On March 18, 2021 Xspray Pharma reported an update on the upcoming pivotal study with its improved version of Sprycel (dasatinib), based on the company’s HyNap-Dasa formulation (Press release, Xspray, MAR 18, 2021, View Source [SID1234650109]). The study has been initiated and the dosing for the bioequivalence study will start in the second quarter with the aim to submit an application for market approval in accordance with the 505(b)(2) procedure in the second half of 2021.

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In parallel with its development of generic protein kinase inhibitors (PKIs) based on the company’s amorphous technology platform, Xspray Pharma also develops improved versions of the original pharmaceutical agents. The overall strategy for HyNap-Dasa is unchanged and based on fastest possible route to market for;

a generic (ANDA) HyNap-Dasa version of Sprycel during the patent window
an improved (505(b)(2)) HyNap-Dasa version of Sprycel with relevant medical benefits
The improved version of Sprycel is designed to offer patients suffering from acute lymphocytic leukemia (ALL) and chronic myeloid leukemia (CML) an improved quality of life by enabling treatment with protein pump inhibitors, PPIs (omeprazole), together with the life-saving treatment with dasatinib. This improved version is also designed to overcome the issue with patients with low or no uptake as demonstrated for Sprycel in earlier bioequivalence studies. The improved version will also be administrated at a significantly lower strength compared to Sprycel and reduce variability. With these improvements HyNap-Dasa will offer meaningful medical benefits for patients and caregivers.

"Almost a third of the patient population has a need for PPIs. I hope that this improved version will offer them a treatment where you can treat cancer and for example ulcer at the same time. We will use the same formulation of HyNap-Dasa as was used in the bioequivalence studies that we ran in 2020 but giving a lower strength of HyNap-Dasa compared to Sprycel. Since we have already tested the formulation in healthy volunteers it is a de-risked study without significantly affecting our financial situation. We have a very robust set of pharmacokinetic data supporting the design of this study which reduces the risk considerably.", says Per Andersson, CEO Xspray Pharma.

The pivotal bioequivalence study aims to demonstrate that Xspray Pharma’s improved version can be administrated using significantly lower strength compared to the original drug and still obtain the same bioavailability. Previous studies with this formulation have already showed no food interaction and no drug-drug interaction with PPI, omeprazole.

"With our multiple pathway strategy, we are now in parallel developing both an improved and a generic version. Thereby we will be able to challenge the original product’s market position and create substantial value for the company and its shareholders. Our clinical work on the generic version of dasatinib continues according to plan. We are currently running a bioequivalence study with a slightly modified formulation and we expect data from this study in April. As a risk mitigating strategy, we are prepared to start studies with an additional formulation that has shown encouraging data in laboratory tests," concludes Per Andersson.

In 2020 Sprycel sold worldwide for USD 2,140 million of which USD 1,295 million was in the US. Xspray Pharma is aiming for market approval for the improved version of dasatinib in US, Europe, and all other major markets.

On March 18, 2021 Swedish-based Newbury Pharmaceuticals AB, a hybrid pharmaceutical company for specialty prescription drugs, innovation and brands, has successfully completed its Series A funding round of 25 MSEK (Press release, Newbury Pharmaceuticals, MAR 18, 2021, View Source [SID1234632241]).

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The oversubscribed Series A financing brings 25 MSEK from selected strategic investors. Proceeds from the funding round will support to continue building a pipeline of proprietary and licensed products. The portfolio strategy includes niche and value-added small molecules, product development based on peptide technology as well as biosimilars in a variety of therapeutic categories.

"We have the ambition to become the local champion and alternative partner to the multinationals. We strive to have a positive impact in the society, bring products and technology that contribute to the overall healthcare system and patient’s wellbeing – and give our partner the local attention they deserve" says Karl Karlsson, Founder & CEO.

On March 18, 2021 Shanghai Fosun Pharmaceutical (Group) Co., Ltd. ("Fosun Pharma"; stock code: 600196.SH; 02196.HK) reported that its subsidiary YaoPharma Co., Ltd. ("YaoPharma") had recently received the approval from the NMPA regarding the clinical trial for the YP01001 capsules (the "Investigational New Drug") for the treatment of advanced solid tumors (Press release, Fosun Pharma, MAR 18, 2021, View Source [SID1234626451]).

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The Investigational New Drug is an innovative small molecule chemical drug intended for the treatment of advanced solid tumors (including, among others, liver cancer and gastric cancer). YaoPharma plans to conduct Phase I clinical trial for the Investigational New Drug in China (excluding Hong Kong, Macao and Taiwan) recently after the conditions are available.

As of February 2021, Fosun Pharma has invested about RMB 33.66 million (unaudited) in the R&D of the Investigational New Drug at this stage.

Driven by innovation and R&D, Fosun Pharma continuously improves its drug R&D system based on the combination of generic and innovator drugs and builds international R&D platforms for small molecule innovator drugs, high-cost generic drugs, biologics and new technology-based therapies, etc.

In the future, the Company will continue to focus on clinical demands, increase its investment in R&D and improve innovation efficiency, so as to bring high-quality and affordable innovator drugs to patients.

On March 18, 2021 Instil Bio, Inc. ("Instil"), a clinical-stage biopharmaceutical company focused on developing an innovative cell therapy pipeline of autologous TIL therapies for the treatment of patients with cancer, reported the pricing of its upsized initial public offering of 16,000,000 shares of common stock at a price to the public of $20.00 per share (Press release, Instil Bio, MAR 18, 2021, View Source [SID1234583988]). The gross proceeds of the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Instil, are expected to be $320.0 million, excluding any exercise of the underwriters’ option to purchase additional shares.

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The shares are expected to begin trading on the Nasdaq Global Select Market under the symbol "TIL" on March 19, 2021, and the offering is expected to close on March 23, 2021, subject to customary closing conditions. In addition, Instil has granted the underwriters a 30-day option to purchase up to 2,400,000 additional shares of common stock at the initial public offering price less underwriting discounts and commissions.

Morgan Stanley, Jefferies and Cowen are acting as joint book-running managers for the offering. Truist Securities is acting as lead manager for the offering.

The offering is being made only by means of a prospectus. A copy of the final prospectus, when available, 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]; Jefferies, LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022 or by emailing [email protected]; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, Attention: Prospectus Department, 1155 Long Island Avenue, Edgewood, New York 11717, by telephone at (833) 297-2926 or by email at [email protected].

A registration statement relating to these securities has 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 these securities, 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 March 18, 2021 Ossium Health, a therapeutics company harnessing the power of stem cell science to improve treatment for patients with blood and immune diseases, reported that the completion of its $63 million Series B funding round co-led by General Catalyst and Vivo Capital with participation from previous investors First Round Capital, Manta Ray Ventures, and XYZ Capital (Press release, Ossium Health, MAR 18, 2021, View Source [SID1234578744]). The company has built a platform for recovering, banking, and transplanting bone marrow rich in adult stem cells from deceased organ donors to bring life-saving cell therapies to more patients.

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The vast potential of stem cell science to improve patient outcomes has not been realized. For 60 years, transplants of adult stem cells have been used to treat patients with more than 70 blood and immune diseases. But only 5 percent of the 200,000 US patients per year diagnosed with diseases potentially treatable with stem cell therapies receive transplants. The scarcity of available cells has limited access to treatment and stymied research for decades.
Ossium is accelerating development of stem cell therapies by bringing the existing US deceased donor transplant ecosystem into the fight against blood cancers, inflammatory bowel disease, organ rejection, and other life-threatening diseases where stem cell science holds the promise of a cure. The company has built a sprawling national network of partnerships with the organ procurement organizations (OPOs) responsible for recovering organs from nearly half the US population. Ossium wants to make every organ donor a bone marrow donor, and the adult stem cell populations in bone marrow are key to the company’s plan to end immunosuppression and expand access to organ transplants.

Ossium’s research and business partnerships to date are just the first steps toward its vision of transforming the global healthcare system into a tool for proactively preserving health rather than retroactively treating disease. "Humanity’s deepening understanding of biology is driving a revolution in bioengineering that parallels the industrial revolutions that followed the birth of modern physics and chemistry," said Ossium Co-Founder and CEO, Kevin Caldwell. "Ossium is using stem cell science to create a new paradigm for medicine in which the building blocks of life are the raw materials of therapeutics. The future of healthcare is in preserving health, not treating symptoms. Our industrialized platform for cell therapies will define the emerging era of regenerative medicine."

Ossium’s $63M Series B is the latest financing for the five-year-old company which has raised a total of $74M. Ossium’s research has also been supported by more than $6M in NIH grants, bringing the company’s total resources to more than $80M. The funds will support an initial suite of clinical trials to use donor-matched hematopoietic stem cells to re-educate the immune systems of organ recipients to accept donor organs, to deploy the anti-inflammatory properties of mesenchymal stem cells to promote healing in patients with fistulizing Crohn’s disease, and to reset the malignant immune systems of hard to match blood cancer patients using bone marrow transplants from organ donors. Each clinical study leverages the company’s unique deceased donor adult stem cell banking platform. The company has proprietary technology for processing adult stem cells from the vast US organ donor population.
"From my first conversation with Kevin and his team, I knew that Ossium had the potential to transform the transplant landscape and that LifeGift needed to get involved," said Kevin Myer, CEO of Houston-based LifeGift, one of the nation’s largest organ procurement organizations. "Our partnership with Ossium gives us a groundbreaking opportunity to extend the gift of organ and tissue donation into new and life-saving applications like blood cancer treatment."

"Ossium is taking an innovative and impactful approach to improving access to treatment for blood cancer patients while also unlocking powerful new uses for bone marrow transplants," said Andrew D. Goldberg, MD, Partner on the Innovation team at Vivo Capital. "At Vivo, we leverage our extensive scientific, clinical, and operating experience to help healthcare companies develop therapeutics, commercialize, and scale. We are inspired by what Kevin and his team have accomplished and look forward to working with them during this new and exciting period of growth."
"Right now, more than a quarter of all people who need a bone marrow transplant fail to find a match. What Ossium is building isn’t just a new methodology for procuring the lifesaving therapeutics like bone marrow and stem cells. It’s also a chance to build both resilience and equity into an area of healthcare that has the potential to save thousands of lives every year," said Hemant Taneja, managing partner, General Catalyst.

"Ossium combines a deeply experienced team with a demonstrated ability to build crucial transplant community partnerships," said Bill Trenchard, Managing Partner at First Round Capital. "But what really set Ossium apart for First Round is the company’s mission to improve human health using a bold, platform-based model for developing powerful new stem cell therapies."

"We’re proud to support Ossium’s disruptive approach to building the world’s first deceased donor bone marrow bank," said Lawrence Barclay, Managing Partner of Manta Ray Ventures. "Ossium’s vision of using donor bone marrow cell infusions to enable immunosuppression free transplants could reshape how organ transplants are done worldwide and drive dramatically improved outcomes for patients."