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Bicara Therapeutics to Present at Upcoming November Investor Conferences

On November 8, 2021 Bicara Therapeutics, a clinical-stage biotechnology company developing dual-action biologics designed to elicit a potent and durable immune response in the tumor microenvironment, reported that company leadership will participate in two upcoming virtual investor conferences in November (Press release, Bicara Therapeutics, NOV 8, 2021, View Source [SID1234594746]):

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Stifel 2021 Virtual Healthcare Conference
Format: Live presentation
Date: Monday, November 15, 2021
Time: 10:40 – 11:10 a.m. ET

Piper Sandler 33rd Annual Virtual Healthcare Conference
Format: On-demand presentation
Date: Monday, November 22, 2021
Time: 10:00 a.m. ET

NeoImmuneTech Announces First Patient Dosed in Phase 2 Study of NT-I7 (efineptakin alfa) in Combination with PD-L1 Checkpoint Inhibitor in Frontline Locally Advanced or Metastatic Non-Small Cell Lung Cancer

On November 8, 2021 NeoImmuneTech, Inc. (KOSDAQ: 950220), a clinical-stage T cell-focused biopharmaceutical company, reported that the first patient has been dosed in a Phase 2 study evaluating NT-I7 (efineptakin alfa), a novel long-acting human interleukin-7 (IL-7), in combination with atezolizumab (Tecentriq) as a first-line (1L) treatment for patients with PD-L1-expressing, locally advanced or metastatic non-small cell lung cancer (NSCLC) (Press release, NeoImmuneTech, NOV 8, 2021, View Source [SID1234594745]).

NSCLC accounts for approximately 85% of all cases of lung cancer. Lung cancer is the second most commonly diagnosed cancer worldwide – in 2020, an estimated 2.2 million new cases of lung cancer were diagnosed globally, accounting for approximately 11.4% of the global cancer burden. An estimated 1.8 million lung cancer deaths occurred in 20201. Atezolizumab has shown clinically meaningful benefit in various types of lung cancer, with six currently approved indications in the US. Atezolizumab now has five approved indications in NSCLC in the US, including as a single agent or in combination with targeted therapies and/or chemotherapies. It was also the first approved cancer immunotherapy for the first-line treatment of adults with extensive-stage small cell lung cancer (SCLC) in combination with carboplatin and etoposide (chemotherapy) and the first approved cancer immunotherapy for adjuvant NSCLC.

"Following preclinical studies which showed promising evidence that adding NT-I7 to atezolizumab increased the anti-tumor activity, we are pleased to have commenced this Phase 2 trial," said Se Hwan Yang, Ph.D., President and Chief Executive Officer of NIT. "NT-I7’s T cell-amplifying properties may make it an excellent partner in combination with a checkpoint inhibitor, like atezolizumab, and this study could bring us closer to a new chemo-free treatment option for patients with PD-L1-expressing NSCLC. We look forward to evaluating how the addition of NT-I7 impacts the effects of single-agent atezolizumab in frontline locally advanced or metastatic NSCLC."

This multicenter Phase 2 study will evaluate the efficacy and safety of the combination therapy. Roche will supply NeoImmuneTech with atezolizumab for the clinical trial. More information can be found at www.neoimmunetech.com or www.clinicaltrials.gov, identifier: NCT04984811.

Tecentriq (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.

About NT-I7

NT-I7 (efineptakin alfa) is the only clinical-stage long-acting human IL-7, and is being developed for oncologic and immunologic indications, in which T cell amplification and enhanced functionality may provide clinical benefit. IL-7 is a fundamental cytokine for naïve and memory T cell development and for sustaining immune response to chronic antigens (as in cancer) or foreign antigens (as in infectious diseases). In clinical trials to date, NT-I7 has exhibited favorable PK/PD and safety profiles, both as a monotherapy and in combination with other anticancer treatments. NT-I7 is being studied in multiple clinical trials in solid tumors and as a vaccine adjuvant. Studies are being planned for testing in hematologic malignancies, additional solid tumors and other immunology-focused indications.

TYME Technologies, Inc. Provides Business Update and Announces Second Fiscal Quarter 2022 Financial and Operating Results

On November 8, 2021 TYME Technologies, Inc. (Nasdaq: TYME) (the Company or TYME), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs), reported financial and operating results for its second fiscal quarter ended September 30, 2021 (Press release, TYME, NOV 8, 2021, View Source [SID1234594744]).

Second Fiscal Quarter 2022 Business and Recent Highlights:

Commenced enrollment and dosed first patient in OASIS breast cancer trial, a multicenter Phase II single-arm, open-label study examining SM-88 with methoxsalen, phenytoin, and sirolimus (MPS) in patients with metastatic disease who have received two prior hormonal therapies. The trial is being conducted by Georgetown University (NCT04720664) at five MedStar Health hospitals. (MedStar Health is Georgetown’s academic clinical partner).
Five new sites planned to be added in early 2022 with an additional 10 sites expected by the end of 2022, on top of the 15 already participating (for a total of 30 sites), in the Precision Promise trial, a Phase II/III randomized adaptive trial in metastatic pancreatic cancer sponsored by the Pancreatic Cancer Action Network (PanCAN). These sites are among the top research institutions in the country for pancreatic cancer treatment.
The HOPES Sarcoma trial, an investigator-sponsored trial, had a meaningful increase in the rate of enrollment during the quarter. We anticipate completing trial enrollment by the end of the first half of calendar year 2022.
Launched preclinical initiative with Evotec to evaluate the potential of expanding SM-88 platform to other targeted indications.
Announced plans to explore the development of a Tyrosine-based tumor targeted technology and the receipt of a patent on such platform.
"Our second quarter was a period of significant action at TYME as we continued to implement our strategic imperatives. We commenced the OASIS breast cancer study with the first patient dosed in late September, and initiated our preclinical work, including our all-important biomarker research. We believe this will provide us with a better understanding of how best to address treatment opportunities. Our existing trials are also progressing, as planned. PanCAN’s Precision Promise trial is in the process of seeking five new sites early next year with plans to add 10 more by the end of the year and enrollment continues in our HopES sarcomas study. This is particularly noteworthy given how difficult it is to recruit patients with this ultra-rare sarcoma. Finally, we began early discovery work on a tyrosine-based tumor targeted technology platform," stated Richie Cunningham, Chief Executive Officer of TYME.

"Given all the positive momentum, these are exciting times at TYME, and we are in a strong financial position to advance these programs. We look forward to sharing information on our progress in the upcoming quarters," concluded Cunningham.

Second Fiscal Quarter 2022 Financial Results

As of the quarter ended September 30, 2021, the Company had approximately $96.6 million in cash and marketable securities, compared to $101.5 million as of the quarter ended June 30, 2021. TYME’s operational cash burn rate for the second quarter of fiscal year 2022 was $5.0 million compared to $6.0 million for the first quarter and $6.6 million for the second quarter of fiscal year 2021.

The burn rate was below the Company’s previous guidance and reflected expenses associated with ongoing clinical trials in pancreatic cancer (Precision Promise), breast cancer (Oasis), and sarcoma cancers (HopES), as well as reduced costs associated with our discontinued pancreatic cancer trial, 88-Panc-Part II. TYME continues to anticipate that its quarterly cash usage or "cash burn rate" will range from $6.0 to $8.0 million for the remaining quarters of fiscal year 2022, based on costs associated with the Company’s active clinical trials, the ongoing and close out activities related to our discontinued pancreatic cancer study, our pre-clinical studies in biomarker and mechanism of action research of SM-88, and TYME-19 pre-clinical studies.

Net loss was $5.6 million for the quarter ended September 30, 2021, or ($0.03) per basic and diluted share, as compared to a net loss of $6.9 million for the quarter ended September 30, 2020, or ($0.05) per basic and diluted share. The decrease reflected lower ongoing trial costs primarily due to the discontinued TYME—88- Panc Part 2 trial.

After adjusting for the change in fair value of warrant liability, and amortization of employee, director and consultant stock options, adjusted net loss for the three months ended September 30, 2021, was $5.3 million, or ($0.03) per share, compared to adjusted net loss of $6.5 million, or ($0.04) per share, for the three months ended September 30, 2020. Adjusted net loss and adjusted net loss per share are non-GAAP measures. See "Use of Non-GAAP Measures" below for a reconciliation to the comparable GAAP measures.

TYME has reported its full financial results for the quarter ended September 30, 2021, in the Company’s Form 10-Q filed with the Securities and Exchange Commission ("SEC"). TYME’s 10-Q is located in the SEC filings section of the Company’s website.

Conference Call and Webcast Details

The webcast will be accessible on the Events & Presentations page of the Investors section of the TYME website, tymeinc.com, and will be archived for 90 days following the event.

Use of Non-GAAP Measures

Adjusted net loss and adjusted net loss per share as presented in this report are non-GAAP measures. The adjustments relate to the change in fair value of warrant liability, amortization of employees, directors and consultants stock options and gain on warrant exchange. These financial measures are presented on a basis other than in accordance with U.S. generally accepted accounting principles ("Non-GAAP Measures"). In the reconciliation tables that follow, we present adjusted net loss and adjusted net loss per share, reconciled to their comparable GAAP measures, net loss and net loss per share. These items are adjusted because they are not operational or because they are significant noncash charges and management believes these adjustments are meaningful to understanding the Company’s performance during the periods presented. These Non-GAAP Measures should be considered a supplement to, not a substitute for, or superior to, the corresponding financial measures calculated in accordance with GAAP. Our definitions of adjusted net loss and adjusted loss per share may not be comparable to similar measures reported by other companies.

Sesen Bio Reports Third Quarter 2021 Financial Results and Business Update

On November 8, 2021 Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, reported operating results for the third quarter ended September 30, 2021 (Press release, Sesen Bio, NOV 8, 2021, View Source [SID1234594743]). During the quarter, the Company continued to work on its path forward to address chemistry, manufacturing, and controls (CMC) and clinical issues identified by the US Food & Drug Administration (FDA) in its Complete Response Letter (CRL) regarding the Company’s Biologics License Application (BLA) for the Company’s lead program, Vicineum for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).

"Our team is making progress in advancing our dialogue with the FDA as we work toward potential resolution of the issues raised in the CRL for Vicineum, as demonstrated by our recent CMC Type A Meeting with the agency," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "We remain dedicated to saving and improving the lives of patients, and we look forward to continuing to work collaboratively with the FDA in our upcoming Clinical Type A Meeting, expected later this year, to carry our mission into the next stage of the regulatory process and beyond."

Regulatory Update

US:

On August 13, 2021, Sesen Bio announced that it had received a CRL from the FDA regarding its BLA for the Company’s lead program, Vicineum for the treatment of BCG-unresponsive NMIBC. The FDA determined that it could not approve the BLA for Vicineum in its present form and provided recommendations specific to additional clinical/statistical data and analyses, in addition to CMC issues pertaining to a recent pre-approval inspection and product quality.
On October 29, 2021, Sesen Bio participated in a productive CMC Type A Meeting with the FDA (CMC Type A Meeting). The purpose of the meeting was to discuss questions related to CMC raised in the CRL. During the meeting, the Company and the FDA reviewed issues related to CMC to be further discussed during the review of the BLA for Vicineum upon potential resubmission. Key takeaways from the meeting include:
The FDA confirmed that Vicineum manufactured using the proposed commercial process is comparable to Vicineum used in prior clinical trials.
The FDA confirmed that Sesen Bio can utilize Vicineum manufactured during process validation for any potential future clinical trials needed to address issues raised in the CRL, and that these potential trials can proceed while addressing CMC issues.
The Company believes it has a clear understanding of the path forward regarding CMC for resubmission of the BLA.
Sesen Bio is preparing for a separate Type A Meeting to discuss the recommendations specific to additional clinical/statistical data and analyses that the FDA raised in the CRL (Clinical Type A Meeting), which the Company expects to occur later this year. As previously disclosed, the Company anticipates needing to conduct an additional clinical trial with 90-100 patients, and will provide further guidance after the Clinical Type A Meeting.

The Company intends to use the information from the CMC Type A Meeting and the Clinical Type A Meeting to synchronize the regulatory reviews of Vicineum for the treatment of BCG-unresponsive NMIBC in the US and the European Union.

European Union:

On August 20, 2021, Sesen Bio withdrew its marketing authorization application (MAA) to the European Medicines Agency (EMA) for Vysyneum1 for the treatment of BCG-unresponsive NMIBC. Given that certain components in the EMA’s review are interrelated with elements of the FDA’s decision to issue a CRL for Vicineum, the Company decided to pause its plans to pursue regulatory approval of Vysyneum in the European Union until there is more clarity from the FDA on next steps in the United States.
Other Business Updates

On August 30, 2021, Sesen Bio approved a restructuring plan to reduce operating expenses, to better align its workforce with the needs of its business following receipt of the CRL from the FDA for Vicineum, and to better position the Company to execute on next steps as they are determined. The Company expects the plan to decrease its annual cash costs by approximately $5.7 million.
The Company also implemented a program designed to retain employees as the Company continues to work toward the potential resolution of the issues detailed in the CRL. This retention program applies to all current employees except for the Chief Executive Officer.
Third Quarter 2021 Financial Results

Cash Position: Cash, cash equivalents and restricted cash were $175.3 million as of September 30, 2021, compared to $55.4 million as of December 31, 2020.
R&D Expenses: Research and development expenses for the third quarter of 2021 were $5.0 million compared to $10.2 million for the same period in 2020. The decrease of $5.2 million was primarily due to lower costs associated with technology transfer and manufacturing ($6.3 million), partially offset by increased license fees related to a milestone payment to the University of Zurich triggered by the completion of the BLA review by the FDA ($0.5 million), regulatory fees triggered by withdrawal of the Company’s MAA to the EMA for Vysyneum ($0.3 million), and regulatory consultant fees ($0.2 million).
G&A Expenses: General and administrative expenses for the third quarter of 2021 were $8.7 million compared to $4.1 million for the same period in 2020. The increase of $4.6 million was due to increases in sales and marketing expense for Vicineum pre-commercial launch planning ($2.4 million), employee-related compensation driven by increased headcount as part of the commercial build ($1.3 million), and professional fees for accounting services ($0.2 million). The majority of these expenses were incurred prior to receipt of the CRL in August 2021. Additionally, an increase in legal fees was driven primarily by legal proceedings and the on-going independent review related to Vicineum ($0.9 million). Such increase was partially offset by certain other decreases in G&A expenses, none of which were individually material ($0.2 million).
Restructuring Charges: Restructuring charges for the third quarter of 2021 were $5.5 million, which were due to one-time costs of approximately $2.7 million associated with the termination of certain contracts, and severance and other employee-related costs of approximately $2.8 million.
Non-Cash Related Expenses:
Intangibles impairment charge for the third quarter of 2021 was $31.7 million. In light of the CRL, the Company performed an interim impairment test for In-Process Research and Development (IPR&D) assets, which resulted in the decrease in fair value of Vicineum’s US rights.
The change in fair value of contingent consideration was a decrease of $114.0 million compared to an increase of $18.4 million for the same period in 2020. This was primarily due to management’s assessment of a lower probability of regulatory success and a refinement of timelines given the CRL.
Income Tax Benefit (Provision): Benefit from income tax was $8.6 million compared to $1.1 million tax expense for the same period in 2020. In connection with the intangibles impairment charge for the third quarter of 2021, the Company wrote-down the associated deferred tax liability by $8.6 million as a benefit.
Net Income (Loss): Net income was $71.7 million, or $0.36 per basic and $0.36 per diluted share, for the third quarter of 2021, compared to net loss of $22.6 million, or $0.19 per basic and diluted share, for the same period in 2020. The change was primarily attributable to favorable changes in non-cash related expenses ($110.4 million, including tax benefit), offset by restructuring charges ($5.5 million) and lower license revenue recognized ($11.2 million).
1 Vysyneum is the proprietary brand name that was conditionally approved by the EMA for oportuzumab monatox in the European Union.

About Vicineum

Vicineum, a locally administered fusion protein, is Sesen Bio’s lead product candidate being developed for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). Vicineum is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A. Vicineum is constructed with a stable, genetically engineered peptide tether to ensure the payload remains attached to the antibody binding fragment until it is internalized by the cancer cell. This fusion protein design is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical trials conducted by Sesen Bio, EpCAM has been shown to be overexpressed in NMIBC cells with minimal to no EpCAM expression observed on normal bladder cells. Sesen Bio is currently in the follow-up stage of a Phase 3 registration trial in the US for the treatment of BCG-unresponsive NMIBC. In February 2021, the FDA accepted the Company’s BLA file for Vicineum for the treatment of BCG-unresponsive NMIBC and granted the application Priority Review with a target PDUFA date of August 18, 2021. On August 13, 2021, the Company received a Complete Response Letter (CRL) from the FDA regarding its BLA for Vicineum. Additionally, Sesen Bio believes that cancer cell-killing properties of Vicineum promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. For this reason, the activity of Vicineum in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.

Instil Bio to Present at Upcoming Investor Conferences in November

On November 8, 2021 Instil Bio, Inc. ("Instil") (Nasdaq: TIL), a clinical-stage biopharmaceutical company focused on developing tumor infiltrating lymphocyte, or TIL, therapies for the treatment of patients with cancer, reported that company management will participate in two upcoming investor conferences in November (Press release, Instil Bio, NOV 8, 2021, View Source [SID1234594742]):

Cowen 5th Annual IO Next Summit
Monday, November 15, 2021
Session Time: 4:45 PM – 5:05 PM ET
Live Session Link: View Source

Jefferies Global Healthcare Conference (London)
Thursday, November 18, 2021
Session Time: 3:00 AM ET
Session Link: View Source
An archived replay of the webcast will be available on the Company’s website for approximately 90 days following the presentation.

Both sessions can also be accessed by visiting the News & Events section of the Instil Bio website at www.instilbio.com.