Instil Bio Announces Pricing of Upsized Initial Public Offering

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.

Ossium Health Raises $63M Series B to Revolutionize Bioengineering

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."

Repeated Alpha1H treatments creates long-term protection against bladder tumor growth in mice

On March 18, 2021 Hamlet Pharma reported that new treatment advances in an experimental model of bladder cancer (Press release, HAMLET Pharma, MAR 18, 2021, View Source;utm_medium=rss&utm_campaign=repeated-alpha1h-treatments-creates-long-term-protection-against-bladder-tumor-growth-in-mice [SID1234576937]).

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A potent treatment effect of Alpha1H has previously been reported in mice with bladder cancer. We now show that continued treatment can provide long-term protection as well. Repeated treatment prevented tumor growth and the bladders remained similar to the control group without tumors.

In contrast, mice treated with placebo showed rapid tumor progression and severe disease after 12 days. The first round of Alpha1H treatment prevented tumor development for 4 weeks and long-term protection was achieved when treatment was repeated at 4-week intervals, as evidenced by marked differences in tumor size, pathology score, biomarkers and gene expression.

Cancer is often a chronic condition and several rounds of treatment are usually necessary. The results presented here suggest that repeated Alpha1H treatment regimens may be beneficial to ensure long-term protection against bladder cancer. This needs further validation in future clinical trials.

"Repeated treatment rounds appeared to maintain a high degree of protection against tumor progression in mice", says Catharina Svanborg, CMO and chairman of the board of Hamlet Pharma Ltd.

"This information is important for the design of future clinical trials", says Mats Persson, CEO of Hamlet Pharma Ltd.

This information is insider information that Hamlet Pharma AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication trough the agency of the contact persons set out above, on March 18, 2021 at 08.45 CET.

NICE backs AstraZeneca’s Calquence for CLL

On March 18, 2021 AstraZeneca reported that The UK National Institute for Health and Care Excellence (NICE) has recommended Calquence for use on the NHS to treat a common form of leukaemia (Press release, AstraZeneca, MAR 18, 2021, View Source [SID1234576924]).

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NICE has recommended the twice-daily Calquence (Acalabrutinib) for the treatment of certain adult patients with chronic lymphocytic leukaemia (CLL).

It has been approved as monotherapy for CLL if there is a 17p deletion or TP53 mutation or if fludarabine plus cyclophosphamide and rituximab (FCR), or bendamustine plus rituximab (BR) is unsuitable.

The approval of Calquence will offer a new chemotherapy-free treatment option for these patients, which could be particularly useful during the COVID-19 pandemic as patients would less require hospital visits.

Patients experts involved in NICE’s consultation for the drug also highlighted that Calquence is well tolerated and causes fewer side effects compare to current treatments for CLL.

For a 30-day pack of Calquence 100mg tablets, the list price is £5,059 – although AZ has made the drug available to the NHS with a discount.

This appraisal only considered Calquence as monotherapy, as the company did not submit any data for the combination of this drug with another cancer treatment commonly used to treat CLL – Roche’s Gazyvaro (Obinutuzumab).

WuXi Biologics in Two Deals with Pfizer, CMAB Biopharma in China

On March 18, 2021 WuXi Biologics, a contract biologics manufacturer, reported that it is increasing its position in China with two separate deals: an agreement to acquire Pfizer’s biologics drug-substance and drug-product manufacturing facilities in Hangzhou, China, and a separate agreement to acquire a more than 90% interest in CMAB Biopharma, a biologics CDMO headquartered in Suzhou, China (Press release, WuXi Biologics, MAR 18, 2021, View Source [SID1234576923]).

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Pfizer’s 50,000-m2 facilities, operational since 2018, include drug-substance capacities equipped with 2 x 2,000-L single-use bioreactors expandable to 4 x 2,000-L and drug-product capacities for vial filling and pre-filled syringes. The agreement includes the associated workforce of the facilities.

The transaction is expected to close in the first half of 2021. Production at the facilities is expected to commence shortly after the deal closure.

Separately, WuXi Biologics has entered into a purchase agreement with CBC Group, a healthcare-dedicated investment firm, under which WuXi Bio will acquire more than a 90% interest in CMAB Biopharma.

CMAB, which has more than 250 employees, provides cell-line development, process development, and GMP clinical manufacturing services. The deal will allow WuXi Biologics to increase 7,000-L drug-substance capacity and drug-product capacity for liquid and lyophilized products.

The transaction is expected to close in the second quarter of 2021.

Overall, WuXi Biologics has total biopharmaceutical production capacity planned in China, Ireland, the US, Germany, and Singapore exceeding 300,000 liters after 2023.