On February 10, 2021 Targovax ASA (OSE: TRVX), a clinical stage immuno-oncology company developing immune activators to target hard-to-treat solid tumors, reported that it has entered into a research collaboration agreement with Papyrus Therapeutics to assess the potential of combining their respective proprietary technology platforms to develop a first-in-class oncolytic virus concept with RTK inhibitor functionality (Press release, Targovax, FEB 10, 2021, View Source [SID1234574815]).

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On February 9, 2021 Bolt Biotherapeutics, Inc. (Nasdaq: BOLT), a clinical-stage immuno-oncology company, reported the closing of its initial public offering of 13,225,000 shares of its common stock, inclusive of the full exercise by the underwriters of their option to purchase 1,725,000 shares of common stock, at a price to the public of $20.00 per share (Press release, Bolt Biotherapeutics, FEB 9, 2021, View Source [SID1234618698]). The shares are listed for trading on The Nasdaq Global Select Market under the ticker symbol "BOLT".

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Morgan Stanley, SVB Leerink, Stifel and Guggenheim Securities acted as joint bookrunners for the offering.

The offering was made only by means of a prospectus. Copies of the final prospectus relating to the offering may be obtained from Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014, or by email at [email protected]; or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, or by telephone at (800) 808-7525, ext. 6105 or by email at [email protected].

Registration statements relating to these securities have been filed with, and declared effective by, the Securities and Exchange Commission. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On February 9, 2021 Arla Foods Ingredients Group P/S (Arla), a subsidiary of Arla Foods amba, and drug formulation company Zerion ApS (ZERION) reported that they have entered into an agreement covering the supply of Arla’s novel and very pure ingredient Lacprodan BLG that is produced through a patented new technology (Press release, Zerion, FEB 9, 2021, View Source [SID1234598618]). ZERION utilises this highly purified protein as a critical component in its patented Dispersome technology that enables poorly soluble drugs to reach their true therapeutic potential. The agreement marks an important milestone in a year long collaboration between the two companies.

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"Since 2018, we have evaluated a range of protein excipients with our Dispersome technology and among those, Arla’s Lacprodan BLG has consistently demonstrated an impressive solubility enhancement of many small molecule drug compounds", explains ZERION’s Chief Scientific Officer, Dr. Korbinian Löbmann. "As an integral part of the drug evaluation and approval for the Dispersome formulations, the protein will undergo regulatory assessment by FDA and EMA as a novel pharmaceutical excipient. It is therefore of utmost importance for us to source a protein of the highest quality and purity. Here, we have been very fortunate to work with Arla and to identify Lacprodan BLG for our applications."

The agreement between Arla and ZERION sets forth the intention of the parties to complete a full license and supply agreement. Under the final long-term supply agreement, Arla will supply Lacprodan BLG for use as a pharmaceutical excipient to ZERION.

"The agreement with Arla confirms our excellent collaboration and represents an important step forward for ZERION to secure the long-term supply of Lacprodan BLG as an enabling excipient for our Dispersome technology", says Ole Wiborg, CEO of ZERION. "We are grateful for the support and willingness to explore novel pharmaceutical applications from Arla. We are confident that Lacprodan BLG can play a pivotal role as a novel excipient in our Dispersome technology to enable novel drugs and enhance the quality and the safety of medicines for patients."

Poor drug solubility is a major problem for the pharma industry
ZERION is a pharmaceutical development company specialised in improving the bioavailability of oral drug products by increasing their solubility. The company has pioneered the patented Dispersome formulation technology that enables poorly soluble drugs to reach their true therapeutic potential. Poor drug solubility is one of the biggest challenges hampering the commercial development of novel small molecule drugs. Approximately 90% of all oral drugs in pharmaceutical pipelines do not sufficiently dissolve in the gastrointestinal tract and therefore cannot be absorbed into the circulation and exert their therapeutic effect. Many otherwise promising drug candidates are thus discontinued during early-stage development due to poor bioavailability.

The Dispersome platform technology
The Dispersome technology uses Lacprodan BLG, a patented high quality whey protein, and environmentally friendly by-product from cheese production, to disrupt the drug crystal structure. A unique amorphous composition is formed from the mixture of Lacprodan BLG and drug molecules resulting in improved drug solubility and bioavailability. The technology enables lowering of the drug dose, resulting in fewer and smaller tablets enhancing patient compliance as well as minimising any side effects. Dispersome formulations can be produced using standard pharmaceutical equipment.

In addition to its internal product portfolio, ZERION is collaborating with established pharmaceutical companies to assist them in optimising the therapeutic performance of their drug compounds.

On January 27, 2021 PDX Pharmaceuticals, a privately held company developing first-in-class nanotechnology-based therapies for treating cancer, reported that it received a second round of Series A funding in the amount of $2 million from the Kuni Foundation (Press release, PDX Pharmaceuticals, FEB 9, 2021, View Source [SID1234578143]).

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PDX Pharmaceuticals, a startup that originated in the Biomedical Engineering Department of Oregon Health & Science University (OHSU) in collaboration with the Knight Cancer Institute, has developed a new class of therapeutics based on co-delivery of siRNA and drugs on immuno-nanoparticles. The OHSU Knight Cancer Center is the only National Cancer Institute (NCI) Comprehensive Cancer Center between Sacramento and Seattle, an honor earned only by the nation’s top cancer centers.

PDX’s CEO and Founder, Wassana Yantasee, PhD commented: "My team and I are excited to embark on this next phase of our clinical development initiatives with the intention of vastly improving the efficacy of currently approved cancer therapies, overcoming drug resistance to targeted therapies, and triggering antitumor immunity in cancer patients. We are truly fortunate to have the strategic and financial backing of the Kuni Foundation, contributing invaluable leadership and financial support to PDX as we continue to execute our mission of developing and commercializing next-generation, highly-effective therapies in oncology."

PDX Pharmaceuticals is conducting Investigational New Drug (IND) enabling studies of its first drug candidate, AIRISE, a novel intra-tumoral immunotherapy injected into solid tumors such as melanoma, breast, colorectal and head and neck cancer. AIRISE utilizes tumor antigens "in situ" to generate anti-tumor immune effects to attack cancer cells anywhere in the body, including metastatic cancer. One of PDX’s key priorities is to study the effect of adding its nano-based AIRISE to FDA-approved immune checkpoint inhibitors (ICIs). ICIs currently do not work in many patients due to the lack of existing anti-tumor immune cells and immunosuppression in tumors, and AIRISE overcomes these limitations. The addition of AIRISE to widely prescribed immune checkpoint inhibitor therapies has shown a profound increase in tumor killing activity and cure rates in preclinical studies, and PDX expects that its clinical studies will demonstrate this similar performance in humans.

Dr. Yantasee and her team have raised more than $11 million of growth financing and support from organizations including the National Institutes of Health. The nanoparticle technology was jointly developed with Oregon Health & Science University, funded by the Knight Cancer Institute, Prospect Creek Foundation, Hillcrest Committee, OHSU Center for Women’s Health Circle of Giving and the Kuni Foundation. This most recent round of funding from the Kuni Foundation will propel the research to further advance the company’s compelling scientific findings to date.

"This next round of investment underscores our excitement regarding the progress Wassana and her team have made and our confidence in the potential of this approach," said Greg Goodwin, Board Chair of the Kuni Foundation. "This is an example of the kind of innovative thinking that will lead to better outcomes for cancer patients, while also improving accessibility and affordability."

On February 9, 2021 Herantis Pharma Plc ("Herantis"), an innovative clinical stage biotech company pioneering new disease modifying and regenerative biologic and gene therapies, reported that they have entered into a Biologics Proof of Concept Agreement with Nanoform Finland Plc, an innovative nanoparticle medicine enabling company (Press release, Herantis Pharma, FEB 9, 2021, https://news.cision.com/herantis-pharma-oyj/r/herantis-pharma-and-nanoform-enter-into-agreement-for-proof-of-concept-collaboration,c3282448 [SID1234577510]). The collaboration provides for formulation Proof of Concept studies (PoCs) to combine Herantis’ intranasally administered CDNF therapy for Parkinson’s disease, with Nanoform nanoparticle technology.

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Following completion of the Phase I study with CDNF in Parkinson’s Disease (PD) in August 2020, the Company announced that moving forward it would focus on additional administration routes not requiring invasive surgery, such as intranasal administration. This strategy is intended to target earlier stage patients, accelerate development timelines, and expedite potential partnering transactions. In parallel to the Company’s ongoing intranasal program for CDNF, the Nanoform project will also separately assess possible enhancement of intranasal drug delivery to the brain of CDNF therapy for Parkinson’s Disease using Nanoform’s proprietary biological nanoparticle technology. This collaboration will compliment Herantis’ current development program on additional administration routes for CDNF. Under the agreement, Nanoform will undertake up to two proof of concept studies with Herantis’ CDNF molecules.

"CDNF is now one of a few clinical stage assets in development with the potential for disease modification of Parkinson’s Disease. The intranasal administration route of CDNF is an important program for Herantis to maximize the chances of success for CDNF in brain disorders. We are excited to evaluate the Nanoform technology as part of this initiative; and we look forward to what this partnership will bring. It is our hope that this collaboration will shine a light on new possibilities to improve the lives of patients with Parkinson’s and other related diseases," said Dr. Craig Cook, CEO, Herantis Pharma.

"We are delighted to finalize this collaborative Agreement with Herantis and initiate our partnership together. Brain delivery for biologicals and small molecules is an immensely challenging route of administration and we firmly believe nanoparticles have a significant role to play in enhancing and hopefully enabling this. We are excited with the prospect of exploring how our nanoparticles can potentially enable drug delivery opportunities and solve challenges in this space," said Christian Jones, Chief Commercial Officer of Nanoform.