On April 14, 2023 Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported its participation in the upcoming 2023 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, taking place in Orlando, Florida from April 14 through April 19, 2023, where VAL-083 data will be presented (Press release, Kintara Therapeutics, APR 14, 2023, View Source [SID1234630086]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Data Presentations:

Session Title: Late-Breaking Research: Clinical Research 1 / Endocrinology
Poster Section 34, Presentation Time: Monday, April 17, 2023 – 1:30 to 5:00 p.m. ET

Abstract LB126: RELA fusion-positive ependymoma and diffuse midline glioma treated with VAL-083 under expanded access – case reports

The abstract describes two patient case reports, one with ependymoma and one with diffuse midline glioma, treated with VAL-083 under an expanded access program. The cases highlight that VAL-083 may be a treatment option for recurrent RELA fusion-positive ependymoma and diffuse midline glioma refractory to other treatments. Safety and efficacy data will be updated at the poster presentation at the meeting.

Abstract LB127: VAL-083 in patients with recurrent glioblastoma treated under expanded access program

The abstract reports on background characteristics, and safety and efficacy measures, from 24 patients with recurrent GBM treated with VAL-083 under an expanded access program. Use of VAL-083 continues to show benefit in the treatment of GBM patients who have had multiple recurrences and have limited therapeutic options. This information will be updated in the poster presentation at the meeting.

On April 14, 2023 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported it will present updated data from the Phase 1 study evaluating the safety and efficacy of once-weekly selinexor in combination with ruxolitinib in patients with treatment-naïve myelofibrosis (NCT04562389) at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023, taking place April 14-19, 2023 in Orlando, Florida (Press release, Karyopharm, APR 14, 2023, View Source [SID1234630085]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Twelve and 24 week data from all patients in this Phase 1 study, including the recommended dose, will be presented in a poster session at the meeting.

Title: A Phase 1, Open-Label, Dose-Escalation Study of Selinexor Plus Ruxolitinib in Patients with Treatment-Naïve Myelofibrosis
Abstract Presentation Number: CT261
Session Title: Phase I Clinical Trials 2
Session Date and Time: Tuesday April 18, 2023, 1:30pm -5:00pm (ET)

Investor Webcast on Selinexor Data in Patients with Treatment-Naïve Myelofibrosis at AACR (Free AACR Whitepaper) 2023

Karyopharm will host a webcast on, April 18, 2023, at 4:30 p.m. Eastern Time with a key opinion leader to discuss the updated data on selinexor in combination with ruxolitinib as well as the current treatment landscape and unmet medical need in treating patients with myelofibrosis.

To access the event, please dial (888) 349-0102 (local) or (412) 902-4299 (international) at least 10 minutes prior to the start time and ask to be joined into the Karyopharm Therapeutics call. A live audio webcast of the call, along with accompanying slides, will be available under "Events & Presentations" in the Investor section of the Company’s website, View Source An archived webcast will be available on the Company’s website following the event.

About XPOVIO (selinexor)

XPOVIO is a first-in-class, oral exportin 1 (XPO1) inhibitor and the first of Karyopharm’s Selective Inhibitor of Nuclear Export (SINE) compounds to be approved for the treatment of cancer. XPOVIO functions by selectively binding to and inhibiting the nuclear export protein XPO1. XPOVIO is approved in the U.S. and marketed by Karyopharm in multiple oncology indications, including: (i) in combination with Velcade (bortezomib) and dexamethasone (XVd) in patients with multiple myeloma after at least one prior therapy; (ii) in combination with dexamethasone in patients with heavily pre-treated multiple myeloma; and (iii) in patients with diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy. XPOVIO (also known as NEXPOVIO in certain countries) has received regulatory approvals in various indications in a growing number of ex-U.S. territories and countries, including but not limited to the European Union, the United Kingdom, China, South Korea, Canada, Israel and Taiwan. XPOVIO and NEXPOVIO is marketed by Karyopharm’s partners, Antengene, Menarini, Neopharm and FORUS, in China, South Korea, Singapore, Australia, Hong Kong, Germany, Austria, Israel and Canada.

Please refer to the local Prescribing Information for full details.

Selinexor is also being investigated in several other mid- and late-stage clinical trials across multiple high unmet need cancer indications, including in endometrial cancer and myelofibrosis.

For more information about Karyopharm’s products or clinical trials, please contact the Medical Information department at:

Tel: +1 (888) 209-9326
Email: [email protected]

SELECT IMPORTANT SAFETY INFORMATION

Warnings and Precautions

Thrombocytopenia: Monitor platelet counts throughout treatment. Manage with dose interruption and/or reduction and supportive care.
Neutropenia: Monitor neutrophil counts throughout treatment. Manage with dose interruption and/or reduction and granulocyte colony–stimulating factors.
Gastrointestinal Toxicity: Nausea, vomiting, diarrhea, anorexia, and weight loss may occur. Provide antiemetic prophylaxis. Manage with dose interruption and/or reduction, antiemetics, and supportive care.
Hyponatremia: Monitor serum sodium levels throughout treatment. Correct for concurrent hyperglycemia and high serum paraprotein levels. Manage with dose interruption, reduction, or discontinuation, and supportive care.
Serious Infection: Monitor for infection and treat promptly.
Neurological Toxicity: Advise patients to refrain from driving and engaging in hazardous occupations or activities until neurological toxicity resolves. Optimize hydration status and concomitant medications to avoid dizziness or mental status changes.
Embryo–Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential and males with a female partner of reproductive potential, of the potential risk to a fetus and use of effective contraception.
Cataract: Cataracts may develop or progress. Treatment of cataracts usually requires surgical removal of the cataract.
Adverse Reactions

The most common adverse reactions (≥20%) in patients with multiple myeloma who receive XVd are fatigue, nausea, decreased appetite, diarrhea, peripheral neuropathy, upper respiratory tract infection, decreased weight, cataract and vomiting. Grade 3–4 laboratory abnormalities (≥10%) are thrombocytopenia, lymphopenia, hypophosphatemia, anemia, hyponatremia and neutropenia. In the BOSTON trial, fatal adverse reactions occurred in 6% of patients within 30 days of last treatment. Serious adverse reactions occurred in 52% of patients. Treatment discontinuation rate due to adverse reactions was 19%.
The most common adverse reactions (≥20%) in patients with multiple myeloma who receive Xd are thrombocytopenia, fatigue, nausea, anemia, decreased appetite, decreased weight, diarrhea, vomiting, hyponatremia, neutropenia, leukopenia, constipation, dyspnea and upper respiratory tract infection. In the STORM trial, fatal adverse reactions occurred in 9% of patients. Serious adverse reactions occurred in 58% of patients. Treatment discontinuation rate due to adverse reactions was 27%.
The most common adverse reactions (incidence ≥20%) in patients with DLBCL, excluding laboratory abnormalities, are fatigue, nausea, diarrhea, appetite decrease, weight decrease, constipation, vomiting, and pyrexia. Grade 3–4 laboratory abnormalities (≥15%) are thrombocytopenia, lymphopenia, neutropenia, anemia, and hyponatremia. In the SADAL trial, fatal adverse reactions occurred in 3.7% of patients within 30 days, and 5% of patients within 60 days of last treatment; the most frequent fatal adverse reactions was infection (4.5% of patients). Serious adverse reactions occurred in 46% of patients; the most frequent serious adverse reaction was infection (21% of patients). Discontinuation due to adverse reactions occurred in 17% of patients.
Use In Specific Populations
Lactation: Advise not to breastfeed.

For additional product information, including full prescribing information, please visit www.XPOVIO.com.

To report SUSPECTED ADVERSE REACTIONS, contact Karyopharm Therapeutics Inc.at 1–888–209–9326 or FDA
at 1–800–FDA–1088 or www.fda.gov/medwatch.

On April 14, 2023 HOOKIPA Pharma Inc. (NASDAQ: HOOK, the "Company"), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, reported that the Compensation Committee of the Company’s Board of Directors approved the grant of non-statutory options to a new employee to purchase an aggregate of 50,000 shares of the Company’s Common Stock under HOOKIPA’s 2023 Inducement Plan (Press release, Hookipa Biotech, APR 14, 2023, View Source [SID1234630084]). The award was granted as an inducement material to the employee’s acceptance of employment with HOOKIPA in accordance with Nasdaq Listing Rule 5635(c)(4). The options have an exercise price equal to $1.00 per share. The options have a ten year term and vest over four years, with 25% vesting on the one-year anniversary of the grant date and the remainder vesting in equal quarterly installments for three years thereafter, subject to the employee’s continued service with HOOKIPA on each such vesting date. The options are subject to the terms and conditions of HOOKIPA’s 2023 Inducement Plan approved by the Board of Directors in April 2023 and the terms and conditions of award agreements covering the grants.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On April 14, 2023 Flamingo Therapeutics ("Flamingo") reported a presentation at the 2023 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, taking place April 14-19, 2023, in Orlando, Florida (Press release, Flamingo Therapeutics, APR 14, 2023, View Source;utm_medium=rss&utm_campaign=flamingo-therapeutics-announces-poster-presentation-on-ftx-001-at-the-2023-american-association-for-cancer-research-aacr-annual-meeting [SID1234630083]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Flamingo will present preclinical results highlighting the candidate selection and characterization of FTX-001, a novel antisense oligonucleotide targeting MALAT1 for the treatment of cancer. Flamingo is currently advancing FTX-001 through Phase 1 enabling preclinical activities and is planning for a First-in-Human trial in solid tumors.

Details of the poster presentation are below:

Title: "Preclinical development of FTX-001: First-in-class inhibitor of the long non-coding RNA MALAT1"

Session Category: Experimental and Molecular Therapeutics
Session Title: New Drug Targets
Session Date and Time: Sunday Apr 16, 2023, 1:30 PM – 5:00 PM
Location: Poster Section 16
Poster Board Number: 14
Published Abstract Number: 450

Abstracts and full session details are available through the AACR (Free AACR Whitepaper) Annual Meeting planner: AACR (Free AACR Whitepaper) Annual Meeting 2023 | Meetings | AACR (Free AACR Whitepaper)

On April 14, 2023 EORTC reported that Radiation oncology is among the main pillars of the its scientific strategy and plays a vital part in its mission to improve clinical research through multidisciplinary partnerships (Press release, EORTC, APR 14, 2023, View Source [SID1234630082]). The annual ESTRO congress provides an opportunity for radiation oncologists to present results from EORTC studies that advance radiotherapy (RT) treatment and provide benefits for patients, and this year’s congress, to be held in Vienna from 12-16 May, is no exception.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Oligometastatic disease
Professor Filippo Alongi will present new results from the first patients included in the ESTRO/EORTC E2-RADIatE OligoCare cohort. Oligometastatic disease (OMD) is an intermediate state where a primary cancer has metastasised to a limited number of regions. It is not a homogenous cancer state, and this makes the determination of optimal treatment strategies difficult. The analysis to be presented is based on 1468 patients from the first 1600 enrolled. "Traditionally, treatment for metastases has been considered to be palliative rather than curative, but the concept of oligometastasis has increased interest in different forms of treatment," says Prof Alongi.

The patients in the cohort were treated with the high precision therapy stereotactic body radiation (SBRT) at 32 centres in nine European countries for oligometastatic breast, colorectal, non-small cell lung, or prostate cancer. In most patients, fewer than four metastases were irradiated, with most patients receiving treatment for a single metastasis. Very little high grade toxicity was found, and the vast majority of patients were still alive six months after treatment. "Although we believe that RT is useful in cases of oligometastasis, there are still few data from randomised trials to confirm this. The Oligocare project is helping us to consolidate evidence and build up a large database to evaluate the impact of the use of SBRT in these patients," Prof Alongi says.

For more information: Session

Note: Further patients have been included in the analysis to be presented, hence the difference from the abstract as submitted.

Regional lymph node radiation treatment in breast cancer
New results from the EORTC 22922/10925 breast cancer study will also be presented. The study, carried out between 1996 and 2004, randomised 4004 stage 1 – 3 breast cancer patients to receiving lymph node radiation after surgery, or not receiving it. Primary surgery included mastectomy or breast conservation surgery (BCS), and was followed by whole breast/chest wall/RT in almost every case. The results to be presented arise from the analysis of the effect on local (LR) and regional recurrence (RR) of internal mammary and medial supraclavicular lymph node (IM-MS) irradiation.

Breast cancer can spread to the regional lymph nodes located under the arm, near the collarbone, and under the breastbone, but there are uncertainties surrounding the use of lymph node radiation and more specifically about for which groups of patients it can be of most value. "Even though the trial was conducted almost 20 years ago," says presenter Dr Orit Kaidar-Person, "the meticulous work done by EORTC researchers and the team at headquarters allowed us to perform an additional, unplanned analysis that can benefit breast cancer patients and help decision-making in RT."

The researchers mapped the special location of locoregional recurrences following the different therapies. The most important findings, they say, are the low rate of locoregional recurrences, and that the extent of locoregional therapy impacts significantly on LR and RR rates and spatial location. "We will be carrying out further research to try to understand these results in the context of disease stages and RT techniques. In the meantime, these data are unique and may influence future decision-making for these patients," says Dr Kaidar-Person.

For more information: Session

Stereotactic body radiotherapy for central lung tumours
Professor Ursula Nestle will present results from the EORTC 22113-08113 Lungtech trial at the conference. The trial looked at the safety and efficacy of the use of the high precision treatment stereotactic body radiotherapy (SBRT) in patients with inoperable central lung tumours. Although SBRT has had promising results in patients with peripheral tumours, the position of central tumours close to other organs can lead to severe toxicities. Indeed, the trial closed early, in 2017, because repeated safety-related halts in treatment made it difficult to enrol sufficient patients to have a dependable result.

Eligible patients with non-small cell lung cancer from 13 sites in six European countries were recruited to the trial between 2015 and 2017. "We found a high rate of local tumour control, with a median overall survival (OS) rate of 46 months, and a three-year OS of 61%," says Prof Nestle. However, these patients also had other illnesses (comorbidities), particularly affecting the heart and lungs.

"Although the small numbers included in the analysis make it difficult to be certain, we observed a relevant but not excessive risk of severe late toxicity after SBRT of central tumours", Professor Nestle says. "But almost all of the patients treated were very comorbid. As SBRT is highly efficient in terms of tumour control, the risks must be put in context with the comorbidities and weighed against those of tumour progression with limited therapeutic options on a case by case basis. We are happy that our prospective data will help informed decision-making in the future."

For more information: Session

Reviewing models of normal tissue complication probabilities in head and neck cancer
The aim of radiotherapy is to achieve a high level of local tumour control with a low risk of normal tissue complication probability, or NTCP. It is therefore crucial to identify models that can predict which patients are least likely to suffer side effects from new, advanced RT techniques such as proton therapy. There are several NCTP models for each side effect, and new research to be presented at the conference will help identify their quality and applicability.

Dr Makbule Tambas and colleagues originally identified over 10 000 potentially relevant articles and 55 ongoing trials. Further screening reduced numbers to 755, and then to 114. "We were then able to summarise the current evidence on their predictive performance. This review will be helpful in understanding which models are useful for therapeutic decision-making, and to what extent they should be able, as well as which models should not be used and which are promising but still require further investigation," she says. "Our results show that there is a need for external validation models in clinical practice, and an improvement in the quality of the conduct and reporting of prediction model studies in this subject."

For more information: Session

Radiotherapy quality assurance in head and neck cancer trials
Dr Daniel Portik will present new results from the ongoing EORTC 1420 ‘Best of’ trial, which aims to compare swallowing function after trans-oral surgery versus radiotherapy in head and neck cancer. Problems with swallowing (dysphagia) are common in head and neck cancer patients after curative treatment, and have a major impact on patients’ quality of life. The inclusion of quality assurance in radiotherapy trials is essential in order to ensure patient safety and to improve treatment outcomes.

Participating centres were required to complete a benchmark case procedure by delineating and planning a specific patient case according to the study protocol. The study then analysed differences in contouring (the outlining of the area to be irradiated) and treatment planning when compared to a gold standard case. Despite the drawing up of detailed contouring protocols, tumour delineation remained the main reason for the plans having to be resubmitted for approval, and this happened in 32 out of the 42 participating centres.

"This outcome was particularly important, since the trial asked participating centres to delineate new swallowing structures intended to decrease radiation-induced side effects," says Dr Portik. "Our results underline the importance of rigorous RTQA measures in order to maintain high standards, and will help assure patients that they are receiving the best possible care."

For more information: Session

Dr Denis Lacombe, EORTC CEO, said: "As cancer care moves further towards individually-tailored treatments, multidisciplinarity becomes more and more important. Radiotherapy plays a major part in providing high quality patient care and EORTC is committed to moving forward in RT research, which we see as an essential tool in our mission to provide the best treatment for every cancer patient.