On April 6, 2021 Evaxion Biotech A/S (Nasdaq: EVAX), a clinical-stage biotechnology company specializing in the development of AI-driven immunotherapies to improve the lives of patients with cancer and infectious diseases, reported the fourth quarter and full year 2020 financial results and provided an operational update (Press release, Evaxion Biotech, APR 6, 2021, View Source [SID1234578287]).

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Lars Wegner, CEO of Evaxion, said: "Evaxion made outstanding progress in 2020 in redefining the immunotherapy discovery process through our AI platform technologies, despite the complications caused by the COVID-19 pandemic. We are very pleased with the successful initial public offering on U.S. Nasdaq, concluded in February 2021, which raised gross proceeds of $30 million and positions Evaxion for further progress with our patient-specific cancer immunotherapies."

"In 2020, we initiated a Phase 1/2a clinical trial of the adjuvant immunotherapy EVX-02, in combination with checkpoint inhibitors in patients with advanced melanoma. Both this study and our Phase 1/2a trial with EVX-01 remain on track and our other product candidates – EVX-03 for multiple cancer indications and EVX-B1, a vaccine for prevention of S. aureus – are progressing well through preclinical development."

"Financially, Evaxion is in a strong position with cash and cash equivalents of $5.8 million at December 31, 2020, to which we have now added the proceeds from our IPO. This provides funding to advance our four product candidates into 2022, covering a number of key expected milestones. These include Phase 1/2a data on EVX-01 and EVX-02 expected in late Q2 2021 and filing for approval of a clinical trial of EVX-03 in multiple cancers in the second half of the year."

Operational and Business Highlights in 2020

Dosed first patient in Phase 1/2a melanoma trial of cancer vaccine EVX-02 in combination with checkpoint inhibitors
Appointed Marianne Søgaard, previously an attorney practicing technology law, including processes to acquire technology solutions, and commercial law, as Chairwoman of the Board of Directors
Launched new AI powered platform, RAVEN, to enable faster response to emerging viral pandemics
Partnered with SB3000 for rapid scale up for commercial production of corona virus vaccines with its continuous manufacturing technology
Publication of an article in Nature Communications showing how deep data on immune complex stability could optimize immunotherapy in cancer
Events after the Reporting Period

Closed U.S. initial public offering of 3,000,000 American Depositary Shares at a public offering price of $10.00 per ADS. The gross proceeds from the offering, before deducting underwriting fees and commissions and other offering expenses, were $30 million.
The shares began trading on the Nasdaq Capital Market on February 5, 2021 under the ticker symbol "EVAX".
Opened new corporate headquarters and research laboratory facility located in the DTU Science Park in Hoersholm near Copenhagen, Denmark.
Expected milestones in 2021

Phase 1/2a data on EVX-01 in metastatic melanoma – Q2 2021
Phase 1/2a data on EVX-02 in adjuvant melanoma – Q2 2021
Regulatory filing for clinical trial of EVX-03 in multiple cancers – H2 2021
Fourth Quarter and Full Year 2020 Financial Results

Cash position: As of December 31, 2020, cash and cash equivalents were $5.8 million compared to $9.6 million as of December 31, 2019. On February 9, 2021, we closed our recent IPO raising net proceeds of $27.9 million after underwriting discounts and commissions.
Research and Development expenses were $10.9 million for the year ended December 31, 2020, compared to $8.2 million for the same period in 2019. The increase of $2.7 million was primarily related to increased spending, net of grant income, for ongoing development on our platform, pre-clinical product candidates, and clinical trials. In addition, employee-related costs increased due to higher headcount.
General and Administrative expenses were $5.7 million for the year ended December 31, 2020, compared to $2.6 million for the same period in 2019. The increase of $3.1 million was primarily related to increased employee-related costs due to increased headcount and increases in overhead and professional fees related to the expansion of our corporate function for our initial public offering.
Net loss was $15.0 million for the year ended December 31, 2020 or ($0.97) loss per basic and diluted share, compared to $11.2 million, or ($0.81) loss per basic and diluted share, for the same period in 2019.
Guidance

Evaxion’s operating plan extends its cash runway into 2022.
Webcast and Conference Call

Evaxion will host a webcast and conference call today, April 6, 2021, at 8.30 a.m. EDT.

To access dial-in details for the conference call, please use the following link:
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On April 6, 2021 Ionis Pharmaceuticals, Inc. (NASDAQ: IONS) reported that it intends to offer, subject to market conditions and other factors, $500.0 million aggregate principal amount of Convertible Senior Notes due 2026 (the "notes") in a private placement (the "offering") to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act") (Press release, Ionis Pharmaceuticals, APR 6, 2021, View Source [SID1234577950]). Ionis also intends to grant the initial purchasers of the notes an option to purchase, within the 13-day period beginning on, and including, the first date on which the notes are issued, up to an additional $75.0 million principal amount of notes.

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The notes will be general unsecured obligations of Ionis and will accrue interest payable semiannually in arrears. Upon conversion, Ionis will pay or deliver, as the case may be, cash, shares of its common stock or a combination of cash and shares of its common stock, at its election. The interest rate, initial conversion rate and other terms of the notes will be determined at the time of pricing of the offering.

Ionis expects to use a portion of the net proceeds from the offering to repurchase for cash certain of its 1% Convertible Senior Notes due 2021 (the "2021 notes") in privately negotiated transactions. In addition, Ionis expects to use a portion of the net proceeds from the offering to pay the cost of the convertible note hedge transactions described below (after such cost is partially offset by the proceeds to Ionis from the sale of the warrant transactions described below). Ionis expects to use the remaining net proceeds from the offering for general corporate purposes, including expansion of manufacturing, research and development, and commercial infrastructure to support its wholly owned pipeline.

In connection with the pricing of the notes, Ionis expects to enter into convertible note hedge transactions with one or more of the initial purchasers or their affiliates and/or other financial institutions (the "Option Counterparties"). The convertible note hedge transactions are generally expected to reduce potential dilution to Ionis common stock upon any conversion of notes and/or offset any cash payments Ionis is required to make in excess of the principal amount of converted notes, as the case may be. Ionis also expects to enter into privately negotiated warrant transactions with the Option Counterparties. The warrant transactions would separately have a dilutive effect to the extent that the market price per share of Ionis common stock exceeds the strike price of the warrants. If the initial purchasers exercise their option to purchase additional notes, Ionis expects to enter into additional convertible note hedge and additional warrant transactions relating to the additional notes with the Option Counterparties.

In connection with establishing their initial hedges of the convertible note hedge and warrant transactions, Ionis expects that the Option Counterparties or their respective affiliates will purchase shares of Ionis common stock and/or enter into various derivative transactions with respect to Ionis’ common stock concurrently with or shortly after the pricing of the notes. This

activity could increase (or reduce the size of any decrease in) the market price of Ionis common stock or the notes at that time.

In addition, the Option Counterparties or their respective affiliates may modify their hedge positions by entering into or unwinding various derivatives with respect to Ionis common stock and/or by purchasing or selling Ionis’ common stock or other securities of Ionis in secondary market transactions following the pricing of the notes and prior to the maturity of the notes (and are likely to do so during any observation period related to a conversion of notes or in connection with any repurchase of notes by Ionis on any fundamental change repurchase date or otherwise). This activity could also cause or avoid an increase or a decrease in the market price of Ionis’ common stock or the notes, which could affect the ability of noteholders to convert the notes and, to the extent the activity occurs during any observation period related to a conversion of notes, it could affect the amount and value of the consideration that noteholders will receive upon conversion of such notes.

Further, in connection with any repurchases of the 2021 notes, Ionis expects that holders of the 2021 notes who agree to have their 2021 notes repurchased and who have hedged their equity price risk with respect to such notes (the "hedged holders") will unwind all or part of their hedge positions by buying Ionis’ common stock and/or entering into or unwinding various derivative transactions with respect to Ionis’ common stock. The amount of Ionis’ common stock to be purchased by the hedged holders may be substantial in relation to the historic average daily trading volume of Ionis’ common stock. This activity by the hedged holders could increase (or reduce the size of any decrease in) the market price of Ionis’ common stock, including concurrently with the pricing of the notes, resulting in a higher effective conversion price of the notes. Ionis cannot predict the magnitude of such market activity or the overall effect it will have on the price of the notes offered hereby or Ionis’ common stock.

The notes, the warrants and any shares of common stock issuable upon conversion of the notes or exercise of the warrants have not been and will not be registered under the Securities Act, any state securities laws or the securities laws of any other jurisdiction, and unless so registered, may not be offered or sold in the United States absent registration or an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and other applicable securities laws.

This press release is neither an offer to sell nor a solicitation of an offer to buy any of these securities nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to the registration or qualification thereof under the securities laws of any such state or jurisdiction.

On April 6, 2021 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in class therapeutics in hematology and oncology, reported that the National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application for a Phase I clinical trial to evaluate safety and tolerability of ATG-019 (monotherapy or combined with niacin ER) in patients with advanced solid tumors or non-Hodgkin’s lymphoma (NHL) in China (Press release, Antengene, APR 6, 2021, View Source [SID1234577709]).

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As an orally bioavailable dual PAK4/NAMPT inhibitor, ATG-019 can lead to antitumor effects through energy depletion, inhibition of DNA repair, cell cycle arrest, inhibition of proliferation, and ultimately cell apoptosis. Hematological and solid tumor cells that are dependent on both PAK4 and NAMPT pathways may be susceptible to single-agent anti-tumor activity by ATG-019. ATG-019 has clear preclinical anti-tumor activity and a superior pharmacokinetics (PK) and safety profile making it an attractive novel drug candidate. Antengene has recently been conducting a Phase I clinical trial (TEACH) of ATG-019 in advanced solid tumors and NHL in Taiwan.

"The NMPA‘s approval of the IND application for ATG-019 indicates the potential of this drug to be applied to Chinese patients. We look forward to initiating the first clinical trial of ATG-019 in mainland China," said Dr. Jay Mei, Founder, Chairman and CEO of Antengene. "ATG-019 is an orally available dual PAK4/NAMPT inhibitor that achieves synergistic antitumor effects through the co-inhibition of the two pathways. We believe that ATG-019, as a novel agent under investigation, can potentially provide an additional treatment option for patients with advanced solid tumor and NHL."

About ATG-019
ATG-019 is a global first-in-class oral dual PAK4/NAMPT inhibitor developed by Karyopharm Therapeutics Inc. (NASDAQ: KPTI). Antengene reached an exclusive agreement of cooperation and authorization with Karyopharm and obtained the exclusive development and commercialization rights of ATG-019 in multiple Asia-Pacific markets, including Greater China, South Korea, Australia, New Zealand and ASEAN countries.

PAK4 is a signaling protein regulating numerous fundamental cellular processes, including intracellular transport, cellular division, cell shape and motility, cell survival, immune defense and the development of cancer. PAK4 interacts with many key signaling molecules involved in cancer development such as beta-catenin, CDC42, Raf-1, BAD and myosin light chain. NAMPT is a pleiotropic protein with intra- and extra-cellular functions as an enzyme, cytokine, growth factor, and hormone that can be found in a complex with PAK4 in the cell. In preclinical mouse models, ATG-019 in combination with anti-PD-1 therapies showed improved antitumor efficacy over anti-PD-1 monotherapy, indicating the potential of the combined therapy to treat anti-PD-1 resistant patients.

Antengene is conducting a Phase I clinical trial of ATG-019 in Taiwan in patients with advanced NHL and solid tumors and are planning to conduct clinical trials exploring its combination potential with other agents.

On April 6, 2021 I-Mab (the "Company") (Nasdaq: IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, and ABL Bio, Inc. (Kosdaq:298380, hereafter "ABL"), a South Korean biotech specializing in bispecific antibody technology, reported that the first patient has been dosed in a phase 1 trial for bispecific antibody TJ-L14B/ABL503 (Press release, I-Mab Biopharma, APR 6, 2021, View Source [SID1234577685]). The phase 1 clinical trial is an open-label, multi-center, dose-escalation and dose-expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), preliminary antitumor activity, maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of TJ-L14B/ABL503 in locally advanced or metastatic solid tumors (NCT04762641).

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Being developed jointly with ABL, TJ-L14B/ABL503 is a differentiated PD-L1-based bispecific antibody with the PD-L1 arm as the tumor-dependent T-cell activator and the 4-1BB arm as the conditional T cell activator upon tumor engagement. Using ABL’s ‘Grabody-T’ bispecific antibody platform technology, TJ-L14B/ABL503 stimulates 4-1BB activation only in the presence of PD-L1 expressing tumor cells to minimize the risk of off-tumor toxicity. Preclinical studies have demonstrated that the bispecific antibody shows better anti-tumor activity than equimolar doses of single agents alone or in combination.

"Immune checkpoint inhibitors, such as PD-L1, have created a new paradigm for cancer treatment; however, they have limitations in their efficacy and response rates," said Dr. Joan Shen, CEO of I-Mab. "Co-targeting of PD-L1 with a bispecific antibody molecule using this particular platform is postulated to enhance antitumor activity while ensuring the safety of the patients. It may provide an alternative therapeutic approach for patients who have not responded to existing treatments."

"We are very pleased to advance the clinical development of TJ-L14B/ABL503 as planned.," said Dr. Sang Hoon Lee, CEO of ABL. "With phase 1 trial for TJ-L14B/ABL503 being the first testbed for our Grabody-T bispecific antibody platform, we look forward to validating our company’s technology in the field of cancer immunotherapy."

"We are excited to be the first center to conduct this study for TJ-L14B/ABL503," said Dr. Anthony W. Tolcher, FRCPC, FACP, CEO and director of clinical research at NEXT Oncology. "TJ-L14B/ABL503 has demonstrated potential to overcome the adverse toxicity issues of anti-4-1BB antibodies. In collaboration with I-Mab and ABL, we hope for a thorough evaluation to deliver a highly promising treatment for the benefit of cancer patients." NEXT Oncology is a phase 1 center in the U.S. dedicated to providing patients with advance cancer access to the newest cancer treatments available.

On April 6, 2021 HiFiBiO Therapeutics reported that it will share with the scientific community preclinical data for novel monoclonal antibodies for clinical development as new cancer immunotherapeutic options (Press release, HiFiBiO Therapeutics, APR 6, 2021, View Source [SID1234577676]). Two of these programs, HFB3010 and HFB2003, are slated to enter Phase I clinical trials later this year.

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The team will present highlights in four poster sessions at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting, April 10-15 and May 17-21, 2021. These four programs highlight the continual evolution of HiFiBiO Therapeutic’s robust pipeline and unique capability to develop novel antibodies to address unmet medical needs.

"We are excited to share the latest data from four of our programs with the oncology research community at AACR (Free AACR Whitepaper). These include our two most advanced oncology antibodies, HFB301001, a highly differentiated second-generation OX40 agonist, and HFB200301, a novel anti-TNFR2 agonist bridging innate and adaptive immunity. We also share the profile of antibody candidates against CXCR5 and Galectin-9 that hold exceptional promise for the treatment of hematological malignancies and solid tumors," said Francisco Adrian, Global Head of Research.

"Applying single-cell immuno-profiling insights from our groundbreaking DIS platform to our oncology trials is a step towards realizing one of greatest ambitions; to deliver significant benefit to patients through targeted immunotherapies. Our novel biomarker strategy by analyzing tumor immune profiles at the single cell level aims to enrich for responding patients in our upcoming HFB3010 and HFB2003 clinical studies," said Andreas Raue, PhD, Global Head of Drug Intelligent Science.

The four HiFiBiO Therapeutics pipeline programs being presented at AACR (Free AACR Whitepaper) are:

HFB3010 (OX40)

HFB301001 is a second-generation novel, fully human IgG1 class OX-40 agonistic antibody with an optimized pharmacological profile. In contrast to previous anti-OX-40 antibodies, the agonistic activity of HFB301001 is further enhanced in the presence of the endogenous ligand OX-40L, does not result in reduced levels of OX-40 on T-cells, and leads to superior anti-tumor activity in a human OX-40 knock-in mouse model compared to a benchmark antibody. HiFiBiO is also applying a biomarker strategy by leveraging its DIS platform to select patients who may benefit the most from treatment.

HFB2003 (TNFR2)

HFB200301 is a first-in-class agonistic anti-TNFR2 candidate antibody that binds potently and selectively to TNFR2, recognizes cyno TNFR2, and induces CD4 and CD8 T-cell activation and proliferation cooperatively with TNFα without requiring crosslinking. In vivo, HFB200301 demonstrates potent antitumor activity alone and combined with anti-PD-1. It is also well tolerated in mice and NHPs. HiFiBiO is also utilizing its DIS platform to implement a biomarker strategy for HFB2003.

HFB2009 (Gal-9)

Galactoside-binding lectin Galectin 9 (Gal-9) is a key pleiotropic immunosuppressive modulator present in the tumor microenvironment. HFB9-2, an anti-Gal-9 blocking antibody with demonstrated single agent anti-tumor activity in a mouse cancer model, offers improved survival in combination with anti-PD-1 therapy as compared to anti-PD-1 alone, and shows good tolerability in NHPs.

HFB1002 (GPCR)

CXCR5 is a GPCR expressed on B cells, as well as on follicular helper T cells. CXCR5 plays a key role in the migration of B cells to germinal centers and the production of autoantibodies. CXCR5 is implicated in autoimmune diseases, such as Sjögren syndrome, and in cancers such as B cell lymphomas and solid tumors, where it has been associated with metastasis and poor prognosis. HiFiBiO generated and characterized a novel anti-hCXCR5 blocker with potent ADCC activity to treat tumor and autoimmune diseases.