onCARlytics and Artemis® T cells combination presented as part of
abstract at American Society of Gene and Cell Therapy’s Annual Meeting

On May 3, 2023 Imugene Limited (ASX: IMU), a clinical stage immunooncology company, reported its onCARlytics technology, in combination with Eureka Therapeutics’ Artemis T cell platform, has been presented as part of an abstract at the American Society of Gene and Cell Therapy’s Annual Meeting (ASGCT) (Free ASGCT Whitepaper) (Press release, Imugene, MAY 3, 2023, View Source [SID1234630865]).

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The abstract, titled ‘Effective combination immunotherapy using onCARlytics and Artemis CD19 T cells against hepatocellular carcinoma’, investigates the combination in the most primary type of liver cancer and sixth most common cancer worldwide.

While hepatocellular carcinoma (HCC) has systemic therapies and curative treatment options, CD19 targeting CAR T cell therapy has shown positive clinical outcomes, despite some ongoing challenges in bringing effective results into solid cancers.

The abstract presented at ASGCT (Free ASGCT Whitepaper) noted that the combination of onCARlytics and Artemis CD19 T cells demonstrated impressive in vivo anti-tumour responses in a human xenograft HepG2 model. It also stated that the combination strategy can be applied to otherwise target-less tumours such as HCC, and this shows the potential this could be applicable to a wide array of solid cancers as an effective immunotherapy approach.

The ASGCT (Free ASGCT Whitepaper) event is now in its 26th year and attracts a range of professionals in the area of gene and cell therapy, who observe new scientific research and technologies alongside peers in the industry. It is being held 16-20 May 2023 at the Los Angeles Convention Center, CA, USA.

The full abstract can be viewed at: View Source

Medigene AG reports financial results and business update for Q1 2023

On May 3, 2023 Medigene AG (Medigene, FSE: MDG1, Prime Standard), an immuno-oncology platform company focusing on the discovery and development of T cell immunotherapies for solid tumors, reported financial results for the first quarter of 2023 (Press release, MediGene, MAY 3, 2023, View Source [SID1234630860]). The full Quarterly Statement Q1 2023 can be downloaded here: View Source

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"Since the beginning of 2023, we have been making significant progress on our strategy in addressing the unmet needs in treating solid tumors. We have expanded the technologies in our end-to-end technology platform through our research collaboration with the National Cancer Institute as well as with the addition of a second exclusive costimulatory switch receptor CD40L-CD28, designed to optimize both the efficacy and safety profiles of TCR-T therapies. I remain convinced that our unique end-to-end platform and our approach to its continued innovation will be the key differentiators for Medigene allowing us to develop new, best-in-class therapies," said Selwyn Ho, Chief Executive Officer of Medigene. "Further, our internal programs MDG1015 and MDG10xx as well as our partnerships with BioNTech and 2seventy bio have continued to advance well, further validating our end-to-end platform. Finally, we continue to explore options to extend our cash reach beyond 4Q 2024 in order to meet these planned future milestones and create further shareholder value."

Financial and Corporate Development

The financial performance in Q1 2023 was in line with the Executive Management Board’s expectations. Revenues amounted to EUR 1.5 million, primarily from the partnership with BioNTech. Reflecting the strong commitment towards advancing the pipeline, R&D expenses amounted to EUR 2.3 million. The Company maintains strong liquidity of EUR 32.1 million, with cash & cash equivalents in the amount of EUR 21.1 million and time deposits of EUR 11.0 million as of March 31, 2023.

The Management Board therefore maintains its guidance for fiscal year 2023 published in the annual report 2022 on March 29, 2023, in its entirety. Management is confident to achieve further progress with partnerships, potentially generating additional milestone payments and revenues.

As previously announced, Medigene moves forward with a strengthened leadership team. During the first quarter, Pamela Keck joined as Head of Investor Relations and Corporate Communications with more than 15 years of experience in the field, as well as Kirsty Crame, MD, who brings more than 10 years of experience in drug development and clinical operations, focused primarily in immuno-oncology and in cell therapy development, into her role as Head of Clinical Research & Development.

Scientific progress

Presented at the American Academy of Cancer Research (AACR) (Free AACR Whitepaper) in April 2023, pre-clinical data for the Company’s lead program MDG1015 highlighted the potential for significant benefits of MDG1015 in improving long-term anti-tumor effects by mitigating the immunosuppressive tumor microenvironment (TME) that currently limits solid tumor therapies. Specifically, the findings demonstrate that the combination of a NY-ESO-1-specific T cell receptor (TCR) combined with co-expression of Medigene’s chimeric PD1-41BB switch receptor on the TCR-T cell surface significantly increases anti-tumor activity, compared to T cells expressing the TCR alone.

Just after the end of Q1, Medigene entered into a cooperative R&D agreement with the U.S. National Cancer Institute to evaluate the use of Medigene’s proprietary TCRs in novel cell constructs. Also subsequent to the end of the quarter, as announced on May 2, Medigene has partnered with Helmholtz Munich to acquire the exclusive, worldwide rights to the CD40L-CD28 costimulatory switch receptor.

Alloy Therapeutics to Empower Drug Discovery of Lundbeck’s Biologics for Brain Health

On May 2, 2023 Alloy Therapeutics, a biotechnology ecosystem company, reported it is collaborating with Lundbeck, a global pharmaceutical company specializing in brain diseases, in the discovery of novel biologics therapies (Press release, Alloy Therapeutics, MAY 2, 2023, View Source [SID1234642129]).

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Through this agreement, Lundbeck will gain access to Alloy’s Antibody Discovery Services and its SeqImmune discovery module, which is a sequence-first workflow for early-on repertoire capture and generation of maximum initial diversity.

Lundbeck has licensed Alloy’s ATX-Gx humanized transgenic mouse platform since 2020, and this partnership reflects a deepening of the relationship between the companies, with Lundbeck looking to Alloy for complementing capabilities to its biologics discovery efforts.

"We have been impressed with Alloy’s innovative mindset and shared commitment to its partners’ success, and we are excited to complement Lundbeck’s internal scientific expertise with Alloy’s sophistication around biologics discovery," said Allan Jensen, Vice President of Biotherapeutic Discovery at Lundbeck.

Alloy started in 2017 with a mission to democratize foundational, pre-competitive biologics discovery technologies and expertise to enable the global scientific community to make better medicine together, starting with the ATX-Gx platform. Alloy quickly followed with its Antibody Discovery Service organization to enable its collaborators to fully outsource their discovery services needs to the foremost experts on the ATX-Gx platform.

Alloy’s Antibody Discovery Service is committed to finding its partners the best therapeutic antibodies against their target and delivering each campaign a sophisticated data package with the option for additional value-add offerings around machine-learning-driven affinity maturation and optimization, bispecific engineering, translational medicine, and advanced antibody production.

Alloy is committed to reinvesting 100 percent of its revenue back into innovation, and as a result is continuously improving and expanding the technologies and protocols deployed in its discovery campaigns.

Biotherapeutic Discovery at Lundbeck is focused on restoring brain health through the discovery and development of antibodies and biologics. The unique biology and additional complexities associated with the treatment of brain disease set highly stringent specifications on potential drug lead candidates.

"The ability to discover highly diverse antibody repertoires is key to finding the few potential drug leads, and the SeqImmune discovery module on top of the ATX-Gx platform holds that promise," said Allan Jensen, Vice President Biotherapeutic Discovery at Lundbeck.

"Our relationship with Lundbeck is a reflection of how we work to support the global scientific community in their mission to advance the best medicines for patients," said Errik Anderson, Alloy Therapeutics Founder and CEO. "We are grateful that Lundbeck has been collaborating with us for years on our platform technology and have put their trust in us as an extension of their discovery services team with this expanded partnership leveraging our SeqImmune antibody discovery workflow."

Leidos Holdings, Inc. Reports First Quarter Fiscal Year 2023 Results

On May 2, 2023 Leidos reported its First Quarter Fiscal Year 2023 Results (Press release, Leidos, MAY 2, 2023, View Source [SID1234632884]).

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Ten63 Therapeutics Raises $15.9 Million in Oversubscribed Series A Financing to Drug the Undruggables by Combining the Power of AI and Physics-based Models

On May 2, 2023 Ten63 Therapeutics, a company combining generative AI and physics-based models to develop first- and best-in-class therapeutics, reported the closing of an oversubscribed $15.9 million Series A financing led by new investor Hatteras Venture Partners (Press release, Ten63 Therapeutics, MAY 2, 2023, View Source [SID1234632173]). Morpheus Ventures, SOSV, Draper Associates, Alexandria Venture Investments, the Sigma Group and other new investors also participated in the round.

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Proceeds will be used to advance and expand Ten63’s internal pipeline of first-in-class small molecules inhibiting high-impact, but thus far undruggable, cancer targets, including continued progression of its lead Myc inhibitor program. Key to Ten63’s pipeline is the continued development of BEYOND, Ten63’s proprietary computational drug discovery platform. The financing also allows Ten63 to selectively enter key strategic partnerships to further enhance its pipeline.

"We are thrilled to welcome some of the leading biotechnology and technology venture funds to accelerate our pipeline and platform," said Marcel Frenkel, PhD, CEO of Ten63. "At Ten63, we are dedicated to developing groundbreaking therapeutics that benefit patients, and we are pleased to strengthen our syndicate with the experience and expertise to help us get there. Our investors have repeatedly demonstrated the ability to help companies grow to have a positive impact on patients’ lives. We look forward to building on that tradition."

"Marcel Frenkel, Mark Hallen and the Ten63 team have taken AI/machine learning (ML) drug discovery to the next level. Their approach enables the search of a massively expanded universe of compounds and binding pockets," said Clay Thorp, Co-Founder and General Partner at Hatteras and Ten63’s new Chairman of the Board. "We are excited to be a part of Ten63 and help the company leverage its platform to bring life-changing therapeutics to patients."

This new phase of growth builds on Ten63’s unprecedented progress toward one of the most sought-after cancer therapeutics: a small-molecule drug targeting Myc.

"We are more than doubling our investment because Ten63 has experimentally demonstrated in head-to-head comparisons that BEYOND outperforms over 40 years of academic and industry best-efforts and methods when pursuing difficult targets like Myc," said Damien Petty, Partner at Morpheus Ventures, the lead investor of Ten63’s previous round.

Set on drugging the "undruggable"

Ten63’s journey began with Dr. Frenkel’s mother, Gilda Szacher Frenkel.

"Like many, her cancer was driven by a set of mutations to key proteins that regulate cellular processes. Unfortunately, most of these proteins, despite being widely studied, remain undruggable by current methods," said Dr. Frenkel. "Ten63 has set out with a vengeance to change this paradigm through the application of next-generation computational drug discovery methods."

Despite advances in drug discovery, 80% of the proteins in the human body remain evasive, and some of these so-called "undruggable" proteins are believed to be major oncogenes (cancer-driving proteins). Ten63 is progressing multiple targets within its pipeline, but is currently only disclosing its lead program, a Myc inhibitor. Myc is one of the most-studied oncogenes and believed to drive up to 70% of all cancers. Despite hundreds of attempts spanning 40 years, it remains infamously elusive. Ten63 believes its computational platform BEYOND has the potential to crack Myc, as well as other undruggable oncogenes, transforming the treatment landscape for patients.

Ten63 developed the BEYOND platform based on over 15 years of academic research by its founders.

"Rather than depending on data alone, BEYOND builds on molecular voxel theory (MVT)," said Mark Hallen, PhD, Ten63’s co-founder and CTO,. "MVT allows BEYOND to explore a chemical space of over 100 trillion compounds, with mathematical guarantees to discover the best small molecule solutions given the company’s state-of-the-art hybrid AI/physics-based models. BEYOND also enables Ten63 to find novel pockets and binding sites, as well as a large diversity of chemical matter."

A visionary team combining pharma experience and cutting-edge technology

Drs. Frenkel and Hallen and their co-founder Bruce Donald, PhD, worked together for years on the academic precursors to these algorithms. Dr. Donald, the James B. Duke Professor of Computer Science at Duke University and professor of chemistry and biochemistry, chairs Ten63’s scientific advisory board. Their work pioneered the prediction of resistance mutations to cancer drugs and antibiotics before they arise in the clinic and the application of ML to scale cutting-edge, quantum chemistry-based models to the massive chemical and conformational spaces needed for drug discovery. In addition to a groundbreaking computational protein and drug design background, launching Ten63 required a much broader range of expertise.

Ten63 has assembled a visionary team of accomplished chemists, biologists and computational experts to accomplish its mission. The team ranges from experienced pharma executives like Nancy Miller-Rich, previously global head of BD and Strategy at Merck, and Melissa Epstein, formerly SVP at Novartis, to drug hunters like Stephen Thomson, PhD, formerly section head at GSK and research fellow at Vertex, and Charlie Holst, PhD, formerly senior director at Ribometrix and previously senior principal scientist at Pfizer. The company also taps into the expertise of a world-class scientific advisory board, including two MacArthur (Genius) Fellowship award winners and one Squirrel AI award winner, as well as members of the National Academies of Medicine, Science and Engineering.

"Much of our algorithmic strategy at Ten63 is built on synthesizing the diverse lines of seminal research that our advisors have pioneered," said Dr. Hallen.

"Ten63’s provable AI algorithms for the exploration of vast chemical and conformational spaces, combined with the accuracy of ML-accelerated quantum chemistry methods, have the potential to revolutionize how we design drugs," said Weitao Yang, PhD, one of the world’s foremost experts in computational quantum chemistry and Ten63’s SAB member.