Inhibrx Announces Pricing of Initial Public Offering of Common Stock

On August 19, 2020 Inhibrx, Inc. ("Inhibrx") (Nasdaq: INBX), a clinical-stage biotechnology company focused on developing a broad pipeline of novel biologic therapeutic candidates, reported the pricing of its initial public offering of 7,000,000 shares of common stock at a price to the public of $17.00 per share (Press release, Inhibrx, AUG 19, 2020, View Source [SID1234563780]). All of the shares of common stock are being offered by Inhibrx . The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Inhibrx, are expected to be $119.0 million. Inhibrx’s common stock is expected to begin trading on the Nasdaq Global Market on August 19, 2020, under the symbol "INBX". The offering is expected to close on August 21, 2020, subject to the satisfaction of customary closing conditions. In addition, Inhibrx has granted the underwriters a 30-day option to purchase up to 1,050,000 additional shares of common stock at the initial public offering price, less underwriting discounts and commissions.

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Jefferies, Evercore ISI and Credit Suisse are acting as joint book-running managers for the offering. LifeSci Capital is acting as co-manager for the offering.

Registration statements relating to these securities became effective on August 18, 2020. This offering is being made only by means of a prospectus. When available, a copy of the final prospectus relating to the offering may be obtained from: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; Evercore Group, L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, NY 10055, by telephone at (888) 474-0200, or by email at [email protected]; or Credit Suisse Securities (USA) LLC, Attn: Prospectus Department, 6933 Louis Stephens Drive, Morrisville, NC 27560, by telephone at (800) 221-1037, or by email at [email protected].

This press release does 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.

Emergent BioSolutions to Participate in Virtual Investor Conferences

On August 18, 2020 Emergent BioSolutions Inc. (NYSE: EBS) reported that members of the company’s executive management team will participate in the following virtual investor conferences through the end of September 2020 (Press release, Emergent BioSolutions, AUG 18, 2020, View Source [SID1234569794]):

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2020 NYSE Healthcare & Technology Investor Access Day
August 18 – virtual one-on-one meetings only

2020 Three Part Advisors Virtual Midwest IDEAS Investor Conference
August 27 – pre-recorded presentation available beginning at 8:00am eastern

2020 Wells Fargo Virtual Healthcare Conference
September 9 – presentation at 8:00am eastern

Robert W. Baird 2020 Global Healthcare Conference
September 10 – presentation at 2:35pm eastern

Morgan Stanley 18th Annual Global Healthcare Conference 2020
September 14 – presentation at 4:30pm eastern

Cantor Virtual Global Healthcare Conference 2020
September 15 – presentation at 3:20pm eastern

2020 Singular Research Compelling Values Webcall
September 17 – presentation at 12:00pm eastern
For conferences where a presentation is planned, the company’s webcast presentation may include a discussion of the company’s recent business developments as well as its financial results and guidance. The webcasts will be available both live, if possible, and by replay, and will be accessible from the Emergent website www.emergentbiosolutions.com under "Investors."

Immatics Announces European Clinical Expansion of its Adoptive Cell Therapy Programs

On August 18, 2020 Immatics N.V. (NASDAQ: IMTX, "Immatics"), a clinical-stage biopharmaceutical company active in the discovery and development of T cell redirecting cancer immunotherapies, reported the treatment of the first patient in the IMA202-101 trial in Europe following the Clinical Trial Application (CTA, the equivalent of an IND approval by FDA) approval by Paul-Ehrlich-Institute (PEI), the regulatory body for cell and gene therapies in Germany (Press release, Immatics Biotechnologies, AUG 18, 2020, View Source [SID1234569537]). In addition, Immatics has been granted regulatory approval by PEI to initiate another phase I clinical trial in Germany to evaluate safety, tolerability and initial signs of clinical efficacy of IMA203.

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The clinical trials of the IMA200 series will investigate up to three novel cancer immunotherapies, which include IMA202 (NCT03441100) and IMA203 (NCT03686124). IMA202 and IMA203 are designed to target unique peptides derived from either melanoma-associated antigen 1 ("MAGEA1") or preferentially expressed antigen in melanoma ("PRAME"), respectively. Both are built on Immatics’ proprietary ACTengine approach in which the patient’s own T cells are genetically engineered to express an exogenous T cell receptor (TCR) directed against true cancer targets. By introducing this novel cancer specific TCR, the goal is to redirect and selectively activate the patient’s T cells to fight the tumor. The studies will investigate the safety and tolerability of Immatics’ Adoptive Cell Therapies (ACT) in patients with target-positive solid cancers and seek initial signals of anti-tumor activity. Moreover, persistence of the infused engineered T cells will be monitored in the patient’s blood as T cell persistence is considered a major pre-requisite to obtain an anti-tumor response. The aim is to develop innovative personalized immunotherapies targeting a patient’s tumor selectively and effectively.

The initial group of clinical trial sites in Germany includes the University Hospital Carl Gustav Carus in Dresden, the University Hospital Bonn and the University Hospital of Würzburg. Previous patients in the IMA200 series were initially enrolled at The University of Texas MD Anderson Cancer Center in Houston, Texas, and more recently at the Columbia University Irving Medical Center in New York and the UPMC Hillman Cancer Center in Pittsburgh, Pennsylvania.

Cedrik Britten, MD, Chief Medical Officer of Immatics commented: "As part of our strategy to increase the geographical foot-print for our clinical sites, we are currently expanding them in the US and in Europe. We are delighted to have gained a new regulatory approval from PEI and to have treated the first patient in Germany. This expansion elevates our clinical organization to a global level and adds operational flexibility that has become even more important in light of the global COVID-19 pandemic. We look forward to continuing to collaborate with leading clinicians to advance our mission of delivering the power of T cells to cancer patients on both sides of the Atlantic."

Dr. Martin Wermke, Coordinating Investigator and Head of the Early Clinical Trial Unit of the National Center for Tumor Diseases Dresden (NCT/UCC) at the University Hospital Carl Gustav Carus in Dresden, Germany, commented: "Having been involved since the early stages of this clinical research, I am excited to witness the next phase of development of this fascinating pipeline of immunotherapies. I am confident that Immatics’ innovative T cell therapies hold the potential to alter the future therapeutic landscape of solid and hematologic malignancies."

Additional information about the clinical studies is available at www.immatics.com/clinical-programs/ and www.clinicaltrials.gov.

About Immatics’ Adoptive Cell Therapies
Adoptive Cell Therapy (ACT) is a therapeutic approach that uses natural or engineered T cells to fight cancer. Immatics has developed three innovative, proprietary approaches to produce Adoptive Cell Therapies: ACTengine, off-the-shelf ACTallo and the multi-target pilot trial ACTolog.

About ACTengine
Immatics’ clinical product class ACTengine is a personalized approach for patients with advanced solid cancers. Patient’s own T cells are genetically modified to express a novel proprietary TCR cognate to one of Immatics’ cancer targets identified by its proprietary XPRESIDENT target discovery platform.

About the ACTengine clinical trials (IMA201, IMA202 and IMA203)

The primary objective of these clinical studies is to evaluate the safety and tolerability of the ACTengine approach in target-positive solid cancer patients.
The secondary objectives are the evaluation of the persistence of T cells in vivo and the assessment of anti-tumor activity.
Patients are potentially eligible for ACTengine cell therapy if the target of interest is present on the patient’s tumor as demonstrated by biomarker profiling (IMADetect).
Each TCR used in these trials has been selected from the human T cell repertoire and developed using Immatics’ XCEPTOR platform targeting highest specificity.
The ACTengine T cell products are manufactured at The Evelyn H. Griffin Stem Cell Therapeutics Research Laboratory in collaboration with The University of Texas Health Science Center at Houston (UTHealth).
Immatics has developed a proprietary manufacturing process, optimized to generate T cell products within a short manufacturing period. TCR-transduced T cells are activated and multiplied outside of the body before being infused into the patient.

Poseida shares plunge after death in solid tumor CAR-T trial, clinical hold

On August 18, 2020 Poseida Therapeutics reported its shares plummet after-hours Monday when it revealed in a Securities and Exchange Commission (SEC) filing that its cancer drug has been slapped with a full clinical hold (Press release, Poseida Therapeutics, AUG 18, 2020, View Source [SID1234563884]).

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The hold has hit its phase 1 test for P-PSMA-101 in metastatic castration-resistant prostate cancer and comes after a patient died of liver failure in the study, the cause of which could "possibly related to P-PSMA-101 pending further investigation," the biotech said in the SEC filing.

"Although the direct cause of the hepatic failure has not yet been confirmed, the patient developed symptoms consistent with macrophage activation syndrome (MAS)," Poseida explained. "MAS is a serious and potentially fatal overactivation of the immune system which has been associated with CAR-T therapies, but can have other causes such as infection and autoimmune disease.

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"The patient also developed blurred vision which was diagnosed as uveitis. The clinical investigator has assessed the SAE as possibly related to P-PSMA-101 pending further investigation." The patient died 17 days after receiving the therapy.

Shares in the biotech, which has been strongly backed by Novartis in its early funding rounds, fell 34% on the news.

It is now awaiting a formal response from the FDA and is "preparing recommendations designed to allow resumption of the clinical trial."

The drug is its first solid tumor autologous CAR-T product candidate targeting prostate-specific membrane antigen, or PSMA. The most success with CAR-T has been across blood cancers, but, like a growing number of other biotechs, Poseida was hoping to unlock its potential in solid tumors.

Poseida had IPO’d this summer on the strength of its pipeline, which includes P-PSMA-101 and leading drug P-BCMA-101, an autologous CAR-T currently in a potentially registrational phase 2 trial for multiple myeloma.

Toxicity in cell therapy has long been an issue for this new cancer R&D area, and Poseida is not the first biotech to be hit by CAR-T trial deaths, with Juno Therapeutics (bought by Celgene, which was bought by Bristol Myers Squibb), seeing a group of deaths in mainly young people from its now ditched CAR-T JCAR015. Here, the deaths were caused by cerebral edema.

Poseida only got off its IPO last month, worth $224 million and valuing the biotech at a cool $1 billion. That second IPO attempt came a year after ditching its first in favor of a new funding round led by Novartis, which was worth a major $142 million.

And, in the middle of its second IPO attempt, it found time to raise a quick $110 million in private funding.

Merck to Build $1.3 Billion Research Hub in London

On August 18, 2020 Merck, known as MSD in Europe to distinguish it from Germany’s Merck KGaA, Darmstadt, Germany, reported that moving ahead with its $1.3 billion research center in London (Press release, Merck & Co, AUG 18, 2020, View Source [SID1234563826]). The plan was originally announced in 2017 as part of a pledge to support post-Brexit Britain. The project has been delayed a bit, some of that related to difficulties in finding space in London, and also because it wanted to be in the life sciences hub near the Francis Crick Institute in north London. Merck has a significant five-year neuroscience research-and-development deal with the Crick Institute.

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The new research hub will be called the London Discovery Research Centre and is expected to open by 2025. Work is expected to begin late next year, and the site expects to create approximately 120 new jobs for researchers and technicians and employ about 800 people overall. The site is expected to be 25,000 square meters.

"We currently view the UK as a world leader in developing science, driven by the long-term emphasis on building a strong research and development infrastructure," David Peacock, MSD managing director for UK and Ireland, told the Financial Times.

The new site is across from King’s Cross station. The deal has not been finalized yet, requiring the council for the London borough of Camden to sign off on it. And there are reports of at least one group that is protesting the move.

A group of brick buildings called Belgrove House are currently at the site and would need to be demolished for the research center to go in. A local activist who is anonymous but runs SaveBloomsbury.co.uk has called the plan "diabolical" and described the plans for the center’s structure a "monstrosity" inappropriate for the neighborhood.

The protester wrote, "Despite being situated in one of the most highly sensitive historic settings in London, the development is one of the ugliest and most inappropriate buildings proposed in recent times, rivaling the Town Hall Annexe itself for the title of ugliest building in Camden."

If Camden’s council approves, Merck will begin construction late in 2021 and finish by 2025, which is five years after the date originally proposed. According to the Financial Times, the researchers at the site will run early-stage research and mostly focus on age-related diseases.

As the 2018 story out of the Crick Institute noted, a team of about 15 Merck chemists and pharmacologists have been based there while plans to build the site have dragged on. The Merck team’s research projects were independent from Crick research, but the team was fully integrated into the Crick scientific community.

In August 2019, researchers from Merck and Crick began a new collaboration to focus on the causes of Motore Neurone Disease. It was the first project out of the five-year collaboration. Motore Neurone Disease is better known as Amyotrophic Lateral Sclerosis (ALS). The project is led by Rickie Patani, a research group leader at Crick and UCL and a consultant neurologist at the National Hospital for Neurology and Neurosurgery.

At the time, Rickie said, "In the clinic, it’s devastating when I have to tell a patient they have Motor Neurone Disease. Often, the patient first walks in with mild weakness in a limb and then I see the disease progressing relentlessly with every visit. Within a year or two, they might be in a wheelchair and require breathing support. This disease destroys families, and I feel profoundly guilty that we still have no effective treatments to offer."

He added, "Through fundamental research, we want to understand the basic biology underpinning the disease. Just knowing what’s happening can offer some comfort to patients, even when there aren’t treatments around the corner."