On December 11, 2018 Aro Biotherapeutics, a newly established biotechnology company, reported that it has raised $13 million in start-up investment to develop and commercialize Centyrins, an innovative next generation protein drug platform (Press release, Aro Biotherapeutics, DEC 11, 2018, View Source [SID1234533213]). Co-founded by Sue Dillon, PhD, and Karyn O’Neil, PhD, both former R&D leaders at the Janssen Pharmaceutical Companies of Johnson & Johnson, Aro has recruited a highly accomplished scientific and executive management team headquartered in the Pennovation Center in Philadelphia. Aro holds an exclusive worldwide license for Centyrin protein therapeutics, which were discovered by Dr. O’Neil and her team at Janssen. Centyrins are designed to achieve improved efficacy and safety profiles for patients diagnosed with cancer and other serious diseases. Aro was established through an initial start-up investment from Johnson & Johnson Innovation – JJDC, Inc. (JJDC) and BioMotiv, LLC.

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"Centyrins were conceived with the aim of simplifying the complexities of antibodies," said Dr. Dillon, Co-founder and Chief Executive Officer of Aro. "This has enabled Aro scientists to rapidly create bi- and multi-specific Centyrins that are simultaneously optimized for potent anti-tumor activity and for efficient manufacture in E. coli. In addition, Aro is progressing Centyrin-nucleic acid drug conjugates to enable delivery to tumor cells, immune cells and other tissues with the aim of addressing disease targets that have been considered ‘undruggable.’"

Building a Pipeline of Life Changing Therapies

Centyrins are small, structurally simple, ultra-stable, highly soluble proteins. These characteristics enable the discovery of medicines with new mechanisms of action for cancer and other devastating diseases. Aro’s lead program, which is a bi-specific Centyrin, is in late-stage lead optimization for advanced non-small cell lung cancer. Aro’s second therapeutic program is focused on creating a Centyrin-siRNA conjugate for other forms of cancer. This first-of-its-kind combination is designed to address unmet medical needs by targeting drug payloads in high concentration to the site of disease, while lowering the toxicity to non-target organs. The company holds an exclusive worldwide license for research, development, manufacturing and commercialization of Centyrin protein therapeutics.

Aro Leaders Bring a Track Record of Success in the Discovery, Development and Commercialization of Blockbuster Biologics for Cancer and Immune Diseases

Co-founder Sue Dillon, PhD is Aro’s Chief Executive Officer. "Our executive management team has the breadth of experience to deliver on our promise to patients," added Dr. Dillon, who previously served as the Global Therapeutic Area Head, Immunology at Janssen, where her team achieved numerous regulatory approvals for innovative antibody products, which included REMICADE, SIMPONI, STELARA and TREMFYA. Dr. Dillon was named one of the Top Women in Biotech by FierceBiotech in 2013. She received her PhD in Immunology from Thomas Jefferson University in Philadelphia and completed a postdoctoral fellowship in Immunology at Duke University.

Co-founder Karyn O’Neil, PhD, is Aro’s Chief Scientific Officer. She previously served as the Director of Antibody Discovery and as the Venture Leader for Centyrex, an internal venture within Janssen. She is co-inventor on the Centyrin patents and led the team focused on advancing the Centyrin platform and establishing its potential for drug delivery. Dr. O’Neil received her PhD from the University of Pennsylvania where she focused on protein engineering and protein biophysics. She has authored more than 55 publications, is inventor on over 30 patents, and serves as an editor for Protein Engineering, Design and Selection.

Steve Nadler, PhD, is Vice President of Discovery and Translational Research. Dr. Nadler has over 25 years of extensive R&D experience, most recently serving as the Executive Director and Head Immunoscience, Immuno-oncology and Oncology Discovery Translational Research at Bristol-Myers Squibb. Dr. Nadler played a major role in discovery and development of ORENCIA and NULOJIX through global approvals. He received his PhD from the University of Texas at Houston followed by postdoctoral studies at Yale Medical School. Dr. Nadler has authored more than 80 publications and is co-inventor on over 10 patents. He is also an adjunct full professor at Rutgers Medical School.

Derek Miller is Chief Business Officer and Head of Corporate Strategy at Aro. Mr. Miller most recently served as Chief Business Officer for Celator Pharmaceuticals, where he was responsible for developing and executing against the company’s corporate development, pipeline and commercial strategies. Prior to Celator, he had successful track records in Global Launches and Commercialization, Business Development, and Portfolio Strategy at Genentech, Centocor and GlaxoSmithKline. Mr. Miller received an MBA from Villanova University and a BA in Biology from the University of Delaware.

Mark Laurenzi joined Aro as Vice President of Finance and Operations. He has held a number of roles at Johnson & Johnson Innovation, including Venture Leader. Previously, Mr. Laurenzi has consulted with private equity and venture capital firms, serving as an operating partner and interim executive for selected portfolio companies. Mr. Laurenzi received an AB in Economics from Princeton University, and is a graduate of New York University School of Law. He began his career practicing corporate and securities law in New York City.

On December 11, 2018 Black Diamond Therapeutics, a biotechnology company developing a new type of precision medicine for cancer, reported that $20 million Series A financing exclusively from founding investor Versant Ventures (Press release, Black Diamond Therapeutics, DEC 11, 2018, View Source [SID1234532909]). Black Diamond is the first company launched out of Ridgeline, Versant’s Discovery Engine based in Basel, Switzerland, and has a unique platform capable of prosecuting allosteric mutant oncogenes.

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Oncogenes are activated by kinase domain mutations or by allosteric mutations. While kinase domain mutations have been successfully drugged with selective inhibitors and are standard of care in many malignancies, allosteric mutations represent an undrugged and unexplored space.

During its stealth stage, Black Diamond built and established proof of concept for its MAP (mutation, allostery and pharmacology) platform to uncover, discover and target allosteric mutant oncogenes. While Black Diamond founders David Epstein, Ph.D., and Elizabeth Buck, Ph.D., constructed and optimized the platform, parallel efforts by the Ridgeline team involved translational work to create leads, validate the resulting targets and bring forward drug candidates.

"The fundamental discovery underlying Black Diamond is there are whole sets of oncogenic lesions outside the ATP binding site that are activated by common mechanisms and are inhibited by a single class of our drugs," said Black Diamond CEO Dr. Epstein. "Our platform generates single molecules able to treat entire baskets of mutations that otherwise would have been deemed unactionable."

Dr. Epstein has extensive experience developing precision medicine cancer therapies. He previously was CSO of OSI Pharmaceuticals (acquired by Astellas Pharma), where he and Dr. Buck led research and translational science on a variety of novel agents including erlotinib, a small molecule inhibitor of epidermal growth factor receptor approved to treat non-small cell lung cancer and pancreatic cancer.

"As a new company in an important field of novel cancer medicines, Black Diamond is a premier example of Versant’s three key differentiating features – a focus on breakthrough innovation, geographic reach and company creation capabilities," said Alex Mayweg, Ph.D., a partner at Versant and a member of Black Diamond’s board. "We are very pleased to support a company that has an exceptionally powerful platform able to fuel its growth and pipeline for the foreseeable future."

To further progress and build out its breakthrough precision medicine platform, Black Diamond is finalizing a financing with additional investors that is expected to be announced in 2019. Proceeds will allow Black Diamond to advance two to three existing development candidates into the clinic in the next 24 months, and to bolster its platform’s ability to rapidly identify precision medicines for mutant cancers intractable to standard care.

MAP: a unique platform

Black Diamond’s industry-leading MAP platform identifies and drugs allosteric mutant disease targets. MAP involves mining a proprietary algorithm for allosteric oncogenes, validating their oncogenicity, elucidating the precise mechanism by which a given oncogene is allosterically activated, and designing drugs specific for these groups of allosteric mutations.

As genomic profiling and sequencing of cancer patients is becoming standard, MAP can pinpoint new druggable mutation baskets from the thousands of lesions identified across genes and patients, and can create high-impact precision medicines. Some of the allosteric mutation baskets represent 2-15% of patients in a given tumor tissue or across tumor sites.

MAP has generated a pipeline of five programs, including three that have progressed compounds through lead optimization or into IND-enabling studies. The fourth and fifth programs are in lead identification.

Black Diamond’s first two disclosed programs are targeting groups of EGFR and HER2 allosteric mutants.

The company also will use a portion of its Series A round to establish operations in Toronto, thus gaining access to the city’s deep pool of computing talent. Black Diamond expects this computational center of excellence will enable machine learning-based target discovery of new allosteric mutants that complements the existing MAP platform.

On December 11, 2018 Northwest Biotherapeutics (OTCQB: NWBO) — ("NW Bio"), a biotechnology company developing DCVax personalized immune therapies for solid tumor cancer, reported that it has entered into agreements with a large multi-national corporation for a package transaction involving the Company’s property located near Cambridge, UK. Pursuant to these agreements, (Press release, Northwest Biotherapeutics, DEC 11, 2018, View Source [SID1234532024])

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•The Company will sell most of its UK property to the multi-national corporation.

•The Company will receive £37.5 million (approximately $47.3 million) cash payment at closing.

•The Company will retain ownership of 17 acres of the property, which are excluded from the sale and which the Company believes will have substantial additional value in the future.

•The Company will retain a lease-back of the approximately 87,000 square foot manufacturing facility which the Company has been developing on the site, along with substantial adjacent areas, for up to 40 years on favorable terms.

The cash purchase price to be paid for the sale of most of the UK property will provide approximately $47.3 million of non-dilutive gross proceeds. Transaction expenses for broker and legal fees are expected to total about £1.3 million. The Company plans to use the transaction proceeds for Company obligations and operations.

The Company acquired the property for approximately £18 million. The Company’s subsequent investments into the property have been focused on the 87,000 square foot manufacturing facility, including refurbishments, structural improvements, extension of an additional level of interior space, and buildout of initial clean-room manufacturing suites. The Company will retain the value and use of these investments through the favorable lease-back of this manufacturing facility. The Company also retains the freedom to make further alterations, additions and improvements.

The lease-back of the manufacturing facility will initially be for 20 years, with a renewal for a second 20 years on the same terms at the Company’s option. The rent is determined by valuing the entire manufacturing facility as a warehouse. No rent is payable for the first year. Starting in year two, the rent is approximately £5.76 per square foot per year, with limited adjustments once every five years.

The lease includes substantial adjacent areas, including for surface parking of 600 vehicles and for equipment, plant and facilities that support or are related to operations in the manufacturing facility. The Company believes that, with internal buildout of further manufacturing suites inside this facility, it will potentially be capable of supporting production of DCVax products for up to 10,000 patients per year.

The property and the manufacturing facility are situated in the heart of the "Golden Triangle" of leading academic centers and rapidly developing R&D centers, from which the Company can draw the technical personnel needed for its operations. The property and manufacturing facility are also situated on or near major transportation arteries, including nearby Stanstead Airport, the major air shipping hub.

"Now that the data from our Phase 3 clinical trial of DCVax-L have further matured and provided a further encouraging picture of patient survival, and we are ready to move forward with the months of work related to completion of the trial, we are very pleased to have a new war chest of funding for this work," commented Linda Powers, CEO of NWBio. "We are also looking forward to proceeding with further DCVax-Direct trials."

"We are especially pleased to obtain this funding on a non-dilutive basis, and to seamlessly continue our activities with the UK manufacturing facility under the favorable lease-back."

On December 11, 2018 Alligator Bioscience AB (Nasdaq Stockholm: ATORX) reported that regulatory approvals have been obtained for the first clinical study of ATOR-1015 and patient recruitment can now be initiated. ATOR-1015 is a wholly-owned drug candidate developed for tumor-directed immunotherapy (Press release, Alligator Bioscience, DEC 11, 2018, View Source [SID1234538673]).

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The phase I study is a first-in-human dose-escalation study in up to 53 patients with advanced solid tumor disease at five different clinics across Sweden and Denmark. The primary aim of the study will be to investigate the safety and tolerability of the drug and to identify the recommended dose for subsequent Phase II studies.

"The start of clinical phase I study with ATOR-1015 represents a significant milestone for Alligator. We are first in the world with a new concept, a tumor-localizing bispecific CTLA-4 antibody. While the target is clinically validated, the clinical use of CTLA-4 blocking agents is restricted by severe toxicity. ATOR-1015 may provide a solution through its potential for selective activation of the immune system in the tumor area but not elsewhere in the body. The drug’s preclinical results are very promising, clearly supporting this concept", said Per Norlén, CEO of Alligator Bioscience.

As previously communicated, Alligator has appointed Theradex Oncology, a global contract research organization with extensive expertise in oncology clinical development, to conduct the phase I study.

For further information, please contact:
Cecilia Hofvander, Director Investor Relations & Communications
Phone +46 46 540 82 06
E-mail: [email protected]

This information is such information as Alligator Bioscience AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 8:00 a.m. CET on December 11, 2018.

About ATOR-1015
ATOR-1015 is a next generation CTLA-4 bispecific antibody developed for tumor-directed immunotherapy with increased capability of regulatory T-cell depletion. It is wholly-owned by Alligator. ATOR-1015 binds to two different immune receptors: the checkpoint receptor CTLA-4 and the co-stimulatory receptor OX40. The immune activation is increased in areas where both target molecules are expressed at high levels, notably in the tumor microenvironment, which is believed to reduce adverse immune reactions.

On December 11, 2018 PharmaMar (MSE:PHM) reported the Australian Regulatory Agency (TGA) has informed STA that Aplidin (plitidepsin) has been approved for the treatment of multiple myeloma in combination with dexamethasone (Press release, PharmaMar, DEC 11, 2018, View Source [SID1234532007]).

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Aplidin will be available to patients who have failed or are resistant to other therapies, after the TGA decision to approve Aplidin before any other country.

The indication has been approved for the treatment of patients that relapse after three lines of treatment, including proteasome inhibitors or immunomodulators. It can also be administered as 3rd line treatment, when the patient has already received two prior lines and is refractory or intolerant to proteasome inhibitors or immunomodulators.

This approval opens the door to many other markets in South America, Mexico, Canada, Asia Pacific, Middle East and North Africa, among others, that will review Aplidin after TGA’s decision, and where PharmaMar has partners for this product.

PharmaMar signed a licensing agreement with Specialised Therapeutics Asia Pte, Ltd (STA), established in Singapore, to market Aplidin in Australia and New Zealand in August 2015, along with a new agreement for 12 other Asian countries in February 2016.

Professor Andrew Spencer, Head of the Malignant Haematology and Stem Cell Transplantation Service at The Alfred Hospital, said: "Aplidin provides a chance for some myeloma patients to extend their lives. We now have another drug to offer patients who have relapsed after being treated with existing therapies. This is important, because once patients become resistant to standard therapies, there have been very limited treatment options."

Professor Jeff Szer, Peter MacCallum Cancer Centre and Royal Melbourne Hospital haematologist, who was the Australian principal investigator on the pivotal Aplidin registration study, said Aplidin had been shown to be effective and well tolerated. He commented: "More Australian myeloma patients were enrolled into the pivotal international trial of Aplidin than anywhere else in the world. These patients in the Phase 3 study known as ADMYRE have now paved the way for others to have access to a new and novel therapy. This really means that some patients with advanced myeloma have the possibility of improved outcomes, when previous therapies have failed."

Carlo Montagner, Chief Executive Officer of Specialised Therapeutics Asia, said Australian regulatory authorities should be commended for ensuring Australian myeloma patients have the first opportunity to access this cutting-edge therapy. He commented: "It is not often that Australian patients are the first in the world to access new medicines. In this case, the TGA is at the forefront, with decision-makers recognizing the great need that exists in multiple myeloma. This disease remains incurable and patients eventually run out of treatment options."

José María Fernández Sousa-Faro, President of PharmaMar, said: "This approval for an incurable disease, corroborates the work that the PharmaMar team has done over the years with Aplidin. Patients and the medical community will now have a new therapeutic alternative with a new mechanism of action, that is different from the products currently in use."

Luis Mora, Managing Director of PharmaMar´s Oncology Business Unit, added: "The approval of Aplidin is a very important step forward for the company. This increases PharmaMar’s presence with a second drug on the Australian market and, together with our partners, we are initiating procedures for other markets, such as South America, Mexico, Canada, Asia and Israel."
In Europe, as already announced, the decision of the European Medicines Agency (EMA) is being appealed to the Luxembourg Court.

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