On February 16, 2021 Epsilogen Ltd, a global leader in the development of novel immunoglobulin E (IgE) antibodies to treat cancer, reported that IgEs and their potential as "a great way for targeting cancer cells for killing" were cited in a Technology Feature article in the leading science journal, Nature (Press release, Epsilogen, FEB 16, 2021, View Source [SID1234575108]). Entitled "Seven technologies to watch in 2021", the article provided views from seven leading researchers from across the life sciences. Alicia Chenoweth, cancer immunologist at King’s College London and co-chair of the 2022 Antibody Biology and Engineering Gordon Research Conference, exemplified IgEs in her section outlining emerging antibody engineering technologies that she believes could have a significant impact on science in the coming year.

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Epsilogen is a pioneer of novel modified IgE antibodies, which have great potential to treat solid cancer tumours. The company is progressing its lead product, MOv18 IgE, towards phase I/IIa clinical trials for the treatment of platinum-resistant ovarian cancer. Phase I data showing safety and initial signs of efficacy of MOv18 IgE in these patients was presented at the 2020 AACR (Free AACR Whitepaper) Virtual Annual Meeting in April.

Dr Tim Wilson, Chief Executive Officer of Epsilogen, commented: "We are pleased to see IgE antibodies recognised in a leading scientific journal as one of the most promising emerging technologies across the entire life sciences sector."

On February 16, 2021 Onconova Therapeutics, Inc. (NASDAQ: ONTX) ("Onconova"), a biopharmaceutical company focused on discovering and developing novel products to treat cancer, reported the closing of its previously-announced underwritten public offering (Press release, Onconova, FEB 16, 2021, View Source [SID1234575124]). A total of 28,750,000 shares of its common stock were sold, including 3,750,000 shares of common stock following the exercise by the underwriters of their over-allotment option, at a public offering price of $1.00 per share. The gross proceeds of the offering to the Company are $28.75 million, before deducting the underwriting discounts and commissions and other estimated offering expenses.

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Guggenheim Securities is acting as sole book-running manager. Maxim Group LLC and Noble Capital Markets, Inc. are acting as co-managers for the offering.

The securities described above were offered by Onconova pursuant to a shelf registration statement on Form S-3 (File No. 333-237844) which was initially filed by the Company with the Securities and Exchange Commission ("SEC") on April 24, 2020, amended on Form S-3/A that was filed with the SEC on May 15, 2020, and was declared effective by the SEC on May 18, 2020.

A preliminary prospectus supplement relating to the offering was filed with the SEC on February 10, 2021 and is available on the SEC’s website at View Source A final prospectus supplement relating to and describing the terms of the offering was filed with the SEC and is also available on the SEC’s website at View Source Copies of the final prospectus supplement and accompanying prospectus relating to the offering may be obtained from Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017, by telephone at (212) 518-9544, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, 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 February 16, 2021 CEL-SCI Corporation (NYSE American: CVM) reported financial results for the quarter ended December 31, 2020, as well as key clinical and corporate developments (Press release, Cel-Sci, FEB 16, 2021, View Source [SID1234575143]).

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Clinical and Corporate Developments include:

In December 2020, CEL-SCI updated the status of its pivotal Phase 3 head and neck cancer study of Multikine* (Leukocyte Interleukin, Injection). Data lock has been completed, and the study entered its final stage of statistical analysis. CEL-SCI remains blinded to the study data and is not involved in this process which is conducted by independent contractors. The statistical analysis plan follows the protocol stated objectives and is designed to meet FDA requirements to define the clinical benefits that Multikine might provide for patients newly diagnosed with advanced primary (not yet treated) squamous cell carcinoma of the head and neck. The analysis looks at multiple parameters to gain the most information on the possible benefits of using Multikine immunotherapy as a first line treatment before standard of care for these patients.
CEL-SCI continued expanding and upgrading its dedicated cGMP facility in which it manufactures Multikine. The construction, which began in 2020, is expected to be completed in the coming months and will double the facility’s capacity to accommodate two shifts for increased production of Multikine.
In December 2020, CEL-SCI announced that its LEAPS COV-19 peptides, delivered as a therapeutic treatment following SARS-CoV-2 virus challenge, achieved a 40% survival rate in human ACE2 transgenic mouse model as compared to 0% survival in the two control groups. These studies were conducted at the University of Georgia Center for Vaccines and Immunology. As COVID-19 mutations increase, LEAPS COV-19’s mechanism of action which targets the non-mutating part of the SARS-CoV-2 virus is becoming more important.
In December 2020, CEL-SCI sold 1,000,000 shares of common stock at a public offering price of $14.65 per share and received aggregate proceeds of approximately $13.6 million. On December 31, 2020, CEL-SCI’s cash position was approximately $21.9 million. After December 31, 2020, CEL-SCI has received approximately $3.9 million through the exercise of warrants and stock options.
"As the data analysis for our Phase 3 trial is being conducted, we are focused on expanding manufacturing of Multikine so that we will be ready to produce significant commercial quantities for this unmet medical need. We believe that Multikine may add substantial clinical benefit and help these patients." stated CEL-SCI CEO, Geert Kersten.

CEL-SCI reported a net loss of approximately $7.9 million for the quarter ended December 31, 2020 versus net loss of approximately $5.5 million for the quarter ended December 31, 2019.

During the three months ended December 31, 2020, CEL-SCI incurred approximately $3.6 million in costs to upgrade its manufacturing facility to prepare for the potential commercial production of Multikine. Total estimated costs of this upgrade are approximately $10.5 million, of which approximately $6.7 million has been incurred through December 31, 2020.

On February 16, 2021 Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) ("Sonnet" or the "Company"), a biopharmaceutical company developing innovative targeted biologic drugs, reported its financial results for the three months ended December 31st, 2020 and provided a business update (Press release, Sonnet BioTherapeutics, FEB 16, 2021, View Source [SID1234579514]).

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"During the past few months, we have continued to accrue pre-clinical data for our lead platform asset, SON-1010. IL-12 has historically been a difficult target given the toxicities associated with its use," commented Pankaj Mohan, Ph.D., Founder and CEO. "To this end, we are increasingly more encouraged that our FHAB technology has the capacity to improve the therapeutic window of IL-12 and will help Sonnet position the SON-1010 asset as a potentially viable therapeutic candidate of significant value to patients and physicians."

First Quarter FY 2021 and Recent Corporate Updates
Sonnet provided the following updates on its lead pipeline assets:

The Company successfully completed a single- and multiple-dose non-human primate (NHP) study with SON-1010, the Company’s proprietary fully human Interleukin 12 (IL-12) therapeutic candidate configured using the Fully Human Albumin Binding (FHAB) platform. These two studies help to inform and de-risk the design of follow-on NHP studies needed to file an IND with the FDA. Importantly, the data demonstrated a well-tolerated agent with interferon-γ levels suggesting potent on-target activity. The Company will present additional data from the NHP studies at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting in April. The Company plans to file an IND and initiate Phase 1 clinical development in SON-1010 in the second half of 2021.

In SON-080 (low-dose recombinant fully human Interleukin 6, or IL-6), the Company is planning to file an IND and initiate Phase 1b/2a pilot efficacy clinical trials during the second half of 2021 for Chemotherapy Induced Peripheral Neuropathy (CIPN), followed by a Phase 1b/2a pilot efficacy trial for Diabetic Peripheral Neuropathy (SON-081) in 2022.

The previously announced letter of intent to negotiate a licensing agreement with New Life Therapeutics with respect to SON-080 and SON-081 continues on-track. The Company expects to finalize this agreement during the first quarter of 2021.

Sonnet is also developing SON-1210 (IL15-FHAB-IL12), the Company’s lead bispecific construct combining FHAB with fully human IL-12 and fully human Interleukin 15 (IL-15), for solid tumor indications, including colorectal cancer. An IND submission for SON-1210 is expected during the second half of 2021.

Fiscal 2021 First Quarter Ended December 31, 2020 Financial Results

Jay Cross, CFO, commented, "Our cash management strategies have been successful over the past quarter, but more importantly we have recently begun to draw from our ATM offering program, strengthening our balance sheet. With the ATM open, we also decided to close the share subscription facility."

As of December 31, 2020, Sonnet had $2.3 million cash on hand.
As previously announced, on February 5, 2021, Sonnet entered into an at-the-market sales agreement with BTIG, LLC, for an aggregate offering of up to $15.9 million. As of today, the Company has sold 380,199 shares for net proceeds of $1.1 million to Sonnet.
All of the Company’s previously outstanding Series A and Series B warrants (except for approximately 42 thousand Series B warrants) have been exercised. The Company has 11.3 million Series C Warrants outstanding with an exercise price of $3.19 that will expire on October 16, 2025. In the event all the Series C Warrants were exercised for cash, the Company would receive up to an additional $36.1 million.
Research and development expenses were $3.9 million for the three months ended December 31, 2020, compared to $1.4 million for the three months ended December 31, 2019. The increase of $2.5 million was primarily due to the development of the cell line for IL12-FHAB and IL12-FHAB-IL15 manufacturing and increased costs for research and development activities due to the acquisition of Relief Therapeutics SA, including an increase in payroll and share-based compensation expense as the Company expanded its operations.
General and administrative expenses were $2.0 million for the three months ended December 31, 2020, compared to $1.1 million for the three months ended December 31, 2019. The increase of $0.9 million was primarily due to an increase in insurance expenses related to directors and officer’s insurance, and an increase in payroll and share-based compensation expense as the Company expanded its operations to support its overall business objectives.
The $20 million share subscription facility that was previously in place has been terminated.

On February 16, 2021 HDT Bio Corp., a developer of immunotherapies for oncology and infectious diseases, reported that it has raised an additional $3M as part of a seed financing round led by Zoic Capital for a total seed-stage raise of $6M (Press release, HDT Bio, FEB 16, 2021, View Source [SID1234575109]). The funding will support advancing HDT Bio’s three lead products into clinical trials this year.

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HDT Bio CEO Steven Reed said, "These funds will keep us on track to move into the clinic with products from all three of our immune activator platform technologies. We are excited to close our seed round and to move forward with clinical development."

Neal Mody, Managing Director at Zoic Capital, commented, "This is a milestone year for HDT Bio as it transitions into clinical development with multiple assets and numerous market opportunities worldwide."

HDT three lead products are:

HDT-301, a COVID-19 RNA vaccine which uses the company’s proprietary Lipid InOrganic Nanoparticle (LION) formulation to offer simpler and cheaper manufacturing, easier deployment, and vastly lower dosing than current mRNA vaccines.

HDT-201, a RIG-I immune-stimulating protein which improves the effectiveness of immuno-oncology drugs such as checkpoint inhibitors.

HDT-104, a protein that breaks down structural defenses erected by epithelial tumors, making cancers more responsive to treatment through immunotherapy and chemotherapy.

Since its founding in 2017, HDT Bio has raised a total of $16M through a combination of non-dilutive funding, international grants, private investment, and partnership revenue.