LifeMine Therapeutics and GSK Enter Drug Discovery and Development Alliance

On March 23, 2022 LifeMine Therapeutics Inc., a biopharmaceutical company reinventing drug discovery by mining genetically-encoded small molecules (GEMs) from the biosphere, reported a strategic R&D collaboration with GlaxoSmithKline (GSK) (Press release, GlaxoSmithKline, MAR 23, 2022, View Source [SID1234610676]). The collaboration will provide GSK with access to LifeMine’s genomically enabled drug discovery platform to identify novel small molecule leads directed to up to three human targets provided by GSK addressing multiple disease areas.

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Under the terms of the collaboration, LifeMine will receive an upfront payment of $70 million that includes both cash and an equity investment by GSK in LifeMine in its Series C round of financing. In addition, LifeMine is eligible to receive undisclosed discovery, development and commercial milestone payments for each collaboration product. LifeMine will be also eligible to receive royalties on net sales of any drug from the collaboration that is commercialized by GSK. LifeMine and GSK will collaborate closely on the discovery process, with each company leveraging its core capabilities and equally sharing costs to IND filing. GSK will be responsible for all development and commercialization.

"This is a transformative collaboration for LifeMine, and marks the first such agreement in genomic drug discovery from fungi, nature’s virtuoso medicinal chemists," said Gregory Verdine, Ph.D., co-founder, chief executive officer and chief scientific officer of LifeMine. "We are thrilled to partner with GSK to expand the potential of our drug discovery engine while we continue to advance our own lead programs. We look forward to a productive partnership which we are confident will result in novel therapeutic options for patients."

LifeMine aims to bring unparalleled speed, predictability and scalability to small-molecule drug discovery, offering the potential to rapidly advance multiple high-impact precision medicines to solve intractable disease challenges, irrespective of therapeutic area. LifeMine’s Avatar-Rx platform seamlessly integrates high-throughput microbiology, data science and machine learning, genome engineering and automation technologies to search the fungal biosphere for novel GEMs having a predetermined target and biological function. Downstream of GEM discovery, LifeMine’s platform further integrates chemoinformatic-assisted drug optimization and state-of-the art chemical synthesis with biotransformation to advance new product candidates into development.

"GSK’s drug discovery approach focuses on advanced technologies, including human genetics, functional genomics and machine learning to increase our probability of success," said John Lepore, SVP, Head of Research, GSK. "This approach leads to genetically validated targets that are twice as likely to succeed as medicines, but due to their novelty often require innovation to unlock their potential. We are looking forward to teaming up with LifeMine to use their cutting-edge platform, so together we can identify what nature might have already created as chemistry starting points to increase our chances of developing transformational new drugs for patients."

AIM ImmunoTech to Participate in the 2022 Virtual Growth Conference Presented by Maxim Group LLC and Hosted by M-Vest

On March 23, 2022 AIM ImmunoTech Inc. (NYSE: American AIM) ("AIM" or the "Company"), an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus, reported Thomas Equels, Chief Executive Officer of AIM, will participate at the 2022 Virtual Growth Conference presented by Maxim Group LLC and hosted by M-Vest, taking place March 28-30, 2022 (Press release, AIM ImmunoTech, MAR 23, 2022, View Source [SID1234610675]).

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In addition to the Company’s corporate presentation available on demand for registered attendees, Mr. Equels will participate in the "Pancreatic Cancer: Turning the Tide for One of the Most Challenging Indications in Oncology" panel on Monday, March 28th at 12:00 PM ET.

During this virtual conference, investors will hear from executives from a wide range of sectors including Biotech, Clean Energy, Electric Vehicles, Financial Services, Fintech & REITS, Gaming & Entertainment, Healthcare, Healthcare IT, Infrastructure, Shipping and Technology/ Media/Telecom. The conference will feature company presentations, fireside chats, roundtable discussions, and live Q&A with CEOs moderated by Maxim Research Analysts.

This conference will be live on M-Vest. To attend, just sign up to become an M-Vest member.

Alligator Bioscience Announces mitazalimab OPTIMIZE-1 Trial Update: Successful Completion of Phase Ib, Phase II enrolling at 900 µg/kg

On March 23, 2022 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported an update on the ongoing OPTIMIZE-1 clinical Phase Ib/II trial in first-line metastatic pancreatic cancer with the company’s lead asset, mitazalimab (Press release, Alligator Bioscience, MAR 23, 2022, View Source [SID1234610658]). Safety evaluation of the second dose-escalation cohort (900 µg/kg of mitazalimab in combination with mFOLFIRINOX) has concluded, which marks the successful completion of the Phase Ib part of the study. The Data Review Committee has declared the 900 µg/kg mitazalimab dose to be safe and recommended that the dosing level should be continued for the Phase II study. Enrollment for the Phase II has begun and is ongoing at sites in Europe (NCT04888312).

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OPTIMIZE-1, an open-label, multi-center Phase Ib/II study is assessing the safety and efficacy of mitazalimab in combination with chemotherapy, mFOLFIRINOX, in patients with metastatic pancreatic ductal adenocarcinoma. First patient was dosed in Q3 2021 (press release). The study’s design utilizes mitazalimab’s differentiated efficacy and tolerability profile, allowing administration of higher and more frequent doses. This increases the likelihood of demonstrating clinical benefit to patients as a potential first-line treatment for metastatic pancreatic cancer in combination with mFOLFIRINOX.

The interim efficacy readout for OPTIMIZE-1 is expected to be announced in Q4 2022.

"I am happy to report that mitazalimab is safe and tolerable at the highest dose tested in OPTIMIZE-1, especially in combination with chemotherapy like mFOLFIRINOX. This allows us to continue on to the Phase II of OPTIMIZE-1, dosing at 900 µg/kg," comments Søren Bregenholt, CEO of Alligator Bioscience. "We continue to enroll patients as projected and make great progress towards the efficacy read-out planned for later this year."

4D pharma Announces Positive Interim Results from the Phase I/II Study of the Combination of MRx0518 and KEYTRUDA® (pembrolizumab) for the Treatment of Renal Cell Carcinoma

On March 23, 2022 4D pharma plc (AIM: DDDD, NASDAQ: LBPS), a pharmaceutical company leading the development of Live Biotherapeutic products (LBPs), a novel class of drug derived from the microbiome, reported that in Part B of its signal finding study of MRx0518 in combination with MSD’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) in patients with solid tumors that have progressed on a prior immune checkpoint inhibitor (ICI), the renal cell carcinoma (RCC) group has met its primary efficacy endpoint ahead of enrollment completion (Press release, 4d Pharma, MAR 23, 2022, View Source [SID1234610651]).

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The ongoing study is being conducted in heavily pre-treated metastatic patients with solid tumors who have previously experienced clinical benefit on prior ICI therapy and subsequently developed progressive disease. The study is being conducted in collaboration with MSD (Merck & Co., Inc., Kenilworth, NJ, USA). The primary efficacy endpoint for Part B of the study is more than three out of 30 patients per tumor group achieving clinical benefit, defined as complete response, partial response, or stable disease for at least six months.

Part B of the study has to date enrolled 20 patients with RCC, of which four out of the first 16 evaluable patients have achieved clinical benefit, each having achieved at least 6 months of stable disease. To date, Part B of the study has enrolled 47 patients of up to a total of 120 patients with RCC, non-small cell lung cancer, bladder cancer, and head and neck squamous cell carcinoma. MRx0518 continues to be safe and well tolerated.

"Today’s results in renal cell carcinoma, meeting the predefined primary efficacy endpoint early in this difficult to treat population, marks another important step forward for MRx0518 and the increasing importance of the microbiome in cancer treatment," commented Dr. Alex Stevenson, Chief Scientific Officer, 4D pharma. "Meeting the primary efficacy endpoint for this group is crucial for the future development of MRx0518, and these data are highly informative for our strategy going forward as we determine next steps in RCC."
4D pharma intends to discuss next steps with partners and its Genitourinary Cancers Advisory Board regarding the development path of MRx0518 and a potentially pivotal study in patients with ICI-refractory RCC. 4D pharma will continue to recruit patients into the ongoing study of MRx0518 and Keytruda in RCC and the three tumor groups, with potential expansion into other types of ICI resistance.

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

Conference Call & Webcast Information

4D pharma will host a conference call and live webcast on Wednesday, March 23, 2022, at 10:00 am ET (2:00 pm GMT) to discuss the interim results of the Phase I/II study of the combination of MRx0518 and Keytruda for the treatment of renal cell carcinoma.

4D pharma management will be joined by key opinion leaders (KOLs) Dr. Petros Grivas, Associate Professor Clinical Research Division at the Fred Hutchinson Cancer Research Center, and Dr. Scott T. Tagawa, Professor of Medicine and Urology at Weill Cornell Medicine, both members of the 4D pharma’s Genitourinary Cancers Advisory Board.

To access the live webcast, please visit the ‘Events’ section of the 4D pharma website. To access audio only, please dial (866) 939-3921 (United States) and (678) 302-3550 (International) and reference Confirmation Number 50287940. A replay of the webcast and accompanying slides will be available on the 4D pharma website following the event.

Jacobio Pharmaceuticals 2021 Annual Results

On March 22, 2022 Jacobio Pharmaceuticals reported its 2021 Annual Results (Presentation, Jacobio Pharmaceuticals, MAR 22, 2022, View Source [SID1234644969]).

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