On December 2, 2021 Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported positive results from the phase 3 FOCUS study (Press release, Delcath Systems, DEC 2, 2021, View Source [SID1234596392]). The FOCUS study’s intent-to-treat (ITT) population was comprised of a total of 102 subjects, across various lines of therapy. Of the ITT group, 91 evaluable patients were administered at least one study treatment.

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Treatment with HEPZATO in the ITT analysis resulted in an objective-response-rate (ORR) of 31.4% [95% CI: 22.55-41.31], including 6.9% of patients with a complete response (CR). Median duration of response was 14 months [95% CI: 8.54, NC], with over half of responders continuing to be monitored for progression events. Disease control rate (DCR) was 65.7% [95% CI, 55.63, 74.81].

On the primary ORR endpoint, the lower bound 95% Confidence Interval (CI) of 22.55% exceeded the FOCUS trial’s prespecified 8.3% upper bound 95% CI threshold for success. This threshold was derived from a meta-analysis of sixteen checkpoint inhibitor publications documenting the treatment of 476 metastatic ocular melanoma patients.

Supportive, predefined, exploratory analyses were conducted comparing patients in the HEPZATO arm versus a BAC group. The BAC arm was comprised of a total of 42 patients, originally randomized in the FOCUS trial prior to its amendment, in consultation with FDA, to a single-arm pivotal study in 2018. The evaluable BAC subjects were treated predominantly with liver-targeted Transarterial Chemoembolization (TACE).

Among patients who received at least one study treatment, patients in the HEPZATO arm had statistically significant improvements over BAC in the following prespecified endpoints:

ORR of 35.2% versus 12.5% for the BAC arm (p=0.0154).
Disease Control Rate of 73.6% versus 37.5% for patients in the BAC arm (p=0.0002).
Median Progression Free Survival of 9.03 months versus 3.12 months for the BAC arm (HR=0.39; p=0.0002).
Enrollment in the FOCUS trial HEPZATO arm ended in late 2020 with overall survival data continuing to mature. Per the statistical plan, a final predefined exploratory survival analysis, versus BAC, will be conducted at 24-months after last patient last treatment.

As of this analysis, survival at 12-months in the evaluable patients was 75% in the HEPZATO arm versus 47% for BAC [HR=0.37, p=0.01]. Delcath will provide future overall survival analysis updates, as patient follow-up continues, and the Kaplan-Meier analysis matures.

In the HEPZATO safety population, the most commonly reported treatment-emergent serious adverse events were anemia (29.7% of patients), thrombocytopenia (26.4% of patients) and neutropenia (19.8% of patients), which were well-manageable. 5.3% of patients experienced treatment-emergent serious cardiac adverse events. In all cases the events resolved with no ongoing complications. There were no treatment-related deaths in the trial.

"Metastatic ocular melanoma is a disease with a dismal prognosis and new therapies are urgently needed. The FOCUS study results, along with the predefined analyses versus a relevant BAC group, clarify HEPZATO overall clinical benefit in this difficult-to-treat patient population," noted Dr. Jonathan Zager MD FACS, global lead investigator of the FOCUS study, senior member and Director of Regional Therapies at Moffitt Cancer Center. "The overall efficacy, coupled with an improved safety profile versus the first-generation product, suggests that HEPZATO would offer a compelling clinical benefit were it approved by FDA."

"We are thrilled by the HEPZATO response rates and duration of response which far exceed that which has been seen with other agents in this difficult-to-treat patient population. Our data further highlights HEPZATO’s potential superiority to other available liver-targeted therapies, which suggests a broader utility for our platform across multiple liver-metastatic tumor types. In addition to re-filing our NDA by mid-2022, Delcath, along with key opinion leaders, intend to study HEPZATO in additional indications in the near future."

The FOCUS trial results will be presented at a comprehensive Investor Update Meeting taking place today from 10:00am EST – 1:30pm EST. In addition to the FOCUS trial, a distinguished panel of physicians will discuss their personal clinical experience with HEPZATO in both the clinical trial setting and the commercial setting in Europe, as well as the potential for HEPZATO to treat liver metastatic tumor types beyond metastatic ocular melanoma.

Event Details:

Event: Delcath Systems Virtual Investor Update Meeting
Date: Thursday, December 2, 2021
Time: 10:00am – 1:30 p.m. EST

To register for this event, please click here.

The live webcast of the event may be accessed through the Events and Presentation page of Delcath’s website, under the Investors section. The archived webcast and presentation will be available on the Company’s website after the event.

On December 2, 2021 Acepodia, a clinical-stage biotechnology company developing first-in-class cell therapies with its unique Antibody-Cell Conjugation (ACC) platform technology to address gaps in cancer care, reported the closing of a $109 million Series C financing round led by Digital Mobile Venture and other new and existing investors (Press release, Acepodia, DEC 2, 2021, View Source [SID1234596391]). The funds will be used to further validate the company’s ACC technology and advance its pipeline of antibody cell effector (ACE) therapies for patients with cancer with limited treatment options. Concurrent with the financing, Samuel Chen, Director at Digital Mobile Venture, will join the Acepodia Board of Directors. Mr. Chen is also the largest shareholder of Polaris Pharmaceuticals.

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"This significant capital raise paves the way for us to deliver on our mission of bringing innovative, effective and affordable cell therapies to the broadest possible population of cancer patients," said Patrick Y. Yang, Ph.D., chairman and co-founder of Acepodia.

Acepodia has raised $166 million to date in venture capital financing, including a $47 million Series B round completed in March 2021. Investors have included Ridgeback Capital Investments, 8VC, DEFTA Partners, CDIB Capital Healthcare, Maxpro, E-Sun Venture, BioEngine Venture, Samuel Chen, Yahoo founder Jerry Yang, and Foxconn founder Terry Gou.

"We are pleased by the strong support and confidence of our investors as we initiate additional research and development programs and continue our clinical trial expansion in the U.S. in the coming years," said Sonny Hsiao, Ph.D., chief executive officer, president and co-founder of Acepodia. "We are also honored to welcome visionary technology investor Samuel Chen to our board of directors, who shares our mission of building a next-generation platform of cell therapies for cancers with high unmet needs."

Acepodia is developing a first-in-class pipeline of ACE therapies that use its ACC technology to link tumor-targeting antibodies to immune cells, such as natural killer (NK) cells or gamma delta T cells. Unlike CAR-based cell therapies that require viral vector-delivered gene transductions or genetic engineering, this technology combines the precision of targeted monoclonal antibodies and cancer-killing immune cells into a potent cell therapy.

On December 2, 2021 ImmunoGen Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported the pricing of an underwritten public offering of 11,636,364 shares of its common stock at a price of $6.60 per share, before underwriting discounts and commissions, and to certain investors in lieu of common stock, pre-funded warrants to purchase up to an aggregate of 27,363,636 shares of its common stock at a price of $6.59, which represents the per share public offering price for the common stock less the $0.01 per share exercise price for each such pre-funded warrant (Press release, ImmunoGen, DEC 2, 2021, View Source [SID1234596389]). The offering is expected to close on or about December 6, 2021, subject to satisfaction of customary closing conditions. ImmunoGen also granted the underwriters a 30-day option to purchase up to an additional 5,850,000 shares of its common stock at the public offering price, less underwriting discounts and commissions. All of the shares of common stock and pre-funded warrants in the offering are to be sold by ImmunoGen.

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ImmunoGen anticipates the total gross proceeds from the offering (before deducting the underwriting discounts and estimated offering expenses) will be $257.1 million, excluding any exercise of the underwriters’ option to purchase additional shares.

ImmunoGen intends to use the net proceeds of the offering to fund its operations, including, but not limited to, commercialization activities, clinical trial activities, supply of drug product, business development activities, capital expenditures, and working capital.

Jefferies, Cowen, and Guggenheim Securities are acting as joint book-running managers for the proposed offering. Canaccord Genuity is acting as lead manager for the proposed offering.

The securities described above are being offered by ImmunoGen pursuant to a shelf registration statement that was previously filed with the Securities and Exchange Commission (SEC) and became effective upon filing. This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in this offering, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. A preliminary prospectus supplement and accompanying prospectus relating to the offering was filed with the SEC and is available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by e-mail at [email protected] or by telephone at (877) 821-7388; Cowen and Company, LLC c/o Broadridge Financial Solutions, Attention: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY,11717, by email at [email protected] or by telephone at (833) 297-2926; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, or by email at [email protected] or by telephone at (212) 518-9544.

On December 2, 2021 GlaxoSmithKline plc and the University of Oxford reported a major five-year collaboration to establish the Oxford-GSK Institute of Molecular and Computational Medicine (Press release, GlaxoSmithKline, DEC 2, 2021, View Source [SID1234596388]). The new Institute, which will be based at the University of Oxford, aims to improve the success and speed of research and development of new medicines, building on insights from human genetics and using advanced technologies such as functional genomics and machine learning.

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Genetic evidence has already been shown to double success rates in clinical studies of new treatments, and the digitisation of human biology has the potential to improve drug discovery by more closely linking genes to patients. The new Institute aims to build on this scientific progress and improve how diseases are understood by drawing on recent advances in pathology, including how to measure changes on a cellular, protein, or tissue level.

Backed by £30 million from GSK, the Institute is intended to pioneer further improvements in how new medicines are discovered and developed. For example, scientists from GSK and Oxford will help prioritise those early R&D programmes most likely to succeed and match them to patients most likely to respond.

The Institute will evaluate and integrate new approaches in genetics, proteomics and digital pathology to understand detailed patterns of disease which vary amongst individuals. The initial focus of research will be on neurological diseases, such as Alzheimer’s and Parkinson’s Disease.

Prime Minister Boris Johnson said: "We saw first-hand during the pandemic how the ingenuity and pioneering spirit of UK scientists and the R&D sector saved thousands of lives, with the rapid development and delivery of medicines and vaccines around the world.

"I am delighted to see that GSK and the University of Oxford are today taking further steps to deepen our understanding of some of the most complex diseases, such as Parkinson’s. Together they will harness the power of scientific collaboration to progress cutting-edge technologies and accelerate drug discovery – helping to cement the UK’s role as a life sciences superpower."

Emma Walmsley, Chief Executive Officer, GSK said: "We are delighted to be joining with the University of Oxford in this new collaboration. By combining the strengths of our two scientific organisations and harnessing advanced technologies, the Oxford-GSK Institute exemplifies the UK’s track-record and continued ambition in life sciences. Together, our aim is to improve drug discovery and development to help bring new and better medicines for patients."

Professor Louise Richardson, Vice-Chancellor of the University of Oxford, said: "On behalf of colleagues across Oxford I would like to say how delighted we are by this new initiative with GSK. The Institute will create a unique partnership with staff from the university’s medical school and GSK working side-by-side to research and develop treatments for some of the most difficult to treat diseases. In addition, the Institute, in keeping with our educational mission, will provide training and build capacity in Britain’s academic and bioscience sectors."

The genetic and genomic revolution of the past decade has amassed vast datasets of promising targets for medicine discovery. These datasets can be combined with functional genomics to provide deep understanding of disease at a molecular level.

By harnessing this understanding, as well as the power of machine learning, the Institute will uncover new indicators and predictors of disease and use them to accelerate the most promising areas for drug discovery. This is particularly important for GSK as it prioritises the large number of genetically informed drug targets generated from its collaborations with organisations, such as 23andMe and UK Biobank. The Institute will also aim to provide new measurements to establish proof of concept for potential medicines earlier in the R&D process, by better identifying the most appropriate patients to enrol in clinical trials, thus accelerating drug development timelines.

GSK and Oxford bring complementary capabilities and expertise into the Institute. GSK has leading capabilities in human genetics and functional genomics, and an in-house artificial intelligence and machine learning function, including its AI hub in central London. The University of Oxford has similar expertise but together they will be using patient, molecular information and state-of-the-art platforms to pinpoint the GSK targets that are most likely to succeed and be developed into safe, effective, disease mechanism-based medicines.

Diseases driven by neuro-immunological mechanisms including Alzheimer’s, Parkinson’s, Multiple Sclerosis (MS), Frontal Temporal Dementia, Amyotrophic Lateral Sclerosis (ALS) and Pain will be within the initial scope of the Institute. GSK has a rich pipeline of genetically informed targets and clinical projects in these areas.

The Institute will recruit a number of new research groups, in addition to drawing upon existing expertise from both GSK and Oxford. Five GSK/Oxford fellowships will be provided for early to mid-career researchers to establish themselves as Principal Investigators researching areas aligned with the Institute’s aims and objectives.

The Institute will have its base in the Nuffield Department of Medicine, and be closely associated with colleagues from across departments, including the University’s Wellcome Centre for Human Genetics and Big Data Institute. GSK and Oxford are in active discussions regarding the nature of the first projects which are anticipated to start in the second half of 2022 and will use the latest laboratory and data science platforms and approaches. A completely new way of collaborating will be established where research teams will have both GSK and University members, including secondments between both institutions.

The Directors of the Institute will be Professor John Todd, Director of the Wellcome Centre for Human Genetics and Dr Tony Wood, SVP, Medicinal Science and Technology at GSK.

On December 2, 2021 Clarity Pharmaceuticals (ASX: CU6) ("Clarity"), a clinical-stage radiopharmaceutical company developing next-generation products to address the growing needs in oncology, and Cardinal Health (NYSE: CAH), reported that the companies have entered into an agreement covering Clarity’s Targeted Copper Theranostics (TCT) platform (Press release, Clarity Pharmaceuticals, DEC 2, 2021, View Source [SID1234596385]).

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Cardinal Health will provide cGMP product manufacturing of ready-to-use TCT for Clarity’s U.S.-based clinical trials from its Center for Theranostics Advancement in Indianapolis, Indiana. TCT are investigational radiopharmaceuticals that pair copper-64 (64Cu) and copper-67 (67Cu) for diagnosis and therapy.

With more than 40 years of experience in the radiopharmaceutical industry, Cardinal Health provides radiopharmaceutical development support, manufacturing, preparation, commercialization, and business and practice management solutions across the care delivery continuum from origin to patient administration. Its Center for Theranostics Advancement is helping shape the future of precision medicine by providing radiopharmaceutical innovators the solutions they need at every stage of the product lifecycle.

Clarity’s Executive Chairman, Dr Alan Taylor, said, "We are pleased to have further strengthened and expanded our U.S. manufacturing capabilities, ensuring seamless product supply for our clinical trials, including those in cancer indications with large patient populations. Cardinal Health has an intricate understanding of the supply chain requirements for copper-based products and the capability to mass-produce these products.

"This is a testament to Clarity’s pairing of copper isotopes fitting into the ‘goldilocks zone’ of half-lives when considering biological half-life of the targeting moieties, centralized manufacture, and broad distribution. The half-life of copper-64 is nearly identical to that of iodine-123, for which Cardinal Health has an established and robust distribution system across the U.S. For the therapeutic isotope copper-67, centralized distribution is well proven in an isotope of comparable half-life, yttrium-90, or the much shorter half-life of samarium-153."

Cardinal Health Nuclear & Precision Health Solutions President Mike Pintek, said, "We are excited to be working together with Clarity on the manufacturing and pharmacy dispensing of the TCT platform of investigational products. The 64Cu and 67Cu isotope pairing holds great promise for the field of radiopharmaceuticals as they are ideally suited for central manufacturing of cGMP ready-to-use products; they will fit easily within our broad distribution network. We are very pleased to enter this agreement and hope it will be another avenue for us to help improve access to next-generation radiopharmaceuticals for diagnosis and treatment of a range of cancers."

Dr Alan Taylor said, "Clarity’s TCT platform is clearly differentiated in the radiopharmaceutical field as all products, once approved by the FDA, can be provided as ready-to-use to patients in any location in the U.S. from a single manufacturing site. The manufacturing agreement with Cardinal Health, in addition to the recent manufacturing agreement signed with Evergreen Theragnostics and other partners, will enable Clarity to create redundancies in the supply of our products – ensuring that we can provide a reliable, seamless supply of TCT that is unique for a company in the radiopharmaceutical field. This agreement further enables Clarity to continue to pursue our ultimate goal of improving treatment of children and adults with cancer."

This announcement has been authorized for release by the Executive Chairman of Clarity Pharmaceuticals.