Applied Biomath LLC, of Concord, Mass., said it is creating semi-mechanistic pharmacokinetic/pharmacodynamic models to support development programs at Xilio Therapeutics Inc., of Waltham, Mass. Xilio is developing XTX-201 (IL-2), which induces immune activity in tumors without the toxicity seen with nonselective IL-2s, and XTX-101 (aCTLA4 mAb), which demonstrates improved antitumor activity compared to ipilimumab, the company said. Applied uses mathematical modeling and simulation to provide quantitative and predictive guidance from early R&D to the clinic.
Astellas Pharma Inc., of Tokyo, entered two new collaborations, one with Harvard University and the other with Insilico Medicine Inc., of Rockville, Md. Astellas and Harvard will partner in a three-year research alliance, with Astellas issuing one or more challenges based on its research scopes to inspire research proposals by Harvard faculty, a number of which will then be selected by Astellas for project funding based on scientific rationale and projected impact on value for patients. Projects may span a range of developmental stages, from early investigations into the biological mechanisms of disease, to identifying therapeutic targets, or to the generation and validation of new therapeutic entities. Insilico and Astellas plan to develop candidates against an unnamed target. Insilico will receive an undisclosed up-front payment and milestones. Astellas will synthesize, optimize and characterize molecules generated by the collaboration using AI.
Biocon Ltd., of Bengaluru, India, and Mylan NV, of Hertfordshire, U.K., said they launched Fulphila, a biosimilar to Neulasta (pegfilgrastim, Amgen Inc.), in Canada following its approval to decrease the incidence of infection, manifested by febrile neutropenia, in individuals with non-myeloid malignancies who are receiving myelosuppressive antineoplastic drugs.
Clearside Biomedical Inc., of Alpharetta, Ga., said it revised its Xipere (triamcinolone acetonide suprachoroidal injectable suspension) NDA resubmission timeline until the fourth quarter of 2020 due to a filling line equipment update at its manufacturing facility and to COVID-19-related issues. Clearside and Bausch + Lomb, of Bridgewater, N.J., also amended and revised their collaboration to develop and commercialize Xipere, a suspension of the corticosteroid triamcinolone acetonide formulated for administration to the back of the eye for treating macular edema associated with uveitis. Bausch + Lomb now has exclusive options for the right to commercialize and develop Xipere in Europe, the U.K., Australia, New Zealand, South America and Mexico. In the amended agreement, Bausch + Lomb also extended the time allowed for Clearside to obtain Xipere approval in the U.S.
Denovo Biopharma LLC, of San Diego, said it is acquiring San Diego-based Tocagen Inc.’s entire retroviral replicating vector platform, including Toca 511 and Toca FC (now known as DB-107), and several early stage development programs targeting PD-L1 and other immune-oncology targets. The acquisition is pending the close of Tocagen's anticipated merger with Forte Biosciences Inc., of Torrance, Calif.
New Brunswick, N.J.-based Johnson & Johnson said the U.S. district judge presiding over the federal multidistrict litigation involving claims that J&J’s Baby Powder causes ovarian cancer decided certain plaintiff expert witnesses did not present scientifically sound evidence to support aspects of their opinions so they cannot present their theories before a jury. The company said the judge limited the testimony of plaintiffs’ asbestos testing expert and held that another expert cannot testify that his experiments showed that talc can cause ovarian cancer.
KBP Biosciences Co. Ltd., of Princeton, N.J., said its tetracycline candidate, KBP-7072, showed potent in vitro activity against geographically diverse strains of the gram-negative pathogen Acinetobacter baumannii, including carbapenem-resistant, colistin-resistant and tetracycline-resistant isolates. Overall, KBP-7072 showed activity comparable to colistin (MIC50/90 = 0.25/1 mg/L vs. <0.5/1 mg/L, respectively), inhibiting 99.2% of isolates at <2 mg/L compared to 92.8% for colistin. Against 38 colistin-resistant strains, KBP-7072 showed an MIC50/90 of 0.5/1 mg/L (100% inhibited at <2 mg/L) vs. >8/>8 mg/L for colistin (0% inhibited at <2 mg/L). The preclinical findings were published online in Antimicrobial Agents and Chemotherapy.
M8 Pharmaceuticals, of Berwin, Pa., and Gennisium Pharma, of Paris, said they formed an agreement giving M8 exclusive rights to register and commercialize in Mexico and Brazil an improved formulation of an existing orphan drug to treat and prevent apnea of prematurity. The partnership includes additional pipeline products to treat conditions that are prevalent in premature newborn infants. Financial terms were not disclosed.
Marinomed Biotech AG, of Vienna, said it received funding from the Austrian Research Promotion Agency to develop a SARS-CoV-2 therapy based on its Carragelose inhalation platform, designed to target viral infections of the respiratory tract. Tolerance of the Carragelose inhalation solution will be evaluated first in healthy volunteers, followed by a proof-of-concept study at the Medical University of Vienna on individuals with viral pneumonia. In parallel, existing data on the effectiveness of Carragelose will serve as the basis for in vitro tests to establish safety and effectiveness, also performed in collaboration with the Medical University of Vienna. The project, part of Austria’s emergency call for research on COVID-19 in the wake of the SARS-CoV-2 outbreak, is expected to be funded at more than €4 million (US$4.3 million).
OBN (U.K.) Ltd., of Abingdon, U.K., an industry organization that supports the country’s life sciences companies, said it launched OBN Ventures Ltd. (OBNV) as a wholly owned subsidiary offering an online investment platform for pre-revenue life sciences companies through the private equity firm Envestors Ltd. OBNV was designed to complement OBN’s major investment conferences, Biotrinity and Bioseed, while leveraging a wider range of investors year-round. OBN said the platform is open to all life sciences companies, with OBNV’s core strategy focused on early stage life sciences companies with strong intellectual property operating in segments with market potential of £100 million (US$124.2 million) or more.
Philogen SpA, of Siena, Italy, through its wholly owned Swiss subsidiary, Philochem AG, said Janssen Biotech Inc., a unit of Johnson & Johnson, of New Brunswick, N.J., exercised an option in connection with a 2019 drug discovery collaboration to identify small molecule-based therapeutics using Philochem's lead-generation technologies. Financial terms were not disclosed.
Photocure ASA, of Oslo, Norway, said it reached an agreement with Ipsen Pharma SAS, of Paris, on key terms for the return of sales, marketing and distribution rights in Europe and other markets controlled by Ipsen for the product known in Europe as Hexvix (hexaminolevulinate hydrochloride). In 2011, Photocure inked a global commercialization agreement with Ipsen for the sales, marketing and distribution of the 5-aminolevulinic acid ester optical molecular imaging agent outside the Nordic region and the U.S. To regain Hexvix marketing rights, Photocure agreed to pay Ipsen €15 million (US$16.3 million) no later than the fourth quarter of 2020. Ipsen will continue to book sales in the meantime and also will receive earn-out payments ranging from 10% to 15% of sales in its current markets for the first seven years post-termination and 7.5% of sales for years eight to 10. The final agreement is subject to customary conditions as well as adequate financing to complete the settlement. Photocure, which had a cash position of NOK125 million (US$12 million) at year-end 2019, may satisfy the financing condition through equity, debt or a combination. The company said it secured offers from debt providers for potential financing arrangements to ensure completion of the deal. Photocure plans to initiate Hexvix commercialization in Europe in the fourth quarter of 2020 and expects the agreement to be EBITDA accretive beginning in calendar year 2021. Hexvix, branded Cysview in the U.S. and Canada, is selectively taken up by tumor cells in the bladder so they glow during blue light cystoscopy to improve tumor detection and treatment management.
Pneumagen Ltd., a spin-out of the University of St. Andrews (U.K.), said three in vitro studies showed that Neumifil and other multivalent carbohydrate binding modules (mCBMs) generated from its Glycotarge platform reduced the number of SARS-CoV-2 plaques in assays evaluating the mCBMs both for prevention and treatment of coronavirus infection. Pneumagen said the research conducted at Public Health England's Porton facility and at the University of Glasgow's MRC Centre for Virus Research extended its internal experiments with a clinically relevant coronavirus that can cause the common cold, where a plaque reduction assay also showed antiviral activity for mCBMs. Neumifil is in development for the universal treatment of respiratory tract infections, including influenza virus and respiratory syncytial virus in addition to those related to COVID-19.
Prokarium Ltd., of London, said it inked an exclusive global option agreement with the Lausanne (Switzerland) University Hospital – CHUV to acquire a license covering the treatment of non-muscle invasive bladder cancer (NMIBC) with intravesical instillations of Salmonella. Prokarium is investigating the use of engineered bacteria to develop microbial immunotherapy for solid tumors, with NMIBC as the first oncology indication in preclinical development. The company began collaborating in 2019 with a team in the CHUV’s department of urology, which is running a phase I trial in NMIBC patients investigating intravesical administration of Salmonella Typhi Ty21a, a live attenuated bacterial vaccine. Prokarium is working with the medical team to generate an adequate preclinical data package to file an IND.
Ritter Pharmaceuticals Inc., of Los Angeles, said it advised stockholders to vote in favor of all proposals, including a proposed reverse stock split, related to its proposed merger with privately held Qualigen Inc., of Carlsbad, Calif. The reverse stock split, a condition to closing the merger, is needed to ensure that the combined company meets Nasdaq’s minimum bid price requirement for listing following the merger. Ritter stockholders are set to own 7.5% of the post-merger company and to receive contingent value rights to net proceeds from any monetization event involving Ritter’s RP-G28 gut microbiome intellectual property or technology. Ritter’s shares (NASDAQ:RTTR) fell 1 cent on April 28 closing at 32 cents.
Sarepta Therapeutics Inc., of Cambridge, Mass., said it inked a Cooperative Research and Development Agreement with the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) involving use of its phosphorodiamidate morpholino oligomer (PMO) platform in a collaboration to identify antisense oligonucleotides with activity against SARS-CoV-2 for the potential treatment of COVID-19. The agreement calls for Sarepta to design, synthesize, manufacture and provide to USAMRIID multiple peptide-conjugated PMO constructs based on genetic sequencing of SARS-CoV-2 for COVID-19. USAMRIID will evaluate the constructs on characterized wild-type SARS-CoV-2 viruses for their potential to inhibit viral infection. Based on results, Sarepta and USAMRIID will consider collaborative funding proposals to advance development of treatments for COVID-19.
Secarna Pharmaceuticals GmbH & Co. KG, of Munich, said it inked a cooperative agreement with First Affiliated Hospital at Guangzhou Sun Yat-sen University (SYSU) to develop a treatment or prophylactic for SARS-CoV-2 viral infections using Secarna’s locked nucleic acid (LNAplus) platform to develop antisense oligonucleotides (ASOs) that suppress the expression of a certain host factor essential for the viral infection cycle. Feasibility of the concept was demonstrated in 2019, when Secarna employed LNAplus to develop ASOs targeting the host factor NPC1 to reduce Ebola virus infection in vitro. Applicability to SARS-CoV-2 is being assessed by researchers at Belgium’s University of Ghent and the First Affiliated Hospital at SYSU. Financial terms were not disclosed.
Shionogi & Co. Ltd., of Osaka, Japan, said it is working with public institutions, academic researchers and partner companies to accelerate development of vaccine and therapeutic candidates against COVID-19. The company initiated a collaborative research effort with the Hokkaido University Research Center for Zoonosis Control to identify drugs active against COVID-19 and identified multiple potential lead compounds from internal in vitro studies. Shionogi said it aims to start clinical trials of one or more of those agents by year-end. Additionally, UMN Pharma Inc., a Shionogi unit, is pursuing discovery and development of a recombinant protein vaccine for COVID-19 using its Baculovirus Expression Vector System technology. The project, which began in March 2020, is supported by the Japan Agency for Medical Research and Development. Shionogi plans to start clinical trials in Japan within the year.
Therapix Biosciences Ltd., of Tel Aviv, Israel, said it received notice that Nasdaq granted the company an extension until May 18, 2020, to regain compliance with the minimum equity requirement for continued listing. Because Nasdaq elected to provide temporary relief from continued listing bid prices due to the COVID-19 pandemic for companies presently in compliance periods for any price-based requirements, Therapix said it will have until Nov. 5, 2020, to regain compliance with the bid price rule.
Vistagen Therapeutics Inc., of South San Francisco, said it plans to expand clinical development of its vomeropherin compound-based PH-94B to include treatment of adjustment disorder due to stressors related to the COVID-19 pandemic. It plans to submit its proposed protocol for a phase II study of the candidate in the indication through the FDA's new Coronavirus Treatment Acceleration Program. The regulator previously designated PH-94B for fast track development for treatment of social anxiety disorder, an indication in which Vistagen is preparing for phase III development.