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.

On August 15, 2024 NuCana plc (NASDAQ: NCNA) reported financial results for the second quarter ended June 30, 2024 and provided an update on its broad clinical development program with its transformative ProTide therapeutics (Press release, Nucana BioPharmaceuticals, AUG 15, 2024, View Source [SID1234645945]).

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As of June 30, 2024, NuCana had cash and cash equivalents of £11.6 million compared to £12.9 million as of March 31, 2024 and £17.2 million at December 31, 2023. NuCana continues to advance its numerous clinical programs and reported a net loss of £7.0 million for the quarter ended June 30, 2024, as compared to a net loss of £5.4 million for the quarter ended June 30, 2023. Basic and diluted loss per ordinary share was £0.12 for the quarter ended June 30, 2024, as compared to £0.10 per ordinary share for the comparable quarter ended June 30, 2023.

"During the first half of the year, we remained focused on the execution of our clinical programs, all of which are on track for data updates this year," said Hugh S. Griffith, NuCana’s Founder and Chief Executive Officer. "NUC-3373, a ProTide transformation of 5-FU, is currently being evaluated in three clinical studies: NuTide:323, a randomized, 182-patient Phase 2 study for the second-line treatment of patients with metastatic colorectal cancer; NuTide:302, a Phase 1/2 study in patients with metastatic colorectal cancer; and NuTide:303, a Phase 1b/2 study in patients with solid tumors and lung cancer. We are pleased to report that all three studies are progressing as planned, and we look forward to sharing data updates in the second half of 2024."

Mr. Griffith continued: "In addition, NUC-7738, a ProTide transformation of a novel nucleoside analog, 3’-deoxyadenosine, is being assessed in the Phase 2 part of the ongoing Phase 1/2 NuTide:701 study in PD-1 inhibitor-resistant melanoma patients. Following a positive data update at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting earlier this year, we plan to announce additional data at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024, being held September 13-17 in Barcelona, Spain."

Mr. Griffith concluded, "Our commitment to improving treatment outcomes for patients with cancer is what drives us to advance our development programs. We expect to announce numerous important data readouts in the second half of this year and look forward to providing updates on our progress."

2024 Anticipated Milestones

NUC-3373 (a ProTide transformation of 5-FU)

In 2024, NuCana expects to:

Announce data from the randomized Phase 2 (NuTide:323) study of NUFIRI + bevacizumab compared to the standard of care FOLFIRI + bevacizumab for the second-line treatment of patients with metastatic colorectal cancer;
Announce data from the Phase 1b/2 (NuTide:302) study of NUFIRI + bevacizumab and NUFOX + bevacizumab for the second-line treatment of patients with metastatic colorectal cancer; and
Announce data from the Phase 1b/2 (NuTide:303) modular study of NUC-3373 in combination with pembrolizumab in patients with solid tumors and in combination with docetaxel in patients with lung cancer.
NUC-7738 (a ProTide transformation of 3’-deoxyadenosine)

In 2024, NuCana expects to:

Announce data from the Phase 2 part of the Phase 1/2 study (NuTide:701) of NUC-7738 in combination with pembrolizumab in patients with melanoma.