On June 15, 2021 Linnaeus Therapeutics, Inc. (Linnaeus), a privately held clinical-stage biopharmaceutical company focused on the development and commercialization of novel small molecule oncology therapeutics, reported that the expansion of its ongoing clinical collaboration with Merck to include multiple additional phase 2 cohorts(Press release, Linnaeus Therapeutics, JUN 16, 2021, View Source [SID1234584073]). Based on promising preliminary safety, pharmacodynamic and efficacy data, this expanded agreement will allow the companies to further evaluate the combination of LNS8801 and Merck’s anti-PD-1 therapy, KEYTRUDA(pembrolizumab) in patients with selected advanced solid tumors.

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LNS8801 is a first-in-class, orally bioavailable small molecule that is a highly specific and potent agonist of the G-protein estrogen receptor (GPER). GPER is widely expressed on cancers. Stimulating GPER rapidly and durably depletes the c-Myc oncoprotein, stops cancers from proliferating, and makes them more visible to the immune system.

Linnaeus and Merck are currently evaluating the combination of LNS8801 and KEYTRUDA in patients who had previously responded to PD-1/L1 therapy but have subsequently progressed on PD-1/L1 inhibitors. Additionally, Linnaeus is currently evaluating LNS8801 as a monotherapy in patients that cannot tolerate PD-1/L1 therapy due to serious immune-related adverse events.

Under the terms of the agreement, Linnaeus will conduct six additional Phase 2 cohorts evaluating the combination of LNS8801 and KEYTRUDA in several indications including NSCLC, head and neck cancer, cutaneous and uveal melanoma, among others.

"We are very pleased to expand our collaboration with Merck, the established leader in cancer immunotherapy, as we advance LNS8801 into Phase 2 clinical trials," said Patrick Mooney, MD, Chief Executive Officer of Linnaeus. "Based on the encouraging signals we have seen so far in the advanced cancer patients treated with the combination of LNS8801 and KEYTRUDA as well as LNS8801 as monotherapy, we are optimistic that the combination of LNS8801 and KEYTRUDA will provide meaningful benefit to this patient population."

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About LNS8801

LNS8801 is an orally bioavailable and highly specific, potent agonist of GPER whose activity is dependent on the expression of GPER. GPER activation by LNS8801 rapidly and durably depletes c-Myc oncoprotein levels. In preclinical cancer models, LNS8801 displays potent antitumor activities across a wide range of tumor types, rapidly shrinking tumors and inducing immune memory. In the ongoing phase human 1/2a study, LNS8801 monotherapy has been safe and well tolerated. Additionally, LNS8801 has demonstrated target engagement, c-Myc oncoprotein depletion, and durable clinical benefit in patients with advanced cancer.

On June 16, 2021 New Equilibrium Biosciences reported Endpoints News that intelligence, with its grandiose claims and sweeping promises to revolutionize drug discovery, may seem omnipresent in biopharma now (Press release, New Equilibrium Biosciences, JUN 16, 2021, View Source [SID1234584057]). But Virginia Burger and RA Capital believe there are niches it has yet to touch.

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After taking up residency at the star-studded Boston accelerator Petri, Burger’s startup — named New Equilibrium Biosciences — has scored $10 million in seed cash from the VC firm to prove that by reaching into those corners, they could uncover drugs against "Holy Grail" targets in everything from cancer to neurodegenerative diseases.

Specifically, the biotech is interested in a class of proteins called intrinsically disordered proteins that doesn’t have a single folded structure. MYC, for instance, is a cancer-causing IDP.

"They break this paradigm of sequence to structure to function because it’s really sequence to multiple of different conformations which have many different functions," she told Endpoints News.

They can also range from fully unstructured to partially structured ones containing a disordered region, something condensate players like Dewpoint are focused on.

Cracking this special class, RA Capital principal Nathaniel Brooks Horwitz said, required a new breed of company that integrates AI in physics modeeling for drug discovery, beyond what the pioneers — he counts Schrödinger, Relay, Silicon Atomwise, Recursion and Exscientia among others — are doing.

"What we’re really excited about is when a company like New Equilibrium can enable a target about which we can say the following — ‘If only we could develop a drug for this target’ — we’re confident it will be successful," he said.

As a PhD in Pittsburgh and later postdoc at MIT, Burger would read papers highlighting their importance as drug targets. But they were so hard to target that until midway through her postdoc, scientists weren’t even sure if ligands could bind to them — they wiggle around too quickly to be even seen in experiments. Even when they did find molecules that bound weakly to the proteins, there was no real way to optimize them into drug candidates.

Immersed in the entrepreneurial environment at MIT, it seemed natural to build a startup around the computational methods she had been developing to identify the set of conformations the proteins would switch between. First, though, she took a job at XtalPi, the US-China AI biotech startup backed by Tencent and later SoftBank and Morningside.

It was during that two-year stint that she met Peter Tompa, a professor at Flanders Institute for Biotechnology who’s devoted his career to studying IDP structure and function. He was interested in starting a company together.

Two weeks later, she was out.

The first thing she did after receiving funding from Petri — an accelerator set up to tailor to the needs of young founders — was to buy quantum chemical software and start generating their own training data for a new kind of physics model.

Existing computational models, Burger said, were built on what’s already known about folded structures, which renders them the wrong fit for intrinsically disordered proteins. By using AI to learn quantum chemistry — the energies and forces on each atom that give rise to a shape at any given moment — New Equilibrium’s algorithms can "see," in silico, thousands or even millions of possible structures over time.

"We’re redoing how simulations have been done in the past by rebuilding the underlying simulation architecture to use AI for each step instead of introducing a single — the standard calculation for each step," she said.

The next step is to zero in on the structures that are more stable or appear more frequently, screen ligands against them in a wet lab, and then fuse the fragments binding to different structures in the same molecule. Burger can’t yet reveal how many fragments they’d need for each drug made this way, but noted that the seed funding will get them closer to preclinical candidates.

For RA Capital, the deal marks another move in their shift toward earlier stages of venture financing.

Quantum computing, Horwitz noted, is looming on the horizon with hardware starting to take shape. And the technology will ultimately make it possible to "fully model the true biophysical state of even the most complex molecular interactions."

"Which will be the companies that are the first to use quantum computing and all the power that brings to rationally design medicines for meaningful targets?" he said. "I think New Equilibrium can be that company."

On June 16, 2021 New Equilibrium Biosciences reported it has been awarded a National Science Foundation (NSF) Small Business Innovation Research (SBIR) for [$$$ AMOUNT] to conduct research and development (R&D) work on drug candidates that regulate intrinsically disordered proteins implicated in cancers and neurodegenerative disorders (Press release, New Equilibrium Biosciences, JUN 16, 2021, View Source [SID1234584055]).

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New Equilibrium Biosciences is dedicated to developing new medicines through cutting edge sciences and cross-disciplinary collaborates. New Equilibrium combines big data, artificial intelligence, and biophysical experiments to accurately visualize the many different conformations that IDP’s, a class of shapeshifting proteins, may adopt. The overarching motivations for this work is to benefit the greater good by specifically targeting and drugging malfunction IDPs to restore normal cell function in those with cancer and neurodegenerative disorders.

"NSF is proud to support the technology of the future by thinking beyond incremental developments and funding the most creative, impactful ideas across all markets and areas of science and engineering," said Andrea Belz, Division Director of the Division of Industrial Innovation and Partnerships at NSF. "With the support of our research funds, any deep technology startup or small business can guide basic science into meaningful solutions that address tremendous needs."

Once a small business is awarded a Phase I SBIR/STTR grant (up to $256,000), it becomes
eligible to apply for a Phase II grant (up to $1,000,000). Small businesses with Phase II grants
are eligible to receive up to $500,000 in additional matching funds with qualifying third-party
investment or sales.

Startups or entrepreneurs who submit a three-page Project Pitch will know within three weeks if
they meet the program’s objectives to support innovative technologies that show promise of
commercial and/or societal impact and involve a level of technical risk. Small businesses with
innovative science and technology solutions, and commercial potential are encouraged to apply.
All proposals submitted to the NSF SBIR/STTR program, also known as America’s Seed Fund powered by NSF, undergo a rigorous merit-based review process. To learn more about
America’s Seed Fund powered by NSF, visit: View Source

About the National Science Foundation’s Small Business Programs: America’s Seed Fund
powered by NSF awards $200 million annually to startups and small businesses, transforming
scientific discovery into products and services with commercial and societal impact. Startups
working across almost all areas of science and technology can receive up to $1.75 million to
support research and development (R&D), helping de-risk technology for commercial success.
America’s Seed Fund is congressionally mandated through the Small Business Innovation
Research (SBIR) program. The NSF is an independent federal agency with a budget of about
$8.1 billion that supports fundamental research and education across all fields of science and
engineering.

On June 16, 2021 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, reported that Manuel Litchman, M.D., President and Chief Executive Officer, will present at the Raymond James Human Health Innovation Conference, taking place virtually from June 21 – 23, 2021(Press release, Mustang Bio, JUN 16, 2021, View Source [SID1234584089]). The company will present on Wednesday, June 23, 2021, at 8:00 a.m. ET and will also participate in one-on-one meetings during the conference. A webcast of the company’s presentation will be available on the Events page of the Investor Relations section of Mustang’s website, www.mustangbio.com, for approximately 30 days after the meeting.

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On June 15, 2021 Quirem Medical reported that A first clinical QuiremSpheres patient procedure took place with radioactive holmium-166 microspheres that were activated at the BR2 reactor in Mol, Belgium (Press release, Quirem Medical, JUN 15, 2021, View Source [SID1234584001]). QuiremSpheres is an innovative product for treating liver cancer patients. In 2020, primary liver cancer was the 7th most common cancer worldwide, responsible for 905,677 new cases. This equates to 4.7% of all cancers diagnosed in 2020. Primary liver cancer became fatal that year for 830,180 patients worldwide, making liver cancer the third most deadly cancer of 2020, accounting for 8.3% of all cancer-related deaths.

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"We are very pleased that after a period of extensive testing and validation, we can now use the BR2 reactor for clinical productions." says Jan Sigger, CEO of Quirem Medical. "SCK CEN has proven to be a strong partner and we value their commitment during the development process leading up to this first clinical case. With the high reliability of the BR2 reactor, we are confident we can meet the strongly increasing demand for our products throughout Europe and beyond."

"The Belgian Nuclear Research Centre (SCK CEN) is a global leader in the field of nuclear research, services and education. SCK CEN is operating the BR2 reactor and has a long-standing tradition of partnering with healthcare companies to secure the global supply of medical radioisotopes. We are excited that we are now also able to support the production of holmium-166 microspheres for the treatment of liver cancer." says Bernard Ponsard, Stakeholder Manager of the BR2 reactor for radioisotope production and silicon doping.

QuiremScout is a unique product that allows for screening of patients that are candidates for Selective Internal Radiation Therapy (SIRT). QuiremScout is unique, as it is the only CE-marked product on the market for that purpose. It is more predictive than the current standard, Tech-99m-MAA.

QuiremSpheres, the next generation of radio-embolization microspheres, is the only commercially available SIRT product that contains holmium-166 microspheres. Unlike the widely adopted yttrium-90 microspheres, holmium-166 microspheres can be visualized in low concentrations by means of Single Photon Emission Computed Tomography (SPECT) and Magnetic Resonance Imaging (MRI). This allows clinicians to quantitatively assess the distribution of microspheres in the liver, enabling accurate evaluation of treatment directly after the radio-embolization procedure.