BAD HOMBURG, Germany I October 09, 2018 I Fresenius Kabi announced today that MSB11455, a biosimilar candidate of Neulasta®* (pegfilgrastim) ...
BAD HOMBURG, Germany I October 09, 2018 I Fresenius Kabi announced today that MSB11455, a biosimilar candidate of Neulasta®* (pegfilgrastim) ...
A collaboration between Bicycle Therapeutics and Cancer Research UK has yielded its first peptide to enter clinical trials for solid tumors.
Bicycle Therapeutics, the pioneer of the bicyclic peptide platform, has dosed the first patient in a Phase I/IIa trial with its solid tumors candidate, BT1718. The study will test the drug’s safety and efficacy in around 120 patients with tumors that express high levels of a molecule called Membrane Type 1 Matrix Metalloproteinase (MT1-MMP).
The technology was developed by Greg Winter, who founded Cambridge Antibody Technology, which discovered the blockbuster therapeutic antibody, Humira, and Christian Heinis, one of his postdocs. Their tripartite molecules are made up of a ‘Bicycle’ that recognizes the tumor target, a linker that is cleaved once the drug reaches the tumor microenvironment, and a toxin to kill cancer cells. The linker is essential in keeping the toxin inert until it reaches the tumor, which ensures that the body is exposed to it for as little time as possible.
BT1718 is Bicycle Therapeutics’ lead molecule, which is an example of a ‘Bicycle Toxin Conjugate’. The candidate targets MT1-MMP, a protein that plays an important role in cell invasion and metastasis, with its expression in solid tumors associated with poor patient outcomes. So far, BT1718 has shown promising efficacy in treatment-resistant cancer samples taken from patients and reduced toxicity in comparison with other highly potent cancer treatments.
Nigel Blackburn, Cancer Research UK’s director of drug development, has high hopes for the candidate: “BT1718 has shown great promise in preclinical studies, and trials like this are a big step towards helping more patients survive their cancer. We urgently need new, safe and effective therapies for patients with hard to treat cancers such as non-small cell lung cancer and triple negative breast cancer that this drug will be tested on.”
With Bicycle’s technology entering the clinic, an exciting showdown with antibody-drug conjugates (ADCs) has been set up. The field is being led by ADC Therapeutics, which raised $200M (€170M) to see its two lead candidate through the clinic. However, Winter told us that his technology could “get the toxins deep into tissues.”
With the approval of the first two CAR-T therapies by Novartis and Gilead, this hype area of biotech could provide strong competition if the two companies can expand their technology into the solid tumors space. In addition, Belgian biotech Celyad is developing its own version of CAR-T, which binds 8 ligands that are expressed on over 80% of solid and hematological malignancies.
Bicycle’s announcement adds even more competition to the cancer therapies field, which is already overflowing with exciting technology. This is no bad thing, with cancer still one of the biggest killers in the world, so any help would be welcomed by patients and clinicians alike.
Images – sezer66 / shutterstock.com; Bicycle Therapeutics
HARRISON, N.Y., June 26, 2018 (GLOBE NEWSWIRE) -- Sapience Therapeutics, Inc., a biotechnology company focused on developing peptide therapeutics to address difficult to treat oncology indications, announced today that it was selected by Johnson & Johnson Innovation, JLABS (JLABS) as a winner of the JLABS @ NYC QuickFire Challenge. Sapience was awarded one year of residency at the JLABS @ NYC, which includes laboratory space and access to Johnson & Johnson Innovation’s network of experts.
The JLABS QuickFire Challenges are contests designed to attract game-changing, early-stage innovation in the pharmaceutical, medical device, consumer and health tech sectors. With a platform capable of discovering peptides that disrupt protein-protein interactions (PPIs), Sapience is building a pipeline of innovative cancer treatments targeting previously “undruggable” targets that reside within the cancer cell. Sapience’s molecules target PPIs responsible for transcriptional regulation of oncogenic and immune-modulatory proteins. Sapience’s lead program, ST101, based on intellectual property licensed from Columbia University, inhibits ATF5-driven transcription and drives cancer cells toward cell death. Additional programs currently being developed via internal R&D efforts and in collaboration with the University of Bath (U.K.), target the cJun/cFos AP1 complex, undisclosed targets in the WNT pathway, and undisclosed immune-modulatory targets.
“We are very excited to join the community of QuickFire Challenge winners. At Sapience, we strive to change outcomes for patients with high mortality cancers. We have a vision of developing molecules that combine the best properties of traditional chemical-based drugs and newer biologic-based drugs, providing opportunities to hit therapeutic targets that these other classes of molecules cannot,” said Dr. Barry Kappel, founder and chief executive officer of Sapience Therapeutics. “We greatly appreciate this recognition of our innovative efforts. The network and resources available to us will be valuable as we continue to build out a broad pipeline of peptide-based therapeutics and drive towards the clinic.”
JLABS is a global network of open innovation ecosystems, enabling and empowering innovators to create and accelerate the delivery of life-enhancing health and wellness solutions to patients around the world. As a leader in innovation, JLABS helps entrepreneurs in pharmaceutical, medical device, consumer, and health tech bring healthcare solutions to patients and consumers.
About Sapience Therapeutics
Sapience Therapeutics, Inc., is a privately held, preclinical biotechnology company focused on developing peptide-based therapeutics for major unmet medical needs, particularly high mortality cancers. Our drug development program involves translating science into novel therapies, and our lead compound, ST101, is a first-in-class molecule with potential applications in various solid tumors and hematologic malignancies. In 2016, Sapience Therapeutics closed its Series A financing, which was led by Eshelman Ventures and included investments from Celgene Corporation, TaiAn Technologies Corporation and Healthlink Capital. For more information on Sapience Therapeutics, please visit www.sapiencetherapeutics.com.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements, and any statements other than statements of historical fact could be deemed to be forward-looking statements. These forward-looking statements may include, among other things, statements regarding future events that involve significant risks and uncertainties. These statements are based on management’s current expectations, and actual results and future events may differ materially as a result of certain factors, including, without limitation, risks related to the application of the net proceeds from the offering to Sapience’s product development objectives, our ability to obtain additional funds, and meet applicable regulatory standards and receive required regulatory approvals. These are forward-looking statements, which speak only as of the date of this press release. Sapience does not undertake any obligation to update any forward-looking statements as a result of new information, future events, changed assumptions or otherwise.
Sapience Therapeutics, Inc.:
President and Chief Executive Officer
Source: Sapience Therapeutics, Inc.
GERMANTOWN, Md.--(BUSINESS WIRE)--Today, Neuraly announced its launch to pioneer the development of disease-modifying agents for neurodegenerative disorders. The company’s pipeline is centered around NLY01, a potent, brain-penetrant long-acting Glucagon-like peptide-1 receptor (GLP-1R) agonist that has demonstrated promise as a neuroprotective agent for neurologic disorders such as Alzheimer’s disease and Parkinson’s disease. In conjunction with this launch, Neuraly has raised a Series A financing of $36 million from holding company, D&D Pharmatech with participation by major Korean venture funds, including: Smilegate Investment, InterVest, LB Investment, Magna Investment, Geon Investment and Dongkoo Bio&Pharma. Two U.S.-based funds, Octave Life Sciences and Maryland Venture Fund, also participated in this financing. In turn, the following representatives will join Seulki Lee, Ph.D., Chairman and Founder, and Viktor Roschke, Ph.D., Co-founder on the Board of Directors: John Ku, Executive Vice President of Smilegate Investment, Phillip Jung, Associate at Maryland Venture Fund, Junghee Lim, Executive Managing Director of InterVest and Keele Park, CEO of Magna Investment.
“Block of A1 astrocyte conversion by microglia is neuroprotective in models of Parkinson's disease.”
“Currently, there aren’t any treatments that reverse, stop, or even slow neurodegeneration in diseases like Parkinson’s and Alzheimer’s. The treatments that do exist – all symptomatic – provide only temporary improvement in motor and cognitive function, but even these become less effective over time,” said Dr. Lee, Chief Executive Officer of Neuraly. “We believe that the science supports NLY01 as a potential disease-modifying therapy capable of slowing the progression of disease.”
Dr. Roschke, Chief Scientific Officer of Neuraly added, “We expect NLY01 to be a pioneering treatment for Parkinson’s with low development risks as we have seen unprecedented efficacy in pre-clinical models and well-characterized safety profiles in a similar class of molecules. We look forward to initiating NLY01 into clinical trials later this year.”
Neuraly, a startup biotech company, was formed in 2016 following foundational research by world class neuroscientists led by Ted Dawson, M.D., Ph.D., Leonard and Madlyn Abramson Professor in Neurodegenerative Diseases and Director of the Institute for Cell Engineering at the Johns Hopkins School of Medicine. Following the acquisition of exclusive licenses to patents covering the composition of matter and methods of use, research supporting the development of NLY01 was recently published in Nature Medicine1. These data demonstrated the critical role of the glial compartment of the neural tissue in the pathogenesis of neurodegenerative diseases such as Parkinson’s and Alzheimer’s diseases. Activated microglial cells cause direct toxic effects on neuronal cells in the affected areas and induce differentiation of astroglia into neurotoxic A1 astrocytes further exacerbating neurotoxic effects of glial activation. In clinically relevant animal models, NLY01 was found to prevent neuronal cell death by inhibition of microglial activation and formation of A1 neurotoxic astroglial cells. As a result, treatment with NLY01 slowed down disease progression, improved motor and cognitive functions, and extended the lifespan in mice with Parkinson’s disease.
NLY01 is a proprietary long-acting analogue of Glucagon-like peptide-1 receptor (GLP-1R) agonists, a class of drugs with a well-known safety profile as illustrated by already approved treatments of Type 2 diabetes. NLY01 is being developed as a disease-modifying agent for neurodegenerative disorders such as Parkinson’s disease and Alzheimer’s disease with a Phase 1 clinical trial expected to be initiated in 2018.
Neuraly, a biotech company founded on technology created at the Johns Hopkins School of Medicine, is focused on the development of neuroprotective agents for neurologic disorders such as Alzheimer’s disease and Parkinson’s disease. In addition to NLY01, Neuraly’s growing pipeline includes two candidates in early development targeting complementary mechanisms of neurodegenerative diseases.
1 Yun, S.P., et. al. “Block of A1 astrocyte conversion by microglia is neuroprotective in models of Parkinson's disease.” Nat Med. 2018 Jun 11. doi: 10.1038/s41591-018-0051-5
MacDougall Biomedical Communications
Cammy Duong, 781-591-3443
From Genetic Engineering and News
Novo Nordisk has announced a drug discovery collaboration with New York–based Kallyope to develop peptide therapeutics to treat obesity and diabetes.
Under the terms of the agreement, the value of which was not disclosed, Kallyope will receive an up-front payment and research support in exchange for granting a option for Novo Nordisk to license exclusive worldwide rights to develop and commercialize up to six products discovered in the collaboration. Kallyope will receive a license fee if Novo Nordisk chooses to exercise an option to a therapeutic discovered and validated in the joint research plan and potential research, development, and sales milestones. In addition, Kallyope will receive royalties on worldwide product sales of licensed products.
Kallyope has developed a platform to interrogate the gut–brain axis and discover new medicines in multiple therapeutics areas. This axis includes released circulating peptides and metabolites, immune factors, and direct neuronal innervation. According to the company, the platform integrates single-cell sequencing, bioinformatics, functional and anatomical circuit mapping, and organoids, and has had some success identifying multiple potential secreted products that may play a role in metabolism.
"Novo Nordisk is renowned for its expertise in the discovery and development of peptide therapeutics, as well as its commitment to and leadership in therapeutics for obesity and diabetes," said Nancy Thornberry, CEO of Kallyope. "Coupling Novo Nordisk's formidable capabilities with Kallyope's unique, sophisticated platform makes for a very attractive strategic collaboration that complements our small-molecule focus."
Under the collaboration, the two companies will conduct in vitro and in vivo studies to validate a number of product candidates. Following validation and option exercise, Novo Nordisk will assume responsibility for further preclinical and clinical development, manufacturing, and commercialization.
"Novo Nordisk is very excited about the opportunity to collaborate with Kallyope. The company has developed a unique and innovative platform and is led by an outstanding leadership team,” said Marcus Schindler, senior vice president, Global Drug Discovery at Novo Nordisk. “In combination with the experience that Novo Nordisk has in disease biology understanding, peptidomics, and peptide production, the projects that we will collaborate on hold potential to make a real difference for people living with diabetes and obesity.”
MENLO PARK, Calif., July 12, 2018 (GLOBE NEWSWIRE) -- CohBar, Inc. (NASDAQ:CWBR), a clinical stage biotechnology company developing mitochondria based therapeutics (MBTs) to treat age-related diseases, today announced that it has initiated a Phase 1a/1b safety and biomarker study of CB4211, its lead MBT candidate under development as a potential treatment for non-alcoholic steatohepatitis (NASH) and obesity. CB4211 is the first mitochondria based therapeutic to enter clinical testing.
“The successful completion of our preclinical studies, filing and clearance of the IND, and initiation of this clinical study represent major milestones for the company, as we begin to validate the therapeutic potential of peptides encoded in the mitochondrial genome,” said Kenneth C. Cundy, CohBar CSO. “The peptide showed impressive efficacy in preclinical models, and this clinical study is designed to assess safety, as well as to provide an early indication of the therapeutic potential of CB4211 in the setting of NASH and obesity.”
The double-blind, placebo-controlled clinical study will initially assess the safety, tolerability, and pharmacokinetics of CB4211 following single and multiple-ascending doses in healthy subjects. The final Phase 1b stage of the study will be an assessment of safety, tolerability, and activity in obese subjects with non-alcoholic fatty liver diseases (NAFLD). Assessments will include changes in liver fat assessed by MRI-PDFF, body weight, and biomarkers relevant to NASH and obesity.
CB4211 is a first-in-class mitochondria based therapeutic that has demonstrated significant therapeutic potential in preclinical models of nonalcoholic steatohepatitis (NASH) and obesity. CB4211 is a novel and improved analog of MOTS-c, a naturally occurring mitochondrial-derived peptide (MDP), which was discovered in 2012 by CohBar founder Dr. Pinchas Cohen and his academic collaborators and has been shown to play a significant role in the regulation of metabolism. Data were presented at the 2018 American Diabetes Association meeting providing in vitro evidence that CB4211 inhibits adipocyte lipolysis, a process that is foundational in the development of liver steatosis, through an insulin-dependent mechanism. These data provide a potential mechanistic explanation for previous observations in vivo, including efficacy of CB4211 in animal models of NASH, and anti-steatotic effects on livers of mice on a high fat diet, where a corresponding reduction in circulating fat and biomarkers of liver damage was also observed. The activity of CB4211 appears to be specific to sensitizing insulin action on the insulin receptor. NASH has been estimated to affect as many as 12% of adults in the U.S. and there is currently no approved treatment for the disease.
CohBar is a clinical stage biotechnology company focused on the research and development of mitochondria based therapeutics (MBTs), an emerging class of drugs for the treatment of age-related diseases. MBTs originate from the discovery by CohBar’s founders of a novel group of peptides within the mitochondrial genome which regulate metabolism and cell death, and whose biological activity declines with age. CohBar’s efforts focus on the development of these mitochondrial-derived peptides (MDPs) into clinically relevant MBTs that offer the potential to address a broad range of age-related diseases with underlying metabolic dysfunction, including nonalcoholic steatohepatitis (NASH), obesity, Type 2 diabetes, cancer, and cardiovascular and neurodegenerative diseases. To date, the company and its founders have discovered more than 100 MDPs. For additional company information, please visit www.cohbar.com.
This news release contains forward-looking statements (statements which are not historical facts) within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include CohBar’s plans and expectations for its lead CB4211 drug candidate program, including statements regarding the efficacy, mechanism of action and therapeutic and commercial potential of CB4211 and other mitochondria based therapeutics. Forward-looking statements are based on current expectations, projections and interpretations that involve a number of risks and uncertainties that could cause actual results to differ materially from those anticipated by CohBar. These include uncertainties inherent in research and development, such as the possible inability to complete clinical studies as anticipated, the possibility of unfavorable study results, including unfavorable new data or additional analyses of existing data; risks associated with initial data, including the risk that results of clinical studies may be different from (including less favorable than) those suggested by earlier data results and may not support further clinical development or which otherwise affect the viability or commercial potential of CB4211 or other candidate programs. Additional assumptions, risks and uncertainties are described in detail in our registration statements, reports and other filings with the Securities and Exchange Commission and applicable Canadian securities regulators, which are available on our website, and at www.sec.gov or www.sedar.com.
You are cautioned that such statements are not guarantees of future performance and that our actual results may differ materially from those set forth in the forward-looking statements. The forward-looking statements and other information contained in this news release are made as of the date hereof and CohBar does not undertake any obligation to update publicly or revise any forward-looking statements or information, whether as a result of new information, future events or otherwise, unless so required by applicable laws.
Investor and Media Contact:
Jon Stern, COO
From Renaissance Capital
Crinetics Pharmaceuticals, a clinical stage biotech developing oral therapies for rare endocrine diseases, raised $102 million by offering 6 million shares at $17, the high end of the $15 to $17 range. The company had originally planned to raise $80 million by selling 5 million shares at $16. Insiders intended to purchase $30 million (29% of deal size) of the IPO. At pricing, Crinetics commands a fully diluted market value of $421 million and an enterprise value of $256 million. Crinetics Pharmaceuticals plans to list on the Nasdaq under the symbol CRNX. J.P. Morgan, Leerink Partners and Piper Jaffray acted as lead managers on the deal.
The article Rare endocrine disease biotech Crinetics Pharmaceuticals prices upsized IPO at $17 high end originally appeared on IPO investment manager Renaissance Capital's web site renaissancecapital.com.
Investment Disclosure: The information and opinions expressed herein were prepared by Renaissance Capital's research analysts and do not constitute an offer to buy or sell any security. Renaissance Capital's Renaissance IPO ETF (symbol: IPO) , Renaissance International ETF (symbol: IPOS) , or separately managed institutional accounts may have investments in securities of companies mentioned.
Peptilogics, a Pittsburgh, PA- and San Jose, CA-based pre-clinical stage company utilizing an innovative peptide platform to treat multidrug-resistant bacterial infections, closed a $5.5m Series A financing.
Backers included Peter Thiel, Stefan Roever, BlueTree Ventures and others. Read more...
BAGSVAERD, Denmark I September 29, 2017 I Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved Fiasp® (fast-acting insulin aspart), a new fast-acting mealtime insulin, for the treatment of adults with diabetes. The FDA's decision comes after Fiasp® in clinical trials demonstrated benefits for people in need of improved overall glucose control. Read more...
Peter Thiel has invested in Peptilogics. The Paypal founder contributed to the $5.5 million series A Peptilogics put together to advance its lead treatment for multidrug-resistant bacterial infections toward an IND.
Thiel joined with Stefan Roever, BlueTree Ventures and others to power Peptilogics to the series A. The financing follows the generation of preclinical data Peptilogics says suggest its platform and, in particular, its lead candidate can take out a broad spectrum of resistant bacteria. Those data have put Peptilogics in a position to work toward filing an IND next year. Read more...