On September 23, 2020 Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) reported that it has entered into separate, privately-negotiated exchange agreements with certain holders of its 5.25% Convertible Senior Notes due 2021 under which such holders have agreed to exchange an aggregate principal amount of $62.55 million of Notes in exchange for aggregate consideration consisting of $41.03 million in cash (including $1.07 million of accrued interest) and 8,746,117 shares of Lexicon’s common stock, par value $0.001 per share (Press release, Lexicon Pharmaceuticals, SEP 23, 2020, View Source [SID1234565517]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The transactions are expected to close by September 28, 2020, subject to customary closing conditions. Immediately following the closings, $24.95 million in aggregate principal amount of the Notes will remain outstanding.

The completion of the transactions will reduce Lexicon’s remaining interest expense through 2021 on the exchanged Notes by approximately $3.9 million. Once completed, and together with other debt reductions, including the repayment of Lexicon’s secured loan concurrent with the closing of its sale of XERMELO (telotristat ethyl) and related assets to TerSera Therapeutics, LLC, Lexicon will have reduced the principal amount of its outstanding debt by approximately 90% since June 30, 2020, better aligning with its strategic focus on its LX9211 neuropathic pain program and other research and development assets.

This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities of the Company. The issuance of common stock has not been registered under the Securities Act of 1933 (the "Securities Act") or the securities laws of any other jurisdiction, and these securities may not be offered or sold in the United States absent registration or an applicable exemption from the Securities Act and applicable state laws.

About LX9211
LX9211 is a potent, orally delivered, selective small molecule inhibitor of AAK1, a target with a pain phenotype discovered and extensively characterized in an alliance with Bristol Myers Squibb. Preclinical studies of LX9211 demonstrated central nervous system penetration and reduction in pain behavior in models of neuropathic pain without affecting opiate pathways. Lexicon holds exclusive research, development and commercialization rights to LX9211 and additional compounds acting through AAK1 under the alliance.

On September 23, 2020 Immunomic Therapeutics, Inc. reported that it will be participating in Precision Medicine’s webinar on utilizing liquid biopsy to promote oncolytic therapeutic development. On Thursday, September 24, Vice President of Clinical Development at Immunomic, Dr. Andrew Eisen, will be discussing methods and tools to utilize liquid biopsy to promote oncology therapeutic development alongside Akoya Biosciences’ CMO, Dr. Gerald Messerschmidt and Sr. Vice President, Dr. Darren Davis (Press release, Immunomic Therapeutics, SEP 23, 2020, View Source [SID1234565516]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

This webinar will examine:

– Clinical utility of liquid biopsy and specifically of circulating tumor cells (CTC) biomarkers
– Methods to capture and concentrate CTCs to enable effective analysis
– Tools to image CTCs and analyze CTC biomarkers
– Case study exploring CTCs as a tool to understand drug pharmacodynamics in melanoma patients

Webinar details are as follows:

Title: Utilizing Liquid Biopsy to Promote Oncolytic Therapeutic Development

Date and Time: Thursday, September 24, 2020 12:00 PM ET

Register here: View Source

About UNITE

ITI’s investigational UNITE platform, or UNiversal Intracellular Targeted Expression, works by fusing pathogenic antigens with the Lysosomal Associated Membrane Protein 1, an endogenous protein in humans, for immune processing. In this way, ITI’s vaccines (DNA or RNA) have the potential to utilize the body’s natural biochemistry to develop a broad immune response including antibody production, cytokine release and critical immunological memory. This approach puts UNITE technology at the crossroads of immunotherapies in a number of illnesses, including cancer, allergy and infectious diseases. UNITE is currently being employed in a Phase II clinical trial as a cancer immunotherapy. ITI is also collaborating with academic centers and biotechnology companies to study the use of UNITE in cancer types of high mortality, including cases where there are limited treatment options like glioblastoma and acute myeloid leukemia. ITI believes that these early clinical studies may provide a proof of concept for UNITE therapy in cancer, and if successful, set the stage for future studies, including combinations in these tumor types and others. Preclinical data is currently being developed to explore whether LAMP1 nucleic acid constructs may amplify and activate the immune response in highly immunogenic tumor types and be used to create immune responses to tumor types that otherwise do not provoke an immune response.

On September 23, 2020 Silverback Therapeutics, Inc. ("Silverback") ("the Company"), a clinical-stage biopharmaceutical company leveraging its proprietary ImmunoTAC technology platform to develop systemically delivered and tissue-targeted therapeutics for the treatment of cancer and other serious diseases, reported the close of an $85 million Series C financing round. EcoR1 Capital led the round, with participation from new investors including Boxer Capital of Tavistock Group, Fidelity Management & Research Company LLC, Nantahala Capital Management, and RA Capital (Press release, Silverback Therapeutics, SEP 23, 2020, View Source [SID1234565515]). Existing investors also participating in the financing included OrbiMed Advisors, U.S. Venture Partners, Nextech Invest Ltd., Hunt Technology Ventures, and Pontifax Venture Capital. Silverback intends to use the proceeds to support its clinical development of SBT6050, a TLR8 agonist conjugated to a HER2-directed antibody currently in a Phase 1 clinical study for the treatment of HER2-expressing solid tumors, and to advance its robust pipeline of other ImmunoTAC therapeutics.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Silverback has made impressive progress developing a differentiated approach to immuno-oncology," said Scott Platshon, principal, EcoR1 Capital. "Broad activation of innate immune cells has been difficult to achieve due to systemic toxicities. Silverback has persisted in understanding how to deliver TLR8 agonists with a good preclinical safety and tolerability profile, and we are excited to lead an investment round that will help Silverback investigate the translatability of these findings to patients with HER2-expressing solid tumors."

The Company also announced two key executive promotions. Valerie Odegard, Ph.D., has been named president and chief scientific officer, and Naomi Hunder, M.D., has been named chief medical officer. "Drs. Odegard and Hunder bring comprehensive drug development expertise to Silverback, as well as a fierce drive for scientific excellence and improving patient outcomes," said Laura Shawver, Ph.D., chief executive officer of Silverback Therapeutics. "We are at an important growth phase for the company and their ongoing leadership will be critical as we progress SBT6050 through clinical development, as well as advance our robust preclinical pipeline. It is awesome to work with them and the entire Silverback team as we create a new generation of much-needed therapies."

Valerie Odegard, Ph.D., joined Silverback in 2016 and has served as chief scientific officer since 2018. She brings over 15 years of research and drug development experience to the Company. Prior to Silverback, Dr. Odegard served as vice president of research at Juno Therapeutics, where she was responsible for discovery, preclinical development, and translational research efforts to advance novel cancer immunotherapies into clinical development. Previously, she held research leadership positions at Novo Nordisk and Trubion Pharmaceuticals, where she oversaw the discovery and preclinical development of therapeutics for oncology and inflammatory conditions. Dr. Odegard received her Ph.D. in immunobiology from Yale University.

Naomi Hunder, M.D., joined Silverback in 2019, bringing both late-stage and early clinical development experience to the Company. Prior to Silverback, Dr. Hunder was vice president, head of clinical development and medical affairs at Acerta Pharma, responsible for the acalabrutinib clinical program and lifecycle strategy. Before joining Acerta, Dr. Hunder was vice president of clinical development at Seattle Genetics, where she led the brentuximab vedotin clinical program and early phase programs in lymphoma and myeloma. Dr. Hunder previously served as medical director at ZymoGenetics, developing therapeutics for oncology and viral hepatitis. A board-certified medical oncologist, Dr. Hunder received her M.D. from Jefferson Medical College and her internal medicine training at the University of Pennsylvania. She completed her oncology fellowship training at Fred Hutchinson Cancer Research Center/University of Washington.

On September 23, 2020 MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported the publication of a manuscript in Molecular Cancer Therapeutics, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper), highlighting the development of MGC018, the Company’s investigational antibody-drug conjugate (ADC) targeting B7-H3 for the treatment of solid tumors (Press release, MacroGenics, SEP 23, 2020, View Source [SID1234565512]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

B7-H3 has been identified as a cell surface protein with limited expression on normal tissues but over-expressed on the epithelium and tumor-associated vasculature in solid tumors. Overexpression of this molecule has been shown to be associated with cancer disease severity, risk of recurrence and reduced survival. The Company’s early studies showed that ligation of B7-H3 by select monoclonal antibodies (mAbs) led to mAb internalization and antitumor activity toward B7-H3-expressing tumor cells when conjugated to a toxic payload. Based on these results, MacroGenics selected a lead candidate mAb and developed MGC018, an ADC targeting B7-H3 for the treatment of cancer.

As described in the paper "Preclinical Development of MGC018, a Duocarmycin-based Antibody-drug Conjugate Targeting B7-H3 for Solid Cancer," the authors report on preclinical studies that showed that MGC018 mediated specific in vitro killing across a range of B7-H3-expressing solid tumor cell types. Furthermore, the preclinical studies showed that MGC018 mediated bystander in vitro killing of B7-H3-negative tumor cells in the presence of B7-H3-positive tumor cells.

MGC018 displayed potent antitumor activity in preclinical tumor xenograft models of breast, ovarian and lung cancer, as well as melanoma. Additionally, antitumor activity was observed toward patient-derived tumor xenograft models of breast, prostate and head and neck cancer displaying heterogeneous expression of B7-H3. Importantly, MGC018 exhibited an acceptable pharmacokinetic and safety profile in cynomolgus monkeys following repeat-dose administration.

"With its overexpression on a wide range of solid cancers but limited presence on normal tissues, B7-H3 is an attractive candidate for an ADC-targeting approach," said Deryk Loo, Ph.D., Senior Director of Research at MacroGenics and the lead author of the paper. "The published preclinical antitumor activity data and safety profile provided evidence of a potentially favorable therapeutic index to support the development of MGC018 for the treatment of solid tumors."

Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics, further commented: "Encouraged by the MGC018 interim clinical dose escalation data presented at ASCO (Free ASCO Whitepaper) in May, we have recently initiated recruitment of patients with metastatic castration-resistant prostate, triple negative breast and non-small cell lung cancers in the dose expansion portion of the Phase 1 clinical study. We expect to provide an update on this study next year."

About MGC018

MGC018 is comprised of an anti-B7-H3 humanized IgG1/kappa monoclonal antibody conjugated via a cleavable linker to the prodrug seco-DUocarmycin hydroxyBenzamide Azaindole (DUBA; licensed from Byondis, B.V.), with an average drug-to-antibody ratio (DAR) of ~2.7. DUBA is an alkylating agent that can damage DNA in both dividing and non-dividing cells, causing cell death. MGC018 is being evaluated in a Phase 1 study (NCT03729596). Preliminary clinical results from the dose escalation portion of this study were presented at the 2020 American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Scientific Program. MacroGenics retains full worldwide rights to MGC018.

On September 23, 2020 Eagle Pharmaceuticals, Inc. ("Eagle" or the "Company") (NASDAQ: EGRX) reported that its marketing partner, SymBio Pharmaceuticals Limited ("SymBio"), has received regulatory approval for TREAKISYM ready-to-dilute ("RTD") (250 ml) liquid formulation from the Pharmaceuticals and Medical Devices Agency ("PMDA") in Japan (Press release, Eagle Pharmaceuticals, SEP 23, 2020, View Source [SID1234565511]). The approval covers all indications for which TREAKISYM is currently approved (low-grade non-Hodgkin’s lymphoma, mantle cell lymphoma, and chronic lymphocytic leukemia). Approval for the additional indication of r/r DLBCL is currently under review by the PMDA, which will create another large market opportunity beyond the current indications. As a result of the approval of TREAKISYM, Eagle will receive a $5 million milestone payment.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

With this approval, SymBio will convert its current lyophilized formulation of TREAKISYM to the new RTD liquid formulation upon launch in January 2021.

In addition, SymBio is currently conducting a clinical safety trial for the ten-minute RI (50 ml) liquid formulation and will seek approval in the second half of 2022. Upon approval of the RI formulation, SymBio intends to convert from the RTD product to the new 50 ml liquid version licensed from Eagle. The RTD and RI liquid formulations bring key benefits to patients and healthcare providers in Japan by eliminating the need for manual reconstitution and significantly reducing preparation time.

"We are pleased that SymBio has received regulatory approval for TREAKISYM in Japan. SymBio is an innovator, and we look forward to their successful commercialization of the ready-to-dilute bendamustine product, enabling patients in Japan to benefit from TREAKISYM’s key advantages. This approval represents another significant extension of the durability of this important franchise and the successful execution of our business development activities to bring value for Eagle and our shareholders," stated Scott Tarriff, Chief Executive Officer.

According to SymBio, sales in Japan for its current TREAKISYM product totaled $84.8 million in the twelve months ended June 30, 2020. Together, milestones and royalty payments for the RTD and RI formulations could generate from $10 million to $25 million annually for Eagle.

In September 2017, Eagle licensed to SymBio intellectual property necessary to develop, market and sell RTD and RI formulations of TREAKISYM in Japan utilizing Eagle’s proprietary technology. As part of the agreement, SymBio assumed responsibility for securing regulatory approval of the TREAKISYM RTD and RI products using the licensed technology in Japan.

The $5 million milestone payment due upon approval of TREAKISYM RTD is in addition to a $12.5 million upfront milestone payment Eagle received upon execution of the agreement with SymBio. Eagle is entitled to royalties on future net sales and an additional milestone payment upon achievement of a cumulative sales threshold.