On December 1, 2022 Pfizer Inc. (NYSE: PFE) and Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) reported that antibody persistence data six months after the completion of a three-dose (Month 0-2-6) or a two-dose (Month 0-6) vaccination schedule with their Lyme disease vaccine candidate, VLA15 in both children and adults (Press release, Valneva, DEC 1, 2022, View Source [SID1234624706]). This is the first time antibody persistence data are reported in pediatric populations for this vaccine candidate.

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Following positive immunogenicity and safety data for Phase 2 study VLA15-221 in April 20221, Valneva and Pfizer evaluated the persistence of antibodies six months after the Month 0-2-6 and the Month 0-6 vaccination schedule with VLA15 in healthy adults and pediatric participants (5 to 65 years of age). Data were collected in 96 healthy adults and 81 pediatric participants (5-17 years of age) for the Month 0-2-6 vaccination schedule and in 84 healthy adults and 78 pediatric participants (5-17 years of age) for the Month 0-6 schedule.

As observed in previous clinical studies with VLA15, antibody levels declined over time in all study groups but remained above baseline, confirming their persistence six months after completion of both vaccination schedules. Overall, antibody levels remained higher with the three-dose vaccination schedule compared to the two-dose schedule. Geometric mean fold rise (GMFRs) compared to baseline were 1.9-fold for Serotype 1 (ST1) to 3.2-fold Serotype 2 (ST2) across all age groups in the Month 0-2-6 vaccination schedule. The highest GMFRs were reported in the 5 to 11 years old age group, with GMFR levels at 2.8-fold (ST1) to 6.6-fold (ST2).

These results further validate the use of the three-dose vaccination schedule which is also included in the Phase 3 protocols for all participants.

No vaccine-related serious adverse events (SAEs) and no safety concerns were observed in this six-month observational follow up.

Juan Carlos Jaramillo M.D., Chief Medical Officer of Valneva, said, "We are pleased with these antibody persistence data that further validate the use of the three-dose vaccination schedule in our ongoing Phase 3 study and the acceptable safety and tolerability profiles of our vaccine candidate. Lyme disease continues to spread, representing a high unmet medical need that impacts the lives of many in the Northern Hemisphere, and each new report of positive data takes us a step closer to potentially bringing this vaccine to both adults and children who could benefit from it."

Earlier this year, Pfizer and Valneva initiated a Phase 3 clinical study, Vaccine Against Lyme for Outdoor Recreationists (VALOR) (NCT05477524), to investigate the efficacy, safety and immunogenicity of VLA152. Approximately 6,000 participants 5 years of age and older will receive three doses of VLA15 180 µg or saline placebo as a primary vaccination series followed by one booster dose of VLA15 or saline placebo (1:1 ratio). Enrollment is ongoing in Europe and the United States and expected to be completed in the second quarter of 2023. To learn more, visit www.pfizerclinicaltrials.com/nct05477524. To achieve the required pediatric safety database, Pfizer and Valneva are planning to initiate a complementary Phase 3 clinical study in early December 2022 to collect additional VLA15 safety data in participants 5 to 17 years of age.

"Rates of Lyme disease continue to increase globally, underscoring the importance of a vaccine that may help protect both adults and children," said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer of Vaccine Research & Development at Pfizer. "These six-month antibody persistence data are encouraging, and we hope that the data generated from the Phase 3 studies will further support the positive evidence for VLA15 to date."

Pending successful completion of the Phase 3 studies, Pfizer could potentially submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) and Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) in 2025.

About VLA15

VLA15 is the only Lyme disease vaccine candidate currently in clinical development. This investigational multivalent protein subunit vaccine uses an established mechanism of action for a Lyme disease vaccine that targets the outer surface protein A (OspA) of Borrelia burgdorferi, the bacteria that cause Lyme disease. OspA is a surface protein expressed by the bacteria when present in a tick. Blocking OspA inhibits the bacterium’s ability to leave the tick and infect humans. The vaccine covers the six most common OspA serotypes expressed by the Borrelia burgdorferi sensu lato species that are prevalent in North America and Europe. VLA15 has demonstrated a strong immune response and satisfactory safety profile in pre-clinical and clinical studies so far. Valneva and Pfizer entered into a collaboration agreement in April 2020 to co-develop VLA15, with updates to the terms within this agreement made in June 2022.3,4 The terms of the collaboration agreement include a $25 million milestone payment made to Valneva upon Pfizer’s initiation of the Phase 3 study. The program was granted Fast Track designation by the U.S. FDA in July 2017.5

About Clinical Study VLA15-221
VLA15-221 is a randomized, observer-blind, placebo-controlled Phase 2 study. It is the first clinical study with VLA15 which enrolled a pediatric population (5-17 years old).

585 healthy participants received VLA15 at two different immunization schedules (month 0-2-6 [N=190] or month 0-6 [N=187]) or three doses of placebo (month 0-2-6 [N=208]). Vaccine recipients received VLA15 at a dose of 180 µg, which was selected based on data generated in the two previous Phase 2 studies. The main safety and immunogenicity readout was performed one month after the primary vaccination series. A subset of participants will receive a booster dose of VLA15 or placebo at month 18 (booster phase) and will be followed for three additional years to monitor antibody persistence.

VLA15 is tested as an alum-adjuvanted formulation and administered intramuscularly. The study is being conducted at U.S. sites located in areas where Lyme disease is endemic and has enrolled both volunteers with a cleared past infection with Borrelia burgdorferi as well as Borrelia burgdorferi-naïve volunteers.

About Lyme Disease

Lyme disease is a systemic infection caused by Borrelia burgdorferi bacteria transmitted to humans by infected Ixodes ticks.6 It is considered the most common vector-borne illness in the Northern Hemisphere.7 While the true incidence of Lyme disease is unknown, it is estimated to annually affect approximately 476,000 people in the United States and 130,000 people in Europe.8,9 Early symptoms of Lyme disease (such as a gradually expanding erythematous rash called Erythema migrans or more nonspecific symptoms like fatigue, fever, headache, mild stiff neck, arthralgia or myalgia) are often overlooked or misinterpreted. Left untreated, the disease can disseminate and cause more serious complications affecting the joints (arthritis), the heart (carditis) or the nervous system.9 The medical need for vaccination against Lyme disease is steadily increasing as the geographic footprint of the disease widens.8

On December 1, 2022 Theratechnologies Inc. ("Theratechnologies" or the "Company") (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, reported that it has decided to pause the enrollment of patients in its Phase 1 clinical trial of TH1902, the Company’s lead investigational peptide drug conjugate (PDC) for the treatment of sortilin-expressing cancers (Press release, Theratechnologies, DEC 1, 2022, View Source [SID1234624704]). The Company plans to submit an amendment to its protocol to the U.S. Food and Drug Administration (FDA) for approval.

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Theratechnologies voluntarily made the decision to pause enrollment and revisit the study design after consulting with its investigators. Efficacy results observed thus far were not convincing enough to pursue enrolling patients and did not outweigh the adverse events seen in some patients. As previously reported, these adverse events consist mainly of neuropathy and eye toxicity.

The current intent for the protocol amendment is to modify the dosage regimen to optimize the delivery of TH1902, with lower doses at more frequent intervals. The Company continues to investigate the results obtained thus far in the Phase 1 clinical trial.

"While we are disappointed with these developments, we remain committed to advancing our SORT1+ Technology platform and will continue investigating its potential in the treatment of advanced cancers," said Christian Marsolais, Ph.D., Senior Vice President and Chief Medical Officer, Theratechnologies.

About SORT1+ Technology and TH1902

Theratechnologies is currently developing a platform of proprietary peptides called SORT1+ TechnologyTM for cancer drug development targeting SORT1 receptors. The SORT1 receptor plays a significant role in protein internalization, sorting and trafficking. It is highly expressed in cancer cells compared to healthy tissue, which makes SORT1 an attractive target for cancer drug development. Expression of SORT1 is associated with aggressive disease, poor prognosis and decreased survival. It is estimated that the SORT1 receptor is expressed in 40% to 90% of cases of endometrial, ovarian, colorectal, triple-negative breast and pancreatic cancers.

TH1902 is currently Theratechnologies’ lead investigational PDC candidate for the treatment of cancer derived from its SORT1+ Technology. It is the Company’s proprietary peptide linked to docetaxel – a commonly used cytotoxic agent used to treat many cancers. The FDA granted fast track designation to TH1902 as a single agent for the treatment of all sortilin-positive recurrent advanced solid tumors that are refractory to standard therapy.

On December 1, 2022 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS’’ or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported results from a preclinical in vivo study for its highly selective CDK9 inhibitor, GFH009, that demonstrate robust inhibition of tumor growth in a mouse xenograft model of small cell lung cancer (SCLC) (Press release, Sellas Life Sciences, DEC 1, 2022, View Source [SID1234624703]).

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GFH009 was tested against NCI-H209 SCL xenografts in athymic nude mice in four treatment groups of eight mice each (n=32) consisting of GFH009 alone, olaparib (a PARP inhibitor) alone, a combined regimen of GFH009 and olaparib, and a vehicle control. Treatments were initiated after tumor xenograft volumes exceeded 120 mm3 in each animal group and mice were subsequently sacrificed after mean tumor volume exceeded 1,500 mm3 in the control group.

GFH009 treated mice exhibited a 40.4% decrease in mean tumor growth compared to the control group in this very aggressive cancer model which had a tenfold increase in average tumor volume over 20 days. Strongest effects were observed with GFH009 in combination with olaparib, with mean tumor growth decreased by 72.3%. Treatment with olaparib alone resulted in a 30.2% mean decrease in tumor growth. No significant toxicity or safety concerns were observed in any of the treatment groups.

"We are looking forward to expanding use of GFH009 into solid cancers and these results indicate CDK9 can be an actionable target not only in the apoptotic pathway but also the DNA damage response pathway," said Dragan Cicic, MD, Senior Vice President, Clinical Development, of SELLAS. "This opens up additional avenues for the use of GFH009 in an expanding array of difficult to treat cancers based on their genomic and proteomic traits, moving another step towards truly personalized medicine."

Olaparib is a commercially available targeted oncology drug that acts as a PARP inhibitor and induces synthetic lethality in BRCA mutated cancer cells via DNA damage and response (DDR) pathways. Recently published clinical trials have demonstrated early signals of efficacy for olaparib both as a single agent and in combination with agents targeting DDR, specifically ATR pathways in refractory SCLC patients. CDK9 is known to bind with cyclin K, forming a complex that plays a key role in the DDR pathway which could enhance synthetic lethality of olaparib.

On December 1, 2022 Seagen Inc. (Nasdaq: SGEN) reported that new data for ADCETRIS (brentuximab vedotin) will be featured at the upcoming 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, taking place December 10-13, 2022 (Press release, Seagen, DEC 1, 2022, View Source [SID1234624702]). The abstracts, including five oral presentations, highlight updated and interim efficacy and safety clinical trial results for ADCETRIS in both early- and advanced stage settings of classical Hodgkin lymphoma (cHL), and in patients with other CD30-expressing lymphomas and other rare cancers.

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"The investigation of ADCETRIS as a single agent or in novel combinations with other agents demonstrates its continued potential to help people impacted by early- and advanced stage Hodgkin lymphoma," said Marjorie Green, M.D., Senior Vice President and Head of Late-Stage Development at Seagen. "Additional data from real-world settings further support the efficacy, safety and impact of ADCETRIS treatment in its approved indications for multiple types of lymphoma."

ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of cHL that is expressed on the surface of several types of lymphomas. It is approved in seven indications in the U.S.

Updated results will also be presented from a phase 1 study of the investigational agent SEA-BCMA in patients with relapsed/refractory multiple myeloma.

Presentations of Company-Sponsored ADCETRIS Clinical Development Trials

Abstract Title

Abstract #

Presentation Time

Lead Author

Brentuximab Vedotin, Nivolumab, Doxorubicin, and Dacarbazine (AN+AD) for Advanced Stage Classic Hodgkin Lymphoma: Updated Efficacy and Safety Results from the Single-Arm Phase 2 Study (SGN35-027 Part B)

314

Oral Presentation

Saturday, Dec. 10

4–5:30 p.m. CT

H. Lee

Population Pharmacokinetics (PPK) and Exposure-Response to Support Body Surface Area (BSA)-Based Dosing of Brentuximab Vedotin in Pediatric Patients with Advanced-Stage Newly Diagnosed Hodgkin Lymphoma (HL)

1616

Poster Session I
Saturday, Dec. 10

5:30–7:30 p.m. CT

X. Zhou

Brentuximab Vedotin, Nivolumab, Doxorubicin, and Dacarbazine (AN+AD) for Early-Stage Classic Hodgkin Lymphoma: Interim Efficacy and Safety Results from the Single-Arm Phase 2 Study (SGN35-027 Part C)

4230

Poster Session III
Monday, Dec. 12

6–8:00 p.m. CT

H. Lee

Brentuximab Vedotin in Frontline Therapy of Hodgkin Lymphoma in Patients with Significant Comorbidities Ineligible for Standard Chemotherapy (SGN35-015 Part E)

1598

Online Abstract

C. Yasenchak

Efficacy and Safety of Retreatment with Brentuximab Vedotin in Patients with Relapsed or Refractory Classical Hodgkin Lymphoma or CD30-Expressing Peripheral T-Cell Lymphoma

5469

Online Abstract

D. Sano

A Phase 4 Multicenter Study of Brentuximab Vedotin Treatment in Chinese Patients with CD30-Positive Cutaneous T-Cell Lymphoma

5491

Online Abstract

Q. Wang

A Spanish Medical Record Review of Adults with Relapsed or Refractory CD30+ Malignancies When Re-Treated with Brentuximab Vedotin (BV): Preliminary Analysis of the BELIEVE Study (NCT04998331)

5528

Online Abstract

A. Sureda

Presentations of Company-Sponsored Health Economic Outcomes Research

Abstract Title

Abstract #

Presentation Type

Lead Author

Real-World Treatment Patterns and Clinical Outcomes with Brentuximab Vedotin or Other Standard Therapies in Patients with Previously Treated Cutaneous T-Cell Lymphoma (CTCL): A Retrospective Chart Review Study in the United States

2265

Poster Session I
Saturday, Dec. 10

5:30–7:30 p.m. CT

S. Barta

Real-World Patient Characteristics, Treatment Patterns, and Outcomes in Patients with Stage III/IV Classic Hodgkin Lymphoma Treated with Frontline ABVD: A Retrospective Analysis Using a Real-World Database

3596

Poster Session II
Sunday, Dec. 11

6–8 p.m. CT

A. Winter

10-Year Impact on Productivity Costs Associated with Mortality in Stage III or IV Classical Hodgkin Lymphoma Based on the Overall Survival Update of the ECHELON-1 Trial: Application of an Oncology Simulation Model in the United States

4846

Poster Session III
Monday, Dec. 12

6–8 p.m. CT

T. Phillips

Economic Burden of Hematopoietic Cell Transplantation (HCT) Among Commercially Insured Patients with Hematological Malignancies in the United States

4850

Poster Session III
Monday, Dec. 12

6–8 p.m. CT

M. Narkhede

Presentation of Company-Sponsored Trials of Pipeline Agents

Abstract Title

Abstract #

Presentation Type

Lead Author

SEA-BCMA Mono- and Combination Therapy in Patients with Relapsed/Refractory Multiple Myeloma: Updated Results of a Phase 1 Study (SGN-BCMA001)

4562

Poster Session III
Monday, Dec. 12

6–8 p.m. CT

J. Hoffman

Presentations of Investigator- and Cooperative-Group Sponsored ADCETRIS Trials

Abstract Title

Abstract #

Presentation Type

Lead Author

Treatment Related Morbidity in Patients with Classical Hodgkin Lymphoma: Results of the Ongoing, Randomized Phase III HD21 Trial by the German Hodgkin Study Group

317

Oral Presentation

Saturday, Dec. 10

4–5:30 p.m. CT

P. Borchmann

Frontline PET-Directed Therapy with Brentuximab Vedotin Plus AVD Followed by Nivolumab Consolidation in Patients with Limited Stage Hodgkin Lymphoma

728

Oral Presentation

Monday, Dec. 12

10:30 a.m.–12 p.m. CT

S. Park

Brentuximab Vedotin Combined with Chemotherapy in Newly Diagnosed, Early-Stage, Unfavorable-Risk Hodgkin Lymphoma: Extended Follow-Up with Evaluation of Baseline Metabolic Tumor Volume and PET2

730

Oral Presentation
Monday, Dec. 12
10:30 a.m.–12 p.m. CT

R. Stuver

Addition of Brentuximab Vedotin to Gemcitabine in Relapsed or Refractory T-Cell Lymphoma: Final Analysis of a LYSA Multicenter, Phase II Study "The TOTAL Trial"

956

Oral Presentation
Monday, Dec. 12
4:30–6 p.m. CT

O. Tournilhac

A Phase I Trial Assessing the Feasibility of Romidepsin Combined with Brentuximab Vedotin for Patients Requiring Systemic Therapy for Cutaneous T-Cell Lymphoma

2911

Poster Session II
Sunday, Dec. 11

6–8 p.m. CT

S. Barta

Peripheral Neuropathy in Children with High-Risk Hodgkin Lymphoma (HL): The Role of Protocol-Stipulated Dose Modification in the Children’s Oncology Group (COG) AHOD1331 Study

2914

Poster Session II
Sunday, Dec. 11

6–8 p.m. CT

S. Parsons,

F. Keller

Evaluating CHIPS in Pediatric High Risk Hodgkin Lymphoma Treated on AHOD1331

2921

Poster Session II

Sunday, Dec. 11

6–8 p.m. CT

C. Schwartz

Phase I Trial of Brentuximab Vedotin Plus Cyclosporine in Relapsed/Refractory Hodgkin Lymphoma

4239

Poster Session III
Monday, Dec. 12

6–8 p.m. CT

S. Kambhampati, M. Mei

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 recognizes royalty revenues from Takeda based on a percentage of Takeda’s net sales of ADCETRIS in its licensed territories based on annual net sales tiers. Seagen and Takeda jointly fund 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.

Please see full Prescribing information, including BOXED WARNING, for ADCETRIS here.

On December 1, 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 the company’s Board of Directors has appointed Francois Martelet as new Chief Executive Officer (CEO) (Press release, Scandion Oncology, DEC 1, 2022, View Source;m-d–as-new-chief-executive-officer,c3675834 [SID1234624701]). Francois will take up his new position on January 2, 2023.

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Trained as a Medical Doctor with a Master’s degree in Business, Francois Martelet is an experienced executive and CEO with a career spanning more than 30 years in the global pharmaceutical and biotech industry and more than 20 years of experience as an executive. He has significant experience within early and late-stage clinical development in oncology (cancer) as well as business and partnership development.

"We are delighted to appoint Francois Martelet as the new CEO of Scandion. Francois brings a wealth of highly relevant experiences to Scandion as an experienced and passionate business leader with the qualifications to successfully develop Scandion and our lead asset, SCO-101", says Martin Møller, Chairman of the Board of Directors of Scandion.

Francois Martelet has worked and held leadership positions in large pharmaceutical companies including Roche, Eli Lilly, Novartis and MSD. He has also been the CEO of a number of biotech companies, most recently Vivesto AB, where he completed a full turnaround and led the build-up of an oncology pipeline through organic and external growth.

"I am very excited by the opportunity to join and lead Scandion in its pursuit to revert cancer drug resistance, which would make a tremendous difference to patients. Scandion has a huge medical and therefore commercial potential which I am looking forward to help fulfil", says Francois Martelet.

Acting CEO & CFO Johnny Stilou will continue in this role until January 2, 2023, and afterwards resume his role as CFO of Scandion.