On November 13, 2018 Kleo Pharmaceuticals Inc., an immuno-oncology company pioneering a new class of bi-specific, small molecule compounds designed to emulate or enhance biologics against cancer, reported the closing of an oversubscribed $21 million Series B financing to advance its first clinical candidates through IND-enabling studies and into the clinic in 2020 (Press release, Kleo Pharmaceuticals, NOV 13, 2018, View Source [SID1234531411]). The financing was led by the company’s development partner, PeptiDream, Inc., (TOKYO:4587), with participation from current strategic investor Biohaven Pharmaceuticals Inc. (NYSE:BHVN).

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Kleo’s lead candidates are based on the Company’s modular Antibody Recruiting Molecules (ARMs) technology, which enables Kleo’s compounds to bind at one end to specific targets on cancer cells and to the body’s endogenous antibodies. This unique approach redirects the activity of any ARM-bound antibody against the cancer cells without inhibiting the antibody’s native function. In parallel, Kleo is continuing to advance its two additional immuno-oncology therapy platforms, including its Synthetic Antibody Mimics (SyAMs) and Monoclonal Antibody Therapy Enhancers (MATEs).

Douglas Manion, CEO of Kleo Pharmaceuticals, said, "Successful completion of this financing represents an important step in the translation of our groundbreaking approach into therapies that may improve patients’ lives. Having improved the modularity of our platforms and expanded the applicability of our ARMs to recruit antibodies to target cancer cells, we are now well funded to advance our first next-generation candidates into human clinical studies. We are excited to welcome our development partner PeptiDream to our community of investors, and we’re humbled by the continued support of our founding investor Biohaven."

Patrick Reid, CEO of PeptiDream, stated, "We have worked with Kleo since July 2017 and we are impressed by the scientific progress they have made in validating their technology platforms. We are enthusiastic about the robust pipeline they are building from all three of their unique immunotherapy platforms and we are very happy to be a part of it, both as a strategic partner and now as an investor. We believe Kleo’s clinical candidates represent a paradigm shift in immuno-oncology development that elegantly delivers the therapeutic power of highly complex bi-specific antibodies, but in a more simple, less costly, and potentially more beneficial manner. When combined with PeptiDream’s robust discovery platform, we expect Kleo to generate many novel drug franchises that can bring incredible value for patients suffering from cancer."

On November 13, 2018 Helix BioPharma Corp. (TSX, FSE: "HBP"), an immuno-oncology company developing drug candidates for the prevention and treatment of cancer, reported a strategic update of its LDOS47 clinical program (Press release, Helix BioPharma, NOV 13, 2018, View Source [SID1234531459]).

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Helix’s L-DOS47 strategic development plan has two parts. The first part is to ensure L-DOS47 will be used in a well-established treatment setting, while being ready to be applied in novel therapies. For this reason, L-DOS47 clinical programs will focus primarily in a combination setting. In this plan L-DOS47 will be studied with well-established chemotherapeutics and in combination with novel immunotherapy. The Company is well advanced in carrying out the study of L-DOS47 with chemotherapy in lung cancer. The planning for combining with immunotherapies in this indication is also in progress.

In the second part of the strategic development plan, the Company will focus on expanding the utility of L-DOS47 to indications other than lung cancer. In choosing a new indication for L-DOS47, the company has considered available preclinical and clinical L-DOS47 data, consulted with key opinion leaders and considered the best strategic application of limited financial resources. To this end, the Company has recently announced the start of a new pancreatic cancer program.

As of today, the Company has completed a monotherapy study of L-DOS47 in lung cancer, with two combination studies in the same indication that are actively recruiting patients. The Company is also working diligently to prepare for regulatory filing of a new pancreatic cancer study with the United Sates Food and Drug Administration ("FDA").

The following is a status update of active studies currently taking place.

LDOS001

LDOS001 is a Phase I dose escalation study of L-DOS47 with pemetrexed and carboplatin for the first line treatment in recurrent or metastatic non-squamous non-small cell lung cancer. A total of seven (7) cohorts comprising of L-DOS47 doses at 0.59, 0.78, 1.5, 3.0, 6.0, 9.0 and 12.0 ug/kg were approved. To date, five (5) cohorts have been completed and a total of 12 patients were dosed. No dose limiting toxicity was observed. In cohort 1, one patient had a partial response (36% tumor regression). In cohort 2, three other patients had partial response (40%, 44% and 91% tumor regression) and one additional patient experienced stable disease for 13.3 months. In cohort 4, one patient had a partial response (69% tumor regression). The company expects to enroll six more patients to complete recruitment for study dosing cohorts if no dose limiting toxicity is observed.

LDOS003

LDOS003 is a phase II, open-Label, randomized study of immunoconjugate L-DOS47 in combination with vinorelbine and cisplatin versus vinorelbine and cisplatin alone in patients with lung adenocarcinoma. Regulatory and Ethics approvals to dose patients were first received from Ukraine in March and from Poland in April. While the company had planned to enroll patient shortly thereafter, the program was delayed due to financial constraints. The company has recently reprioritized its resources and expects to enroll patients in this study immediately.

LDOS006

The Company recently announced the launch of a U.S. Phase I/II study of L-DOS47 in combination with doxorubicin for the treatment of metastatic pancreatic cancer. The study will be led by Dr. Daniel Von Hoff and his team. The Company is currently completing the study protocol and related documents necessary for an investigational new drug ("IND") application to the FDA.

On November 13, 2018 ISA Pharmaceuticals B.V., a clinical-stage immuno-oncology company, reported that its Chief Scientific Officer Prof. Cornelis Melief has been selected by the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) to receive the 2018 ESMO (Free ESMO Whitepaper) Immuno-Oncology Award in recognition of his life’s work in studying the interactions of the immune system with cancer (Press release, ISA Pharmaceuticals, NOV 13, 2018, View Source [SID1234531236]). He will receive the award during an official ceremony at the opening keynote and award lecture of this year’s ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress in Geneva, Switzerland, on December 13, 2018 (01:30-01:45 pm CET, Hall A2 – Room A). The title of his lecture will be "Combination immunotherapy of cancers caused by high risk human papilloma virus".

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Prof. Melief will be the second recipient of the ESMO (Free ESMO Whitepaper) Immuno-Oncology Award, which was created in 2017 in commemoration of European cancer research and treatment pioneer Prof. Georges Mathé, a founding member of ESMO (Free ESMO Whitepaper).

In addition to his role at ISA Pharmaceuticals, Prof. Melief is Professor Emeritus in tumor immunology at the Leiden University Medical Center in the Netherlands. He focuses on the development of effective immunotherapies for virus-induced tumors and has created the concept of synthetic long peptide (SLP) vaccines for the treatment of cancer patients. Prof. Melief and his team were able to show the clinical effectiveness of these therapeutic vaccines in patients with pre-malignant lesions caused by Human Papilloma Virus type 16 (HPV-16).

Among the most promising results obtained to date, Melief and his team found that a combination of SLP vaccination and standard chemotherapy strengthened cervical cancer patients’ immune response and prolonged their survival. They further discovered that a similar effect could be achieved among patients with HPV-related head and neck cancer by administering the vaccines in conjunction with immunotherapy in the form of immune system boosting monoclonal antibodies.

Prof. George Coukos and John Haanen, Scientific Co-Chairs of the upcoming congress, outlined the reasons for nominating Cornelis Melief:

"Professor Melief dedicated his career to understanding how the immune system, specifically cytotoxic lymphocytes, interact with cancer, and used this knowledge for the development of new therapeutic cancer vaccine strategies," said Coukos.

"With this award, we are recognizing him as a true pioneer in the field of cancer immunology, who has trained and inspired a whole generation of young scientists with his research," Haanen added.

"This is a great honor and a wonderful recognition of the fact that after many years of concept building and evaluation in lab models and investigational trials, we have finally arrived at immunotherapy approaches that can make a difference for patients," said Prof. Cornelis Melief. "To me, this award also means recognition of the outstanding teamwork delivered by talented investigators at Leiden University Medical Center and ISA Pharmaceuticals as well as by many medical oncologists in the Netherlands, Belgium and the USA."

On November 13, 2018 AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, will participate in the Evercore ISI HealthConX Conference on Tuesday, November 27, 2018. Bill Chase, executive vice president, finance and administration, will present at 8 a.m. Eastern time.

A live audio webcast of the presentation will be accessible through AbbVie’s Investor Relations website at investors.abbvie.com. An archived edition of the session will be available later that day.

On November 13, 2018 Sutro Biopharma, Inc. (NASDAQ: STRO), reported that the U.S. Food and Drug Administration (FDA) has concluded their 30-day review of the Investigational New Drug (IND) application for STRO-002 to be evaluated in a Phase1 clinical study as a potential treatment for ovarian and endometrial cancer (Press release, Sutro Biopharma, NOV 13, 2018, View Source [SID1234531416]). The antibody-drug conjugate STRO-002 targets folate receptor-α, a cell-surface protein expressed in 80% of ovarian and endometrial cancers.

"The ability to begin our Phase I clinical study marks an important milestone that expands Sutro’s clinical development pipeline and further validates our technology for the design of unique and potent antibody-drug conjugates," said Bill Newell, Sutro’s Chief Executive Officer. "The Phase 1 clinical trial of STRO-002 is expected to begin in early 2019 with the goal to investigate the safety, tolerability and preliminary anti-tumor activity of STRO-002 in patients with gynecologic malignancies."

Patients with ovarian cancer will be enrolled during the dose escalation-phase of the study, and two separate cohorts for ovarian and endometrial cancer will be evaluated during dose expansion.

"Ovarian and endometrial cancer patients need targeted treatment options with better tolerability and efficacy," commented Dr. Wendel Naumann, MD Gynecologic Oncologist Professor, Dept. Ob/Gyn Levine Cancer Institute, Carolinas Medical Center.

In preclinical studies, STRO-002 effectively delivered its cytotoxin to targeted cancer cells without significant accumulation of a toxic metabolite in the blood. Testing of clinically relevant doses in non-human primates showed no evidence of ocular toxicity, a vexing problem associated with conventional ADCs containing standard tubulin-inhibiting agents.

"This is an important development for ADC-based cancer therapeutics and could provide new means to achieving greater anti-tumor activity in the clinic before the onset of dose-limiting side effects," added Dr. Arturo Molina, Sutro’s Chief Medical Officer.

Unlike first-generation ADCs, STRO-002 is a homogeneous, site-specific antibody-drug conjugate that incorporates a novel, proprietary linker-warhead, thereby enabling effective and precise payload delivery to targeted cancer cells. Preclinical studies demonstrated STRO-002’s potent in vitro cytotoxicity in ovarian and endometrial cancer cell lines, and tumor growth inhibition in multiple in vivo ovarian and endometrial cancer models. Safety studies conducted in non-human primates have shown tolerability at clinically relevant doses with no observed ocular toxicity.

About STRO-002

STRO-002 was developed with Sutro’s proprietary cell-free protein synthesis and site-specific conjugation platform, XpressCF+TM, which enables precise design, rapid empirical optimization, and manufacture of site-specific ADCs. Sutro’s technology results in highly optimized ADCs comprising a single molecular species, in contrast to first-generation commercial ADCs that comprise a mixture of imprecisely conjugated antibodies. STRO-002 has been engineered to use Sutro’s novel, proprietary SC239 linker-warhead, designed for increased stability and potency, which results ineffective targeting of cancer cells and precise delivery of the payload.

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