On 3rd June 2020 Enara Bio (formerly Ervaxx), a biotechnology company leveraging its proprietary T-cell/T-cell receptor (TCR) discovery and Dark Antigen platforms to deliver targeted cancer immunotherapies, reported its new name – Enara Bio Limited (Press release, Ervaxx, JUN 3, 2020, View Source [SID1234607515]). This new name reflects the company’s expanded product discovery and development strategy beyond its initial focus on endogenous retroviral (ERV) antigens for the development of cancer vaccines (hence "Ervaxx").

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"Enara" is derived from an Arabic word that means illumination, enlightenment and bringing light into darkness. The company believes this new name more closely illustrates Enara Bio’s mission as a science-led organization exploring the genomic dark matter as a source of novel cancer-specific T-cell antigens. The rebrand also recognizes the company’s new TCR research capabilities, including programs that could enable immune recognition of a broad range of tumor cell types in an HLA-independent fashion, and thus offer broadly applicable T-cell therapies. By building discovery efforts on both sides of the T-cell/cancer-cell interface (the "immune synapse"), Enara Bio is building a pipeline of cancer immunotherapies for broad patient populations.

The company was founded as Ervaxx Ltd. in late 2016 with an initial focus on the development of therapeutic cancer vaccines utilizing novel antigens derived from endogenous retroviral (ERV) DNA sequences. Since then, and based on breakthrough science coming from both internally-generated and in-licensed insights, Enara Bio has broadened its horizons to include TCR-based immunotherapies targeting an extended cancer-associated antigenic repertoire derived from the entire genomic dark matter, termed Dark Antigens.

To accelerate this evolution, Enara Bio in-licensed patents covering T cells and TCRs reactive to cancer-specific antigens and ligands from Cardiff University in January 2020. These exciting new technologies, while early research-stage, present compelling opportunities to develop immunotherapies with the potential to address a broad range of tumor types independent of the patient’s genetic background.

Kevin Pojasek, President and CEO of Enara Bio commented:

"Our new name – Enara Bio – reflects the progression of our strategy and capabilities to align more broadly with our purpose of delivering impactful immunotherapies to all cancer patients. Our ground-breaking work in identifying and characterizing Dark Antigens is now joined by other exciting new programs focused on pan-cancer, pan-HLA targets, which greatly expand our opportunities for the development of novel immunotherapies with broad utility across patients with diverse cancers. While we continue to press ahead with these exciting programs internally, we are increasingly seeking partnerships to advance the full diversity of our science and product opportunities."

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About Enara Bio

Enara Bio (formerly Ervaxx) is a science-led company targeting the T-cell/cancer-cell interface (the "immune synapse") to develop new targeted cancer immunotherapies designed to treat a broad patient population.

Enara Bio is exploring the hidden depths of cancer and T-cell biology to discover and characterize novel immunotherapy targets, such as Dark Antigens and MR1-presented ligands. We are pioneering approaches to exploit these targets with TCR-directed T-cell immunotherapy and therapeutic vaccines.

To achieve our mission, we are leveraging our differentiated Dark Antigen and TCR discovery platforms that integrate bioinformatics, immunopeptidomics, metabolomics and immunology in our Oxford, UK-based research lab.

Enara Bio is backed by leading life science investors, including SV Health Investors. We have partnerships with world-class academic institutions, including the Francis Crick Institute, Cardiff University, Johns Hopkins School of Medicine and the University of Oxford, to help drive the leading edge of these new areas of science.

On June 3, 2020 Maverick Therapeutics, Inc., a private biopharmaceutical company pioneering conditionally active bispecific T cell targeted immunotherapies, announced pipeline updates for its robust set of Conditional Bispecific Redirected Activation (COBRA) programs at the Jefferies Virtual Healthcare Conference taking place June 2-4, 2020 (Press release, Maverick Therapeutics, JUN 3, 2020, View Source [SID1234570575]).

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By nature of its elegant and innovative design, the COBRA platform is the most mature bispecific T cell engaging platform in its class that can safely target solid tumors with highly specific and potent activity. COBRA molecules are prodrugs selected to bind to specific targets, which may be expressed in both tumor and healthy tissue. However, COBRAs are engineered to take advantage of the tumor’s unique microenvironment for T cell activation; triggering T cell mediated killing only at the site of the tumor while sparing damage to patients’ healthy tissues.

"As we continue to advance our pipeline, we look forward to initiating the clinical development of our lead first-in-class COBRA programs, MVC-101 and MVC-280, both of which have generated promising pre-clinical data designed to validate the COBRA mechanism of action and be predictive of translation to patients. Our pipeline reflects our single focus on developing potent and conditionally active T cell engaging therapies for solid tumor cancers. Beyond our two lead programs, we have also generated compelling in vivo data for two additional COBRA molecules," said Jim Scibetta, Chief Executive Officer, Maverick Therapeutics. "The first patient who is safely and effectively treated for a solid tumor cancer with any form of T cell therapy, whether CAR T cell therapy or redirected T cell engagers like our COBRAs, will serve as a major breakthrough in the field of cancer immunotherapy. For us at Maverick, this is an incredibly important and humbling mission."

"Although evidence of anti-tumor activity has been observed in patients with solid cancers, the full potential of T cell engaging therapies against solid tumor cancers continues to be hindered by unacceptable toxicity," said Jim Vasselli, M.D., Senior Vice President, Clinical Development, Maverick Therapeutics. "Underpinning the pre-clinical development of COBRA technology is Maverick’s commitment to using gold standard in vivo and in vitro models to maximize our understanding of the molecules. We are encouraged by the early results generated by these first two programs and are excited to continue development towards the clinic."

MVC-101 Is a Highly Potent COBRA Targeting Tumors that Express EGFR

Maverick Therapeutics’ lead program candidate, MVC-101, is a proprietary COBRA molecule designed to target Epidermal Growth Factor Receptor (EGFR), a protein expressed on both malignant and healthy tissues. MVC-101 regressed established human tumors in several preclinical models. Exposures of MVC-101 at efficacious relative to tolerated doses in safety studies demonstrates an increased therapeutic index compared to standard T cell engagers. MVC-101 is designed to be a universal solution for patients with EGFR expressing solid tumor cancers. EGFR is expressed on a wide range of solid tumor cancers, including but not limited to colorectal, head & neck, renal, pancreatic, cervical and non small cell lung cancers. Maverick expects to initiate a Phase 1 trial in Q1 2021.

MVC-280 Is a Highly Potent COBRA Targeting Tumors that Express B7H3

Maverick Therapeutics’ second program candidate, MVC-280, is a proprietary COBRA molecule designed to target B7H3 (CD276). B7H3 is expressed in a broad range of malignant and healthy tissues, similar to EGFR. MVC-280 regressed established tumors in several preclinical models. It is cross-reactive to its target protein expressed on mouse tissues, creating an opportunity to measure both efficacy and relative safety in the same preclinical model and use that data to calculate a therapeutic index. MVC-280 is designed to be a universal solution for patients with B7H3 expressing solid tumor cancers. B7H3 is expressed on a wide range of solid tumor cancers, including but not limited to prostate, renal, triple negative breast, head & neck, ovarian and urothelial cancers. Maverick expects to initiate a Phase 1 trial in H2 2021.

About the COBRA Therapeutics Platform

Maverick Therapeutics’ COBRA platform is the most mature conditionally active bispecific T cell engaging platform designed to safely target a broad range of solid tumors with highly specific and potent activity while limiting on-target toxicities in normal tissues. By nature of its highly innovative design, the COBRA platform reflects a novel approach to T cell engaging immunotherapies where T cell activation and resulting cell killing only take place where it is needed – in tumors. This unique design delivers the long sought after trifecta in cancer care; high specificity, high potency and reduced toxicity.

On June 3, 2020 Isofol Medical AB (publ) (Nasdaq First North Premier Growth Market: ISOFOL) ("Isofol" or the "Company") reported that fully guaranteed new share issue with preferential rights for the Company’s existing shareholders (the "Rights Issue"), which ended on June 1, 2020, was oversubscribed (Press release, Isofol Medical, JUN 3, 2020, View Source [SID1234561554]). Due to the strong demand from strategic investors, a directed issue with deviation from the shareholders’ preferential rights of approximately SEK 30 million (the "Over-Allotment Option") was exercised. Through the Rights Issue and the Over-Allotment Option, Isofol will receive proceeds amounting to approximately SEK 180 million before transaction costs.

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Not for publication, distribution or release, directly or indirectly, in whole or in part, within or into the US, Canada, Japan, Australia, Hong Kong, New Zeeland or any other jurisdiction in which such publication, distribution or release may be contravening to any applicable laws or rules. Additional restrictions are applicable, please see "Important information" in the end of this press release.

The result of the Rights Issue of maximum 42,739,736 shares shows that 41,501,048 new shares, corresponding to approximately 97.1 percent of the Rights Issue, have been subscribed for with subscription rights. Additionally, 94,170,568 shares were subscribed for without subscription rights of which 1,238,688 shares, corresponding to 2.9 percent of the Rights Issue, have been allotted to investors that have subscribed for shares without subscription rights. The Rights Issue is thus oversubscribed. Allotment of shares subscribed for without subscription rights has been made in accordance with the resolved allotment principles. Notice of allotment of shares subscribed for without subscription rights will only be sent to those who have been allotted shares. Payment shall be made in accordance with the instructions on the contract note. Nominee-registered shareholders will receive notice of allotment and payment in accordance with the procedures of each nominee.

Due to the oversubscription of the Rights Issue, the Board of Directors of Isofol has exercised the Over-Allotment Option to meet additional demand from strategic investors through a directed issue of 8,571,428 new shares. Shares in the Over-Allotment Option were allotted to several investors, among others, The Fourth Swedish National Pension Fund ("AP4"), thereby broadening Isofol’s shareholder base.

Isofol’s CEO Ulf Jungnelius comments: "We are very pleased with the strong support from both existing and new shareholders in the Rights Issue which made it possible to exercise the Over-Allotment Option. The Rights Issue in combination with the Over-Allotment Option will give Isofol the financial resources to execute the global Phase III study AGENT and ensure that we continue our successful development of arfolitixorin in accordance with our business plan and strategy."

Following the Rights Issue and Over-Allotment Option, Isofol’s share capital will increase by approximately SEK 1,570,993.9 to approximately SEK 2,552,442.3 and the number of shares in Isofol will increase by 51,311,164 shares to 83,365,966 shares.

The shares subscribed for with subscription rights are expected to be registered with the Swedish Companies Registration Office (the "SCRO") on or about June 5, 2020 and are expected to begin trading on Nasdaq First North Premier Growth Market on June 9, 2020.

The shares subscribed for without subscription rights and through exercise of the Over-Allotment Option are expected to be registered with the SCRO on or about June 16, 2020 and are expected to begin trading on Nasdaq First North Premier Growth Market on June 18, 2020.

Advisers
Carnegie Investment Bank AB (publ) and Pareto Securities AB act as Joint Bookrunners in connection with the Rights Issue and the potential Over-Allotment Option. Vinge law firm acts as legal adviser to Isofol, and Baker McKenzie acts as legal adviser to the Joint Bookrunners.

This information is such information that Isofol Medical AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation (EU) No 596/2014. The information was submitted for publication through the agency of the Company’s CEO at 08:00 CET on June 3, 2020.

About arfolitixorin
Arfolitixorin is Isofol’s proprietary drug candidate being developed to increase the efficacy of standard of care chemotherapy for advanced colorectal cancer. The drug candidate is currently being studied in a global Phase III study, AGENT. As the key active metabolite of the widely used folate-based drugs, arfolitixorin can potentially benefit all patients with advanced colorectal cancer, as it does not require complicated metabolic activation to become effective.

On June 3, 2020 Purdue University reported that Acute myeloid leukemia (AML), an aggressive blood cancer, is one of the most lethal cancers. More than 19,000 new cases are diagnosed a year, and more than 11,000 people a year die from it, according to the American Cancer Society (Press release, KinaRx, JUN 3, 2020, View Source,-which-aims-to-better-treat-relapse.html [SID1234560885]).

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A $1,999,998 SBIR Phase I/II grant from the National Cancer Institute to KinaRx LLC, a Purdue University-affiliated startup, will help fast-track to human trials a novel platform aimed at treating relapse for AML and other diseases.

"We are ready to take our technology to the next level and potentially help people who are dealing with aggressive and deadly diseases that offer few treatment options, particularly for relapse patients," said Herman O. Sintim, the Drug Discovery Professor of Chemistry in Purdue’s Department of Chemistry.

KinaRx was founded by Sintim, who is its chief scientific officer, along with M. Javad Aman, Rena Lapidus, Ashkan Emadi, Frederick Holtsberg and Joe O’Neill.

The compounds under development by KinaRx were developed using Sintim’s platform that makes complex drug molecules rapidly using bioinformatics, multi-component compound synthesis and the understanding of disease biology.

KinaRx has licensed drug compounds through the Purdue Research Foundation Office of Technology Commercialization, which is now housed in the Convergence Center for Innovation and Collaboration in Discovery Park District, adjacent to the Purdue campus.

"These compounds have shown promise in treating people who have a recurrence of AML and now we want to do further testing and move into clinical trials," said Sintim, who is a member of the Purdue University Center for Cancer Research and the Purdue Institute for Drug Discovery.

About 30 percent of AML patients have a mutation caused by a kinase called FLT3, which makes the leukemia more aggressive. Although a few FLT3 inhibitors have already been approved in the clinic, patients can relapse due to mutations in the FLT3 protein, which cause drug resistance. KinaRx is commercializing a series of new compounds that inhibit mutant FLT3 kinases, especially mutant versions that are resistant to current FDA-approved FLT3 inhibitors such as gilteritinib. These compounds were developed by researchers in Sintim’s lab at Purdue.

The researchers are looking for partners to continue testing and developing their technology. For more information on other opportunities related to the technology, contact Sintim at [email protected].

On June 3, 2020 argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer, reported that Tim Van Hauwermeiren, Chief Executive Officer, will participate in a fireside chat at the Goldman Sachs 41st Annual Global Healthcare Conference on Wednesday, June 10, 2020 at 8:00 a.m. ET (Press release, argenx, JUN 3, 2020, View Source [SID1234560839]).

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A live webcast of the fireside chat will be available on Investors section of the Company’s website at www.argenx.com. A replay of the webcast will be available for 90 days following the presentation.