On January 26, 2021 OS Therapies, a clinical-stage biopharmaceutical company focused on discovering and developing innovative therapies to treat and cure Osteosarcoma (OS) and other deadly cancers in kids and adults, reported the approval of the OST-HER2 PhIIb clinical trial in recurred, resected Osteosarcoma (Press release, OS Therapies, JAN 26, 2021, View Source;ost31-164-01-an-open-label-phase-2-study-of-maintenance-therapy-with-ost31-164-after-resection-of-recurrent-osteosarcoma-301214754.html [SID1234574322]).

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The trial will be conducted in collaboration with the Children’s Oncology Group (COG) and will be opened at multiple selected sites within the COG’s national network of children’s hospitals across the country. The trial has a forty-eight (48) week enrollment period, and will include thirty-nine (39) patients. Osteosarcoma is a cancer of the bone that is very deadly, and a majority of the patients are young adults and adolescents. When it recurs, it is often fatal.

"We are very grateful to the entire team for diligently working through the entire Covid-19 global pandemic to get this protocol finalized," said Dr. Robert Petit, Chief Medical & Scientific Officer of OS Therapies. "We are stimulating the patient’s immune system to hunt down hidden cancer that escaped chemotherapy and can cause the disease to return. The Osteosarcoma community has been waiting with a great deal of enthusiasm to get this trial started in kids with this horrible disease. They won’t have to wait much longer."

On January 26, 2021 Lipocine Inc. (NASDAQ:LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, reported the pricing of an underwritten public offering of 14,285,714 shares of its common stock, offered at a price of $1.75 to the public (Press release, Lipocine, JAN 26, 2021, View Source [SID1234574321]). Additionally, the Company has granted the underwriters a 30-day option to purchase up to an additional 2,142,857 shares of common stock. All of the shares in the offering are being offered by the Company. The offering is expected to close on or about January 28, 2021, subject to customary closing conditions. The gross proceeds to the Company from this offering are expected to be approximately $25.0 million, before deducting underwriting discounts and commissions and other estimated offering expenses payable by the Company. This amount assumes no exercise of the underwriters’ option.

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The Company intends to use the net proceeds from this offering for general corporate purposes. General corporate purposes may include additions to working capital and capital expenditures. The Company has not yet determined the amount of net proceeds to be used specifically for any particular purpose or the timing of these expenditures.

Raymond James & Associates, Inc. is acting as sole book-running manager and Ladenburg Thalmann & Co. Inc. is acting as co-manager for the public offering.

This offering is being made pursuant to an effective shelf registration statement on Form S-3 (No. 333-250072) previously filed with the U.S. Securities and Exchange Commission (the "SEC") and declared effective by the SEC on November 23, 2020. A preliminary prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and are available on the SEC’s web site at www.sec.gov. Copies of the preliminary prospectus supplement and accompanying prospectus, and when available, copies of the final prospectus supplement and accompanying prospectus may also be obtained from Raymond James & Associates, Inc., Attention: Equity Syndicate, 880 Carillon Parkway, St. Petersburg, Florida 33716, by telephone at (800) 248-8863 or by e-mail at [email protected]

This press release shall not constitute an offer to sell or the solicitation of an offer to buy 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.

On January 26, 2021 Eucure Biopharma, a subsidiary of Biocytogen, reported the first patient enrollment for a Phase I clinical trial in China to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of its anti-CTLA4 monoclonal antibody (YH001) in patients with solid tumors (Press release, Biocytogen, JAN 26, 2021, View Source [SID1234574320]).

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In May 2020, Eucure Biopharma initiated a first-in-human Phase I dose-escalation trial of YH001 in advanced solid tumors in Australia. One run-in cycle was used to explore the safety and tolerability of escalating doses of YH001 monotherapy, followed by four treatment cycles of YH001 in combination with fixed dose Toripalimab (an anti-PD-1 antibody). In the first four cohorts, no grade 3 or higher adverse events (AE) were observed, demonstrating a favorable safety profile.

The Phase I trial in China will assess the safety and preliminary efficacy of YH001 as a single agent in patients with advanced solid tumors. The leading principal investigator is Professor Cai-Cun Zhou, Director of the Department of Oncology at Shanghai Pulmonary Hospital. The trial will be conducted concurrently with Professor Yongsheng Wang at West China Hospital and Professor Tongtong An at Peking University Cancer Hospital.

Dr. Yuelei Shen, CEO of Biocytogen and Eucure Biopharma, said that the first patient enrolled for YH001 treatment in China "will be another important milestone for Eucure Biopharma". "Eucure Biopharma’s mission is to bring the latest global therapeutic concepts and new drugs to Chinese patients, with scientific innovation and patient welfare as our top priority. We hope to take this opportunity to strengthen our cooperation with domestic experts to smoothly advance the business of Biocytogen/Eucure Biopharma in China."

About YH001
YH001 is an anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) humanized monoclonal antibody that relieves CTLA-4-mediated immunosuppression and enhances the T-cell-mediated antitumor immune response. YH001 can trigger antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) to remove CTLA-4 expressing cells, especially regulatory T cells, to treat various tumors. YH001 has demonstrated excellent affinity, safety, and in vivo efficacy in Biocytogen’s humanized mouse models.

On January 26, 2021 Imvax, Inc., an emerging oncology leader that is revolutionizing immunotherapy for patients with Glioblastoma Multiforme (GBM), reported publication of Phase 1b clinical trial results in Clinical Cancer Research, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) (Press release, Imvax, JAN 26, 2021, View Source [SID1234574319]). The article — "Phase1b Clinical Trial of IGV-001 for patients with Newly Diagnosed Glioblastoma" — is available online.

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IGV-001 is a first-in-class personalized immunotherapy that uses the patient’s own tumor cells combined with an antisense molecule to induce a potent immune response. The treatment comprises irradiated autologous glioma cells with an antisense oligodeoxynucleotide directed at the IGF-1R (Insulin-like Growth Factor type one Receptor) named IMV-001. Delivered through an implantable and removable bio-diffusion chamber, antigenic products are released and initiate both an innate and adaptive response.

The four cohorts in this Phase 1b study represent 33 patients accrued over three years at Thomas Jefferson University. The optimal dose cohort demonstrated progression-free survival at 17.1 months and overall survival at just below 22 months. The methylated subgroup demonstrated a notable increase in progression-free survival at 38.4 months. The average life expectancy for a patient with GBM is 15-16 months. Evidence of immune activation was noted.

"This study demonstrates that an antigen inclusive approach can benefit GBM patients, both in terms of survival and quality of life," said David W. Andrews, M.D., Founder and Chief Medical Officer of Imvax and the Anthony Alfred Chiurco MD Professor of Neurosurgery at Jefferson. "These results show that progression-free survival was in fact significantly improved — almost threefold above the reported progression-free survival for the standard of care."

"We are addressing the great unmet need in the battle against GBM through the development of IGV-001," said John Furey, CEO of Imvax. "I’m proud of the strides our team is making by establishing proof of concept and of what lies ahead as we embark on our Phase 2 study."

"The strengths of this study are significant and noteworthy including the innovative approach, which was granted ‘Orphan Drug’ designation by the FDA in 2017, the impressive increase in PFS, and the various immunological correlations," said Andrew E. Sloan, MD, FAANS, FACS, Director of the Brain Tumor and Neuro-Oncology Center and the Center of Excellence in Translational Neuro-Oncology at the Seidman Cancer Center and the Neurological Institute of the University Hospitals, Cleveland, OH. "This is a highly meritorious study of a novel technique that demonstrates statistically-significant clinical benefit, even as a stage 1b study, for a disease that is universally fatal. The paper adds significantly to the field and is an exciting development."

The Phase 2b study is to begin in the first half of 2021.

On January 26, 2021 Amgen (NASDAQ:AMGN) reported that it will host a webcast call for the investment community in conjunction with the 2020 World Conference on Lung Cancer (WCLC) on Friday, Jan. 29, at 8:00 p.m. ET. David M. Reese, M.D., executive vice president of Research and Development at Amgen, along with members of Amgen’s clinical development team and clinical trial investigators, will discuss the registrational Phase 2 non-small cell lung cancer (NSCLC) data being presented on the Company’s investigational KRASG12C inhibitor sotorasib.

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Live audio of the conference call will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

The webcast, as with other selected presentations regarding developments in Amgen’s business given at certain investor and medical conferences, can be accessed on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.