On May 10, 2022 Iktos, a company specialized in Artificial Intelligence (AI) for new drug design and Sygnature Discovery, a leading integrated drug discovery CRO headquartered in Nottingham, UK, with expertise across a range of therapeutic and biological target classes reported a collaboration agreement in AI for new drug design (Press release, Iktos, MAY 10, 2022, View Source [SID1234614046]).

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!

Under the 3-year agreement, Sygnature will deploy Iktos’ de novo generative design software Makya, which will be used by Sygnature scientists to facilitate rapid and efficient design of novel compounds and accelerate hit-to-lead/lead optimisation, reinforcing Sygnature Discovery’s drug design expertise delivering its integrated drug discovery solutions to its world-wide customer base.

In the recent years, Iktos has emerged as one of the world leaders in AI for drug design, establishing multiple collaborations with renowned pharmaceutical companies and successfully developing the AI software platforms Makya for new drug design and Spaya for synthesis planning.

Makya, a generative AI-driven de novo design software for Multi-Parametric Optimization (MPO), is available either as a SaaS platform or for implementation on customer premises or in the customer’s Virtual Private Cloud (VPC). Makya’s user-friendly interface enables it to be used by medicinal or computational chemists, and Makya can also be operated as a Python package through a Jupyter notebook interface. Makya is based on Iktos’ generative AI technology, which helps bring speed and efficiency to the drug discovery process by automatically designing virtual novel molecules that have desired activities for treating a given disease. It is a novel solution, validated through many collaborations, to one of the key challenges in drug design: the rapid identification of molecules that simultaneously satisfy multiple parameters, such as potency, selectivity, safety, and project-specific properties.

Sygnature Discovery serves its growing customer base with fully integrated drug discovery services from target validation through to preclinical candidate selection. The company has a relentless focus on quality and continually looks to improve on its ability to deliver novel therapeutics to the clinic.

Colin Sambrook-Smith, Director of Computational Sciences at Sygnature Discovery commented:

"Late stage lead optimisation projects routinely generate substantial data sets which are ideally placed for exploitation by AI and Machine Learning technologies. Our experience with the Iktos Makya AI/ML technology demonstrates that it generates high quality compound ideas, the QSAR models can be rapidly updated, and the interface allows us to distribute the software broadly and quickly. We believe that Makya will allow us to blend our proven medicinal and computational chemistry expertise with the benefit of AI/ML technologies to impact compound design. This is why we have selected Makya to enhance how we help our customers with their lead optimisation projects, with a view to reducing the number of compounds required to identify pre-clinical candidates and so keep overall costs and timelines down."

"We are very pleased to collaborate with Sygnature Discovery, they truly are a leading integrated drug discovery CRO and with a great track record. We are excited and proud to announce our first multi-year collaboration deal in the dynamic CRO sector and to have Sygnature’s scientists use our software to speed up their customers’ discovery programs," said Yann Gaston-Mathé, Co-founder and CEO of Iktos. "We are more than ever committed to make our technology available to biopharma companies around the world and maximize the impact of AI on the productivity of drug discovery."

On May 10, 2022 Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) reported financial results for its fiscal second quarter ended March 31, 2022 (Press release, Arrowhead Research Corporation, MAY 10, 2022, View Source [SID1234614078]). The company is hosting a conference call today, May 10, 2022, at 4:30 p.m. ET to discuss the results.

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!

Conference Call and Webcast Details

Investors may access a live audio webcast on the Company’s website at View Source For analysts that wish to participate in the conference call, please dial 855-215-6159 or 315-625-6887 and provide Conference ID 3791265.

A replay of the webcast will be available on the company’s website approximately two hours after the conclusion of the call and will remain available for 90 days. An audio replay will also be available approximately two hours after the conclusion of the call and will be available for 3 days. To access the audio replay, dial 855-859-2056 or 404-537-3406 and provide Conference ID 3791265.

Selected Recent Events

Initiated the PALISADE Phase 3 clinical study to evaluate the efficacy and safety of ARO-APOC3, Arrowhead’s investigational RNA interference (RNAi) therapeutic designed to inhibit the production of apolipoprotein C-III (APOC3), a key regulator of triglyceride metabolism, in adults with familial chylomicronemia syndrome
Completed enrollment of 204 patients in the Phase 2b ARCHES-2 clinical study of ARO-ANG3, our investigational medicine designed to reduce production of angiopoietin-like protein 3 ANGPTL3 as a potential treatment for patients with mixed dyslipidemia
ARCHES-2 is expected to be complete around the end of 2022 and topline data are anticipated to be available in the first half of 2023
Initiated the Phase 2 GATEWAY clinical study of ARO-ANG3, Arrowhead’s investigational medicine designed to silence the hepatic expression of angiopoietin-like protein 3 (ANGPTL3), in patients with homozygous familial hypercholesterolemia (HoFH)
Initiated a Phase 1/2 study of ARO-C3, Arrowhead’s investigational medicine designed to reduce production of complement component 3 (C3) as a potential therapy for various complement mediated diseases, in up to 24 adult healthy volunteers, up to 24 adult patients with paroxysmal nocturnal hemoglobinuria (PNH), and up to 14 adult patients with complement-mediated renal disease
Filed Clinical Trial Applications (CTA) requesting regulatory clearance to begin clinical studies for two new investigational medicines designed to treat various muco-obstructive and inflammatory pulmonary conditions
ARO-MUC5AC, an investigational RNAi therapeutic designed to inhibit the production of mucin 5AC (MUC5AC)
ARO-RAGE, an investigational RNAi therapeutic designed to inhibit the production of Receptor for Advanced Glycation End products (RAGE)
Formed a joint venture, Visirna Therapeutics, with Vivo Capital to expand the reach of innovative medicines in Greater China
Broke ground on construction of a new drug manufacturing facility and announced awards of up to $18.5 million in tax incentives from the city of Verona and the Wisconsin Economic Development Corporation

On May 10, 2022 Bio-Techne Corporation (NASDAQ:TECH) reported that Exosome Diagnostics, a Bio-Techne brand, will have a major scientific presence at the annual American Urological Association Conference (AUA) taking place May 13-16 in New Orleans, LA (Press release, Bio-Techne, MAY 10, 2022, View Source [SID1234614094]). Exosome Diagnostics will have two poster presentations, including a podium presentation, six in-booth scientific presentations, and a live symposium with American icon, National Baseball Hall of Famer, and former Baltimore Orioles player "Iron Man" Cal Ripken, Jr. with leading urologist, Dr. Ronald Tutrone of Medical Director of Clinical Research at Chesapeake Urology in Baltimore, Maryland.

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!

Scientific presentations include:

A Combined Biomarker/mpMRI Approach Provides Enhanced Clinical Information Prior to Prostate Biopsy by Dr. Alexander Kretschmer et al. on Friday, May 13, 2022, 1:00 pm – 3:00 pm, Room 245, Ernest N. Morial Convention Center

Development of Exosome-based Plasma RNA Biomarkers for High-Risk Prostate Cancer by Dr. Sandra Gaston, et al. on Saturday, May 14, 2022, 10:30 am – 11:45 am, Room 222, Ernest N. Morial Convention Center

Validation of a urinary exosome mRNA signature for the diagnosis of human kidney transplant rejection by Dr. Rania El Fakih on Sunday, May 15, 2022, 7:00 am – 8:15 am, Room 228, Ernest N. Morial Convention Center

Exosome’s Chief Scientific Officer, Dr. Johan Skog, will lead the in-booth scientific presentation series with recently published results of the association of the ExoDx Prostate (EPI) test with post-prostatectomy outcome. Additional presentations include results of the ExoDx Prostate test clinical utility study as well as a 2.5 year follow-up and interim analysis of subjects who participated in the study and will conclude with the combined performance of the ExoDx Prostate test and MRI in the early detection of prostate cancer.

Cal Ripken, Jr. returns to partner with Exosome Diagnostics and Bio-Techne as an ambassador and advocate of the ExoDx Prostate test, which became part of Cal’s own prostate cancer journey. During his live appearances at the AUA, Cal will use his high-profile platform and strong reputation among men in his age group to raise awareness of the importance of early detection of prostate cancer.

"We are so pleased to have a robust scientific presence at the AUA, and excited to continue our campaign with an American baseball legend, Cal Ripken, Jr.," stated Kim Kelderman, President of Diagnostics and Genomics Segment of Bio-Techne. "Cal is a great example of the powerful role our ExoDx Prostate test plays in the prostate cancer journey. We look forward to continuing to provide this important tool to the millions of men and their families who are facing difficult choices in the management of this disease."

One in nine American men will be diagnosed with prostate cancer during his lifetime. Prostate cancer (PCa) is the second leading cause of cancer death among American men and is the most commonly diagnosed cancer. The American Cancer Society estimates that 268,000 men will be diagnosed with prostate cancer in 2022 and projects that ~34,000 men will die from the disease. Currently, nearly 3.6 million American men are living with the disease – only slightly less than the population of Los Angeles.

The EPI test is a urine-based genomic test that helps inform the prostate biopsy decision. This liquid biopsy test has a positive coverage decision from Medicare and is included in the National Comprehensive Cancer Network (NCCN) guidelines for early detection of prostate cancer in men for both initial and repeat biopsy. It is performed by Exosome Diagnostics in its CLIA, ISO, NY certified and CAP-accredited laboratory located in Waltham, Massachusetts. The EPI test is a risk assessment tool that assists physicians and their patients with determining if a prostate biopsy is needed when presented with an ambiguous PSA test result, thereby reducing complications from unnecessary and invasive procedures. The ExoDx Prostate is the leading test for at-home collection, enabling thousands of patients unable to travel to their healthcare professional for a routine office visit to assess prostate cancer risk.

On May 10, 2022 F-star Therapeutics, Inc. (NASDAQ: FSTX) ("F-star" or the "Company"), a clinical-stage biopharmaceutical company dedicated to developing next-generation immunotherapies to transform the lives of patients with cancer, reported first quarter 2022 financial results and provided a corporate update (Press release, F-star, MAY 10, 2022, View Source [SID1234614110]).

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 year is one of the most important years in F-star’s history, with data readouts expected across all four of our clinical programs, expansion of our partnering activities, and continued development of our organization," said Eliot Forster, CEO of F-star Therapeutics, Inc. "During the quarter, we increased the number of clinical sites for FS118 and FS120 by expanding beyond the US into the EU. We have also further advanced our understanding of the differentiated mechanism of FS118 in modulating LAG-3 cell surface expression. F-star continues to execute and create value for shareholders by advancing our programs and enabling our partners to develop next-generation bispecific therapeutics by leveraging the power of our discovery platform."

First Quarter 2022 and Recent Highlights:

Patients dosed in FS120 and FS118 trials in Europe, adding to the ongoing clinical activities in the US.
Appointment of James Sandy as Chief Development Officer: Mr. Sandy brings over 35 years of experience in the pharmaceutical and biotechnology industries. James brings valuable additional expertise to the team in accelerating cancer treatment programs through early and late-stage development that will greatly benefit our clinical development strategy.
FS118 poster presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2022 Annual Meeting demonstrating a novel LAG-3 reduction and shedding mechanism: Data revealed that the tetravalent and unique structure of FS118 plays a critical role in evoking LAG-3 shedding and cell surface reduction by tumor-infiltrating lymphocytes (TILs), enabling FS118 to overcome compensatory upregulation of LAG-3 induced by PD-(L)1 blockade.
Fourth licensing option exercised by Merck KGaA, Darmstadt, Germany: Under the terms of the agreement, Merck KGaA, Darmstadt, Germany will be responsible for all future development and commercialization costs of the bispecific program and will pay future success-based milestones and royalties on any net sales resulting from programs covered by the agreement.
IP portfolio expansion with the issuance of U.S. patent further protecting FS118: United States Patent and Trademark Office (USPTO) has granted a patent protecting the composition of matter of FS118, F-star’s tetravalent bispecific antibody which blocks PD-L1 and LAG-3 receptors. U.S. Patent No. 11,214,620 is entitled "Binding Molecules Binding PD-L1 and LAG-3" and is expected to provide F-star with exclusivity for FS118 out to at least August 2038.
Participation in investor conferences: The management team participated in four investor conferences in the first quarter.
Anticipated 2022 Program Milestones:

A clinical efficacy readout of FS118 in PD-1 acquired resistance head and neck cancer patients who have failed checkpoint therapies.
Clinical update on FS222 Phase 1 trial.
Clinical update on the Phase 1 trial of FS120 and initiation of the combination with Merck’s pembrolizumab.
Clinical update of the dose-escalation study of SB 11285.
First-Quarter 2022 Financial Update

Cash Position
Cash and cash equivalents were $68.8 million as of March 31, 2022, compared to $78.5 million at December 31, 2021.

Research & Development Expense
Research & Development (R&D) expenses were $8.0 million for the quarter ended March 31, 2022, compared to $7.1 million for the corresponding quarter in 2021. This increase of $0.9 million in R&D expense is primarily due to increased CRO costs as more patients are enrolled in clinical studies, increased R&D staff related costs primarily to support clinical operations, offset by a reduction in manufacturing costs.

General & Administrative Expense
General & Administrative (G&A) expenses were $5.7 million for the quarter ended March 31, 2022, compared to $6.4 million for the first quarter 2021. The $0.7 million decrease is primarily due to a decrease in stock compensation expense, and legal and professional costs due to costs incurred in the comparative period for work in relation to the share exchange transaction with Spring Bank Pharmaceuticals. These decreases were offset by increases in facilities-related costs and information technology costs.

Net Loss Attributable to Common Shareholders
Net loss attributable to common shareholders was $12.1 million or $0.57 per share, for the quarter ended March 31, 2022, as compared to a net loss of $9.7 million or $1.07 per share for the quarter ended March 31, 2021.

Conference Call and Webcast

F-star will host a conference call today, May 10, 2022, at 9:00 a.m. EDT.

To access the call, participants may join via a live webcast on the Investors & News section of the F-star Therapeutics website, under Events and Presentations. To join by phone, participants may dial the following numbers at least 10 minutes prior to the start of the call:

A replay of the conference call will be available for 90 days from the call and may be accessed in the Investor & News/Events and Presentations section of the F-star Therapeutics website.

On May 10, 2022 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that Susan Altschuller, Chief Financial Officer, will present at the upcoming H.C. Wainwright Global Investment Conference (Press release, ImmunoGen, MAY 10, 2022, View Source [SID1234614126]). The presentation will be available on May 24, 2022 at 7:00am ET.

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!

A webcast of the presentation will be accessible through the "Investors and Media" section of the Company’s website, www.immunogen.com. Following the webcast, a replay will be available at the same location.