On March 29, 2021 Genmab A/S (Nasdaq: GMAB) reported the initiation of a share buy-back program to mitigate dilution from warrant exercises and to honor our commitments under our Restricted Stock Units program (Press release, Genmab, MAR 29, 2021, View Source [SID1234577241]).

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The share buy-back program is expected to be completed no later than June 30, 2021 and comprises up to 200,000 shares.

The following transactions were executed under the program from March 22, 2021 to March 26, 2021:

Details of each transaction are included as an appendix to this announcement.

Following these transactions, Genmab holds 190,477 shares as treasury shares, corresponding to 0.29% of the total share capital and voting rights.

The share buy-back program is undertaken in accordance with Regulation (EU) No. 596/2014 (‘MAR’) and the Commission Delegated Regulation (EU) 2016/1052, also referred to as the "Safe Harbour Regulation." Further details on the terms of the share buy-back program can be found in our company announcement no. 11 dated February 23, 2021.

On March 29, 2021 Silverback Therapeutics, Inc. (Nasdaq: SBTX) ("Silverback"), a clinical-stage biopharmaceutical company leveraging its proprietary ImmunoTAC technology platform to develop systemically delivered, tissue targeted therapeutics for the treatment of cancer, chronic viral infections, and other serious diseases, reported financial results and provided a corporate update for the fourth quarter and full year ended December 31, 2020 (Press release, Silverback Therapeutics, MAR 29, 2021, View Source [SID1234577264]).

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"2020 was an extraordinary year for Silverback, with the initiation of our first clinical study for SBT6050, in which pharmacological activity was observed in the first dose cohort, the advancement of each of our preclinical programs, expansion of our strong team, and the successful closing of our IPO in December," said Laura Shawver, Ph.D., chief executive officer of Silverback. "We are well-positioned to execute on our mission to develop a new class of tissue-localized therapies that are designed to modulate fundamental biological pathways in cancer and beyond."

2020 Corporate Highlights and 2021 Anticipated Milestones

SBT6050 (HER2-TLR8 ImmunoTAC) Phase 1/1b clinical study initiated, with pharmacological activity demonstrated in the first dose cohort. SBT6050 is being studied as a monotherapy and in combination with pembrolizumab, in patients with advanced or metastatic HER2-expressing solid tumors. Changes in pharmacodynamic markers consistent with the potential mechanism of action have been observed in patients treated in the first monotherapy dose cohort. Enrollment is ongoing in Part 1 of the study (SBT6050 monotherapy dose escalation) and treatment has been initiated in Part 3 of the study (SBT6050 plus pembrolizumab dose-escalation). Silverback is on track to deliver interim clinical data from Part 1 of the study in the second half of 2021.
SBT6290 (Nectin4-TLR8 ImmunoTAC) continues to advance through preclinical development. SBT6290 includes the same TLR8 agonist linker-payload used in SBT6050, conjugated to a proprietary Nectin4-directed monoclonal antibody. Pre-Investigational New Drug (IND) alignment with the FDA was achieved in February 2021 and an IND application is expected in the fourth quarter of 2021. The initiation of a Phase 1/1b clinical study is anticipated in the first quarter of 2022.
SBT8230 (ASGR1-TLR8 ImmunoTAC) development candidate selected in the fourth quarter of 2020. SBT8230 includes the same TLR8 agonist linker-payload used in SBT6050, conjugated to a proprietary ASGR1-directed monoclonal antibody, and is designed to activate human myeloid cells in the liver for treatment of chronic hepatitis B viral infection. CMC scale up and preclinical work continues with IND-enabling toxicology studies expected to commence in the first quarter of 2022.
Completed initial public offering resulting in $277.7 million in gross proceeds. Silverback completed an IPO in December 2020, selling 13,225,000 shares at a public offering price of $21.00 per share, raising gross proceeds of $277.7 million (before deducting underwriting discounts and commissions and offering costs). In September 2020, the Company completed a Series C financing, raising $85.0 million in gross proceeds, and in March, July and September 2020, completed a Series B financing, raising $78.5 million in gross proceeds (including $10.1 million upon the conversion of then outstanding convertible notes and accrued interest thereon).
Financial Results

For the fourth quarter ended December 31, 2020, Silverback reported a net loss of $13.1 million, compared to a net loss of $7.0 million for the comparable period in 2019. For the year ended December 31, 2020, the Company reported a net loss of $32.9 million, compared to a net loss of $24.0 million for 2019. Net loss for the fourth quarter and full year of 2020 included non-cash stock-based compensation expense of $2.3 million and $2.6 million, respectively, compared to $42,000 and $148,000 for the same periods in 2019, respectively.

Research and development expenses for the fourth quarter ended December 31, 2020 were $8.8 million, compared to $6.3 million for the same period in 2019. For the year ended December 31, 2020, research and development expenses were $24.6 million, compared to $21.5 million for 2019. The increases in the Company’s research and development expenses for the 2020 periods, as compared to the same periods in 2019, were primarily attributable to the advancement of pipeline programs, including SBT6290 and SBT8230, into preclinical development. Silverback also incurred additional personnel-related expenses in 2020 as compared to 2019 as operations grew in support of program advances. These increases were partially offset by a decrease in expenses related to the development of SBT6050 as the program completed manufacturing activities and initiated a Phase 1/1b clinical trial in the second half of 2020.

General and administrative expenses for the fourth quarter ended December 31, 2020 were $4.3 million, compared to $0.7 million for the same period in 2019. For the year ended December 31, 2020, general and administrative expenses were $8.3 million, compared to $2.6 million for the same period in 2019. The increases in general and administrative expenses for the 2020 periods, as compared to the same periods in 2019, were primarily attributable to an increase in personnel-related expenses due to increased headcount in 2020, including new executives, as well as increases in salaries, bonuses, and stock-based compensation. The increase in general and administrative expenses was also due to an increase in legal fees, professional fees, and other various general and administrative expenses as we prepared to become a public company.

As of December 31, 2020, Silverback reported cash and cash equivalents of $386.6 million, compared to $10.0 million at December 31, 2019, which is expected to fund operating expenses and capital expenditure requirements for at least the next 24 months. The Company’s cash and cash equivalents balance at December 31, 2020 included $255.3 million of proceeds, net of offering costs, from the Company’s initial public offering in December 2020, and $153.3 million of proceeds, net of offering costs, from the Company’s Series B and Series C financings in 2020. As of December 31, 2020, the Company had 34,801,537 common shares outstanding.

On March 29, 2021 Hansa Biopharma AB "Hansa" (Nasdaq Stockholm: HNSA), a pioneer in enzyme technology for rare immunological conditions, reported that they have entered into a preclinical research collaboration agreement with argenx BV to evaluate the therapeutic potential of combining the two companies’ IgG-modulating technologies (Press release, Hansa Biopharma, MAR 29, 2021, View Source [SID1234577297]).

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The preclinical research collaboration is set up to explore the potential of combining imlifidase, Hansa’s IgG antibody-cleaving enzyme, and efgartigimod, argenx’s FcRn antagonist, which are both in development for indications known to be driven by disease-causing IgGs. A combination of imlifidase and efgartigimod could potentially be used in both the acute and chronic setting of autoimmune diseases and transplantation.

Under the preclinical research collaboration agreement, both parties will contribute equally in terms of resource allocation and will share all intellectual property and data developed through the collaboration. Both parties will maintain exclusive rights to their respective technologies and products.

This is information that Hansa Biopharma AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out below, at 20:00 CET on March 29 2021.

About imlifidase

Imlifidase is an enzyme derived from the bacterium Streptococcus pyogenes, with the ability to specifically target and cleave all classes of immunoglobulin G (IgG) antibodies. Imlifidase has a rapid onset of action, cleaving IgG-antibodies and inhibiting their activity within two to six hours after administration. Imlifidase was granted conditional European Marketing Authorization from the European Medicine’s Agency (EMA) in August 2020 for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch test against an available deceased donor. Beyond kidney transplantation imlifidase is also being developed for potential treatment of acute episodes in relation to post-transplantation management and acute autoimmune diseases.

On March 29, 2021 Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) ("Sonnet" or the "Company"), a biopharmaceutical company developing innovative targeted biologic drugs, reported a business update on its ongoing programs (Press release, Sonnet BioTherapeutics, MAR 29, 2021, View Source [SID1234577318]).

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"Last year we continued execution across our pipeline, and I am excited to share an update on our ongoing activities," commented Pankaj Mohan, Ph.D., Founder and CEO. "This year we expect to be in the clinic with multiple programs, which we believe is an important milestone for patients."

SON-1010 (FHAB-IL12): Sonnet has completed nonhuman primate (NHP) GLP toxicity studies with SON-1010 and is awaiting data to prepare an IND submission, while working in parallel to initiate clinical trials during the second half of this year. Prior to IND submission, the Company will initiate pre-IND interactions with FDA, which are expected during the second quarter, and will work to finalize the first-in-human protocol, along with selecting a CRO to perform the studies. CMC activities are on schedule to deliver GMP material prior to the IND filing.

SON-080 (Fully Human IL-6) – Chemotherapy Induced Peripheral Neuropath (CIPN): With successful GLP toxicity studies completed, the CMC manufacturing is well underway, and product is expected to be available for a clinical trial commencing during the second half of this year. Plans have been initiated to complete the study design protocol for a Phase 1b/2a study, as well as the completion of diligence and selection of a CRO.

SON-081 (Fully Human IL-6) – Diabetic Peripheral Neuropathy (DPN): Sonnet anticipates completing the partnership deal in South East Asia during April 2021 that Sonnet expects will position New Life Therapeutics (NLT) to fund and progress the asset forward into a Phase 1b/2a clinical trial. NLT has elected to focus on the acceleration of the development of low dose IL-6 for DPN at this time, and to hold an option to the CIPN indication for several months following the execution of a definitive agreement. Sonnet anticipates that clinical trial initiation will occur during the second half of this year. Sonnet has recently obtained positive initial comparability data from the new batch being manufactured using an updated process and awaits final study completion and reports of product comparability, prior to IND filing.

SON-1210 (IL12-FHAB-IL15): Sonnet’s first bispecific candidate is undergoing cell line and process development. Sonnet has engaged a novel intensified perfusion manufacturing process to generate clinical grade material and expects completion of NHP studies in the second half of this year with an IND submission during the first half of 2022.

SON-2014 (GMcSF-FHAB-IL18): In addition to GMcSF-FHAB-IL18, Sonnet has manufactured bi-specific preclinical constructs of IL18-FHAB-IL12 and IL12-FHAB-GMcSF that are being evaluated for in vivo efficacy, biomarker profiles and fluorescence-activated cell sorting (FACS) assessment in single dose and multi-dose preclinical studies.

Upon completion of the preclinical efficacy evaluation in the second quarter of this year, Sonnet intends to initiate commercial cell line development necessary for future clinical trials. An IND submission for SON-2014 is currently targeted for the second half of 2022.

SON-3015 (Anti-IL6-FHAB-Anti-TGFβ): Sonnet is in the discovery phase of SON-3015 development and is currently panning the candidate for binding and stability, after which the preclinical bispecific product will be evaluated in a mice model, expected during the second half of 2021. Sonnet is planning to initiate commercial cell line development in the first quarter of 2022.

INTELLECTUAL PROPERTY: Sonnet has received Notice of Allowance from the USPTO for its first issued patent on the FHAB delivery technology. Formal issuance is expected during the balance of 1H21.

On March 29, 2021 Hutchison China MediTech Limited ("HUTCHMED") (Nasdaq/AIM: HCM) reported that it has initiated two international Phase I studies of HMPL-306, its novel selective small molecule dual inhibitor of isocitrate dehydrogenase ("IDH") 1 and 2 mutations (Press release, , MAR 29, 2021, View Source [SID1234583625]). One trial is in patients with advanced solid tumors and one trial is in patients with hematological malignancies. Both trials have sites in the US and Europe. The first international patient was dosed on March 25, 2021, following a Phase I trial that was initiated in China in the second half of 2020. This new program is a demonstration of HUTCHMED’s accelerating and expanding global clinical development presence.

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These two trials are multi-center studies to evaluate the safety, tolerability pharmacokinetics, pharmacodynamics and preliminary efficacy of HMPL-306. The first trial is in solid tumors (including but not limited to gliomas, chondrosarcomas, or cholangiocarcinomas), while a second trial is in advanced relapsed, refractory or resistant hematological malignancies that harbor IDH1 or IDH2 mutations. The first stage of each study is a dose escalation phase where cohorts of patients will receive ascending oral doses of HMPL-306 to determine the maximum tolerated dose and/or the recommended Phase II dose ("RP2D"). The second stage is a dose expansion phase where patients will receive HMPL-306 to further evaluate the safety, tolerability, and clinical activity at the RP2D. Additional details may be found at clinicaltrials.gov, using identifiers NCT04762602 and NCT04764474, respectively.

The MD Anderson Cancer Center ("MDACC") is the lead institution on both studies. The lead investigator for the hematological malignancies study is Dr. Farhad Ravandi, the Janiece and Stephen A. Lasher Professor of Medicine and Chief of Section of Developmental Therapeutics in the Department of Leukemia at The University of Texas MDACC. The lead investigator for the solid tumor study is Dr. Filip Janku, Associate Professor, Department of Investigational Cancer Therapeutics at The University of Texas MDACC.

A Phase I study of HMPL-306 is underway in China, with the first patient dosed in July 2020. Additional details of that study may be found at clinicaltrials.gov, using identifier NCT04272957.

HMPL-306 is HUTCHMED’s ninth innovative oncology drug candidate that it has discovered that has entered clinical development and the sixth to enter global clinical development. Cytoplasmic mutant IDH1 and mitochondrial mutant IDH2 have been known to switch to the other form when targeted by an inhibitor of IDH1 mutant alone or IDH2 mutant alone. By targeting both IDH1 and IDH2 mutations, HMPL-306 could potentially provide therapeutic benefits in cancer patients harboring either IDH mutation, and may address acquired resistance to IDH inhibition through isoform switching.

About IDH and Malignancies

IDHs are critical metabolic enzymes that help to break down nutrients and generate energy for cells. When mutated, IDH creates a molecule that alters the cell’s genetic programming and prevents cells from maturing, 2-hydroxyglutarate ("2-HG"). Reduction in 2-HG levels can be used as a marker of target engagement by an IDH inhibitor. IDH1 or IDH2 mutations are common genetic alterations in various types of blood and solid tumors, including acute myeloid leukemia ("AML") with approximately 20% of patients having mutant IDH genes, myelodysplastic syndrome (MDS), myeloproliferative neoplasms (MPNs), low-grade glioma and intrahepatic cholangiocarcinoma ("IHCC"). Mutant IDH isoform switching, either from cytoplasmic mutant IDH1 to mitochondrial mutant IDH2, or vice versa, is a mechanism of acquired resistance to IDH inhibition in AML and cholangiocarcinoma.1,2,3 Currently, the U.S. Food and Drug Administration (FDA) has approved one drug for IDH1 mutation and one drug for IDH2 mutation, but no dual inhibitor targeting both IDH1 and IDH2 mutants has been approved.

In the US, it is estimated that there were approximately 20,000 new cases of AML in 2020 and the five-year relative survival rate is 28.7%.4

IDH mutations are present in a number of solid tumors, including malignant glioma and IHCC. In the US, the annual incidence of malignant glioma is estimated to be 20,000, 50-70% of which are glioblastoma.5,6 Approximately 60-80% of Grade 2 or 3 glioma and secondary glioblastoma harbor IDH mutations.7 IHCC accounts for 10-20% of primary liver cancer, which was estimated to be diagnosed in 42,810 US patients in 2020.8,9 Approximately 20-30% of IHCC harbors IDH mutations.10