On April 7, 2021 OncoDNA, a theranostic and genomic company specializing in precision medicine, and myNEO, an AI-driven company revolutionizing target identification within immuno-oncology, reported a new collaboration that will revolutionize cancer care (Press release, OncoDNA, APR 7, 2021, View Source [SID1234577697]). The two companies agreed to consolidate their core technologies to enable the production of personalized vaccines for patients who have run out of treatment options.

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With the COVID-19, the field of mRNA therapeutics has been moving faster than ever before. In oncology, personalized vaccines can help fight cancer by selectively boosting the immune system. These vaccines can teach the body to recognize and eliminate tumor-specific neoantigens.

OncoDNA and myNEO will leverage their sequencing and bioinformatics technologies to identify and select the most effective neoantigens to target in a patient. While OncoDNA will perform whole genome and whole transcriptome sequencing, myNEO will handle the advanced interpretation of the sequenced data and design the optimal vaccine construct for maximum clinical benefit.

The project promises to guide patients through a completely personalized journey. The eligible patients would receive tailor-made vaccines as well as personalized follow-up by monitoring circulating tumor DNA after inoculation. With its OncoFOLLOW liquid biopsy, OncoDNA will help monitor the patient response and the evolution of the cancer very closely using personalized next-generation sequencing method.

"OncoDNA is delighted to jump with myNEO into this ambitious project. We stand at the forefront of innovation and the challenges ahead are herculean. Together we will work towards a world where patients with a hard-to-treat disease will have the opportunity to design their personalized elixirs. It may take years before this technology becomes a reality. However, the ongoing pilot tests on patients who do not respond to any therapy are showing promising results", commented Jean-Pol Detiffe, Chief Strategy & Innovation Officer and Founder of OncoDNA.

"Since day 1, myNEO’s mission has been to unlock the promise of immunotherapy via deep genomic and immune profiling of tumors," described Cedric Bogaert, co-founder and CEO of myNEO. "Currently, our technology is used by biopharma partners to design the upcoming breakthrough immuno-oncology therapies. This project takes our ambition one step further in enabling OncoDNA’s vast network of clinicians and patients to directly benefit from this deep genomic and immune profiling. As such, this project holds great potential to make individualized immunotherapies more accessible to patients."

On April 7, 2021 Fortress Biotech, Inc. (NASDAQ: FBIO) ("Fortress"), an innovative biopharmaceutical company focused on acquiring, developing and commercializing or monetizing promising biopharmaceutical products and product candidates cost-effectively, reported that Lindsay A. Rosenwald, M.D., Chairman, President and Chief Executive Officer, will participate in the 20th Annual Needham Virtual Healthcare Conference, taking place April 12-15, 2021 (Press release, Fortress Biotech, APR 7, 2021, View Source [SID1234577696]). The company will present on Monday, April 12, 2021, at 4:30 p.m. ET and will also participate in one-on-one meetings during the conference. A webcast of the company’s presentation will be available on the Events page under the News & Media section of Fortress’ website: www.fortressbiotech.com for approximately 30 days following the presentation.

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On April 7, 2021 Alkermes plc (Nasdaq: ALKS) reported that it has entered into a clinical trial collaboration and supply agreement with MSD (a tradename of Merck & Co., Inc. Kenilworth, NJ, USA) for a planned phase 3 study to evaluate nemvaleukin alfa ("nemvaleukin", formerly referred to as ALKS 4230), Alkermes’ novel investigational engineered interleukin-2 (IL-2) variant immunotherapy, in combination with MSD’s KEYTRUDA (pembrolizumab), in comparison to investigator choice chemotherapy in patients with platinum-resistant ovarian cancer (Press release, Alkermes, APR 7, 2021, View Source [SID1234577695]). Under the terms of the agreement, Alkermes is responsible for conducting the phase 3 study, which is planned to initiate in the second half of 2021.

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"We are pleased to collaborate with MSD to evaluate nemvaleukin in combination with KEYTRUDA in patients with platinum-resistant ovarian cancer, a patient population for which there are limited treatment options available and overall survival remains low. Importantly, there are no anti-PD-1 treatments currently approved for this tumor type," said Jessicca Rege, Ph.D., Vice President, Head of Oncology at Alkermes. "Nemvaleukin in combination with KEYTRUDA has demonstrated antitumor activity in heavily pre-treated patients with platinum-resistant ovarian cancer in the ongoing ARTISTRY-1 study, with durable and deepening responses observed. We look forward to initiating this phase 3 study to further evaluate the potential clinical utility of this combination in this tumor type and advancing our interactions with regulatory authorities related to potential registration strategies for the combination in platinum-resistant ovarian cancer."

About nemvaleukin alfa
Nemvaleukin is an investigational, 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 nemvaleukin is designed to leverage the proven antitumor 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 nemvaleukin in patients with advanced solid tumors.

ARTISTRY-1 and ARTISTRY-2 are phase 1/2 studies evaluating the safety, tolerability, efficacy and pharmacokinetic and pharmacodynamic effects of nemvaleukin in patients with refractory advanced solid tumors, in both monotherapy and combination settings with the PD-1 inhibitor pembrolizumab (KEYTRUDA). In ARTISTRY-1, nemvaleukin is administered as an intravenous infusion daily for five consecutive days, followed by an off-treatment period. In the ongoing phase 2 efficacy expansion stage of ARTISTRY-2, nemvaleukin is administered subcutaneously once every seven days.

ARTISTRY-3 is a phase 2 study evaluating the clinical and immunologic effects of intravenous nemvaleukin monotherapy on the tumor microenvironment of a variety of advanced, malignant solid tumors.

On April 7, 2021 XOMA Corporation (Nasdaq: XOMA) ("XOMA" or the "Company") reported the pricing of its underwritten registered public offering of 1,400,000 depositary shares at an initial public offering price of $25.00 per depositary share, raising gross proceeds of $35.0 million before deducting underwriting discounts and other estimated offering expenses (Press release, Xoma, APR 7, 2021, View Source [SID1234577694]). Each depositary share represents a 1/1000th fractional interest in a share of the Company’s 8.375% Series B Cumulative Perpetual Preferred Stock. Dividends on the Series B Preferred Stock underlying the depositary shares will be paid when declared by the Board at a fixed rate of 8.375% with liquidation preference equivalent to $25.00 per depositary share.

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In connection with the offering, the Company has granted the underwriters a 30-day option to purchase up to an additional 200,000 depositary shares. The offering is expected to close on or about April 9, 2021, subject to customary closing conditions.

The Company’s depositary shares are expected to begin trading on NASDAQ under the symbol "XOMAO" within 30 business days of the closing date of this offering, if approved.

The Company expects to use the net proceeds of this offering to fund the segregated dividend account and the remaining net proceeds for general corporate purposes, including funding future acquisitions of milestone and royalty rights associated with drug development programs with third-party funding.

B. Riley Securities, Inc., National Securities Corporation, Ladenburg Thalmann & Co. Inc., and William Blair & Company are acting as joint book-runners for this offering. Aegis Capital Corp., Boenning & Scattergood, Inc., Incapital LLC, and Northland Capital Markets are acting as co-managers.

The depositary shares will be offered under the Company’s shelf registration statement on Form S-3, which was declared effective by the U.S. Securities and Exchange Commission ("SEC"). The offering of these depositary shares will be made only by means of a prospectus and prospectus supplement. A copy of the prospectus and prospectus supplement relating to these securities may be obtained, when available, from the website of the SEC at View Source or by contacting: B. Riley Securities, Inc., 1300 17th Street North, Suite 1300, Arlington, Virginia 22209, Attn: Prospectus Department, Email: [email protected], Telephone: (703) 312-9580.

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of the depositary shares in any state or jurisdiction in which such offer, solicitation, or sale would not be permitted.

On April 7, 2021 NovalGen Ltd ("NovalGen"), a biopharmaceutical company developing breakthrough cancer therapies, reported that its Clinical Trial Application ("CTA") has been accepted by the UK Medicines and Healthcare products Regulatory Agency ("MHRA"), and that University College London Hospital ("UCLH") has been activated as NovalGen’s first UK clinical site (Press release, UCLB, APR 7, 2021, View Source [SID1234577693]). The Company is now ready to conduct a Phase 1/2 first in human study evaluating the safety and efficacy of its lead product, NVG-111. The study will include patients with both Chronic Lymphocytic Leukemia ("CLL") & Mantle Cell Lymphoma ("MCL"), and the Company expects to dose the first patient in Q2 2021. NVG-111 is a first-in-class bispecific antibody T-cell engager which simultaneously binds CD3 on T-cells and Receptor Tyrosine Kinase Like Orphan Receptor 1 ("ROR1") on tumour cells.

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"Approval to start our first clinical study represents an important validation of our approach and is a significant milestone for NovalGen only 2 years following the company’s formation" said Professor Amit Nathwani, CEO of NovalGen. "We are developing bispecific therapies that can safely harness the immune system to treat both hematological malignancies and solid tumours, and we are excited to imminently bring our first antibody forward to patients with CLL and MCL in this study."

NVG-111 redirects endogenous T-cells to sites of tumours and, upon engagement with the ROR1 antigen on cancer cells, promotes the formation of immunological synapses, selectively killing the tumour independently of major histocompatibility complex, costimulatory molecules and antigen presentation. It is designed to be highly effective in the killing of cancer cells without affecting healthy immune cells or tissues and may potentially target cancer-initiating stem cells, a subpopulation of cancer cells that are resistant to standard cancer therapies. In preclinical studies, NVG-111 showed efficacy in a range of hard-to-treat blood cancers as well as solid tumours. The initial clinical focus with NVG-111 is in previously treated CLL and MCL patients to establish the drug’s safety and efficacy profile, followed by clinical expansion to target other ROR1-expressing cancers. The Company’s proprietary ROR1 and CD3-targeting bispecific molecule has been engineered for optimal tumour targeting and T-cell activation, respectively, for the efficient killing of cancer cells without excessive release of cytokines.