On May 17, 2021 SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, reported financial results for the first quarter ended on March 31, 2021 and provided an update on recent clinical and corporate developments (Press release, Scynexis, MAY 17, 2021, View Source [SID1234580158]).

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"Our team is executing on all cylinders as we approach our June 1, 2021 PDUFA for Brexafemme," said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. "So far this year, we have received a total of approximately $35 million in non-dilutive funding, which is adequate to support our Brexafemme U.S. launch in the second half of the year while further extending our cash runway into 2023. We are also advancing the development of ibrexafungerp in the hospital setting, including our new IV formulation currently in Phase 1. With ibrexafungerp poised to become the first new antifungal class approved in over 20 years, we believe that the approval of the VVC indication may represent just the first step in the larger build-out of our antifungal franchise."

Ibrexafungerp Update

Remain on track for anticipated June 1st approval of ibrexafungerp for the treatment of VVC and commercial launch in the second half of 2021. SCYNEXIS is currently in discussions with the FDA to finalize its recommended wording for different sections of the drug’s Prescribing Information to provide adequate information to prescribers.

Dosing is ongoing in Phase 1 testing of the liposomal IV formulation of ibrexafungerp. Based on promising pre-clinical data of our liposomal IV formulation of ibrexafungerp, SCYNEXIS is conducting a Phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of the IV liposomal formulation of ibrexafungerp in healthy subjects. The study is being conducted in South Africa and dosing began in March 2021.
Enrollment is complete in the Phase 3 CANDLE study, investigating the efficacy and safety of oral ibrexafungerp for the prevention of recurrent VVC, for which there is no approved therapy in the U.S. SCYNEXIS expects the last-patient / last-visit by the end of 2021 with top-line results and a supplemental NDA submission anticipated in the first half of 2022, resulting in a potential approval in late 2022.
Enrollment is ongoing in our refractory invasive fungal infections (rIFI) program, which comprises two open-label Phase 3 studies (FURI and CARES). On March 2, 2021 SCYNEXIS presented positive data from its third interim analysis of the FURI study and first interim analysis of the CARES study, showing oral ibrexafungerp’s ability to treat severe fungal infections in the hospital setting. Consistent with two prior interim analyses, the FURI results confirm positive clinical activity of oral ibrexafungerp in patients with difficult-to-treat, severe, mucocutaneous and invasive fungal infections, including those caused by resistant strains. In total, oral ibrexafungerp showed clinical benefits in 64 out of 74 patients (86.5%), with 46 patients achieving a complete or partial response. The first interim analysis of CARES study showed strong clinical activity of oral ibrexafungerp in patients with invasive candidiasis and candidemia due to Candida auris, a high-mortality infection classified by Centers for Disease Control and Prevention as an urgent threat to public health, with 8 out of 10 patients (80.0%) experiencing a complete response. The results support continued enrollment in both open-label Phase 3 studies, with potential future submissions under the LPAD regulatory pathway.
Ibrexafungerp Phase 3 data were presented at a key medical conference, reporting efficacy in non-albicans Candida (NAC) and severe patients with vulvovaginal candidiasis infections. On April 30, SCYNEXIS presented posters on two data sets from SCYNEXIS’s Phase 3 VANISH program demonstrating the therapeutic potential of ibrexafungerp at the 2021 American College of Obstetricians and Gynecologists (ACOG) Annual Meeting that took place virtually from April 30-May 2, 2021. The data highlighted ibrexafungerp efficacy in treating patients with NAC, which was comparable to that of the total patient population enrolled in the trial. Additionally, ibrexafungerp was shown to be efficacious in patients with severe VVC, and may provide a treatment alternative where currently available therapies may not be satisfactory.
Corporate Developments and Subsequent Events

On February 11, 2021, SCYNEXIS entered into a licensing and strategic partnership agreement for ibrexafungerp with Hansoh Pharmaceutical that covers the Greater China region. So far SCYNEXIS received $11 million in upfront and milestone payments and is eligible to receive additional development and commercial milestone payments of up to $111 million, plus double-digit royalties on net sales.
On February 23, 2021, SCYNEXIS announced that it has partnered with Amplity Health, a leading global contract commercialization organization, to support the anticipated U.S. commercialization of Brexafemme (the conditionally FDA-approved brand name for ibrexafungerp for vaginal yeast infections) in the second half of 2021. SCYNEXIS will utilize Amplity’s commercial execution expertise and resources for sales force, remote engagement, training, market access and select operations services.
In May 2021, SCYNEXIS entered into an agreement with a third party to sell a portion of its unused 2020 New Jersey NOLs for approximately $4.2 million.
On May 10, 2021, SCYNEXIS granted stock options to three new employees to purchase an aggregate of 15,000 shares of SCYNEXIS common stock at a per share exercise price of $6.50, the closing trading price on May 10, 2021. Each option has a ten-year term, with one-fourth of the shares subject to the option vesting on the one-year anniversary of the employee’s first date of employment and the remainder vesting in equal monthly installments for thirty-six months thereafter, provided the employee continues to provide service to SCYNEXIS. The stock options were granted pursuant to SCYNEXIS’s 2015 Inducement Award Plan, as amended in April 2021, which was adopted by the SCYNEXIS’s board of directors in March 2015 under Rule 5635(c)(4) for equity grants to induce new employees to enter into employment with SCYNEXIS.
On May 11, 2021, SCYNEXIS announced the appointment of Christine Coyne as its Chief Commercial Officer to lead the anticipated U.S launch and commercialization of Brexafemme. She brings to the team deep anti-infective commercial expertise across hospital and community settings.
On May 13, 2021, SCYNEXIS entered into a loan agreement with Hercules Capital, Inc. and Silicon Valley Bank for an aggregate principal amount of $60.0 million. Under the terms of the loan agreement, SCYNEXIS received an initial tranche of $20.0 million from the lenders on the Closing Date and is eligible to receive an additional $10.0 million upon FDA approval of ibrexafungerp for the treatment of vaginal yeast infections. Subsequent cash injections will be available upon achieving certain milestones.
First Quarter 2021 Financial Results

Cash and cash equivalents totaled $92.0 million on March 31, 2021, compared to $93.0 million in cash and cash equivalents on December 31, 2020.

Research and development expense for the three months ended March 31, 2021 decreased to $6.9 million from $9.9 million for the three months ended March 31, 2020. The decrease of $2.9 million, or 30%, for the three months ended March 31, 2021, was primarily driven by a decrease of $2.1 million in clinical development expense, a decrease of $0.9 million in chemistry, manufacturing, and controls (CMC) expense, and a decrease of $0.5 million in preclinical expense, offset in part by an increase in salary related costs of $0.3 million and a net increase in other research and development expense of $0.3 million.

Selling, general & administrative expense for the three months ended March 31, 2021 increased to $6.7 million from $2.6 million for the three months ended March 31, 2020. The increase of $4.1 million, or 156%, for the three months ended March 31, 2021 was primarily driven by a $1.7 million increase in commercial related expense, an increase of $1.0 million in business development expense, an increase of $0.5 million in expense associated with increased information technology costs, and an increase of $0.3 million salary related costs.

Total other expense was $2.0 million for the three months ended March 31, 2021, compared to total other income of $5.5 million for the three months ended March 31, 2020. During the three months ended March 31, 2021 and 2020, SCYNEXIS recognized non-cash income of $1.3 million and $4.8 million, respectively, on the fair value adjustment of the warrant liabilities and during the three months ended March 31, 2021 and 2020, recognized non-cash expense of $0.1 million and non-cash gains of $0.7 million on the fair value adjustment of the derivative liabilities, respectively.

Net loss for the three months ended March 31, 2021 was $4.7 million, or ($0.18) per basic and ($0.23) per diluted share, compared to a net loss of $7.0 million, or ($0.72) per basic and diluted share for the three months ended March 31, 2020.

About Ibrexafungerp

Ibrexafungerp [pronounced eye-BREX-ah-FUN-jerp] is an investigational antifungal agent and the first representative of a novel class of structurally-distinct glucan synthase inhibitors, triterpenoids. This agent combines the well-established activity of glucan synthase inhibitors with the potential flexibility of having oral and intravenous (IV) formulations. Ibrexafungerp is currently under regulatory review for the treatment of vaginal yeast infection, also known as vulvovaginal candidiasis (VVC), and in late-stage development for multiple indications, including life-threatening fungal infections caused primarily by Candida (including C. auris) and Aspergillus species in hospitalized patients. It has demonstrated broad-spectrum antifungal activity, in vitro and in vivo, against multidrug-resistant pathogens, including azole- and echinocandin-resistant strains.

The FDA has accepted a New Drug Application for ibrexafungerp for the treatment of VVC and granted a Prescription Drug User Fee Act (PDUFA) action date of June 1, 2021. It also granted Qualified Infectious Disease Product (QIDP) and Fast Track designations for the IV and oral formulations of ibrexafungerp for the indications of invasive candidiasis (IC) (including candidemia) and invasive aspergillosis (IA), and has granted Orphan Drug Designation for the IC and IA indications. Ibrexafungerp is formerly known as SCY-078.

On May 17, 2021 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported its recent accomplishments and financial results for the quarter ended March 31, 2021 (Press release, Soligenix, MAY 17, 2021, View Source,quarter%20ended%20March%2031%2C%202020. [SID1234580157]).

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"This year continues to be an exciting year of progress for Soligenix," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "We recently announced presentation of clinical data from our successful pivotal Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) clinical trial for HyBryte (SGX301) in the treatment of cutaneous T-cell lymphoma (CTCL) at both the American Academy of Dermatology, where HyBryte was designated "Top 12 late-breaking research," and the Society for Investigative Dermatology. We also received U.S. Food and Drug Administration (FDA) conditional acceptance of HyBryte as the proposed brand name for SGX301 (synthetic hypericin), as we continue to prepare for a new drug application (NDA) submission and U.S. commercialization for this novel first-in-class photodynamic therapy for treatment of early stage CTCL. Under our Public Health Solutions business segment, supported by non-dilutive government funding, we continue to advance multiple therapeutic and vaccine candidates. CiVax, our heat stable COVID-19 vaccine, recently demonstrated that the proprietary subunit protein antigen, locked into its receptor-binding configuration, was immunogenic in both mice and non-human primates, which is an important step in advancing CiVax towards human clinical trials."

Dr. Schaber continued, "With approximately $30 million in cash, not including our non-dilutive government funding, we anticipate having sufficient capital to achieve multiple inflection points as we advance our rare disease pipeline, including NDA filing and U.S. commercialization of HyBryte in CTCL, where we estimate peak U.S. annual net sales to exceed $90 million and the total U.S. revenues during the 10-year forecast period to be greater than $700 million."

Soligenix Recent Accomplishments

On May 10, 2021, the Company announced that HyBryte (hypericin) was awarded an "Innovation Passport" for the treatment of early stage CTCL in adults under the United Kingdom’s (UK’s) Innovative Licensing and Access Pathway (ILAP). To view this press release, please click here.
On April 28, 2021, the Company announced that its Senior Vice President and Chief Scientific Officer, Oreola Donini, PhD, delivered a presentation demonstrating the potency of the CiVax (COVID-19 vaccine) development program in mice and non-human primates (NHPs), at the Annual Conference on Vaccinology Research, held April 26-27, 2021. To view this press release, please click here.
On April 26, 2021, the Company announced that Ellen Kim, MD, Medical Director, Dermatology Clinic, Perelman Center for Advanced Medicine, Professor of Dermatology at the Hospital of the University of Pennsylvania, and the Lead Principal Investigator for the Phase 3 FLASH study, delivered a presentation at the American Academy of Dermatology Association Virtual Meeting Experience, held April 23-25, 2021, expanding on data related to the efficacy and safety of HyBryte in the treatment of CTCL. To view this press release, please click here.
On April 7, 2021, the Company announced that the FDA had conditionally accepted HyBryte as the proposed brand name for SGX301 (synthetic hypericin), the Company’s novel first-in-class photodynamic therapy for first-line treatment of early stage CTCL. To view this press release, please click here.
On March 30, 2021, the Company announced its recent accomplishments and financial results for the year ended December 31, 2020. To view this press release, please click here.
Financial Results – Quarter Ended March 31, 2021

Soligenix’s revenues for the quarter ended March 31, 2021 were $0.1 million as compared to $0.9 million for the quarter ended March 31, 2020. Revenues included payments on a contract in support of RiVax, our ricin toxin vaccine candidate, and grants received to support the development of: SGX943 for treatment of emerging and/or antibiotic-resistant infectious diseases; ThermoVax, our thermostabilization technology; and CiVax, our vaccine candidate for the prevention of COVID-19.

Soligenix’s basic net loss was $2.4 million, or ($0.06) per share, for the quarter ended March 31, 2021, as compared to $7.6 million, or ($0.32) per share, for the quarter ended March 31, 2020. This decrease in net loss was primarily due to a $5.0 million success milestone due to Hy Biopharma that was paid in common stock (based upon an effective per share price of $2.56) as a result of SGX301 demonstrating statistically significant treatment response in the pivotal Phase 3 clinical trial Inc. during the three months ended March 31, 2020.

Research and development expenses were $1.4 million as compared to $2.7 million for the quarters ended March 31, 2021 and 2020, respectively. The decrease in research and development spending for the quarter ended March 31, 2021 was primarily attributable to the reduction in expense due to the completion of the HyBryte and SGX942 clinical trials.

General and administrative expenses were $0.9 million for both the three months ended March 31, 2021 and 2020.

As of March 31, 2021, the Company’s cash position was approximately $30.5 million.

On May 17, 2021 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, reported financial results for the three months ending March 31, 2021 and provided a corporate update (Press release, Altimmune, MAY 17, 2021, View Source [SID1234580156]).

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"With AdCOVID, our single-dose intranasal vaccine candidate for COVID-19 and ALT-801, our GLP-1/glucagon dual agonist candidate for non-alcoholic steatohepatitis (NASH) now advancing in the clinic, 2021 has the potential to be a data-rich period for the Company," remarked Vipin K. Garg, Ph.D., President and Chief Executive Officer at Altimmune. "We anticipate data readouts from both of these clinical trials in June. If the data from the AdCOVID Phase 1 trial are positive, we plan to quickly transition into a comprehensive global Phase 2 clinical development program. We strongly believe that a vaccine candidate like AdCOVID, which can be administered via a simple nasal spray along with what we hope will be an excellent safety and tolerability profile, could become an important tool for the global COVID-19 vaccination effort."

Dr. Garg continued, "ALT-801 is also progressing as planned through its first-in-human clinical trial in Australia and we anticipate 6-week data to be available later this quarter. We are excited about the potential of ALT-801, and hope that clinical studies will show ALT-801 can deliver similar therapeutic benefits to current GLP-1 based treatment options in development but without the GI intolerability that leads to treatment discontinuation. The NASH opportunity, together with a potential indication in obesity, could be very large for ALT-801 and early clinical success could have a dramatic effect on Altimmune’s growth."

Recent Highlights:

AdCOVID, a novel, needle-free, intranasal vaccine candidate for COVID-19

Enrollment target met in amended AdCOVID Phase 1 clinical trial evaluating the safety and immunogenicity of AdCOVID in healthy volunteers

The Phase 1 trial will measure systemic antibody responses including serum neutralizing antibody, T cell responses and mucosal IgA, a measure of mucosal immunity in the nasopharyngeal cavity
The study protocol was amended to reduce the number of adult subjects to approximately 80. The amendment was necessary due to the widespread availability of authorized vaccines. The final sample size of the study is comparable to the number of participants in Phase 1 studies of the U.S. authorized vaccines
A topline data readout is anticipated in June 2021
Progressed development of adapted AdCOVID vaccine candidates targeting emerging SARS-CoV-2 variants

Initiated preclinical evaluation of AdCOVID vaccine candidates targeting E484K variants, including P.1, B.1.351 and B.1.617
Initiation of a Phase 2 trial with a variant AdCOVID vaccine candidate expected in Q4 2021
Expanded manufacturing capabilities through an agreement with Lonza to commission a dedicated manufacturing suite for clinical and potential future commercial supply

Complements and extends existing network of strategic manufacturing partners, building extra capacity and redundancy into the AdCOVID manufacturing effort
Supports manufacturing of clinical supply material for potential late-stage clinical trials and commercial scale
Announced new data from preclinical studies conducted in collaboration with the University of Alabama at Birmingham (UAB)
In these preclinical studies, a single intranasal dose of AdCOVID provided:

100% protection against a lethal challenge from the SARS-CoV-2 virus, with 1000-fold reduction of replicating virus in the nasal cavity and respiratory tract following infection with SARS-CoV-2
Sterilizing immunity, i.e., undetectable levels of infectious virus in the lungs, believed to be essential to fully block viral transmission
Long-lived systemic and mucosal immune responses, which were essentially unchanged over 6 months
Established plans for a robust Phase 2 clinical development program, which is anticipated to include:

A multi-national study in adults 18 years of age and older in regions where vaccine access has been limited
An evaluation of AdCOVID as a potential booster for previously-infected and vaccinated individuals using a parental and P.1 variant AdCOVID vaccine
An age-based de-escalation study in children and adolescents
A study evaluating safety and immunogenicity in mother-infant pairs
ALT-801, a novel GLP-1/glucagon dual agonist candidate for NASH

Progressed ongoing Phase 1 clinical trial of ALT-801 in Australia

Completed enrollment in the single ascending dose (SAD) phase and 3 planned cohorts of multiple ascending dose (MAD) phase of the trial, with 6-week data anticipated in June 2021, and 12-week data anticipated in Q3 2021
Plans to commence a 52-week, Phase 2, biopsy-trial based on NASH endpoints in early 2022
Anticipated mid-year IND filing to initiate U.S. NASH studies

Potential filing of a second IND for an obesity indication in 2H 2021

The filing of a second IND in obesity in 2H 2021 is being evaluated, with the final decision based on the weight loss data from the upcoming Phase 1 trial readout
Other programs

Continued progress in Phase 1/2 clinical trial of T-COVID, a therapeutic candidate for the treatment of SARS-CoV-2 and other respiratory infections, and a Phase 2 clinical trial of HepTcell, an immunotherapeutic candidate for the treatment of chronic hepatitis B
Financial Results for the Three Months Ended March 31, 2021

Altimmune had cash, cash equivalents and short-term investments totaling $226.5 million at March 31, 2021 compared to $216.0 million at December 31, 2020. The increase is primarily attributable to $34.2 million of net receipts during the quarter due to its utilization of the at-the-market offering program, partially offset by $19.6 million of cash used for operating activities.
Revenue was $0.8 million for the three months ended March 31, 2021 compared to $2.2 million in the prior period, a decrease of $1.4 million. The change in revenue quarter over quarter was primarily due to a decrease of $2.0 million in BARDA revenue during the current period due to the timing of clinical trials and development activities for NasoShield, partially offset by $0.5 million in revenue attributable to T-COVID.
Research and development expenses were $11.9 million for the three months ended March 31, 2021, compared to $7.2 million in the prior period, representing an increase of $4.7 million. The change was primarily the result of increased expenses of $5.4 million related to development activities for the Company’s COVID-19 programs, partially offset by a decrease of $1.5 million resulting from a decrease in the fair value of contingent consideration liability connected with the acquisition and development of ALT-801.
General and administrative expenses were $3.8 million for the three months ended March 31, 2021 compared to $2.3 million in the prior period, an increase of $1.5 million. The increase during the quarter is primarily due to increased stock compensation expense and additional labor related costs.
Net loss for the three months ended March 31, 2021 was $14.9 million, or $0.38 net loss per share, compared to $3.9 million in the prior period, or $0.26 net loss per share. The difference in net loss is primarily attributable to higher research and development expenses and general and administrative expenses.
Conference Call Information
Following the conclusion of the call, the webcast will be available for replay on the Investor Relations page of the Company’s website at www.altimmune.com. The company has used, and intends to continue to use, the IR portion of its website as a means of disclosing material non-public information and for complying with disclosure obligations under Regulation FD.

On May 17, 2021 Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating cancer and neurodegenerative disease through the inhibition of SEMA4D, reported financial results for the first quarter ended March 31, 2021 and provided a corporate update (Press release, Vaccinex, MAY 17, 2021, View Source [SID1234580155]).

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"During the first quarter and subsequent period, we achieved notable progress across our proprietary clinical programs in cancer and neurology as well as our technology partnerships," stated Maurice Zauderer, Ph.D., president and chief executive officer. "We were very pleased to announce the commencement of our Phase 2 clinical trial of pepinemab in combination with KEYTRUDA for front-line, recurrent or metastatic head and neck cancer, a solid tumor indication in which SEMA4D is highly expressed. This represents an expansion of our development pipeline and, together with the recently published results of our non-small cell lung cancer trial, we believe that pepinemab can be a valuable new addition to cancer immunotherapy.

"Continued analysis of the full data set from our Phase 2 SIGNAL trial in Huntington’s disease indicates that pepinemab can provide a cognitive benefit in this and potentially other neuroinflammatory and neurodegenerative indications with significant unmet medical needs. To that end, we remain on track to initiate a Phase 1/2a trial of pepinemab in Alzheimer’s disease by the end of the second quarter while we continue to engage in discussions with potential partners regarding a planned Phase 3 trial in Huntington’s disease.

"Finally, during the quarter we announced that we entered into a licensing agreement with Surface Oncology following on delivery and qualification of a fully human anti-CCR8 antibody. This is meaningful as we continue to leverage our proprietary ActivMab platform as a potential source of non-dilutive funding that can help advance our other programs."

Pepinemab Clinical Updates:

Head and Neck Cancer. Subsequent to the end of the first quarter, Vaccinex announced it initiated a Phase 2 clinical trial evaluating pepinemab in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) for advanced, recurrent or metastatic head and neck cancer. Multiple prior studies suggest that inhibition of SEMA4D increases immune infiltration and alters the balance of cytotoxic and immunosuppressive cells in the tumor microenvironment. As SEMA4D is highly expressed in head and neck cancer, we believe there is a strong rationale for development in this indication.
The study is expected to enroll up to 65 subjects and key endpoints are expected to include objective response, duration of response, progression free survival and overall survival.

Alzheimer’s Disease. By the end of the second quarter, Vaccinex intends to initiate a Phase 1/2a clinical trial of pepinemab in Alzheimer’s disease, funded in part by a $750,000 development grant from the Alzheimer’s Association under the 2020 Part the Cloud Program, as well as a $3 million award from the Alzheimer’s Drug Discovery Foundation.
The awards are based in part on earlier findings that treatment with pepinemab prevented the characteristic loss of glucose transport in the brain during underlying Huntington’s disease progression as detected by conventional FDG-PET imaging. Uptake of glucose, the main source of energy in the brain, is also known to decline with underlying disease progression in Alzheimer’s disease, and multiple studies in Alzheimer’s disease have shown that decline in glucose transport correlates with cognitive decline. The randomized, placebo-controlled, multi-center study is anticipated to enroll 40 subjects for 12 months treatment duration.

Huntington’s disease. Based on analysis of the full data set from the Phase 2, double-blind, placebo-controlled SIGNAL trial of pepinemab in patients with early manifest Huntington’s disease (HD), Vaccinex determined that pepinemab appeared to confer cognitive benefit to patients as determined from results of the Huntington’s Disease Cognitive Assessment Battery (HD-CAB). As a result, Vaccinex believes that a phase 3 trial is warranted and is currently engaged in discussions of such a study with several potential pharmaceutical partners.
Other Trials. Pepinemab is also being evaluated in multiple investigator-sponsored trials (ISTs) being conducted by the Winship Cancer Institute of Emory University to evaluate pepinemab in combination with checkpoint inhibitors in short term "Window of Opportunity" studies in colorectal, pancreatic, and head and neck cancer and melanoma.
Other First Quarter and Recent Accomplishments:

Announced the publication of results from the CLASSICAL-Lung phase 1b/2 clinical trial in non-small cell lung cancer in the peer-reviewed journal Clinical Cancer Research. The publication presents data showing that pepinemab is clinically active when combined with BAVENCIO, a checkpoint inhibitor, and that the combination was well-tolerated with no major new safety signals identified. It was of particular interest that the combination appeared to extend treatment benefit to immunotherapy naïve patients whose tumors were PD- L1 negative or low, a patient population that has, in general, been less responsive to immunotherapy. Combination treatment also appeared to halt or reverse tumor progression (partial response or stable disease) in select patients with primary or acquired resistance to anti-PD-1/L1 therapy.
Entered into multi-project deals with two leading pharmaceutical companies focused on leveraging Vaccinex’s ActivMAb antibody discovery and novel viral display platform for drug discovery against difficult but important multi-pass membrane receptors such as GPCR and ion channels.
Announced that Surface Oncology will be exercising its option to license an anti-CCR8 antibody discovered using Vaccinex’s ActivMAb platform. The terms of agreement with Surface Oncology providedthat Surface Oncology pay technology access and licensing fees to Vaccinex in addition to providing research funding, and that Vaccinex will qualify for development milestone payments and royalties.
Raised $32 million in net proceeds through its existing open sale market agreement, or ATM, facility.
Upcoming Anticipated Milestone Dates:

Q2 2021 – Initiation of Alzheimer’s disease Phase 1/2a trial
Mid-2022 – Initial data from open label head and neck cancer trial
Late 2022/Early 2023 – Data from randomized Alzheimer’s trial
Financial Results for the Three Months Ended March 31, 2021:

Revenue. Revenue for the three months ended March 31, 2021 was $850,000. The Company’s revenues were generated from the licensing arrangement with Surface Oncology.

Research and Development Expenses. Research and development expenses for the three months ended March 31, 2021 were $5.5 million as compared to $5.4 million for the comparable period in 2020.

General and Administrative Expenses. General and administrative expenses for the three months ended March 31, 2021 were $1.6 million as compared to $1.8 million for the comparable period in 2020.

Cash and Cash Equivalents and Marketable Securities. Cash and cash equivalents and marketable securities on March 31, 2021 were $29.4 million, as compared to $10.6 million as of December 31, 2020. The increase in cash was a result of $32 million in net proceeds raised by the Company through its ATM facility.

On May 17, 2021 Vincerx Pharma, Inc. (Nasdaq: VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, reported financial results for the first quarter ended March 31, 2021 and provided a corporate update (Press release, Vincerx Pharma, MAY 17, 2021, View Source [SID1234580154]).

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"The clearance of Vincerx’s first company-sponsored IND is an important milestone that paves the way for the initiation of our planned Phase 1b dose escalation study of VIP152 in patients with relapsed/refractory chronic lymphocytic leukemia and Richter syndrome in the second half of the year," said Ahmed Hamdy M.D., Chief Executive Officer of Vincerx. "This rapid execution is a testament to our team’s capabilities, and builds upon our Phase 1b expansion study in patients with MYC-driven hematologic malignancies and solid tumors, expected to begin patient dosing in the second quarter. Both studies are part of our comprehensive clinical program, which leverages early signals of Phase 1 clinical activity to evaluate the potential of VIP152 in challenging oncology populations. We look forward to continued progress across these important milestones in the clinic, which will also include the presentation of Phase 1 data in patients with double-hit lymphoma at ASCO (Free ASCO Whitepaper)."

Dr. Hamdy continued, "For our preclinical assets, we were pleased to present compelling preclinical data on VIP236 at the AACR (Free AACR Whitepaper) Annual Meeting, highlighting that VIP236 has the potential to provide potent, highly targeted antitumor activity to address the needs of patients with advanced and aggressive cancers. We remain focused on rapidly advancing our pipeline from a clinical and regulatory standpoint and look forward to providing further updates."

Recent Highlights

Announced U.S. Food and Drug Administration (FDA) clearance of Investigational New Drug (IND) Application to initiate a Phase 1b dose escalation study evaluating VIP152, a highly selective PTEFb/CDK9 inhibitor, in patients with relapsed/refractory chronic lymphocytic leukemia (CLL) and Richter syndrome (RS)

Presented preclinical data on VIP236, a novel small molecule drug conjugate (SMDC), at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021

Hosted Key Opinion Leader (KOL) event on bioconjugation and CDK9 inhibitors, featuring presentations by Brian Druker, M.D., Knight Cancer Institute, and Anthony W. Tolcher, M.D., NEXT Oncology

Announced that Phase 1 safety and efficacy dose escalation data from patients with double-hit lymphoma will be presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting
Announced formation of Scientific Advisory Board (SAB) composed of world leading academics and industry leaders in cancer research and therapeutics

Announced completion of public warrant redemption and receipt of cash proceeds of approximately $37.3 million.
First Quarter 2021 Financial Results

Vincerx Pharma ended the first quarter with $53.4 million in cash and cash equivalents, which does not include the proceeds from the public warrant redemption noted above, compared to $61.8 million at December 31, 2020.

Net loss for the first quarter ended March 31, 2021 was $6.3 million, or $0.46 per share, basic and diluted.

Research and development (R&D) expenses were $4.8 million for the quarter ended March 31, 2021, consisting primarily of $2.7 million in stock-based compensation expense, $1.3 million in new employee salaries and $0.8 million of outside services in preparation for our anticipated clinical trials.

General and administrative (G&A) expenses were $4.8 million for the quarter ended March 31, 2021, consisting primarily of $2.0 million in stock-based compensation expense, $0.9 million related to new employee salaries and $1.5 million of legal, accounting and other professional services in support of our intellectual property protection and operations as a newly formed public company.