910]). Additionally, members of Cytokinetics’ senior management team will also participate in the Global Mizuho Investor Conference on December 3-4, 2018 at the Lotte New York Palace in New York.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Interested parties may access the live webcast of these presentations by visiting the Investors & Media section of the Cytokinetics website at www.cytokinetics.com. The webcast replay of each presentation will be archived on the Presentations page within the Investors & Media section of Cytokinetics’ website for 90 days following the conclusion of the event.

On November 7, 2018 BioInvent International AB (OMXS: BINV), focused on the discovery and development of novel and first-in-class immuno-regulatory antibodies to treat cancer, and Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies, reported they will be presenting two back-to-back posters featuring positive data supporting their ongoing collaboration to develop a novel oncolytic virus encoding for an anti-CTLA-4 antibody at the annual meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) to be held November 7-11 in Washington, D.C (Press release, Transgene, NOV 7, 2018, View Source [SID1234530909]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

This novel oncolytic virus combines a Transgene Invir.IO Vaccinia virus (VV)-based oncolytic vector, with BioInvent’s human anti-CTLA-4 antibody (IgG1) and a human cytokine.

BioInvent and Transgene are together creating a novel armed oncolytic virus that will be able to infect and selectively replicate within the tumor, inducing cancer cell destruction, and to elicit a strong immune response that is further enhanced by the local expression of the immune checkpoint inhibitor and the cytokine. This novel oncolytic virus is expected to deliver better treatment outcomes with an improved safety profile as the patient is not exposed to the potential systemic toxicity of the anti-CTLA-4 antibody.

In the posters, Transgene and BioInvent provide further details on the strengths and advantages of their respective technologies:

Transgene’s VV is a highly oncolytic and immunogenic viral vector that has demonstrated its ability to ensure the expression of a fully functional, full-length antibody in the tumor and trigger a massive immune infiltration into the tumor with low systemic exposition to the molecule;
BioInvent has developed a potent anti-CTLA-4 antibody, selected and characterized for its improved FcγR-dependent Treg depleting efficacy. FcγR-dependent Treg depletion was recently found to play a key role in the anti-CTLA-4 antibody’s efficacy in vivo.
Björn Frendéus, Chief Scientific Officer of BioInvent said: "Having identified a lead human anti-CTLA-4 antibody candidate with improved Treg-depleting activity compared with ipilimumab, we are looking forward to advancing the program presented at the SITC (Free SITC Whitepaper) in collaboration with Transgene, and develop a potentially safe and more efficacious strategy to combine anti-CTLA-4 and anti-PD-1/PDL1 checkpoint inhibition in the context of oncolytic virotherapy."

Eric Quéméneur, Pharm.D., Ph.D., Executive VP, Chief Scientific Officer of Transgene, said: "We are very pleased with the progress of our collaboration with BioInvent. The data that both companies present at SITC (Free SITC Whitepaper) underline the potential of combining our synergistic expertise to generate a novel oncolytic virus capable of delivering a potent anti-CTLA-4 antibody directly into the tumor micro-environment. The concept of combining the merits of our respective technologies was already demonstrated in preclinical experiments and we look forward to demonstrating its potential in the clinic."

The posters will be on display both Friday, November 9 and Saturday, November 10 in the Poster Hall (Hall E). They will also be available after the conference on the companies’ respective websites, www.transgene.fr and www.bioinvent.com.

Antibody-armed oncolytic Vaccinia virus to block immunosuppressive pathways in the tumor microenvironment – Poster P615

Authors: Marchand JB, Semmrich M, Fend L, Tornberg UC, Silvestre N, Frendéus B, Quéméneur E
Generation and characterization of a CTLA-4 antibody with improved FcγR-dependent

Treg deletion for tumor microenvironment-targeted oncolytic virotherapy of cancer – Poster 602

Authors: Semmrich M, Marchand JB, Holmkvist P, Mårtensson L, Tornberg UC, Fend L, Kovacek M, Teige I, McAllister A, Quéméneur E, Frendéus B

On November 7, 2018 Onconova Therapeutics, Inc. (NASDAQ:ONTX), a Phase 3-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, with a primary focus on myelodysplastic syndromes (MDS), reported the appointment of Dr. Richard "Ric" Woodman as Chief Medical Officer and Senior Vice President of Research & Development. Dr. Woodman will report to Dr. Steve Fruchtman, President and former CMO of the Company (Press release, Onconova, NOV 7, 2018, View Source [SID1234530908]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Ric Woodman, M.D., served most recently as Senior Vice President and Head of U.S. Oncology Clinical Development and Medical Affairs for Novartis. In his role, Ric provided strategic medical and scientific leadership for both marketed and development-stage compounds. Previously, Ric served as Franchise Head for Hematology in Global Medical Affairs at Novartis Oncology with global oversight of non-registration clinical programs and has worked on the development and life-cycle management of several compounds including Tasigna, Glivec, Farydak, Rydapt, Odomzo and Kymriah.

Before joining Novartis Oncology, Dr. Woodman was Senior Medical Director with Johnson & Johnson, leading the Oncology franchise at Ortho Biotech Products, LP. Prior to Ortho Biotech, Ric held academic appointments as Professor in the Departments of Medicine and Oncology at the University of Calgary in Canada where he joined the faculty in 1990.

Dr. Woodman completed his hematology/oncology clinical fellowship and postdoctoral research fellowship at Scripps Clinic and Research Institute in the Department of Experimental Medicine.

In his welcome statement, Dr. Steve Fruchtman said, "The addition of Ric to the Onconova leadership team is an exciting boost to our expertise in drug development in malignant hematology and oncology. Ric has a proven track record and expertise in the approval of novel agents that have changed the standard of care in hematology, including an erythropoietic stimulatory agent to promote red cell production by the marrow, a common issue in patients with MDS, as well as agents for CML that have transformed the life expectancy of these patients and the management of CML from a previously lethal disease to a chronic disorder. As a key part of the team, Ric’s expertise will help optimize the development of Rigosertib for patients with unmet medical needs in MDS and cancer."

"I am excited to join Onconova at this advanced stage of development of Rigosertib and other promising pipeline assets," said Dr. Woodman. "The anticipated completion of the INSPIRE trial in higher-risk MDS and advancing the design of a pivotal combination trial of oral rigosertib and azacitidine towards a Special Protocol Assessment (SPA) are positioning the Company for late stage development, which are areas within my experience and expertise. These trials have set a solid foundation for Rigosertib in patients with MDS. While focused on advancing Rigosertib towards regulatory approval for MDS, Onconova has also created additional opportunities for advancement. I am delighted to join my new colleagues at Onconova, and have the opportunity to work with Steve again in advancing new medicines for patients with unmet medical needs."

Onconova is also pleased to announce the hiring of Matthew Parris to the position of Senior Director, Clinical Operations. Matt joined us after leadership roles in Europe and the U.S. at several Biotechnology companies, including, most recently, Inovio, and at Clinical Research Organizations (CROs), including Orion and Pharm-Olam.
Onconova also welcomes David Evans, who joined recently as Associate Director, Regulatory Affairs, after a decade-long successful career at Celgene.