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SELLAS Strengthens Year-End Balance Sheet with Addition of Approximately $30.5 Million

On December 17, 2020 SELLAS Life Sciences Group, Inc. (Nasdaq: SLS) ("SELLAS" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, reported the closing on December 16, 2020 of a registered direct offering of common stock of the Company for net proceeds of approximately $14.9 million, after deducting placement agent fees and other estimated offering expenses (Press release, Sellas Life Sciences, DEC 17, 2020, View Source [SID1234572981]). SELLAS also announced the exercise, as of December 16, 2020, of outstanding warrants for net proceeds to the Company of approximately $8.1 million. Following the issuance of shares of common stock in the registered direct offering and upon the exercise of warrants, there are currently 14,194,610 shares of common stock of the Company outstanding. SELLAS previously announced on December 7, 2020 that it had entered into an Exclusive License Agreement granting rights to 3D Medicines, Inc. to develop and commercialize galinpepimut-S (GPS), its lead late-stage clinical candidate, as well as its next generation heptavalent immunotherapeutic, GPS+, in the Greater China territory (mainland China, Hong Kong, Macau and Taiwan). Under the terms of the License Agreement, SELLAS expects to receive prior to year-end a non-dilutive license fee of $7.5 million.

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Proceeds from the registered direct offering and the warrant exercises, together with the upfront license fee from 3D Medicines, will be used to fund the Company’s development programs for GPS, including the ongoing pivotal global Phase 3 clinical trial (the REGAL study) of GPS in patients with acute myeloid leukemia (AML) who have reached second complete remission, as well as regulatory- and CMC-related preparatory projects supporting a future potential GPS biologics licensing application (BLA) filing for GPS, assuming positive data from the REGAL study.

"We are pleased that we have been able to significantly strengthen our balance sheet with the proceeds from the registered direct offering of common stock and the warrant exercises as well as the expected upfront license fee. These proceeds, together with our current cash, will allow us to aggressively execute on our clinical development plans, including taking steps to mitigate, to the extent possible, the impact of the COVID-19 pandemic on our clinical trial timelines as well as, among other things, to begin preparations for potential regulatory filings around our Phase 3 REGAL AML study," commented Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS.

Perrigo to Present Virtually at Upcoming Investor Conferences

On December 17, 2020 Perrigo Company plc (NYSE; TASE: PRGO), reported that EVP and President of Consumer Self-Care Americas, Rich Sorota will present at the ICR Conference at 11:30 AM EST on Monday, January 11, 2021 (Press release, Perrigo Company, DEC 17, 2020, View Source [SID1234572980]).

Perrigo President & CEO Murray S. Kessler and CFO, Ray Silcock, will present at the 39th Annual J.P. Morgan Global Healthcare Conference at 3:40 PM EST on Wednesday, January 13, 2021. Interested parties can access the presentation webcasts at View Source

Taiho Pharmaceutical Concludes Licensing of Automated PDPS Platform with PeptiDream

On December 17, 2020 Taiho Pharmaceutical Co., Ltd. reported that it has entered into a Technology License Agreement with PeptiDream Inc., to non-exclusively license PeptiDream’s proprietary automated Peptide Discovery Platform System (PDPS) technology platform (Press release, Taiho, DEC 17, 2020, View Source [SID1234572977]).

Under the terms of the agreement, Taiho Pharmaceutical will make an undisclosed upfront payment as a licensing fee. In addition, Taiho Pharmaceutical may make payments based on the achievement of certain predetermined development milestones for any constrained peptides and/or small molecules discovered from use of the automated PDPS platform, as well as royalties on sales of certain products that arise from use of the automated PDPS technology. Taiho Pharmaceutical and PeptiDream will also enter into a separate sales agreement related to the supply of reagents required for operation of the automated PDPS platform. Similar to previous technology license agreements, work on peptide-drug conjugates (PDCs) is excluded from the non-exclusive license.
Taiho Pharmaceutical is focusing on drug discovery using medium-sized molecules, a new modality, in addition to conventional drug discovery using small molecules. By utilizing the automated PDPS platform, the company aims to expand the possibilities of medium-sized molecule drug discovery and improve the probability of success in innovative new drug development.

"Thanks to its sophisticated automatic screening system and overwhelming diversity of compounds, including special peptides, we believe that PeptiDream’s drug discovery platform technology, PDPS, will expand the possibilities of drug discovery for treatment targets (undruggable targets) previously difficult in developing new drugs. We will carry out innovative drug discovery research using PDPS and commit to delivering new drugs to patients who currently have no treatment options." said Teruhiro Utsugi, Managing Director of Taiho Pharmaceutical.

"We are very much pleased by Taiho’s decision to adopt our automated PDPS platform, which we believe is a fruit of their appreciation of the value of PeptiDream’s macrocyclic/constrained peptide screening technology. With the automated PDPS platform, we are confident that Taiho’s drug discovery and research efforts will be greatly accelerated and contribute to further advance development of new therapeutics, including those with "difficult" targets by traditional approaches. We look forward to working with and supporting Taiho not only through the automated PDPS platform and supplies of reagents but on all aspects of our PDPS technology." said Keiichi Masuya PhD, Executive Vice President of PeptiDream.

Surface Oncology Announces Exclusive License Agreement with GSK for Novel Immunotherapy Program

On December 17, 2020 Surface Oncology (Nasdaq: SURF) reported an agreement for GSK to exclusively license worldwide development and commercial rights to Surface Oncology’s preclinical program SRF813, a fully human IgG1 antibody targeting PVRIG (also known as CD112R), an inhibitory protein expressed on natural killer cells (NK cells) and T cells (Press release, Surface Oncology, DEC 17, 2020, View Source [SID1234572976]).

Under the terms of the agreement, GSK will make an $85 million upfront payment. In addition, Surface Oncology may receive up to an additional $730 million in future milestone payments, as well as be eligible to receive tiered royalties on global net sales.

"We are extremely pleased to be entering into this agreement with GSK given the strong strategic fit for SRF813 within GSK’s oncology portfolio, including the possibility of pursuing compelling novel clinical combinations. Furthermore, the economics of the transaction position us well to continue to drive the development of our wholly-owned clinical programs, SRF617 and SRF388, while also advancing SRF114, our CCR8 targeted program," said Jeff Goater, chief executive officer at Surface Oncology. "We believe this transaction is further validation of our strong immuno-oncology drug discovery capabilities."

"GSK’s R&D approach focuses on the science of the immune system and I am excited to add a natural killer cell approach, such as SRF813, as it complements our existing programs focused on T cell/adaptive immunity," said Dr. Axel Hoos, senior vice president and head of oncology R&D at GSK. "We’re making great progress to build an exciting pipeline of new oncology therapies with transformational potential for patients. I strongly believe that we are uniquely positioned to maximize the potential of SRF813 for patients, both as monotherapy and in potential combinations with our investigational anti-CD96 and anti-PD1 assets."

Goodwin Procter is serving as legal counsel to Surface Oncology.

Financial Outlook:

Following the close of the GSK license agreement, together with current cash and cash equivalents, Surface Oncology projects cash runway sufficient to fund its operations through 2023.

About SRF813:

SRF813 is a fully human, IgG1 antibody targeting PVRIG (also known as CD112R), an inhibitory protein expressed on natural killer cells (NK cells) and T cells. SRF813 binds to a distinct epitope on PVRIG and blocks the interaction of PVRIG with CD112, its binding partner that is overexpressed on tumor cells. Preclinically, SRF813 promotes the activation of both NK cells and T cells, with the potential to elicit a strong anti-tumor response and promote immunological memory. SRF813 is currently in IND-enabling studies with an IND planned for 2021.

Moleculin Announces FDA Permission to Begin Clinical Study of Annamycin for Sarcoma Lung Metastases

On December 17, 2020 Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, reported that the US Food and Drug Administration (FDA) is allowing the company’s Investigational New Drug (IND) application to study Annamycin for the treatment of soft tissue sarcoma lung metastases to go into effect (Press release, Moleculin, DEC 17, 2020, View Source [SID1234572975]). This allows Moleculin to begin a Phase 1B/2 clinical trial in the US for patients with soft tissue sarcoma that has metastasized to the lungs after first-line therapy for their disease.

It is estimated that there are approximately 36,000 new cases of soft tissue sarcoma (STS) in the 7 major markets (US, EU5 and Japan) each year, and an estimated annual market size of over $177 million for the treatment of STS lung metastases. Our clinical advisors estimate that approximately half of all STS patients will eventually develop lung metastases from their primary tumor. Although first-line treatments such as surgical resection, chemotherapy and radiation may provide initial therapeutic benefit for an estimated 35% of those patients, there are no approved or emerging second-line therapies for the remaining 65% who relapse or are refractory. Although the lungs tend to be a major site of relapse, we are aware of only 2 active clinical trials specifically targeting STS lung metastases, indicating that Annamycin faces limited competition in this area of development.

Moleculin recently announced that Annamycin demonstrates consistently high antitumor activity in vivo in all tested animal models of different types of lung-localized cancers, including sarcoma. These promising findings correlate with surprisingly high uptake of Annamycin to the lungs in animal models. This uptake is up to 34-fold higher than that of doxorubicin, the primary first-line chemotherapy for STS. The limited pulmonary uptake of doxorubicin in animal models may help explain its lack of activity against STS lung metastases in humans. Additionally, clinical data show no cardiotoxicity associated with the use of Annamycin, as well as the ability to avoid multidrug resistance mechanisms, both of which are often treatment-limiting effects of anthracyclines (which includes doxorubicin) in this setting. Taken together, these factors suggest that Annamycin could represent an important treatment to help address a significant unmet need in patients with STS lung metastases.

"Since the discovery in animal models of Annamycin’s effectiveness in lung metastases, we have been moving quickly to begin a clinical trial in the US to study Annamycin for this indication," commented Walter Klemp, Chairman and CEO of Moleculin. "Recognizing the importance of building on the results with human clinical data, we preemptively included this upcoming trial as part of our budget plan, so our anticipated cash runway into the third quarter of 2021 remains unchanged. We are also collaborating with our partners and physicians in Poland who have shown a high level of interest in testing Annamycin in STS lung metastases and are currently pursuing a possible investigator-led clinical trial in Europe. It is our goal to have to have our US clinical trial begin by mid-2021, with the possibility of also initiating a European investigator-funded clinical trial in 2021."

Mr. Klemp concluded: "Along with the results in STS lung metastases, our animal models have shown significant activity in other lung metastases, including colorectal and triple negative breast cancer, as well as meaningful concentration levels of Annamycin in the liver, spleen and pancreas. Additionally, when tested in a highly aggressive AML mouse model, Annamycin significantly reduced tumor burden in the spleen, lungs and liver, leading to a significant increase in survival. Based on this promising preclinical data, we believe the ultimate market opportunity for Annamycin could be much larger than just STS lung metastases. For all these reasons, we are excited to be moving from the animal models to clinical study."