On November 10, 2022 Scandion Oncology (Scandion), a biotech company developing first-in-class medicines aimed at treating cancer which is resistant to current treatment options, reported that it will publish its Q3 2022 interim report on Wednesday November 16, 2022, before 09:00 CET (Press release, Scandion Oncology, NOV 10, 2022, View Source;2022,c3664593 [SID1234623700]).

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Scandion’s Executive Management will host a webcast and conference call the same day at 10:00 CET presenting the results and a company update. At the end of the presentation there will be a Q&A session.

On November 10, 2022 Seagen Inc. (Nasdaq: SGEN) reported that the U.S. Food and Drug Administration (FDA) has approved ADCETRIS (brentuximab vedotin) for the treatment of pediatric patients 2 years and older with previously untreated high risk classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide (Press release, Seagen, NOV 10, 2022, View Source [SID1234623699]). The approval is based on data from a phase 3 study (AHOD1331) conducted by the Children’s Oncology Group (COG) and funded by the National Cancer Institute that showed patients receiving ADCETRIS in combination with standard of care dose-intensive chemotherapy AVE-PC (Adriamycin [doxorubicin], vincristine, etoposide, prednisone and cyclophosphamide) had superior event-free survival (EFS) compared to patients who received standard of care chemotherapy ABVE-PC (Adriamycin [doxorubicin], bleomycin, vincristine, etoposide, prednisone and cyclophosphamide). Patients had a 59% reduction in the risk of disease progression or relapse, second cancer or death (Hazard ratio 0.41 [95% Confidence Interval: 0.25, 0.67]; p=0.0002).

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Please see Important Safety Information including BOXED WARNING for PML at the end of this news release.

"ADCETRIS is a groundbreaking medicine approved for adults with certain types of lymphomas. Today’s FDA approval extends its availability to younger patients with high-risk classical HL," said Marjorie Green, M.D., Senior Vice President and Head of Late-Stage Development, Seagen. "We want to acknowledge and thank the patients, families and care providers who participated in the Children’s Oncology Group clinical trial that supported this approval."

"We are excited about the approval of ADCETRIS for children and adolescents with high risk classical Hodgkin lymphoma because this medicine, which has become part of standard of care for adults with previously untreated advanced stage Hodgkin lymphoma, will now be accessible to young patients as well," said Sharon M. Castellino, M.D., M.Sc., Professor, Department of Pediatrics, Emory University School of Medicine, AHOD1331 Study Chair and COG Hodgkin Lymphoma Disease Committee Chair.

Hodgkin lymphoma is blood cancer that starts when lymphocytes, a type of white blood cell, grow out of control. It represents about 6% of all childhood cancers and is the most common cancer diagnosed in adolescents ages 15 to 19 years.1,2 About one-third of all Hodgkin lymphoma patients are classified as high risk, typically stageIIB, IIIB, and IVA or IVB.3,4 People with cHL have abnormal white blood cells that usually have a special protein on their surfaces called CD30, a key marker of cHL.

About AHOD1331

AHOD1331 is a National Cancer Institute (NCI)-sponsored study conducted by the Children’s Oncology Group (COG), and is the largest multicenter, randomized, open-label phase 3 immunotherapy study ever conducted with newly diagnosed high risk Hodgkin lymphoma (HL) pediatric patients. The study enrolled 587 patients from 2 to 21 years of age across 151 institutions who had previously untreated HL stages IIB + bulk, IIIB, IVA and IVB. Patients were randomized to five cycles of either standard of care dose-intensive chemotherapy (Adriamycin [doxorubicin], bleomycin. vincristine, etoposide, prednisone and cyclophosphamide [ABVE-PC]) or brentuximab vedotin plus AVE-PC (BV-AVE-PC) given every 21 days with granulocyte colony-stimulating factor support. The primary objective was event-free survival (EFS); events included relapse/progression, second malignant neoplasm (SMN) or death. Seagen provided brentuximab vedotin for the study.

About ADCETRIS

ADCETRIS is an antibody-drug conjugate (ADC) comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seagen’s proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing cells.

ADCETRIS is indicated for the treatment of:

Adult patients with previously untreated Stage III/IV cHL in combination with doxorubicin, vinblastine, and dacarbazine.
Pediatric patients 2 years and older with previously untreated high risk cHL in combination with doxorubicin, vincristine, etoposide, prednisone and cyclophosphamide.
Adult patients with cHL at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation.
Adult patients with cHL after failure of auto-HSCT or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates.
Adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone.
Adult patients with sALCL after failure of at least one prior multi-agent chemotherapy regimen.
Adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy.
Seagen and Takeda jointly develop ADCETRIS. Under the terms of the collaboration agreement, Seagen has U.S. and Canadian commercialization rights, and Takeda has rights to commercialize ADCETRIS in the rest of the world. Seagen and Takeda are funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where Takeda is solely responsible for development costs.

ADCETRIS (brentuximab vedotin) for injection U.S. Important Safety Information

BOXED WARNING

PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML): JC virus infection resulting in PML and death can occur in ADCETRIS-treated patients.

CONTRAINDICATION

Contraindicated with concomitant bleomycin due to pulmonary toxicity (e.g., interstitial infiltration and/or inflammation).

WARNINGS AND PRECAUTIONS

Peripheral neuropathy (PN): ADCETRIS causes PN that is predominantly sensory. Cases of motor PN have also been reported. ADCETRIS-induced PN is cumulative. Monitor for symptoms such as hypoesthesia, hyperesthesia, paresthesia, discomfort, a burning sensation, neuropathic pain, or weakness. Patients experiencing new or worsening PN may require a delay, change in dose, or discontinuation of ADCETRIS.

Anaphylaxis and infusion reactions: Infusion-related reactions (IRR), including anaphylaxis, have occurred with ADCETRIS. Monitor patients during infusion. If an IRR occurs, interrupt the infusion and institute appropriate medical management. If anaphylaxis occurs, immediately and permanently discontinue the infusion and administer appropriate medical therapy. Premedicate patients with a prior IRR before subsequent infusions. Premedication may include acetaminophen, an antihistamine, and a corticosteroid.

Hematologic toxicities: Fatal and serious cases of febrile neutropenia have been reported with ADCETRIS. Prolonged (≥1 week) severe neutropenia and Grade 3 or 4 thrombocytopenia or anemia can occur with ADCETRIS.

Administer G-CSF primary prophylaxis beginning with Cycle 1 for adult patients who receive ADCETRIS in combination with chemotherapy for previously untreated Stage III/IV cHL or previously untreated PTCL, and pediatric patients who receive ADCETRIS in combination with chemotherapy for previously untreated high risk cHL.

Monitor complete blood counts prior to each ADCETRIS dose. Monitor more frequently for patients with Grade 3 or 4 neutropenia. Monitor patients for fever. If Grade 3 or 4 neutropenia develops, consider dose delays, reductions, discontinuation, or G-CSF prophylaxis with subsequent doses.

Serious infections and opportunistic infections: Infections such as pneumonia, bacteremia, and sepsis or septic shock (including fatal outcomes) have been reported in ADCETRIS-treated patients. Closely monitor patients during treatment for infections.

Tumor lysis syndrome: Patients with rapidly proliferating tumor and high tumor burden may be at increased risk. Monitor closely and take appropriate measures.

Increased toxicity in the presence of severe renal impairment: The frequency of ≥Grade 3 adverse reactions and deaths was greater in patients with severe renal impairment. Avoid use in patients with severe renal impairment.

Increased toxicity in the presence of moderate or severe hepatic impairment: The frequency of ≥Grade 3 adverse reactions and deaths was greater in patients with moderate or severe hepatic impairment. Avoid use in patients with moderate or severe hepatic impairment.

Hepatotoxicity: Fatal and serious cases have occurred in ADCETRIS-treated patients. Cases were consistent with hepatocellular injury, including elevations of transaminases and/or bilirubin, and occurred after the first ADCETRIS dose or rechallenge. Preexisting liver disease, elevated baseline liver enzymes, and concomitant medications may increase the risk. Monitor liver enzymes and bilirubin. Patients with new, worsening, or recurrent hepatotoxicity may require a delay, change in dose, or discontinuation of ADCETRIS.

PML: Fatal cases of JC virus infection resulting in PML have been reported in ADCETRIS-treated patients. First onset of symptoms occurred at various times from initiation of ADCETRIS, with some cases occurring within 3 months of initial exposure. In addition to ADCETRIS therapy, other possible contributory factors include prior therapies and underlying disease that may cause immunosuppression. Consider PML diagnosis in patients with new-onset signs and symptoms of central nervous system abnormalities. Hold ADCETRIS if PML is suspected and discontinue ADCETRIS if PML is confirmed.

Pulmonary toxicity: Fatal and serious events of noninfectious pulmonary toxicity, including pneumonitis, interstitial lung disease, and acute respiratory distress syndrome, have been reported. Monitor patients for signs and symptoms, including cough and dyspnea. In the event of new or worsening pulmonary symptoms, hold ADCETRIS dosing during evaluation and until symptomatic improvement.

Serious dermatologic reactions: Fatal and serious cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported with ADCETRIS. If SJS or TEN occurs, discontinue ADCETRIS and administer appropriate medical therapy.

Gastrointestinal (GI) complications: Fatal and serious cases of acute pancreatitis have been reported. Other fatal and serious GI complications include perforation, hemorrhage, erosion, ulcer, intestinal obstruction, enterocolitis, neutropenic colitis, and ileus. Lymphoma with pre-existing GI involvement may increase the risk of perforation. In the event of new or worsening GI symptoms, including severe abdominal pain, perform a prompt diagnostic evaluation and treat appropriately.

Hyperglycemia: Serious cases, such as new-onset hyperglycemia, exacerbation of pre-existing diabetes mellitus, and ketoacidosis (including fatal outcomes) have been reported with ADCETRIS. Hyperglycemia occurred more frequently in patients with high body mass index or diabetes. Monitor serum glucose and if hyperglycemia develops, administer anti-hyperglycemic medications as clinically indicated.

Embryo-fetal toxicity: Based on the mechanism of action and animal studies, ADCETRIS can cause fetal harm. Advise females of reproductive potential of this potential risk, and to avoid pregnancy during ADCETRIS treatment and for 6 months after the last dose of ADCETRIS.

ADVERSE REACTIONS

The most common adverse reactions (≥20% in any study) are peripheral neuropathy, fatigue, nausea, diarrhea, neutropenia, upper respiratory tract infection, pyrexia, constipation, vomiting, alopecia, decreased weight, abdominal pain, anemia, stomatitis, lymphopenia, mucositis, thrombocytopenia, and febrile neutropenia.

DRUG INTERACTIONS

Concomitant use of strong CYP3A4 inhibitors has the potential to affect the exposure to monomethyl auristatin E (MMAE). Closely monitor adverse reactions.

USE IN SPECIAL POPULATIONS

Lactation: Breastfeeding is not recommended during ADCETRIS treatment.

Females and Males of Reproductive Potential: Advise females to report pregnancy immediately and advise males with female sexual partners of reproductive potential to use effective contraception during ADCETRIS treatment and for 6 months after the last dose of ADCETRIS.

On November 10, 2022 Celyad Oncology SA (Euronext & Nasdaq: CYAD) (the "Company"), a biotechnology company focused on the discovery and development of chimeric antigen receptor T cell (CAR T) therapies for cancer, reported an update on its financial results and recent business developments for the fiscal quarter ended September 30, 2022 (Press release, Celyad, NOV 10, 2022, View Source [SID1234623698]).

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"This past quarter has been a pivotal moment for the Company as we focus on a new Celyad 2.0 strategy as we seek to monetize our valuable IP estate and leverage our dynamic shRNA technology for our R&D programs. We’ve bolstered our cash runway with an asset purchase agreement for our manufacturing business unit and we believe we are well-positioned to unleash the power of our IP estate and potentially redefine the cell therapy space," said Michel Lussier, interim Chief Executive Officer of the Company.

Recent Highlights

The Company entered into a €6 million asset purchase agreement with Cellistic whereby Cellistic acquired Celyad Oncology’s Good Manufacturing Practice (GMP) grade cell therapy manufacturing facility
Based on a strategic, financial and medical review, taking into account the costs associated with the pursuit of the program and the delays to reach key medical milestones following the resolution of the previously announced clinical hold, the Company has decided to discontinue the development of CYAD-101
Update on Business Model and Research Programs

As previously announced, with Celyad 2.0, Celyad Oncology is implementing a strategic shift from an organization focused on clinical development to one prioritizing R&D discovery and the monetization of its IP estate through partnerships, collaborations and license agreements. The Company intends to focus its R&D efforts on areas of expertise where it believes it can leverage the differentiated nature of its platform technology and continue to bolster its IP estate.

The Company possesses key technology and controls IP which covers the potential development of next-generation therapies, including those using short hairpin RNA (shRNA) and T cell receptor Inhibitor Molecule (TIM). Celyad Oncology has expanded the IP estate in-licensed from Dartmouth College with additional patents to broadly cover aspects of allogeneic cell therapy.Current discovery programs have the potential to create additional independent IP. The Company is developing a potential next-generation NKG2D Type I receptor CAR T candidate and a technology to potentially utilize this receptor as a basis for dual CAR technology. The Company is also considering the potential to focus R&D efforts on either B7-H6 CAR T or bispecific antibody candidates for a powerful new antigenic target in the oncology field.

In addition, the Company is seeking to advance its shRNA platform through multiplexing technology that allows it to modulate multiple genes simultaneously. This technology is potentially complementary to the Company’s All-in-One Vector approach, which allows for the expression of multiple shRNAs in a single construct within a single transduction step. Combining multiplexed shRNAs with CARs and additional genes of choice provides potential for broad therapeutic functionality.

Update on Clinical Programs

CYAD-211 – Allogeneic shRNA-based, anti-BCMA CAR T candidate for r/r MM

The dose-escalation Phase 1 IMMUNICY-1 trial is evaluating the tolerability and clinical activity of a single infusion of CYAD-211 following preconditioning with CyFlu (cyclophosphamide and fludarabine) in patients with relapsed / refractory multiple myeloma (r/r MM).
CYAD-211 was developed to demonstrate potential proof of concept of shRNA technology in the clinic. Our other clinical studies of shRNA disclosed to date have demonstrated encouraging safety and bioactivity signals, and its use as a technology to avoid Graft-versus-Host disease of allogeneic CAR Ts could be a viable approach
Clinical updates are expected by year end
Third Quarter 2022 Financial Review

As of September 30, 2022, the Company had cash and cash equivalents of €13.4 million ($13.1 million). Net cash burn during the first quarter of 2022 amounted to €1.0 million ($1.0 million), in line with expectations. The Company confirms its previous guidance that its existing cash and cash equivalents should be sufficient to fund operating expenses and capital expenditure requirements up to mid-2023. This guidance does not include any potential proceeds from the equity purchase agreement established with Lincoln Park Capital Fund, LLC.

After due consideration of detailed budgets and estimated cash flow forecasts for the years 2022 and 2023 which reflect the current strategy of the Company and include expenses and cash outflows estimations in relation to the development of discretionary research programs and pipeline of products candidates, the Company continues to project that its existing cash and cash equivalents will not be sufficient to fund its estimated operating and capital expenditures over at least the next 12 months from the date that the release is issued.

On November 10, 2022 Targovax ASA (OSE: TRVX) and Hubro Therapeutics AS (Hubro) reported that they have entered into an asset purchase agreement whereby Hubro acquires Targovax’s GM-CSF (Granulocyte macrophage colony-stimulating factor) process development and production project (Press release, Targovax, NOV 10, 2022, View Source [SID1234623697]).

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Under the agreement, Hubro will make a cash payment to Targovax of 10MNOK for the acquisition of the GM-CSF project. Targovax retains conditional buy-back and supply options, and a share in gross proceeds in the event of a re-sale of the asset within a time-limited period.

Dr. Lubor Gaal, Chief Financial Officer of Targovax, said: "With the switch to QS-21 STIMULON from our collaboration partner Agenus as the adjuvant of choice for the next generation mutant RAS TG vaccines, Targovax is no longer prioritizing further investments into GM-CSF development. We are delighted that Hubro will now take over the GM-CSF adjuvant project and this deal shows that we can create value from non-strategic assets."

Jon Amund Eriksen, Chief Executive Officer of Hubro, said: "For the commercial development of our therapeutic and prophylactic cancer vaccines it is important for us to have full control over production and supply of all pharmaceutical active components, including GM-CSF. We are therefore delighted for having the opportunity to take over the GM-CSF development project from Targovax, which will provide significant savings of development costs and time towards obtaining the high-quality product we need for pivotal clinical development and later marketing of our cancer vaccines."

GM-CSF is an immuno-modulator used for protein and peptide-based vaccines and was the adjuvant component of Targovax’s first generation mutant RAS TG vaccine products. Following a collaboration agreement with Agenus Inc. [NASDAQ: AGEN] announced earlier in 2022, Targovax will develop its next generation mutant RAS TG vaccines with Agenus´ proprietary adjuvant QS-21 STIMULON. Two clinical trials with Targovax´s lead mutant RAS candidate TG01 adjuvanted by QS-21 STIMULON are expected to open during 2022. The GM-CSF asset purchase agreement with Hubro ensures the continued development of the GM-CSF adjuvant product, which will serve as an integral part of Hubro’s technology platform. Hubro aims at introducing its own developed GM-CSF product in clinical testing as adjuvant for its peptide cancer specific vaccines in 2024.

About Targovax

Activating the patient’s immune system to fight cancer

Targovax (OSE:TRVX) is a clinical stage immuno-oncology company developing immune activators to target hard-to-treat solid tumors. Targovax’s focus is to activate the patient’s immune system to fight cancer, and to bring benefit to cancer patients with few available treatment alternatives. Targovax is developing its product candidates in different cancer indications, including melanoma, mesothelioma, and multiple myeloma, and has demonstrated a favorable safety and tolerability profile.

Targovax’s lead clinical candidate, ONCOS-102, is a genetically modified oncolytic adenovirus, which has been engineered to selectively infect cancer cells and activate the immune system against the tumor. Following very encouraging clinical data in several indications, both as monotherapy and in combinations, ONCOS-102 is progressing into a randomized phase 2 trial in melanoma patients resistant to PD-1 checkpoint inhibitor treatment.

Building on successful clinical studies which have provided deep mechanistic insights into the tumor biology and the human immune systems, Targovax is researching circular RNA (circRNA) as novel cancer medicines. In addition, Targovax has a KRAS immunotherapy program, with lead cancer vaccine candidate, TG01, expected to enter the clinic in an enhanced format in the second half of 2022. Together this provides Targovax with a rich pipeline of innovative future immunotherapy product candidates to follow ONCOS-102.

On November 10, 2022 Enterome, a clinical stage biopharmaceutical company developing first-in-class immunomodulatory drugs based on its bacterial Mimicry drug discovery platform, reported updated safety, immunogenicity and efficacy data of its Phase 1/2 clinical trial of EO2401 in combination with an immune checkpoint inhibitor (nivolumab) +/- an anti-VEGF therapy (bevacizumab), for the treatment of patients with first progression/recurrence of glioblastoma (ROSALIE trial) (Press release, Enterome, NOV 10, 2022, View Source [SID1234623696]). The data were presented in an oral and a poster presentation at the 37th Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in Boston, MA, US, today.

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Jan Fagerberg, Chief Medical Officer of Enterome said, "We are very excited to present these updated data from the ROSALIE trial, evaluating EO2401 in combination with checkpoint blockade, and with checkpoint blockade plus anti-VEGF therapy, at SITC (Free SITC Whitepaper) 2022. These new data show that the memory CD8+ T cell response was found as early as two weeks after the first administration and that a strong and stable immune response continued to be detected for more than 10 months. Additionally, the observation that some patients exhibit up to 5% of circulating specific CD8+ T cells following administration is remarkable, and together with the clinical responses seen, reinforces the strong potential of our OncoMimics peptide-based immunotherapy in this difficult-to-treat patient population."

EO2401 is Enterome’s first-in-class off-the-shelf OncoMimics peptide-based immunotherapy. It is designed to activate the patient’s memory T cells that cross-react with tumor associated antigens (TAAs) present on the cancer being treated. EO2401 includes synthetically produced HLA-A2 peptides with molecular mimicry to TAAs upregulated in glioblastoma (IL13Ra2, BIRC5 and FOXM1) and the CD4 helper peptide UCP2.

Enterome selected these OncoMimics peptides using its Mimicry platform, which applies best-in-class biocomputational tools and bioassays to identify novel therapeutics from its proprietary database of 20+ million bioactive peptides and proteins isolated from gut bacteria.

Key highlights from the EO2401 oral and poster presentation covering the Phase 1/2 ROSALIE trial were:

Data published to date confirm that EO2401 in combination with nivolumab +/- bevacizumab is well tolerated with a safety profile consistent with the safety profiles of nivolumab and bevacizumab, with the addition of local administration site reactions.
EO2401 in combination with nivolumab generated strong systemic immune responses through activation of specific effector memory CD8+ T cells, corresponding with clinical efficacy.
As compared to the administration of EO2401 in combination with nivolumab without the addition of the strong anti-edema compound bevacizumab, the symptom-driven addition of low-dose, time-limited, bevacizumab (LDB) resulted in longer treatment durations (median treatment duration 3.2 months with LDB vs 1.4 months without LDB), and some improvement of efficacy (ORR 20% vs 13%, median PFS 3.6 months vs 1.6 months).
In a subsequent cohort, the addition of continuous standard bevacizumab (as labelled in the USA) to EO2401 in combination with nivolumab further improved median treatment duration (to 5.0 months), objective response rate (to 55%), and median PFS (to 5.5 months).
Median survivals have not yet been reached for both EO2401 in combination with nivolumab and with LDB (median follow-up 7.8 months) or EO2401 in combination with nivolumab and bevacizumab (median follow-up 14.1 months).
CD8+ T cells against at least one of the EO2401 peptides was detected in 26 out of 28 patients with some patients exhibiting up to 5% of circulating specific CD8+ T cells. Memory specific CD8+ T cells response were found as early as two weeks after the first vaccination and maintenance of a strong and stable immune response could be detected for more than 10 months.
Additional patients are to be treated with triple combination of EO2401 in combination with nivolumab and bevacizumab to support final regimen selection.