Starpharma to present at Bell Potter Healthcare Conference

On November 14, 2023 Starpharma (ASX: SPL, OTCQX: SPHRY) reported that it will present at the Bell Potter Healthcare Conference, a virtual investor conference that showcases Australia’s leading healthcare companies to institutional investors and Bell Potter’s retail network (Press release, Starpharma, NOV 14, 2023, View Source;mc_eid=bf52dd3418 [SID1234637576]).

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!

Starpharma will present an overview of the business, with a focus on recent milestones, including the positive clinical data reported for DEP cabazitaxel1 and DEP irinotecan2 in multiple cancers, as well as the positive preclinical data from the DEP radiotheranostics programs.

The Bell Potter Healthcare Conference presentation is appended.

MOLECULAR PARTNERS TO PRESENT ON DARPIN ONCOLOGY INNOVATIONS AT PROTEIN & ANTIBODY ENGINEERING SUMMIT EUROPE (PEGS)

On November 14, 2023 Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics, reported that it will present on several of its programs at the 15th Annual Protein & Antibody Engineering European Summit (PEGS Europe), which runs November 14-16 in Lisbon, Portugal (Press release, Molecular Partners, NOV 14, 2023, View Source [SID1234637575]). The presentation will focus on the multiple ways Molecular Partners has designed DARPins to activate the immune system against cancer only under certain conditions. This conditional activation is intended to focus immune attack more specifically against tumor cells and minimize damage to healthy cells, a major challenge for current oncology drugs and development efforts.

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 presentation consists of a review of several differentiated mechanisms of action that leverage the DARPin platform and conditional activation approaches/MoAs being advanced by Molecular Partners:

MP0317, a CD40 agonist, is designed to activate immune cells specifically within the tumor microenvironment by anchoring to fibroblast activation protein (FAP), which is highly expressed on tumor cells. Positive data from MP0317’s ongoing Phase 1 clinical study in patients with advanced solid tumors was recently presented at the 2023 Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper).
MP0533, a novel tetra-specific DARPin for the treatment of patients with relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndrome (AML/MDS), engages CD3 on T cells and targets three tumor-associated antigens (TAAs) CD33, CD123, and CD70. MP0533 preferentially binds with higher avidity to cells expressing at least two of these three TAAs. This proposed MoA focuses on T cell-mediated preferential killing of AML cells while potentially sparing healthy cells. MP0533 is currently in Phase 1/2a clinical development and initial data will be presented at the 2023 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition.
The SWITCH-DARPin platform, a versatile novel DARPin design for conditionally triggering an immune cell attack only in the presence of defined tumor antigens.
Details of the presentation can be found below. The presentation will be made available on Molecular Partners’ website after the conference.

Title: From Clustering Activated Agonists to SWITCH-DARPins
Presenter: Dr Daniel Steiner, Senior Vice President of Research, Molecular Partners
Agenda section: Engineering: Conditionally Activated Biologics
Timing: Tuesday November 14, 2023, 11:15am GMT

In addition to the conditionally activated DARPin designs referenced above, Molecular Partners continues to progress its Radio-DARPin Therapy (RDT) platform and portfolio of projects, both in-house and in partnership with Novartis. The portfolio of RDT candidates represent a unique delivery system for radioactive payloads to solid tumors and has significantly expanded the company’s work in oncology therapeutics.

Nouscom Raises €67.5 million ($72 million) in Oversubscribed ?Series C Financing Round

On November 14, 2023 Nouscom, a clinical stage immuno-oncology company developing off-the-shelf and personalized viral vector-based cancer vaccines targeting neoantigens, reported the completion of its oversubscribed Series C equity financing raising €67.5 million ($72 million) from a syndicate of renowned international healthcare investors (Press release, NousCom, NOV 14, 2023, View Source;utm_medium=rss&utm_campaign=nouscom-raises-e67-5-million-72-million-in-oversubscribed-series-c-financing-round [SID1234637571]).

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 C round was co-led by Andera Partners, Bpifrance (through its InnoBio 2 fund) and M Ventures, with participation from Revelation Partners, Indaco Venture Partners, Panakès Partners, XGen Ventures, and other undisclosed investors together with continued support from existing investors 5AM Ventures, EQT Life Sciences and Versant Ventures. Concurrent with the financing, representatives from Andera Partners, Bpifrance and M Ventures have joined the Nouscom Board of Directors.

The proceeds will be used to continue advancing and expanding Nouscom’s wholly owned clinical pipeline to achieve multiple clinical value catalysts, including:

Readout from Nouscom’s ongoing randomized Phase 2 clinical trial for NOUS-209, an off-the-shelf vaccine targeting 209 shared neoantigens, in combination with pembrolizumab for the treatment of Mismatch Repair/Microsatellite Instable (dMMR/MSI) Metastatic Colorectal Cancer (mCRC).
Final readout from the ongoing Phase 1b study and advancement of NOUS-209 monotherapy in Lynch Syndrome (LS) carriers investigating the potential to intercept, prevent or delay cancer before it occurs. LS carriers have a genetic predisposition to and consequently higher risk of developing certain cancers. Promising initial results from this study were reported in a Late-breaking Abstract at the recent Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2023 Annual Meeting – see press release here
Completion of a Phase 1b study evaluating NOUS-PEV, a personalized cancer immunotherapy, in combination with a checkpoint inhibitor in patients with advanced melanoma and entry into randomized Phase 2 trials in indications with high unmet medical needs.
Dr. Marina Udier, Chief Executive Officer of Nouscom, said: "This oversubscribed financing, in what is a challenging environment for all biotech companies, is testament to the faith that new and existing investors place in Nouscom and our best-in-class technology. I am constantly inspired by the relentless drive our team exhibits on a daily basis to advancing our innovative medicines for the benefit of cancer patients. This financing will allow us to further accelerate development across our wholly owned clinical portfolio reporting multiple clinical trial readouts including from our ongoing randomized Phase 2 clinical trial with NOUS-209. These Phase 2 data, if positive, have the potential to position Nouscom’s neoantigen based cancer vaccines amongst the most thrilling developments in the field."

Dr. Goran Ando, Independent Chairman of Nouscom, said: "In conjunction with the financing, I am delighted to welcome all our new investors to the company and Sofia, Thibaut and Hakan from Andera, Bpifrance and M Ventures, respectively, to our Board of Directors. Together, with the experience of our existing Board Members, I look forward to their contributions as Nouscom navigates the next exciting steps in its journey."

Dr. Sofia Ioannidou, Partner of Andera Partners, said: "We at Andera are delighted to support Marina and her team in their mission to advance the development of their innovative cancer treatments for patients. We believe that the robustness of the clinical results generated so far positions Nouscom as one of the leading biotech companies in the vibrant neoantigen cancer vaccine space. We look forward to supporting the company towards the further clinical validation of its platform."

Dr. Thibaut Roulon, Senior Investment Director at Bpifrance, said: "We consider Nouscom’s neoantigen cancer vaccine platform to be one of the most promising. It is backed by excellent science and increasingly promising clinical data. The next couple of years will be exciting as ongoing clinical trials complete and further validate its potential."

Dr. Hakan Goker, Managing Director and Head of Biotechnology Investments at M Ventures, said: "A key criteria for our investment in Nouscom was the quality of the data that have been presented over the past few years, the breadth of its pipeline, and the expertise built in the team. The emerging data positions Nouscom’s pipeline among the most exciting in the field of neoantigen based cancer vaccines creating significant value for the company. We are excited to support the company to continue bringing these innovative candidates closer to patients."

Oncopeptides selected to present additional data from OCEAN study at the American Society of Hematology meeting

On November 13, 2023 Oncopeptides, a biotech company focused on difficult-to-treat cancers, reported that long-term outcomes from its Phase 3 OCEAN study has been accepted as a poster and will be presented at the 65th annual American Society of Hematology (ASH) (Free ASH Whitepaper) Meeting and Exposition (Press release, Oncopeptides, NOV 13, 2023, View Source [SID1234646781]). The conference takes place in San Diego between December 9-12.

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!

ASH is the world’s largest professional hematologic society serving both clinicians and scientists around the world who are working to conquer blood diseases.

The phase 3 OCEAN study is a global, randomized, head-to-head, open-label study, evaluating the efficacy and safety of melflufen and dexamethasone, versus pomalidomide and dexamethasone in patients with relapsed refractory multiple myeloma who have received 2-4 prior therapies.

"This long-term follow-up of OCEAN confirms the favorable safety and overall survival outcomes of melflufen + dexametason in patients that have not progressed within 36 months after a stem cell transplantation and supports its use in patients with relapsed, refractory multiple myeloma," says Fredrik Schjesvold, MD, Head of Oslo Myeloma Center, Oslo University Hospital. "We are happy to have been selected to present our findings at ASH (Free ASH Whitepaper) and look forward to the opportunity."

Find more details about the abstract and presentation below. The abstract including key data has been published and is available through this link.
For more information about ASH (Free ASH Whitepaper) Annual Meeting and Exposition, click here.

Title Long-Term Outcomes from the Phase 3 OCEAN (OP-103) Study: Melflufen and Dexamethasone (Dex) Versus Pomalidomide (Pom) and Dex in Relapsed Refractory Multiple Myeloma (RRMM)
Publication Number 2018
Presenting author Fredrik Schjesvold, MD, Head of Oslo Myeloma Center, Oslo University Hospital
Program Oral and Poster Abstracts
Session 653. Multiple Myeloma: Prospective Therapeutic Trials: Poster I

Rezolute Reports First Quarter Fiscal 2024 Results

On November 13, 2023 Rezolute, Inc. (Nasdaq: RZLT), a clinical-stage biopharmaceutical company committed to developing novel, transformative therapies for serious metabolic and rare diseases, reported its financial results for the first quarter of fiscal 2024 ended September 30, 2023 (Press release, Rezolute, NOV 13, 2023, View Source [SID1234639828]).

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!

"We are on track to commence our Phase 3 study for RZ358 to treat congenital hyperinsulinism prior to year-end and are delighted to have recently obtained PRIME eligibility from the European Medicines Agency for this indication," said Nevan Charles Elam, Chief Executive Officer and Founder of Rezolute. "We also anticipate completing enrollment this quarter for our ongoing Phase 2 study of RZ402 for the treatment of diabetic macular edema and plan to provide an update on the study prior to year end."

Clinical Highlights

· RZ358, a monoclonal antibody for the treatment of hyperinsulinism
o Received EMA priority medicines (PRIME) designation for the treatment of congenital hyperinsulinism (cHI) from the European Medicines Agency
o Plan to initiate sunRIZE, a pivotal Phase 3 clinical study in patients with cHI, in Europe and other geographies outside the US in the fourth quarter 2023
o Continuing the administration of RZ358 in the US with FDA approval under a compassionate use program to treat patients with tumor associated hyperinsulinism, including for a patient with refractory hypoglycemia due to metastatic insulinoma who has remained on RZ358 for nearly a year

· RZ402, an oral plasma kallikrein inhibitor in Phase 2 to treat diabetic macular edema (DME)
o Multi-center, randomized, double-masked, placebo-controlled, parallel-arm study ongoing to evaluate the safety, efficacy, and pharmacokinetics of RZ402 administered as a monotherapy over a 12-week treatment period in participants with DME who are naïve to or have received limited anti-VEGF injections
o Study is in the latter stages of patient recruitment and an update on the study will be provided prior to year end

First Quarter Fiscal 2024 Financial Results

· Cash, cash equivalents and investments in marketable debt securities totaled $106.9 million as of September 30, 2023, compared to $118.4 million as of June 30, 2023

· Research and development expenses were $12.2 million for the first quarter of fiscal 2024, compared to $7.7 million for the same period in fiscal 2023, with the increase primarily attributable to increased expenditures in clinical trial activities, manufacturing costs and higher personnel-related expenses, which included employee compensation and stock-based compensation

· General and administrative expenses were $3.7 million for the first quarter of fiscal 2024, compared to $2.5 million for the same period in fiscal 2023, with the increase primarily attributable to higher personnel-related expenses, including employee compensation and stock-based compensation

· Net loss was $14.5 million for the first quarter of fiscal 2024, compared to $9.8 million for the same period in fiscal 2023