On August 15, 2024 DermBiont, a clinical-stage biotechnology company that is advancing first-in-class topical therapeutics to address patient needs in rare disease oncology and aesthetic dermatology, reported positive initial data from its ongoing open label, multi-center Phase 2a study for the treatment of basal cell carcinoma (BCC) (Press release, DermBiont, AUG 15, 2024, View Source [SID1234645951]). As a result, DermBiont has reprioritized SM-020, a first-in-class, patient-applied, and topical kinase inhibitor, for the development of two lead orphan disease oncology indications: treatment of locally advanced basal cell carcinoma (laBCC) and prevention of BCC in Gorlin Syndrome patients.

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DermBiont’s Phase 2a open-label trial is actively enrolling and treating up to 30 subjects with one to five superficial, nodular, or infiltrating primary BCCs. Lesions are being treated with SM-020 1% gel BID (twice daily) for 28 days, with the primary endpoint based on percent change from baseline in greatest tumor diameter at week 6. The safety of the drug product is being evaluated based on frequency of adverse events (AEs) and application site reactions (ASRs).

At the time of this release, seven subjects with a total of nine BCCs (1 superficial, 4 nodular, and 4 infiltrating) have been treated and show a prompt (within days of starting treatment) and robust clinical response to the application of SM-020 1% gel, clearly demonstrating the disease modifying potential of SM-020. All nine tumors have also demonstrated a partial or total reduction in clinically visible tumor.

Dr. Karl Beutner, M.D., Ph.D., and CEO of DermBiont said: "We are excited about these early results in BCC and the potential for a topical product for the treatment of laBCC and the prevention of BCCs in Gorlin Syndrome. An effective topical treatment would be welcomed by patients with laBCC given the limitations and side effects of the currently approved oral hedgehog inhibitors, while also providing patients with Gorlin Syndrome with an alternative to expensive and painful surgical procedures to remove chronic BCCs that result in significant scarring, require post-operative wound care, and lead to significant down time."

SM-020 has been well tolerated to date with no drug-related adverse events and only rare and transient primarily mild-to-moderate severity application site reactions. The same drug product has also been shown to be extremely well tolerated by subjects with seborrheic keratoses (SK), having been administered by over 100 subjects with SKs twice daily for at least 28 days in prior clinical trials.

Emma Taylor, M.D. and Chief Medical Officer at DermBiont, added: "SM-020 in vitro is highly potent at killing BCC cells and has a well-defined mechanism of action that hits established tumorigenesis pathways known to be the cause of BCCs, so the robust response that we are seeing in the clinic is not surprising."

Basal Cell Carcinoma is the most common cancer with over three million cases annually in the United States alone. A BCC that is at least 10mm in diameter and that has either failed or is not appropriate for conventional treatment is considered a laBCC. In the United States, over 10,000 individuals suffer from laBCC annually, at least 10,000 individuals suffer from Gorlin Syndrome, and more than 30,000 people suffer from high frequency sporadic BCC, with tens of thousands of individuals being diagnosed with multiple basal cell carcinomas annually.

In parallel to ongoing pivotal trial-enabling nonclinical and CMC scale-up work, DermBiont plans to seek Orphan Drug and Fast Track Designations for the treatment of laBCC and the prevention of BCC in patients with Gorlin Syndrome, to be followed by pivotal trials in two orphan indications for the approval of SM-020 for treatment of laBCC and prevention of BCC in Gorlin Syndrome patients. Following the reprioritization of SM-020 for laBCC and Gorlin Syndrome, Dermbiont is evaluating options for its SK program.

On August 15, 2024 Incyte (Nasdaq: INCY) reported positive topline results from the pivotal Phase 3 inMIND trial evaluating the efficacy and safety of tafasitamab (Monjuvi), a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, or placebo in combination with lenalidomide and rituximab compared to lenalidomide and rituximab alone in patients with relapsed or refractory follicular lymphoma (FL) (Press release, Incyte, AUG 15, 2024, View Source [SID1234645950]).

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The trial met its primary endpoint of progression free survival (PFS) by investigator assessment in FL. It also met key secondary endpoints of PFS in the overall population by investigator assessment as well as the positron-emission tomography-complete response rate in the FDG-avid FL population. In addition, the secondary endpoint of PFS results by blinded independent review are consistent with investigator based PFS results. No new safety signals with tafasitamab were observed.

"While many patients with follicular lymphoma initially benefit from first-line treatment, relapse of the disease is common, underscoring the need for additional therapies," said Steven Stein, M.D., Chief Medical Officer, Incyte. "These results demonstrate the potential of tafasitamab added to the standard of care to be a meaningful new treatment option for patients with FL whose disease has progressed after at least one prior therapy."

FL is the most common indolent, or slow growing, form of B-cell non-Hodgkin lymphoma (NHL) and accounts for approximately 13-26% of overall NHL cases.1,2,3,4,5 There are limited treatment options for the more than 17,000 new cases of relapsed or refractory FL treated every year in the United States, Europe and Japan.6

Based on these positive results, Incyte expects to file a supplemental Biologics License Application for tafasitamab for the treatment of patients with FL who have failed at least one prior systemic anti-CD20 immunotherapy or chemo-immunotherapy by the end of the year.

The full inMIND data will also be submitted for presentation at an upcoming scientific meeting.

Tafasitamab was approved in combination with lenalidomide by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in 2020 and 2021 respectively, for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified including DLBCL arising from low-grade lymphoma, and who are not eligible for autologous stem cell transplant. Tafasitamab is marketed as Monjuvi (tafasitamab-cxix) in the United States and Minjuvi (tafasitamab) in Europe and Canada.

About inMIND

A global, double-blind, randomized, controlled Phase 3 study, inMIND (NCT04680052) evaluated the clinical benefit of tafasitamab and lenalidomide as an add-on to rituximab compared with lenalidomide alone as an add-on to rituximab in patients with relapsed or refractory follicular lymphoma (FL) Grade 1 to 3a or relapsed or refractory nodal, splenic or extranodal marginal zone lymphoma (MZL). The study enrolled a total of 654 adults (age ≥18 years).

The primary endpoint of the study is progression-free survival (PFS) by investigator assessment in the FL population, and the key secondary endpoints are PFS in the overall population as well as positron emission tomography complete response (PET-CR) and overall survival (OS) in the FL population.

For more information about the study, please visit View Source

About Tafasitamab

Tafasitamab (Monjuvi) is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP). MorphoSys and Incyte entered into: (a) in January 2020, a collaboration and licensing agreement to develop and commercialize tafasitamab globally; and (b) in February 2024, an agreement whereby Incyte obtained exclusive rights to develop and commercialize tafasitamab globally.

In the United States, Monjuvi (tafasitamab-cxix) received accelerated approval by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). In Europe, Minjuvi (tafasitamab) received conditional Marketing Authorization from the European Medicines Agency in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory DLBCL who are not eligible for ASCT.

XmAb is a registered trademark of Xencor, Inc.

Monjuvi, Minjuvi, the Minjuvi and Monjuvi logos and the "triangle" design are registered trademarks of Incyte.

IMPORTANT SAFETY INFORMATION

What are the possible side effects of MONJUVI?

MONJUVI may cause serious side effects, including:

Infusion reactions. Your healthcare provider will monitor you for infusion reactions during your infusion of MONJUVI. Tell your healthcare provider right away if you get fever, chills, flushing, headache, or shortness of breath during an infusion of MONJUVI.
Low blood cell counts (platelets, red blood cells, and white blood cells). Low blood cell counts are common with MONJUVI, but can also be serious or severe. Your healthcare provider will monitor your blood counts during treatment with MONJUVI. Tell your healthcare provider right away if you get a fever of 100.4°F (38°C) or above, or any bruising or bleeding.
Infections. Serious infections, including infections that can cause death, have happened in people during treatment with MONJUVI and after the last dose. Tell your healthcare provider right away if you get a fever of 100.4°F (38°C) or above, or develop any signs and symptoms of an infection.
The most common side effects of MONJUVI include:

Feeling tired or weak
Diarrhea
Cough
Fever
Swelling of lower legs or hands
Respiratory tract infection
Decreased appetite
These are not all the possible side effects of MONJUVI. Your healthcare provider will give you medicines before each infusion to decrease your chance of infusion reactions. If you do not have any reactions, your healthcare provider may decide that you do not need these medicines with later infusions. Your healthcare provider may need to delay or completely stop treatment with MONJUVI if you have severe side effects.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before you receive MONJUVI, tell your healthcare provider about all of your medical conditions, including if you:

Have an active infection or have had one recently.
Are pregnant or plan to become pregnant. MONJUVI may harm your unborn baby. You should not become pregnant during treatment with MONJUVI. Do not receive treatment with MONJUVI in combination with lenalidomide if you are pregnant because lenalidomide can cause birth defects and death of your unborn baby.
You should use an effective method of birth control (contraception) during treatment and for at least 3 months after your final dose of MONJUVI.
Tell your healthcare provider right away if you become pregnant or think that you may be pregnant during treatment with MONJUVI.
Are breastfeeding or plan to breastfeed. It is not known if MONJUVI passes into your breastmilk. Do not breastfeed during treatment for at least 3 months after your last dose of MONJUVI.
You should also read the lenalidomide Medication Guide for important information about pregnancy, contraception, and blood and sperm donation.

Tell your healthcare provider about all the medications you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Please see the full Prescribing Information for Monjuvi, including Patient Information, for additional Important Safety Information.

On August 15, 2024 Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused biopharmaceutical company, reported that it has entered into a Master Services Agreement with Aronnax, Inc. for its HT-KIT cancer therapeutic (Press release, Hoth Therapeutics, AUG 15, 2024, View Source [SID1234645949]).

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HT-KIT research, which was conducted at NC State University to evaluate the efficacy of HT-KIT in cancerous and non-cancerous cells, has demonstrated that HT-KIT effectively kills human mast cells that rely on signaling through the KIT receptor to survive. The effect of a single dose lasted for about two weeks, while reduced KIT expression lasted for 7 days. This result also demonstrated HT-KIT’s potential to reduce KIT expression using GIST cells and kill within 48 and 72 hours along with lower KIT expression in AML cells over 72 hours.

HT-KIT is an antisense oligonucleotide that targets the proto-oncogene cKIT being developed for the treatment of mast cell-derived cancers and anaphylaxis and previously received Orphan Drug Designation from FDA.

Aronnax will oversee the third-party provider, ITR Laboratories, conducting intravenous injection using increasing/decreasing doses for each subsequent group. A timeframe of forty-eight hours will be allowed between each dose group. This study will provide Hoth key metrics in both max dose and range finding elements which will help formulate its proposed clinical trial.

"We continue to make quick progress in moving HT-KIT from the lab to patients. This further analysis will help us with that process, finalizing the protocols in our upcoming IND-enabling study," stated Robb Knie, Chief Executive Officer. "We are pleased to further engage Aronnax and ITR Laboratories on these key studies given their reputation for IND-enabling studies."

On August 15, 2024 TC BioPharm (Holdings) PLC ("TC BioPharm" or the "Company") (NASDAQ: TCBP) a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer and other indications, reported the closing of its previously announced public offering of 2,000,000 shares of its American Depository Shares ("ADSs")(or pre-funded warrants in lieu thereof), together with Series G warrants ("Series G Warrants") to purchase up to 2,000,000 ADSs at a combined public offering price of $1 per ADS (or pre-funded warrant in lieu thereof) and associated Series G Warrant (Press release, TC Biopharm, AUG 15, 2024, View Source [SID1234645948]). The Series G Warrants have an exercise price of £0.78 per ADS, are exercisable upon issuance and will expire one year from the date of issuance. Each ADS represents two hundred ordinary shares of the Company.

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The gross proceeds to the Company from the offering were $2.0 million, before deducting offering expenses payable by the Company. The Company intends to use the net proceeds from this offering to support its upcoming clinical trial focusing on relapse/refractory Acute Myeloid Leukemia, and for continuing operating expenses and working capital.

A registration statement on Form F-1 (File No. 333-280659) relating to these securities described above was filed with the Securities and Exchange Commission, or the SEC, and was declared effective by the SEC on August 12, 2024. The offering was made only by means of a prospectus, which is part of the effective registration statement. A final prospectus relating to the offering was filed with the SEC. Electronic copies of the final prospectus may be obtained for free on the SEC’s website located at View Source

This press release does not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

On August 15, 2024 Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company developing first-in-classi targeted and immune-mediated therapeutics to fight cancer, reported positive feedback from its end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) for amezalpat (TPST-1120) in combination with atezolizumab and bevacizumab to treat first-line unresectable or metastatic hepatocellular carcinoma (HCC) (Press release, Tempest Therapeutics, AUG 15, 2024, View Source [SID1234645946]).

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"We are thrilled with the positive outcome of our end-of-Phase 2 meeting with the FDA," said Sam Whiting, M.D., Ph.D., chief medical officer and head of R&D at Tempest. "Tempest and the FDA are in broad agreement on all major aspects of the proposed pivotal Phase 3 clinical trial for amezalpat in patients with hepatocellular carcinoma in the first line setting. This planned Phase 3 study closely mirrors the randomized Phase 2 study and the strongly favorable hazard ratio for overall survival observed at top-line analysis of the Phase 2, confirmed at the latest survival follow-up, give us confidence in the potential success of the Phase 3."

Key outcomes of the FDA meeting include:

Agreement on Phase 3 study design, including the standard-of-care control arm and the primary and secondary study endpoints
Agreement on appropriateness of the current amezalpat dose and schedule for the Phase 3 study
Agreement on the Phase 3 statistical plan including a pre-specified early efficacy analysis that the company currently estimates could shorten the time to primary analysis by up to 8 months
About the TPST-1120-301 Study

The planned Phase 3 study is a global, blinded, 1:1 randomized study of amezalpat plus atezolizumab and bevacizumab vs. atezolizumab and bevacizumab, the standard of care, in patients with unresectable or metastatic HCC treated in the first line setting. The company is preparing for the Phase 3 study start in the first quarter of 2025.

About Amezalpat (TPST-1120)

Amezalpat is an oral, small molecule, selective PPAR⍺ antagonist. Tempest’s data suggest that amezalpat treats cancer by targeting tumor cells directly and by modulating immune suppressive cells and angiogenesis in the tumor microenvironment. In an ongoing global randomized phase 1b/2 study of amezalpat in combination with atezolizumab and bevacizumab in first-line patients with advanced HCC, the amezalpat arm showed clinical superiority across multiple study endpoints when compared to atezolizumab and bevacizumab alone, the standard of care. These randomized data were supported by positive results observed in the Phase 1 clinical trial in patients with heavily pretreated advanced solid tumors.