Alexa Roeper, Co-Founder and CEO

Closely-held Penta Medical is now on the sales and marketing trail, targeting sports teams, orthopedic doctors and physical therapists with its PentaVO device. The wearable cold laser therapy and data collection device received FDA approval in July for the improvement of circulation and the reduction of joint pain and stiffness.

“Our device is the only portable clinical-quality device on the market for inflammation-related chronic and acute injuries, ranging from tendon and muscle strains and tears to arthritis and common pain,” co-founder and CEO, Alexa Roeper, says in an interview with BioTuesdays.

“PentaVO has an important role in increasing patient compliance and tracking injury progression, and we believe it is more effective than, yet still complementary to ultrasound treatment,” she adds.

Ms. Roeper explains that PentaVO includes an analytics platform that sends patient data via a smartphone to an orthopedic physician or physical therapist, saving time compared with manually checking a patient’s status. The system asks for the location and type of injury, severity of pain and range of motion. The data is sent back to the device to customize treatment as would happen in a clinic.

PentaVO

“We determined that laser therapy is the most versatile treatment based on existing modalities,” she adds. It can also be used for post-surgical recovery but is limited by the depth of penetration.

She points out that depending on the type of injury, the device is usually worn for six to eight weeks or for the entire length of an injury. “The PentaVO software sets the treatment for the patient and analyzes the data collected. Because the software becomes more accurate with use, this is the only tool to precisely measure injury progression.”

PentaVO’s physiological effects include increased production and release of endorphins, which are naturally-produced analgesics; cortisol, a precursor to cortisone; growth hormone, which can be instrumental in tissue repair; and ATP to improve cellular metabolism.

In addition, the device is designed to facilitate venous and lymphatic blood flow, increase angiogenesis and elevate oxygen perfusion.

PentaVO’s FDA-approved claims include relief of muscle and joint pain, muscle spasm and stiffness, as well as promoting relaxation of muscle tissue and temporarily increasing local blood circulation where it is applied.

Ms. Roeper has a background in biomedical science at the University of Waterloo in Canada and is an avid athlete. A personal injury after horseback riding, which was predicted to take months to recover, inspired her to look into alternative healing methods, which ultimately led to the creation of Penta Medical.

“I began thinking of all the other people that must experience the frustration of having limited options available to expedite the healing process,” she recalls. “So that’s when I began exploring ideas to help not only myself to heal faster, but others as well.”

The result was a serious fascination with the science of infrared therapies. Ms. Roeper wanted to innovate and build on existing physical therapy techniques to offer a more convenient, rapid and remote way to help people with muscular and/or skeletal injuries heal more quickly.

“Our goal is to automate the data collection process to work in cooperation with doctors as they populate their electronic medical records,” Ms. Roeper contends.

“We quantify the patient recovery process so that medical providers can make better, more informed decisions and reduce unnecessary treatments, which can turn personal care information into actionable insights.”

Ms. Roeper and a sales team of two other people are initially targeting U.S. professional sports teams and orthopedic team doctors. These doctors usually have their own clinics to treat their regular patients, resulting in a “natural crossover,” she adds. Currently, the company isn’t selling PentaVO directly to consumers.

There are several CPT (current procedure terminology) reimbursement codes for remote patient monitoring and chronic care management, which cover the use of PentaVO. “For physical therapists, this is a value-based approach to benchmark how patients are recovering.”

According to Ms. Roeper, the athletic market represents a potential of 600 customers and a $30-million market, and is a stepping-stone to the much larger clinical market, which represents 124,000 customers and a revenue opportunity of more than $6-billion, with 10% annual growth.

“In the first 30 days on the market, we generated $100,000 of annual recurring revenue, consisting of hardware and software sales on a subscription model for physical therapy clinics, and we’re projecting to close another $500,000 in sales over the next eight-to-12 months,” she adds.

“We are seeing people using the product, liking it and referring it to their friends”

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Dr. Charles Theuer, President and CEO

TRACON Pharmaceuticals (NASDAQ:TCON) is expected to report several important potential milestones over the next two quarters, including two randomized data points from its product development pipeline.

“This is an exciting time for us as we approach top-line Phase 2 data from our TRAXAR clinical trial in renal cell carcinoma in December and interim Phase 3 results from our TAPPAS trial in angiosarcoma in the first quarter of 2019,” Dr. Charles Theuer, president and CEO, says in an interview with BioTuesdays.

The company also expects to receive Phase 2 data in mid-2019 from its partner, Santen Pharmaceutical of Japan, which is testing TRACON’s DE-122 drug candidate in combination with Lucentis for the treatment of wet AMD.

“Our pipeline has been developed around an opportunity to enhance the efficacy of VEGF (vascular endothelial growth factor) inhibitors and checkpoint inhibitors with our companion therapeutics,” he adds. “This was the rationale in starting the company around our lead asset, TRC105.”

Broad Pipeline with Multiple Expected Near-term Readouts

In addition to its internal product development, Dr. Theuer says that as a start up, TRACON realized that it was spending too much time and money for services from contract research organizations.

“Since 2011, we have been doing all of our own clinical trials and data management, without sourcing to clinical CROs. We’ve found this approach cuts time lines and costs, and increases the quality of our trials because we are in direct contact with clinicians conducting the work.”

For example, the adaptive design of the company’s Phase 3 TAPPAS trial in angiosarcoma was published in the peer-reviewed, Annals of Oncology, in October 2018 and was recognized as the most innovative trial of 2017 by Clinical and Research Excellence Awards.

TRC105: Lead Asset Oncology Development Strategy

In the first quarter of 2019, the company plans to announce an interim analysis of 120 patients from the pivotal TAPPAS trial of TRC105 in combination with Votrient, an approved VEGF inhibitor, which is used as a second line treatment after chemotherapy.

“On its own, Votrient has limited survival benefits in angiosarcoma, so clearly patients need something added to Votrient,” Dr. Theuer suggests.

Based on the interim analysis, the adaptive design would allow the Data Monitoring Committee to recommend that the trial continue as planned to enrol 190 patients, if a highly robust treatment effect is being seen; increase the sample size to 340 patients in order to improve the chances of seeing a clear treatment effect; enrol 220 patients if only patients with cutaneous angiosarcoma are responding; or stop the trial if no treatment effect is being seen.

Angiosarcoma is an orphan cancer disease of the inner lining of blood vessels, with about 1,800 annual cases in the U.S. and Europe, and a greater incidence in Asia. TRACON estimates a market potential of more than $100-million in angiosarcoma in the U.S. and Europe.

“We are encouraged by the rapid rate of patient accrual into the Phase 3 TAPPAS angiosarcoma trial,” he adds. Angiosarcoma represents a high unmet medical need, with a five-year survival rate of less than 12%, compared with a five-year survival rate of about 56% for all soft tissue sarcoma.

Patients in the TAPPAS study are being randomized one-to-one to receive TRC105 plus Votrient in a treatment arm versus Votrient alone. The primary endpoint is progression free survival.

TRC105 is an anti-endoglin antibody. Endoglin is a protein overexpressed on proliferating endothelial cells, which is essential for angiogenesis, the process of new blood vessel formation. TRC105 has received orphan designation for the treatment of soft tissue sarcoma in both the U.S. and EU.

“Our initial development strategy with TRC105 is to achieve regulatory approval in an orphan indication like angiosarcoma, where there is a large unmet medical need, and then follow up in larger markets like renal cell and hepatocellular carcinoma, and ultimately even larger markets like lung and breast cancer,” Dr. Theuer points out.

In an initial small study with TRC105 and Votrient in angiosarcoma patients, Dr. Theuer says progression free survival reached 7.8 months, compared with three months expected with Votrient alone. In addition, most patients stayed on treatment longer with TRC105 plus Votrient, compared with prior chemotherapy, he adds. “Patients also had durable complete responses, which is very unusual.”

In December, TRACON plans to release top-line data, including progression free survival, with biomarker correlations, from the randomized Phase 2 TRAXAR trial of TRC105 in combination with Inlyta, another approved VEGF inhibitor, in patients with advanced or metastatic renal cell carcinoma.

TRC105 also is being studied in a multicenter Phase 2 trial combination with another VEGF inhibitor, Nexavar, in 33 patients with hepatocellular carcinoma to confirm the 25% response rate seen in a earlier Phase 1/2 study conducted by the NCI. Interim data presented at GI ASCO in January 2018 showed partial responses in two of the first eight patients, matching the response achieved by the NCI. Dr. Theuer says additional data from the study is expected at GI ASCO in January 2019.

In 2017, TRACON inked a licensing agreement with China-based Ambrx to develop and commercialize TRC105 for oncology indications, with an initial focus on hepatocellular carcinoma, in China, Hong Kong, Macau and Taiwan.

Another important read out for TRACON is Phase 1b safety and efficacy data of TRC105 in combination with Opdivo, a checkpoint inhibitor, in patients with non-small cell lung cancer, which is expected in December.

“This is our lead approach in immuno-oncology, where we have very strong preclinical data,” Dr. Theuer says, adding that the trial is expected to move into the Phase 2 portion in 2019, with two cohorts: Opdivo naïve and Opdivo relapsed patients.

“Our approach in cancer is to combine TRC105 with standard of care treatments, either VEGF inhibitors or checkpoint inhibitors”

TRACON’s other product candidates include DE-122, an ophthalmic formulation of TRC105 designed for wet AMD, which has been licensed to Japan’s Santen Pharmaceutical.

Citing failed Phase 2 and 3 AMD trials by Ophthotech and Regeneron, which were targeting a different pathway than endoglin, Dr. Theuer says Santen now appears to be the “lead player in combining a new targeted agent with established VEGF-inhibitors in wet AMD.”

Santen’s Phase 2 AVANTE study with DE-122 is currently enrolling patients, with data expected in mid-2019. Patients are receiving Lucentis plus a sham, Lucentis plus a low dose of DE-122, or Lucentis plus a high dose of DE-122. The primary endpoint is best-corrected visual acuity following six monthly intravitreal injections.

Dr. Theuer says the National Cancer Institute currently is funding Phase 2 clinical testing with another TRACON oncology asset, TRC102, which is being combined with several chemotherapies as a possible treatment to reverse resistance of chemotherapy.

The focus of these TRC102 programs is to identify a biomarker that will correlate with response to treatment with chemotherapy and TRC102. “We expect to see data in mesothelioma and solid tumors in 2019,” he adds.

Dr. Theuer says TRACON’s ability to conduct its own clinical trials led to an in-licensing deal in 2016 for two Janssen Pharmaceutical drug candidates: TRC253 for the treatment of metastatic castration-resistant prostrate cancer, which has now moved into the Phase 2 portion of a Phase 1/2 trial; and TRC694, a first-in-class treatment for myeloma, which is expected to begin human testing in 2019.

“We believe the Janssen deal validates our development platform,” he adds. “We provide Janssen with efficient and rapid clinical development and we share in the potential upside of the product.”

As part of the deal, Janssen made an equity investment in TRACON. Following the Phase 2 study, Janssen has rights to re-acquire the prostate cancer drug candidate, with TRACON entitled to receive $45-million in cash, $137.5-million in future milestones and low single digit royalties.

Under the deal for TRC694, Janssen has a right of first negotiation after TRACON completes a Phase 1 study. If TRACON retains rights to the myeloma drug candidate, it would owe Janssen development and regulatory milestones of up to $60-million and low single digit royalties.

“While our goal is to become a commercial company in the U.S. with our own sales force in the 2021-22 time frame, we also are aggressively looking to expand our product pipeline with two additional assets,” Dr. Theuer points out. “We believe our development platform would be attractive to companies outside of the U.S. that do not have U.S. drug development and commercial infrastructure.”

Dr. Theuer suggests that while TRACON’s specialty is oncology, “we would be interested in products earmarked for medical specialties, rather than a general practitioner audience.”

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Dr. Robert Foster, CEO

Dr. Robert Foster is teeing up another possible home run as the new CEO of ContraVir Pharmaceuticals (NASDAQ:CTRV) and its lead programs for liver disease arising from chronic viral infection and NASH (non-alcoholic steatohepatitis). He joined ContraVir as CSO in 2016 after the company acquired his startup, Ciclofilin Pharmaceuticals.

Dr. Foster’s resume includes discovering the immunosuppressive drug, voclosporin, at Isotechnika Pharma and then refocusing its development to lupus nephritis after he acquired Aurinia Pharmaceuticals (NASDAQ:AUPH) in 2013. Aurinia expects to report Phase 3 data for voclosporin at the end of 2019.

“ContraVir is reminiscent of my past 30 years at Isotechnika, Aurinia and Ciclofilin,” Dr. Foster recalls.

“When I arrived at ContraVir, the company had a Phase 3 program underway for shingles-associated pain, even though there was a vaccine for shingles on the market and recruiting patients for the trial was slow. I personally thought it was not the best use of resources, especially in a market that seemed to be shrinking.”

After moving into the executive suite at ContraVir in October 2018, Dr. Foster conducted a full review of the company’s development pipeline and corporate strategy. Critical evaluation of its drug candidates from scientific and commercial standpoints revealed untapped potential.

A thorough analysis demonstrated a strong therapeutic potential for ContraVir’s drug candidate, CRV431, not only in viral hepatitis but also other diseases of the liver.

CRV431 and TXL™ - Anti-HBV Mechanisms and Actions

In preclinical studies on hepatitis B, CRV431 had shown the potential to block hepatitis B virus (HBV) entry into liver cells and complement current HBV treatments by reducing multiple markers of infection. This contrasts with current treatments, which usually only reduce HBV DNA.

In addition, studies in non-viral models had demonstrated that CRV431 also could reduce progression of fibrosis as well as the number and size of liver tumors, or hepatocellular carcinoma (HCC). Fibrosis and HCC develop in many liver diseases and are primary concerns in the rapidly growing condition of NASH.

With CRV431 as a cornerstone, ContraVir will now focus on the development and commercialization of therapeutic drugs for the treatment of chronic hepatitis B and NASH.

Each disease afflicts approximately 250 million people worldwide, and industry analysts suggest that global sales of HBV and NASH treatments each could exceed $200-billion during the next 20 years. Approximately 25% of patients with chronic hepatitis B die prematurely from liver failure, cirrhosis or liver cancer.

Contravir’s second development program is TXL (tenofovir exalidex), a liver-targeting conjugate of tenofovir for chronic HBV.

Dr. Foster says TXL is a Phase 3-ready compound with a 505(b)(2) pathway with the FDA. It is further advanced than CRV431 but “we’ve decided to make it available for partnering in return for milestone payments and future royalties.” The company is having discussions with a number of groups in North America and Asia.

“Our studies have shown TXL has potent antiviral activity at lower doses than Gilead Sciences’ HBV treatment, Viread (tenofovir disoproxil fumarate), and has a strong safety profile, with the potential for decreased bone and kidney toxicity due to increased liver targeting,” he points out. TXL also has favorable pharmacokinetics, compared with Viread, with significantly lower levels of circulating tenofovir in the blood.

“Overall, we believe that the observed properties of CRV431 are very compelling and are pointing us in the direction of redefining ContraVir more as a company addressing liver disease, rather than being strictly focused on the treatment of HBV. Aligning our vision with liver disease treatment ought to build significant value for the company,” Dr. Foster contends.

HBV and NASH are both risk factors for the development of liver disease, including fibrosis, which is why “we are aiming to target both HBV and NASH,” he adds.

And, with HBV, CRV431 does not specifically target viral replication. “Rather, we’re targeting multiple proteins produced by the virus and also targeting innate immunity in a way that we believe will significantly reduce clinical events leading to liver disease.”

ContraVir recently completed Phase 1 testing with CRV431 and expects to begin a proof-of-concept HBV trial in December, with data expected in mid-2019. The 28-day study will assess safety, tolerability, pharmacokinetics, and preliminary signals of antiviral efficacy, as well as identify clinically relevant biomarkers of CRV431 in combination with Viread.

According to Dr. Foster, CRV431 targets common pathways to end-stage liver disease. Liver injury usually begins with alcohol, viral hepatitis, or NASH, with progression to inflammation and fibrosis, ultimately ending with cirrhosis and/or cancer.

“A cure for HBV is a challenging goal, although drug combinations ultimately should be able to control the virus and improve the health of patients,” he suggests. For example, some work now is being done to interrupt the viral life cycle, including reducing the viral load, reducing viral antigens, stimulating immunity, and altering virus trafficking. But the limited efficacy of current antiviral treatments towards a cure highlights the need for new therapies in HBV, he adds.

Dr. Foster explains that HBV produces high amounts of antigens, including surface antigens, which may exhaust the immune system’s T-cell response that would normally attack the virus.

“CRV431 has demonstrated multiple activities that are linked to the way the drug candidate is designed to target host proteins, called cyclophilins, to reduce HBV surface antigens and other proteins, and to stimulate an innate immune response, bringing us one step closer to creating the potential for a functional cure,” he points outs.

ContraVir also has studied combining CRV431 and TXL, finding significant reductions in HBV DNA in transgenic mice, which suggests additive-to-synergistic efficacy. The combination also demonstrated a reduction in surface antigens.

NASH, which involves inflammation of the liver, can cause serious problems such as fibrosis, cirrhosis and liver cancer. It also represents an unmet medical need, with no approved drug treatments currently, and an estimated global prevalence of 4% of the population and growing.

HCC is the fifth most common cancer in men and seventh most common cancer in women. The annual global incidence of HCC is more than 500,000 and the five-year survival is about 10%.

The Stelic Institute in Japan and Prof. Philippe Gallay of Scripps Research Institute in San Diego have conducted NASH studies with oral administration of CRV431 in mice, finding reductions in liver fibrosis that are similar to other leading drug candidates in development.

Prof. Gallay also has studied anti-cancer activity of CRV431 in NASH mice. After 10 weeks of treatment following evidence of liver tumors, the study found a 44% reduction in tumor numbers and 52% reduction in tumor score, significantly impacting overall tumor burden. Prof. Gallay now is conducting further studies on CRV431 in liver disease.

Dr. Foster is hopeful that one or more HBV markers will show responses to CRV431 in the small Phase 2 pilot trial to begin in December. In parallel with that trial, planning is underway for a 90-day toxicology study in animals that would support moving into longer Phase 2 hepatitis B or NASH trials.

Expansion into NASH will require either a new IND filing or at least amending the company’s current IND to facilitate a study in these patients, he adds.

Dr. Foster admits that putting the spotlight on CRV431 gives a fresh look to ContraVir but also makes perfect sense based on the science and the huge interest in developing treatments for liver disease and especially NASH. “I did it before, moving voclosporin from kidney transplant to lupus nephritis, and I think I can do it again with ContraVir.”

Preclinical, Mid-, and Late-Stage Product Candidates

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Steve Rhodes, Co-Chairman and Co-CEO

With 11 years of progressive growth in the value of its expanding portfolio, The Trendlines Group (SGX:42T; OTCQX:TRNLY), an Israeli investment company, takes a very hands-on approach with its early-stage medical and agrifood tech startups.

“We require them to have an office in our head office complex and we provide them with a tremendous amount of support,” co-chairman and co-CEO, Steve Rhodes, says in an interview with BioTuesdays.

“We pay for all of their overhead expenses. Plus, we have a staff of consultants who assist our companies on an almost daily basis, creating an entrepreneurial ecosystem that includes business development, market research and communications, technology development and financial structuring,” he adds.

“Having this additional level of oversight helps us identify problems very early before they become big problems. The people who come to us have very smart ideas but in most cases, they’ve never run a company before and never raised money before. This is where we come in and provide professional support.”

Trendlines includes three life science incubators: Trendlines Agtech and Trendlines Medical in Israel, and Trendlines Medical Singapore

Mr. Rhodes explains that the corporate structure of Trendlines includes three life science incubators: Trendlines Agtech and Trendlines Medical in Israel, and Trendlines Medical Singapore, which was established in 2017. “We only invest in agtech and medical technologies because these are very large markets with the potential to improve the human condition.”

Trendlines Group also has an in-house innovation center, Trendlines Labs, which invents and develops technologies to address unmet market needs, he adds.

“With Trendlines Labs, we have created technologies that we have spun off into our own portfolio, creating new companies in Israel and Singapore,” he points out. “It also gives us a leg up to work with multinational corporate investors. Trendlines Labs is a powerful tool to innovate, create new relationships and generate recurring revenue.”

For example, he says B. Braun, the largest privately-owned medical device company in the world, has a nearly 4% stake in The Trendlines Group and has invested in three of its portfolio companies. On the agtech side, Bayer Crop Science has invested $10-million in a fund for agtech start-ups, which is managed together with Trendlines Agtech.

Trendlines Labs has turned inventions into four portfolio companies so far – Limaca, InterVaal, PregnanTech and Hyblate Medical – with more to come soon, Mr. Rhodes promises. It also has established partnerships in Singapore, Japan, China, the U.S. and Europe.

He cites inventions in urology, neurology, women’s health, cardiology, diagnostics and aging population as some of the areas that have been targeted by Trendlines Labs. Two technologies now in clinical trials include low cost monitoring of dehydration and a device for stress urinary incontinence.

The Trendlines Group currently has more than 50 active companies. Its 10 most valuable include StimatixGI, Leviticus Cardio, ApiFix, EdenShield, BioFishency, Saturas, STS Medical, Arcuro Medical, Fidmi Medical and AquiNovo.

Trendlines has fully diluted stakes of between 20% and 49% in its top 10 holdings, which represented 69% of the total $96.2-million value of its portfolio at June 30, 2018. The company also has $15.6-million of cash at mid-2018, with no significant liabilities against its assets.

Among its holdings, ApiFix is targeting sales in Canada, Europe and Asia of a minimally invasive scoliosis correction system; Leviticus Cardio has successfully completed preclinical studies for a breakthrough wireless system to provide constant power needs of heart pump implants; StimatixGI, which was acquired by B. Braun in 2014 for cash, milestones and royalties, is currently launching StimatixGI’s innovative colostomy bag to improve patient’s quality of life; BioFishency is selling its cost-effective water treatment system for land-based aquaculture mostly in Asia; and EdenShield is in the Mediterranean market with natural, nontoxic bio-insecticide products for greenhouse crops, ornamentals, and masking odors for cannabis growers in North American greenhouses to reduce insect attraction.

According to Mr. Rhodes, The Trendlines Group has achieved an estimated return of 10.1 times and an internal rate of return of 95% from the sale of eight companies to date. In addition, 10-to-15 of the group’s most advanced companies are “queued up for possible exits in the next two-to-three years.”

Mr. Rhodes says a typical investment by The Trendlines Group in a startup is about $1.42-million (U.S.), consisting of $870,000 of direct and $650,000 of indirect investment capital over two years so that a startup does not have to go out and obtain in-house services.

Of the direct investment portion, he says $120,000 is capital from Trendlines and about $650,000 is a Government of Israel grant. “The government does not receive equity and we repay the grant from royalties in the event the company has a successful market launch. This allows us to leverage our capital and reduce our financial risk,” he suggests.

Mr. Rhodes says the company reviews about 600 deals a year and invests in about 1.5% of them. “By the end of year one, we hope to establish proof of concept and after year two, we’d like to be able to raise an A-round of funding and soon thereafter, be in a position to consider business development with a path to either commercialization or an exit for us.”

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