On August 18, 2022 Immedica Pharma AB reported that Zepzelca (lurbinectedin) has received the Innovation Passport (Innovative Medicine Designation) by the MHRA (UK Medicines and Healthcare products Regulatory Agency), presented earlier by our valued partner PharmaMar (see full press release below) (Press release, Immedica Pharma, AUG 18, 2022, View Source [SID1234618471]).

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Anders Edvell, CEO says: "To be awarded an Innovation Passport under the new Innovative Licensing and Access Pathway means a lot to us. We are excited about engaging with UK healthcare system stakeholders through this new pathway to explore the opportunities for bringing Lurbinectedin to patients as quickly as possible".

The pressrelease from PharmaMar, follows below.

AUGUST 5, 2022

PharmaMar has announced today that Zepzelca (lurbinectedin) has received the Innovation Passport (Innovative Medicine Designation) by the MHRA (UK Medicines and Healthcare products Regulatory Agency).

The MHRA’s Innovative Licensing and Access Pathway (ILAP) aims to accelerate the time to market, facilitating patient access to medicines. The ILAP comprises as the first step an "Innovation Passport" designation which supports innovative approaches to the safe, timely and efficient development of medicines to improve patient access. The criteria for the innovation passport include where the condition is life-threatening or seriously debilitating, or where there is a significant patient or public health need and where the medicinal product has the potential to offer benefits to patients (improved efficacy or safety, improved patient care or quality of life as compared to alternative therapeutic options).

Ali Zeaiter, M.D., VP Clinical Development & Regulatory Affairs of PharmaMar, said:

"Lurbinectedin is an innovative medicine that showed clinical benefit for patients with relapsed Small Cell Lung Cancer (SCLC) and obtained provisional approvals in a number of countries (including USA, Canada and Australia) and is being developed in other clinically significant indications. SCLC represents an unmet medical need in the UK and worldwide, and our objectives are aligned with those of the UK public health authorities to facilitate and improve patients access to medicines such as lurbinectedin," and added: "We believe that the innovation passport designation is an important step towards facilitating SCLC patients’ access to a new treatment option."

On May 4th 2022, PharmaMar announced it had submitted a conditional marketing authorization application to the UK’s MHRA for the treatment with lurbinectedin in adult patients with metastatic Small Cell Lung Cancer who have progressed following prior platinum-based chemotherapy based on data from the Phase II basket trial with lurbinectedin in monotherapy. PharmaMar expects a response to such application by the end of this year or first quarter of 2023. In addition, the LAGOON Phase III trial could be used as a confirmatory trial.

On 2020 PharmaMar and Immedica Pharma AB signed an agreement for the exclusive distribution and marketing of lurbinectedin for the UK and other territories.

Legal warning
This news release does not constitute an offer to sell or the solicitation of an offer to buy securities, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction.

On August 18, 2022 Targovax ASA (OSE: TRVX), a clinical stage biotechnology company developing immune activators to target hard-to-treat solid tumors, reported its second quarter and first half year 2022 results (Press release, Targovax, AUG 18, 2022, View Source [SID1234618470]).

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Members of Targovax’s executive management team will give an online presentation to investors, analysts and the press at 10:00 CET today (details below).

FIRST HALF YEAR 2022 HIGHLIGHTS
ONCOS-102
Signed a clinical collaboration agreement with Agenus for PD-1 and CTLA-4 checkpoint inhibitor supply to the upcoming ONCOS-102 phase 2 melanoma trial
CircRNA pipeline program
Established a research collaboration with Prof. Michael Uhlin at Karolinska Institutet in Stockholm, Sweden, for development of circRNA and NextGen ONCOS viruses
Mutant KRAS platform
Signed a clinical supply agreement with Agenus to include the adjuvant QS-21 STIMULON as an immune-stimulatory component of the TG mutant KRAS cancer vaccines
Awarded two prestigious research grants, totaling NOK 18m, towards the TG mutant RAS program from Innovation Norway and the Norwegian Research Council
Entered a collaboration with Oslo University Hospital to test TG01/QS-21 vaccination in a phase 1/2 study in multiple myeloma
Received IND approval from the US FDA to initiate clinical trials with the enhanced TG01/QS-21 vaccine in the USA
Organization
Appointed circRNA discoverer and pioneer Dr Thomas B Hansen as VP of Research to lead the circRNA pipeline research program
Strengthened the executive management team with Dr Lubor Gaal as Chief Financial Officer
Refreshed the Board of Directors with the addition of Dr Raphael Clynes and Mr Thomas Falck
Erik Digman Wiklund, CEO commented: "Looking ahead to the second half of the year and beyond – Targovax is establishing a broad and innovative immunotherapy pipeline designed to generate a rich flow of both clinical and pre-clinical data. Through differentiated combinations ONCOS-102 is in position to separate from the competition in anti-PD-1 refractory melanoma. The collaborative TG01 trials offer additional upside potential for the major unmet medical need in mutant RAS cancers, at low cost to Targovax. We believe the biggest opportunity long-term lies in our pre-clinical circular RNA program, which provides a cutting-edge innovation engine for platform expansion, partnering and future value creation for our shareholders."

Presentation
We invite to a live webcast today at 10.00 CET. You can join the webcast here. It will be possible to submit questions during the presentation.

On August 18, 2022 ArcticZymes Technologies (OSE: AZT) reported sales of NOK 30.4 million (21.3) and an EBITDA of NOK 9.5 million (6.0) for the second quarter of 2022 (Press release, Biotec Pharmacon, AUG 18, 2022, View Source [SID1234618468]).

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Highlights from Q2 and first 6 months 2022

ArcticZymes Technologies (AZT) had Q2 sales of NOK 30.4 million growing by 43% (Q2 2021: NOK 21.3 million) and sales for the first 6 months of NOK 79.5 million growing by 28% (6M 2021: NOK 62.2 million)
AZT had a positive EBITDA for Q2 of NOK 9.5 million growing by 58% (Q2 2021: NOK 6.0 million) and a positive EBITDA for the first six months of NOK 37.4 million growing by 18 % (6M 2021: NOK 31.8 million)
Cash flow for Q2 was positive NOK 16.4 million (Q2 2021: NOK 13.5 million) giving a cash balance of NOK 231.0 million (Q2 2021: NOK 176.8 million)
Initiated the establishment of a Drug Master File (DMF) for the SAN HQ enzyme
Appointed Dirk Hahneiser as new Vice President of Business Development and Marketing

CEO Jethro Holter comments:

"We are delighted with the quarterly performance and continued commercial development of the business post-pandemic. Both Molecular Tools and Biomanufacturing remain instrumental in delivering growth.

Furthermore, we welcome Dirk Hahneiser as new Vice President of Business Development and Marketing to the team. We look forward to working closely with Dirk in elevating commercial activities to the next level.

We would like to take this opportunity to thank Dirk´s predecessor, Dino DiCamillo, for his outstanding achievements in delivering commercial growth of the enzyme business over the last decade."

On August 17, 2022 Vascular Research Group (VRG), a peptide-based pharmaceuticals, cellular & gene therapy (CGT) company reported that their proprietary chlorotoxin (CTX) analogue, CTXA8, an antigen recognition domain in CAR T-cells, shows high potency in eliminating glioblastoma multiforme (GBM) cells in a preclinical in vitro GBM model (Press release, VRG Therapeutics, AUG 17, 2022, View Source [SID1234633162]). CTXA8 CAR modified T-cells demonstrated superior efficacy over the CAR T candidate employing natural CTX currently in a Phase 1 clinical trial.

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CTXA8 has been developed using VRG’s "designer miniprotein" platform. "We are very excited about these preclinical results that are in line with CTXA8’s superior affinity and selectivity towards MMP2 versus the natural CTX containing clinical stage competitor" – said Dr. Zalán Péterfi, Managing Director of VRG. "We look forward to reaching out and working with prospective partners to translate these promising developments into significant improvements in patient outcomes".

About CAR-T therapy targeting brain tumors: CAR T-cells are modified white blood cells expressing a chimeric antigen receptor (CAR) against a specific tumor antigen that holds the potential of identification and elimination of cancer cells. High overexpression of MMP2 protein in GBM has recently been utilized as a new target and the initial results from the ongoing Phase 1 trial show that CTX targeted CAR T therapy could be a game changer for this indication.

The safety and efficacy of CAR T therapies strongly depend on the specificity and selectivity of the tumor-targeting domain of the chimeric antigen receptor. Using its designer "miniprotein" platform, VRG has developed a proprietary CTX analog, CTXA8 that provides a solution for directed antitumor activity. CTXA8 as a targeting agent of CAR T-cells, exerts a major effect on MMP2-overexpressing GBM while sparing normal tissues with low MMP2 expression. VRG’s latest results show that CTXA8 CAR T-cells demonstrate faster and improved killing of tumor cells within 24 hours with an effector-target ratio of 1:3, which predicts higher efficacy and lower off-tumor effect compared to the CAR T therapy with original CTX currently in Phase 1. The increased efficacy of CTXA8-based CAR T therapy is due to the increased affinity and selectivity of CTXA8 versus original CTX towards MMP2 overexpressing tumor cells. This is further supported by a cytokine release assay in which CTXA8 CAR T-cells secreted 3 times more IFN gamma than CTX CAR Ts.

On August 17, 2022 Imperial College London reported that its spin out startup GlioQuell has the power to shut down cancer cells (Press release, GlioQuell, AUG 17, 2022, View Source [SID1234629314]). A new company using research from the Department of Brain Sciences will look for drugs to treat brain cancers and diseases of old age.

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Cancer cells grow at an extraordinary rate inside the body. To do this, they need energy, which is provided by mitochondria, the powerhouses of the cell. Dr Kambiz Alavian in the Department of Brain Sciences has been looking for ways to turn off cancer cells’ power supply. He has now co-founded a company, GlioQuell, to accelerate the development of a new kind of cancer treatment.

"We think we have a new way of looking at the mitochondria of cancer cells, and of treating cancer, based on reducing the efficiency of these beasts inside the cells," he says

All cells in the human body contain mitochondria, structures that produce energy and biomolecules for whatever activity the cells need to carry out. Looking closely at the cells involved in glioblastoma, one of the most aggressive and deadliest forms of cancer, revealed that their mitochondria are extraordinarily efficient.

"There is almost no cell that I have seen that is as efficient as these particular cells, in terms of utilising their resources for growth," says Dr Alavian. "They resemble mini-embryos, growing very quickly inside the brain."

This characteristic can be exploited when looking for treatments, for example by seeking out molecules that undermine the electrochemical mechanism that mitochondria use to make energy.

"By allowing ions to leak through the mitochondrial membrane, we can render the mitochondria inefficient at supplying energy to the cells, and furthering cell growth," Dr Alavian says. "Although mitochondria have previously been considered as therapeutic targets, this is a new and elegant way of tackling this disease, because it goes after a mechanism that is particularly active in cancer cells."

It’s an approach that could be applied to many other kinds of cancer. "But we are particularly interested in glioblastoma, because there is no effective treatment and no cure."

To the clinic
Dr Alavian’s lab at Imperial has designed and patented a high-throughput assay for identifying potential drugs that have this effect on glioblastoma mitochondria. GlioQuell has been set up to advance this innovation and to raise enough funding to expedite the translation of discoveries into the clinic.

GlioQuell will also benefit from the knowledge built up during the research process at Imperial. "We have a unique knowledge-base and set of technologies in our lab, and would like to transfer that knowhow to the company. We want to ensure that the company is equipped to do a full spectrum of studies: to characterise the mechanism, to design and develop new drugs, and to test the new drugs in the most efficient way."

There is another, quite different situation in which it would be useful to slow down mitochondria, which GlioQuell will also investigate. In addition to energy production, mitochondria start the process by which cells shut down and eventually die. Changing the way they function through pharmaceutical and nutraceutical intervention could also promote healthy ageing and offer ways of slowing the degeneration of muscles, brain and other tissues in old age.

Dr Alavian has co-founded GlioQuell with Dr Travis Tierney, Dr Valentin Gribkoff, and Dr Carlos Sanchez, three colleagues in the USA with extensive expertise in cancer biology, neuroscience, clinical medicine and drug development.