On December 14, 2021 Idera Pharmaceuticals, Inc. ("Idera," the "Company," "we," "us," and "our") (Nasdaq: IDRA) reported clinical updates regarding tilsotolimod, its synthetic Toll-like receptor 9 agonist (Press release, Idera Pharmaceuticals, DEC 14, 2021, View Source [SID1234597077]).

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ILLUMINATE-206 Trial for the Treatment of Previously Treated Patients with Immunotherapy-Naïve Micro-Satellite Stable Colorectal Cancer (MSS-CRC)
Preliminary data from the second 10 patients dosed in the safety cohort of ILLUMINATE-206, which involves tilsotolimod in combination with ipilimumab and nivolumab, showed a safety profile consistent with the first 10 patients in ILLUMINATE-206 and with prior studies. Eight patients had a post-baseline disease assessment evaluated per Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1). Of those, one patient experienced Stable Disease (SD) with disease control for more than six months; the remaining patients experienced Progressive Disease (PD). However, one of the RECIST v1.1 PD patients was determined to have experienced pseudo-progression, meaning that the initial increase from baseline in overall tumor burden was followed by a decrease from baseline in overall tumor burden. At the most recent disease assessment, the total decrease from baseline was 46.2%, which is considered an Immune-Related Partial Response (irPR) by Immune-Related RECIST (irRECIST). Per protocol, the patient is continuing in active treatment. No further enrollment in ILLUMINATE-206 is planned at this time.

Collaboration with AbbVie for the Treatment of Head and Neck Squamous Cell Carcinoma
AbbVie Inc. ("AbbVie") is conducting a Phase 1b study for treatment of patients with recurrent/metastatic head and neck squamous cell carcinoma with ABBV-368 plus tilsotolimod and other therapy combinations. AbbVie has discontinued further patient enrollment in the study; this decision was not related to safety concerns. Current patient treatment and follow-up is ongoing. AbbVie is solely responsible for the conduct of the study, with Idera contributing tilsotolimod supply.

Investigator-Sponsored Trial for the Intradermal Treatment of Melanoma
The VU University Medical Center (VUmc) Amsterdam, which is conducting a randomized, controlled trial of a single, intradermal injection of tilsotolimod at the primary melanoma excision site in 214 patients, recently shared with the Company early translational data supporting the mechanism of action of tilsotolimod. "As expected, immune activation, including elevated frequencies of key dendritic cells, was seen in early analysis by flow cytometry of sentinel lymph node biopsies collected seven days post-injection," said Dr. Tanja de Gruijl of VUMC. "These data are consistent with previously reported translational data relating to tilsotolimod in other pre-clinical and clinical settings. We are eager to see if this evidence of immune system stimulation will translate to clinical benefit in this patient population." Enrollment in this study is ongoing.

Investigator-Sponsored Trial for the Treatment of Advanced Cancers
The Gustave Roussy Cancer Campus in Paris is conducting an open-label, Phase 1b study of intratumoral tilsotolimod in combination with intratumoral ipilimumab and intravenous nivolumab in advanced cancers, including non-squamous cell lung cancer, refractory advanced melanoma, and MSS-CRC. Dosing in Part A of the study, which involved 24 patients across two different dose frequencies of ipilimumab and tilsotolimod, is complete; patient follow up is ongoing.

Out-Licensing Consideration
"While our clinical trials with tilsotolimod have not yet translated into a new treatment alternative for patients, data supporting tilsotolimod’s mechanism of action and encouraging safety profile from across the array of pre-clinical and clinical work to date, together with its intellectual property protection, are noteworthy," stated Vincent Milano, Idera’s Chief Executive Officer. "As a result, we will consider an out-licensing arrangement for tilsotolimod so that its full potential may continue to be explored on behalf of patients who do not respond to traditional immunotherapy. We also continue both to preserve cash and to identify and explore potential development or commercial-stage assets for Idera’s portfolio, and we are encouraged by the opportunities presented to us."

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 checkpoint inhibitors (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 is being evaluated in multiple tumor types and in combination with multiple CPIs. For more information on tilsotolimod trials, please visit www.ClinicalTrials.gov.

On December 14, 2021 ERYTECH Pharma (Nasdaq & Euronext: ERYP) (the "Company"), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported that it has entered into a definitive agreement with Armistice, a health-care focused institutional and accredited investor, for the purchase and sale of 769,608 units ("Units"), each Unit consisting of four ordinary shares in the form of American Depositary Shares (each an "ADS") and three warrants, each to purchase one ordinary share (each a "Warrant"), in a registered direct offering to specified categories of investors, described below (Press release, ERYtech Pharma, DEC 14, 2021, View Source [SID1234597072]). The subscription price for one Unit is $10.20 (€9.04), corresponding to $2.55(€2.26) per ADS and associated 0.75 warrant. Each ADS represents the right to receive one ordinary share, €0.10 nominal value, of the Company. The Warrants have an exercise price of €2.83 ($3.19) per share, will be immediately exercisable upon issuance and will expire two years from the issuance date. The closing of the offering is expected to occur on or about December 20, 2021, subject to satisfaction of customary closing conditions.

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On December 14, 2021 Targovax ASA’s (the "Company") reported that published on 30 November 2021 regarding the commencement of the subscription period in the rights issue of 101,744,186 new shares in the Company (the "Offer Shares") at a subscription price of NOK 1.72 per offer share (the "Rights Issue") (Press release, Targovax, DEC 14, 2021, View Source [SID1234597070]).

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The subscription period for the Rights Issue expired at 16:30 hours (CET) today, on 14 December 2021.

Preliminary counting indicates that the Company has received subscriptions for approximately 110 million Offer Shares in the Rights Issue.

The final allocation of the Offer Shares will take place on 15 December 2021 in accordance with the allocation criteria set out in the Company’s prospectus dated 29 November 2021, comprising a registration document and a securities note (jointly, the "Prospectus"). The final result of the Rights Issue will be published shortly thereafter, and letters regarding allocation of the Offer Shares and the corresponding subscription amount to be paid by each subscriber, are expected to be distributed on 15 December 2021.

The due date for payment of the Offer Shares is expected to be on or about 17 December 2021.

On December 14, 2021 Lantern Pharma (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported that Lantern Pharma presented positive data on the effectiveness of LP-284 in hematologic cancers at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, which was held in-person and virtually from December 11 – 14, 2021 (Press release, Lantern Pharma, DEC 14, 2021, View Source [SID1234597068]). This poster presentation can be viewed on Lantern Pharma’s website at: View Source

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LP-284 is a fully synthetic molecule belonging to the new generation of acylfulvenes, a family of naturally derived anti-cancer drug candidates. LP-284 is the stereoisomer (enantiomer) of LP-184 and has the potential for development as monotherapy and also as a synergistic agent in combination with other drugs. LP-284 is currently being evaluated for activity in a wide spectrum of hematological cancers. Earlier this year, Lantern filed multi-national patent applications directed to both the composition and manufacture of LP-284.

LP-284 demonstrated nanomolar potency in a variety of hematologic cell lines

The study demonstrated LP-284’s broad in vitro anti-tumor activity in lymphoma, multiple myeloma, and leukemia cells. Notably, the enantiomer pair, LP-184 and LP-284, exhibit distinct patterns of anti-tumor activities. As a result, the novel enantiomer LP-284 may provide a targeted therapy option for hematologic cancers with compromised DNA repair, supporting further targeted development plans for LP-284.

"Approximately every 3 minutes, one person in the U.S. is diagnosed with leukemia, lymphoma or myeloma and approximately every 9 minutes someone in the U.S. dies from a blood cancer1," commented Panna Sharma, CEO and President of Lantern Pharma Inc. "There is an urgent need to develop new, targeted therapies; however, the current industry approach is time consuming and expensive. This latest data provides further validation of Lantern’s RADR platform, which leverages A.I. and machine learning with the aim of dramatically shortening the timeline and reducing costs associated with drug discovery and development. Specifically, these findings support our hypothesis that LP-284 has the potential to become a targeted therapy option for hematologic cancers with compromised DNA repair. We plan to apply the insights obtained from this work to advance the development of LP-284 in rare blood cancer indications. This data is very encouraging, and we look forward to advancing LP-284 towards the clinic, while leveraging our RADR platform to develop new cutting-edge treatments for rare blood cancers and other indications."

Lantern’s proprietary RADR A.I. platform leverages over 10 billion data points, machine learning, genomics, and computational biology to accelerate the discovery of potential mechanisms of action, and biomarker signatures that correlate to drug response in rare blood cancers.

On December 14, 2021 Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage company developing disruptive therapeutics for the treatment of patients with cancer, reported positive preclinical data supporting the activity of SBP-101 in ovarian cancer cell lines (Press release, Panbela Therapeutics, DEC 14, 2021, View Source;utm_medium=rss&utm_campaign=panbela-announces-positive-preclinical-data-strongly-supporting-the-activity-of-sbp-101-in-ovarian-cancer-cell-lines [SID1234597067]). Panbela expects to launch a development effort for SBP-101 in ovarian cancer in the first half of 2022 and will host a virtual R&D day to discuss the new ovarian cancer program early in the new year.

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"The preclinical results illustrate SBP-101’s potential to expand into another area of high unmet need," said Jennifer K. Simpson, PhD, MSN, CRNP, President & Chief Executive Officer. "According to the American Cancer Society, ovarian cancer is the fifth leading cause of cancer deaths among women, accounting for more deaths than any other cancer of the female reproductive system. Therefore, it is vital to progress new therapies such as SBP-101 for ovarian cancer."

As stated by the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper), ovarian cancer represents a significant unmet need in gynecological cancers, with the absence of well-defined screening programs and inconsistent initial symptoms leading to late diagnosis in most patients. Considered largely incurable, ovarian cancer typically relapses within 3 years in 80% of women, with subsequent recurrences arising sooner each time as resistance to chemotherapy develops.

About SBP-101
SBP-101 is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for pancreatic ductal adenocarcinoma and other tumors. The molecule has shown signals of tumor growth inhibition in clinical studies of US and Australian metastatic pancreatic cancer patients, suggesting potential complementary activity with an existing FDA-approved standard chemotherapy regimen. In data evaluated from clinical studies to date, SBP-101 has not shown exacerbation of bone marrow suppression and peripheral neuropathy, which can be chemotherapy-related adverse events. Serious visual adverse events have been evaluated and patients with a history of retinopathy or at risk of retinal detachment will be excluded from future SBP-101 studies. The safety data and PMI profile observed in the current Panbela sponsored clinical trial provides support for continued evaluation of SBP-101 in a randomized clinical trial. For more information, please visit View Source