Dark Matter Blog

JULY 16, 2021

My last stop at Arrakis Therapeutics is with a company targeting RNA with small molecules. I was enticed by Arrakis’ founder Jen Petter to serve in one more operational role, leading the research group at Arrakis as the company launched as one of the first biotechs to target RNA with drug-like small molecules.

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The Pharma Data

JUNE 17, 2022

In a Phase 2/3 clinical trial, the Pfizer-BioNTech COVID-19 Vaccine elicited a strong immune response in this age group Three 3-µg doses had favorable safety profile similar to placebo in young children ages 6 months through 4 years in Phase 2/3 clinical trial Pfizer-BioNTech COVID-19 Vaccine now authorized in the U.S.

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The Pharma Data

JANUARY 19, 2021

Other products include SY-2101, a novel oral form of arsenic trioxide for acute promyelocytic leukemia, and SY-5609, a highly selective and potent oral CDK7 inhibitor for solid tumors. Its lead candidate is CLN-081, an oral small molecule designed to be a next-generation, irreversible EGFR inhibitor.

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The Pharma Data

FEBRUARY 24, 2022

The Committee considered that the available evidence was sufficient to conclude that the immune response to a booster dose in adolescents would be at least equal to that in adults. Pfizer Inc. No new safety concerns were identified from the data available.

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The Pharma Data

DECEMBER 15, 2020

Small Molecule Inhibitors. NMD670 is a first-in-class small molecule inhibitor of the muscle specific chloride ion channel, the ClC-1 ion channel. Oral, Small Molecules. CUE-300 Series Immuno-STATs may offer autoimmune patients therapeutic benefits without compromising their immune systems.

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The Pharma Data

OCTOBER 14, 2020

(Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that the first participant was enrolled in the observational PRECISION study (TNX-C002), to examine the immune responses to COVID-19 in healthy volunteers who have recovered from COVID-19 or were asymptomatic. 1 Noyce RS, et al.

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The Pharma Data

SEPTEMBER 9, 2020

producing CD8+ T cell responses, which is thought to promote an anti-viral effect. In a preclinical murine model, a single IM immunization of BNT162b2 (0.2, CD4+ and CD8+ T-cells from splenocytes isolated from BNT162b2-immunized mice were strongly positive for IFN?

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The Pharma Data

AUGUST 20, 2020

T cell immune responses elicited by BNT162b2 are being evaluated in the German study and the companies expect to submit the data for peer review and potential publication. trial and we look forward to sharing T cell immune response data from the German trial in the near future.”. “It View the full release here: [link].

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The Pharma Data

SEPTEMBER 9, 2020

During preclinical and clinical studies, BNT162b1 and BNT162b2 emerged as strong candidates based on assessments of safety and immune response. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines.

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The Pharma Data

MAY 7, 2021

The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564 (b) (1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.

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The Pharma Data

DECEMBER 11, 2020

The Phase 3 trial is designed as a 1:1 vaccine candidate to placebo, randomized, observer-blinded study to obtain safety, immune response, and efficacy data needed for regulatory review. Data are not available to assess the effects of Pfizer BioNTech COVID-19 Vaccine on the breastfed infant or on milk production/excretion.

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The Pharma Data

JULY 21, 2021

At full operational capacity, the annual production will exceed 100 million finished doses annually. This is why we will continue to evaluate sustainable approaches that will support the development and production of mRNA vaccines on the African continent.”. “We Procedures should be in place to avoid injury from fainting.

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The Pharma Data

MAY 6, 2021

The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564 (b) (1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.

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The Pharma Data

DECEMBER 27, 2020

This year has been difficult, but it has reinforced the importance of our mission: to treat and potentially even reverse the effects of serious diseases and conditions by advancing our novel cell therapy product candidates through clinical trials and into the hands of physicians.

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Agency IQ

JUNE 9, 2023

Before a drug or biological product can be moved into clinical studies, sponsors must conduct nonclinical studies to demonstrate the product is reasonably safe and that its pharmacological effects and mechanisms of action are sufficiently characterized. General toxicity studies typically include several immune-related endpoints (e.g.,

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Advarra

JANUARY 11, 2024

mRNA Cancer Vaccines mRNA cancer vaccines represent a newer class of vaccines utilizing mRNA’s ability to encode for almost any protein, while maintaining an acceptable safety profile with flexible delivery and production processes. Only after these trials are successful can sponsors seek market approval for mRNA-based products.

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The Pharma Data

JANUARY 17, 2021

By inhibiting calcineurin, the drug blocks IL-2 expression and T-cell mediated immune responses. Only two days earlier, on December 15, Aurinia expanded an exclusive manufacturing relationship with Switzerland’s Lonza to build a dedicated manufacturing capacity within Lonza’s existing small molecule API facility in Visp, Switzerland.

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The Pharma Data

FEBRUARY 22, 2021

RIPK1 is a critical signaling protein implicated in a broad range of key inflammatory cellular processes including necroptosis, a type of regulated cell death, and cytokine production. In necroptosis, cells rupture leading to the dispersion of cell contents which can trigger an immune response and enhance inflammation.

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DrugBank

FEBRUARY 26, 2025

In 2020, MIT researchers demonstrated the potential of AI by discovering salicin , a novel antibiotic that targets bacterial energy production. Immunomodulatory therapies, which enhance the host immune response to infections, are also being investigated as adjunctive treatments.

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The Pharma Data

AUGUST 3, 2021

– Revenue from all key products grew in the quarter and 2021 year-to-date. announced an exclusive collaboration focused on the discovery, development and commercialization of potential novel small molecules that stimulate tumor-specific immune responses. Loxo Oncology at Lilly and Kumquat Biosciences Inc.

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The Pharma Data

DECEMBER 10, 2020

The Phase 3 trial is designed as a 1:1 vaccine candidate to placebo, randomized, observer-blinded study to obtain safety, immune response, and efficacy data needed for regulatory review. A breakdown of the diversity of clinical trial participants can be found here from approximately 150 clinical trials sites in the U.S.,

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The Pharma Data

MARCH 11, 2021

The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564 (b) (1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.

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The Pharma Data

SEPTEMBER 28, 2020

Australian biotech Ena Respiratory has revealed new data demonstrating that its novel nasal spray almost halted replication of the SARS-CoV-2 in animals when used as a prophylactic, showing potential to improve immune response when used alongside COVID-19 vaccines. . We’ve been amazed with just how effective our treatment has been.

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DrugBank

FEBRUARY 5, 2025

These ligands can be antibodies, peptides, aptamers, or small molecules. By encapsulating antigens within nanoparticles, researchers can achieve improved stability, controlled release, and targeted delivery to immune cells, leading to a more robust and long-lasting immune response.

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The Pharma Data

JUNE 26, 2021

BNT111 is the lead product candidate from BioNTech’s FixVac platform that targets a fixed combination of mRNA-encoded, tumor-associated antigens with the objective of triggering a strong and precise immune response against cancer and is fully owned by BioNTech. These results were published in Nature in July 2020.

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Drug Target Review

OCTOBER 4, 2023

Groundbreaking strategies like proteolysis-targeting chimeric molecules (PROTACs) are also being explored. 6 Combining the effect of payloads with different mechanisms of action – an approach that revolutionised small molecule chemotherapy – also holds the promise of enhanced therapeutic activity for ADCs.

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The Pharma Data

SEPTEMBER 15, 2020

Based on the acceptable safety profile and the favorable immune response data, including the 4th dose response data, Pfizer received Breakthrough Therapy Designation. 20vPnC showed a safety and tolerability profile that was similar to Prevnar 13 ® Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein].

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The Pharma Data

APRIL 27, 2021

up 60%) driven by increase disease and product awareness as well as adoption of new ISTH (International Society on Thrombosis and Haemostasis) TTP guidelines. Globally, diagnosis of the disease and product awareness remain impacted by the COVID-19 environment. . Cardiovascular and Established Rx Products. Net sales (€ million).

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Codon

AUGUST 27, 2024

Extra pieces of data, including proteins, lipids, or small molecules, are helpful when a particular DNA sequence is difficult to amplify or isolate from a sample, or when sequencing results don’t point squarely at a single disease-causing organism.

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Vial

DECEMBER 11, 2023

The Food and Drug Administration (FDA) approved and recommended dozens of small-molecule drugs. Related but genetically diverse virus variants can occur within the same infected patient, which may lead to quasispecies and resistance to antibody and T-cell-mediated immune responses. Zhao et al. Let’s Connect !

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The Pharma Data

JUNE 24, 2021

based sites involved in the production of the COVID-19 vaccine include Kalamazoo, MI, Andover, MA, Chesterfield, MO, Groton, CT, and McPherson, KS. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer?BioNTech government in Pfizer’s U.S.

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The Pharma Data

DECEMBER 27, 2020

GA Depot is a long-acting injection of the approved Glatiramer Acetate products (Copaxone and its generic formulations). The drug is an autologous IL13Ralpha2-CAR-T cell product. It is a selective modulator of neuropilin-2 that downregulates the innate and adaptive immune response in inflammatory diseases.

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Drug Target Review

DECEMBER 4, 2024

The MC4R-based ConfoGen was used to immunize llamas, resulting in an immune response that generated a highly diverse panel of MC4R-specific agonists. In addition to generating agonistic antibodies, Confo is also successfully applying the ConfoBody/ConfoChimer technology to drugging GPCR with small molecules.

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Drug Target Review

NOVEMBER 7, 2024

Agonist antibodies of immune checkpoint regulators These represent a groundbreaking class of immunotherapeutic agents that mimic the natural function of endogenous ligands by binding to specific cell-surface receptors. This approach augments the strength of achieving immune homeostasis.

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The Pharma Data

DECEMBER 20, 2020

Pfizer and BioNTech announced additional data on neutralizing antibody and T-cell responses from their Phase I/II trial of their COVID-19 vaccine conducted in Germany. Auxora is a potent and selective small molecule CRAC channel inhibitor that prevents CRAC channel overactivation.

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Codon

DECEMBER 12, 2024

Lacking natural predators, mirrored bacteria could hitch a ride on transported animals, plants, or products made from them, on surfaces, or perhaps via inadvertent hitchhiking insects — all before reinfecting host organisms. Different molecules racemize at different rates. The report maps out at least three options.

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Codon

APRIL 16, 2023

Skin microbes can trigger strong immune responses. These microbes were engineered to express tumor antigens that could “elicit T cells that were licensed by the commensal immune program but specific for a tumor,” including both CD4+ and CD8+ T cells, according to the study. Billerbeck S. ACS Synthetic Biology.

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