Mosaic Therapeutics Closes $28m Series A Funding and Appoints Brian Gladsden as CEO

On April 04, 2023 Mosaic Therapeutics, Ltd, an oncology therapeutics company dedicated to resolving cancer’s complexity to power new treatments for patients, reported the close of its $28 million series A funding round (Press release, Mosaic Therapeutics, APR 4, 2023, View Source [SID1234629826]). The Company also announces the appointment of former Novartis Oncology SVP Brian Gladsden as CEO. The investment in this round was raised from Syncona Investment Management, Ltd, and Cambridge Innovation Capital.

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!

The Series A funding will be used to further advance Mosaic’s pipeline of targeted oncology therapies for biomarker-stratified populations, progressing its lead programmes through preclinical development to IND-enabling studies. The funds will also support recruitment efforts, building the Company’s senior leadership, experimental biology, and computational teams.

Mosaic’s use of advanced computational methods, while combining mining of large datasets with experimental approaches to identify and develop novel targeted therapies, completely reinvents the traditional approach to target and drug discovery. The Company’s bespoke relationship with the Wellcome Sanger Institute provides it unique access to deep scientific expertise, infrastructure, and biological assets.

Brian Gladsden joins Mosaic as CEO following a 25-year career in biopharmaceuticals, including 5 years with Bayer AG and 15 years with Novartis Oncology, where he was Senior Vice President and a member of the Worldwide Leadership Team, with responsibility for global commercialisation and strategy for the portfolio. Mr Gladsden has held various leadership positions, including country CEO, leading cancer therapeutic development and commercial launch across the US, Europe, Australia, South Korea and Japan.

Mosaic’s proprietary platform applies research from co-founder Dr Mathew Garnett’s Translational Cancer Genomics Laboratory at the Wellcome Sanger Institute. Dr Garnett is a Senior Group Leader at Sanger with over 20 years’ experience in genomics and cancer therapeutics, with past achievements including co-discovery of BRAF mutations in cancer and Werner Syndrome helicase as a target in MSI tumours.

Brian Gladsden, CEO, Mosaic Therapeutics, commented: "I believe that Mosaic is ideally positioned to resolve the complexity of cancer, to discover and develop targeted therapies that address areas of high unmet need. The people, platform, connection to a world-leading genomics research institute, and strong investor partnerships are truly best in class.

To receive funding from such high calibre investors is testament to the potential of Mosaic’s technology and multidisciplinary team, as well as the exceptional support provided by the Wellcome Sanger Institute."

Alongside Dr Garnett, the Company was co-founded by Professor Emile Voest and Dr Adrian Ibrahim. Professor Voest is Professor of Medical Oncology, Chairman of the Board of Cancer Core Europe, Group Leader at the Netherlands Cancer Institute and Oncode Institute, and Independent Director of the Board of Sanofi S.A. Dr Ibrahim was formerly Head of Technology Translation at the Wellcome Sanger Institute, has 30 years’ experience across the discovery and development of cancer and genomics technologies, and has been involved in multiple genomics company spin-outs.

Dr Mathew Garnett, co-founder of Mosaic Therapeutics, added: "Mosaic is ready to lead the next wave of treatments for cancer, through the discovery of effective targeted therapies in molecularly-defined patients. Cancer is a complex disease and our platform, combining large-scale screening in advanced cancer models and cancer big data, gives Mosaic unprecedented clarity and insights. With high calibre investors, an experienced CEO, and solid scientific foundations, we’re building an exceptional team to deliver on our vision to develop safer and more effective medicines."

Magdalena Jonikas, Lead Partner at Syncona Investment Management Limited and Director of Mosaic, said: "The unprecedented insights provided by the genomic revolution have enabled more targeted drug development, with drug targets being de-risked by genetics or data. This approach to drug discovery is a focus for us at Syncona and Mosaic is a great example of a company built around this concept. With a differentiated strategy that can accelerate entry to the clinic, and the potential for application in a number of oncology settings in cancers which have previously been difficult to treat, we are excited for the potential of this platform. The opportunity for the Company, and most importantly for patients, is significant. I am thrilled that Brian has joined Mosaic to lead the next stage of the Company’s growth, and look forward to building this business in partnership with its world-class team."

Anne Horgan, Partner at Cambridge Innovation Capital and Director of Mosaic, said: "We are delighted to invest in Mosaic Therapeutics and its outstanding founders, backing our third spin out from the Wellcome Sanger Institute. We also welcome Brian, a seasoned oncology executive, to the team. Mosaic’s unique combination of advanced data science, large dataset mining and experimental approaches has the capability to identify and develop novel targeted therapies for the patient groups most likely to respond to these treatments. Cambridge (UK) is a globally important hub for biotechnology and life sciences, and Mosaic is a great example of innovation in the ecosystem."

Mosaic is the most recent spin-out company from the Wellcome Sanger Institute, a world leader in genome research, with notable achievements including being the single largest contributor to the Human Genome Project, co-founding the International Cancer Genome Consortium, and identifying specific BRAF mutations that underpinned a new class of transformational targeted cancer therapeutics.

Learn more about Mosaic’s approach to genomics-guided oncology medicine: View Source

FDA Accepts Pfizer’s Supplemental New Drug Applications for BRAFTOVI + MEKTOVI

On April 4, 2023 Pfizer Inc. (NYSE:PFE) reported that the U.S. Food and Drug Administration (FDA) has accepted for review the Supplemental New Drug Applications (sNDAs) for BRAFTOVI (encorafenib) + MEKTOVI (binimetinib) for patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test (Press release, Pfizer, APR 4, 2023, View Source [SID1234629825]).

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!

The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is in Fourth-Quarter 2023 for the sNDAs. In the U.S., BRAFTOVI + MEKTOVI is currently approved for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test. BRAFTOVI is also approved, in combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy.

"For more than a decade, Pfizer Oncology has been at the forefront of bringing biomarker-driven treatment options to patients with cancer. Since their initial regulatory approvals, BRAFTOVI and MEKTOVI have helped improve outcomes in their respective indications of BRAF-mutated metastatic melanoma and BRAF-mutated metastatic colorectal cancer," said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology and Rare Disease, Pfizer Global Product Development. "Through our comprehensive development program, the BRAFTOVI and MEKTOVI combination has shown the potential to help more patients, such as those living with BRAF V600E-mutant non-small cell lung cancer. These sNDAs build on Pfizer’s long heritage of meeting the diverse needs of people with NSCLC, and we look forward to working with the FDA on their review of these applications."

These sNDAs are supported by results from the PHAROS trial (NCT03915951), an open-label, multicenter, non-randomized, Phase 2 study (n=98) to determine the safety, tolerability, and efficacy of BRAFTOVI given in combination with MEKTOVI in patients with BRAF V600E-mutant metastatic NSCLC. PHAROS met its primary endpoint of objective response rate. Detailed results from the PHAROS study will be presented at an upcoming scientific congress.

About Non-Small Cell Lung Cancer (NSCLC)

Lung cancer is the second most common type of cancer and the number one cause of cancer-related death around the world.1 In 2023, the American Cancer Society estimates there will be about 238,340 new cases of lung cancer diagnosed in the U.S.2 NSCLC accounts for approximately 80-85% of all lung cancers.3

Some lung cancers are linked to acquired genetic abnormalities. For instance, a BRAF V600E mutation occurs in approximately 2% of NSCLC cases4 and stimulates tumor cell growth and proliferation by altering the MAP kinase (MAPK) signaling pathway. Targeting components of this pathway could potentially inhibit unchecked tumor growth and proliferation caused by BRAF mutations.5

Precision medicine is increasingly being developed for NSCLC patients with genetic changes, such as BRAF mutations, that can be detected using biomarker tests.6,7 Advances in targeted therapy have been associated with significant improvements in population-level NSCLC mortality in recent years.8

About PHAROS

PHAROS (NCT03915951) is an open-label, multicenter, non-randomized, Phase 2 study to determine the safety, tolerability, and efficacy of BRAFTOVI given in combination with MEKTOVI in 98 patients with BRAF V600E-mutant metastatic NSCLC. The primary endpoint is objective response rate, based on independent radiologic review (per RECIST v1.1); secondary objectives will evaluate additional efficacy endpoints and safety. Duration of response is a key secondary endpoint. The trial is conducted across 53 sites in: Italy (5 sites), the Netherlands (2 sites), South Korea (3 sites), Spain (4 sites), and the U.S. (39 sites).

About BRAFTOVI + MEKTOVI

BRAFTOVI is an oral small molecule BRAF kinase inhibitor and MEKTOVI is an oral small molecule MEK inhibitor which target key proteins in the MAPK signaling pathway (RAS-RAF-MEK-ERK). Inappropriate activation of this pathway has been shown to occur in many cancers, including melanoma, CRC, and NSCLC.

In 2018, the FDA approved BRAFTOVI + MEKTOVI in combination for patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test. The approval was based on COLUMBUS, a randomized, active-controlled, open-label, Phase 3 trial.

In 2020, BRAFTOVI was FDA-approved, in combination with cetuximab, for the treatment of adults with metastatic CRC with a BRAF V600E mutation, as detected by an FDA-approved test. The approval was based on results from the BEACON CRC trial.

Pfizer has exclusive rights to BRAFTOVI and MEKTOVI in the U.S., Canada, and all countries in the Latin America, Africa, and Middle East regions. Ono Pharmaceutical Co. Ltd. has exclusive rights to commercialize both products in Japan and South Korea, Medison has exclusive rights in Israel, and Pierre Fabre has exclusive rights in all other countries, including Europe and Asia-Pacific (excluding Japan and South Korea).

INDICATIONS AND USAGE

BRAFTOVI (encorafenib) and MEKTOVI (binimetinib) are kinase inhibitors indicated for use in combination for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation as detected by an FDA-approved test.

BRAFTOVI is indicated, in combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy.

Limitations of Use: BRAFTOVI is not indicated for treatment of patients with wild-type BRAF melanoma or wild-type BRAF CRC.

IMPORTANT SAFETY INFORMATION

This information applies to the safety of BRAFTOVI when used in combination with either MEKTOVI or cetuximab.

WARNINGS AND PRECAUTIONS

New Primary Malignancies, cutaneous and non-cutaneous malignancies can occur with BRAFTOVI. BRAFTOVI may promote malignancies associated with activation of RAS through mutation or other mechanisms. Perform dermatopathologic evaluations prior to initiating treatment, every 2 months during treatment, and for up to 6 months following discontinuation of treatment. Manage suspicious skin lesions with excision and dermatopathologic evaluation. Dose modification is not recommended for new primary cutaneous malignancies. Monitor patients receiving BRAFTOVI for signs and symptoms of non-cutaneous malignancies. Discontinue BRAFTOVI for RAS mutation-positive non-cutaneous malignancies.

BRAF-mt metastatic melanoma (COLUMBUS study): Cutaneous squamous cell carcinoma (cuSCC), including keratoacanthoma (KA), occurred in 2.6% and basal cell carcinoma occurred in 1.6% of patients receiving BRAFTOVI with MEKTOVI. Median time to first occurrence of cuSCC/KA was 5.8 months
BRAF-mt metastatic CRC (BEACON CRC study): cuSCC, including KA, occurred in 1.4% of patients with CRC, and new primary melanoma occurred in 1.4% of patients who received BRAFTOVI with cetuximab
Tumor Promotion in BRAF Wild-Type Tumors: In vitro experiments have demonstrated paradoxical activation of MAP-kinase signaling and increased cell proliferation in BRAF wild-type cells exposed to BRAF inhibitors. Confirm evidence of BRAF V600E or V600K mutation using an FDA-approved test prior to initiating BRAFTOVI.

Hemorrhage: Hemorrhage can occur when BRAFTOVI is administered in combination with MEKTOVI or cetuximab. Withhold, reduce dose, or permanently discontinue based on severity of adverse reaction.

BRAF-mt metastatic melanoma (COLUMBUS study): Hemorrhage occurred in 19% of patients receiving BRAFTOVI with MEKTOVI and Grade 3 or higher hemorrhage occurred in 3.2% of patients. The most frequent hemorrhagic events were gastrointestinal, including rectal hemorrhage (4.2%), hematochezia (3.1%), and hemorrhoidal hemorrhage (1%). Fatal intracranial hemorrhage in the setting of new or progressive brain metastases occurred in 1.6% of patients
BRAF-mt metastatic CRC (BEACON CRC study): Hemorrhage occurred in 19% of patients receiving BRAFTOVI with cetuximab; Grade 3 or higher hemorrhage occurred in 1.9% of patients, including fatal gastrointestinal hemorrhage in 0.5% of patients. The most frequent hemorrhagic events were epistaxis (6.9%), hematochezia (2.3%), and rectal hemorrhage (2.3%)
Uveitis: Uveitis, including iritis and iridocyclitis, has been reported in patients treated with BRAFTOVI with MEKTOVI. Assess for visual symptoms at each visit. Perform an ophthalmological evaluation at regular intervals and for new or worsening visual disturbances, and to follow new or persistent ophthalmologic findings. Withhold, reduce dose, or permanently discontinue based on severity of adverse reaction. In the COLUMBUS study, uveitis, including iritis and iridocyclitis, was reported in 4% of patients treated with BRAFTOVI with MEKTOVI.

QT Prolongation: BRAFTOVI is associated with dose-dependent QTc interval prolongation in some patients. Monitor patients who already have or who are at significant risk of developing QTc prolongation, including patients with known long QT syndromes, clinically significant bradyarrhythmias, severe or uncontrolled heart failure and those taking other medicinal products associated with QT prolongation. Correct hypokalemia and hypomagnesemia prior to and during BRAFTOVI administration. Withhold, reduce dose, or permanently discontinue for QTc >500 ms.

BRAF-mt metastatic melanoma (COLUMBUS study): An increase in QTcF to >500 ms was measured in 0.5% (1/192) of patients who received BRAFTOVI in combination with MEKTOVI
Embryo-Fetal Toxicity: Both BRAFTOVI and MEKTOVI can cause fetal harm when administered to a pregnant woman. BRAFTOVI can render hormonal contraceptives ineffective.

BRAF-mt metastatic melanoma (COLUMBUS study): Nonhormonal contraceptives should be used during treatment and for at least 30 days after the final dose for patients taking BRAFTOVI + MEKTOVI
BRAF-mt metastatic CRC (BEACON CRC study): Advise females of reproductive potential to use effective nonhormonal contraception during treatment with BRAFTOVI and for 2 weeks after the final dose
BRAFTOVI as a Single Agent is associated with increased risk of certain adverse reactions compared to when BRAFTOVI is used with MEKTOVI.

BRAF-mt metastatic melanoma (COLUMBUS study): Grades 3 or 4 dermatologic reactions occurred in 21% of patients receiving BRAFTOVI as a single agent compared to 2% in patients receiving the combination of BRAFTOVI with MEKTOVI
If MEKTOVI is temporarily interrupted or permanently discontinued, reduce the dose of BRAFTOVI as recommended
Risks Associated with Combination Treatment

In BRAF-mt metastatic melanoma (COLUMBUS study), BRAFTOVI is used in combination with MEKTOVI so refer to the prescribing information for MEKTOVI for additional risk information
In BRAF-mt metastatic CRC (BEACON CRC study), BRAFTOVI is used in combination with cetuximab so refer to the prescribing information for cetuximab for additional risk information
Additional WARNINGS and PRECAUTIONS for MEKTOVI When Used With BRAFTOVI in BRAF-mt Metastatic Melanoma (COLUMBUS study)

Cardiomyopathy, manifesting as left ventricular dysfunction associated with symptomatic or asymptomatic decreases in ejection fraction, has been reported in patients. Patients with cardiovascular risk factors should be monitored closely. Withhold, reduce dose, or permanently discontinue based on severity of adverse reaction.

Assess left ventricular ejection fraction (LVEF) by echocardiogram or multi-gated acquisition (MUGA) scan prior to initiating treatment, 1 month after initiating treatment, and then every 2 to 3 months during treatment
The safety has not been established in patients. In with a baseline ejection fraction that is either below 50% or below the institutional lower limit of normal (LLN)
BRAF-mt metastatic melanoma (COLUMBUS study): evidence of cardiomyopathy occurred in 7% and Grade 3 left ventricular dysfunction occurred in 1.6% of patients. receiving MEKTOVI with BRAFTOVI. The median time to first occurrence of left ventricular dysfunction (any grade) was 3.6 months. Cardiomyopathy resolved in 87% of patients.
Venous Thromboembolism (VTE): VTE occurred in 6% of patients with BRAF-mt metastatic melanoma (COLUMBUS study), including 3.1% of patients who developed pulmonary embolism. Withhold, reduce dose, or permanently discontinue based on severity of adverse reaction.

Other Ocular Toxicities:

Serous retinopathy occurred in 20% of patients receiving MEKTOVI with BRAFTOVI; 8% were retinal detachment and 6% were macular edema. Symptomatic serous retinopathy occurred in 8% of patients with no cases of blindness. The median time to onset of the first event of serous retinopathy (all grades) was 1.2 months.
Retinal vein occlusion (RVO) is a known class-related adverse reaction of MEK inhibitors and may occur in patients receiving MEKTOVI with BRAFTOVI. In BRAF-mt metastatic melanoma (COLUMBUS study), 1 patient experienced RVO (0.1%) in the MEKTOVI with BRAFTOVI group (n=690).
The safety of MEKTOVI has not been established in patients with a history of RVO or current risk factors for RVO including uncontrolled glaucoma or a history of hyperviscosity or hypercoagulability syndromes
Perform ophthalmological evaluation for patient-reported acute vision loss or other visual disturbance within 24 hours. Permanently discontinue MEKTOVI in patients with documented RVO
Interstitial Lung Disease (ILD): ILD, including pneumonitis occurred in 0.3% (2 of 690 patients) with BRAF-mt metastatic melanoma receiving MEKTOVI with BRAFTOVI. Assess new or progressive unexplained pulmonary symptoms or findings for possible ILD. Withhold, reduce dose, or permanently discontinue based on severity of adverse reaction.

Hepatotoxicity: Hepatotoxicity can occur when MEKTOVI is taken with BRAFTOVI. Monitor liver laboratory tests before initiation of MEKTOVI, monthly during treatment, and as clinically indicated. Withhold, reduce dose, or permanently discontinue based on severity of adverse reaction.

BRAF-mt metastatic melanoma (COLUMBUS study): The incidence of Grade 3 or 4 increases in liver function laboratory tests in patients receiving MEKTOVI with BRAFTOVI was 6% for alanine aminotransferase (ALT), 2.6% for aspartate aminotransferase (AST), and 0.5% for alkaline phosphatase. No patient experienced Grade 3 or 4 serum bilirubin elevation
Rhabdomyolysis: Rhabdomyolysis can occur when MEKTOVI is taken with BRAFTOVI. Monitor creatine phosphokinase and creatinine levels prior to initiating MEKTOVI, periodically during treatment, and as clinically indicated. Withhold, reduce dose, or permanently discontinue based on severity of adverse reaction.

BRAF-mt metastatic melanoma (COLUMBUS study): Elevation of laboratory values of serum CPK occurred in 58% of patients receiving MEKTOVI with BRAFTOVI. Rhabdomyolysis was reported in 0.1% (1 of 690 patients) with BRAF mutation-positive melanoma receiving MEKTOVI with BRAFTOVI
ADVERSE REACTIONS

BRAF-mt Metastatic Melanoma (COLUMBUS study)

Most common adverse reactions (≥ 20%, all grades) for patients receiving BRAFTOVI and MEKTOVI compared to vemurafenib were fatigue (43% vs 46%), nausea (41% vs 34%), diarrhea (36% vs 34%), vomiting (30% vs 16%), abdominal pain (28% vs 16%), arthralgia (26% vs 46%), myopathy (23% vs 22%), hyperkeratosis (23% vs 49%), rash (22% vs 53%), headache (22% vs 20%), constipation (22% vs 6%), visual impairment (20% vs 4%), serous retinopathy/RPED (20% vs 2%)
Other clinically important adverse reactions occurring in <10% of patients who received BRAFTOVI with MEKTOVI were facial paresis, pancreatitis, panniculitis, drug hypersensitivity, and colitis
Most common laboratory abnormalities (≥ 20%, all grades) for BRAFTOVI with MEKTOVI compared to vemurafenib included increased creatinine (93% vs 92%), increased CPK (58% vs 3.8%), increased gamma glutamyl transferase (GGT) (45% vs 34%), anemia (36% vs 34%), increased ALT (29% vs 27%), hyperglycemia (28% vs 20%), increased AST (27% vs 24%), and increased alkaline phosphatase (21% vs 35%)
BRAF-mt Metastatic CRC (BEACON CRC study)

Most common adverse reactions (≥25%, all grades) in patients receiving BRAFTOVI with cetuximab compared to irinotecan with cetuximab or FOLFIRI with cetuximab (control) were fatigue (51% vs 50%), nausea (34% vs 41%), diarrhea (33% vs 48%), dermatitis acneiform (32% vs 43%), abdominal pain (30% vs 32%), decreased appetite (27% vs 27%), arthralgia (27% vs 3%), and rash (26% vs 26%)
Other clinically important adverse reactions occurring in <10% of patients who received BRAFTOVI with cetuximab was pancreatitis
Most common laboratory abnormalities (≥20%, all grades) in patients receiving BRAFTOVI with cetuximab compared to irinotecan with cetuximab or FOLFIRI with cetuximab (control) were anemia (34% vs 48%) and lymphopenia (24% vs 35%)
DRUG INTERACTIONS With BRAFTOVI When Used in Combination With Either MEKTOVI or Cetuximab

Avoid coadministration of BRAFTOVI with strong or moderate CYP3A4 inhibitors (including grapefruit juice) or CYP3A4 inducers and use caution with sensitive CYP3A4 substrates. Avoid coadministration of BRAFTOVI with hormonal contraceptives.
Modify BRAFTOVI dose if coadministration with a strong or moderate CYP3A4 inhibitor cannot be avoided.
Avoid coadministration of BRAFTOVI with drugs known to prolong QT/QTc interval.
Dose reductions of drugs that are substrates of OATP1B1, OATP1B3, or BCRP may be required when used concomitantly with BRAFTOVI.
Lactation: Advise women not to breastfeed during treatment with BRAFTOVI and for 2 weeks after final dose.

Infertility: Advise males of reproductive potential that BRAFTOVI may impair fertility.

For BRAF-mt metastatic melanoma, see full Prescribing Information and Medication Guide for BRAFTOVI and full Prescribing Information and Patient Information for MEKTOVI. See full Prescribing Information for BRAFTOVI and for MEKTOVI for dose modifications for adverse reactions.

For BRAF-mt metastatic CRC, see full Prescribing Information and Medication Guide for BRAFTOVI. See full Prescribing Information for BRAFTOVI for dose modifications for adverse reactions. Refer to cetuximab prescribing information for recommended dosing and safety information.

Please see full Prescribing Information for BRAFTOVI and full Prescribing Information for MEKTOVI.

Boundless Bio to Present at the 22nd Annual Needham Virtual Healthcare Conference

On April 4, 2023 -Boundless Bio, a next-generation precision oncology company developing innovative therapeutics directed against extrachromosomal DNA (ecDNA) in oncogene amplified cancers, reported that its Chief Business Officer, Neil Abdollahian, will present at the 22nd Annual Needham Healthcare Conference which will take place virtually (Press release, Boundless Bio, APR 4, 2023, View Source [SID1234629824]). Presentation details are as follows:

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!

Date: Tuesday, April 18, 2023
Time: 4:30 – 5:10 PM ET

Transgene to Host KOL Webinar on TG4050: an Individualized Cancer Vaccine for the Treatment of HPV-Negative Head & Neck Cancers

On April 4, 2023 TRANSGENE (Paris:TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, reported that it will host a virtual Key Opinion Leader (KOL) event on Wednesday, April 19, 2023 at 12:00 pm ET / 6:00 pm CET (Press release, Transgene, APR 4, 2023, View Source [SID1234629823]).

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!

The KOL webinar will provide insights on TG4050 from expert medical oncologist Professor Christian Ottensmeier, MD, PhD, FRCP (University of Liverpool, La Jolla Institute for Immunology) who will also discuss the unmet medical need and outlook on treatment landscape for patients suffering from head and neck cancers. Prof. Ottensmeier’s presentation will be followed by a Q&A session.

In addition, Transgene’s management team will provide a company update, highlighting new Phase I data presented at AACR (Free AACR Whitepaper) on April 18, 2023, confirming the high immunogenicity and promising efficacy profile of TG4050, an individualized neoantigen cancer vaccine developed by Transgene in collaboration with NEC Corporation.

To register for the event, please click here.

Transgene will also present eight posters and have a booth (#310) at AACR (Free AACR Whitepaper) which is taking place in Orlando, Florida, on April 14-19, 2023.

Adcendo ApS Announces Extension of Series A Financing to 82M EUR to Ensure Broad Development of its First-in-class ADC Pipeline

On April 4, 2023 Adcendo ApS ("Adcendo"), a biotech company focused on the development of breakthrough antibody-drug conjugates (ADCs) for the treatment of cancers with a high unmet medical need, reported the successful completion of a Series A extension financing, raising a further 31 million EUR, following the 51 million EUR Series A financing in April 2021 (Press release, ADCendo, APR 4, 2023, View Source [SID1234629822]). The financing was led by Pontifax Venture Capital, a leading healthcare-focused venture capital firm and existing investors Novo Holdings and Ysios Capital. Current investors RA Capital Management, HealthCap and Gilde Healthcare participated as well. As part of the investment, Ohad Hammer, partner at Pontifax Venture Capital, will join the Adcendo Board of Directors.

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!

uPARAP is a novel cancer target overexpressed on the cell surface of sarcoma and other mesenchymal cancers. The intriguing expression profile and internalizing properties of uPARAP make it a highly attractive ADC target. uPARAP ADC has shown potential to be effective across multiple sarcoma subtypes, an indication with a very high unmet medical need.

Adcendo intends to use the proceeds from the financing to initiate a broad clinical development program for uPARAP ADC in Sarcoma and is also planning to advance the development of its 2nd ADC pipeline asset with Development Candidate Nomination (DCN) planned in H1 2024.

Michael Pehl, Chief Executive Officer of Adcendo, said: "This financing underscores the confidence that our investors have in Adcendo’s capabilities and potential to develop innovative ADC cancer therapies in high unmet medical need cancers. We are pleased to welcome Ohad Hammer to the Adcendo Board of Directors, who brings a wealth of experience in supporting and advancing early-stage biotech companies. 2022 was a pivotal year for Adcendo with the expansion of our team, uPARAP ADC Development Candidate Nomination and the recent linker/payload license agreement with Duality Biologics. This financing will enable us to ensure a broad development program of our lead asset uPARAP and further advance our 2nd first-in-class ADC pipeline asset."

Ohad Hammer, Board Director of Adcendo and Partner at Pontifax Venture Capital, commented: "We are excited to support Adcendo’s efforts to bring new treatments to patients with cancer as we continue our focus on seeking exciting transformative technologies to treat substantial unmet medical need indications. Adcendo’s ADC capabilities offer significant potential and I look forward to closely working with the team to develop their pipeline assets and bring innovative therapies to patients in need."