All posts in Peptide News from Biotech and Pharma

CAMBRIDGE, Mass.--(BUSINESS WIRE)--FogPharma, a biopharmaceutical company pioneering a new class of precision medicines that could ultimately prove applicable to all therapeutic targets, including those previously considered “undruggable,” today announced the selection of its lead product development candidate, FOG-001, a first-and-only-in-class direct β-catenin inhibitor. FOG-001 represents the first of FogPharma’s proprietary, conformationally hyperstabilized α-helical polypeptides (Helicon polypeptides), a new class of therapeutics designed to combine the targeting strength and specificity of antibodies with the broad tissue distribution, intracellular target engagement and oral dosing optionality of small molecules.

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RALEIGH, NC / ACCESSWIRE / February 28, 2022 / 9 Meters Biopharma, Inc. (NASDAQ:NMTR), a clinical-stage company pioneering novel treatments for people with rare or debilitating digestive diseases, announced today an update on its late stage pipeline products vurolenatide, a proprietary long-acting glucagon-like peptide (GLP-1) agonist in a Phase 2 trial for adults with short bowel syndrome (SBS), and larazotide, a gut-selective tight junction modulator in a Phase 3 trial for celiac disease.

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RALEIGH, NC / ACCESSWIRE / February 25, 2022 / 9 Meters Biopharma, Inc. (NASDAQ:NMTR), a clinical-stage company pioneering novel treatments for people with rare or debilitating digestive diseases, announced the publication of encouraging data in the journal Critical Care Explorations, accessible online here, on the use of larazotide to treat pediatric patients with multisystem inflammatory syndrome in children (MIS-C) resulting from COVID-19. MIS-C is a rare but severe and potentially life-threatening condition that usually develops in children weeks to months after they have experienced a mild or even asymptomatic case of COVID-19.

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HARRISON, N.Y., Jan. 6, 2022 /PRNewswire/ -- Sapience Therapeutics, Inc., a biotechnology company focused on the discovery and development of peptide therapeutics to address difficult-to-treat cancers, announced today the initiation of Phase 2 and dosing of the first patient in the glioblastoma (GBM) expansion cohort in the ongoing Phase 1-2 Study of ST101.  

The expansion cohorts in the study include patients with refractory, locally advanced and metastatic cutaneous melanoma, hormone-receptor-positive breast cancer, castrate-resistant prostate cancer, and GBM, and are designed to determine proof-of-concept efficacy of ST101 and provide further insights into safety, pharmacokinetics (PK) and pharmacodynamics (PD).  

READ MORE AT SAPIENCE THERAPEUTICS PRESS RELEASE

Novo Nordisk, the Danish drug maker on Thursday announced the launch of oral semaglutide in India for treatment of type 2 diabetes.

The oral semaglutide will cost Rs 315 per pill or around Rs 10000 for a full month treatment.

"We have kept it at the (similar) price range of the injectable GLP-1, not only that we have followed price equilibrium band, which means if a person goes from 3 mg to 7 mg, the cost they pay is just 9-10% higher, and not double, as per conventional models ..

Read more at:
https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/novo-nordisk-launches-anti-diabetes-pill-semaglutide-in-india/articleshow/89024394.cms?utm_source=contentofinterest&utm_medium=text&utm_campaign=cppst

VANCOUVER, BC, Feb. 16, 2022 /PRNewswire/ - Asep Medical Holdings Inc. ("Asep Inc." or the "Company") (CSE: ASEP) is dedicated to addressing antibiotic failure by developing novel solutions for significant unmet medical needs, including both proprietary diagnostic tools, enabling the early and timely identification of severe sepsis, as well as broad-spectrum therapeutic agents to address multidrug-resistant biofilm infections. The Company announces that its novel antibiofilm peptide technology is in advanced development through its collaboration with its pre-clinical partner, iFyber, LLC, and grant funding from the United States Army Medical Research and Materiel Command (USAMRMC)1.

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Calabasas, Calif., August 2, 2018 – ArmaGen, Inc., a privately held biotechnology company focused on developing groundbreaking therapies to treat severe neurological disorders, today announced that the U.S. Food and Drug Administration’s (FDA) Office of Orphan Products Development granted Orphan Drug Designation to GT-184 for the treatment of mucopolysaccharidosis type IIIA (also known as Sanfilippo Syndrome A or MPS IIIA). MPS IIIA is a lysosomal storage disease (LSD) that arises from a deficiency in the gene encoding for the enzyme N-sulfoglucosamine sulfohydrolase (SGSH), which results in a buildup of complex sugar polymers within the brain causing progressive intellectual disability and the loss of previously acquired skills (developmental regression).

AGT-184 is an IgG-SGSH fusion protein, where the IgG domain is a human anti-insulin receptor monoclonal antibody. The insulin receptor antibody domain triggers transport of the AGT-184 fusion protein across the blood brain barrier (BBB), via binding to endogenous insulin receptors present on the BBB. ArmaGen is currently conducting IND-enabling activities (manufacturing/toxicology) with the goal of filing an IND with the U.S. FDA in late 2019.

“We are very pleased to receive FDA orphan drug designation for AGT-184, as this designation is an important regulatory milestone for the Company as we work to develop a potential treatment option for patients suffering from this rare and life-threatening disease,” said Mathias Schmidt, Ph.D., Chief Executive Officer of ArmaGen. “This moment represents a transformational period in the Company’s evolution as we prepare to leverage our clinically validated BBB platform to advance additional pipeline assets.”

The FDA grants Orphan Drug Designation to drugs intended to treat a rare disease or condition affecting fewer than 200,000 people in the U.S. This designation confers special incentives to the drug developer, including tax credits on the clinical development costs, prescription drug user fee waivers and may entitle a period of seven-year market exclusivity in the US upon FDA approval.

In a mouse model of MPSIIIA, a surrogate version of AGT-184 (AGT-m184) showed activity in both CNS and somatic organs, further substantiating the applicability of ArmaGen’s Trojan Horse approach to MPS IIIA. Mice were treated three times per week for six weeks with AGT-m184. Compared to the control mice, there was a 70% reduction in brain heparan sulfate levels at the end of the six-week study, which provides direct evidence that the fusion protein crossed the BBB and delivered the SGSH enzyme payload into the brain. There was also an 85% reduction in liver heparan sulfate levels as compared to control, which is evidence of somatic or peripheral activity of the IgG-SGSH fusion protein.

About AGT-184
AGT‑184 is an investigational enzyme replacement therapy (ERT) for the treatment of the cognitive effects of Sanfilippo A syndrome, a lysosomal storage disease that arises from a deficiency in the gene encoding for the enzyme N-sulfoglucosamine sulfohydrolase (SGSH), which results in a buildup of complex sugar polymers in brain cells. Currently, there are no approved therapies for the treatment of Sanfilippo A syndrome. Unlike recombinant SGSH, which does not cross the BBB, AGT-184 is a re-engineered form of the SGSH enzyme that is able to penetrate the BBB, and which has the same enzyme activity of the native SGSH enzyme.

About ArmaGen
ArmaGen, Inc., is a privately held biotechnology company focused on developing groundbreaking therapies for severe neurological disorders. The company is developing a robust pipeline of innovative therapies for the treatment of lysosomal storage disorders including neurological symptoms such as Hurler syndrome (MPS I), Hunter syndrome (MPS II), metachromatic leukodystrophy, Sanfilippo A and B syndromes, as well as other diseases with severe CNS manifestations. ArmaGen’s pipeline is based on decades of scientific leadership in engineering therapies to cross the blood-brain barrier and a dominant intellectual property portfolio. The company is advancing its pipeline through licensing and collaboration agreements, in-house development programs, and other partnering opportunities. For more information, visit www.armagen.com.

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Contacts:

ArmaGen, Inc.
Derek Kelaita
Vice President, Business Development
818-252-8200
dkelaita@armagen.com

For media inquiries:
Alex Van Rees
SmithSolve LLC
973-442-1555 ext. 111
alex.vanrees@smithsolve.com

EMERYVILLE, Calif., Dec. 17, 2018 (GLOBE NEWSWIRE) -- Gritstone Oncology, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company developing the next generation of cancer immunotherapies to fight multiple cancer types, today announced that data demonstrating the predictive performance of its EDGETM (Epitope Discovery in cancer GEnomes) platform in the identification of tumor-specific neoantigens (TSNA) and neoantigen-reactive T-cells was published in Nature Biotechnology.

Three distinct datasets were used in the manuscript to validate the EDGE platform as a robust machine-learning tool for neoantigen identification. First, the authors showed that EDGE increases the accuracy of predicting human leukocyte antigen (HLA)-presented peptides on tumor cells by up to nine-fold over industry-standard methods using relevant metrics. Second, independently validated neoantigens from published third-party studies (mostly from the U.S. National Cancer Institute) were used to compare the performance of EDGE versus public prediction tools. Using only patient tumor mutation data from these studies to predict neoantigens, EDGE correctly identified validated TSNA for 11 of 12 patients, versus only 4 of 12 patients identified with the standard approach. Finally, using routine blood samples obtained from nine non-small cell lung cancer patients receiving PD-(L)1 checkpoint inhibitors, EDGE enabled identification of circulating T-cells specific for true neoantigens in the majority of (5 of 9) patients.

“Neoantigens are critical targets of immunotherapy and can drive an effective anti-tumor T-cell response; yet, existing tools have had low success rates in identifying true neoantigens,” said Roman Yelensky, Ph.D., executive vice president and chief technology officer. “We built our EDGE platform to be a best-in-class machine-learning model using the largest dataset of HLA-presented peptides from human tumor samples. The data published in Nature Biotechnology support EDGE as a transformative tool for the development of the next generation of neoantigen-targeted cancer immunotherapies.”

“EDGE represents the cutting edge in personalized immunotherapy,” said Timothy Chan, M.D., Ph.D., co-founder and scientific advisory board member of Gritstone. “I am very excited to see this state-of-the-art technology used to improve neoantigen vaccine development.”

EDGE’s prediction model was trained using a large dataset of human tumor and normal tissue samples with paired class I HLA-presented peptide sequences, HLA types and transcriptome RNA sequencing. A variety of tumor types, such as breast, lung, melanoma, colon and ovarian cancers were collected for sequencing, and combined with publicly available data. The training dataset for EDGE has since grown to now include more than 300 tumor and normal tissue samples, yielding over one million peptides, from patients of various ancestries with diverse HLA types. In addition to the training dataset, a key differentiator that contributed to improved performance was a novel integrated neural network model architecture. This neural network enabled EDGE to jointly model multiple key features, such as variable peptide length and the dependence of peptide presentation on gene expression level using RNA, essential for accurate prediction of true TSNA. The United States Patent Office issued Gritstone its first patent covering EDGE, on August 21, 2018 (Yelensky, et al., Neoantigen identification, manufacture and use, US 10,055,540.).

About Gritstone Oncology
Gritstone Oncology (Nasdaq:GRTS), a clinical-stage biotechnology company, is developing the next generation of cancer immunotherapies to fight multiple cancer types. Gritstone develops its products by leveraging two key pillars—first, a proprietary machine learning-based platform, Gritstone EDGE™, which is designed to predict, from a routine tumor biopsy, the tumor-specific neoantigens (TSNA) that are presented on a patient’s tumor cells; and second, the ability to develop and manufacture potent immunotherapies utilizing patients’ TSNA to potentially drive the patient’s immune system to specifically attack and destroy tumors. The company’s lead product candidate, GRANITE-001, is a personalized neoantigen-based immunotherapy in Phase 1 clinical testing. Gritstone’s second product candidate, SLATE-001, is a shared neoantigen (“off-the-shelf”) immunotherapy which is advancing towards the clinic. Novel tumor-specific antigens can also provide targets for bispecific antibody (BiSAb) therapeutics for solid tumors, and Gritstone’s BiSAb program is currently in lead optimization. For more information, please visit gritstoneoncology.com.

Gritstone Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements related to the predictive capabilities of the EDGE platform in human clinical trials. Such forward-looking statements involve substantial risks and uncertainties that could cause Gritstone’s research and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including Gritstone’s programs’ early stage of development, the process of designing and conducting preclinical and clinical trials, the performance of EDGE and Gritstone’s other products in clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, Gritstone’s ability to successfully establish, protect and defend its intellectual property and other matters that could affect the sufficiency of existing cash to fund operations. Gritstone undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the company in general, see Gritstone’s most recent Quarterly Report on Form 10-Q filed on November 14, 2018 and any subsequent current and periodic reports filed with the Securities and Exchange Commission.

Contacts
Media:
Dan Budwick
1AB
(973) 271-6085
dan@1abmedia.com

Investors:
Alexandra Santos
Wheelhouse Life Science Advisors
(510) 871-6161
asantos@wheelhouselsa.com

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Source: Gritstone Oncology, Inc

MENLO PARK, Calif., Nov. 05, 2018 (GLOBE NEWSWIRE) -- CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company developing mitochondria based therapeutics (MBTs) to treat age-related diseases, announced today the Phase 1 clinical study of CB4211, its lead MBT candidate under development as a potential treatment for non-alcoholic steatohepatitis (NASH) and obesity, has been temporarily suspended in order to address mild injection site reactions that have been unexpectedly persistent.

“Patient safety is very important to us and is also the primary objective of our CB4211 Phase 1 clinical trial,” said Simon Allen, CohBar CEO. “While only mild adverse events have occurred in the study to date, we are taking the time to address these injection site reactions in order to reduce the risk of any safety or tolerability issues in the trial going forward. We continue to believe in the potential of this novel compound as a treatment for NASH and obesity, and the timely resolution of this issue is our top priority.”

“Mild injection site reactions are common in Phase 1 clinical studies of subcutaneously injected peptide drugs, and for most drugs they resolve quickly,” said Kenneth C. Cundy, PhD., CohBar CSO. “In general, what we have seen are persistent painless bumps that can be felt under the skin and in most cases would be otherwise undetectable. Information to date suggests that some of the CB4211 dose persists at the injection site. We have a plan to address this issue in the near term and are seeking regulatory feedback with the goal of resuming the clinical dosing of CB4211 as soon as possible.”

Details for the Conference Call:

Date: November 6, 2018
Time: 11:00 a.m. (Eastern Time)

Conference Audio
- Dial-in U.S. and Canada: (800) 263-0877
- Dial-in International: (646) 828-8143
- Conference ID No.: 2857214
We kindly request that you call into the conference audio approximately 10 minutes before the start time so that we can begin promptly.

An audio replay of the call will be available beginning at 2:00 p.m. Eastern Time on November 6, 2018, through 11:59 p.m. Eastern Time on November 13, 2018. To access the recording please dial (844) 512-2921 in the U.S. and Canada, or (412) 317-6671 internationally, and reference Conference ID No. 2857214. The audio replay will also be available at www.cohbar.com from November 6, through November 13, 2018.

About CB4211

CohBar’s lead program is based on CB4211, a first-in-class mitochondria based therapeutic (MBT) 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. CB4211 entered a Phase 1a/b clinical trial in mid-2018, which includes a potential activity readout relevant to NASH and obesity. 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.

About CohBar

CohBar (NASDAQ: CWBR) 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.

Forward-Looking Statements

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 suspension of the Phase 1 clinical trial for CB4211, planned steps to address the adverse events, suggested causes of injection site reactions and anticipated resumption of the Phase 1 clinical trial for CB4211. 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 the possibility that the Phase 1 clinical trial will remain suspended for longer than anticipated or may not be resumed; CohBar’s possible inability to mitigate the prevalence and/or persistence of the injection site reactions; receipt of unfavorable feedback from regulators regarding the safety or tolerability of CB4211 or the possibility of other developments affecting the viability of CB4211 as a clinical candidate or its commercial potential. 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 securities laws. Nothing herein shall constitute an offer to sell or the solicitation of an offer to buy any securities.

Contacts:
Jon Stern, COO
CohBar, Inc.
(650) 446-7888
jon.stern@cohbar.com

Joyce Allaire
LifeSci Advisors, LLC
jallaire@lifesciadvisors.com