On February 19, 2021 Affibody Medical AB (publ) ("Affibody" or "the Company"), a Swedish biotech company focused on developing next generation biopharmaceuticals based on its unique proprietary technology platforms: Affibody molecules and Albumod, reported its Year-End Report for 2020 (Press release, Affibody, FEB 19, 2021, View Source [SID1234575695]).

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Financial Highlights

Revenue for the quarter amounted to SEK 1.9 (17.2) m, and to 121.3 (311.8) m for the full year
Operating result for the quarter amounted to SEK -87.5 (-66.1) m, and to -214.9 (44.8) m for the full year
Net result for the quarter amounted to SEK -89.4 (-72.9) m, and to -220.3 (44.6) m for the full year
Cash flow for the quarter amounted to SEK -42.3 (-14.4) m, and to -238.9 (283.8) m for the full year
Cash and cash equivalents at the end of the period amounted to SEK 135.9 (374.8)
Significant Events during the rest of the Reporting Period

On November 10, 2020, we announced the initiation of a 52-week trial investigating the novel bispecific IL-17A inhibitor ABY-035 in patients with psoriatic arthritis (PsA).
Significant Events during the rest of the Year

An EGM on February 17, 2020 elected José Suarez as Board member.
On April 30, 2020 we announced that Daewoong, a South Korea-based pharmaceutical company, had exercised an option under the collaboration related to a half-life extended biotherapeutics product
On May 15, 2020, we and Inmagene Biopharmaceuticals announced a strategic partnership to develop and commercialize ABY-035, a bispecific molecule targeting Interleukin-17A (IL-17), for multiple auto-immune diseases. Inmagene will be responsible for commercialization in mainland China, Hong Kong, Taiwan, and Macau (Greater China), and South Korea, as well as development activities in the Asia Pacific region, excluding Japan. Affibody will retain global commercial rights outside of Greater China and South Korea. The partners will work together to enroll patients into global registrational trials to support Biologics License Applications (BLAs) in multiple indications worldwide. Under the terms of the agreement, Affibody will receive a $10 million upfront payment and is eligible to receive up to $215.5 million in additional regulatory and sales milestones, plus royalties on sales in Inmagene’s commercialization territory.
On June 15, 2020 we announced positive top-line data from our Phase 2, 52-week trial investigating the novel bispecific IL-17A inhibitor ABY-035 in patients with moderate-to-severe psoriasis ("AFFIRM-35").
On June 15, 2020 we announced the completion of the ABY-039 Phase 1 trial and the termination of the ABY-039 program, our FcRn inhibitor, due to tolerability observations that would limit the target product profile of subcutaneous high dose once monthly maintentance injections. Based on these observations Alexion has terminated the co-development agreement with Affibody.
Significant Events after the close of the Reporting Period

On February 10, Affibody AB and Inmagene Biopharmaceuticals announced that the U.S. FDA has cleared izokibep (ABY-035) to proceed to Phase 2 clinical development in Ankylosing Spondylitis (AS), a subset of Axial Spondyloarthritis (axSpA). The partners are jointly developing izokibep to treat multiple autoimmune diseases, and Inmagene has taken the responsibility to manage the global clinical trials for axSpA.
Affibody is a clinical stage biopharmaceutical company with a broad product pipeline focused on developing innovative bi- and multi-specific next generation biopharmaceuticals based on its unique proprietary technology platforms: Affibody molecules and Albumod.

The company operates a focused experimental medicine model and currently has two clinical stage programs. The first is a therapeutic program that targets IL-17 mediated autoimmune and inflammatory diseases. The second program is a diagnostic imaging program that is directed primarily towards metastatic breast cancer.

Affibody AB is a holding of Patricia Industries.

On February 19, 2021 Octapharma reported that New expert consensus guidelines on the use of immunoglobulin replacement therapy (IgRT) in patients with haematological malignancy and secondary antibody deficiencies (SAD) were recently published in the European Journal of Haematology (Press release, Octapharma, FEB 19, 2021, View Source [SID1234575392]).

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The publication, sponsored by Octapharma, marks the first pan-European consensus guidance on the use of IgRT in patients with hypogammaglobulinaemia secondary to haematological malignancies and aims to support harmonisation of clinical practice across Europe.

Octapharma has a longstanding commitment to improving the management of patients with secondary immunodeficiencies (SID) and in 2020 launched PRO-SID, a phase III clinical trial investigating primary infection prophylaxis with intravenous immunoglobulin (IVIg) in patients with chronic lymphocytic leukaemia (CLL). These efforts address the need for both robust clinical data and unified guidance on managing infection risk in patients with SID.

Absence of guidance leaves patients at risk

SAD is a common complication in patients with haematological malignancies such as CLL and multiple myeloma (MM). Up to 85% of CLL patients and up to 83% of patients with smouldering MM have low immunoglobulin levels, which leaves patients more susceptible to infections1,2. Infections are the likely cause of death in 22% of patients with MM and up to 50% of patients with CLL3,4. IgRT is effective at reducing the risk of infections in patients with haematological malignancies5.

In 2019, the EMA approved an expanded use of IVIg in patients with SID6. However, detailed European guidelines on the use of IgRT in patients with haematological malignancies and SAD were lacking. Differences in treatment approaches to reduce the infection burden remain significant across Europe, including different strategies for initiation, dosing and discontinuation of IgRT.

Stephen Jolles, lead author of the publication and Professor at the Immunodeficiency Centre for Wales in Cardiff, UK, commented: "Developing consensus guidelines for the use of IgRT in secondary antibody deficiency (SAD) aims to address a major need for treatment recommendations for patients with haematological malignancies and SAD. IgRT can reduce morbidity and mortality in a selected group of these patients and it is important that physicians have consistent guidance on defining this group and managing infection risk."

A Task Force of eight experts in immunology and haemato-oncology developed statements on key aspects of IgRT, which were reviewed by a panel of 32 European experts. This Delphi consensus exercise developed clear recommendations for SAD due to haematological malignancies such as: measurement of IgG levels at the beginning of anti-cancer treatment; initiation of IgRT in patients who have received appropriate anti-infective therapy during or after a single severe infection or during recurrent or persistent infections when IgG levels are <4 g/l or if test immunization has failed; initiation of IgRT with a minimum IgG dose of 0.4 g/kg bodyweight every 3-4 weeks or stopping IgRT after at least 6 months without infections and concomitant evidence of immunological recovery. The 21 consensus statements emphasise the importance of IgRT for patients with SAD who experience severe, recurrent or persistent infections and provide guidance on initiation, dosing and discontinuation of IgRT, as well as measurement of IgG levels and the use of subcutaneous immunoglobulin (SCIg) therapy. The publication is available through open access at "Treating Secondary Antibody Deficiency in Patients with Haematological Malignancy: European Expert Consensus".

More information on SID in patients with haematological malignancies, including detailed information on the recent consensus guidelines, can be found at View Source

Patient recruitment continues for the PRO-SID study

Recruitment for the phase III PRO-SID study (NCT04502030) of IVIg in patients with CLL and SID is underway, in 22 sites across 7 countries. The PRO-SID study is investigating the efficacy and safety of IVIg (Panzyga) as primary prophylaxis in patients with CLL and SID. Secondary prophylaxis with IVIg is an established approach to reduce the rate of infections in patients with haematological malignancies and SAD, but there is a need for robust data on IVIg as primary infection prophylaxis, i.e. before a major infection occurs7.

Commenting on Octapharma’s involvement in the field of SID, Olaf Walter, Board Member at Octapharma, said that: "Infections remain a serious concern for patients with haematological malignancies and SID, and at Octapharma we continue to strive for a better understanding of how to minimise the risk of such potentially life-threatening complications."

About the PRO-SID study

The PRO-SID study (NCT04502030) is a prospective, double-blind, randomised, multi-centre, placebo-controlled, interventional, phase III study investigating the efficacy and safety of Panzyga in patients with chronic lymphocytic leukaemia (CLL) and hypogammaglobulinaemia (IgG < 5 g/L) who are receiving antineoplastic treatment. The study is conducted at multiple sites across Europe (Italy, Poland, Denmark, Hungary, Germany and Russia) and the USA and plans to recruit at least 240 patients.

About Panzyga

Panzyga is a 10% human normal immunoglobulin solution ready for intravenous administration. Panzyga is approved for use in treatment of primary immunodeficiency and idiopathic thrombocytopenic purpura in the USA, Europe and Canada. It is also approved for secondary immunodeficiencies and Guillain Barré syndrome in Europe and Canada and for Kawasaki disease, chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) and multifocal motor neuropathy (MMN) in Europe.

On February 19, 2021, Ayala Pharmaceuticals, Inc. (the "Company", "we", "us", and "our") reported that it entered into a Securities Purchase Agreement (the "Purchase Agreement") with the purchasers named therein (the "Investors") (Filing, 8-K, Ayala Pharmaceuticals, FEB 19, 2021, View Source [SID1234575365]).

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Pursuant to the Purchase Agreement, the Company agreed to sell (i) an aggregate of 333,333 shares of its common stock (the "Shares"), par value $0.01 per share (the "Common Stock"), together with warrants to purchase an aggregate of 116,666 shares of Common Stock with an exercise price of $18.10 per share (the "Common Warrants"), for an aggregate purchase price of $4,999,995.00 and (ii) pre-funded warrants to purchase an aggregate of 1,333,333 shares of Common Stock with an exercise price of $0.01 per share (the "Pre-Funded Warrants" and collectively with the Common Warrants, the "Warrants"), together with an aggregate of 466,666 Common Warrants, for an aggregate purchase price of $19,986,661.67 (collectively, the "Private Placement"). The closing of the Private Placement is expected to occur on or about February 23, 2021.

The exercise price and the number of shares of Common Stock issuable upon exercise of each Warrant are subject to adjustment in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting the Common Stock. In addition, in certain circumstances, upon a fundamental transaction, a holder of Common Warrants will be entitled to receive, upon exercise of the Common Warrants, the kind and amount of securities, cash or other property that such holder would have received had they exercised the Warrants immediately prior to the fundamental transaction. The Pre-Funded Warrants will be automatically exercised on cashless basis upon the occurrence of a fundamental transaction. Each Common Warrant is exercisable from the date of issuance and has a term of three years and each Pre-Funded Warrant is exercisable from the date of issuance and has a term of ten years. Pursuant to the Purchase Agreement, the Company agreed to use reasonable best efforts to register the Shares and Warrants for resale by the Investors on a registration statement on Form S-3 promptly following the date such form is available for use by the Company, but in no event later than June 15, 2021.

The Company intends to use the net proceeds from the Private Placement to advance the development of AL102 for the treatment of desmoid tumors into a pivotal Phase 2/3 study, for product pipeline development and for general corporate purposes. Based on the Company’s current plans, it believes that its existing cash and cash equivalents and short-term restricted bank deposits, together with the expected net proceeds from the Private Placement, will be sufficient to fund its operating expenses and capital expenditure requirements into 2023.

The Private Placement is exempt from registration pursuant to Section 4(a)(2) of the Securities Act and Regulation D promulgated thereunder, as a transaction by an issuer not involving a public offering. The Investors have represented to the Company that they are acquiring the securities for investment only and not with a view to or for sale in connection with any distribution thereof, and appropriate legends will be affixed to the securities issued in this transaction.

The foregoing summaries of the Purchase Agreement and Warrants do not purport to be complete and are qualified in their entirety by reference to the Purchase Agreement and Forms of Warrants, which are filed as Exhibits 10.1, 4.1 and 4.2 to this Current Report on Form 8-K.

On February 19, 2021 Leidos Holdings, Inc. (NYSE: LDOS) reported that its Board of Directors has declared a quarterly cash dividend of $0.34 per outstanding share of common stock of Leidos Holdings, Inc (Press release, Leidos, FEB 19, 2021, View Source [SID1234575346]). The cash dividend is payable on March 31, 2021 to stockholders of record as of the close of business on March 15, 2021.

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On February 19, 2021 ForDoz Pharma reported that it has entered into an agreement with LipoMedix for manufacturing its lead compound, pegylated liposomal Promitil (PL-MLP) for a Phase 2 clinical study (Press release, ForDoz Pharma, FEB 19, 2021, View Source [SID1234575338]).

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Promitil’s unique liposomal formulation is designed for selective delivery of the therapeutic agent to cancer-affected tissues and is ideally suited for cancer chemoradiotherapy. In studies, it has been shown to be active against a broad variety of cancer types in animal models, including colorectal, gastric, pancreatic and multi-drug resistant tumors.

"Our mission is to ultimately aid in the delivery of innovative medicines that will help people live longer and better lives," said James He, founder and CEO of ForDoz. "We are proud to partner with LipoMedix to help them develop and manufacture Promitil here in the United States."

"We continue to move full-steam ahead, knowing that the patients we can help with Promitil have been long awaiting a low-toxicity and effective treatment option," said Dr. Alberto Gabizon, President and Chief Scientific Officer of LipoMedix. "We are thinking long term when selecting our partnerships and look forward to partnering with ForDoz on the next phase of our journey to bring Promitil to those who need it most."

Sanjeev Luther, Executive Chairman of the Board of LipoMedix, said, "ForDoz has a proven track record in manufacturing and in successful commercialization. Selecting the right partner for each step of the journey is critical to the strategic process of developing a drug. By leveraging ForDoz’s drug delivery technology and experience, LipoMedix will be able to effectively troubleshoot the many challenges of product development and manufacturing."