On July 5, 2022 Spago Nanomedical reported that the company raised 58.4 MSEK in the completed capital round. The proceeds give the company the resources to maintain the pace in its two projects – SpagoPix in cancer diagnostics and Tumorad, in which it is developing a new radionuclide cancer treatment (Press release, Spago Nanomedical, JUL 5, 2022, View Source [SID1234616476]). BioStock reached out to CEO Mats Hansen for comments on recent events and what awaits in the coming six months.

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!

Spago Nanomedical recently raised 58.4 MSEK before costs in a completed rights issue. The capital will primarily be used to initiate a clinical phase I/II trial with the company’s radionuclide treatment for cancer, the Tumorad candidate drug 177Lu-SN201.

The SpagoPix project has also advanced during the year. The new gadolinium-free contrast agent for magnetic resonance imaging has shown positive clinical results in the company’s ongoing study on breast cancer. The study has been expanded to also include pancreatic cancer and Spago Nanomedical expects to complete the study before the end of the year. Read more.

The potential of Tumorad
The cancer treatment project Tumorad is based on Spago’s physiological targeting of cancer tumours with functional nanoparticles, which makes the treatment independent of the biology of tumour cells. This means that the potential application area for Tumorad is broad and not limited to a specific form of cancer, as a biological approach often is.

During the year, Spago has also become interested in using 177Lu-SN201 for ovarian cancer – the seventh most common cancer in women and the fifth most fatal. This direction allows Spago to apply for Orphan Drug Designation (ODD) for the candidate, providing benefits during the development phase and market exclusivity for an approved drug.

CEO on the progress towards clinical phase
The company is now working to produce materials according to Good Manufacturing Practice and to complete documentation to apply to start the phase I/IIa study with Tumorad.

BioStock reached out to CEO Mats Hansen to comment on the company’s past six months, the issue and what to expect during the rest of 2022.

Mats, the first half of 2022 is recently concluded – what milestones have been the most important to achieve for Spago Nanomedical so far this year?

– Last winter, we achieved good interim results in our clinical study with SpagoPix. The results are not only beneficial for our new contrast agent. Equally important, we have been able to clinically validate our technology platform – that our functional nanomaterial combined with physiological targeting of cancer tumours works in humans.

– Another milestone was the preclinical results with Tumorad. We successfully conducted the preclinical toxicology studies and presented promising efficacy data with the candidate in a preclinical model for colorectal cancer.

– Tumorad’s potential within cancer is wide, only within the ODD indication ovarian cancer is the commercial opportunity significantly greater than for SpagoPix in the contrast agent market.

The rights issue went ahead in difficult market conditions, how would you like to comment on it?

Mats Hansen, CEO Spago Nanomedical
Mats Hansen, CEO Spago Nanomedical
– It is obvious to everyone what the investment climate is like right now and given that, we are extremely happy and grateful for the support of our existing shareholders in this rights issue.

– With the financing in place, we now have the resources to keep up the pace and can hopefully start our clinical study with Tumorad around the end of the year.

Preparations are in full swing for the clinical study with Tumorad – what are the most important events in the coming six months for Spago Nanomedical?

– As mentioned, the preclinical data package is ready, right now we are finalising the application for our phase I/II study with 177Lu-SN201 and securing the manufacturing process for the candidate.

– At the same time, we are waiting for preclinical data with the candidate in ovarian cancer. These results will be significant for our ODD application, which we plan to submit in the autumn.

– With good results in SpagoPix, preparatory work according to plan in Tumorad and a completed capital round, we are confidently progressing the development.

The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.

On July 5, 2022 Sanofi reported that hosts a hybrid ESG Investor Event to present its key CSR programs and discuss the CSR strategy (Press release, Sanofi, JUL 5, 2022, View Source [SID1234616475]). The CSR strategy is embedded within its broader Play to Win strategy to help create value and propel the cultural transformation of the company. The integrated approach also aims to have a meaningful positive impact on society.

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!

"At Sanofi, we believe we have a responsibility to make a difference to the health of our communities and for the care of the planet. We want to elevate our ambition for our Corporate Social Responsibility strategy and ensure it is fully embedded into our mission to chase the miracles of science and to improve people’s lives, with the vision for a better future. At Sanofi, we strive to do more."

Sanofi has been steadily advancing on the implementation of its CSR strategy since 2020 along four key pillars:

To further improve Affordable access to medicines, Sanofi has made significant progress since the launch of its Global Health Unit (GHU) a year ago. The event highlights achievements of the GHU since its creation including the recently announced launch of an impact investment fund that will support start-up companies and other innovators that can deliver scalable solutions for sustainable healthcare in underserved regions. In parallel, Sanofi GHU is also launching Impact, the new GHU dedicated brand for non-profit distribution and that will enable the secure distribution of 30 Sanofi medicines in 40 lower-income countries.

With its focus on R&D for unmet needs, the elimination of sleeping sickness has been a long-standing mission for Sanofi, where the company continues to do more to change the treatment paradigm for the most vulnerable communities.

As part of Sanofi’s efforts for Planet care, the company announced its ambition to be carbon neutral by 2030 and net zero by 2050 last year, which marks an acceleration of 20 years versus its previous commitments. This year, Sanofi will outline its roadmap to reach carbon neutrality by 2030 and illustrate the positive impact of carbon offsetting programs on communities as well as the environment, contributing to its 2050 net zero commitment.

To ensure its Diversity, Equity & Inclusion (DE&I) strategy is rightly executed, monitor progress on the company’s 2025 targets and learn from external thought-leaders, Sanofi announced the creation of its first DE&I board in April 2022. Dr Rohini Anand, DE&I board member and renowned thought-leader, will be joining the event for a conversation on Sanofi DE&I ambitions in and beyond the workplace.

Sandrine Bouttier Stref
Head of Corporate Social Responsibility, Sanofi
We have effectively initiated a process of transformation and support for CSR within the company. We believe in CSR as a cultural transformation and value creation enabler. We are on the move and we are making great strides.

Finally, a panel discussion with Paul Hudson, Sanofi CEO, Lise Kingo, Sanofi Board Director, Sandrine Bouttier Stref, Head of CSR, moderated by Thomas Scheiwiller, co-founder of the Biopharma Sustainability Roundtable will wrap up the event focusing on how governance is instrumental in embedding and integrating Sanofi’s CSR commitments into all its activities.

ESG Investor Event details
For background slides and webcast, please refer to the following link:
View Source

On July 5, 2022 Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, reported that the Company has entered into a definitive agreement for the sale of its wholly-owned non-healthcare subsidiary, Trans Ova Genetics, L.C. ("Trans Ova"), an industry-leading animal reproductive technologies company, to URUS, a holding company with cooperative and private ownership, for $170 million in upfront cash and up to $10 million earn-out based on the performance of Trans Ova in 2022 and 2023 (Press release, Precigen, JUL 5, 2022, View Source [SID1234616474]). Consummation of the transaction, anticipated in Q3 2022, is subject to customary closing conditions, including clearance under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.

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 believe this transaction will support Precigen’s mission as a premier cell and gene therapy company laser focused on the rapid development of our top clinical assets to maximize shareholder value and potentially improve the way devastating diseases like cancer are treated," said Helen Sabzevari, PhD, President and CEO of Precigen. "I am proud of Precigen management and the Trans Ova team for successfully leading the financial turnaround of Trans Ova operations to maximize the value of this asset over the last two years. We expect to have the capacity to pay the convertible notes upon maturity and to focus on fast regulatory paths for our healthcare portfolio."

Rabo Securities USA, Inc. is acting as exclusive financial advisor to Precigen and Davis Polk & Wardwell LLP is providing Precigen with legal support for the transaction.

On July 5, 2022 Outlook Therapeutics, Inc. (Nasdaq: OTLK), a pre-commercial biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, reported the full cash pre-payment of its unsecured convertible promissory note dated November 4, 2020, as amended November 16, 2021 (the "Note") (Press release, Outlook Therapeutics, JUL 5, 2022, https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeutics-announces-full-cash-pre-payment-convertible [SID1234616473]). All obligations under the Note have been repaid in cash and satisfied.

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 company requires a good financial position to support the potential FDA approval and subsequent launch of ONS-5010/ LYTENAVA (bevacizumab-vikg)," commented Lawrence A. Kenyon, Chief Financial Officer of Outlook Therapeutics. "We are also mindful of current financial market conditions and the potential for dilution to our stockholders. We are pleased to be in a position to fully repay this unsecured convertible promissory note to prevent the dilution associated with redemption of the Note for common stock at a 25% discount to market price that could have begun on July 1, 2022."

On November 5, 2020, the Company received $10,000,000 in net proceeds from the Note with face amount of $10,220,000, which was amended in November 2021 and became convertible. On November 16, 2021, the Company entered into a note amendment which, among other things, (i) extended the maturity date to January 1, 2023, (ii) increased the interest rate from 7.5% per annum to 10% per annum beginning on January 1, 2022, and (iii) provided for the lender’s right to redeem some or all of the outstanding balance of the note for shares of the Company’s common stock beginning July 1, 2022, subject to certain limitations.

On July 5, 2022 IVERIC bio, Inc. (Nasdaq: ISEE) and DelSiTech Ltd, reported an exclusive global license agreement providing Iveric Bio with the right to develop and commercialize new formulations of Zimura (avacincaptad pegol) using DelSiTech’s silica-based sustained release technology (Press release, Ophthotech, JUL 5, 2022, View Source [SID1234616472]). As part of Iveric Bio’s lifecycle expansion plan for Zimura, the Company is committed to developing sustained release technologies for the treatment of age-related macular degeneration (AMD). These technologies potentially could address patients being treated for geographic atrophy (GA) and intermediate AMD.

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 thrilled to collaborate with the DelSiTech team on investigating additional sustained release formulations for Zimura with their drug delivery expertise and advanced technology and look forward to evaluating a sustained release formulation in GA and potentially earlier stages of AMD," stated Pravin U. Dugel, MD, President of Iveric Bio. "Previously reported post-hoc analyses from GATHER1 suggest that Zimura may have the potential to impact AMD in early stages before atrophy occurs in patients. We believe Zimura, which is a chemically synthesized RNA aptamer, is amenable to injectable sustained release formulations."

"As a leading developer of long-acting controlled release formulations for small molecules and biological entities, we are excited about collaborating with Iveric Bio on bringing innovative solutions to patients living with AMD," stated Lasse Leino, PhD, Chief Executive Officer of DelSiTech. "We are inspired by the opportunity to leverage our drug delivery technology to potentially help AMD patients early and improve their treatment experience."

"This agreement underscores our commitment to invest in lifecycle initiatives for Zimura," said Glenn P. Sblendorio, Chief Executive Officer of Iveric Bio. "We are excited about the possibilities to expand Zimura into earlier stages of AMD and potentially allow for a next-generation treatment to help patients with GA."

"We are proud to bring our competencies into this promising alliance and contribute to Iveric Bio’s mission to address unmet needs for patients," said Dr. Frederic Dargelas, Head of Business Development and Alliance Management for DelSiTech.
Under the terms of the license agreement, Iveric Bio will pay DelSiTech an upfront payment of €1,250,000, as well as development and commercial milestones and royalties on net sales of licensed products.

In addition to working with DelSiTech, Iveric Bio plans to explore the potential for Zimura in earlier stages of AMD by initiating a clinical trial studying the current formulation of Zimura in patients with intermediate AMD in the fourth quarter of 2022. The development strategy in this indication is subject to global regulatory feedback from the U.S. Food and Drug Administration (FDA) and other regulatory authorities, which Iveric Bio plans to obtain before initiating this trial.

About Zimura GATHER1 and GATHER2 Clinical Trials
Iveric Bio previously announced that GATHER1, the Company’s first Phase 3 clinical trial for Zimura (avacincaptad pegol) for GA, met its pre-specified primary efficacy endpoint with statistical significance. The most frequently reported ocular adverse events in this trial were related to the injection procedure. The Company expects topline data for GATHER2, the Company’s second Phase 3 clinical trial for Zimura for GA, to be available in the third quarter of 2022, approximately one year after the enrollment of the last patient in the trial plus the time needed for database lock and analysis. If 12-month results from GATHER2 are positive, the Company plans to submit applications with the FDA and the European Medicines Agency (EMA) for marketing approval of Zimura for GA. There are no FDA or EMA approved treatments available for patients with GA.

About Zimura
Zimura (avacincaptad pegol) is an investigational drug product and has not been approved for use anywhere globally. Zimura is designed to target and inhibit the cleavage of complement protein C5 and the formation of its downstream fragments, C5a and C5b. By inhibiting the formation of these fragments, Zimura is believed to decrease or slow the chronic inflammation and cell death associated with the retinal aging process by decreasing the formation of membrane attack complex (MAC) and inflammasome activity, thereby potentially avoiding or slowing the degeneration of retinal pigment epithelial cells. This potential mechanism is the rationale for Zimura as a potential therapy for GA and earlier stages of AMD.