On March 14, 2023 Photocure ASA (OSE: PHO), the Bladder Cancer Company, reported its participation in the congress, and two abstract presentations at the European Association of Urology congress (EAU) in Milan, Italy, highlighting the benefits of Blue Light Cystoscopy (BLC) in Bladder Cancer management (Press release, PhotoCure, MAR 14, 2023, View Source [SID1234628688]).

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The EAU annual meeting is one of the largest international meetings in the urology calendar, showcasing the latest and most relevant knowledge in this area of patient care. This year’s event was held on March 10-13, 2023 and attracted urologists from all over the world. In addition to an active presence & support for the event, Photocure will also be making bladder cancer session highlights available post event by means of video interviews with the presenters of these sessions. This initiative is supported by two of the leading names in Bladder Cancer in Europe, Prof. M. Rouprêt, APHP, Sorbonne University Paris, France and Prof. P. Gontero, Division of Urology, University of Studies of Torino, Italy. In addition to this activity, two abstract presentations were presented as part of the EAU scientific program that feature the blue light cystoscopy procedure: Immunological changes following blue light cystoscopy with hexaminolevulinate in bladder cancer (A0431-Sunday 10:45) The project conducted at Department of Molecular Medicine, Aarhus University Hospital, Denmark, presents results from a pilot study of bladder cancer patients, showing that blue light cystoscopy with Hexaminolevulinate (HAL) during TURBT* may influence the immune cell composition and tumor microenvironment. Preliminary findings suggest that BLC-guided TURBT changes the expression of immune cells of both the adaptive and innate immune system compared to WLC-guided TURBT. Further studies are required to validate the clinical impact of these observations. Read the abstract: View Source Blue Light Cystoscopy Delays Time to Recurrence in Non-Muscle Invasive Bladder Cancer Patients Treated in a Real-World Setting (A0710 – Sunday 15:45) Real-world data taken from the Blue Light Cystoscopy with Cysview Registry (Clinicaltrials.gov; NCT02660645), the largest non-muscle-invasive bladder cancer registry in the U.S., showed that use of BLC significantly decreased the risk of recurrence and prolonged time to recurrence compared to White Light alone (HR 0.33; 95% 95% CI 0.2-0.40, p<0.0001). Additionally, BLC in patients with primary tumors extended time to recurrence compared to recurrent patients (HR 1.12; 95% CI 0.89-1.41, p<0.001), suggesting that the earlier use of BLC might have more favorable long-term outcomes in a real-world setting. Read the abstract: View Source "These new study results continue to emphasize the importance of performing a thorough TURBT using Blue Light Cystoscopy in the treatment of bladder cancer, and also demonstrate the strong interest from the scientific community to investigate Hexvix/Cysview’s potential immunologic effects in bladder cancer management. BLC has been shown to clinically increase TURBT quality, more accurately stage disease for treatment, and enable better recurrence monitoring, supporting the long-term utility to help improve the lives of patients with bladder cancer," said Dan Schneider, President and CEO of Photocure. "As we continue to broaden the awareness of BLC with Hexvix throughout Europe, it is a privilege to participate in the EAU congress, and to see so much engagement from the scientific community and urologists alike. The expanding number of scientific sessions featuring Blue Light is impressive this year. It empowers us on our journey to bring this important product and procedure to even more new users in Europe" added Susanne Strauss, Vice President and General Manager Europe. *TURBT: trans-urethral resection of bladder tumors Note to editors Hexvix/Cysview and BLC are registered trademarks of Photocure ASA. This press release may contain product details and information which are not valid, or a product that is not accessible, in your country. Please be aware that Photocure does not take any responsibility for accessing such information, which may not comply with any legal process, regulation, registration, or usage in the country of your origin. About Bladder Cancer Bladder cancer ranks as the 8th most common cancer worldwide – the 5th most common in men – with 1 720 000 prevalent cases (5-year prevalence rate)1a, 573 000 new cases and more than 200 000 deaths annually in 2020.1b Approx. 75% of all bladder cancer cases occur in men.1 It has a high recurrence rate, with up to 61% in year one and up to 78% over five years.2 Bladder cancer has the highest lifetime treatment costs per patient of all cancers.3 Bladder cancer is a costly, potentially progressive disease for which patients have to undergo multiple cystoscopies due to the high risk of recurrence. There is an urgent need to improve both the diagnosis and the management of bladder cancer for the benefit of patients and healthcare systems alike. Bladder cancer is classified into two types, non-muscle invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC), depending on the depth of invasion in the bladder wall. NMIBC remains in the inner layer of cells lining the bladder. These cancers are the most common (75%) of all cases and include the subtypes Ta, carcinoma in situ (CIS), and T1 lesions. In MIBC, the cancer has grown into deeper layers of the bladder wall. These cancers, including subtypes T2, T3, and T4, are more likely to spread and are harder to treat.4 1 Globocan. a) 5-year prevalence / b) incidence/mortality by population. Available at: View Source, accessed [January 2022]. 2 Babjuk M, et al. Eur Urol. 2019; 76(5): 639-657 3 Sievert KD et al. World J Urol 2009;27:295–300 4 Bladder Cancer. American Cancer Society. View Source About Hexvix/Cysview (hexaminolevulinate HCl) Hexvix/Cysview is a drug that preferentially accumulates in cancer cells in the bladder, making them glow bright pink during Blue Light Cystoscopy (BLC). BLC with Hexvix/Cysview, compared to standard white light cystoscopy alone, improves the detection of tumors and leads to more complete resection, fewer residual tumors, and better management decisions. Cysview is the tradename in the U.S. and Canada, Hexvix is the tradename in all other markets. Photocure is commercializing Cysview/Hexvix directly in the U.S. and Europe and has strategic partnerships for the commercialization of Hexvix/Cysview in China, Chile, Australia, New Zealand and Israel. Please refer to View Source for further information on our commercial partners.

On March 14, 2023 Newron Pharmaceuticals S.p.A. ("Newron") (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, reported its financial results and operational highlights for the business year ended December 31, 2022, and provided an outlook for 2023 (Press release, Newron, MAR 14, 2023, View Source [SID1234628687]).

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Highlights 2022:

Evenamide (Schizophrenia)

Striking interim efficacy and safety results from world-first Phase II clinical trial evaluating evenamide as add-on therapy for patients with treatment-resistant schizophrenia (TRS), after six weeks and, post-period, six months and one year

Enrolment of patients in study 014 completed, with 161 subjects randomized (post-period); full results from the study after six weeks of treatment expected in March 2023

Following the interim data in patients suffering from TRS, study 003, a potentially pivotal, multinational, randomized, double-blind, ten-week, placebo-controlled study assessing the efficacy, safety and tolerability of 15 and 30 mg bid of evenamide as an add-on treatment in patients with TRS, is expected to commence in 2023

Patient recruitment in potentially pivotal study 008A to evaluate evenamide in patients with chronic schizophrenia who are not classed as treatment resistant is ongoing, results from the study are expected in 2023

Xadago/safinamide (Parkinson’s disease)

Newron and its partners Zambon and Supernus continue to work to protect intellectual property rights associated with Xadago/safinamide in the US, responding to Paragraph IV Notice Letters regarding Abbreviated New Drug Applications submitted from generic pharmaceutical manufacturers

Corporate

Newron continues its dialogue with industry partners around potential future collaboration opportunities for the development of evenamide. The company also continues to explore a number of potential opportunities to expand its pipeline in central nervous system diseases

Gillian Dines proposed for election as new member to the Board of Directors at the AGM on April 18, 2023

Development of ESG strategy completed, with focus areas and objectives for 2023 – Reporting will be based on 10 out of the 17 Sustainable Development Goals, as defined by the UN

Stefan Weber, CEO of Newron, commented:

"The last twelve months have been an exciting period for our Company, particularly given the announcement of three sets of compelling interim efficacy results from our ongoing Phase II clinical study 014/015 with evenamide in patients with treatment-resistant schizophrenia (TRS). We have also made significant progress with the Phase III study of evenamide (study 008A) in another indication – patients with chronic schizophrenia currently being treated with a second-generation antipsychotic, but who are not classed as having TRS – and have strengthened both our management team and our Environment, Social and Governance (ESG) efforts".

Evenamide

In June 2022, Newron was excited to share the first set of data from its Phase II study with evenamide, a new chemical entity being developed for the treatment of patients with schizophrenia. The results showed that the addition of evenamide improved symptoms of psychosis in patients with TRS. This was reflected by an approximately 12% reduction in the Positive and Negative Syndrome Scale (PANSS) score, Clinical Global Impression – Severity of illness (CGI-S) improvement of 0.7, and Clinical Global Impression – Change from baseline (CGI-C) ratings indicating that 77% of patients responded to the treatment.

Post-period, in Q1 2023, Newron was able to announce interim data from study 014 as well as its extension arm, study 015, showing results in the first 100 patients in the study after six months (30 weeks) and one year (52 weeks) of treatment with evenamide:

– In January 2023, Newron announced six-month interim data which demonstrated a continued improvement in TRS symptoms following treatment with evenamide, as well as a substantially greater proportion of patients experiencing a meaningful improvement when compared to six weeks of treatment.

– Closely following, in February 2023, the Company disclosed one-year interim data from study 014/015. Results provided further striking new evidence of the sustained efficacy of the addition of evenamide to antipsychotics in TRS patients by demonstrating substantially greater benefit at one year than noted at the six-week and six-month datapoints.

These results after six months and one year were highly compelling, statistically significant (paired t-test), and clinically meaningful, as not only was evenamide well tolerated with few adverse effects, but there was a sustained and continued improvement at all doses. Newron was particularly struck by data suggesting there is a continued improvement over time in these measures. While recognizing that this study has no control arm, clinically meaningful improvements over baseline in key efficacy measures after one year are, to the Company’s knowledge, unprecedented in patients with diagnosed TRS.

The enrolment of study 014 has now been completed with 161 subjects. The Company expects to announce the full results from this study still in March 2023, which will include six-week data from all 161 patients enrolled into the study. One-year data from all 161 patients in extension study 015 is expected by Q1 2024.

Study 003 is planned to be a potentially pivotal, multinational, randomized, placebo-controlled, ten-week global study to assess the efficacy, safety and tolerability of evenamide (15/30 mg bid) as an add-on treatment in outpatients with treatment-resistant schizophrenia (TRS) not responding adequately to their monotherapy treatment with atypical antipsychotics (including clozapine). Positive data from this study would confirm the potential of evenamide as the first medication that could be added to an antipsychotic and improve symptoms of TRS in patients. Newron plans to initiate this study in 2023.

Alongside the R&D-work with evenamide in TRS, the Company is also conducting study 008A, a four-week, randomised, double-blind and placebo-controlled study assessing the efficacy, tolerability, and safety (including electroencephalogram effects) of evenamide (30 mg bid) in patients with chronic schizophrenia currently being treated with a second-generation antipsychotic, but who demonstrate an inadequate response to that treatment. Recruitment at treatment centers in Europe, Asia and Latin America is ongoing and results are expected in 2023. If results from the study are positive, it would represent the first well-controlled, potentially pivotal study of evenamide in schizophrenia patients who demonstrate an inadequate response to treatment with atypical antipsychotics.

Xadago/safinamide

In partnership with Zambon and Supernus, Newron continues to further develop and market its product, Xadago/safinamide.

In reference to the receipt of several Paragraph IV Notice Letters in May 2021 regarding the submission by generic manufacturers of an Abbreviated New Drug Application to the US Food and Drug Administration (FDA), seeking approval to engage in the commercial manufacture, use or sale of safinamide mesylate drug product in the US before expiration of certain US patents, Newron and its partners Zambon and Supernus filed an infringement case against these manufacturers to secure its intellectual property rights. Newron continues to challenge these submissions and note that its patents on Xadago (safinamide) tablets remain protected by three patents in the FDA Approved Drugs Product List (Orange Book) until at least 2027.

Newron and Zambon have reached an agreement to discontinue their plans to initiate a clinical study with safinamide in Parkinson’s disease patients with levodopa-induced dyskinesia (PD LID). As a matter of settlement, Zambon will advance an undisclosed fee to Newron.

ESG commitment and reporting

Sustainability is one of the most crucial current challenges, for every company, regardless of size or industry. Newron has already issued several policies and procedures and taken some specific actions that are part of ESG best practices, but in 2022 the strategic process started formally with a materiality analysis in close dialogue with internal and external stakeholders to best understand how each one of them could relate with relevance of all the possible areas to Newron’s ESG efforts. An ESG strategy based on a key materiality review has been developed, and Sustainable Development Goals that the Company can contribute to have been identified. ESG focus areas and objectives for 2023 have been defined and Newron’s Annual ESG reporting efforts commence with the Annual Report 2022 published today.

Financial Key takeaways 2022:

In 2022, Newron reported a net loss of EUR 17.5 million, compared to EUR 14.9 million in 2021
Cash used in operating activities has decreased to EUR 11.1 million from EUR 11.4 million in 2021
Xadago revenues from Zambon increased from EUR 5.8 million in 2021 to EUR 6.0 million in the reporting period
Newron’s R&D expenses have risen to EUR 12.0 million from EUR 10.7 million in 2021
G&A expenses were stable at EUR 7.4 million
Cash and Other current financial assets as at December 31, 2022, were at EUR 22.8 million, compared to EUR 34.6 million at the beginning of the year
Financial Summary (IFRS) 2022 and 2021:

In thousand EUR (except per share information)

2022

2021

Licence income from contracts with customers

14

34

Royalties from contracts with customers

5,936

5,728

Revenue

6,094

5,762

Research and development expenses, net

(12,005)

(10,725)

Operating Result

(13,302)

(12,357)

Financial result, net

(4,170)

(2,527)

Net loss

(17,493)

(14,901)

Loss per share

(0.98)

(0.84)

Cash used in operating activities

(11,092)

(11,445)

Cash, cash equivalents and Other current financial assets

22,774

34,594

Total assets

37,195

50,486

Newron’s Annual Report 2022 is available for download on the Company’s website: www.newron.com/investors/reports-and-presentation/year/2022

Outlook 2023:

The Company anticipates that 2023 will be another exciting year, with further clinical updates from its evenamide program. Following the striking six-month and one-year results in TRS, Newron is continuing its dialogue with industry partners around potential future collaboration opportunities for the development of evenamide and to potentially expand its pipeline of CNS drugs.

Newron looks forward to presenting the full results from study 014 with evenamide in March 2023 and one-year results from extension study 015 in all patients by Q1 2024. The Company also remains on track to commence study 003 in 2023, the first potentially pivotal study of evenamide in TRS. In patients with chronic schizophrenia currently being treated with a second-generation antipsychotic, but who are not classed as having TRS, Newron looks forward to reporting data from study 008A in the second half of 2023.

Newron’s total available cash resources will fund the Company’s planned development programs and operations well into 2024.

2023 Shareholders’ Meeting Agenda:

Newron’s Board of Directors has approved the below agenda for the April 18, 2023, Shareholders’ meeting, which will take place at the Company’s registered office (Via Antonio Meucci 3) in Bresso (Mi), Italy, starting at 10 am CET. The formal invitation to shareholders will be issued and disclosed in the statutory papers on or around March 14, 2023.

The full invitation and supporting material will be made available on the Company’s website (www.newron.com/investors/shareholders-meeting) on the same date. The agenda is as follows:

Approval of the balance sheet as at 31 December 2022. Connected and consequent resolutions;
Appointment of the members of the Board of Directors, for the financial years 2023, 2024 and 2025 and, therefore, until the approval of the financial statements as of December 31st, 2025, as follows:
2.1. determination of the relevant number,

2.2. proposal to appoint:

Ulrich Köstlin in quality of Chairman of the Board and non-executive director;
Stefan Weber, in quality of executive director;
Patrick Langlois in quality of non-executive director;
Luca Benatti in quality of non-executive director; and,
Gillian Dines in quality of non-executive director*.
2.3. Determination of the remuneration of the Board of Directors. Connected and consequent
resolutions.

* Gillian Dines – introduction as new candidate for non-executive director position:

Gillian Dines is the Senior Vice President and Head of Research and Early Development at Jazz Pharmaceuticals. Prior to that she was SVP R&D Operations at GW Pharmaceuticals and VP, Head of R&D Strategic Planning at UCB. One of her key roles in 2008 was Company Director and Chief Development Officer at RespiVert, a UK based biotech that delivered clinical phase assets from start-up to acquisition by global pharma player in only 18 months, with a budget of £20M. Her previous experience covers various leadership roles at GlaxoSmithKline. In her career she led 20+ novel medicines and devices through successful IND and clinical submissions in areas of respiratory, immunology, rare disease, anti-infective and neurology therapy areas. She has a MSc in Toxicology from the University of Surrey and a BSc from University of Leeds in Biochemistry and Genetics. She is English.

Dial-in details to the media/analyst/investor conference call on March 14, 2023, 3 pm CET

Newron’s management team will present the 2022 full-year results and provide an update and guidance for 2023.

Please dial in five to ten minutes prior to the beginning of the call using one of the following telephone numbers:

Switzerland/Europe: +41 (0)58 310 50 00

United Kingdom: +44 (0)207 107 0613

United States: +1 (1)631 570 5613

or connect to the webcast

Participants’ Link: View Source

The investor presentation is available on 14 March as of 7 am CET at www.newron.com/investors/reports-and-presentation/year/2022

Financial calendar

AGM 2023: April 18, 2023
Half-year report 2023: September 14, 2023

On March 14, 2023 Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies and cytokines for the treatment of cancer and autoimmune diseases, reported it will present preclinical data on novel XmAb CD28 bispecific antibody programs at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, being held April 14-19, 2023 at the Orange County Convention Center in Orlando, Florida (Press release, Xencor, MAR 14, 2023, View Source [SID1234628686]).

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"T cells in the tumor microenvironment require engagement of their T cell receptor (TCR) and their co-stimulatory receptors like CD28 to achieve full activation. This is diminished in cancer because tumor cells usually do not express CD28 ligands. We have developed an XmAb antibody platform that allows for the rapid generation of drug candidates that co-stimulate CD28 only in the presence of tumor cells and TCR engagement," said John Desjarlais, Ph.D., senior vice president and chief scientific officer at Xencor. "We are using the platform to explore the universe of solid tumor targets, and at AACR (Free AACR Whitepaper) we will present data on candidates targeting CEACAM5, mesothelin, STEAP1 and Trop-2, which have broad applicability across a range of solid tumors."

Poster Presentation Details

Abstract 2983, "Tumor-specific CD28 costimulatory bispecific antibodies enhance T cell activation in multiple solid tumors"

Session: Immunology – Therapeutic Antibodies 3
Date and Time: Monday, April 17, 2023, 1:30 p.m. – 5:00 p.m. EDT
Location: Poster Section 24, Board Number 30
Abstracts are available on AACR (Free AACR Whitepaper)’s website located at www.aacr.org. Posters will be archived under "Events & Presentations" in the Investors section of the Company’s website located at www.xencor.com.

On March 14, 2023 Seagen Inc. (Nasdaq: SGEN) reported the presentation of 17 abstracts featuring new clinical and preclinical data at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting taking place in Orlando from April 14-19, 2023 (Press release, Seagen, MAR 14, 2023, View Source [SID1234628685]). The broad range of data being presented at this year’s meeting includes research from Seagen’s approved medicines, as well as data from early-stage clinical, preclinical, and discovery research programs.

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"Seagen’s robust presence at AACR (Free AACR Whitepaper) this year, highlighting progress across our diverse pipeline, underscores our commitment to improving and extending the lives of people living with cancer," said Roger Dansey, M.D., President of Research and Development and Chief Medical Officer at Seagen. "As a pioneer in antibody-drug conjugates, we strive to optimize and expand the potential of our core technology, while also progressing innovative, targeted cancer approaches."

Highlights include an interim analysis from the innovaTV 207 Phase 2 study of tisotumab vedotin (TV) given every 2 weeks in patients with recurrent or metastatic squamous cell carcinoma of the head and neck who have progressed after prior platinum combination, immunotherapy, and targeted therapy, if eligible. TV, which is being developed in partnership with Genmab, is a tissue factor (TF)-directed antibody-drug conjugate (ADC). The innovaTV 207 study is currently ongoing and evaluating alternative dosing regimens of TV across multiple advanced solid tumors.

Other notable clinical data include initial results from a Phase 1 dose-escalation study of SEA-TGT monotherapy in patients with advanced malignancies. SEA-TGT is a novel investigational nonfucosylated human IgG1 antibody directed against TIGIT, an inhibitory immune checkpoint receptor that has emerged as a clinically relevant immuno-oncology target. SEA-TGT continues to be evaluated both as monotherapy and in combination with an anti-PD1 agent.

Seagen will also present new preclinical findings on the antitumor activity of disitamab vedotin, an ADC that targets cancers expressing HER2, as a monotherapy and in combination with tucatinib in breast and gastric cancer models, and on SGN-B6A, a wholly-owned, first-in-class vedotin ADC that targets integrin beta-6, which is highly expressed in a range of solid tumors.

Seagen and Sanofi will also unveil the first preclinical data from a novel topoisomerase I inhibitor ADC targeting CEACAM5, showing potent antitumor activity in patient-derived colorectal cancer models. These are the first data disclosed from the companies’ 2022 collaboration to develop and commercialize multiple novel ADCs.

Additional preclinical data disclosures are planned, highlighting vedotin programs and novel ADC and tumor targeting technologies, including payloads with immune stimulatory properties.

Details of Seagen Presentations at AACR (Free AACR Whitepaper) Annual Meeting 2023

Abstract Title

Abstract #

Presentation Time

Lead Author

ADCETRIS (brentuximab vedotin)

CD30 is a marker of activated effector regulatory T cells in solid tumors providing clinical rationale for the combination of brentuximab vedotin and PD-1 inhibitors

3253

Poster Presentation

Clinical Research Excluding Trials / Combination Immunotherapies 1

Mon., April 17

1:30 – 5:00 p.m. ET

B. Grogan

Exposure-response and age subgroup analyses to support body-weight (BW) dosing of brentuximab vedotin (BV) in newly diagnosed high-risk classical Hodgkin lymphoma (cHL) in children and young adults (aged 2-21 years [y]): A randomized Children’s Oncology Group phase 3 trial (AHOD1331)

6737

Poster Presentation

Clinical Research Excluding Trials / Preclinical Therapies and Clinical Observations in Pediatric Oncology

Wed., April 19

9:00 a.m. – 12:30 p.m. ET

Z. Zhang

PADCEV (enfortumab vedotin)

Enfortumab vedotin, a Nectin-4-directed antibody-drug conjugate, demonstrates compelling antitumor activity in non-muscle invasive bladder cancer models and accurately predicts minimal systemic exposure when administered by intravesical instillation in patients

LB246

Poster Presentation

Late-Breaking Research: Experimental and Molecular Therapeutics 2

Tues., April 18

1:30 – 5:00 p.m. ET

D. Olson

TIDVAK (tisotumab vedotin)

Tisotumab vedotin (TV) in squamous cell carcinoma of head and neck (SCCHN): interim analysis from innovaTV 207

CT164

Poster Presentation

Phase II Clinical Trials 1

Mon., April 17

1:30 – 5:00 p.m. ET

B. Cirauqui

TUKYSA (tucatinib)

Phase 3 study of tucatinib or placebo in combination with trastuzumab and pertuzumab as maintenance therapy for HER2+ metastatic breast cancer (HER2CLIMB-05, trial-in-progress)

CT065

Poster Presentation

Phase II and Phase III Clinical Trials in Progress

Mon., April 17

9:00 a.m. – 12:30 p.m. ET

E. Hamilton

Tucatinib does not alter oxaliplatin PK or associated renal function: An OCT2/MATE transport inhibition study

5060

Poster Presentation

Experimental and Molecular Therapeutics – Theranostics and Radionuclides / Pharmacologic Approaches

Tues., April 18

1:30 – 5:00 p.m. ET

A. Topletz-Erickson

Disitamab Vedotin

Disitamab vedotin, an investigational HER2-directed antibody-drug conjugate, shows potent antitumor activity as a monotherapy and in combination with tucatinib in preclinical cancer models

560

Poster Presentation

Experimental and Molecular Therapeutics / Oncogenes and Tumor Suppressor Genes as Targets for Therapy 1

Sun., April 16

1:30 – 5:00 p.m. ET

K. Willis

Early-Stage Programs

SGN-BB228, a CD228-directed costimulatory antibody anticalin bispecific provides potent and conditional 4-1BB costimulation to T cells in vivo and in an in vitro model of T-cell exhaustion

5676

Poster Presentation

Clinical Research Excluding Trials / Therapeutic Antibodies, Including Engineered Antibodies

Tues., April 18

1:30 – 5:00 p.m. ET

B. Updegraff

SGN-B6A induces immunogenic cell death as an additional mechanism of action

1522

Poster Presentation

Experimental and Molecular Therapeutics / Antibody-Drug Conjugates

Mon., April 17

9:00 a.m. – 12:30 p.m. ET

V. Trang

Generation of an antibody-drug conjugate-optimized TLR7/8 agonist payload

1542

Poster Presentation

Experimental and Molecular Therapeutics / Antibody-Drug Conjugates

Mon., April 17

9:00 a.m. – 12:30 p.m. ET

K.P. Wang

Phase 1 dose-escalation study of SEA-TGT monotherapy in patients with advanced malignancies

CT265

Poster Presentation

Phase I Clinical Trials 2

Tues., April 18

1:30 – 5:00 p.m. ET

E. Garralda Cabanas

Using a clinical utility index (CUI) to determine the optimal biological dose of a nonfucosylated anti-TIGIT antibody: A proposed alternative to maximum tolerated dose (MTD)

5668

Poster Presentation

Clinical Research Excluding Trials / Therapeutic Antibodies, Including Engineered Antibodies

Tues., April 18

1:30 – 5:00 p.m. ET

G. Patilea-Vrana

A preclinical model of acquired anti-PD-1 resistance is responsive to SEA-TGT, an effector-function enhanced anti-TIGIT monoclonal antibody

6361

Poster Presentation

Immunology / Immune Checkpoints

Wed., April 19

9:00 a.m. – 12:30 p.m. ET

D. Gruber

A novel topoisomerase I inhibitor antibody-drug conjugate targeting CEACAM5 has potent antitumor activity in colorectal cancer models

4890

Poster Presentation

Experimental and Molecular Therapeutics / Anticancer Approaches: Antibody-Drug Conjugates, Epigenetics, and Tumor Environment

Tues., April 18

1:30 – 5:00 p.m. ET

Y. Baudat

Discovery Research

Oxidized anthracycline payloads induce antitumor immunogenic cell death and show linker-dependent tolerability when delivered as ADCs

2013

Poster Presentation

Chemistry / Drug Delivery

Mon., April 17

9:00 a.m. – 12:30 p.m. ET

J. Hamilton

Reversible chemical modification of antibodies: A complementary approach to tuning FcγR binding that maintains antitumor activity while mitigating peripheral immune activation

2656

Poster Presentation

Experimental and Molecular Therapeutics / Antibody Technologies

Mon., April 17

9:00 a.m. – 12:30 p.m. ET

P. Moquist

MMAE drives immunomodulatory changes in a preclinical xenograft model that are distinct from other clinical-stage ADC payloads

4892

Poster Presentation

Experimental and Molecular Therapeutics / Anticancer Approaches: Antibody-Drug Conjugates, Epigenetics, and Tumor Environment

Tues., April 18

1:30 – 5:00 p.m. ET

M. Ulrich

On March 14, 2023 PharmaLogic Holdings Corp. ("PharmaLogic" or "the Company"), a contract development and manufacturing organization and radiopharmaceutical manufacturer, reported the signature of a Master Services Agreement with Viewpoint Molecular Targeting, Inc., a wholly-owned subsidiary of Perspective Therapeutics, Inc. ("Perspective") (NYSE AMERICAN: CATX), for the development and production of theranostic candidates VMT-01 and VMT-α-NET (Press release, Perspective Therapeutics, MAR 14, 2023, View Source [SID1234628684]). The radiopharmaceuticals are currently in development for the diagnosis and treatment of metastatic melanoma and neuroendocrine tumors (NETs), respectively.

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Under the terms of the agreement, PharmaLogic will produce and supply doses of VMT-01 and VMT-α-NET for use in Perspective’s early-stage clinical trials. This will complement the existing radiopharmaceutical GMP capability that Perspective already has at its mid-west site.

Scott Holbrook, PharmaLogic’s Chief Strategy Officer and General Manager, stated "Targeted alpha therapy (TAT) with Pb-212 labeled radioligands offers one of the most exciting platforms for novel cancer therapy within the rapidly expanding precision radiotherapy ecosystem. The expertise of Perspective Therapeutics and PharmaLogic are well aligned to yield a successful collaboration around VMT-01 and VMT-α-NET."

"We are delighted to select PharmaLogic as a trusted CDMO partner at this important juncture of the Viewpoint’s clinical development journey" said Thijs Spoor, Perspective Therapeutics’ CEO. "Radiopharmaceutical diagnostic imaging and therapeutic agents have a limited shelf life from time of manufacture to patient administration in the clinical setting. PharmaLogic’s domain expertise in radiopharmaceuticals and broad national distribution footprint helps address our need for specialty radiopharmaceutical manufacturing at the highest level. As we have been given the safe to proceed authorizations from the U.S. Food and Drug Administration, we look forward to commencing enrollment of the Company’s two image guided alpha-particle therapy studies at multiple clinical trial centers around the country. Furthermore, we look forward to reporting preliminary results from the clinical trials later in the year."

"PharmaLogic is excited to partner with Perspective Therapeutics on the production and distribution of these personalized alpha-particle theranostics." said Chris Parr, PharmaLogic’s Vice President of Radiochemistry and Technical Operations. "We value Perspective’s scientific leadership in this area and believe it aligns perfectly with our mission of delivering clinically relevant precision medicine products to patients in the communities we serve."