On September 8, 2021 Labcorp (NYSE: LH), a leading global life sciences company, reported that members of its executive management team will participate in a virtual fireside chat at the Morgan Stanley 19th Annual Global Healthcare Conference on Monday, Sept. 13 at 3:30 p.m. ET (Press release, LabCorp, SEP 8, 2021, View Source [SID1234587398]).

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A live webcast of the presentation will be available via the Investor Relations section of the company’s website at www.Labcorp.com and archived for replay.

On September 8, 2021 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) will webcast management participation as follows (Press release, Regeneron, SEP 8, 2021, View Source [SID1234587396]):

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Morgan Stanley 19th Annual Global Healthcare Conference at 8:45 a.m. ET on Monday, September 13, 2021

Cantor Fitzgerald Virtual Global Healthcare Conference at 9:20 a.m. ET on Monday, September 27, 2021
The sessions may be accessed from the "Investors & Media" page of Regeneron’s website at View Source Replays of the webcasts will be archived on the Company’s website for at least 30 days.

On September 8, 2021 Avid Bioservices, Inc. (NASDAQ:CDMO), a dedicated biologics contract development and manufacturing organization (CDMO) working to improve patient lives by providing high quality development and manufacturing services to biotechnology and pharmaceutical companies, reported financial results for the first quarter of fiscal 2022, ended July 31, 2021 (Press release, Avid Bioservices, SEP 8, 2021, View Source [SID1234587395]).

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Highlights Since April 30, 2021

"We are pleased to announce another strong quarter. During the first quarter of fiscal 2022, we recorded an increase in revenues compared to the prior year period. Our margins significantly improved during the first quarter, reflecting the efficiencies of our business model and our ability to strategically leverage our existing fixed costs. In business development, we continued to expand and diversify our pipeline. And, as always, our business development team remains highly engaged in pursuit of multiple new business opportunities. Finally, with respect to operations, both Phase 1 and Phase 2 of our buildout remain on track as work continues to enhance our high throughput capabilities for upstream, downstream and analytical services, and we expect the Phase 1 expansion to be online in January of 2022," stated Nicholas Green, president and chief executive officer of Avid Bioservices.

"As we now have the first quarter behind us, and we are well into the second quarter, we believe we are on track to achieve our stated full year fiscal 2022 revenue guidance of between $115 million and $117 million. This represents a year-over-year growth rate of between 20% and 22%. Multiple factors contribute to our confidence in reaching this milestone, including an increase in existing customer demand, a growing pool of new customer projects, and our substantial backlog. Having said that, we remain keenly aware of the supply chain challenges that many companies continue to face due to the COVID-19 pandemic. While we have not experienced any material delays or shortages to date, it is important to recognize that uncertainty remains in the supply market, and we are cognizant of the impact it may have on timing and pricing of materials. As of today, we are aware of no supply related factors affecting our business.

"Having completed two successful fundraisings in December 2020 and March 2021, the company is very well capitalized, with approximately $160 million of cash on hand. These proceeds support our expansion and enhancement efforts, and will allow the company to explore value-creating opportunities for organic and inorganic growth in the future."

Financial Highlights and Guidance

The company is confirming revenue guidance for the full fiscal year 2022 of $115 million to $117 million.

Revenues for the first quarter of fiscal 2022 were $30.8 million, representing a 21% increase compared to $25.4 million recorded in the prior year period. The increase in revenues can be attributed to an increase in process development revenues primarily associated with services provided to new customers combined with an increase in manufacturing revenues primarily due to an increase in the number and scale of manufacturing runs in-process and/or completed in the current year period compared to the prior year period.

As of July 31, 2021, revenue backlog was $110 million, an increase of 83% compared to $60 million at the end of the same quarter last year. The company expects to recognize the majority of this backlog over the next twelve months.

Gross margin for the first quarter of fiscal 2022 was 37% compared to a gross margin of 34% for the first quarter of fiscal 2021. The increase in gross margin was primarily due to higher manufacturing and process development revenues during the period, as well as the receipt of a $3.3 million fee for unutilized reserved capacity from a customer during the quarter, similar to the $3.1 million fee from a customer received during the first quarter of fiscal 2021. The gross margin percentages for both the current-year and the prior-year periods were strengthened by approximately 7% and 9%, respectively, from these unused reserved capacity fees. While we believe the positive trend in our margins demonstrates the growing efficiencies of our business model, we do expect to increase hiring in the coming months to support our growing manufacturing capacity, and this may impact margins in future quarters.

Selling, general and administrative expenses ("SG&A") for the first quarter of fiscal 2022 were $4.5 million, an increase of 17% compared to $3.8 million recorded for the first quarter of fiscal 2021. The increase in SG&A during the quarter was primarily due to increases in stock-based compensation and consulting fees, partially offset by a decrease in payroll and benefit related expenses.

For the first quarter of fiscal 2022, the company recorded net income attributable to common stockholders of approximately $6.3 million or $0.10 per basic and diluted share, as compared to a consolidated net income attributable to common stockholders of $3.3 million or $0.06 per basic and diluted share, for the first quarter of fiscal 2021. The increase in net income attributable to common stockholders during the fiscal 2022 period is partially due to preferred stock accumulated dividends of $1.4 million included during the prior year period.

Avid reported $159.7 million in cash and cash equivalents as of July 31, 2021 compared to $169.9 million as of the prior fiscal year ended April 30, 2021.
More detailed financial information and analysis may be found in Avid Bioservices’ Quarterly Report on Form 10-Q, which will be filed with the Securities and Exchange Commission today.

Recent Corporate Developments

Appointed Esther M. Alegria, Ph.D. to the Avid board of directors. Dr. Alegria joins the Avid board bringing nearly 30 years of biopharmaceutical industry experience spanning research and development, manufacturing, quality control, assurance and compliance, technology transfer and regulatory submissions supporting the development and commercialization of small and large molecule therapeutics and vaccines.

Signed multiple new orders during the first quarter, totaling approximately $23 million. These projects span all areas of the business, from process development to commercial manufacturing.

The two-part expansion of the Myford facility continues to progress according to plan. The first phase of the expansion, which was initiated during the second quarter of fiscal 2021, expands the production capacity of the company’s existing Myford North facility by adding a second downstream processing suite. The second phase, which was initiated during the fourth quarter of fiscal 2021, is designed to further expand capacity through the build out of a second manufacturing train, including both upstream and downstream processing suites within Myford South.

Combined, the company estimates that the first and second phases of this expansion will result in a total revenue generating capacity of up to approximately $270 million annually. While the company believes that this expansion is critical to its ability to service the future needs of its customers, Avid presently has adequate capacity to accommodate current demand.
Statement Regarding Use of Non-GAAP Financial Measures

The company uses certain non-GAAP financial measures such as non-GAAP adjusted net income, free cash flow, as well as adjusted EBITDA. The company uses these non-GAAP financial measures for financial and operational decision making and as a means to evaluate period-to-period comparisons. The company believes that they provide useful information about operating results, enhance the overall understanding of our operating performance and future prospects, and allow for greater transparency with respect to key metrics used by management in our financial and operational decision making. These non-GAAP financial measures exclude amounts that the company does not consider part of ongoing operating results when planning and forecasting and when assessing the performance of the organization and our senior management. The company computes non-GAAP financial measures using the same consistent method from quarter to quarter and year to year, and may consider whether other significant items that arise in the future should be excluded from our non-GAAP financial measures.

The company reports non-GAAP financial measures in addition to, and not as a substitute for, or superior to, measures of financial performance prepared in accordance with U.S. generally accepted accounting principles (GAAP). These non-GAAP financial measures are not based on any comprehensive set of accounting rules or principles, differ from GAAP measures with the same names, and may differ from non-GAAP financial measures with the same or similar names that are used by other companies. The company believes that non-GAAP financial measures should only be used to evaluate our results of operations in conjunction with the corresponding GAAP financial measures, and encourages investors to carefully consider our results under GAAP, as well as the supplemental non-GAAP information and the reconciliations between these presentations, to more fully understand our business.

Non-GAAP net income excludes stock-based compensation; business transition and related costs including corporate initiatives into new business activities such as consulting and other costs directly associated with such activities, and severance and related expenses; and non-cash interest expense on senior convertible notes for the accretion of the debt issuance costs associated with our senior convertible notes. Adjusted EBITDA excludes non-cash operating charges for stock-based compensation, depreciation and amortization as well as non-operating items such as interest income, interest expense, and income tax expense or benefit. For the reasons explained above, adjusted EBITDA also excludes certain business transition and related costs. The company also uses measures such as free cash flow, which represents cash flow from operations less cash used in the acquisition and disposition of capital.

Additionally, non-GAAP net income and adjusted EBITDA are key components of the financial metrics utilized by the company’s compensation committee to measure, in part, management’s performance and determine significant elements of management’s compensation. The company encourages investors to carefully consider its results under GAAP, as well as its supplemental non-GAAP information and the reconciliation between these presentations, to more fully understand its business. Reconciliations between GAAP and non-GAAP financial measures included at the end of this press release.

Conference Call

Avid will host a conference call and webcast this afternoon, September 8, 2021, at 4:30 PM EDT (1:30 PM PDT).

To listen to the conference call, please dial (877) 312-5443 or (253) 237-1126 and request the Avid Bioservices conference call. To listen to the live webcast, or access the archived webcast, please visit: View Source

On September 8, 2021 Amgen (NASDAQ: AMGN) reported results from two analyses of the Phase 2 CodeBreaK 100 clinical trial evaluating LUMAKRAS (sotorasib), the first and only KRASG12C inhibitor approved in the U.S., in the treatment of previously treated patients with advanced or metastatic KRAS G12C-mutated non-small cell lung cancer (NSCLC) (Press release, Amgen, SEP 8, 2021, View Source [SID1234587394]). These new analyses, respectively, provide encouraging evidence of durable systemic anticancer activity in patients with previously treated, stable brain metastases with LUMAKRAS, as well as insights into biomarkers of LUMAKRAS response. Together with a poster describing a recently initiated clinical study of the investigational half-life extended (HLE) bispecific T cell engager (BiTE) molecule acapatamab (formerly AMG 160) in patients with NSCLC, these data are being featured during the virtual 2021 World Conference on Lung Cancer (WCLC21) hosted by the International Association for the Study of Lung Cancer (IASLC).

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"Amgen is expanding the reach, impact and potential of our innovative therapies to personalize care for patients with historically difficult-to-treat cancers like lung cancer," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "We are pleased to present additional analyses for LUMAKRAS, our newly approved KRASG12C inhibitor, as well as a trial-in-progress poster for acapatamab, our investigational BiTE molecule being studied in NSCLC and other solid tumors. Of the data presented at WCLC, we are particularly encouraged by the first evaluation of LUMAKRAS’ ability to maintain stabilization of brain metastases in patients with previously treated, stable brain metastases. We look forward to the results from our CodeBreaK 101 study where we are studying a cohort of KRAS G12C-mutated NSCLC patients with untreated, active brain metastases to better understand the clinical benefit of LUMAKRAS."

New Analyses From the LUMAKRAS Phase 2 CodeBreaK 100 Clinical Trial
In a post-hoc analysis (WCLC21 Poster 52.03) of 40 patients (23% of 174 trial participants) with KRAS G12C-mutated advanced NSCLC who had stable, previously treated brain metastases at their enrollment in the CodeBreaK 100 trial, LUMAKRAS achieved a 77.5% disease control rate (DCR), a median progression-free survival (PFS) of 5.3 months and a median overall survival (OS) of 8.3 months. This DCR was similar to patients without brain metastases. In patients evaluable by Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria, 14 of 16 patients (88%) maintained intracranial disease control of their stable brain lesions during LUMAKRAS therapy with two achieving complete responses of non-target lesions. The safety profile of LUMAKRAS in the brain metastases group was consistent with previous reports. Amgen is enrolling patients with active brain metastases in an arm of the CodeBreaK 101 study (NCT04185883).

"Up to 40% of patients with KRAS G12C-mutated NSCLC may develop brain metastases.1 Given the overall poor prognosis for this patient subset, there is an urgent need for novel treatment options,"2 said lead author Suresh S. Ramalingam, M.D., executive director of Winship Cancer Institute of Emory University in Atlanta. "Our results demonstrate the potential of sotorasib to provide meaningful clinical benefit for KRAS G12C-mutated NSCLC in the brain."

An additional exploratory descriptive analysis of CodeBreaK 100 being presented during a Mini Oral Presentation (MA14.03) examined whether the mutation profile of the tumors, in addition to KRASG12C, is correlated with patients’ responses or resistance to LUMAKRAS. An analysis of baseline tumor samples from 65 patients revealed no single genetic signature that predicted LUMAKRAS responses and ongoing evaluations will be needed to further identify potential targetable mechanisms of resistance. However, the KEAP1 mutation, a known driver of poor clinical outcomes, was observed in 7 of 22 patients with early progression and PFS of less than 3 months.

"The introduction of sotorasib ushered in a new standard of care for patients with KRAS G12C-mutated NSCLC," said lead author Ferdinandos Skoulidis, M.D., Ph.D., assistant professor of Thoracic/Head and Neck Medical Oncology at The University of Texas MD Anderson Cancer Center. "These biomarker data provide direction for continued research into characterizing mutation profiles associated with sotorasib treatment response to help guide clinical practice and inform innovative combination approaches to overcome potential mechanisms of resistance."

Advancing BiTE Molecule Acapatamab in NSCLC
In addition to the LUMAKRAS data, a trial-in-progress abstract outlined the design of an ongoing open-label, Phase 1b study (NCT04822298) evaluating the safety and tolerability of acapatamab, a half-life extended BiTE immuno-oncology therapy that targets prostate specific membrane antigen (PSMA)-expressing cancer cells in adults with relapsed/refractory NSCLC. The encouraging benefit-risk profile of acapatamab in an ongoing trial of patients with metastatic castration-resistant prostate cancer (mCRPC) (NCT03792841) suggested its potential for patients with NSCLC, as up to 49 to 85% of the endothelial cells in a tumor’s newly grown blood supply express PSMA.3,4 Acapatamab engages PSMA on cancer cells and CD3 on T cells, inducing T-cell activation, proliferation and target cell lysis to prompt a cancer-fighting immune response.5

About LUMAKRASTM (sotorasib)
Amgen took on one of the toughest challenges of the last 40 years in cancer research by developing LUMAKRAS, a KRASG12C inhibitor.6 LUMAKRAS has demonstrated a positive benefit-risk profile with rapid, deep and durable anticancer activity in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring the KRAS G12C mutation with a once daily oral formulation.7

In May 2021, LUMAKRAS was the first KRASG12C inhibitor to receive regulatory approval anywhere in the world with its approval in the U.S., under accelerated approval. LUMAKRAS is also approved in the United Arab Emirates.

Amgen is progressing the largest and broadest global KRASG12C development program with unparalleled speed and exploring more than 10 sotorasib combination regimens, including triplets, with clinical trial sites spanning five continents. To date, LUMAKRAS has treated almost 3,000 patients around the world through the clinical development program and commercial use.

In the U.S., LUMAKRAS was reviewed by the FDA under its Real-Time Oncology Review (RTOR), a pilot program that aims to explore a more efficient review process that ensures safe and effective treatments are made available to patients as early as possible. Amgen is participating in the FDA’s Project Orbis initiative and through the initiative, has submitted Marketing Authorization Applications (MAAs) for sotorasib in Australia, Brazil, Canada and the United Kingdom. Additionally, Amgen has submitted an MAA in the EU and New Drug Applications in Japan (J-NDA), Switzerland, South Korea, Singapore, Israel, Turkey and Taiwan.

LUMAKRAS is also being studied in multiple other solid tumors.6

LUMAKRASTM (sotorasib) U.S. Indication
LUMAKRASTM is indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy.

This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

LUMAKRAS (sotorasib) Important Safety Information

Hepatotoxicity

LUMAKRAS can cause hepatotoxicity, which may lead to drug-induced liver injury and hepatitis.
Among 357 patients who received LUMAKRAS in CodeBreaK 100, hepatotoxicity occurred in 1.7% (all grades) and 1.4% (Grade 3). A total of 18% of patients who received LUMAKRAS had increased alanine aminotransferase (ALT)/increased aspartate aminotransferase (AST); 6% were Grade 3 and 0.6% were Grade 4. In addition to dose interruption or reduction, 5% of patients received corticosteroids for the treatment of hepatotoxicity.
Monitor liver function tests (ALT, AST and total bilirubin) prior to the start of LUMAKRAS, every 3 weeks for the first 3 months of treatment, then once a month or as clinically indicated, with more frequent testing in patients who develop transaminase and/or bilirubin elevations.
Withhold, dose reduce or permanently discontinue LUMAKRAS based on severity of adverse reaction.
Interstitial Lung Disease (ILD)/Pneumonitis

LUMAKRAS can cause ILD/pneumonitis that can be fatal. Among 357 patients who received LUMAKRAS in CodeBreaK 100, ILD/pneumonitis occurred in 0.8% of patients, all cases were Grade 3 or 4 at onset, and 1 case was fatal. LUMAKRAS was discontinued due to ILD/pneumonitis in 0.6% of patients.
Monitor patients for new or worsening pulmonary symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, fever). Immediately withhold LUMAKRAS in patients with suspected ILD/pneumonitis and permanently discontinue LUMAKRAS if no other potential causes of ILD/pneumonitis are identified.
Most Common Adverse Reactions

The most common adverse reactions ≥ 20% were diarrhea, musculoskeletal pain, nausea, fatigue, hepatotoxicity and cough.
Drug Interactions

Advise patients to inform their healthcare provider of all concomitant medications, including prescription medicines, over-the-counter drugs, vitamins, dietary and herbal products.
Inform patients to avoid proton pump inhibitors and H2 receptor antagonists while taking LUMAKRAS.
If coadministration with an acid-reducing agent cannot be avoided, inform patients to take LUMAKRAS 4 hours before or 10 hours after a locally acting antacid.
Please see LUMAKRASTM full Prescribing Information.

About Non-Small Cell Lung Cancer and the KRAS G12C Mutation
Lung cancer is the leading cause of cancer-related deaths worldwide, and it accounts for more deaths worldwide than colon cancer, breast cancer and prostate cancer combined.8 Overall survival rates for NSCLC are improving but remain poor for patients with advanced disease and 5-year survival is only 7% for those with metastatic disease.9

KRAS G12C is the most common KRAS mutation in NSCLC.10 In the U.S., about 13% of patients with non-squamous NSCLC harbor the KRAS G12C mutation.11 Unmet medical need remains high and treatment options are limited for NSCLC patients with the KRAS G12C mutation whose first-line treatment has failed to work or has stopped working. The outcomes with current therapies are suboptimal with a median progression-free survival of approximately 4 months following second-line treatment of KRAS G12C-mutated NSCLC.12

About CodeBreaK
The CodeBreaK clinical development program for Amgen’s drug sotorasib is designed to treat patients with an advanced solid tumor with the KRAS G12C mutation and address the longstanding unmet medical need for these cancers. As the most advanced KRAS G12C clinical development program, CodeBreaK has enrolled more than 800 patients across 13 tumor types since its inception.

CodeBreaK 100, the Phase 1 and 2, first-in-human, open-label multicenter study, enrolled patients with KRAS G12C-mutant solid tumors. Eligible patients must have received a prior line of systemic anticancer therapy, consistent with their tumor type and stage of disease. The primary endpoint for the Phase 2 study was centrally assessed objective response rate. The Phase 2 trial in NSCLC enrolled 126 patients, 124 of whom had centrally evaluable lesions by RECIST at baseline. The Phase 2 trial in colorectal cancer (CRC) is fully enrolled and results have been submitted for publication.

A global Phase 3 randomized active-controlled study comparing sotorasib to docetaxel in patients with KRAS G12C-mutated NSCLC (CodeBreaK 200) has completed enrollment. Amgen also has several Phase 1b studies investigating sotorasib monotherapy and sotorasib combination therapy across various advanced solid tumors (CodeBreaK 101) open for enrollment. A Phase 2 randomized study will evaluate sotorasib in patients with stage IV KRAS G12C-mutated NSCLC in need of first-line treatment (CodeBreaK 201).

For information, please visit www.hcp.codebreaktrials.com.

About BiTE Technology
BiTE (bispecific T cell engager) technology is a targeted immuno-oncology platform that is designed to engage a patient’s own T cells to any tumor-specific antigen, activating the cytotoxic potential of T cells to eliminate detectable cancer. The BiTE immuno-oncology platform has the potential to treat different tumor types through tumor-specific antigens. The BiTE platform has a goal of leading to off-the-shelf solutions, which have the potential to make innovative T cell treatment available to all providers when their patients need it. Amgen is advancing BiTE molecules across a broad range of hematologic malignancies and solid tumors and further investigating BiTE technology with the goal of enhancing patient experience and therapeutic potential.

About Acapatamab (formerly AMG 160)
Acapatamab is a half-life extended (HLE) BiTE immune-oncology therapy that targets PSMA-expressing cancer cells being investigated in prostate cancer and non-small cell lung cancer (NSCLC).

Simultaneously binding to PSMA on tumor cells and CD3 on T cells, acapatamab is designed to engage patients’ own T cells to fight cancer. In an ongoing Phase I, first-in-human study in patients with metastatic castration-resistant prostate cancer (mCRPC), acapatamab has demonstrated a manageable safety profile and promising efficacy as monotherapy.3

The mCRPC study is also examining acapatamab in combination with pembrolizumab. A Phase 1/2, master protocol study is investigating the safety, tolerability, dosing and efficacy of acapatamab, in combination with enzalutamide, abiraterone, or the PD-1 inhibitor AMG 404 in patients with earlier-line mCRPC. An ongoing open-label, Phase 1b study is evaluating the safety and tolerability of acapatamab in adults with relapsed/refractory NSCLC.

On September 8, 2021 ISA reported the start of patient dosing in a pivotal clinical trial investigating the combination of ISA101b and Libtayo (cemiplimab) in advanced HPV16 positive oropharyngeal cancer (Press release, ISA Pharmaceuticals, SEP 8, 2021, View Source [SID1234587393]). This new study is the third with active recruitment under ISA Pharmaceuticals’ strategic immuno-oncology collaboration with Regeneron.

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The oropharyngeal cancer phase 2 study (NCT04398524) will include 86 patients with recurrent/metastatic HPV16 positive oropharyngeal cancer that progressed with prior anti-PD-1 therapy, a cancer with a high unmet medical need. The primary efficacy outcome parameter is Overall Response Rate (ORR) and the study expects top line data in the second half of 2023.

The other studies testing the combination of ISA101b and Libtayo are:
A cervical cancer phase 2 study (NCT04646005) that is being conducted by Regeneron. It will enrol 103 adult patients with recurrent/metastatic HPV16 positive cervical cancer who have experienced disease progression after first line chemotherapy. Primary endpoint of this study will be ORR.
A randomised, placebo controlled phase 2 study in first and second line HPV16 positive head-and-neck cancer (NCT03669718) that will include 194 patients also with ORR as primary endpoint. ISA Pharmaceuticals runs this study. Top line results for this study are expected in the second half of 2022.

ISA101b immunotherapy targets HPV16 positive cancers. It induces strong and specific immune responses to the HPV16 virus, and (re-)establishes a powerful and targeted T-cell immune response against infected and/or cancerous cells and tissues. ISA101b is using ISA’s proprietary Synthetic Long Peptide (SLP) technology. Libtayo is an anti-PD-1 antibody that is being jointly developed by Regeneron and Sanofi.

Gerben Moolhuizen, Chief Executive Officer of ISA Pharmaceuticals, said: "We are pleased to announce that the first patient has been treated in this new study. It highlights the productive collaboration we have with Regeneron, with active operational involvement from both companies. This additional trial offers a potentially shortened path to first approval in a HPV16 positive cancer indication."

Head-and-neck and cervical cancers can be severe and life-threatening, often diagnosed in young to middle aged adults, with low overall survival rates once these cancers progress to advanced stages. HPV16 is a major cause of head & neck cancer with over 25,000 new cases and 11,000 deaths in Europe(1) and 46,000 new cases and 9,000 deaths in the US(2).