On October 21, 2019 TRACON Pharmaceuticals (Nasdaq:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer, wet age-related macular degeneration through our license to Santen Pharmaceutical Co. Ltd., and utilizing our product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., reported that it has entered into a Common Stock Purchase Agreement of up to $15.0 million with Aspire Capital Fund, LLC ("Aspire Capital") (Press release, Tracon Pharmaceuticals, OCT 21, 2019, View Source [SID1234542387]). Aspire Capital has committed to purchase up to $15.0 million of shares of the Company’s common stock at TRACON’s request from time to time during a 30 month period beginning on the effective date of a registration statement related to the transaction and at prices based on the market price at the time of each sale. There are no warrants, derivatives, or other share classes associated with this agreement. Proceeds from the Agreement will be used to further advance the Company’s pipeline and product development platform, as well as general corporate purposes.

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"We are pleased to enter into another transaction with Aspire Capital and believe that this agreement provides TRACON with the opportunity to access capital in an efficient manner," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "The financial flexibility provided by this transaction will further support our business development efforts as we continue to identify opportunities to leverage our product development platform through potential new partnerships with ex-U.S. companies that could benefit from our rapid and capital-efficient U.S. drug development and commercialization solution."

"We are very pleased to be expanding our investment in TRACON and to be continuing our long-term relationship with such an experienced and capable development team. Given the number of significant milestones anticipated in 2020 including data from ongoing clinical trials with DE-122, TRC253, and TJ004309, we firmly believe TRACON has the potential for considerable near-term value creation. Furthermore, TRACON has assembled and refined a highly efficient development platform which has already attracted a number of inimitable and potentially lucrative partnerships including those with Janssen and I-Mab. In particular, we feel the collaboration with I-Mab, which provides an opportunity to access an underappreciated, potentially best-in-class pipeline of bispecific antibodies, provides a strong foundation for similar, high-value ex-US partnerships in the future. We’re excited to see what’s next for TRACON and as a result, are thrilled to provide the company with added financial strength and flexibility as they continue their effort towards making meaningful therapeutic advances for patients with cancer and other diseases of high unmet need," said Steven G. Martin, Managing Member of Aspire Capital.

Under the terms of the Common Stock Purchase Agreement, TRACON will control the timing and amount of any further sale of shares of common stock to Aspire Capital. Aspire Capital has no right to require any sales by TRACON but is obligated to make purchases according to TRACON’s direction. There are no limitations on the use of proceeds, financial covenants or restrictions on future financings and there are no rights of first refusal, participation rights, penalties or liquidated damages in the purchase agreement. TRACON maintains the right to terminate the purchase agreement at any time, at its discretion, without any additional cost or penalty.

As consideration for Aspire Capital’s obligations under the Agreement, TRACON also issued 1,426,579 shares of common stock to Aspire Capital as a commitment fee. TRACON also entered into a Registration Rights Agreement with Aspire Capital in connection with its entry into the purchase agreement that requires TRACON to file a registration statement regarding the shares sold to Aspire Capital. Additional detail regarding the Common Stock Purchase Agreement and related Registration Rights Agreement is set forth in TRACON’s Current Report on Form 8-K, filed today with the SEC.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities nor will there be any sale of these securities in any state or other 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 other jurisdiction.

On October 21, 2019 Propanc Biopharma, Inc. (OTC: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company developing new cancer treatments for patients suffering from recurring and metastatic cancer, reported that the mode of action of the company’s lead product candidate, PRP, a formulation consisting of two proenzymes, has been elucidated by the company’s researchers, by suppressing pathways relating to the Epithelial to Mesenchymal Transition (EMT) and metastasis (Press release, Propanc, OCT 21, 2019, View Source [SID1234542386]). The EMT is a biological process by which cells become motile and invasive, but in cancer stem cells (CSCs), results in metastasis, a process whereby secondary tumors are formed often in remote distances from a primary tumor, causing the cancer to return and spread. Scientific data relating to these key findings were published in Scientific Reports, an online open access journal from the Publishers of Nature, entitled, "Pancreatic Proenzymes treatment suppresses BXPC-3 pancreatic Cancer Stem Cell subpopulation and impairs tumor engrafting."

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"Our findings from our recently published paper confirms the mechanism of action of PRP, which may prove to be effective tool in the fight against metastatic cancer, the main cause of patient death for sufferers," said Dr Julian Kenyon, Propanc’s Chief Scientific Officer. "By targeting CSCs, PRP is targeting the fundamental mechanism by which cancer spreads, especially after exposure to chemo or radiation, because they are non-dividing cells and are therefore resistant to standard treatments. The mode of action of PRP is complex due to the biological nature of the proenzymes and its multiple modes of action. By defining how it works, it gives us confidence that this treatment method has potential implications in a clinical setting, for example, by reducing recurrence after drug treatment failures in cancer patients."

CSCs have been characterized as immortal cells that grow inside tumours and have a great tumour-initiating capacity. Disturbingly, CSCs have a capacity to remain dormant that make them radio- and chemo-resistant, whilst highly metastatic. As cancer treatment moves towards more personalised medicine targeting specific genes, proper therapies to target and treat specifically CSCs are needed for reducing recurrence after drug resistance failures.

Recently, an exhaustive scientific study with the company’s joint researchers proved that PRP dramatically impairs the maintenance of CSCs characteristics, eradicating these malignant cell populations, even under cell culture conditions that support their enrichment and growth.

The recent study addresses, in depth, the effect of PRP on the cellular mechanism characteristic of pancreatic CSCs. The modulation of hundreds of genes after treatment were analysed and proved the high impact that PRP has on the CSCs population. In fact, the treatment inhibited the expression of genes related to CSCs characteristics, which means that PRP was able to change the nature of these malignant cells toward a more differentiated and less dangerous cellular condition.

From a more detailed scientific perspective, PRP treatment regulates up to four pathways related to cancer spread and metastasis, such as TGFβ, Hippo, Wnt and Notch pathways. The cascade of reactions that PRP imposes on tumour cells, implies the disruption of the CSC characteristics, which reverses the malignant EMT process that leads to tumour invasion.

Furthermore, PRP downregulation of TGFβ-1, had implications in tumour engraftment. In vivo experiments using a nude mice model, in which tumours were induced by inoculation of pancreatic CSCs, showed that PRP impaired CSCs subpopulation activation, niche formation and tumour initiation. In others words, PRP treatment seems to have a preventive effect against cancer. CSCs that were inoculated after treatment with PRP did not find a "comfortable surrounding" where to nest, implying the anticancer potential of this novel drug.

"We continue to make significant progress with our scientific understanding and development of our lead product, PRP, as a targeted cancer stem cell therapy. The global metastatic cancer treatment market is predicted to reach nearly $100 Billion over the next 5-year period, and we believe PRP has the potential to impact the way we view and treat cancer, by minimizing the potential for its return and spread in patients. We have recently completed preclinical development and look forward to advancing PRP into clinical trials in the near future," said James Nathanielsz, Propanc’s Chief Executive Officer.

According to a new market intelligence report by BIS Research, titled "Global Metastatic Cancer Treatment Market – Analysis and Forecast, 2018-2025", the global metastatic cancer treatment market was estimated at $54.11 billion in 2017, and anticipated to reach $98.24 billion by 2025.

On October 21, 2019 Alkermes plc (Nasdaq: ALKS) reported that it has entered into a clinical research collaboration with Fred Hutchinson Cancer Research Center (Fred Hutch) for ALKS 4230, Alkermes’ immuno-oncology drug candidate (Press release, Alkermes, OCT 21, 2019, View Source [SID1234542385]). ALKS 4230 is a novel, engineered fusion protein designed to selectively expand tumor-killing immune cells while avoiding the activation of immunosuppressive cells by preferentially binding to the intermediate-affinity interleukin-2 (IL-2) receptor complex.

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The planned phase 2 multi-site trial, ION-01, is designed to estimate the response rate to ALKS 4230 in combination with the anti-PD-1 therapy KEYTRUDA (pembrolizumab) in patients with advanced or recurrent head and neck squamous cell cancer who did not achieve complete remission with an anti-PD-(L)1 antibody treatment. Secondary objectives include evaluation of the duration of response, progression-free survival, time to progression and overall survival of patients with advanced or recurrent head and neck squamous cell cancer receiving treatment with ALKS 4230 in combination with pembrolizumab. As an exploratory objective, the ION-01 study will assess the tumor microenvironment using paired tumor biopsies to evaluate potential predictive biomarkers for response to the addition of ALKS 4230. This multi-site study is designed to leverage the scientific, clinical and management resources of the Immune Oncology Network (ION), a network of foremost academic immunologists at top North American universities and cancer centers. The study is expected to initiate in the fourth quarter of 2019.

"We are honored to collaborate with Fred Hutch, given its commitment to improving outcomes and advancing care for people living with cancer," said Craig Hopkinson, M.D., Chief Medical Officer and Senior Vice President of Medicines Development and Medical Affairs at Alkermes. "We’re encouraged by the profile emerging from the preclinical and initial clinical data for ALKS 4230 and are eager to explore whether this novel investigational drug may improve the therapeutic benefit of checkpoint inhibition with pembrolizumab, in patients with head and neck cancers. The ION-01 study, along with our ongoing ARTISTRY clinical development program, offers the opportunity to strengthen and advance our scientific and clinical understanding of ALKS 4230 and its potential role in treating cancer patients with high unmet needs."

About ALKS 4230
ALKS 4230 is a novel, engineered fusion protein comprised of modified interleukin-2 (IL-2) and the high affinity IL-2 alpha receptor chain, designed to selectively expand tumor-killing immune cells while avoiding the activation of immunosuppressive cells by preferentially binding to the intermediate-affinity IL-2 receptor complex. The selectivity of ALKS 4230 is designed to leverage the proven anti-tumor effects of existing IL-2 therapy while mitigating certain limitations.

About the ARTISTRY Clinical Development Program
ARTISTRY is an Alkermes-sponsored clinical development program evaluating ALKS 4230 in patients with advanced solid tumors. ARTISTRY-1 is an ongoing phase 1/2 study in which ALKS 4230 is administered as an intravenous infusion daily for five consecutive days. ARTISTRY-1 has three distinct stages: an ongoing monotherapy dose-escalation stage, a recently-initiated monotherapy expansion stage and an ongoing combination therapy stage with the PD-1 inhibitor KEYTRUDA (pembrolizumab) in patients with select advanced solid tumors. ARTISTRY-2 is an ongoing phase 1/2 study of ALKS 4230 administered subcutaneously as monotherapy and in combination with pembrolizumab in patients with advanced solid tumors. ARTISTRY-2 is designed to explore the safety, tolerability and efficacy of ALKS 4230 administered subcutaneously and assess once-weekly and once-every-three-week dosing schedules.

On October 21, 2019 Idera Pharmaceuticals, Inc. (Nasdaq: IDRA), or the Company, reported that the U.S. Patent and Trademark Office will issue on November 5, 2019 U.S. Patent No. 10,10,463,686 entitled "Immune Modulation With TLR9 Agonists For Cancer Treatment," which includes the Company’s investigational therapy tilsotolimod (IMO-2125) (Press release, Idera Pharmaceuticals, OCT 21, 2019, View Source [SID1234542384]).

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The patent includes 24 claims directed to methods of treating melanoma with intratumoral administration of tilsotolimod in combination with certain immune checkpoint inhibitor therapies including CTLA-4, PD-1 or PD-L1 proteins. The patent provides exclusivity through September 2037.

"We are pleased with the continued development of tilsotolimod, including the breadth and duration of our patent portfolio," said Vincent Milano, Idera’s Chief Executive Officer. "This new patent provides additional intellectual property coverage and demonstrates our ongoing commitment to tilsotolimod, patients living with melanoma and innovation."

About Tilsotolimod (IMO-2125)
Tilsotolimod is a TLR 9 agonist that received Fast Track Designation from the U.S. Food and Drug Administration (FDA) in 2017 for the treatment of anti-PD-1 refractory melanoma, in combination with ipilimumab as well as orphan drug designation from the FDA for the treatment of melanoma Stages IIb to IV. It signals the immune system to create and activate cancer-fighting cells (T-cells) to target solid tumors. Currently approved immuno-oncology treatments, specifically check-point inhibitors, provide benefit for some patients, but these therapies are limited in patients whose immune responses are missing or weak. Intratumoral injections with tilsotolimod are designed to selectively enable the tumor-specific T-cells to recognize and attack cancers that remained elusive and unrecognized by the immune system exposed to checkpoint inhibitors alone, while limiting toxicity or impact on healthy cells in the body.

On October 21, 2019 4SC AG (4SC, FSE Prime Standard: VSC) reported that a poster entitled: The preclinical rationale and clinical design for the combination of domatinostat with avelumab in Merkel Cell Carcinoma patients: the MERKLIN 1 and MERKLIN 2 studies by Dr. René Bartz will be presented at the 1st International Symposium on Merkel Cell Carcinoma 21-22 October 2019, Tampa, Florida, USA (Press release, 4SC, OCT 21, 2019, View Source [SID1234542383]). The poster will be available on 4SC’s website after the presentation.

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