On July 27, 2022 vTv Therapeutics Inc. (Nasdaq: VTVT), a clinical stage biopharmaceutical company focused on the development of orally administered treatments for type 1 diabetes (T1D), reported that Paul Sekhri will lead the company as President and Chief Executive Officer, effective August 1, 2022 (Press release, vTv Therapeutics, JUL 27, 2022, View Source [SID1234617022]). Rich Nelson, who has been serving as Interim Chief Executive Officer since March 2, 2022, will continue to support the company as Executive Vice President, Corporate Development and as a member of the Board of Directors. Mr. Sekhri will also join vTv’s Board of Directors.

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Paul joins vTv as it sets to launch Phase 3 pivotal studies for its most advanced product, TTP399, which was granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) in April 2021 as an oral adjunctive therapy for the treatment of T1D.

Positive results from the Phase 2 study showed treatment with TTP399 resulted in a statistically significant improvement in HbA1c relative to placebo and a clinically meaningful 40% decrease in the frequency of severe and symptomatic hypoglycemia.

Last month, vTv announced a $25 million investment by G42 Investments AI Holding RSC Ltd. and entry into a collaboration and license agreement with affiliates of G42 Healthcare whereby G42’s affiliate will be funding a significant portion of the Phase 3 clinical trials for TTP399.

"While I’ve served in the Interim CEO role for the past four months, we diligently searched for the right candidate to steer the company through this final stage of TTP399 development and are highly confident that Paul is the right person for the role," said Rich Nelson. "We are thrilled to have Paul join vTv at this very exciting time in the company’s lifecycle as we actively engage in activities in preparation of the initiation of our Phase 3 trials and continue to have positive discussions with institutions in the biotech community about further investment in vTv. Paul brings extensive experience as CEO of several prominent healthcare companies and has strong ties to the biotech investment community. We are very excited to have Paul on board and I look forward to continuing to support vTv in my new role and to support Paul in his."

Mr. Sekhri brings nearly 30 years of healthcare experience, including serving as President and CEO of several healthcare companies such as eGenesis, Lycera Corp., Cerimon Pharmaceuticals, as well as senior business development and strategy roles at Sanofi, Teva Pharmaceutical Industries Ltd., TPG Biotech, Cerimon, Ariad Pharmaceuticals and Novartis Pharma AG. He has been a director on more than 30 private, public company and non-profit boards and is currently a Director at Ipsen, S.A., Compugen, Pharming N.V., Veeva Systems, Longboard, Spring Discovery and eGenesis. Additionally, he is on the Board of Directors of the Metropolitan Opera.

"During my long career as a biotechnology executive, I have been attracted to truly novel therapeutic approaches that address serious medical challenges and/or improve patient care," said Mr. Sekhri. "T1D is a challenging enough disease for patients to manage without also having to worry about hypoglycemia. A treatment that significantly reduces the risk of hypoglycemia while also improving Hb1Ac would be a significant advance for treating this disease. I look forward to working with the vTv team to initiate and successfully complete our Phase 3 trials."

On July 26, 2022, Mr. Sekhri was granted stock options (the "Options") to purchase 2,200,000 shares of the Class A common stock of vTv at an exercise price of $0.79 per share pursuant to an inducement award agreement (the "Inducement Award Agreement"). Subject to potential acceleration upon the achievement of certain performance metrics as set forth in the Inducement Award Agreement, 25% of the Options will vest on the first anniversary of the grant date and thereafter the Options will vest in equal quarterly installments over the next three years. Upon certain terminations of employment, a portion of the Options will vest on a pro rata basis based on the number of days employed during the four-year term. The grant of Options was made as an inducement grant under NASDAQ Listing Rule 5635(c)(4).

On July 27, 2022 Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies and cytokines for the treatment of cancer and autoimmune diseases, reported it will release second quarter 2022 financial results after the market closes on Wednesday, August 3, 2022 (Press release, Xencor, JUL 27, 2022, View Source [SID1234617021]).

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Xencor management will host a webcast and conference call the same day at 4:30 p.m. ET (1:30 p.m. PT) to discuss the financial results and provide a corporate update.

The live webcast will be available under "Events & Presentations" in the Investors section of the Company’s website located at investors.xencor.com and will be archived for at least 30 days. Participants may register for the conference call at the following link: register.vevent.com/register/BI8b3886bf9772414c8dd5900d3aa4457b.

On July 27, 2022 VerImmune, Inc. ("VerImmune"), a biotechnology company developing new therapeutic modalities that aim to redirect the body’s pre-existing immunity toward cancer, reported the close of $2.5 million in Seed funding (Press release, VerImmune, JUL 27, 2022, View Source [SID1234617020]). The round was led by SeedFolio, a seed series venture capital firm focused on innovative, early-stage companies with game-changing impact potential. The round also included participation from US and global investment venture firms such as Ulu Ventures, and Proxima VC as well as leading private investment syndicate funds such as the NuFund Venture group (previously Tech Coast Angels- San Diego), Gaingels, Mana Ventures, and others.

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VerImmune intends to use this Seed round financing to further accelerate VerImmune’s lead product development timelines as well as grow the company’s team.

"We are delighted to successfully complete this new seed financing round. Our ability to attract a high-quality diverse group of both US and international investors reflects the global enthusiasm for VerImmune’s technology, management and plans to develop this potentially transformative immuno-oncology treatment for all cancer patients," said Joshua Wang, Founding CEO. "This closing comes at an exciting time for VerImmune as it marks the third wave of deals VerImmune has been able to achieve in the last 6 months following announcements on collaborations with well-established global pharmaceutical companies earlier this year."

"We are delighted to have led the financing for VerImmune. They have stood out due to their highly differentiated platform and mechanistic approach to target tumors for destruction," said Joe Gatto, Managing Director of SeedFolio and VerImmune’s lead investor. "Despite their founding during the Covid-19 pandemic and recent market uncertainties, I have been very impressed by their resiliency and continued ability to produce strong supportive preclinical data."

Another major investor, Haolin Sung, Partner at Proxima VC, a healthcare investment firm that focuses on outstanding enterprises with highly innovative technologies, also said the following: "We are extremely excited for VerImmune’s ViP (Virus-inspired Particle) platform technology. Cancer remains as a huge unmet medical need, and we see the potential pivotal role of benefiting cancer patients through the Anti-tumor Immune Redirection (AIR) approach. Importantly, we see the opportunity for the ViP to change treatment paradigms beyond oncology." Mr. Sung, will be joining VerImmune’s board of directors and represent this round of seed investors.

VerImmune was founded in early 2020 and had been headquartered for the past two years at Fastfoward 1812, near Johns Hopkins East Baltimore Campus in Maryland. In early 2022, the company moved its research and development laboratories to Johnson & Johnson Innovation – JLABS @ Washington, DC and is now fully operational. The relocation of VerImmune’s laboratory headquarters continues to be within the BioHealth Capital Region (BHCR) cluster which consists of Maryland, Washington D.C and Virginia.

"As we contemplated expanding our presence and growth in 2022, remaining in the BHCR cluster was crucial for us given our strong existing relationships within this rich ecosystem of public and private institutions. This is an exciting time for us as we look towards expanding our team and maturing our company development pipeline with our funding, partnerships, and new state-of-the-art research facilities at JLABS @ Washington, DC," said John Troyer, COO.

On July 27, 2022 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported that it will report second quarter 2022 financial results on Thursday, August 11, 2022, prior to the open of the market (Press release, UroGen Pharma, JUL 27, 2022, View Source [SID1234617019]). The announcement will be followed by a live audio webcast and conference call at 10:00 AM Eastern Time.

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A live public webcast of the earnings conference call can be accessed on UroGen’s Investor Relations website. Following the live webcast, a replay will be available on the site for approximately 30 days.

On July 27, 2022 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 that it has received agreement from the US Food & Drug Administration (FDA) on an initial pediatric study plan (iPSP) for HyBryte (synthetic hypericin) for the treatment of cutaneous T-cell lymphoma (CTCL) (Press release, Soligenix, JUL 27, 2022, View Source [SID1234617018]). The agreed iPSP stipulates that Soligenix intends on requesting a full waiver of pediatric studies upon submission of a new drug application (NDA). Agreement with FDA on an iPSP is one of the regulatory requirements that must be met prior to submitting a NDA.

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"We are pleased to have FDA’s agreement on our proposal to request a full waiver of pediatric studies at the time of our HyBryte NDA filing later this year," stated Christopher J. Schaber, PhD, President & Chief Executive Officer of Soligenix. "This is consistent with decisions by the European Medicines Agency (EMA) and Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom which have previously granted product-specific waivers from the requirement for pediatric studies in applications for marketing authorization of HyBryte in the UK and Europe."

About HyBryte
HyBryte (research name SGX301) is a novel, first-in-class, photodynamic therapy utilizing safe, visible light for activation. The active ingredient in HyBryte is synthetic hypericin, a potent photosensitizer that is topically applied to skin lesions that is taken up by the malignant T-cells, and then activated by visible light 16 to 24 hours later. The use of visible light in the red-yellow spectrum has the advantage of penetrating more deeply into the skin (much more so than ultraviolet light) and therefore potentially treating deeper skin disease and thicker plaques and lesions. This treatment approach avoids the risk of secondary malignancies (including melanoma) inherent with the frequently employed DNA-damaging drugs and other phototherapy that are dependent on ultraviolet exposure. Combined with photoactivation, hypericin has demonstrated significant anti-proliferative effects on activated normal human lymphoid cells and inhibited growth of malignant T-cells isolated from CTCL patients. In a published Phase 2 clinical study in CTCL, patients experienced a statistically significant (p=0.04) improvement with topical hypericin treatment whereas the placebo was ineffective. HyBryte has received orphan drug and fast track designations from the FDA, as well as orphan designation from the European Medicines Agency (EMA).

The recently published Phase 3 FLASH trial trial enrolled a total of 169 patients (166 evaluable) with Stage IA, IB or IIA CTCL. The trial consisted of three treatment cycles. Treatments were administered twice weekly for the first 6 weeks and treatment response was determined at the end of the 8th week of each cycle. In the first double-blind treatment cycle, 116 patients received HyBryte treatment (0.25% synthetic hypericin) and 50 received placebo treatment of their index lesions. A total of 16% of the patients receiving HyBryte achieved at least a 50% reduction in their lesions (graded using a standard measurement of dermatologic lesions, the CAILS score) compared to only 4% of patients in the placebo group at 8 weeks (p=0.04) during the first treatment cycle (primary endpoint). HyBryte treatment in the first cycle was safe and well tolerated.

In the second open-label treatment cycle (Cycle 2), all patients received HyBryte treatment of their index lesions. Evaluation of 155 patients in this cycle (110 receiving 12 weeks of HyBryte treatment and 45 receiving 6 weeks of placebo treatment followed by 6 weeks of HyBryte treatment), demonstrated that the response rate among the 12-week treatment group was 40% (p<0.0001 vs the placebo treatment rate in Cycle 1). Comparison of the 12-week and 6-week treatment groups also revealed a statistically significant improvement (p<0.0001) between the two groups, indicating that continued treatment results in better outcomes. HyBryte continued to be safe and well tolerated. Additional analyses also indicated that HyBryte is equally effective in treating both plaque (response 42%, p<0.0001 relative to placebo treatment in Cycle 1) and patch (response 37%, p=0.0009 relative to placebo treatment in Cycle 1) lesions of CTCL, a particularly relevant finding given the historical difficulty in treating plaque lesions in particular.

The third (optional) treatment cycle (Cycle 3) was focused on safety and all patients could elect to receive HyBryte treatment of all their lesions. Of note, 66% of patients elected to continue with this optional compassionate use / safety cycle of the study. Of the subset of patients that received HyBryte throughout all 3 cycles of treatment, 49% of them demonstrated a positive treatment response (p<0.0001 vs patients receiving placebo in Cycle 1). Moreover, in a subset of patients evaluated in this cycle, it was demonstrated that HyBryte is not systemically available, consistent with the general safety of this topical product observed to date. At the end of Cycle 3, HyBryte continued to be well tolerated despite extended and increased use of the product to treat multiple lesions.

Overall safety of HyBryte is a critical attribute of this treatment and was monitored throughout the three treatment cycles (Cycles 1, 2 and 3) and the 6-month follow-up period. HyBryte’s mechanism of action is not associated with DNA damage, making it a safer alternative than currently available therapies, all of which are associated with significant and sometimes fatal, side effects. Predominantly these include the risk of melanoma and other malignancies, as well as the risk of significant skin damage and premature skin aging. Currently available treatments are only approved in the context of previous treatment failure with other modalities and there is no approved front-line therapy available. Within this landscape, treatment of CTCL is strongly motivated by the safety risk of each product. HyBryte potentially represents the safest available efficacious treatment for CTCL. With no systemic absorption, a compound that is not mutagenic and a light source that is not carcinogenic, there is no evidence to date of any potential safety issues.

The Phase 3 CTCL clinical study was partially funded by the National Cancer Institute via a Phase II SBIR grant (#1R44CA210848-01A1) awarded to Soligenix, Inc.

About Cutaneous T-Cell Lymphoma (CTCL)
CTCL is a class of non-Hodgkin’s lymphoma (NHL), a type of cancer of the white blood cells that are an integral part of the immune system. Unlike most NHLs which generally involve B-cell lymphocytes (involved in producing antibodies), CTCL is caused by an expansion of malignant T-cell lymphocytes (involved in cell-mediated immunity) normally programmed to migrate to the skin. These malignant cells migrate to the skin where they form various lesions, typically beginning as patches and may progress to raised plaques and tumors. Mortality is related to the stage of CTCL, with median survival generally ranging from about 12 years in the early stages to only 2.5 years when the disease has advanced. There is currently no cure for CTCL. Typically, CTCL lesions are treated and regress but usually return either in the same part of the body or in new areas.

CTCL constitutes a rare group of NHLs, occurring in about 4% of the approximate 700,000 individuals living with the disease. It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of CTCL that it affects over 25,000 individuals in the U.S., with approximately 3,000 new cases seen annually.