On December 15, 2020 Lantern Pharma (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") platform to transform drug discovery and development, and identify patients who will benefit from its portfolio of targeted oncology therapeutics, reported new scientific data that substantiates blood brain barrier permeability (BBB) for its drug candidate LP-184 (Press release, Lantern Pharma, DEC 15, 2020, View Source;utm_medium=rss&utm_campaign=lantern-pharma-announces-scientific-preclinical-data [SID1234572868]). LP-184 is being targeted for treating Glioblastoma Multiforme (GBM), an aggressive malignant form of brain cancer that comprises about 52% of all primary malignant brain tumors according to the American Association of Neurological Surgeons. GBM has a median survival rate of only 15 months and ranks among the most aggressive of human cancers. It is considered an orphan disease for which there is no cure. The global GBM treatment market is projected to reach $3.3 billion by 2024, according to GlobalData, with the U.S. representing the largest market.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The ability of a drug candidate to cross the blood brain barrier is of critical importance in treatment outcomes for CNS and brain cancers. Many drugs fail in clinical trials because of their low blood brain barrier permeability. Lantern’s A.I. engine along with algorithms tuned to predict BBB permeability played an important role in helping determine which CNS cancers and which genomically-defined subtypes of CNS cancer should be prioritized for development.

The current standard of care for GBM consists of de-bulking surgery followed by combined treatments with fractionated ionizing radiation (IR) and the DNA alkylating agent temozolomide (TMZ). The effectiveness of standard therapy with TMZ is limited because the response of GBM to TMZ is dependent upon the expression of the DNA repair enzymatic protein, O6-alkylguanine DNA alkyltransferase (MGMT). Over the period of treatment, tumors can evolve and begin to overexpress MGMT and therefore become largely resistant to TMZ. At the stage of GBM relapse and recurrence, no effective therapy strategies currently exist. LP-184 has a different mechanism of action relative to TMZ and has not demonstrated limitations due to MGMT levels, the enzymatic protein associated with resistance to TMZ in GBM and gliomas.

LP-184 works by causing DNA damage in cancer cells via the nucleotide excision repair (NER) pathway, while TMZ causes damage via the base excision repair pathway (BER). These approaches may be complementary and represents potential for future therapeutic applications. Using in-silico tools, and also generating further in-vitro data from both neuronal cell-plates, and neurospheres, LP-184 demonstrated permeability that was in line with TMZ and other therapies being used in GBM today, while also demonstrating nano-molar potency.

Panna Sharma, CEO of Lantern Pharma, stated: "This data is extremely significant as it provides evidence that opens up a range of brain cancers with high clinical need that we should pursue, and also provides evidence that our RADR platform is working as was designed. Our mission is to transform and accelerate the cancer drug development process. If we can compress the time to clinical trials, and de-risk LP-184, we can save years of research and millions of dollars in developing treatments for GBM and potentially other CNS and brain cancers."

Mr. Sharma continued, "As part of our development strategy we will be providing updates on new collaborations and research studies with leading research and translational cancer centers to help us further validate our findings and guide the ideal clinical usage of the compound in GBM. Based on data from our RADR platform, the blood brain barrier profile validation, and information on the genomics that seem to drive response to LP-184 we are now targeting a broader range of central nervous system cancers, including cancers that metastasize to the brain, and pediatric brain tumors."

On December 15, 2020 Nascent Biotech, Inc. (OTCQB:NBIO) On December 7, the Company reported that received a letter from the US Food and Drug Administration (FDA) removing a partial clinical hold on Nascent’s proprietary monoclonal antibody Pritumumab (Press release, Nascent Biotech, DEC 15, 2020, View Source [SID1234572866]). This allows Nascent to commence Phase I Human Clinical Trials, effective immediately.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Nascent CEO Sean Carrick stated, "The approval by the FDA is a major milestone in Nascent’s efforts to begin Phase 1 clinical trials. With this achievement, Nascent has advanced the asset to begin testing the antibody on humans. Receiving FDA clearance vital first step in the clinical process.

On December 15, 2020 Idera Pharmaceuticals, Inc. (Nasdaq: IDRA) reported the closing of a second tranche under its April 7, 2020, securities purchase agreement (the "Purchase Agreement"), resulting in aggregate proceeds of up to $20.7 million in common stock and warrant investment by funds affiliated with an institutional investor (Press release, Idera Pharmaceuticals, DEC 15, 2020, View Source [SID1234572865]). Pursuant to the Purchase Agreement, under the second tranche Idera sold 2,747,252 shares of common stock (or common stock equivalents), together with accompanying warrants to purchase 1,373,626 shares of common stock, for aggregate gross proceeds of $5.0 million. The placement is exempt from the registration requirements of the Securities Act of 1933, as amended.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We believe this funding and other financial arrangements we have in place reflect optimism in the significant commercial opportunity for tilsotolimod, the most advanced TLR9 agonist therapy in development, to address the unmet medical need for patients living with anti-PD-1 refractory advanced melanoma and other difficult to treat tumor types," stated Vincent Milano, Chief Executive Officer of Idera. "It also provides us the potential cash runway to help make tilsotolimod, if approved, available to those patients."

The Company plans to use the $10.0 million in cash proceeds from the first and second tranches of this private placement to fund the completion of the ongoing ILLUMINATE-301 clinical trial and potential NDA filing of its lead product, tilsotolimod, for the treatment of anti-PD-1 refractory metastatic melanoma, and for general corporate purposes. The Company plans to use the subsequent proceeds of up to $10.7 million, if associated warrants are exercised, to fund the potential commercial launch of tilsotolimod, as well as the ongoing ILLUMINATE-206 trial exploring tilsotolimod in tumor types beyond melanoma and general corporate purposes.

The shares of common stock (or common stock equivalents) and warrants sold in the private placement have not been registered under the Securities Act of 1933, as amended, or under any state securities laws and, unless so registered, may not be offered or sold in the United States except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and applicable state securities laws.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Tilsotolimod (IMO-2125)

Tilsotolimod is an investigational, synthetic Toll-like receptor 9 agonist. Intratumoral injection of tilsotolimod has been shown to promote both innate (Type-I IFN, antigen presentation) and adaptive (T cells) immune activation. Tumors with an active immune response appear to respond better to CPIs than those that exclude or inhibit anti-tumor immune cells. Tilsotolimod in combination with CPIs may cause regression of locally injected and distant tumor lesions and increase the number of patients who benefit from immunotherapy.

Tilsotolimod has received both Fast Track designation and Orphan Drug designation from the FDA and is being evaluated in multiple tumor types and in combination with multiple checkpoint inhibitors. For more information on tilsotolimod trials, please visit www.ClinicalTrials.gov.

On December 15, 2020 Veracyte, Inc. (Nasdaq: VCYT) reported it has expanded its long-term strategic collaboration with the Lung Cancer Initiative at Johnson & Johnson1 (Press release, Veracyte, DEC 15, 2020, View Source [SID1234572864]). The collaboration will include a focus on the NOBLE trial, a 9,000-patient, prospective, multicenter clinical study designed to distinguish genomic and other differences in lung cancer development and progression among patients with lung nodules detected by CT imaging.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

As Veracyte plans for the 2021 launch of the first noninvasive nasal swab test to guide the work-up of patients with potentially cancerous lung nodules, this new study will position the company to develop future tests that benefit broader patient populations, including nonsmokers and those with pre-cancerous changes who are likely to develop lung cancer.

"We are pleased to expand upon our collaboration in our goal of reducing lung cancer deaths," said Bonnie Anderson, Veracyte’s chairman and chief executive officer. "The NOBLE trial will provide a robust biorepository of genomic, clinical and outcome data, which we plan to translate into future tests that can help diagnose lung cancer at its earliest stages. It will also further our ability to address a nearly $40 billion global lung cancer market that is now more accessible to Veracyte through our own distributed testing platform, which enables advanced genomic testing to be performed locally by laboratories worldwide."

The NOBLE trial is a prospective, multicenter study involving up to 50 sites globally. It is anticipated to enroll 9,000 individuals with lung nodules detected through CT imaging either via lung cancer screening or incidentally and will include patients who are benign at initial nodule diagnosis but who subsequently develop lung cancer. Researchers will collect nasal-swab, longitudinal blood and other samples, as well as imaging and clinical information at enrollment and at multiple points throughout the study. Patients will be followed according to current guidelines for three years or until a lung cancer diagnosis.

"We are proud to participate in the NOBLE trial," said Kim Rieger-Christ, Ph.D., chief scientific officer and director of translational research at Lahey Hospital & Medical Center and the study’s principal investigator. "We believe this study will shed important new light on the natural progression of lung cancer and, more importantly, may enable development of new tests and treatments that will help physicians provide better care for patients and ultimately save more lives."

In January 2019, Veracyte announced a long-term strategic collaboration with the Lung Cancer Initiative at Johnson & Johnson to advance the development and commercialization of novel diagnostic tests to detect lung cancer at its earliest stages, when the disease is most treatable. The collaboration has focused on accelerating two key lung cancer programs for Veracyte: the commercialization of its Percepta Genomic Sequencing Classifier on the company’s RNA whole-transcriptome sequencing platform, which was achieved in June 2019, and the development of the first noninvasive nasal swab test for early lung cancer detection.

About Lung Cancer

Lung cancer is the deadliest cancer globally, killing more than 1.75 million people worldwide each year, according to the World Health Organization. Early detection is key, with a five-year survival rate of nearly 60 percent when the cancer is found early, compared to six percent when it is found at a later stage, according to the American Lung Association. Lung nodules are typically the first sign of lung cancer. While the vast majority of lung nodules ultimately prove to be benign, physicians currently lack clear diagnostic tools to determine which patients have cancer and which do not. This can lead to unnecessary invasive biopsies, which are costly and risky, as well as to delayed diagnosis and treatment.

On December 15, 2020 IO Biotech reported that the U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation for a combination of the potential therapy IO102 and IO103 with anti-PD-1 mAb for patients with unresectable/ metastatic melanoma (Press release, IO Biotech, DEC 15, 2020, View Source [SID1234572863]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

IO102 and IO103 are IO Biotech’s lead immuno-oncology candidates. Both compounds are based on IO Biotech’s proprietary T-win technology platform which enables the identification of compounds with a dual mechanism of action targeting and directly killing immunosuppressive cells and tumor cells while indirectly activating other T-effectors, leading to strong anti-tumor responses without adding additional safety concern. Specifically, IO102 and IO103 are first-in-class, immune modulatory vaccines designed to engage and activate IDO and PD-L1 specific human T-cells.

The FDA decision to grant breakthrough therapy was based on data from the MM1636 Phase 1/2 clinical trial with 30 patients with metastatic melanoma receiving IO102, IO103 and anti-PD-1. According to the data recently presented in a late-breaking abstract at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020, the combination of IO102 and IO103 vaccines and nivolumab was shown to be safe with encouraging early efficacy data; an overall response rate (ORR) of 79 percent was reached and 45 percent of patients achieved a complete response (CR), or complete disappearance of their tumors. Vaccine specific T-cells were located in the peripheral blood mononuclear cells (PBMCs) and at the tumor site.

"A breakthrough designation is an expedited program in which FDA will work closely with IO Biotech to provide guidance on subsequent development of "Synthetic Peptide Vaccines (IO103) Encoding Human PD-L1 (9-27) and (IO102), targeted to IDO, Indoleamine 2,3-dioxygenase and anti-PD-1" for treatment of unresectable/metastatic melanoma, including providing advice on generating evidence needed to support approval of the drug in an efficient and potentially expedited manner"," said Mai-Britt Zocca, PhD, Chief Executive Officer and founder of IO Biotech. "This is an important achievement for IO Biotech’s clinical program and we are committed to bring this forward to patients as soon as possible."

About MM1636 trial
The MM1636 trial is an investigator-initiated trial at the Copenhagen University Hospital, Herlev which entered 30 patients with metastatic melanoma. In this Phase 2 clinical trial, patients were treated with IO Biotech’s multi antigen vaccine, IO102-IO103 in combination with anti-PD-1 antibody, as first line treatment. IO102-IO103 are administered every second week until 12 weeks and thereafter every fourth week up to one year. The trial objectives are to assess safety, immune responses in blood and biopsies as well as efficacy.

About Melanoma
Globally, about 290,000 new cases of cutaneous melanoma, the most aggressive type of skin cancer, are diagnosed and annually more than 60,000 will die (Bray et al. 2018). The incidence of cutaneous melanoma is increasing (Forman et al. 2014) and advanced melanoma (unresectable or metastatic) will have a fatal outcome if left untreated. The median overall survival (OS) in patients with stage IV melanoma (untreated or treated with BRAF inhibitor and MEK inhibitor) is between 22-25 months and a 3-5-year OS is around 40% (Ascierto et al. 2016; Long et al. 2017).

Therefore, there is a clear unmet need for improved combination therapies enhancing anti-PD-1 efficacy without a significant increase in toxicity.