Achaogen Inc., of South San Francisco, disclosed a collaboration with CARB-X (Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator), a global public-private partnership focused on funding the development of new antibiotics and diagnostics. The company is developing a new class of antibiotic designed to inhibit LpxC. Achaogen was awarded $3.2 million over 12 months, and potentially up to a total award of $11.4 million after that period upon achievement of certain milestones. The money will help advance the lead candidate through the first phase I trials. LpxC is an essential enzyme in most gram-negative bacteria for the biogenesis of the bacterial outer membrane, which is a significant barrier that protects the pathogens from the extracellular milieu.

Alpine Immune Sciences Inc., of Seattle, closed its previously disclosed merger with Nivalis Therapeutics Inc., of Boulder, Colo., and the combined company changed its name to Alpine Immune Sciences Inc. immediately following the merger, trading on Nasdaq under the ticker ALPN. The deal leaves Alpine with about $90 million in cash and cash equivalents, which includes proceeds from a financing that closed immediately prior to the merger in which the company collected gross proceeds of approximately $17 million in new investment from current Alpine investors, Orbimed Advisors, Frazier Healthcare Partners and Alpine Bioventures. Late last year, Nivalis' lead candidate, cavosonstat, failed its first phase II experiment in adult patients with cystic fibrosis who had two copies of the F508del-CFTR mutation and were being treated with Orkambi (lumacaftor/ivacaftor, Vertex Pharmaceuticals Inc.). (See BioWorld Today, Nov. 30, 2016.)

Anika Therapeutics Inc., of Bedford, Mass., said regulatory authorities in India granted approval to Monovisc, its single injection viscosupplement for the treatment of pain associated with osteoarthritis of all human synovial joints. The treatment already is commercially available in the U.S., Canada and Europe, and Anika plans to expand into India, Australia, New Zealand and additional international markets over the next six to nine months. Anika has a multiyear, exclusive distribution agreement with Modi-Mundipharma Pvt. Ltd., of New Delhi, to market the product in India. Monovisc is composed of highly purified, partially cross-linked sodium hyaluronate in a phosphate buffered saline solution.

Antabio SAS, of Labege, France, was awarded up to $8.9 million in nondilutive funding from CARB-X (Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator), a public-private partnership devoted to antibacterial research and development. The award provides immediate funding of up to $2.8 million with options for up to $8.9 million upon achievement of milestones. Antabio will use the funding to accelerate the development up to completion of phase I trials of a small-molecule drug for the treatment of chronic Pseudomonas infections in cystic fibrosis patients. Antabio's PEI (Pseudomonas elastase inhibitors) program seeks to develop inhibitors of the Pseudomonas aeruginosa LasB elastase virulence factor, thereby targeting the bacterium's ability to evade the immune system and cause disease.

Aslan Pharmaceuticals Pte. Ltd., of Singapore, is partnering with Taiwan's Hope Foundation for Cancer Care to develop a new digital application to assist cancer patients in managing their care. Funded by a grant from Aslan, the new mobile application will help patients track their medical appointments, follow-up treatments and medications via their phones. The app will be made available for free to all cancer patients in Taiwan, Aslan said.

Bristol-Myers Squibb Co., of Princeton, N.J., said the FDA accepted its supplemental BLAs to update dosing of PD-1 inhibitor Opdivo (nivolumab) to include 480 mg infused over 30 minutes every four weeks for all currently approved monotherapy indications. The applications are under review with an action date of March 5, 2018. In separate news, BMS extended a licensing agreement with The Medicines Patent Pool to further increase access to atazanavir, part of the World Health Organization-preferred second-line treatment for adults and children with HIV. Disclosed during the International AIDS Society meeting in Paris, the amendment adds 12 countries, home to 1.4 million people living with HIV, to the 110 included in the original 2013 agreement.

Cellectis SA, of Paris, said the European Patent Office has granted it patent, No. EP3004337, for the invention of using RNA-guided endonucleases, such as Cas9 or Cpf1 for the genetic engineering of T cells. The patent will be issued on Aug. 2. The company already has patents on certain other gene editing technologies such as TALEN, its flagship nuclease structure for gene editing, based on a class of proteins derived from transcription activator-like effectors. But, while TALEN is the company's "most robust and adaptable technology for human therapeutic use and for the company's product pipeline, our team does sometimes use CRISPR-based nucleases for T-cell research, as it is a less-expensive option and convenient for gene discovery purposes," said CEO and Chairman André Choulika.

Cryoport Inc., of Irvine, Calif., said it signed an agreement to provide cryogenic shipping support over an initial three-year period to Novartis AG, of Basel, Switzerland, for its CAR T candidate, CTL-019 (tisagenlecleucel). The biologics license application for the therapy, which received a unanimous endorsement earlier this month from the FDA's Oncologic Drugs Advisory Committee, is under review by the agency, with an Oct. 3 PDUFA date. (See BioWorld, July 13, 2017.)

Debiopharm International SA, of Lausanne, Switzerland, has been selected to receive up to $2.6 million of funding over 15 months from the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator, or CARB-X, to advance the development of its antibiotic, Debio-1453, a FabI inhibitor specifically targeting Neisseria gonorrhoeae. At the end of the project, the goal is to select a candidate that meets a commercial target product profile and is ready for further testing in preparation for clinical trials for uncomplicated gonorrhea caused by susceptible and drug-resistant N. gonorrhoeae. CARB-X, public-private partnership devoted to early stage antibacterial R&D, has the option of extending the program for an additional nine months at a cost of up to $1.4 million.

Eisai Inc., of Woodcliff Lake, N.J. submitted a supplemental new drug application to the FDA for the first-line use of Lenvima (lenvatinib), the company's multiple receptor tyrosine kinase inhibitor, in patients with hepatocellular carcinoma (HCC). The filing is based on the positive results of the pivotal phase III Reflect trial (Study 304), in which Lenvima demonstrated noninferior overall survival vs. Nexavar (sorafenib, Bayer AG) in previously untreated patients with unresectable HCC and demonstrated statistically significant and clinically meaningful improvements in all three secondary efficacy endpoints: progression-free survival, time to progression and objective response rate.

Flex Pharma Inc., of Boston, gained FDA fast track status for FLX-787, the company's co-activator of TRPA1 and TRPV1, to treat severe muscle cramps in patients with amyotrophic lateral sclerosis (ALS). The company expects to start phase II trials in both ALS and Charcot-Marie-Tooth (CMT) this quarter in the U.S. As the phase II ALS trial, called Commend, gets underway in the U.S., the company said it would end a small exploratory Australian ALS study early. Flex Pharma shares (NASDAQ:FLKS) rose 11 percent on Tuesday to close at $4.33.

Frontier Biotechnologies Inc., of Nanjing, China, signed an agreement with Rockefeller University, of New York, for a worldwide license for combining 3BNC-117, an experimental broad-spectrum HIV neutralizing antibody discovered in the lab at the university, with its lead candidate, albuvirtide, for the treatment and prophylaxis of HIV infection and AIDS. Frontier plans to start testing the combination in clinical trials in 2018. Financial terms of the deal were not disclosed.

Hedgepath Pharmaceuticals Inc., of Tampa, Fla., said FDA staff told company representatives that no additional nonclinical toxicology studies appear necessary to support filing a new drug application (NDA) for SUBA-itraconazole under the 505(b)(2) pathway. The company is developing the medicine for the treatment of patients with basal cell carcinoma nevus syndrome (BCCNS), also known as Gorlin syndrome. The company said the agency also indicated that it "[w]ould accept a single study to support an NDA if results show a significant effect on a clinically meaningful endpoint." Hedgepath is now taking a closer look at individual tumor responses from its ongoing trial and intends to present the results of the additional analysis to the agency.

Iterum Therapeutics Ltd., of Dublin, received a $1.5 million award from CARB-X, the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator, to further development of its antibiotic, sulopenem. The candidate, which Iterum expects will reach phase III studies in 2018, is under development as an oral and intravenous antibiotic for the treatment of gram-negative multidrug-resistant infections. The new grant funding will support a phase I study to measure the pharmacokinetics of different formulations of sulopenem; studies of gram-negative bacteria and their resistance to existing antibiotics; and refinements in the process of the large-scale manufacturing of sulopenem. In May, Iterum announced that it had raised $65 million in an oversubscribed series B round to fund phase III development of sulopenem. (See BioWorld Today, May 22, 2017.)

Eli Lilly and Co., of Indianapolis, and Incyte Corp., of Wilmington, Del., said resubmission of a new drug application for baricitinib, a once-daily oral medicine for the treatment of moderate to severe rheumatoid arthritis (RA), will be delayed beyond 2017. The partners will also discuss "options for resubmission, including the potential for an additional clinical study," which the agency requested "to further characterize the benefit/risk across doses, in light of the observed imbalance in thromboembolic events that occurred during the placebo-controlled period of the RA clinical program." Lilly is also taking a fresh look at the rest of its pipeline, saying it will focus on seven pipeline assets for priority internal development and three additional assets, pending data from ongoing trials, while seeking external partners on other molecules in clinical development. (See BioWorld Today, April 17, 2017.)

Marina Biotech Inc., of City of Industry, Calif., said it entered a binding letter of intent with an undisclosed biotech company in the gene editing space for the sale of Marina's DiLA2 delivery platform. Under the terms, Marina will receive $1.5 million, with $300,000 due upon the closing of the transaction and the balance of $1.2 million due upon either a successful fundraising by the buyer above a certain minimum dollar amount or the one-year anniversary of the closing of the transaction, whichever comes first. The deadline for closing is Aug. 30, 2017. Marina will retain an exclusive, fully paid and royalty-free license to DiLA2 outside of the field of gene editing, as well as the rights to license DiLA2 outside of gene editing.

Nantkwest Inc., of Culver City, Calif., said researchers at the National Cancer Institute (NCI) reported preclinical data associated with the company's natural killer cell line, or haNK, platform in combination with avelumab (Merck KGaA/Pfizer Inc). The haNK cells were engineered to express the IL-2 cytokine and the high affinity CD16 allele. Consistent with previous studies, results suggested that haNK cells showed enhanced cancer cell-killing abilities, when combined with avelumab, in a range of cancer cell types via the antibody-dependent cell-mediated cytotoxicity mechanism. The study also showed that the activity, cytotoxicity and immune signaling capabilities of haNK cells remained intact post-irradiation. The findings were published in the International Journal of Cancer. (See BioWorld Today, May 10, 2017.)

Onconova Therapeutics Inc., of Newtown, Pa., said it established a collaborative, multi-institutional research and clinical program to evaluate its lead candidate, rigosertib, in pediatric RASopathies. The program will generate nonclinical data and obtain early clinical experience in the pediatric setting with rigosertib, believed to block cellular signaling by targeting RAS effector pathways. The RASopathies are developmental syndromes caused by mutations that alter the RAS subfamily and by mitogen-activated protein kinases that control signal transduction.

Regen Biopharma Inc., of San Diego, said work conducted by contract research organization Chemdiv Inc. identified chemical compounds that activate NR2F6 and selectively inhibit cytokines secreted from activated immune cells, supporting the company's development of small-molecule drugs that activate and inhibit the NR2F6 nuclear receptor. Regen's program aims to identify antagonists of NR2F6 to boost the cancer-killing potential of a patient's immune system and to identify agonists to suppress an overactivated immune system, such as in autoimmune disease.

Roche Holding AG, of Basel, Switzerland, said it received a CE mark for the Ventana anti-ALK rabbit monoclonal primary antibody as a companion diagnostic to identify ALK-positive non-small-cell lung cancer patients eligible for treatment with Zykadia (ceritinib, Novartis AG).

Seattle Genetics Inc., of Bothell, Wash. reported that Health Canada has issued a nonconditional marketing authorization for use of Adcetris (brentuximab vedotin) as post-autologous stem cell transplant (ASCT) consolidation treatment of patients with Hodgkin lymphoma (HL) at increased risk of relapse or progression. The indication was based on positive results from the phase III Aethera trial. Adcetris previously received approval with conditions in Canada for two lymphoma indications: HL patients who relapse after ASCT or relapse after at least two multi-agent chemotherapy regimens in patients who are not ASCT candidates; and for systemic anaplastic large-cell lymphoma patients who relapse after at least one multi-agent chemotherapy regimen. The company recently submitted a supplemental biologics license application (BLA) to the FDA seeking approval to market Adcetris for use in cutaneous T-cell lymphoma and plans to submit a supplemental BLA to the FDA for Adcetris in front-line Hodgkin lymphoma, followed by submissions to Health Canada for the same indications.

Soleno Therapeutics Inc., of Redwood City, Calif., said it sold one of its nonstrategic subsidiaries, Neoforce Inc., which manufacturers and promotes pulmonary resuscitation solutions in the neonatal market, to Flexicare Inc. Terms were not disclosed. Soleno recently refocused its business to develop and commercialize therapeutics targeting rare diseases. A phase III trial testing lead candidate diazoxide choline controlled-release, or DCCR, for Prader-Willi syndrome is set to start by the end of this year.

Som Biotech Ltd., of Barcelona, Spain, said it concluded a worldwide license agreement with Corino Therapeutics Inc., of New York, to develop and market the drug SOM-0226 against transthyretin amyloidosis (ATTR). Prior to the agreement, the drug achieved promising results in a phase II study conducted in Europe, the company said. Som is commencing a series A financing to fund clinical development of SOM-0226 and other programs, as well as a geographic expansion to Cambridge, Mass. Since it was created in 2009, Som has raised more than $6 million in public and private capital.

Taiwan Liposome Co. Ltd., of Taipei, Taiwan, said it is due to receive a government subsidy of NT$30.9 million (US$1 million) from Taiwan's Ministry of Economic Affairs toward its fast track designation plan for ophthalmology product candidate TLC-399, a liposomal encapsulated dexamethasone using TLC's Bioseizer technology. The grant will be allocated in installments over the 36 months of planned development and used for the TLC-399 phase II trial currently enrolling patients at multiple sites in the U.S.

Verastem Inc., of Boston, said findings from studies evaluating focal adhesion kinase (FAK) inhibition in preclinical models of pancreatic and breast cancer were published in PLoS One and Oncotarget. In PLoS One, researchers describe findings demonstrating that FAK inhibition extended the antitumor response to gemcitabine and Abraxane (nab-paclitaxel, Celgene Corp.) in preclinical models of pancreatic ductal adenocarcinoma. The Oncotarget publication demonstrated that FAK inhibition significantly reduced the proportion of cancer stem cells in mice bearing xenograft models of triple-negative breast cancer, as evidenced by a reduced tumor-initiating capability upon re-implantation. Verastem is testing lead FAK inhibitor defactinib in combination with chemotherapeutic and leading immunotherapeutic agents in several types of cancer.