On September 17, 2021 Immix Biopharma, a Phase 1b/2a biotech developing tissue-specific therapies for solid tumors, reported that it filed on Friday with the SEC to raise up to $25 million in an initial public offering (Press release, Immix Biopharma, SEP 17, 2021, View Source [SID1234587965]).

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Immix is developing a novel class of Tissue-Specific Therapeutics ("TSTx") in oncology and inflammation. Its lead asset, IMX-110, is a negatively-charged TSTx that simultaneously disables resistance pathways with a poly-kinase inhibitor and induces tumor cell death with an apoptosis inducer. IMX-110 is currently in Phase 1b/2a trials for solid tumors in the US and Australia.

The Los Angeles, CA-based company was founded in 2012 and plans to list on the Nasdaq under the symbol IMMX. Immix Biopharma filed confidentially on July 20, 2021. ThinkEquity is the sole bookrunner on the deal. No pricing terms were disclosed.

On September 17, 2021 Celsion Corporation (NASDAQ: CLSN), a clinical-stage company focused on DNA-based immunotherapy and next-generation vaccines, and Hainan Poly Pharm Co. Ltd. (Shenzhen Stock Exchange 300630.SZ), a generics manufacturer dedicated to providing therapeutic-value products and services to patients and customers around the world, reported an amendment to their existing contract manufacturing agreement to include development work for Celsion’s investigational DNA-based COVID-19 vaccine (Press release, Celsion, SEP 17, 2021, View Source [SID1234590266]). Under the terms of the amended agreement, Poly Pharm will manufacture clinical batches and, if approved for use, will also manufacture commercial batches for Celsion’s vaccine based on its TheraPlas technology. TheraPlas underlies Celsion’s GEN-1 product and its PLACCINE vaccine technology platform.

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Poly Pharm is experienced with chemistry, manufacturing and controls (CMC), process development and good manufacturing processes (cGMP), including process optimization and manufacturing services to help customers advance new drug development projects. Its sites and pharmaceutical compounds have been approved by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), China’s National Medical Products Administration (NMPA) and the World Health Organization (WHO).

Madame Fang, chief executive officer of Hainan Poly Pharm said, "Poly Pharm is a fully-integrated specialty pharmaceutical company with rich CDMO experience. Poly Pharm and Celsion have a successful cooperation on GEN-1 and have been successfully manufacturing clinical batches of GEN-1 to support Celsion’s OVATION 2 Study in advanced ovarian cancer. The GEN-1 collaboration and the DNA-based COVID-19 vaccine program demonstrate our expertise in highly cost-effective manufacturing of nucleic acid based finished drugs. We are glad that a DNA-based vaccine can be our second cooperative project. Celsion’s DNA vaccine technology platform is a promising platform as it may address global vaccine storage and distribution needs. We are pleased that Celsion has recognized Poly Pharm’s skills and dependability, especially with difficult-to-manufacture products, and we are looking forward to helping address the global COVID-19 pandemic."

Commenting on the agreement, Michael Tardugno, chairman, president and chief executive officer of Celsion said, "This is the second plasmid DNA-based investigational new drug project with Hainan Poly Pharm. Our first collaboration is GEN-1, which incorporates a DNA plasmid encoding IL-12 into a unique nanoparticle delivery system. GEN-1 immunotherapy is being evaluated in the Phase I/II OVATION 2 Study in combination with chemotherapy for patients with newly diagnosed advanced ovarian cancer. We have enjoyed a productive working relationship with Poly Pharm delivering quality product efficiently and are delighted to expand our contract manufacturing agreement with them."

About the PLACCINE platform

PLACCINE is Celsion’s proprietary plasmid and DNA delivery technology and the subject of a provisional patent application that covers a broad range of next-generation DNA vaccines. An adaptation of the Company’s TheraPlas technology, PLACCINE is a DNA vaccine technology platform characterized by a single plasmid DNA with multiple coding regions. The plasmid vector is designed to express multiple pathogen antigens along with a potent immune modifier. It is delivered via a synthetic delivery system and has the potential to be easily modified to create vaccines against a multitude of infectious diseases, addressing:

Viral Mutations: PLACCINE may offer broad-spectrum and mutational resistance (variants) by targeting multiple antigens on a single plasmid vector.
Enhanced Efficacy: The potent immune modifiers such as cytokines and chemokines may improve humoral and cellular responses to viral antigens and can be incorporated in the plasmid.
Durable Efficacy: PLACCINE delivers a DNA plasmid-based antigen that can result in durable antigen exposure and a robust vaccine response to viral antigens.
Storage & Distribution: PLACCINE allows for stability that is compatible with manageable vaccine storage and distribution.
Dosing & Administration: PLACCINE is a synthetic delivery system that should require a simple injection that does not require viruses or special equipment to deliver its payload.

On September 17, 2021 TILT Biotherapeutics, a clinical-stage biotechnology company developing cancer immunotherapeutics, reported that the company presented yesterday clinical study results at the annual congress of the European Society of Molecular Oncology (ESMO) (Free ESMO Whitepaper) (Press release, TILT Biotherapeutics, SEP 17, 2021, View Source [SID1234587847]).

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The ESMO (Free ESMO Whitepaper) poster (1), presented by TILT with collaborators at the National Center for Cancer Immune Therapy Herlev Hospital, Copenhagen University, and CHU Nantes, provided an update on the company’s progress with its TILT-123 oncolytic immunotherapy asset designed to stimulate T-cells, currently in clinical trials in Denmark and France for metastatic melanoma.

Interim data from six patients shows that TILT-123 monotherapy or a combination of TILT-123 and tumor-infiltrating lymphocytes (TILs) is deemed safe with the lowest two dose levels of TILT-123. Also, the company’s engineered oncolytic virus appears to be highly tumor specific, as extended replication in tumors was seen even at the lowest dose level, without quantifiable shedding into saliva or urine.

TILT Biotherapeutics’ CEO, Akseli Hemminki, a biotech entrepreneur and oncologist who has personally treated 300 patients with eleven different oncolytic viruses, said, "The annual ESMO (Free ESMO Whitepaper) congress is one of the world’s most prestigious oncology events, and I am delighted we were able to present there about recent progress with our oncolytic immunotherapy platform. We have now proceeded to the third dose level in our T215 and T115 trials, with patients in France, Denmark, and Finland."

(1) Poster title and link: "A phase I, first-in-human, study of TILT-123, a tumor-selective oncolytic adenovirus encoding TNFa and IL-2, in participants with advanced melanoma receiving adoptive T-cell therapy with tumor-infiltrating lymphocytes." The clinical trial details are here.

On September 17, 2021 Enveric Biosciences (NASDAQ: ENVB) ("Enveric" or the "Company"), a patient-centric biotechnology company developing novel cannabinoid medicines to improve quality of life for cancer patients, reported the closing of its acquisition of MagicMed Industries Inc. ("MagicMed"), a privately-held biotechnology company focused on creating a library of novel derivative psychedelic molecules such as psilocybin, N,N-dimethyltryptamine (DMT) and other molecular derivatives with applications across multiple indications, in an all-stock transaction (Press release, Enveric Biosciences, SEP 17, 2021, View Source [SID1234587880]).

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With the closing, Enveric intends to expand into a next-generation neuroscience drug discovery platform of novel psychedelics that addresses the large unmet mental health challenges related to CNS indications such as Cancer Related Distress, PTSD, anxiety, depression and pain. Complemented by its existing drug development for both the mind and body, the Company is focused on building a pipeline of novel and proprietary psychedelic assets through its disruptive discovery platform, the Psybrary.

The Company has appointed Dr. Joseph Tucker, PhD, former CEO of MagicMed, as CEO of Enveric, and David Johnson, former CEO of Enveric, as Executive Chairman.

"Enveric is a biotechnology company with the platform to create intellectual property for the next generation of mental health treatments to fight a global crisis. With both psychedelic derived molecules and cannabinoids, we have a robust pipeline to take us from discovery through clinical development. Our platform has the potential to disrupt and unlock much needed mental health treatments through psychedelic therapies," commented Dr. Joseph Tucker, incoming CEO of Enveric. "We have brought together pharma and biotech experts with years of experience in bringing innovative treatments to market as well as a discovery team with a world-class biotech laboratory. We are dedicated to our mission to advance the next generation of treatments and look forward to keeping the investment community apprised of our progress."

"It is my pleasure to welcome Dr. Tucker as Chief Executive Officer of Enveric. From the onset of meeting Dr. Tucker and the MagicMed team, I have been impressed by what they have accomplished, most notably their library of Intellectual Property for Next Generation psychedelic molecules. These assets combined with our existing Enveric pipeline opens the door for multiple treatment opportunities to a large patient population," said David Johnson, Executive Chairman of Enveric. "I look forward to working closely with the leadership team, as we navigate the exciting prospects in Enveric’s robust pipeline of assets."

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Transaction Details

The transaction is structured as an amalgamation under the Business Corporations Act (British Columbia). At the closing, a recently formed subsidiary of Enveric amalgamated with MagicMed, with the resulting corporation being an indirect wholly owned subsidiary of Enveric. Under the terms of the amalgamation agreement and other related agreements, Enveric issued the shareholders of MagicMed an aggregate of 9,951,237 shares of common stock of Enveric. Following the amalgamation, existing Enveric shareholders own approximately 68.3% of the combined company’s common stock and previous MagicMed shareholders own approximately 31.7% of the combined company’s common stock. Additionally, as part of the closing of the transaction, Enveric received approximately $4 million (CAD) in cash from the MagicMed Treasury.

On September 17, 2021 PulseCath B.V., a leader in the expanding field of percutaneous ventricular assist devices for high-risk PCI, and Huadong Medicine Co., Ltd., reported that the companies have entered into an exclusive collaboration to develop and commercialize the iVAC technology in mainland China, Hong Kong, Macau and Taiwan (Greater China) and selected other Asian Pacific countries (Press release, Huadong Medicine, SEP 17, 2021, View Source [SID1234587915]).

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The collaboration agreement between PulseCath and Huadong provides Huadong Medicine with a license to distribute iVAC technology in mainland China, Hong Kong, Macau and Taiwan (Greater China) and selected other Asian Pacific countries as well as for local manufacturing and development. PulseCath will retain all rights in the rest of the world.

"With extensive regional experience, the right development and regulatory capabilities, and access to a deep local network of hospitals and clinics across Greater China, Huadong Medicine is an ideal partner for us," said Oren Malchin, PulseCath’s Vice President for Marketing and Sales. "This collaboration reflects iVAC pulsatile technology’s potential to deliver meaningful value to high-risk PCI patients as well as our ability to translate our work in cardiac assist devices into long-term relationships that create sustainable value for PulseCath and our partners. We look forward to working closely with Huadong Medicine to develop and commercialize the iVAC technology in Greater China as we continue to advance the iVAC product family, develop new products, conduct further clinical studies and support our application for FDA approval, which we expect for 2022 in the United States.

Under the terms of the agreement, PulseCath will receive a significant investment in the company’s share capital and is eligible to receive a further investment as a result of potential development and regulatory milestones. In addition, PulseCath will receive a payment for regulatory activities and production in China dedicated to Greater China and selected other Asian Pacific countries. PulseCath is also eligible to royalties on iVAC’s commercial sales by Huadong Medicine in their commercial region.

Huadong Medicine will be responsible for the development as well as regulatory submissions and commercialization of iVAC in Greater China and selected other Asian Pacific countries. Huadong Medicine will also have the opportunity to participate in global clinical studies of PulseCath conducted by PulseCath. PulseCath will continue to be responsible for the development and commercialization of iVAC in Europe, the United States, and other geographies.