BioSpace Global Roundup, Aug. 22

Global Connection

Sernova Corp. – Canada-based Sernova completed the first closing of $2,333,500 of its non-brokered private placement. Net proceeds from the increased portion of the private placement will be used to support funding of Sernova's clinical program including its FDA cleared US Phase I/II regenerative medicine clinical trial and to advance corporate/academic collaborations utilizing the Company’s platform technology to treat diabetes, hemophilia and other serious disease conditions, as well as for investor relations and general corporate purposes. The Phase I/II non-randomized will include diabetic subjects with hypoglycemia unawareness enroll into the study. Participants are implanted with Cell Pouches. Following the development of vascularized tissue chambers within the Cell Pouch, subjects are then stabilized on immunosuppression, and a dose of purified islets, under strict release criteria, is transplanted into the Cell Pouch.

Karolinska Institute – Children with Inflammatory Bowel Disease (IBD) run a greater risk of psychiatric disorders, according to a new study published in JAMA Pediatrics from Sweden-based Karolinska Institutet. The researchers claim that more psychological support and longer follow-up is needed for the children affected and their parents. It is already known that adults with IBD (Ulcerative Colitis or Crohn’s Disease) run an increased risk of psychiatric disorders. Now a new study shows that children with IBD also run a higher risk of mental health problems, the researchers said. More than 6,400 children with IBD, born between 1973 and 2013, were included in the study. During an average follow-up period of 9 years, approximately 17% of the children with IBD were given a psychiatric diagnosis compared with just under 12% of the healthy children and about 10% of the siblings. This means that the risk of psychiatric disorders was 1.6 times higher in children with IBD compared to Swedish children from general population. Likewise, the risk for the children with IBD was greater than for their siblings.

Abivax – France-based Abivax enrolled the first patient in its Phase IIb clinical trial of ABX464 for treatment of patients with moderate to severe active ulcerative colitis (UC). The new Phase IIb trial ABX464-103 will have a primary endpoint of reduction in modified Mayo Score at eight weeks, and secondary endpoints will include clinical remission, endoscopic improvement and biomarker fecal calprotectin. Top-line data from the induction study are expected around the end of 2020. Results of the Phase IIa study which were reported last fall showed a rapid onset of efficacy within two weeks after initiation of treatment. At the end of the eight-week induction treatment, clinical remission was observed in 35% of the ABX464 treated patients, compared to 11% of placebo patients. ABX464 also resulted in 50% mucosal healing, the company said.

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Check-Cap – Based in Israel, Check-Cap and GE Healthcare announced the completion of manufacturing line transfer implementation and qualification for the C-Scan System. The C-Scan is the first preparation-free ingestible scanning capsule-based system for the prevention of colorectal cancer through the detection of precancerous polyps. This collaboration between Check-Cap and GE Healthcare was initiated to enable the manufacture of C-Scan Systems for U.S. clinical trials. Upon the successful completion of this current clinical trial phase, both companies intend to explore collaboration expansion opportunities. Check-Cap is currently conducting a pilot clinical trial in the U.S. to evaluate the safety, usability and subject compliance of the C-Scan System, which will be the basis for an application for approval from the U.S. FDA. The C-Scan System has received marketing approval in Europe and Israel.

Araris Biotech – Switzerland-based Araris announced the closing of an oversubscribed seed financing round of 2.5 million Swiss Francs, with the participation of Swiss investors Redalpine, Schroder Adveq and VI Partners. The proceeds will be used to develop a pipeline of proprietary antibody-drug conjugates.

Inventiva – Inventiva, a France-based biopharmaceutical company focused on developing treatments of diseases in the areas of fibrosis, lysosomal storage disorders and oncology, said the U.S. Patent and Trademark Office granted the company a new patent that protects the use of lanifibranor for the treatment of fibrotic diseases until June 2035. This new patent further strengthens Inventiva’s patent portfolio for lanifibranor, the company’s lead product candidate, in the United States, which already comprised a New Chemical Entity patent and a patent protecting the use of lanifibranor in several diseases including non-alcoholic steatohepatitis.

Sphere Fluidics – U.K.-based Sphere opened new office space in Cambridgeshire. The new facilities support the company’s accelerated expansion and accommodate its plans for further growth. The expansion followed Sphere’s $4.8 million funding round that provided support for its expansion, as well as its Cyto-Mine Single Cell Analysis System. The expansion into Cambridgeshire is expected to provide Sphere with additional opportunities for further collaborations with potential partners, researchers and suppliers.

Rexgenero – London-based Rexgenero, secured a £267,000 grant from Innovate UK. The grant will be used to develop gel stabilization technologies with the first objective of extending the shelf-life of Rexgenero’s cell-based therapies for storage and transport at room temperature. The project will initially focus on developing a stabilization technology for REX-001, Rexgenero’s lead development candidate, but is expected to have broad applicability to a wide range of other cell therapies. The project will benefit from additional expertise and experience provided by the Cell and Gene Therapy Catapult. REX-001 consists of bone marrow-derived white blood cells extracted from a patient’s own bone marrow. Rexgenero is currently recruiting patients for its Phase III SALAMANDER study of REX-001 for the treatment of CLI in diabetic patients. CLI is a chronic condition and the most serious form of peripheral arterial disease (PAD) in which a build-up of fatty deposits in the arteries restricts blood supply to leg muscles, leading to chronic ischemic at-rest pain, ulcers, or gangrene in one or both legs.

Tetra Bio-Pharma – Ontario-based Tetra Bio-Pharma, a cannabinoid-focused company, signed an agreement with Thorne Research Inc. and Onegevity Health LLC to form a joint venture, CB2 Therapeutics Inc. The new entity is focused on leveraging the power of the endocannabinoid system (ECS) using innovative multi-omics and multi-targeted therapeutic options to become a leader in the management of chronic inflammatory conditions. CB2 Therapeutics will focus on developing compounds for chronic inflammatory conditions with high unmet needs or that are poorly served with existing therapies. CB2 Therapeutics’ lead asset is a dietary supplement to support individuals who have functional bladder inflammation leading to urinary frequency and urgency in the absence of infection or other identifiable cause, which is expected to launch in 2020. CB2 Therapeutics also has an earlier-stage drug candidate for symptoms of irritable bowel syndrome and inflammatory bowel disease.

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