1stOncology™: Cancer Intelligence Service – Page 8216 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Tallac SITC2021 Presentation

On October 21, 2021 Tallac Therapeutic reported that it will present new data from ALTA-002, a SIRPα-directed TLR9 agonist antibody conjugate from our Toll-like Receptor Agonist Antibody Conjugate (TRAAC) platform to promote anti-tumor immunity at the upcoming SITC (Free SITC Whitepaper) annual meeting taking place Nov. 10–14, 2021 in Washington, DC (Press release, Tallac Therapeutics, OCT 21, 2021, View Source [SID1234591696])

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!

Title:
ALTA-002, a SIRPα-directed TLR9 agonist antibody conjugate activates myeloid cells and promotes anti-tumor immunity (Abstract 780)

Presentation Time:
November 12 – 14, 2021, 7:00am – 5:00pm ET

Location:
Poster Hall

Quest Diagnostics Reports Third Quarter 2021 Financial Results, Raises Outlook for Full Year 2021

On October 21, 2021 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported its financial results for the third quarter ended September 30, 2021 (Press release, Quest Diagnostics, OCT 21, 2021, View Source,-Raises-Outlook-for-Full-Year-2021 [SID1234591695]).

"We had a strong third quarter, as COVID-19 molecular volumes increased throughout the summer while our base business continued to deliver solid volume growth versus the prior year and 2019," said Steve Rusckowski, Chairman, CEO and President. "In late summer we experienced some softness in the base business across the country, but saw an overall rebound in September. Importantly, our base business continued to improve sequentially in the third quarter which speaks to the ongoing recovery."

"We have raised our outlook for the remainder of the year based on higher than anticipated COVID-19 volumes as well as the continued progress we expect to see in our base business despite rising labor costs and inflationary pressures. The momentum of our base business positions us to deliver the 2022 outlook we shared at our March investor day."

For further details impacting the year-over-year comparisons related to operating income, operating income as a percentage of net
revenues, net income attributable to Quest Diagnostics, and diluted EPS, see note 2 of the financial tables attached below.

The sum of reported and adjusted diluted EPS for the first three quarters of 2021 did not equal the totals for the nine months ended September 30, 2021 due to both quarterly fluctuations in the company’s earnings and in the weighted average common shares outstanding throughout the period as a result of the impact of accelerated share repurchase agreements ("ASRs") that the company entered into during April 2021.

Note on Non-GAAP Financial Measures

As used in this press release the term "reported" refers to measures under accounting principles generally accepted in the United States ("GAAP"). The term "adjusted" refers to non-GAAP operating performance measures that exclude special items such as restructuring and integration charges, certain financial impacts resulting from the COVID-19 pandemic, amortization expense, excess tax benefits ("ETB") associated with stock-based compensation, costs associated with donations, contributions, and other financial support through Quest for Health Equity, the company’s initiative with the Quest Diagnostics Foundation to reduce health disparities in underserved communities, a gain on sale of an ownership interest in a joint venture, gains associated with changes in the carrying value of our strategic investments, and other items.

Non-GAAP adjusted measures are presented because management believes those measures are useful adjuncts to GAAP results. Non-GAAP adjusted measures should not be considered as an alternative to the corresponding measures determined under GAAP. Management may use these non-GAAP measures to evaluate our performance period over period and relative to competitors, to analyze the underlying trends in our business, to establish operational budgets and forecasts and for incentive compensation purposes. We believe that these non-GAAP measures are useful to investors and analysts to evaluate our performance period over period and relative to competitors, as well as to analyze the underlying trends in our business and to assess our performance. The additional tables attached below include reconciliations of non-GAAP adjusted measures to GAAP measures.

Conference Call Information

Quest Diagnostics will hold its quarterly conference call to discuss financial results beginning at 8:30 a.m. Eastern Time today. The conference call can be accessed by dialing 888-455-0391 within the U.S. and Canada, or 773-756-0467 internationally, passcode: 7895081; or via live webcast on the company’s website at www.QuestDiagnostics.com/investor. The company suggests participants dial in approximately 10 minutes before the call.

A replay of the call may be accessed online at www.QuestDiagnostics.com/investor or, from approximately 10:30 a.m. Eastern Time on October 21, 2021 until midnight Eastern Time on November 4, 2021, by phone at 866-360-7722 for domestic callers or 203-369-0174 for international callers. Anyone listening to the call is encouraged to read the company’s periodic reports, on file with the Securities and Exchange Commission, including the discussion of risk factors and historical results of operations and financial condition in those reports.

Precision BioSciences to Present at the Jefferies Virtual Gene Therapy/Editing Summit on Wednesday, October 27, 2021

On October 21, 2021 Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage biotechnology company using its ARCUS genome editing platform to develop allogeneic CAR T and in vivo gene editing therapies, reported that Derek Jantz, Ph.D., Chief Scientific Officer and Co-Founder, will present at the Jefferies Virtual Gene Therapy/Gene Editing Summit, being held October 27-28, 2021 (Press release, Precision Biosciences, OCT 21, 2021, View Source [SID1234591694]).

Details for the fireside chat are below:

Jefferies Virtual Gene Therapy/Gene Editing Summit
Date: Wednesday, October 27, 2021
Time: 1:30 to 1:55 ET PM

The Company expects to report that a balance of cash and cash equivalents is approximately $160.5 million as of September 30, 2021. The Company continues to expect that existing cash and cash equivalents will be sufficient to fund planned operations into 2023.

A live webcast of the fireside chat will be accessible on the Company’s website in the Investors section under Events & Presentations: View Source An archived replay of the webcast will be available for approximately 30 days.

PDS Biotech Provides Update on National Cancer Institute-Led Phase 2 Clinical Trial of PDS0101-Based Combination

On October 21, 2021 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies based on the Company’s proprietary Versamune T-cell activating technology, reported the temporary suspension of recruitment in the National Cancer Institute (NCI)-led Phase 2 clinical trial (NCT04287868) evaluating PDS0101 (Versamune-HPV16) in combination with two investigational immune-modulating agents in advanced HPV cancers (Press release, PDS Biotechnology, OCT 21, 2021, View Source [SID1234591693]).

The issue is not specific to the PDS0101 trial and is unrelated to any safety or efficacy concerns with the triple combination. The NCI anticipates that the issue should be resolved timely, at which time the PDS0101 trial recruitment will resume. The timing of clinical data resulting from this trial is not expected to be affected by the recruitment suspension.

"We know from the interim data that this combination has the potential to significantly improve clinical outcomes for patients with advanced, refractory HPV16-associated cancers who have limited treatment options. While the trial is experiencing a slight administrative delay, we are pleased to report that the PDS0101 trial recruitment has progressed well and it is anticipated that it will resume recruitment shortly. We believe based on the previously reported results, that this treatment could significantly improve survival benefit for these patients, and we look forward to resumption of the trial in the near term," said Dr. Lauren V. Wood, PDS Biotech’s Chief Medical Officer.

The trial is evaluating the novel combination in both checkpoint inhibitor naïve and refractory patients with advanced HPV-associated cancers that have progressed or returned after treatment. The vast majority of these cancers are caused by HPV16.

Karyopharm Announces Dosing of First Patient in a Phase 2 Study Investigating Oral Eltanexor in HMA Refractory Myelodysplastic Syndrome

On October 21, 2021 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported dosing of the first patient in the Phase 2 expansion of an ongoing open-label Phase 1/2 study investigating eltanexor, a novel oral, Selective Inhibitor of Nuclear Export (SINE) compound, as a single-agent or in combination with approved and investigational agents in patients with several types of hematologic and solid tumor cancers (KCP-8602-801; NCT02649790) (Press release, Karyopharm, OCT 21, 2021, View Source [SID1234591692]). The Phase 2 expansion is designed to evaluate eltanexor monotherapy in patients with hypomethylating agents (HMA) refractory, intermediate or high-risk myelodysplastic syndrome (MDS). The primary endpoint for this Phase 2 expansion is overall response rate (ORR) with the secondary endpoints of determining progression-free and overall survival.

Initiation of the Phase 2 expansion follows encouraging results from the Phase 1 portion of the study where single-agent eltanexor showed activity in patients with high-risk, relapsed MDS that was refractory to HMAs. In that study (Sangmin, et al. EHA (Free EHA Whitepaper) 2021), eltanexor demonstrated a 53% ORR and a median overall survival of 9.9 months, comparing favorably to historical controls. At the recommended Phase 2 dose of 10 mg, eltanexor monotherapy was well tolerated with low incidence and grade of gastrointestinal events. Exacerbation of cytopenias occurred in 20-40% of patients. Based on these promising signals, the study has been expanded to include an additional 83 patients with the first patient recently dosed.

"MDS is a group of diseases characterized by ineffective production of the components of the blood due to poor bone marrow function, leading to a high risk of transformation into acute leukemia. HMAs are the current standard of care for patients with newly diagnosed, higher-risk MDS, however only 40-60% patients respond, with these responses typically lasting less than two years. As such, prognosis in HMA refractory disease is poor, with a median overall survival of four to six months. With no agents currently approved for primary HMA refractory MDS, the need for novel, efficacious agents is critical. Based on the promising signal observed in the prior Phase 1 study, we are pleased to initiate dosing in the Phase 2 expansion and look forward to updating you on the progress of this important study in the future," said Sharon Shacham, PhD, MBA, Co-Founder and Chief Scientific Officer of Karyopharm.

About Eltanexor

Eltanexor (KPT-8602) is an investigational novel SINE compound that, like selinexor, functions by binding with, and inhibiting, the nuclear export protein, XPO1, leading to the accumulation of tumor suppressor proteins in the cell nucleus. This reinitiates and amplifies their tumor suppressor function and is believed to lead to the selective induction of apoptosis in cancer cells, while largely sparing normal cells.

In preclinical models, eltanexor has a broad therapeutic window with minimal penetration of the blood brain barrier and, therefore, has the potential to serve as another SINE compound for cancer indications. Following oral administration, animals treated with eltanexor show lower percentage of body weight loss and improved food consumption than animals similarly treated with selinexor. This allows more frequent dosing of eltanexor, enabling a longer period of exposure at higher levels than is possible with selinexor. As a result, we believe that eltanexor represents another novel SINE compound and we are evaluating its safety, tolerability and efficacy in ongoing clinical studies.

Eltanexor is an investigational medicine and has not been approved by the United States Food and Drug Administration, Health Canada, the European Medicines Agency, or any other regulatory agency.