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™E Pharma N.V.: CEO Message H1 2024

Jul 9, 2024 | blog

BERLIN–(BUSINESS WIRE)–Regulatory News:

™E Pharma N.V. (Euronext Growth Paris: AL™E), a clinical-stage biotechnology firm targeted on growing novel therapies for remedy of most cancers by concentrating on the tumor microenvironment (™E), launched as we speak a message from Aram Mangasarian, CEO of ™E Pharma, to its shareholders.

Dear Shareholders,

In the primary half of 2024, we delivered a sequence of serious achievements, additional strengthening the potential of our lead asset NOX-A12 and positioning ™E Pharma as a pioneer in glioblastoma remedy, an pressing medical want.

I’m happy to put in writing to you with an replace on our progress throughout what has been a really busy and thrilling begin to the yr, following a yr of supply on our guarantees together with:

  • Median survival practically double, and 21-month survival 10-fold larger, than that of an ordinary‘of-care reference cohort in mind most cancers (glioblastoma) sufferers with chemotherapy‘refractory residual tumor after surgery1
  • Approval of our mind most cancers Phase 2 medical trial design by the US FDA2
  • Fast Track designation granted by the US FDA for our lead asset, NOX-A12, in glioblastoma3
  • Publication of NOX-A12 medical information within the high-profile scientific journal Nature Communications4
  • Complete elimination of convertible debt from the capital construction of the company5
  • Recruitment of a brand new US-based board member with extremely related partnering and M&A expertise within the mind most cancers space6

Constructive Engagement with Strategic Partners and Investors and a Clear Vision for the Future of ™E Pharma

Based on the profitable supply of those goals, we are actually in discussions with strategic companions and traders within the potential of NOX-A12 program. Our purpose is to finalize these discussions within the 4th quarter of 2024 earlier than one other capital enhance is required. This will permit us to progress in direction of our future imaginative and prescient for the corporate of getting NOX‘A12 accepted to be used in glioblastoma sufferers with ™E Pharma in a strategic partnership with a pharmaceutical firm and having help from governmental/charitable organizations and professional biotech traders. Once we are able to begin the deliberate randomized, managed Phase 2 medical trial, we estimate that in roughly 3 years we could have adequate information to launch a pivotal medical trial that would result in approval with constructive outcomes.

Potential for Unprecedented Clinical Benefit in Glioblastoma

In our most important medical accomplishment so far, we introduced survival information from our GLORIA research obtained in newly recognized glioblastoma sufferers with extraordinarily poor prognosis: tumors resistant to straightforward chemotherapy plus incomplete surgical resection. The research achieved a outstanding 19.9-month median total survival (mOS) price for sufferers receiving NOX-A12 together with the VEGF inhibitor bevacizumab and radiotherapy. This practically doubles the ten.5‘month mOS price demonstrated in the usual of care matched reference cohort. If this result’s confirmed in a bigger, randomized medical trial, it could provide NOX-A12 a transparent clinically and commercially related benefit over the present normal of care.

Moreover, the NOX-A12 survival outcomes surpass these from what we imagine are all related competitor remedy trials in newly recognized glioblastoma sufferers resistant to straightforward chemotherapy7. NOX‘A12’s effectiveness is much more spectacular contemplating the NOX-A12 GLORIA trial enrolled sufferers with a worse prognosis than these within the competitor trials. The NOX-A12 trial solely enrolled sufferers with residual detectable tumor after surgical procedure whereas competitor trials additionally included sufferers with no detectable tumor after surgical procedure, thereby giving the sufferers in these competitor trials a greater anticipated common survival final result.

This progress highlights the immense potential of NOX-A12 to rework the remedy of glioblastoma sufferers, who face a devastating prognosis from this extremely aggressive type of mind most cancers. With a median total survival of 8 months, a staggering 93% of sufferers don’t survive past 5 years and the present normal of care gives no remedy and solely restricted survival benefit8. This large unmet medical want demonstrates the significance of our purpose to develop NOX-A12 to develop into a part of the most effective glioblastoma remedy for newly recognized sufferers and make it accessible to them as quick as we are able to.

Constructive Interactions with US Regulator

We engaged in discussions with the US Food and Drug Administration (FDA) to determine a transparent regulatory roadmap for the following stage of NOX-A12’s medical improvement and submitted an Investigational New Drug (IND) utility for NOX-A12 in glioblastoma. This IND was accepted by the FDA, paving the best way for a brand new randomized, managed Phase 2 medical research. Randomized medical trial information are a key benchmark for giant pharmaceutical firms and later-stage most cancers belongings command larger valuations for milestone funds and in transactions, on common, so it’s essential for us to advance NOX-A12 into this Phase 2 analysis.

Following the IND approval, NOX-A12 was additionally granted Fast Track designation by the US FDA. This designation, a second key regulatory milestone, goals to facilitate the event and expedite the evaluation of medicine addressing critical situations like glioblastoma. Fast Track designation permits for extra frequent interactions with the FDA all through the medical improvement section, enabling ™E Pharma to optimize the design of the Phase 2 research and doubtlessly accelerated timelines. It additionally means we have now the potential to qualify for “accelerated approval” and “priority review” if NOX-A12 meets the related standards.

We understand the achievement of those two key regulatory milestones because the FDA’s recognition not solely of the pressing unmet medical want which glioblastoma represents, but in addition the potential of NOX-A12 to handle it. This paves the best way to speed up NOX-A12’s path to market and to de-risk its improvement, whereas offering traders and potential companions with a transparent improvement pathway for NOX-A12. The open IND will permit us to broaden our medical improvement within the US, essentially the most financially essential marketplace for new pharmaceuticals9, the place we anticipate important curiosity from the medical neighborhood.

Funding Phase 2 Clinical Trial and Managerial Engagement

In our trial design and planning, we have now been implementing methods to optimize timelines and cut back prices of our glioblastoma program total. Sufficient provide of NOX-A12 is obtainable to provoke the trial shortly upon closing the funding hole. We proceed discussions with engaged stakeholders and are pursuing funding choices by way of a mix of non-dilutive grant funding, a strategic alliance and/or funding from professional institutional traders, with the target to materialize these interactions in This fall-2024.

As we work to safe the Phase 2 trial financing, we have now cleaned up our stability sheet eradicating all convertible debt devices and just lately introduced a money runway extension to year-end. To spotlight my confidence in our mission, I personally invested within the firm subscribing to greater than 500,000 new shares since December 202310.

I want to thank all of you, our shareholders, in your continued dedication and help of our efforts. After having achieved all our latest medical, regulatory, and monetary targets we stay targeted on delivering our fundamental mission: to deliver NOX-A12 to market as shortly as attainable to supply an answer to sufferers affected by a devastating illness, glioblastoma.

Yours sincerely,

Aram Mangasarian
CEO, ™E Pharma
July ninth, 2024

About ™E Pharma

™E Pharma is a clinical-stage firm targeted on growing novel therapies for remedy of essentially the most aggressive cancers. The firm’s oncology-focused pipeline is designed to behave on the tumor microenvironment (™E) and the most cancers immunity cycle by breaking tumor safety limitations towards the immune system and blocking tumor restore. By neutralizing chemokines within the ™E, ™E Pharma’s strategy works together with different types of remedy to weaken tumor defenses and allow larger therapeutic influence. In the GLORIA Phase 1/2 medical trial, ™E Pharma is learning its lead drug candidate NOX-A12 in newly recognized mind most cancers sufferers who won’t profit clinically from normal chemotherapy. ™E Pharma has delivered top-line information from the NOX-A12 three dose-escalation cohorts mixed with radiotherapy of the GLORIA medical trial, observing constant tumor reductions and goal tumor responses. Additionally, GLORIA enlargement arms consider security and efficacy of NOX-A12 in different combos the place the interim outcomes from the triple mixture of NOX-A12, radiotherapy and bevacizumab counsel even deeper and extra sturdy responses, and improved survival. US FDA has accepted the design of a randomized Phase 2 trial in glioblastoma and ™E Pharma was awarded quick monitor designation by the FDA for NOX-A12 together with radiotherapy and bevacizumab to be used within the remedy of the aggressive grownup mind most cancers, glioblastoma. NOX-A12 together with radiotherapy had additionally beforehand obtained orphan drug designation (ODD) for glioblastoma within the United States and glioma in Europe. ™E Pharma has delivered remaining top-line information with encouraging total survival and security profile from its NOX-A12 mixture trial with Keytruda ® in metastatic colorectal and pancreatic most cancers sufferers, which was printed within the Journal for ImmunoTherapy of Cancer in October 2021. The firm has entered in its second collaboration with MSD/Merck for its Phase 2 research, OPTIMUS, to additional consider security and efficacy of NOX-A12 together with Merck’s Keytruda ® and two completely different chemotherapy regimens as second-line remedy in sufferers with metastatic pancreatic most cancers. The design of the trial has been accepted in France, Spain and the United States. The firm’s second clinical-stage drug candidate, NOX-E36, is designed to focus on the innate immune system. ™E Pharma is contemplating a number of stable tumors for additional medical improvement. Further data may be discovered at: www.tmepharma.com.

™E Pharma ® and the ™E Pharma brand are registered emblems.

Keytruda ® is a registered trademark of Merck Sharp (OTC:) & Dohme Corp.

Visit ™E Pharma on LinkedIn and X.

About the GLORIA Study

GLORIA (NCT04121455) is ™E Pharma’s dose-escalation, Phase 1/2 research of NOX-A12 together with radiotherapy in first-line partially resected or unresected glioblastoma (mind most cancers) sufferers with unmethylated MGMT promoter (resistant to straightforward chemotherapy). GLORIA additional evaluates security and efficacy of NOX-A12 three further arms combining NOX-A12 with: A. radiotherapy in sufferers with full tumor resection; B. radiotherapy and bevacizumab; and C. radiotherapy and pembrolizumab.

About the OPTIMUS Study

OPTIMUS (NCT04901741) is ™E Pharma’s deliberate open-label two-arm Phase 2 research of NOX-A12 mixed with pembrolizumab and nanoliposomal irinotecan/5-FU/leucovorin or gemcitabine/nab-paclitaxel in microsatellite-stable metastatic pancreatic most cancers sufferers.

Disclaimer

Translations of any press launch into languages apart from English are supposed solely as a comfort to the non-English-reading viewers. The firm has tried to supply an correct translation of the unique textual content in English, however as a result of nuances in translating into one other language, slight variations might exist. This press launch contains sure disclosures that include “forward-looking statements. Forward-looking statements are primarily based on ™E Pharma’s present expectations and are topic to inherent uncertainties, dangers and assumptions which might be tough to foretell. Factors that would trigger precise outcomes to vary embrace, however usually are not restricted to, the dangers inherent in oncology drug improvement, together with medical trials and the timing of and ™E Pharma’s capability to acquire regulatory approvals for NOX-A12 in addition to every other drug candidates. Forward-looking statements contained on this announcement are made as of this date, and ™E Pharma undertakes no responsibility to replace such data besides as required beneath relevant legislation.

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1 ™E Pharma Press Release on February 2, 2024
2 ™E Pharma Press Release on March 5, 2024
3 ™E Pharma Press Release on April 2, 2024
4 ™E Pharma Press Release on June 17, 2024
5 ™E Pharma Press Release on February 9, 2024
6 ™E Pharma Press Release on June 27, 2024
7 ™E Pharma Press Release on September 13, 2023
8 Central Brain Tumor Registry of the United States (CBTRUS) Statistical Report: Primary Brain and Other Central Nervous System Tumors Diagnosed within the United States in 2016-2020
9 European Federation of Pharmaceutical Industries and Associations: the-pharmaceutical-industry-in-figures-2024.pdf (efpia.eu)
10 See Managers Transactions for A. Mangasarian from: December 5, 2023, and February 8 and 12, 2024.

For extra data, please contact:

™E Pharma N.V.
Aram Mangasarian, Ph.D., CEO
Tel. +49 (0) 30 16637082 0
traders@tmepharma.com

Investor and Media Relations:

LifeSci Advisors
Guillaume van Renterghem
Tel. +41 (0) 76 735 01 31
gvanrenterghem@lifesciadvisors.com

NewCap
Arthur Rouillé
Tel. +33 (0) 1 44 71 00 15
arouille@newcap.fr

Source: ™E Pharma N.V.

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