On May 15, 2021 Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies and cytokines for the treatment of cancer and autoimmune diseases, reported financial results for the first quarter ended March 31, 2021 and provided a review of recent business and clinical highlights (Press release, Xencor, MAY 5, 2021, View Source [SID1234579185]).

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"We continue to expand and mature our clinical portfolio of XmAb drug candidates, recently initiating a Phase 1 study for our second cytokine program, XmAb564, a wholly owned IL-2-Fc fusion protein, in healthy volunteers. We engineered this molecule to preferentially activate regulatory T cells, an emerging mechanism for treating patients with autoimmune diseases," said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor. "Additionally, at the AACR (Free AACR Whitepaper) meeting, we presented preclinical data from multiple early-stage programs that highlight our protein engineering expertise with our third cytokine, a wholly owned IL-12-Fc fusion protein, as well as the potential of our CD28 platform and XmAb 2+1 bispecific antibody format. Looking ahead, we will continue to present maturing data from our clinical-stage programs, and we have plans to initiate several additional clinical studies this year and early 2022, including a Phase 2 study in prostate cancer with XmAb717, our PD-1 x CTLA-4 bispecific antibody."

Recent Business and Portfolio Highlights

XmAb564 (IL-2-Fc Cytokine): XmAb564 is a wholly owned, monovalent IL-2-Fc fusion protein, engineered to selectively activate and expand regulatory T cells (Tregs) for the potential treatment of patients with autoimmune diseases. XmAb564 is engineered with reduced binding affinity for IL-2’s beta receptor and increased binding affinity for its alpha receptor. In preclinical studies, XmAb564 was well-tolerated, promoted the selective and sustained expansion of Tregs and exhibited a favorable pharmacokinetic profile. In April 2021, the first subject was dosed in a randomized, double-blind, placebo-controlled Phase 1 clinical study evaluating the safety and tolerability of XmAb564, administered subcutaneously in healthy adult volunteers.
Preclinical Presentations at AACR (Free AACR Whitepaper): At the 2021 AACR (Free AACR Whitepaper) Annual Meeting, the Company presented four posters highlighting several preclinical-stage programs, including its IL-12-Fc cytokine program, two XmAb 2+1 bispecific antibodies (Claudin-6 x CD3 and GPC3 x CD3), and a PD-L1 x CD28 bispecific program. Such targeted CD28 bispecific antibodies, a new class of T cell engager, may provide conditional co-stimulation of T cells, for example, to T cells recognizing neoantigens or in concert with CD3 T-cell engaging bispecific antibodies. The Company is also advancing through preclinical development a wholly owned lead CD28 candidate, a B7-H3 x CD28 bispecific antibody, which will be evaluated for the treatment of patients with a range of solid tumors.
New Academic Collaboration with UCLA: In February, the Company entered an agreement with UCLA to develop novel therapeutic antibodies, pairing novel targets proposed by scientists at UCLA and Xencor’s modular suite of XmAb technology platforms. The UCLA Technology Development Group will work with faculty to propose potential antibody drug candidates. For selected candidates, the Company and UCLA expect to use a framework with predefined terms to enter sponsored research agreements and potential license agreements.
Multiple Clinical Studies Planned to Advance Xencor’s Wholly Owned Programs

XmAb717 (PD-1 x CTLA-4): The Company plans to initiate a Phase 2 study in patients with certain molecular subtypes of castration-resistant prostate cancer (CRPC) in mid-2021. This study will evaluate XmAb717 as a monotherapy or in combination depending on the subtype, as these patients represent a high unmet medical need.
Tidutamab (SSTR2 x CD3): The Company plans to initiate a clinical study in patients with Merkel cell carcinoma and small cell lung cancer, SSTR2-expressing tumor types known to be responsive to immunotherapy, in mid-2021.
Plamotamab (CD20 x CD3): In November 2020, the Company entered a strategic clinical collaboration with MorphoSys AG to investigate the chemotherapy-free triple combination of plamotamab, tafasitamab and lenalidomide in patients with relapsed or refractory (r/r) diffuse large B cell lymphoma (DLBCL), first-line DLBCL and r/r follicular lymphoma (FL). The Company plans to initiate the first of these studies, in patients with r/r DLBCL, an aggressive type of non-Hodgkin lymphoma (NHL), in late 2021 or early 2022.
XmAb698 (CD38 x CD3): The Company plans to support investigator-initiated studies of XmAb698 (formerly AMG 424), and a new study is currently being planned to start later in 2021.
XmAb819 (ENPP3 x CD3): XmAb819 is engineered with the multi-valent XmAb 2+1 bispecific antibody format to enable greater tumor selectivity, and it is in development for patients with renal cell carcinoma. The Company plans to submit an investigational new drug (IND) application in 2021 and initiate a Phase 1 study in early 2022.
Progress Across Partnered Programs

MorphoSys AG: In April 2021, MorphoSys initiated the Phase 3 inMIND study to evaluate the addition of tafasitamab to lenalidomide and rituximab in patients with r/r follicular lymphoma or marginal zone lymphoma. Xencor earned $12.5 million for the development milestone and recognized royalty revenue of $1.4 million on net sales of Monjuvi during the first quarter of 2021.
Vir Biotechnology, Inc.: Vir and its partner GlaxoSmithKline plc (GSK) are evaluating VIR-7831 in an extensive ongoing clinical development program. In March 2021, Vir and GSK submitted an emergency use authorization (EUA) application to the U.S. Food and Drug Administration based on an interim analysis of the Phase 3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial – Intent to Care Early) trial, which demonstrated an 85% reduction in hospitalization or death in high-risk adult outpatients with COVID-19 receiving VIR-7831 as monotherapy compared to placebo, the primary endpoint of the trial.
Monjuvi is a registered trademark of MorphoSys AG.

First Quarter Ended March 31, 2021 Financial Results

Cash, cash equivalents and marketable investment securities totaled $577.1 million at March 31, 2021, compared to $604.0 million at December 31, 2020. The decrease reflects royalties, milestone payments and equity received related to licensing agreements, net of cash used to fund operating activities in the first quarter of 2021.

Total revenue for the first quarter ended March 31, 2021 was $34.0 million, compared to $32.4 million for the same period in 2020. Revenues in the first quarter of 2021 included revenues related to the Janssen collaboration, milestone revenue recognized from MorphoSys and the royalty revenue from Alexion and MorphoSys, compared to revenues from the same period in 2020, which were primarily revenue recognized from MorphoSys, royalty revenue from Alexion, and licensing revenue from Aimmune and Gilead.

Research and development expenditures for the first quarter ended March 31, 2021 were $41.4 million, compared to $33.9 million for the same period in 2020. Additional spending on research and development expenses for the first quarter of 2021 was primarily due to increased spending on XmAb306, XmAb564 and XmAb819 programs.

General and administrative expenses for the first quarter ended March 31, 2021 were $8.2 million, compared to $7.2 million in the same period in 2020. Additional spending on general and administrative expenses for the first quarter of 2021 reflects increased spending related to staffing.

Other income for the first quarter ended March 31, 2021 was $13.2 million and included a gain of $12.9 million from equity related to a licensing transaction, compared to $0.7 million for the same period in 2020, which was primarily net interest income earned for the period.

Non-cash, stock-based compensation expense for the first quarter ended March 31, 2021 was $8.3 million, compared to $6.5 million for same period in 2020.

Net loss for the first quarter ended March 31, 2021 was $2.5 million, or $(0.04) on a fully diluted per share basis, compared to net loss of $8.1 million, or $(0.14) on a fully diluted per share basis, for the same period in 2020. The lower net loss reported for first quarter of 2021 compared to the net loss for the same period in 2020 is primarily due to other income recognized related to equity received in the first quarter of 2021 in excess of increased spending on research and development.

The total shares outstanding were 58,221,953 as of March 31, 2021, compared to 57,001,253 as of March 31, 2020.

Financial Guidance

Based on current operating plans, Xencor expects to have cash to fund research and development programs and operations into 2024. Xencor expects to end 2021 with between $425 million and $475 million in cash, cash equivalents and marketable securities.

Conference Call and Webcast

Xencor will host a conference call today at 4:30 p.m. ET (1:30 p.m. PT) to discuss these first quarter 2021 financial results and provide a corporate update.

The live call may be accessed by dialing (877) 359-9508 for domestic callers or +1 (224) 357-2393 for international callers and referencing conference ID number 2378094. A live webcast of the conference call will be available online from the Investors section of Xencor’s website at www.xencor.com. The webcast will be archived on Xencor’s website for 30 days.

On May 5, 2021 Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported financial results and corporate highlights for the first quarter 2021, as well as anticipated corporate milestones for the second quarter 2021 (Press release, Surface Oncology, MAY 5, 2021, View Source [SID1234579210]).

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"The first quarter of 2021 marked a significant transition for Surface, and I am honored to become CEO during this very exciting time," said Rob Ross, M.D., chief executive officer. "In June, we will be sharing data with the medical community and investors regarding the clinical progress we have made with our Phase 1 trials of both SRF617 and SRF388. We believe that both of these novel agents have the potential to improve outcomes for patients with cancer, and the data we share in June will be the first step in illustrating this potential."

Recent Corporate Highlights:

On February 11, 2021, Surface announced that Rob Ross, chief medical officer, would succeed Jeff Goater as CEO, effective April 1, 2021.

On March 8, 2021, Surface entered into a clinical trial collaboration with Merck, known as MSD outside the United States and Canada, through a subsidiary, to evaluate the safety and efficacy of combining Surface’s SRF388, an investigational antibody therapy targeting IL-27, with Merck’s KEYTRUDA (pembrolizumab), the first anti-PD-1 therapy approved in the United States. This combination will be studied as a component of the first-in-human Phase 1 study of SRF388 and will be evaluated in patients with solid tumors, with a focus on patients with liver cancer and kidney cancer.

On March 29, 2021, the U.S. Food and Drug Administration granted Orphan Drug Designation for SRF617 for the treatment of patients with pancreatic cancer.

Surface presented updated preclinical data on lead candidates SRF617 and SRF388 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2021 Annual Meeting, held virtually April 10-15. The poster presentations can be found in the Posters & Publications section of our website.

On April 27, 2021, Surface announced the appointment of Henry Rath as chief business officer and the promotions of Alison O’Neill, M.D. to chief medical officer, and Jessica Fees to chief financial officer.
Selected Anticipated Near-term Corporate Milestones:

SRF388 clinical data presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2021 Annual Meeting, to be held virtually June 4-8, 2021.
Webcast to provide data from ongoing SRF388 and SRF617 Phase 1 clinical studies, to be held on Friday, June 4, 2021 at 8:00 a.m. ET.
Investigational new drug (IND) filing for SRF813, partnered with GlaxoSmithKline, anticipated in 2021.
Financial Results:

As of March 31, 2021, cash, cash equivalents and marketable securities were $171.0 million, compared to $175.1 million on December 31, 2020.

Research and development (R&D) expenses were $10.5 million for the first quarter ended March 31, 2021, compared to $11.3 million for the same period in 2020. This decrease was primarily driven by reduction in headcount as well as decreased facility and lab costs as a result of the strategic restructuring announced in January 2020, partially offset by increased clinical costs as a result of progression in both our SRF617 and SRF388 Phase 1 clinical trials. R&D expenses included $0.8 million in stock-based compensation expense for the first quarter ended March 31, 2021.

General and administrative (G&A) expenses were $5.6 million for the first quarter ended March 31, 2021, compared to $4.8 million for the same period in 2020. This increase was primarily due to increases in personnel- and facility-related costs, including $0.4 million of stock-based compensation resulting from modifications to previously issued stock option awards in connection with the transition of our chief executive officer to chairman of the board. G&A expenses included $1.6 million in stock-based compensation for the first quarter ended March 31, 2021.

For the first quarter ended March 31, 2021, net loss was $15.6 million, or basic and diluted net loss per share attributable to common stockholders of $0.37. Net income was $22.6 million for the same period in 2020, or basic net income per share attributable to common stockholders of $0.81 and diluted net income per share attributable to common stockholders of $0.74.

Financial Outlook:

Surface Oncology continues to project that current cash, cash equivalents and an anticipated near-term milestone from GSK are sufficient to fund the Company through 2023.

On May 5, 2021 SQZ Biotechnologies (NYSE:SQZ), a cell therapy company developing novel treatments for multiple therapeutic areas, reported that management will be participating in the BofA (Bank of America) Securities 2021 Virtual Health Care Conference taking place May 11-13, 2021 (Press release, SQZ Biotech, MAY 5, 2021, View Source [SID1234579227]). Armon Sharei, PhD, chief executive officer, will present a corporate overview on May 12 at 8:00am EDT with a virtual webcast and the company will be hosting one on one meetings.

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More information about and access to the webcast for the presentation are available on the Investors & Media section of the company website. The webcast will be available for 90 days following the presentation.

On May 5, 2021 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) reported that the Company, together with Bristol-Myers Squibb Company (NYSE: BMY), has launched beLAB1407, a new $ 20 m academic BRIDGE to identify and advance novel and breakthrough drug discovery opportunities across therapeutic areas from the UK’s top-tier academic institutions (Press release, Evotec, MAY 5, 2021, View Source;announcements/press-releases/p/evotec-launches-belab1407-to-accelerate-translational-research-from-the-uks-academic-life-science-ecosystem-in-collaboration-with-bristol-myers-squibb-6064 [SID1234579254]). Through a unique combination of Evotec’s drug discovery and development platforms and early-stage therapeutic concepts from the Universities of Birmingham, Edinburgh, Nottingham, and Dundee, beLAB1407 offers a unique route to the advancement of first-in-class therapeutics and the creation of spin-out companies.

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Evotec’s BRIDGE (Biomedical Research, Innovation & Development Generation Efficiency) collaborations provide an integrated fund and award framework to validate exciting academic projects in collaborations with Pharma and biotech with the goal to form new companies. Since implementing the first academic BRIDGE ‘LAB282’ in Oxford in November 2016, Evotec has continued to evolve similar collaborations with a variety of academic, Pharma and venture capital partners across Europe and North America.

With beLAB1407 representing the continued refinement of the approach, Evotec links one of Europe’s foremost academic clusters of excellence in the life sciences with Bristol Myers Squibb as a major biopharmaceutical partner dedicated to advancing innovation in therapeutics from academia to patient benefit. The beLAB1407 collaboration builds on the longstanding and successful relationship between Evotec and Bristol Myers Squibb in drug discovery across several therapeutic areas.

Dr Werner Lanthaler, Chief Executive Officer of Evotec, said: "We are thrilled to launch beLAB1407 together with our partners at Bristol Myers Squibb with whom we’ve worked on a variety of projects over a period of many years. beLAB1407 provides researchers from the member institutions with a unique way to fast-track their projects, to validate them on our industrial-grade platform and have partnering options including company formations readily available to them."

Dr Thomas Hanke, Head of Academic Partnerships at Evotec, added: "We are delighted to see the BRIDGE concept gaining further traction in the UK and we very much look forward to working closely with our academic partners in the Midlands and Scotland as well as our colleagues at BMS to identify and accelerate the next generation of first-in-class therapeutics across all modalities and therapeutic areas."

Dr Rupert Vessey, Executive Vice President and President, Research and Early Development at Bristol Myers Squibb, commented: "This collaboration builds on our important connection to leading European universities. With beLAB1407, we are supporting U.K.-based universities that are exploring many interesting lines of scientific research and discovery. That research combined with Evotec’s proprietary data platforms has the potential to identify new and novel therapies for areas of unmet medical need."

The name beLAB1407 refers to the distance between Land’s End in the far southwest of Great Britain to its north-easternmost point near the village of John o’ Groats in Scotland, which – if travelled by bike – adds up to 1,407 kilometres. To learn more about beLAB1407, please visit www.belab1407.org.

On May 5, 2021 Tiziana Life Sciences plc (Nasdaq: TLSA / LSE: TILS) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation, and infectious diseases, reported that it has executed an agreement with Takanawa Japan K.K, Pharma Team, (Takanawa) for a strategic business development plan to Identify a clinical partner in Japan and other Asian countries for further clinical development of Milciclib for treatment in advanced hepatocellular carcinoma (HCC) patients (Press release, Tiziana Life Sciences, MAY 5, 2021, View Source [SID1234579295]). HCC is the most common type of liver cancer and affects approximately 200,000 people per year.

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Previously, Tiziana successfully completed a Phase 2 clinical trial with orally administered Milciclib in sorafenib-resistant or intolerant HCC patients. The clinical data, presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)1, demonstrated that the treatment was well-tolerated and produced clinical activity. Recently, a patent covering the use of Milciclib in combination with a tyrosine kinase inhibitor (TKI) or other drugs was granted2. The granted claims provide complete freedom to further develop a combination of Milciclib with an approved TKI for treatment of patients with advanced HCC or other cancers. Because the prevalence of HCC in Asian countries is large and there are no satisfactory therapeutic options for treatment of advanced HCC in Asian countries, the strategic initiative with Takanawa is particularly important to further develop Milciclib for the treatment of advanced HCC patients.

"We are pleased and excited to work with Takanawa, a firm with a distinguished history of business development activities in the Japanese pharmaceutical industry, to identify an appropriate partner in Japan for further clinical development of Milciclib. We believe the positive clinical activity in advanced HCC and other cancers warrant immediate further development in Japan and other Asian countries where the prevalence of this cancer is relatively high, and the current available therapies are not entirely satisfactory" said Dr. Kunwar Shailubhai, CEO and CSO of Tiziana Life Sciences.

"We are honored to get the opportunity to identify a strategic partner for Milciclib for the treatment of advanced hepatocellular carcinoma (HCC) patients. Tiziana has managed to develop a product that will really have an impact and save lives since HCC affects about 200,000 people in the world and 40,000 people in Japan every year. Therefore, we hope to receive a lot of interest from leading pharmaceutical companies " said Dr. Kaoru Nozu, Executive Representative of the Takanawa Pharma Team.

The person who arranged for the release of this announcement on behalf of the Company was
Dr Kunwar Shailubhai, Chief Executive Officer and Chief Scientific Officer of the Company.

Cited References:

1.Abstract #298561: Phase 2a Safety and Efficacy of Milciclib, a Pan-Cyclin Dependent Kinase Inhibitor, in Unresectable, Sorafenib-Refractory or -Intolerant Hepatocellular Carcinoma Patients.
First Author: Erica Villa, MD., et al.
2.US Patent (10,758,541 B2 (Inventor: Shailubhai) Issue Date: September 1, 2020

THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF REGULATION 2014/596/EU (WHICH FORMS PART OF DOMESTIC UK LAW PURSUANT TO THE EUROPEAN UNION (WITHDRAWAL) ACT 2018 (THE "EUWA")) ("UK MAR"). UPON THE PUBLICATION OF THIS ANNOUNCEMENT, THIS INSIDE INFORMATION (AS DEFINED IN UK MAR) IS NOW CONSIDERED TO BE IN THE PUBLIC DOMAIN.

About Milciclib

Milciclib (PHA-848125AC) is a small molecule inhibitor of several cyclin dependent kinases such as CDK1, CDK2, CDK4, CDK5 and CDK7. CDKs are serine threonine kinases that play crucial roles in progression of the cell cycle from G1 to S phase. Overexpression of CDKs and other downstream signalling pathways that regulate cell cycles have been frequently found to be associated with development of resistance towards chemotherapies. In a phase I study, oral treatment with Milciclib was found to be well-tolerated and the drug showed promising clinical responses in patients with advanced solid malignancies such as in NSCLC, pancreatic and colon cancer, thymic carcinoma and thymoma.