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Frontiers in Oncology Publishes an Invited Review Highlighting Soluble TNF’s Impact on Breast Cancer

On April 23, 2020 INmune Bio, Inc. (NASDAQ: INMB) (the "Company"), an immunology company developing treatments that harness the patient’s innate immune system to fight disease, reported publication of an invited review in Frontiers in Oncology: Tumor Necrosis Factor α Blockade: an Opportunity to Tackle Breast Cancer, by Dr. Roxana Schillaci, in the Lab of Molecular Mechanisms, Instituto de Biología y Medicina Experimental-CONICET, Argentina (Press release, INmune Bio, APR 23, 2020, View Source [SID1234556533]).

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This publication is part of the evolving body of work by Dr. Schillaci and her team in the role of soluble TNF in resistance to oncology immunotherapies including trastuzumab and other therapies. Trastuzumab is the leading therapy for women with HER2+ breast cancer. Dr. Schillaci’s has previously reported that women with MUC4 expressing HER2+ breast cancers are resistant to trastuzumab.

"This novel work was first presented at the San Antonio Breast Cancer Symposium in 2018," said RJ Tesi MD, Chief Executive Officer of INmune Bio. "Dr. Schillaci showed that MUC4 expression is driven by soluble TNF. When soluble TNF is neutralized with INB03, MUC4 expression is decreased and the cancer becomes sensitive to trastuzumab."

"This review is one of the first to address the impact of TNFɑ on breast cancer subtypes progression and metastasis and to discuss the participation of soluble and transmembrane TNFɑ in breast cancer," said Dr. Schillaci. "We demonstrate the potential efficacy of TNF blocking agents in the treatment of breast cancer because soluble TNF is involved in resistance to most of the breast cancer therapies, ranging from chemotherapy, hormone therapy to anti-checkpoint inhibitors."

Dr. Schillaci’s work in MUC4 induced resistance to trastuzumab in women with HER2+ breast cancer is the basis for INMB’s planned Phase II trial in women with metastatic HER2+ breast cancer. The article is part of a three article Research Topic in this issue of Frontiers in Oncology entitled, The Tumor Necrosis Factor Superfamily: an Increasing Role in Breast Cancer.

Immunomic Therapeutics Announces Close of $61.3M Financing

On April 23, 2020 Immunomic Therapeutics, Inc., ("ITI") a privately-held clinical-stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms, reported the close of a $61.3M financing led by HLB Co., LTD, a global pharmaceutical company focused on developing novel cancer drugs (Press release, Immunomic Therapeutics, APR 23, 2020, View Source [SID1234556532]). This represents the second closing in the investment process for the HLB Consortium, ($10M was placed in February 2020), and substantially increases their holding in Immunomic Therapeutics to 47.6% of the common stock. HLB also secured an option to make further investment into the company in the months ahead.

"We are pleased to welcome HLB as a significant shareholder of Immunomic Therapeutics and look forward to working with them within the framework of the HLB Bio family of companies. They have a proven track record of success in Asia and share our commitment and passion for developing best-in-class therapies for cancer and other serious diseases," said Dr. William Hearl, CEO of Immunomic Therapeutics. "With HLB’s support, we are well-positioned to accelerate our efforts in immuno-oncology, in particular glioblastoma multiforme, and rapidly advance other key candidates in our pipeline, including our most recent initiative into infectious diseases with development of our vaccine candidate for COVID-19."

Proceeds from the financing will support the acceleration of ITI’s Phase II clinical trial of ITI-1000 for the treatment of glioblastoma multiforme (GBM), advance its emerging pipeline, and expand upon the current applications of its UNITE platform. The financing will also enable Immunomic to expand its team and infrastructure to support the future growth of the company.

In addition, ITI and HLB intend to establish an Asian Brain Cancer Research Center in Seoul that will bring together the world’s leading experts and cutting-edge science to advance research in the GBM field and to deploy ITI-1000 to the Asian population. ITI-1000 is a cell therapy powered by ITI’s UNITE platform that is currently being evaluated in a Phase II clinical trial (ATTAC-II) in collaboration with researchers at the University of Florida (Dr. Duane Mitchell) and Duke University (Dr. John Sampson). ITI-1001 is an alternative, cell-free approach to treating GBM. The company held a successful pre-IND meeting earlier this year for ITI-1001 and expects to be able to file an Investigational New Drug Application (IND) with the U.S. Food and Drug Administration (FDA) by the end of 2020.

Concurrent with the financing, five (5) members from HLB Co., LTD will be joining the Immunomic Therapeutics Board of Directors.

About UNITE

ITI’s investigational UNITE platform, or UNiversal Intracellular Targeted Expression, works by fusing pathogenic antigens with the Lysosomal Associated Membrane Protein, an endogenous protein in humans, for immune processing. In this way, ITI’s vaccines (DNA or RNA) have the potential to utilize the body’s natural biochemistry to develop a broad immune response including antibody production, cytokine release and critical immunological memory. This approach could put UNITE technology at the crossroads of immunotherapies in a number of illnesses, including cancer, allergy and infectious diseases. UNITE is currently being employed in Phase II clinical trials as a cancer immunotherapy. ITI is also collaborating with academic centers and biotechnology companies to study the use of UNITE in cancer types of high mortality, including cases where there are limited treatment options like glioblastoma and acute myeloid leukemia. ITI believes that these early clinical studies may provide a proof of concept for UNITE therapy in cancer, and if successful, set the stage for future studies, including combinations in these tumor types and others. Preclinical data is currently being developed to explore whether LAMP nucleic acid constructs may amplify and activate the immune response in highly immunogenic tumor types and be used to create immune responses to tumor types that otherwise do not provoke an immune response.

Entry into a Material Definitive Agreement

On April 23, 2020, Heat Biologics, Inc. (the "Company") reported that it has entered into Amendment No. 1, dated April 23, 2020 (the "Amendment"), to that certain At Market Issuance Sales Agreement, by and between the Company and B. Riley FBR, Inc. ("B. Riley FBR") dated April 3, 2019 (together with the Amendment, the "Sales Agreement") pursuant to which the Company may offer and sell, from time to time, at its option, shares of the Company’s common stock, par value $0.0002 per share, through B. Riley FBR, as sales agent (the "Sales Agent") in an "at the market" offering (the "ATM Offering") (Filing, 8-K, Heat Biologics, APR 23, 2020, View Source [SID1234556531]). The Amendment will be effective at the time the Company’s Registration Statement on Form S-3 (File No. 333-237808) (the "New Registration Statement") is declared effective by the Securities and Exchange Commission.

The original Sales Agreement provided for the issuance and sale of shares of common stock in the ATM Offering pursuant to the Company’s shelf Registration Statement on Form S-3 (File No. 333-221201)(the "Prior Registration Statement"), which includes a base prospectus and a prospectus supplement dated April 3, 2019 (the "Prior Prospectus"), providing for the sale of up to $18 million of shares of common stock in the ATM Offering. As of April 20, 2020, the Company has issued and sold an aggregate of 15,551,075 shares of common stock for aggregate gross proceeds of approximately $12,843,702 pursuant to the Sales Agreement under the Prior Registration Statement, utilizing the Prior Prospectus.

The Amendment provides for the issuance and sale of shares of common stock in the ATM Offering pursuant to the New Registration Statement. The issuance and sale of shares of common stock in the ATM Offering will be made under the New Registration Statement, once it is declared effective, pursuant to a prospectus, which consists of a base prospectus and a prospectus (the "ATM Prospectus"), each of which has been filed with the New Registration Statement. The ATM Prospectus provides for the sale of up to $50 million of shares of common stock in the ATM Offering under the New Registration Statement.

Under the terms of the Sales Agreement, in no event will the Company issue or sell through the Sales Agent such number or dollar amount of shares of common stock that would (i) exceed the number or dollar amount of shares of common stock registered and available on the Registration Statement, (ii) exceed the number of authorized but unissued shares of common stock, (iii) exceed the number or dollar amount of shares of common stock permitted to be sold under Form S-3 (including General Instruction I.B.6 thereof, if applicable), or (iv) exceed the number or dollar amount of common stock for which the Company has filed a prospectus supplement to the Registration Statement.

Under the terms of the Sales Agreement, the Company may sell shares of its common stock through B. Riley FBR by any method permitted that is deemed an "at the market offering" as defined in Rule 415 under the Securities Act of 1933, as amended (the "Securities Act"). B. Riley FBR will use its commercially reasonable efforts consistent with its normal trading and sales practices and applicable state and federal laws, rules and regulations to sell the Company’s common stock from time to time, based upon the Company’s instructions (including any price, time or size limits or other customary parameters or conditions the Company may impose). Actual sales will depend on a variety of factors to be determined by the Company from time to time, including (among others) market conditions, the trading price of the Company’s common stock, capital needs and determinations by the Company of the appropriate sources of funding for the Company. The Company is not obligated to make any sales of common stock under the Sales Agreement and the Company cannot provide any assurances that it will issue any shares pursuant to the Sales Agreement. The Company will pay a commission rate of up to 3.0% of the gross sales price per share sold and agreed to reimburse B. Riley FBR for certain specified expenses, including the fees and disbursements of its legal counsel in an amount not to exceed $50,000 and have agreed to reimburse B. Riley FBR an amount not to exceed $2,500 per quarter during the term of the sales agreement for legal fees to be incurred by B. Riley FBR. The Company has also agreed pursuant to the Sales Agreement to provide B. Riley FBR with customary indemnification and contribution rights.

GSK presents new data from the GARNET study demonstrating potential of dostarlimab to treat a subset of women with recurrent or advanced endometrial cancer

On April 23, 2020 GlaxoSmithKline plc reported data from an updated analysis of the GARNET trial, which demonstrated that dostarlimab, an investigational anti-programmed death-1 (PD-1) monoclonal antibody, provided clinically meaningful results in women with recurrent or advanced mismatch repair-deficient (dMMR) endometrial cancer who progressed on or after a platinum-based regimen (Press release, GlaxoSmithKline, APR 23, 2020, View Source [SID1234556530]).

This updated analysis included patients with dMMR endometrial cancer who had measurable disease at baseline and ≥6 months of follow-up by the data cutoff (n=71). Patients received 500 mg of dostarlimab once every three weeks for four doses, followed by 1,000 mg once every six weeks until disease progression. The primary endpoints were confirmed objective response rate (ORR) and duration of response (DoR), as assessed against RECIST v 1.1 by blinded independent central review. GARNET is the largest dataset evaluating an anti-PD-1 in endometrial cancer.

Treatment with dostarlimab showed an ORR of 42% (95% CI; 31-55) and a disease control rate of 58% (95% CI; 45-69). Overall, 13% of patients had a complete response and 30% of patients had a partial response. At the time of data cutoff, with a median follow up of 11.2 months, the median DOR had not been reached (1.87+ to 19.61+ months).

Dr. Axel Hoos, Senior Vice President and Head Oncology R&D, GSK said: "We are committed to developing medicines for patients who face high unmet medical need. We believe in the clinical potential of dostarlimab for women with advanced or recurrent dMMR endometrial cancer who urgently need additional treatment options for this incurable disease."

Dr. Ana Oaknin, Head of the Gynaecologic Cancer Program at Vall d’Hebron Institute of Oncology, Barcelona, and primary investigator for GARNET said: "There are limited treatment options for women with advanced or recurrent endometrial cancer, and prognosis of these patients is poor. The results observed in the GARNET trial indicate the potential of dostarlimab to offer a new treatment option for women with this challenging disease."

The safety population included all patients with dMMR endometrial cancer who received at least one dose of dostarlimab (n=104). Results showed that dostarlimab was well tolerated with a low discontinuation rate (2%) due to treatment-related adverse events (TRAEs), consistent with the safety profiles of other anti-PD-1 therapies. The most commonly reported TRAEs were asthenia (15%), diarrhoea (15%), fatigue (14%), and nausea (13%). No deaths associated with dostarlimab were reported in the study.

Dostarlimab is not currently approved for use anywhere in the world.

About GARNET
The ongoing phase I GARNET trial is evaluating dostarlimab as monotherapy in patients with advanced solid tumours. Part 2B of the study includes five expansion cohorts: dMMR/MSI-H endometrial cancer (cohort A1), mismatch repair proficient endometrial cancer (cohort A2), non-small cell lung cancer (cohort E), dMMR/MSI-H non-endometrial cancer (cohort F), and platinum-resistant ovarian cancer without BRCA mutations (cohort G). GARNET is still enrolling patients.[1,2]

About Dostarlimab
Dostarlimab is an investigational humanised anti-PD-1 monoclonal antibody that binds with high affinity to the PD-1 receptor and blocks its interaction with the ligands PD-L1 and PD-L2.[3]

In addition to GARNET, dostarlimab is being investigated for women with recurrent or primary advanced endometrial cancer in combination with standard of care (chemotherapy) in the phase III RUBY trial.[4] Dostarlimab is also being evaluated in combination with other therapeutic agents for patients with advanced solid tumours or metastatic cancer.

About endometrial cancer[v]
Endometrial cancer is a main type of uterine cancer that forms in the inner lining of the uterus, known as the endometrium. Endometrial cancer can be classified as mismatch repair-deficient/microsatellite instability-high or mismatch repair-proficient/microsatellite stable. There are limited treatment options for women whose disease progresses on or after first-line therapy. Endometrial cancer is the sixth most common cancer in women worldwide.[6]

GSK in Oncology
GSK is focused on maximising patient survival through transformational medicines. GSK’s pipeline is focused on immuno-oncology, cell therapy, cancer epigenetics and synthetic lethality. Our goal is to achieve a sustainable flow of new treatments based on a diversified portfolio of investigational medicines utilising modalities such as small molecules, antibodies, antibody drug conjugates and cells, either alone or in combination.

ACCENT THERAPEUTICS ANNOUNCES $63 MILLION SERIES B FINANCING TO ADVANCE NOVEL, PRECISION CANCER THERAPIES TARGETING RNA-MODIFYING PROTEINS

On April 23, 2020 Accent Therapeutics, a biopharmaceutical company developing breakthrough treatments for cancer patients, reported that it has completed a $63 million Series B financing (Press release, Accent Therapeutics, APR 23, 2020, View Source [SID1234556529]). The Series B was led by EcoR1 Capital with participation by GV, AbbVie Ventures, The Mark Foundation for Cancer Research, NS Investment and Droia Ventures as well as existing investors, Atlas Venture and The Column Group.

Proceeds from the financing will be used to advance the development of Accent’s novel therapies targeting RNA-modifying proteins (RMPs), including its lead programs METTL3 and ADAR1, and to continue to expand its pipeline in the rich target space of RNA modification.

"We are thrilled to have the support of this remarkable group of investors that share our vision for developing novel therapies for patients in need," said Shakti Narayan, Chief Executive Officer of Accent Therapeutics. "With the progress we have made to-date and expect to make in the coming months, the next phase of Accent’s growth is set to be truly transformational."

Since launching in 2018, Accent has advanced a broad pipeline of programs, including its two lead programs – METTL3 and ADAR1. METTL3 is an RNA methyltransferase implicated in AML, specific solid tumors and immuno-oncology. ADAR1 is an RNA editor with compelling validation for solid tumors with elevated intrinsic Type I interferon-stimulated gene signaling (comprising ~15-30% of solid tumors) and has also been suggested to play a key role in immuno-oncology. By targeting the proteins that modify RNA, Accent is able to apply the proven approach of enzyme-directed small molecule therapies to a rich and novel class of enzymes with the ability to impact RNA pathobiology.

"Opportunities to have such a broad impact in novel areas of biology are becoming increasingly rare," said Oleg Nodelman, Founder and Managing Director of EcoR1 Capital. "The team at Accent is well-positioned to lead this area of drug development and achieve the rich therapeutic potential of these exciting programs."