On July 29, 2020 Amgen reported a bispecific drug it picked up in a $1.7 billion biobucks deal with Xencor (Press release, Amgen, JUL 29, 2020, View Source [SID1234562548]).

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In its second-quarter results, the biopharma said: "Phase 1 development of AMG 424, a CD38-CD3 XmAb antibody has been stopped, with rights reverting to Xencor."

Amgen nabbed the preclinical asset back in 2015 as part of an early-stage, bispecific six-drug development deal with Xencor. Under the deal, Amgen paid just $45 million upfront to use its R&D tech on some preclinical antibodies designed to harness the body’s natural defenses.

The pact was worth up to $1.7 billion in biobucks.
Xencor had been the biotech partner of choice for a number of Big Pharmas but was beginning to fall out of favor. In January last year, Novartis also returned the rights to a bispecific antibody it had licensed as part of a 2016 deal worth up to $2.41 billion.

A few months down the line, and the biotech was hit again after a second asset from that deal, in development for acute myeloid leukemia, hit a snag in the form of a partial clinical hold from the FDA. This came after a failed phase 2 test in lupus for the company in 2018.

But things had started to turn around: After working with Xencor to change the study protocol, the FDA lifted the partial clinical hold April 30.

And although Xencor lost Novartis as a partner on one of its programs, it picked up a new partner, licensing its preclinical-stage IL-15 cytokine therapeutics to Genentech for $120 million upfront in February last year.

Since then, Xencor has inked an R&D deal with Astellas and started phase 1 studies for two more bispecific antibodies in advanced solid tumors: XmAb2314, which targets PD-1 and ICOS, and XmAb22841, which targets CTLA-4 and LAG-3. The latter treatment is being tested in combination with Keytruda in an effort to block three checkpoints at once.

But the Amgen cull was still a hard hit for the biotech in the short term, with its shares off nearly 5% after-hours Tuesday on the news.

Meanwhile, one of the most keenly watched cancer drugs in development, KRAS drug AMG 510 (now known as sotorasib) is still on track to deliver data from a potentially pivotal phase 2 monotherapy study in patients with advanced non-small cell lung cancer (NSCLC) in the coming months, despite ongoing pandemic disruptions to trials.

Amgen also noted its phase 3 CodeBreaK 200 study comparing sotorasib to docetaxel is also now "enrolling patients with advanced NSCLC," while it has six phase 1 combination cohorts also enrolling.

Sales for Amgen grew 6% to $6.2 billion for the second quarter.

On July 29, 2020 Inhibrx reported that it has set a preliminary $100 million IPO goal, up by about one-third from the target it set last year. The company has applied for a Nasdaq listing under the stock symbol "INBX (Press release, Inhibrx, JUL 29, 2020, View Source [SID1234562541])."

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As of late June, every biotech IPO this year had priced at or above the midpoint of its price range or offered more shares than it initially planned, according to research firm Renaissance Capital.

Inhibrx has four investigational drugs all in Phase 1 testing; three for cancers and another for a rare genetic disease called alpha-1 antitrypsin (AAT) deficiency. The drug candidates deploy single-domain antibodies, antibody fragments that the company believes may best other antibody and biologic therapies on safety and efficacy because of their smaller size and "highly modular" properties.

The company’s most advanced candidate, INBRX-109, is under evaluation in patients with chondrosarcoma and mesothelioma, two rare and aggressive cancers. The drug is designed to stimulate DR5, a member of the tumor necrosis factor (TNF) receptor superfamily, which plays a role in immune response.

Also in early testing is INBRX-106, which is intended to stimulate OX40, another TNF receptor superfamily member, in locally advanced or metastatic solid tumors, and INBRX‑105, which is designed to both inhibit the protein PD-L1 and to stimulate 4-1BB, a receptor found on T cells, to enhance the anti-tumor immune response. Based on preclinical data, Inhibrx says that both drug candidates could be used to complement or replace the use of a class of approved cancer immunotherapies called checkpoint inhibitors.

A Phase 1 study for its AAT program was paused due to the COVID-19 pandemic, but the company aims to resume enrollment in the fourth quarter. Italy’s Chiesi Group last year acquired the option to exclusively license global rights to the AAT program, excluding the US and Canada.

The company anticipates reporting initial data from INBRX-109 and INBRX-106 by year’s end, and additional data from all four programs during 2021.

With its IPO cash the company plans to advance these potential treatments through the ongoing trials and to scale up its commercial manufacturing activities. Currently the biotech’s largest outside shareholders are Lilly Asia Ventures, which owns nearly 10 percent of the company and RA Capital, which holds 8.4 percent, according to the IPO paperwork.

Since raising $40 million last year from Viking Global Investors in the form of a convertible note, Inhibrx has raised $15 million more in a similar financing, from Viking and other investors, according to its prospectus.

The company was founded in 2010 by Mark Lappe, Brendan Eckelman, and Quinn Deveraux, the company’s CEO, chief scientific officer, and head of early research, respectively.

On July 29, 2020 AMERI Holdings, Inc. (NASDAQ: AMRH) ("Ameri"), reported that its proposed amalgamation partner Jay Pharma Inc. ("Jay Pharma" or "the Company") has announced the addition of new senior staff as the Company prepares to file two new investigational new drug (IND) applications for the treatment of radiodermatitis and glioblastoma multiforme (GBM) (Press release, Jay Pharma, JUL 29, 2020, View Source [SID1234562534]).

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Dr. Robert Wilkins is joining Jay Pharma as Chief Medical Officer. He will begin in the role immediately.

"Jay Pharma is seeking to bring oncology drugs to the market through FDA approval," said Dave Johnson, Jay Pharma’s CEO-elect. "With Dr. Wilkins, we are bringing in the skillset necessary to enhance our organization and allow us to navigate the IND process with confidence."

Over the course of a 30-year career, Wilkins has held leadership positions in medical affairs, product development, marketing, commercialization, and business development at leading pharmaceutical companies, such as Abbott, Baxter, and Battelle. Since 2001, Wilkins has consulted with multiple innovators in the medical and pharmaceutical space, such as valve replacement system Endovalve and glucose monitoring equipment GlucoLight.

"Jay Pharma is poised to enter an exciting new stage of growth, and I am delighted to be a part of it," Wilkins said.

Johnson described Wilkins as an "excellent steward" to advance the Company’s plans for filing two INDs: a combination therapy drug for the treatment of GBM, and a topical radiodermatitis treatment.

"We recently announced Investigational Review Board (IRB) approval for a GBM study at the Rabin Institute in Israel, and we plan to commence a study for radiodermatitis in the U.S.," Johnson said. "Bob will be crucial to advancing both of these initiatives."

In addition to Dr. Wilkins, Jay Pharma is pleased to announce the signing of Dr. Steven Weisman and Innovative Science Solutions (ISS) Regulatory Services. Steve and the ISS team have decades of experience developing regulatory strategies, product development, preclinical and clinical testing programs, regulatory submissions, and product defense/communication strategies for drugs, foods, cosmetics, and dietary supplements. Weisman also has specialty knowledge in analyzing the scientific and regulatory aspects of potential new products and the development of responses to FDA rule-makings.

"Steve will be an important voice in the preparation of our INDs, and our quality systems," said Wilkins. "We will work closely to ensure Jay Pharma is properly structured to work with the FDA and other regulatory agencies around the world."

The IND program, administered by the U.S. Food and Drug Administration (FDA), is the process through which a Company receives authorization to conduct human clinical trials in the U.S. According to Johnson, the Company plans to enter clinical trials for both its radiodermatitis and GBM formulations upon receipt of FDA clearance.

The radiodermatitis topical formulation has been designed to utilize the Company’s proprietary cannabidiol (CBD) formula with the cannabinoid Cannabigerol (CBG) and other ingredients to help alleviate the discomfort caused by radiodermatitis, a skin condition that is a consequence of radiation therapy. It is one of the most common side effects experienced by cancer patients. The topical product is intended to be both preventative and to treat existing radiodermatitis.

A rare and aggressive form of brain cancer, glioblastoma multiforme (GBM) is notoriously resistant to currently available cancer treatments. Phase I/II human clinical trials in Israel will administer the Company’s proprietary synthetic CBD formula to 40 enrollees: half of whom will be treated with the CBD formula, and the other half will be treated with the formula in combination with clomiphene, an estrogen binding site inhibitor.

"Our goal is to advance novel treatments that will improve the lives of cancer patients around the world," Johnson said. "With the additions of Dr. Wilkins and Dr. Weisman to the Jay Pharma team, we believe that we have the right individuals to help lead us into this next phase of the Company."

On July 29, 2020 Strata Oncology, Inc., a precision oncology company advancing molecular indications for cancer therapies, reported it has signed an agreement with BioMed Valley Discoveries, Inc. to accelerate patient identification and enrollment for BioMed Valley’s Phase 2 study of BVD-523 (ulixertinib) for patients with advanced malignancies harboring MEK or atypical BRAF alterations (non-BRAF V600E mutations) (Press release, Strata Oncology, JUL 29, 2020, View Source [SID1234562533]).

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Ulixertinib is a first-in-class potent and selective small molecule inhibitor of ERK1/2. BioMed Valley reported positive preliminary Phase I data for ulixertinib in patients harboring MAPK alterations, including atypical BRAF alterations.

Under the terms of the agreement and through the Strata Trial, Strata Oncology will identify patients with advanced solid tumors that harbor mutations in the MAPK signaling pathway and meet other eligibility criteria, for consideration of enrollment into BioMed Valley’s Phase 2 study. The Strata Trial, an ongoing observational study providing tumor molecular profiling for patients with advanced cancer paired with a portfolio of biomarker-guided clinical trials, is available across a network of 25+ select health systems nationwide. Through the Strata Trial, patients with advanced cancer are profiled using StrataNGSTM, a comprehensive molecular profiling test optimized for performance on tissue samples as small as 0.5mm2 surface area.

"This partnership with BioMed Valley Discoveries supports our commitment to improving the lives of patients with cancer by providing local access to promising investigational therapies," said Dan Rhodes, Ph.D., CEO of Strata Oncology. "We are confident our network of health system partners, standardized on the Strata Trial, will help drive rapid enrollment of this important study."

David Chao, President & CEO of BioMed Valley Discoveries, commented, "We are delighted to collaborate with Strata to develop our first-in-class ERK inhibitor. Strata’s ability to rapidly identify patients with specific tumor mutations has the potential to dramatically accelerate the recruitment of patients for our trial."

On July 29, 2020 Horizon Discovery Group plc (LSE: HZD) ("Horizon", "the Company" or "the Group"), a global leader in the application of gene editing and gene modulation for cell line engineering, reported that TrueBinding, Inc. ("TrueBinding", formerly Immutics, Inc.), a biopharmaceutical company, has signed a set of commercial licenses for Horizon’s cGMP-compliant CHOSOURCE platform (Press release, Horizon Discovery, JUL 29, 2020, View Source [SID1234562531]). TrueBinding will use the platform for the development and commercialization of multiple biotherapeutic products for applications in immuno-oncology and other disease areas with great unmet medical need.

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Horizon’s CHOSOURCE platform includes a gene-edited Glutamine Synthetase ("GS") knockout Chinese Hamster Ovary (CHO) K1 cell line, a well-established GS expression system recognized in the industry and by regulators as suitable for high-yield biomanufacturing. TrueBinding has successfully used this platform to develop stable, antibody-expressing cell lines in a proof-of-concept study and will now implement this to support further antibody drug development through commercial manufacturing.

"We are delighted TrueBinding has placed its trust in the capabilities of Horizon’s CHOSOURCE expression platform to support its research and development efforts," commented Jesús Zurdo, Global Head Bioproduction Business Unit, Horizon Discovery. "Horizon is fully committed to supporting innovative organizations of all sizes, from non-profit organizations and early stage startups to clinical stage biotechnology and large pharmaceutical companies, in their journey to develop much-needed novel therapeutic products using our expression platform."

Dr. Fan Chen, SVP of CMC, TrueBinding, explained: "Horizon’s CHOSOURCE platform provides a robust system for generating high protein expression stable cell lines to support TrueBinding antibody drug development through commercial manufacturing. We are very pleased with current program results and move to further collaboration with Horizon Discovery."

Horizon’s proprietary GS knockout CHO line and protocols facilitate the development of stable cell lines for the expression of antibodies and other recombinant proteins. The Company also licenses a CHO expression system to pharmaceutical, biotechnology, and biosimilar companies, as well as contract manufacturing organizations. To enable companies to move from the DNA sequence of their potential biotherapeutic to clinical manufacturing as simply and rapidly as possible, the complete system includes the GS knockout CHO K1 cell line, a comprehensive package of supporting documentation, and an expression vector supplied under license from DNATwoPointO, Inc.

To date, CHOSOURCE has been licensed to 80 organizations globally, with at least seven confirmed biotherapeutics expressed in these cells having progressed to investigational new drug (IND) filings.