On May 4, 2021 AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on emerging immune control mechanisms applicable to inflammation and immuno-oncology indications, reported operating results for the first quarter ended March 31, 2021 and provided pipeline updates (Press release, AnaptysBio, MAY 4, 2021, View Source [SID1234579061]).

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"We look forward to advancing imsidolimab into a Phase 3 trial for GPP following our recent end-of-Phase 2 meeting with the FDA," said Hamza Suria, president and chief executive officer of AnaptysBio. "AnaptysBio continues to pursue a capital-efficient business model where partnership revenues continue to support advancement of our wholly-owned pipeline poised to generate multiple clinical data catalysts through 2021 and 2022."

Imsidolimab (Anti-IL-36 Receptor) Program

We held an end-of-Phase 2 meeting with the FDA during Q2 2021 to review an orphan disease Phase 3 development plan for imsidolimab for the treatment of GPP and anticipate announcing key aspects of our Phase 3 trial design upon its initiation in mid-2021. Our worldwide registry of GPP patients, named RADIANCE, is ongoing, and we expect that this study will improve our understanding of the patient journey and support enrollment of our Phase 3 clinical trial. While initial GPP epidemiology studies suggested at least 3,000 GPP patients in the United States, medical claims analyses conducted by IQVIA indicate approximately 37,000 unique patients were diagnosed with GPP at least once, and approximately 15,000 unique patients were diagnosed with GPP at least twice, by a physician between 2017 and 2019 using the International Classification of Diseases 10th Revision (ICD-10) billing code pertaining to GPP (L40.1).
We initiated a Phase 2 clinical trial of imsidolimab in hidradenitis suppurativa, named HARP, where 120-patients are randomized equally between two dose levels of imsidolimab and placebo, and top-line data is anticipated in H2 2022. We also commenced an imsidolimab Phase 2 trial in moderate-to-severe acne, named ACORN, where 120-patients are randomized equally between two dose levels of imsidolimab and placebo, and top-line data is anticipated in H1 2022. We continue to anticipate top-line data at the end of 2021 from our EMERGE Phase 2 trial of imsidolimab in EGFR/MEK-mediated skin toxicities and top-line data from our Phase 2 INSPIRE trial in ichthyosis during 2022.
We announced in Q1 2021 top-line data from our POPLAR phase 2 clinical trial of imsidolimab monotherapy in PPP, which failed to meet the trial’s primary endpoint. While we continue to review secondary endpoints to further understand the activity of imsidolimab in various PPP patient subsets, we do not currently plan to pursue further clinical development of imsidolimab in PPP.
ANB030 (Anti-PD-1 Agonist) Program

We anticipate top-line data in H2 2021 from our ongoing Phase 1 healthy volunteer clinical trial of ANB030, our wholly-owned PD-1 agonist antibody, designed to assess the safety, pharmacokinetics and pharmacodynamics of ANB030 in single and multiple ascending dose cohorts.
We plan to initiate Phase 2 clinical trials of ANB030 in alopecia areata and vitiligo in Q4 2021.
Preclinical translational data using ANB030 was presented in March 2020 at the Festival of Biologics Meeting.
ANB032 (Anti-BTLA Modulator) Program

We achieved first-in-human dosing of ANB032, our wholly-owned BTLA modulator antibody, upon initiation of a healthy volunteer Phase 1 trial in the first quarter of 2021, under an Australian Clinical Trial Notification (CTN), and anticipate top-line data from this trial during the first half of 2022.
We presented preclinical data regarding ANB032 at the 2020 Federation of Clinical Immunology Societies (FOCIS) Virtual Annual Meeting in October 2020.
GSK Partnered Programs

A BLA for our most advanced partnered program, which is an anti-PD-1 antagonist antibody called JEMPERLI (dostarlimab), was approved by the FDA in April 2021 for the treatment of advanced or recurrent deficient mismatch repair endometrial cancer (dMMREC). This is the first AnaptysBio-generated antibody, of eight currently under clinical development, to obtain FDA approval. We earned a $20.0 million milestone payment as a result of this FDA approval.
In April 2021 the European Medicines Agency (EMA) granted conditional marketing authorization in the European Union for JEMPERLI for use in women with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) recurrent or advanced endometrial cancer who have progressed on or following prior treatment with a platinum containing regimen, which approval makes JEMPERLI the first anti-PD-1 therapy available for endometrial cancer in Europe. We earned a $10.0 million milestone payment as a result of this approval.
A second BLA submitted by GSK was accepted by the FDA during the first quarter of 2021 for JEMPERLI in pan-deficient mismatch repair tumors (PdMMRT). We received a $10.0 million cash milestone payment upon the FDA acceptance of GSK’s second FDA BLA for JEMPERLI and anticipate an additional $20.0 million cash milestone payment upon FDA approval of this second FDA BLA of JEMPERLI during the second half of 2021. We anticipate an additional $15.0 million and $165.0 million in milestone payments upon achievement of certain JEMPERLI regulatory and commercial milestones, respectively.
During Q1 2021, we recognized $1.2 million in royalty revenue related to GSK’s Zejula product sales, which we estimated based on GSK’s historical sales. In October 2020, we amended our GSK collaboration which resulted in increased royalties on global net sales of JEMPERLI to 8-25%, a 1% royalty rate on GSK’s global net sales of Zejula and a one-time cash payment of $60.0 million.
First Quarter Financial Results

Cash, cash equivalents and investments totaled $387.4 million as of March 31, 2021 compared to $411.2 million as of December 31, 2020, for a decrease of $23.8 million. The decrease relates primarily to cash used for operating activities.
Collaboration revenue was $11.2 million for the three months ended March 31, 2021, $10.0 million related to milestone revenue for the FDA accepted BLA filing of the second dostarlimab indication and $1.2 million related to royalties on GSK’s Zejula product sales, compared to $15.0 million of milestone revenue for the three months ended March 31, 2020.
Research and development expenses were $24.2 million for the three months ended March 31, 2021, compared to $21.0 million for the three months ended March 31, 2020. The increase was due primarily to continued advancement of the Company’s clinical programs.
General and administrative expenses were $5.4 million for the three months ended March 31, 2021, compared to $4.3 million for the three months ended March 31, 2020. The increase was due primarily to personnel-related expenses, including share-based compensation.
Net loss was $18.2 million for the three months ended March 31, 2021, or a net loss per share of $0.66, compared to a net loss of $8.3 million for the three months ended March 31, 2020, or a net loss per share of $0.30.
Financial Guidance

AnaptysBio expects its net cash burn in 2021 will be close to $100 million. We anticipate that our cash, cash equivalents and anticipated revenues will fund our current operating plan at least into 2024.

On May 4, 2021 ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, today provided a business update and reported its financial results for the first quarter of 2021 (Press release, ERYtech Pharma, MAY 4, 2021, View Source(U.S.)%20and,its%20financial%20results%20for%20the [SID1234579076]).

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"The first quarter of 2021 has again been one of tremendous progress, and has further set the stage for a catalyst-rich second half of this year," said Gil Beyen, CEO of ERYTECH. "All four of our clinical programs are expected to report significant defining events before the end of the year, two of which potentially supporting the application for regulatory approvals within the next twelve months. Our 512-patient pivotal Phase 3 trial in second-line pancreatic cancer, TRYbeCA-1, is on track for final results in the fourth quarter. Subject to positive results, we expect to submit our applications for approval in this indication in the United States and Europe in the first half of 2022. The second potentially pivotal track of eryaspase is for the treatment of ALL patients who developed hypersensitivities to pegylated asparaginase. We recently requested a pre-BLA meeting with the FDA to discuss the path to approval in this indication and we are targeting the potential submission of a Biologics License Applicaton (BLA) in the second half of this year. We are also continuing work to further broaden the indication scope of eryaspase. The safety profile and encouraging clinical activity observed in the first dose cohort of the ongoing Phase 1 IST in first line pancreatic cancer add to our conviction that eryaspase can be a meaningful contributor to helping cancer patients live longer, better. "

Business Highlights

TRYbeCA-1, pivotal Phase 3 clinical trial in second-line advanced pancreatic cancer

TRYbeCA-1 is a randomized, controlled Phase 3 pivotal trial, evaluating eryaspase in second-line advanced pancreatic cancer at approximately 90 sites in the United States and in Europe. Eryaspase, in combination with standard chemotherapy (gemcitabine/nab paclitaxel or an irinotecan-based regimen), is compared with standard chemotherapy alone in a 1 to 1 randomization. The primary endpoint is overall survival (OS).

Enrollment was completed in January 2021. A total of 512 patients were randomized in the trial, above the target enrollment of 482 patients.

In February 2021, an interim efficacy and safety analysis was performed by an independent data monitoring committee (IDMC), which recommended the trial continue without modification to its final analysis. As with the three previous IDMC reviews, no safety issues have been identified and the Company remains blinded to the primary and secondary endpoint efficacy data.

Reporting of the final results from this trial is expected in the fourth quarter of 2021.

Phase 2 trial in acute lymphoblastic leukemia (ALL), sponsored by the Nordic Society of Pediatric Hematology and Oncology (NOPHO)
The NOPHO trial evaluated the safety and pharmacological profile of eryaspase in ALL patients who had previously experienced hypersensitivity reactions to pegylated asparaginase therapy. The primary objective of the trial was to assess asparaginase enzymatic activity. In December 2020, positive trial results were presented at the 2020 American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting. Eryaspase in combination with chemotherapy, administered every two weeks, provided a sustained asparaginase enzyme activity level, and was generally well tolerated with few hypersentivity reactions.

The Company continued its interactions with the FDA regarding a potential regulatory approval in this indication based on the NOPHO-sponsored trial. In April 2021, ERYTECH requested a pre-BLA meeting to discuss the submission of a Biologics License Application.

Subject to the feedback from this meeting, the Company plans to potentially submit the BLA in the second half of 2021.

TRYbeCA-2, randomized Phase 2 clinical trial in triple-negative breast cancer (TNBC)

The TRYbeCA-2 trial is evaluating eryaspase in combination with gemcitabine and carboplatin chemotherapy, compared to chemotherapy alone, in metastatic TNBC. Target enrollment is approximately 64 patients. The primary end point of the trial is objective response rate.

Following a recommendation of the trial’s investigators, the trial’s inclusion criteria were modified in January 2021 to include second-line patients.

The TRYbeCA-2 Steering Committee met in April 2021 and recommended the trial continue without modification after review of the safety data of the first 19 patients.

Initial data from the TRYbeCA-2 trial are expected to be reported in the fourth quarter of 2021.

rESPECT, Phase 1 investigator-sponsored trial in first-line pancreatic cancer

rESPECT is a Phase 1 trial, sponsored by the Georgetown Lombardi Comprehensive Cancer Center, evaluating the safety of eryaspase in combination with mFOLFIRINOX as a first-line treatment for advanced and locally advanced pancreatic cancer in approximately 18 patients.

Patient enrollment started in January 2021, and the first dose cohort of three patients was enrolled by the end of February.

After review of the safety data, the Dose Escalation Committee concluded that no dose-limiting toxicity (DLT) had been observed in the first cohort treated at a therapeutic dose of 75 U/kg eryaspase, and that the treatment was well tolerated in the cohort thus far.

After the first dose cycle of treatment, two of the three patients had a partial response and significantly decreased levels of CA19-9, a pancreatic cancer tumor marker; the third patient had stable disease after the first cycle of treatment.
The trial has been escalated to the next dosing cohort, where the dose level will be increased to 100 U/kg (the same dose as in TRYbeCA-1) eryaspase. This will be the highest dose level cohort in the trial and the presumed maximum tolerable dose (MTD) assuming no dose limiting toxicity is observed.

Determination of the MTD is expected in the second half of 2021.

First Quarter 2021 Financial Results and Cash Guidance

Key financial figures for the first quarter of 2021 compared with the same period of the previous year are summarized below:

Net loss for the first quarter of 2021 was €11.9 million, down €5.6 million (-32%) year-over-year, with a €5.8 million decrease (-31%) in operating loss and a €0.2 million decrease in financial income. The €5.8 million decrease in operating loss was attributable to the €4.8 million decrease in preclinical and clinical development expenses, concurrent with the completion of patient enrollment in the Company’s Phase 3 clinical trial in pancreatic cancer, a €0.3 million decrease in general and administrative expenses, and a €0.7 million increase in other income, mostly related to R&D tax credits. The €0.2 million decrease in financial result was mostly related to the IFRS accounting of the convertible notes.

As of March 31, 2021, ERYTECH had cash and cash equivalents totaling €37.4 million (approximately $43.9 million), compared with €44.4 million on December 31, 2020. The €7.0 million decrease in cash position during the first quarter of 2021 was the result of a 3-month €7.6 million net cash utilization, which was mostly comprised of a €16.3 million net cash utilization in operating activities, €0.1 million used for investing activities and €8.8 million generated in financing activities, while the variation of the U.S. dollar against the euro led to a €0.6 million positive currency exchange impact.

Financing activities in the first quarter of 2021 included the placement of 744,186 newly issued ordinary shares underlying American Depositary Shares (ADSs) in the United States through the Company’s at-the-market (ATM) equity financing program for net proceeds of €6.4 million, and the draw down of one tranche under the convertible notes (OCABSA) financing agreement signed with Alpha Blue Ocean, for net proceeds of €2.9 million.

As of the date of this press release, all notes of the six OCABSA tranches called to date have been converted and, together with the shares issued under the ATM program, have resulted in the issuance of 3,677,676 new shares and 202,020 warrants, representing 18.3% of the Company’s outstanding share capital to date.

Financing Round of $30 million on April 29, 2021

On April 29, 2021, the Company announced that it has entered into definitive agreements with several health-care focused institutional and accredited investors for the purchase and sale of 1,034,483 units ("Units"), each Unit consisting of four ordinary shares in the form of ADSs and three warrants, each to purchase one ordinary share, in a registered direct offering to specified categories of investors.

The subscription price for one Unit is corresponding to $7.25 (€6.01) per ADS and associated 0.75 warrant. The warrants have an exercise price of €7.50 ($9.05) per share, will be immediately exercisable upon issuance and will expire two years from the issuance date.

The aggregate gross proceeds to the Company from the sale of the Units, excluding any exercise of the warrants, is expected to be approximately $30.0 million. The Company intends to use the net proceeds from this offering to fund further development of its products candidates, including through the completion of the Phase 3 TRYbeCA-1 trial and the costs to prepare the associated regulatory filings, and for associated working capital and other general corporate purposes.

The Company believes that its current cash position and the net proceeds from the April 29, 2021 offering can fund its planned operating expenses and current programs into the first quarter of 2022. Further, the Company believes that it would be able to fund operations into the third quarter of 2022 if it utilizes the OCABSA agreement, subject to the regulatory limit of 20% dilution.

Key News Flow and Milestones Expected Over the Next 12 Months

Final results from TRYbeCA-1 Phase-3 trial of eryaspase in 2L PAC (Q4 2021)

Potential eryaspase BLA filing for ALL (2H 2021)

Initial data from the randomized Phase 2 TRYbeCA-2 trial of eryaspase in TNBC (Q4 2021)

Determination of the maximum tolerated dose in rESPECT, Phase 1 IST in 1L PAC (2H 2021)

First Quarter 2021 Conference Call Details

ERYTECH management will hold a conference call and webcast on Wednesday, May 5, 2021 at 8:30am ET / 2:30 pm CET on the business highlights and financial results for the quarter ended March 31, 2021. Gil Beyen, CEO, Eric Soyer, CFO/COO, and Iman El-Hariry, CMO, will deliver a brief presentation, followed by a Q&A session.

The call is accessible via the below teleconferencing numbers, followed by the Conference ID#: 3887923#

USA/Canada: +1 (833) 818-6807 France: +33 1 70 80 71 53
International Dial-In Number: +1 (409) 350-3501 United-Kingdom: +44 2031070289

The webcast can be followed live online via the link: View Source

An archived replay of the call will be available for 7 days by dialing + 1 855 859 2056, Conference ID: 3887923#.

An archive of the webcast will be available on ERYTECH’s website, under the "Investors" section at investors.erytech.com

Financial Calendar 2021

Business Update and Financial Highlights for the Second Quarter of 2021: September 20, 2021 (after U.S. market close), followed by a conference call & webcast on September 21, 2021 (2:30pm CET/8:30am ET)

Business Update and Financial Highlights for the Third Quarter of 2021: November 15, 2021 (after U.S. market close), followed by a conference call & webcast on November 16, 2021 (2:30pm CET/8:30am ET)

ERYTECH plans on attending the following upcoming investor conferences:

Jefferies 2021 Global Healthcare Conference, June 1-4, New-York (Virtual)

JMP Securities Life Science Conference, June 16-17, New York (Virtual)

European Midcap Event – June 24, Paris (Virtual)

BTIG Biotechnology Conference – August 9-10, New York (Virtual)

On May 4, 2021 Kaleido Biosciences, Inc. (Nasdaq: KLDO), a clinical-stage healthcare company with a differentiated, chemistry-driven approach to targeting the microbiome to treat disease and improve human health, reported financial results for the first quarter ended March 31, 2021 (Press release, Kaleido Biosciences, MAY 4, 2021, View Source [SID1234579102]).

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"Kaleido is off to a strong start in 2021 marked by positive results from our 350-patient clinical study with KB109 in outpatients with mild-to-moderate COVID-19 and a recently completed financing, which will support the continued expansion of our novel, targeted Microbiome Metabolic TherapyTM (MMT) candidates," said Dan Menichella, President and Chief Executive Officer of Kaleido. "Consistent with the interim findings we reported earlier this year, results from the full dataset demonstrated that KB109 has a favorable safety and tolerability profile and reduced COVID-19 related healthcare utilization and recovery time in patients with one or more comorbidity. Based on these results, we are investing in the manufacturing of KB109 and are initiating an IND application with the FDA."

Continued Mr. Menichella: "Beyond our COVID-19 program, we have a robust pipeline of MMT-based candidates that holds immense potential. We continue to make progress enrolling patients in our non-IND study evaluating KB295 in individuals with mild-to-moderate ulcerative colitis with topline data anticipated mid-year. We believe these data are critical as patients and clinicians express interest in novel, oral therapeutic options with a strong safety and tolerability profile."

Recent Program and Corporate Highlights

An analysis from the full dataset (n=350) of the K031 controlled non-IND study of KB109 in patients with mild-to-moderate COVID-19 demonstrated a reduction in overall COVID-19 related healthcare utilization—comprised of hospitalizations, emergency room visits, and urgent care visits. The study also demonstrated a significant reduction in recovery time for patients age 45 and older or with one or more comorbidity who received KB109 plus self-supportive care as compared to patients receiving self-supportive care alone.
In February, Kaleido closed a public offering with gross proceeds of approximately $69.4 million, before deducting underwriting discounts and commissions and other offering expenses.
In April, Kaleido announced a research collaboration with researcher Robert Jenq, M.D. Professor of Genomic Medicine, at The University of Texas MD Anderson Cancer Center, to explore the potential of Kaleido’s novel MMT in preventing febrile neutropenia—a serious complication associated with hematopoietic stem cell transplantations (HSCT).
First Quarter Financial Results

Kaleido reported a net loss of $23.0 million, or $0.58 per common share, for the first quarter of 2021 compared to $19.6 million, or $0.64 per common share, for the same period in 2020. The first quarter net loss includes non-cash stock-based compensation expenses of $4.2 million, as compared to $2.7 million in the first quarter of 2020.

Research and development (R&D) expenses were $17.2 million and $13.1 million for the three months ended March 31, 2021 and 2020, respectively. The increase was primarily due to increased spend relating to our two COVID-19 studies and the modification of the vesting provision of stock options and restricted stock units related to the resignation of our former CMO.

General and administrative (G&A) expenses were $5.5 million and $5.9 million for the three months ended March 31, 2021 and 2010, respectively. The decrease was primarily due to reduced headcount and lower utilization of outside contractors.

As of March 31, 2021, the Company reported cash and cash equivalents of $92.4 million. The Company continues to manage its operating expenses and, as a result, has cash runway into the first quarter of 2022.

About Microbiome Metabolic Therapies (MMT)

Kaleido’s Microbiome Metabolic Therapies, or MMTs, are designed to drive the function and distribution of the microbiome’s existing microbes in order to decrease or increase the production of metabolites, or to advantage or disadvantage certain bacteria in the microbiome community. The Company’s initial MMT candidates are targeted, synthetic glycans that are orally administered, have limited systemic exposure, and are selectively metabolized by enzymes in the microbiome. Kaleido utilizes its discovery and development platform to study MMTs in microbiome samples to rapidly advance MMT candidates rapidly into clinical studies in healthy subjects and patients. These human clinical studies are conducted under regulations supporting research with food, evaluating safety, tolerability and potential markers of effect. For MMT candidates that are further developed as therapeutics, the Company conducts clinical trials under an Investigational New Drug (IND) or regulatory equivalent outside the U.S., and in Phase 2 or later development.

On May 4, 2021 NFlection Therapeutics reported that research to be shared during a plenary talk at the Society for Investigative Dermatology’s 2021 Virtual Meeting, data from investigators at the Tsai Lab at Moffitt Cancer Center, Sarin Lab at the Stanford University School of Medicine and NFlection Therapeutics demonstrate positive efficacy in preclinical models for the use of a topical gel — NFX-179 — to prevent cutaneous squamous cell carcinoma (cSCC) (Press release, NFlection Therapeutics, MAY 4, 2021, View Source [SID1234579135]).

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In a UV-induced mouse model of cutaneous squamous cell carcinoma, topical application of NFX-179 gel reduced the formation of new cSCCs by an average of 92% at doses of 0.5% and greater, at 28 days. No systemic or skin toxicities were observed. The researchers also conducted a split-back randomized controlled study in 5 mice per group. NFX-179 0.5% gel was applied to half of the back, and vehicle was applied to the other half of each of the UV-irradiated mice. Near-complete suppression of cutaneous squamous cell carcinoma was observed only in the drug-treated area, demonstrating the targeted and local effect of the drug candidate. Furthermore, the team found that NFX-179 inhibits the growth of human cutaneous squamous cell carcinoma cell lines in a dose-dependent manner and that topical NFX-179 application penetrates human skin and inhibits ERK signaling in human cSCC explants.

"We are thrilled with the compelling evidence these data provide, that topical application of NFX-179 has the potential to be a safe, effective strategy for prevention of cutaneous squamous cell carcinoma in high-risk individuals, and we feel very optimistic about moving into clinical trials," said Dr. Kenneth Tsai, M.D., Ph.D., Senior Member, Anatomic Pathology and Tumor Biology at Moffitt Cancer Center. "These data also validate a rational design approach for the precision targeting of diseases of the skin, particularly for cancer prevention — I hope this is just the beginning of more research that rationally targets disease-driving molecular changes in the skin."

NFX-179 and the Ras/MEK Pathway
Aberrant activation of the Ras/MEK pathway is connected to a collection of rare disorders and the formation of tumors, and prior research from the Tsai Lab and others has concluded that this pathway is integral to developing cutaneous squamous cell carcinoma, predicting that MEK1, 2 could be a target for preventing these carcinomas.1,2 Re-analysis of this data performed by the Sarin Lab further predicted that the FDA-approved MEK1, 2 inhibitor, selumetinib, could be used as a therapeutic agent for cutaneous squamous cell carcinoma based on its ability to reverse transcriptional signatures associated with cSCC development. As a regulator of ERK activity, the team reasoned MEK would be a viable chemopreventative target.

Although systemic MEK inhibition suppresses tumor formation, it also causes significant adverse effects. For this reason, the team decided to work with NFX-179, a topical MEK inhibitor developed by NFlection Therapeutics. NFX-179 is a proprietary, metabolically labile, or "soft" compound — designed to concentrate key biological effects at the site of application while considerably reducing systemic exposure and thus side effects.

"We are excited about this result because it demonstrates that we can target a specific pathway directly in the skin, achieving clinical efficacy while minimizing systemic toxicity," said Christopher Powala, president & CEO of NFlection Therapeutics. "This topically targeted approach is of critical importance to the immunosuppressed, who are at high risk for this aggressive cancer and require an effective chemoprevention strategy that also minimizes systemic exposure. We looks forward to taking NFX-179 gel into clinical trials."

Key Application for Solid Organ Transplant Recipients
Cutaneous squamous cell carcinoma is one of the most common cancers, with an estimated 700,000 cases diagnosed in the United States annually. Risk factors for cutaneous squamous cell carcinoma include older age, male sex, fair pigmentation, ultraviolet exposure and immunosuppression. In particular, solid organ transplant recipients (SOTRs) have a 65- to 250-fold increased incidence of immunosuppressant-mediated cSCC compared to the general population, and up to 3.2% of SOTRs die from cutaneous squamous cell carcinoma.

"We believe this research, led by Dr. Tsai’s lab, is significant for solid organ transplant recipients, who often face a more aggressive cutaneous squamous cell carcinoma, with up to 25% mortality," said Dr. Guy Webster, Chief Medical Officer of NFlection. "There is currently no preventive treatment for immunosuppressed cSCC individuals, and the surgical options leave scars and commonly lead to recurrence. A topical, precision approach that these patients can tolerate would be an important advance."

Details of Plenary Session
"Topical MEK Inhibition as Precision Targeted Chemoprevention" will be presented during Plenary Session #3, which begins at 10:30 am ET on Thursday, May 6.

About NFX-179
NFX-179 is an investigational mitogen-activated protein kinase kinase inhibitor. NFX-179 is designed as a "soft" (metabolically labile) drug designed to concentrate at the site of action while significantly reducing side effects of systemically available MEK inhibitors.

On May 4, 2021 PerkinElmer, Inc. (NYSE: PKI), a global leader committed to innovating for a healthier world, reported that the Company will host a virtual Investor and Analyst Day on Thursday, June 24, 2021 from 8:30 a.m. to 12:00 p.m. ET (Press release, PerkinElmer, MAY 4, 2021, View Source [SID1234579174]).

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The virtual format will feature presentations by members of PerkinElmer’s senior management team including an update on business conditions and the meeting will conclude with a Q&A session.

A live webcast will be available to registered attendees on the Investors section of the Company’s website at www.perkinelmer.com. We encourage interested parties to preregister prior to the start of the event. A replay of the webcast will be available on the PerkinElmer website following the presentation.