On March 24, 2022 Novocure (NASDAQ: NVCR) reported that Dr. David Tran, Chief of the Division of Neuro-Oncology at the McKnight Brain Institute at the University of Florida, will present updated results from his investigator-initiated phase 2 pilot 2-THE-TOP clinical trial testing the safety and preliminary efficacy of Tumor Treating Fields (TTFields) together with pembrolizumab and temozolomide for the treatment of adult patients with newly diagnosed glioblastoma (GBM) (Press release, NovoCure, MAR 24, 2022, View Source [SID1234610929]).

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These preliminary results, which are based on a median follow-up time of 16.8 months, compare outcomes for 26 patients in the ongoing 2-THE-TOP trial versus a historical, matched-control group of 26 patients from the TTFields plus temozolomide arm of the phase 3 pivotal EF-14 clinical trial. For patients in the 2-THE-TOP trial, median progression-free survival was 12.1 months, compared with 7.9 months for the matched-control patients in EF-14 (hazard ratio=0.46, p=0.033). Patients in 2-THE-TOP had a median overall survival of 25.2 months, compared with 15.9 months for the matched-control patients in EF-14 (hazard ratio=0.38, p=0.020).

Of the 15 patients in 2-THE-TOP with measurable target lesions, six (40%) achieved partial to complete response and eight (53%) had stable disease.

"These data from 2-THE-TOP are exciting and point to the potential benefit of Tumor Treating Fields together with pembrolizumab and temozolomide," said Uri Weinberg, Novocure’s Chief Science Officer. "TTFields’ ability to activate a downstream immune response, effectively turning a cold tumor hot, is a unique element of TTFields therapy."

Dr. Tran will present his data from 2-THE-TOP at the 6th Quadrennial Meeting of the World Federation of Neuro-oncology Societies (WFNOS 2022) in Seoul, South Korea on March 26, 2022. His oral presentation, which has been selected for a Best Abstract Award, will be delivered during the conference’s Top 10 Session 2 at 10:15 a.m. KST, followed by a live question-and-answer session.

In a preclinical study published in the Journal of Clinical Investigation (JCI) on Feb. 24, 2022, Dr. Tran’s research group reported that TTFields-mediated cell disruption activates the immune system, triggering an anti-tumor cell response that may be effectively used together with existing immunotherapy approaches in the treatment of solid tumors with limited systemic toxicity. These preclinical findings provided the mechanistic rationale for the 2-THE-TOP study.

"We are very encouraged by the data from Dr. Tran’s 2-THE-TOP study, and by the mechanistic insights published by his research group in JCI," said William Doyle, Novocure’s Executive Chairman. "We plan to continue exploring the potential of using Tumor Treating Fields with immunotherapies, which could shift the treatment paradigm for patients with this aggressive disease."

Dr. Tran’s oral presentation at WFNOS 2022 is one of three oral presentations at the conference highlighting research on TTFields.

Dr. Carsten Hagemann of the Department of Neurosurgery at University Hospital Würzburg will present preclinical data on TTFields as a novel chemotherapeutic delivery strategy on March 25, 2022 at 17:30 KST.

Dr. Wenyin Shi, Co-Director of the Brain Tumor Center of the Sidney Kimmel Cancer Center, will present data from the SPARE trial: Scalp sparing radiation with concurrent temozolomide and TT Fields (200 kHz) for patients with newly diagnosed glioblastoma on March 26, 2022 at 18:00 KST.

In addition, 28 posters at WFNOS 2022 will feature research on TTFields.

TTFields is investigational for the treatment of newly diagnosed GBM when used together with pembrolizumab.

About 2-THE-TOP

The 2-THE-TOP trial is an investigator-initiated, phase 2 pilot trial designed to assess the safety and preliminary efficacy of Tumor Treating Fields (TTFields) together with pembrolizumab and temozolomide for the treatment of adult patients with newly diagnosed GBM. Patients enrolled in the trial underwent maximal tumor resection followed by standard chemoradiation. Following the completion of chemoradiation, patients began a course of monthly cycles of adjuvant temozolomide. Treatment with TTFields started at approximately the same time as the first cycle of adjuvant temozolomide. Pembrolizumab was introduced in the second cycle of treatment and subsequent cycles of pembrolizumab were administered every three weeks until first disease progression or unacceptable toxicities or 2 years, whichever comes first.

About EF-14

The EF-14 trial was a randomized, phase 3 pivotal trial which compared, post radiation, TTFields plus temozolomide versus temozolomide alone for the treatment of newly diagnosed GBM. Median progression-free survival, the primary endpoint, was 6.7 months for TTFields plus temozolomide versus 4 months for temozolomide alone. Median overall survival was 20.9 months for TTFields plus temozolomide versus 16 months for temozolomide alone.

About Tumor Treating Fields

Tumor Treating Fields, or TTFields, are electric fields that disrupt cancer cell division. Fundamental scientific research extends across more than two decades and, in all preclinical research to date, TTFields have demonstrated a consistent anti-mitotic effect. TTFields therapy is intended principally for use together with other standard-of-care cancer treatments. There is a growing body of evidence that supports TTFields’ broad applicability with certain other cancer therapies, including radiation therapy, certain chemotherapies and certain immunotherapies. In clinical research and commercial experience to date, TTFields therapy has exhibited no systemic toxicity, with mild to moderate skin irritation being the most common side effect. The TTFields global development program includes a network of preclinical collaborators and a broad range of clinical trials across all phases, including four phase 3 pivotal trials in a variety of tumor types. To date, more than 22,000 patients have been treated with TTFields therapy.

On March 24, 2022 Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, reported that Brian M. Culley, the Company’s Chief Executive Officer, will be presenting at the 2022 Virtual Growth Conference, presented by Maxim Group LLC and hosted by M-Vest (Press release, Lineage Cell Therapeutics, MAR 24, 2022, View Source [SID1234610928]). Mr. Culley will be participating in an "Ophthalmology Panel" hosted by Jason McCarthy, Ph.D., Senior Managing Director, Biotechnology, on March 28th, 2022 at 10am ET / 7am PT . Mr. Culley will also provide a corporate overview which will be available to investors on demand, starting on Monday March 28th, 2022.

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The live panel and on-demand presentation will be available to registered users directly through the M-Vest platform: https://m-vest.com/events/2022-virtual-growth-conference. Registration is required for conference participation. An archived webcast of the corporate presentation will also be available on the Events and Presentations page of the Lineage website. Additional videos are available on the Media page of the Lineage website.

On March 24, 2022 Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid") a commercial-stage cancer prevention medical diagnostics company, and majority-owned subsidiary of PAVmed Inc. (Nasdaq: PAVM, PAVMZ) ("PAVmed"), reported that investigators at the Louis Stokes Cleveland Department of Veterans Affairs Medical Center ("Cleveland VA") have enrolled their first patient in a Department of Defense ("DoD") funded study of its EsoGuard Esophageal DNA Test ("EsoGuard") in at-risk patients with gastroesophageal reflux disease ("GERD") (Press release, Lucid Diagnostics, MAR 24, 2022, View Source [SID1234610927]). Cleveland VA gastroenterologist Katarina B. Greer, M.D., Associate Professor of Medicine at Case Western Reserve University School of Medicine, is serving as the study’s principal investigator. Lucid is providing EsoCheck Esophageal Cell Collection Devices ("EsoCheck") for the study and will perform EsoGuard testing on the samples collected.

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"Despite strong clinical practice guideline recommendations, endoscopy has had limited success as a widespread screening tool for Barrett’s Esophagus (BE), a precursor for esophageal adenocarcinoma, a highly lethal form of esophageal cancer"

"We are proud to be partnering with Dr. Greer and the Cleveland VA on this important investigator-initiated clinical study," said Lishan Aklog, M.D., Lucid’s Chairman and Chief Executive Officer. "The study will add important clinical evidence on the impact of EsoGuard in enhancing early detection of esophageal precancer to prevent esophageal cancer deaths by reserving endoscopy for those with a positive EsoGuard test."

"Despite strong clinical practice guideline recommendations, endoscopy has had limited success as a widespread screening tool for Barrett’s Esophagus (BE), a precursor for esophageal adenocarcinoma, a highly lethal form of esophageal cancer," said Dr. Greer. "We hope to demonstrate that a strategy which incorporates initial office-based non-endoscopic testing of at-risk patients with EsoGuard improve the yield of endoscopy and overall cost-effectiveness."

Traditional, invasive upper gastrointestinal endoscopy (EGD) is performed in less than 10% of at-risk GERD patients recommended for esophageal precancer (BE) screening. Of those who do undergo EGD screening, over 80% have a negative result, exposing the vast majority of these patients to a complex, invasive, costly, and inconvenient procedure requiring anesthesia at a specialized procedure center or hospital. EsoGuard performed on samples collected with EsoCheck, has been shown to be 90% sensitive and specific at detecting esophageal precancer and cancer with the potential to eliminate the majority of these negative EGDs delivering benefits to patients, providers, and the healthcare system.

The study will enroll up to 100 Cleveland VA patients who fulfil the American College of Gastroenterology criteria for esophageal precancer screening. The study compares two screening strategies: (1) EGD screening, the current standard of care; and (2) EsoGuard testing followed by EGD only in those with a positive EsoGuard result. The study will report whether using EsoGuard to triage patients to EGD will increase the overall BE screening rate and decrease the percentage of negative screening EGDs. The study will also estimate cost implications within the VA system between these two strategies.

About EsoGuard and EsoCheck
Millions of patients with GERD are at risk of developing esophageal precancer and a highly lethal form of esophageal cancer ("EAC"). Over 80% of EAC patients die within five years of diagnosis, making it the second most lethal cancer in the U.S. The mortality rate is high even in those diagnosed with early stage EAC. The U.S. incidence of EAC has increased 500% over the past four decades, while the incidences of other common cancers have declined or remained flat. In nearly all cases, EAC silently progresses until it manifests itself with new symptoms of advanced disease. All EAC is believed to arise from esophageal precancer, which occurs in approximately 5% to 15% of at-risk GERD patients. Early esophageal precancer can be monitored for progression to late esophageal precancer which can be cured with endoscopic esophageal ablation, reliably halting progression to cancer.

Esophageal precancer screening is already recommended by clinical practice guidelines in millions of GERD patients with multiple risk factors, including age over 50 years, male gender, White race, obesity, smoking history, and a family history of esophageal precancer or cancer. Unfortunately, fewer than 10% of those recommended for screening undergo traditional invasive endoscopic screening. The profound tragedy of an EAC diagnosis is that likely death could have been prevented if the at-risk GERD patient had been screened and then undergone surveillance and curative treatment.

The only missing element for a viable esophageal cancer prevention program has been the lack of a widespread screening tool that can detect esophageal precancer. Lucid believes EsoGuard and EsoCheck are the missing element and constitute the first and only commercially available test capable of serving as a widespread screening tool to prevent esophageal cancer deaths through the early detection of esophageal precancer in at-risk GERD patients.

EsoGuard is a bisulfite-converted NGS DNA assay performed on surface esophageal cells collected with EsoCheck which quantifies methylation at 31 sites on two genes, Vimentin (VIM) and Cyclin A1 (CCNA1). The assay was evaluated in a 408-patient, multicenter, case-control study published in Science Translational Medicine and showed greater than 90% sensitivity and specificity at detecting esophageal precancer and cancer.

EsoCheck is an FDA 510(k) and CE Mark cleared noninvasive swallowable balloon capsule catheter device capable of sampling surface esophageal cells in a less than five-minute office procedure. It consists of a vitamin pill-sized rigid plastic capsule tethered to a thin silicone catheter from which a soft silicone balloon with textured ridges emerges to gently swab surface esophageal cells. When vacuum suction is applied, the balloon and sampled cells are pulled into the capsule, protecting them from contamination and dilution by cells outside of the targeted region during device withdrawal. Lucid believes this proprietary Collect+Protect technology makes EsoCheck the only noninvasive esophageal cell collection device capable of such anatomically targeted and protected sampling. The sample is sent by overnight express mail to Lucid’s third-party CLIA-certified laboratory partner for EsoGuard testing.

On March 24, 2022 SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, reported that it will announce fourth quarter and full year 2021 financial results and provide a business update on Tuesday, March 29, 2022 (Press release, Scynexis, MAR 24, 2022, View Source [SID1234610926]). The company will host a conference call and webcast at 8:30 a.m. Eastern Daylight Time on the same day.

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A recording of the webcast will be posted on the Company’s website, www.scynexis.com, following the event

On March 24, 2022 Aptevo Therapeutics Inc. (NASDAQ:APVO), a clinical-stage biotechnology company focused on developing novel immuno-oncology therapeutics based on its proprietary ADAPTIR and ADAPTIR-FLEX platform technologies, reported its financial results for the year ended December 31, 2021 and provided 2021 business highlights (Press release, Aptevo Therapeutics, MAR 24, 2022, View Source [SID1234610925]).

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"2021 was an eventful year for Aptevo Therapeutics. A year of progress against a backdrop of macro challenges at both the industry and global levels. Among our achievements was completing and announcing positive results for our Phase 1b dose escalation trial for lead drug candidate APVO436 in the treatment of acute myeloid leukemia, or AML, and myelodysplastic syndrome, or MDS. Those results showed a positive safety and tolerability profile and encouraging signs of clinical activity. More specifically, of 40 evaluable patients, promising clinical activity was observed in 11 of 40 or 27.5%, including two complete remissions among AML patients and three complete marrow responses among MDS patients," said Marvin L. White, President and Chief Executive Officer.

Mr. White continued, "Also on the APVO436 front, we initiated the second part of that trial — a dose expansion phase — structured as a multi-center, multi cohort study that will evaluate up to 90 adult AML patients in both monotherapy and in combination with standard of care chemotherapies. Most exciting, we announced a complete remission in the fourth quarter and have since shared that this patient is proceeding to transplant. Our pipeline also continues to progress, as we plan to file an Investigational New Drug Application (IND) for ALG.APV-527 for the treatment of solid tumors, later this year. We are excited about the opportunity to expand our clinical programs and view our progress as continued validation of our technology platforms."

"From a financial perspective we have sufficient cash for at least the next 12 months. Importantly, completion of enrollment of the APVO436 expansion trial and initiation of the ALG.APV-527 clinical program are expected inside this cash window," he concluded.

2021 Highlights

Announced results from the Phase 1b dose escalation trial evaluating lead drug candidate, APVO436, for the treatment of AML and MDS. Results showed:
APVO436 exhibited a favorable safety profile with acceptable tolerability and generally manageable drug-related adverse events.
Promising clinical activity was observed in 11 of 40 patients (27.5%) evaluable for efficacy. This included two complete remissions in patients with AML and three complete marrow responses in patients with MDS.
Initiated the dose expansion part of the APVO436 Phase 1b trial, evaluating adult patients with acute myeloid leukemia (AML) in a multi-center, multi-cohort study of up to 90 patients who will receive APVO436 in combination and monotherapy.
Published three articles in two peer-reviewed publications, Cancers and Frontiers in Medicine, discussing APVO436 data. Results were also presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in November 2021.
Announced that a high-risk AML patient treated with a combination of chemotherapy plus APVO436 achieved a complete remission after one cycle of therapy. The chemotherapy regimen included the standard leukemia drugs Mitoxantrone, Etoposide, and Cytarabine. The patient tolerated treatment without evidence of overt toxicity.
More recently, Aptevo reported that this patient will proceed to transplant.
Solidified plans with Alligator Bioscience to submit an IND for ALG.APV-527 in the second half of 2022 to evaluate the compound for the treatment of multiple solid tumor types.
Aptevo will investigate the initial differentiating benefits of ALG.APV-527 to induce stronger and more tumor-directed T cell activity with the potential for improved safety and efficacy than existing 4-1BB monoclonal antibody treatments
Received $35 million from our sale of the right to royalty payments made by Pfizer Inc. ("Pfizer") with respect to net sales of RUXIENCE to an entity managed by HealthCare Royalty Management, LLC ("HCR").
Earned a $10 million milestone payment related to 2021 sales of RUXIENCE under the terms of its royalty purchase agreement with HCR. Received the proceeds from the milestone payment in March 2022, which will be used to pay down our MidCap Financial term loan to $5 million, further strengthening the company’s balance sheet.
2021 Summary Financial Results

Cash Position: Aptevo had cash and cash equivalents as of December 31, 2021 totaling $46.3 million, including restricted cash of $1.3 million. The restricted cash is expected to be released over the next twelve months.

Royalty Revenue: Royalty revenue increased by $8.0 million from $4.3 million for the year ended December 31, 2020 to $12.3 million for the year ended December 31, 2021. The increase is related to royalty revenue from Pfizer on global net sales of RUXIENCE, a biosimilar to the drug RITUXAN, launched by Pfizer in early 2020. Due to our continuing involvement under the Definitive Agreement originally between Trubion and Wyeth, we continue to recognize royalty revenue on net sales of RUXIENCE and record the royalty payments to HCR as a reduction of the liability when paid. As such payments are made to HCR, the balance of the liability will be effectively repaid over the life of the Royalty Purchase Agreement. RUXIENCE is a trademark of Pfizer; RITUXAN is a trademark of Biogen.

Research and Development Expenses: Research and development expenses increased by $1.1 million, to $19.0 million for the year ended December 31, 2021 from $17.9 million for the year ended December 31, 2020. The increase is due to higher spending on consulting services for our APVO436 clinical trial as we continue to advance that trial and increased spending on analytical analysis for our preclinical programs, including ALG.APV-527, APVO603, and APVO442. Further, we have now started dosing in our Phase 1b expansion program for our APVO436 clinical trial.

General and Administrative Expenses: For the year ended December 31, 2021, general and administrative expenses increased by $0.7 million, or 5%, to $14.7 million from $14.0 million for the year ended December 31, 2020. This increase was primarily due to higher costs related to responding to stockholder activism matters and higher employee costs.

Other Expense: Other expense consists primarily of costs related to debt extinguishment, accrued exit fees on debt, non-cash interest on financing agreements, and interest on debt. Other expense, net was $8.0 million for the year ended December 31, 2021 and $3.4 million for the year ended December 31, 2020. This increase is primarily due to interest expense and accrued exit fees for the MidCap Credit Agreement, as well as non-cash interest expense for the Royalty Purchase Agreement.

Discontinued Operations: Income from discontinued operations was $1.0 million for the year ended December 31, 2021 and $13.2 million for the year ended December 31, 2020. For the year ended December 31, 2021, we collected $0.5 million related to the sale of hyperimmune business to Saol as a result of the collection of certain accounts receivable and deferred payment of $0.5 million received from Medexus related to IXINITY sales. For the year ended December 31, 2020, we recognized net income from discontinued operations totaling $13.2 million. This included the gain on the sale of Aptevo BioTherapeutics of $14.3 million, net operating losses from Aptevo BioTherapeutics of $1.6 million related to the period prior to the sale on February 28, 2020, and $0.4 million deferred payment from Medexus related to IXINITY sales.

Net Loss: Aptevo’s net loss for the year ended December 31, 2021 was $28.5 million or $6.07 per share, compared to a net loss of $17.8 million or $5.23 per share for the corresponding period in 2020.