Recursion and Bayer Expand Fibrosis Collaboration to Include Inferential Search Capabilities

On December 6, 2021 Recursion (NASDAQ: RXRX), a clinical-stage biotechnology company decoding biology to radically improve lives by industrializing drug discovery, development and beyond through disruptive innovation, reported expansion of the company’s existing strategic collaboration in fibrosis with Bayer AG (Press release, Recursion Pharmaceuticals, DEC 6, 2021, View Source [SID1234596535]). The expanded collaboration will include Recursion’s powerful inferential search capabilities based on its growing maps of human cellular biology, giving Bayer the ability to further accelerate the work already underway in expanding the universe of novel fibrotic hypotheses. Recursion and Bayer may now work on more than a dozen programs in total of relevance to fibrotic disease. All projects will remain subject to the previously agreed upon economics, where each potential program could generate more than $100 million in commercial milestone payments plus royalties on future sales.

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Inferential search enables Recursion to materially expand the depth and breadth of the drug discovery space in a more efficient fashion – reducing time and costs to better operationalize the process. In the expanded collaboration, the company will leverage the Recursion Map, a collection of actionable scientific insights derived from the application of machine learning solutions on massive relatable datasets, to explore hundreds of billions of biological relationships that span whole-genome genetic perturbations, hundreds of soluble factors, and hundreds of thousands of pharmacological perturbations. Inferred relationships of interest will be validated in Recursion’s wet-labs and digital vivariums to rapidly advance therapeutic hypotheses and generate data which is fed back into Recursion’s Operating System to improve future predictions.

"Our collaborations are centered around the goal of delivering better drugs to patients faster than we could on our own," said Recursion Co-Founder & CEO Chris Gibson, PhD. "At Recursion, we believe inferential search is the future of drug discovery and have made key advances in this space. We have a deep respect for and trust in our colleagues at Bayer and are looking forward to including these new tools in our collaboration and potentially expanding the number of programs we go after together – all for the benefit of patients."

"The speed and scale of progress made in a short period of time on a number of fibrotic disease models with our collaborators at Recursion has been impressive," said Philip Larsen, Senior Vice President and Global Head of Research and Early Development at Bayer. "Fibrotic diseases are an important cause of morbidity and mortality worldwide. We look forward to the continued collaboration and adding inferential search to further accelerate our mission to deliver transformative therapies for patients with fibrotic diseases of the lung, kidney, heart and more."

Recursion first deployed inferential search internally in July 2020 within the oncology space. In early 2021, Recursion transitioned nearly all new internal discovery efforts to use inferential search. Based on progress achieved to date, Recursion has demonstrated that a program can advance from inference to in vivo validation in less than six months. Through the collaboration expansion, Recursion will bring this powerful new technology to Bayer in order to accelerate and expand the ongoing work the teams have undertaken together in fibrosis.

Novo Nordisk A/S – Share repurchase programme

On 6 December 2021 Novo Nordisk reported that initiated a share repurchase programme in accordance with Article 5 of Regulation No 596/2014 of the European Parliament and Council of 16 April 2014 (MAR) and the Commission Delegated Regulation (EU) 2016/1052 of 8 March 2016 (the "Safe Harbour Rules") (Press release, Novo Nordisk, DEC 6, 2021, View Source [SID1234596534]). This programme is part of the overall share repurchase programme of up to DKK 20 billion to be executed during a 12-month period beginning 3 February 2021.

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Under the programme initiated 5 November 2021, Novo Nordisk will repurchase B shares for an amount up to DKK 3.7 billion in the period from 11 November 2021 to 1 February 2022.

Since the announcement 29 November 2021, the following transactions have been made:

The details for each transaction made under the share repurchase programme are published on novonordisk.com.

With the transactions stated above, Novo Nordisk owns a total of 29,908,560 B shares of DKK 0.20 as treasury shares, corresponding to 1.3% of the share capital. The total amount of A and B shares in the company is 2,310,000,000 including treasury shares.

Novo Nordisk expects to repurchase B shares for an amount up to DKK 20 billion during a 12- month period beginning 3 February 2021. As of 3 December 2021, Novo Nordisk has since 3 February 2021 repurchased a total of 31,155,009 B shares at an average share price of DKK 563.25 per B share equal to a transaction value of DKK 17,547,995,580.

AIM ImmunoTech CEO to Participate in Two Upcoming Investor Conferences

On December 6, 2021 AIM ImmunoTech Inc. (NYSE American: AIM) reported that Thomas Equels, Chief Executive Officer of AIM, will be participating in two upcoming investor conferences (Press release, AIM ImmunoTech, DEC 6, 2021, View Source [SID1234596532]).

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BioFlorida Conference
Mr. Equels will be participating in the "COVID-19: What’s Next in Prevention, Treatment & Diagnostics" panel taking place on Thursday, December 9, 2021 at 1:45 PM EST during the BioFlorida Conference. He will also be participating in the CEO Forum at 5:30 PM EST.

The BioFlorida conference will consist of a series of roundtable panel discussions that will be moderated by Maulik Shah, MD, PhD, from Applied Ingenuity Diagnostics.

For more information on the BioFlorida Conference, please visit BioFlorida.com or contact [email protected].

Benzinga All-Access Event
Mr. Equels is scheduled to participate on December 16, 2021 at 11:20 AM EST during the Benzinga All Access event. The event will be broadcast live and can be viewed here. An archived recording of the presentation will be available on the investor relations section of the AIM website at View Source

The Benzinga All Access Show is a 2-hour talk-show event where a select number of companies are chosen to give a 20-minute interview to discuss their companies. Benzinga All Access is a first-of-its-kind show: part interview, part investor presentation. On All Access, Benzinga partners with companies to bring you in-depth one-on-one conversations with executives across a wide range of industries and asset classes.

Hummingbird Bioscience Announces First Patient Dosed in Phase 1 Clinical Trial of HMBD-001 in Advanced HER3-Expressing Solid Malignancies

On December 6, 2021 Hummingbird Bioscience, an innovative clinical-stage biotech company focused on developing precision therapies against hard-to-drug targets in cancer and autoimmune disease, and Cancer Research UK, the world’s leading cancer charity, reported that the first patient has been dosed in a Phase 1 clinical trial of HMBD-001 for the treatment of patients with advanced HER3-expressing solid malignancies (NCT05057013) (Press release, Hummingbird Bioscience, DEC 6, 2021, View Source [SID1234596530]).

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The Phase 1 clinical trial in the United Kingdom is being sponsored and managed by Cancer Research UK’s Centre for Drug Development and led by Chief Investigator, Professor Johann De Bono at the Royal Marsden Hospital and The Institute of Cancer Research, London. The trial intends to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and explore preliminary evidence of HMBD-001 activity in patients with advanced HER3-expressing solid malignancies, including NRG1 fusion-driven cancers.

HMBD-001 is the first of Hummingbird Bioscience’s deep pipeline of antibody drug candidates to enter clinical trials. Rationally developed using Hummingbird Bioscience’s proprietary Rational Antibody Discovery (RAD) platform, HMBD-001 is the only reported anti-HER3 antibody in clinical development that uses a highly differentiated mechanism of action designed to block the formation of all active HER3 dimers, regardless of NRG1 ligand binding or HER2/EGFR overexpression.

"Dosing of the first patient in the clinical trial of HMBD-001, Hummingbird’s most advanced program, marks the beginning of a potentially transformative approach to treating HER3-driven cancers," said Dr. Jerome Boyd-Kirkup, Chief Scientific Officer, Hummingbird Bioscience. "I am immensely proud of the teamwork that has brought our differentiated program to this point. Hummingbird Bioscience is dedicated to discovering and developing important medicines for cancer and autoimmune disease with our unique Rational Antibody Discovery platform."

"This significant milestone brings us a step closer to provide a much-needed and highly differentiated therapy for patients with HER3-driven cancers," said Dr. Eric Rowinsky, Chief Medical Officer, Hummingbird Bioscience. "We are pleased to partner with Cancer Research UK for this trial, and we look forward to advancing the clinical development of HMBD-001 for cancer patients."

Dr. Nigel Blackburn, Director of Cancer Research UK’s Centre for Drug Development, said, "We are thrilled to be working with Hummingbird Bioscience to advance its novel drug candidate into clinical trials. Although HER3 was discovered over 30 years ago, no therapies able to block its cancer-promoting action have been approved. Hummingbird Bioscience has taken fresh aim at a difficult drug target and has come up with a novel, potentially transformative antibody for cancer patients who desperately need new treatments."

Initial data from the Phase 1 dose escalation is expected in the second half of 2022.

About HMBD-001

HMBD-001 is a clinical-stage IgG1 antibody designed to target HER3. Discovered using our proprietary RAD platform, HMBD-001 is now in development for the treatment of multiple solid tumors. We believe HMBD-001 is the only anti-HER3 antibody in development that has the potential to fully block both ligand-dependent and independent HER3 activation and oncogenic signaling, by targeting a key epitope located at the interface where HER3 forms heterodimers with HER2 or EGFR, independent of the process leading to such dimerization. In preclinical models evaluating HMBD-001, we have observed superior affinity and more potently inhibited tumor growth compared to other existing anti-HER3 antibodies. Our near-term development plan for HMBD-001 focuses on four priority, high-value indications with strong scientific rationale and supporting preclinical data: NRG1 fusion-driven cancers, metastatic castrate resistant prostate cancer (mCRPC), metastatic colorectal cancer (mCRC), and squamous cell carcinoma of the head and neck (SCCHN).

Carisma Therapeutics Announces Collaboration with Merck to Evaluate CAR-Macrophages in Combination with KEYTRUDA® (pembrolizumab) in a Clinical Study

On December 6, 2021 Carisma Therapeutics., a clinical stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, reported that it has entered into a clinical study collaboration with Merck (known as MSD outside the US and Canada) to evaluate their proprietary targeted chimeric antigen receptor macrophages (CAR-M) in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) for the treatment of human epidermal growth factor receptor 2 (HER2) overexpressing cancers (Press release, Carisma Therapeutics, DEC 6, 2021, View Source [SID1234596529]).

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Based on pre-clinical findings outlined in Human chimeric antigen receptor macrophages for cancer immunotherapy, Carisma’s novel CAR-M platform has the potential ability to reprogram the solid tumor microenvironment, leading to immune activation, T cell recruitment, and anti-tumor adaptive immunity.

"The mechanisms of action behind CT-0508 and KEYTRUDA suggest they may be complementary and could help to drive meaningful clinical benefits in patients with HER2 positive cancers, where a high unmet medical need exists," said Steven Kelly, President and Chief Executive Officer at Carisma Therapeutics. "We are extremely pleased to enter into this collaboration with Merck and further expand the potential of macrophage-based cell therapy."

This collaboration announcement comes on the heels of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 36th Anniversary Annual Meeting where lead investigators shared early data from the landmark Phase 1 multi-center clinical trial of CT-0508, a human epidermal growth factor receptor 2 (HER2) targeted CAR-M. The preliminary findings represent the first clinical data with genetically engineered macrophages in humans and demonstrated that CT-0508 was well tolerated after infusion and there were no dose limiting toxicities; data show the immunotherapy was successfully manufactured using macrophages obtained from heavily pre-treated, advanced solid tumor patients and showed high CAR expression, viability, and purity; and that the administered therapy remodeled the tumor microenvironment and mediated expansion/activation of T cells within the tumors.

Additional pre-clinical data generated by Carisma has shown the potential additive benefit of CAR-M in combination with PD-1 blockade in solid tumor models that are resistant to anti-PD-1 monotherapy.

The landmark CT-0508 clinical trial remains open for enrollment and the U.S. Food and Drug Administration recently granted Fast Track designation to CT-0508 for the treatment of patients with solid tumors. The clinical study evaluating CAR-M in combination with KEYTRUDA (pembrolizumab) is expected to launch in 2022.

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