Horst Zerbe, president and CEO

Early in January, IntelGenx (OTCQX:IGXT; TSXV:IGX) will regain exclusive worldwide rights to develop and commercialize its Rizaport oral thin-film treatment of acute migraines.

The move follows a decision by partner, RedHill Biopharma (NASDAQ, TASE:RDHL), to terminate its co-development and commercialization partnership with IntelGenx.

“We were expecting RedHill’s decision because in recent years RedHill has been increasingly focused on its gastrointestinal projects and it has started reallocating its resources accordingly,” Horst Zerbe, president and CEO of IntelGenx, says in an interview with BioTuesdays. 

“Because of that revised product strategy, this decision did not come out of the blue,” he adds. “RedHill has considered Rizaport to be a non-core asset for some time.”

In a statement, RedHill said it expects to report top line data in 2018 from two Phase 3 gastrointestinal programs in Crohn’s disease and H. pylori infection. The company also has a plan in place to gradually reduce the average quarterly cash burn rate in 2018 to approximately $8.5-million.

IntelGenx is a leader in developing oral thin films that provide therapeutic advantages to patients. The product also can be taken without the need for water.  

IntelGenx Drug Delivery Technology Platforms

Rizaport is the first rizatriptan oral disintegrating film for the treatment of migraine to achieve marketing approval in Europe. It was formulated using VersaFilm, IntelGenx’s proprietary oral film technology. Compared to other triptan-based medications, rizatriptan demonstrates high efficacy and provides a quick onset of action to migraine sufferers.

As an oral soluble film and along with its pleasant flavor, Rizaport presents a potentially attractive therapeutic alternative for migraine patients, specifically for patients who suffer from migraine-related nausea, estimated to be approximately 80% of the total migraine patient population, and patients suffering from difficulty swallowing, especially children and the elderly. 

Rizaport previously demonstrated bioequivalence in a successful pivotal clinical trial, compared with the reference-listed drug, Maxalt-MLT, which is sold by Merck & Co.

Dana Matzen, VP of business and corporate development

Dana Matzen, VP of business and corporate development for IntelGenx, says investors should not be concerned that RedHill is exiting the Rizaport partnership. “Rizaport is a fully developed product with no remaining development work outstanding. Going forward there is only upside for us as we don’t need to share any future payments from licensing fees and royalties.”

In addition, she points out that while IntelGenx is grateful for RedHill’s support during the past few years, “we should be able to move quickly to engage with potential marketing partners for Rizaport. We are now definitely in the driver’s seat.”

Dr. Zerbe says RedHill will swiftly transfer all rights and obligations under the existing licensing agreements to IntelGenx, including the NDA submission that is currently pending at the FDA. As a result, IntelGenx will continue its dialogue with existing and prospective new commercial partners for Rizaport in the U.S., Europe and other territories after acceptance of the NDA for review, he adds. 

Earlier this month, the FDA informed RedHill and IntelGenx that it would require additional information before it will start the review clock for the NDA. Dr. Zerbe says the FDA’s questions relate to chemistry, manufacturing and controls, which represent the technical information related to the filing. 

He explains that most of the requested information had already been sent to FDA but apparently not been considered. The FDA did not raise any questions about Rizaport’s safety or efficacy data, and does not require additional clinical testing. 

"We are disappointed by the delay, but remain committed to working with the FDA to achieve our goal of bringing this product to the U.S. market," he adds. "We hope to meet the agency as soon as practicable to clarify its request for additional information. Although, for the most part, we believe the seemingly missing information has previously been provided.”

In 2016, commercialization agreements for Rizaport were signed with Grupo JUSTE for Spain and Pharmatronic for South Korea. Dr. Matzen says IntelGenx is working with Grupo, now Exeltis, to obtain marketing authorization in Spain and “we are preparing for the launch with them.” 

In addition, she says the NDA dossier, when it is accepted for review by the FDA, also will be filed for regulatory approval in South Korea.

Robust Product Pipeline

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Paul Gunn, president and CEO

Closely-held Soricimed Biopharma expects to initiate in the second quarter of 2018 a Phase 1b/2a clinical trial with its SOR-C13 drug candidate in patients with prostate cancer, including men who have failed first line treatment, as well as patients with advanced pancreatic and ovarian cancers.

“The protocol has been designed for early efficacy readouts,” Paul Gunn, president and CEO, says in an interview with BioTuesdays. “We received a very positive response from the FDA to our end-of-Phase 1 meeting submission package with the FDA, providing a clear pathway for our planned Phase 1b/2a clinical trials.”

Mr. Gunn says that the “rolling” study will recruit about 20 patients into the dose escalation Phase 1b portion to establish a maximum tolerable dose. Patients who respond will move into the Phase 2a portion along with additional patients for a total of about 60 patients in both arms of the study.

The two-year trial will be conducted at three-to-four clinical sites, primarily in the U.S., including MD Anderson Cancer Center in Houston. SOR-C13 has received orphan drug status from the FDA for ovarian and pancreatic cancers.

Mr. Gunn explains that SOR-C13 is a synthetic peptide based on a small protein discovered by Soricimed in the venomous saliva of the northern short-tailed shrew, which binds to the TRPV6 calcium ion channel. TRPV6 is implicated in the development and progression of numerous forms of solid tumor cancers, and its over-expression correlates with the aggressiveness of the disease.

TRPV6 Channel (Side View)

TRPV6 Channel (Top View)

“This onco-channel has emerged as a new target for treating and diagnosing various carcinomas,” he adds, noting that calcium-dependent proliferation of cancer cells is linked directly to TRPV6.

Mr. Gunn contends that SOR-C13 has been shown to reduce cancer cell proliferation and metastasis, and block anti-apoptotic pathways, that cancer cells use to avoid programmed cell death.

 TRPV6 plays a key role in cancer pathogenesis 

“SOR-C13 is the first ever TRPV6 inhibitor to enter clinical trials and represents a novel, first-in-class anticancer therapy.”

Soricimed owns all of its IP, including 17 issued patents, of which 11 are in the U.S., and four additional patents pending.

In an earlier Phase 1 study in 23 stage 3 and 4 cancer patients with advanced solid tumors known to express TRPV6, and representing 14 solid tumor types, SOR-C13 was shown to be safe and well tolerated after nearly 500 infusions, with no drug-related serious adverse events. All patients had failed prior therapy.

According to Mr. Gunn, 55% of evaluable subjects in the Phase 1 study had stable disease after 2 cycles of SOR-C13 treatment, with the duration of response ranging from 84 days to more than one year. “These were patients with progressive disease and we were able to stabilize them.”

One subject remained on treatment and in stable disease for 18 cycles of the drug, representing more than 12 months, with no safety or tolerability issues, he adds.

In addition, two patients with advanced pancreatic cancer enrolled in the Phase 1 study at MD Anderson showed stable disease after two cycles of SOR-C13. Mr. Gunn says one patient had a nearly 30% reduction in their primary pancreatic tumor. “This qualifies as a partial clinical response, which is a real marker of efficacy in these clinical trials.”

The tumor response also correlated very tightly with reductions in blood levels of CA 19-9, a validated pancreatic cancer biomarker, he adds.

Mr. Gunn says the results observed in pancreatic cancer patients were compelling enough that we have been approached by a major cancer center to start a physician-sponsored clinical trial this coming February. This would include 30 patients with late-stage pancreatic cancer to assess SOR-C13’s potential in this difficult to treat population. Soricimed will be provide the study drug and some financial support to the institution. The study is expected to take 18 months to complete.

Soricimed’s pipeline also includes development of TRPV6 targeting peptide drug conjugates (PDC) to deliver highly potent cell-killing payloads. “We believe PDC’s have a number of advantages over larger and bulkier monoclonal antibody-drug conjugates (ADC) – several of which are approved for cancer treatment,” Mr. Gunn says

PDC’s can have the same cancer-targeting and payload delivery properties as ADC’s but are essentially small molecules. “This means that PDC’s have better penetration of solid-tumors, than larger and bulkier monoclonal antibodies, and are easier and less expensive to manufacture,” he adds.

“What we’re doing is using peptides that target TRPV6, which is only expressed in cancer cells, and linking highly toxic drugs to them in order to achieve a targeted delivery to the tumor,” Mr. Gunn contends.

Soricimed’s lead PDC currently is SBI-1301. “We’re using an anticancer drug that failed in clinical trials conducted by a multi-national pharmaceutical company because it proved to be too toxic systemically,” he points out. “We believe we have the ability to target that drug at a low concentration to reduce its systemic exposure, but still have a highly potent agent.”

After achieving complete tumor regression in a prostate cancer mouse model with SBI-1301, the company plans to select a lead PDC and begin IND-enabling studies in the first quarter of 2018, with the goal of submitting an IND to the FDA in the second half and beginning clinical studies in early 2019.

Mr. Gunn says Soricimed is seeking to raised at least $15-million to complete the Phase 1b/2a trial with SOR-C13, conduct IND-enabling studies with its PDC candidate, file an IND and prepare to begin a Phase 1 study.

The company has two financing options under review, including a private placement or a public raise through a possible reverse takeover (RTO) of a shell company in conjunction with an initial public offering. “There are a number of RTO targets available if we take this route,” he adds.

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Dan Chicoine, executive chairman and interim CEO

Crescita Therapeutics (TSX:CTX), is aiming to be a $50-million commercial dermatology company in the next five years, with a portfolio of non-prescription skincare products and prescription drug products for the treatment and care of skin conditions, their diseases and their symptoms.

“We have four pillars in our growth strategy,” Dan Chicoine, executive chairman and interim CEO, says in an interview with BioTuesdays, citing organic growth of existing product lines, strategic acquisitions and/or out-licensing agreements, additional international expansion and contract manufacturing.

Crescita, which was spun out of Nuvo Research in 2016, generated revenue of $2.7-million in the third quarter of 2017. Mr. Chicoine was a former co-CEO of Nuvo.

In its non-prescription business, Crescita is currently selling five products, including two lines dedicated to medical skincare for pre and post-procedure treatments: Pro-Derm and Alyria; Laboratoire Dr Renaud, its flagship brand sold exclusively to professional aestheticians; Premiology 360, a line of high-end aesthetics products and ISDIN. 

Non-Prescription Product Lines

Laboratoire Dr Renaud is also sold internationally in Korea and Malaysia. The company is working to increase its export activities as part of its four-pillar growth strategy. Across Canada, a nine-member sales force distributes these products to medical spas, pharmacies and professional aesthetic spas.

Crescita also conducts manufacturing and formulation development at its 50,000-square-foot Health Canada-compliant GMP plant in Laval, Quebec, and offers turnkey manufacturing services to third parties from R&D to commercialization.

“The non-Rx business is well positioned for domestic and international growth,” Mr. Chicoine says, adding that the business could reach profitability in 2018.

“We feature strong niche brands catering to spa and medispas, with superior formulations that have clinically proven results.”

In its prescription products pipeline, Crescita currently has one FDA-approved product, Pliaglis, which it licensed in April to Taro Pharmaceuticals, the Canadian unit of Taro Pharmaceutical Industries (NYSE:TARO). The agreement gives Taro exclusive rights to sell and distribute Pliaglis and its second-generation formulation, Flexicaine, in the U.S.

Status of Prescription Products Pipeline

Under the accord, Crescita has the potential to earn up to $5.75-million (U.S.) in development and sales milestones, plus double-digit tiered royalties on net U.S. sales.

Pliaglis is a topical local analgesia for superficial dermatological and cosmetic procedures. According to Mr. Chicoine, Pliaglis is the most powerful topical analgesia approved by the FDA, consisting of 7% lidocaine and 7% tetracaine.

Taro plans to launch Pliaglis in the U.S. in 2018, while Crescita is concurrently planning for the product’s Canadian launch and is currently seeking a licensing partner for the product in Mexico. 

In December 2015, the company reacquired the development and marketing rights for Pliaglis in the U.S., Canada and Mexico from Galderma Pharma S.A., which owns the rest of the world rights for Pliaglis.

Significant Rx Product Milestones

Crescita also licensed Flexicaine to Taro, which is conducting the final clinical requirements prior to filing for FDA approval. Flexicaine is designed for the topical treatment of pain conditions and will seek approval under the same label as Pliaglis. 

The Flexicaine formulation, which was developed with Crescita’s Peel & DuraPeel technologies, dries to form a film, which can be easily peeled from the skin once the active ingredients have been delivered to the site of pain.

Crescita’s prescription pipeline also includes two dermatology product candidates: MiCal 1 for the treatment of plaque psoriasis and MiCal 2, with an undisclosed indication. 

Crescita is responsible for formulation development/IP of the two products and providing its Multiplexed Molecular Penetration Enhancer (MMPE) technology, which is designed to deliver combinations of FDA-approved excipients through the skin.

The clinical phase of development  for both compounds will be fully funded by development partners, Ferndale Laboratories and a leading U.S. contract research organization.

In September, Crescita received statistically significant topline results from a U.S. Phase 2 clinical trial with MiCal 1 in 89 patients with moderate-to-severe plaque psoriasis. A treatment success, using an Investigator’s Global Assessment score, was achieved in 38% of subject’s in the treatment group, compared with 7% of subjects in a control group.

The companies will be seeking an end-of-Phase 2 meeting with the FDA to discuss advancing MiCal 1 to a Phase 3 study next year as well as requirements for future FDA approval. 

Mr. Chicoine says MiCal 1 may be out licensed before the start of the pivotal program. Formulation development and preclinical work is nearly finished for MiCal 2, with plans to begin a clinical program in 2018.

“Our business development activities and ongoing and focused on in licensing and/or acquiring new products,” he adds. “Internal growth alone won’t get us to our $50-million revenue target. The key will be international expansion and acquisitions. There are lots of small dermatology companies selling into this market that could be a very good fit for us.”

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