On December 3, 2019 Proteostasis Therapeutics, Inc. (NASDAQ: PTI), a clinical stage biopharmaceutical company dedicated to the discovery and development of groundbreaking therapies to treat cystic fibrosis (CF) and other diseases caused by dysfunctional protein processing, reported that Proteostasis management will present at the Piper Jaffray 31st Annual Healthcare Conference on Thursday, December 5, 2019 at 11:00 a.m. ET at the Lotte New York Palace (Press release, Proteostasis Therapeutics, DEC 3, 2019, View Source [SID1234551904]).

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A live audio webcast of the Piper Jaffray conference presentation will be available on the Investor Events page in the Investors & Media section of the Company’s website, www.proteostasis.com. A replay of the webcast will be available on the Company’s website following the presentation.

On December 3, 2019 RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage immunology-based biopharmaceutical company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in oncology and inflammatory diseases, and Hanmi Pharmaceutical Co., LTD reported a license and collaboration agreement for FLX475 in Asia (Press release, RAPT Therapeutics, DEC 3, 2019, View Source [SID1234570684]). FLX475 is an oral, small molecule CCR4 antagonist in development for the treatment of multiple cancers.

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"We are actively building our immuno-oncology portfolio, and see FLX475 as a potential keystone in our effort to deliver new safe and effective cancer therapeutics to patients who need them," said Hanmi CEO Se-Chang Kwon, Ph.D. "This compound complements our current product portfolio and has the potential to address a large and growing population of patients suffering from cancers that are prevalent in Asian countries. We look forward to partnering with RAPT to advance FLX475 through the clinic efficiently."

Under the terms of the agreement, RAPT will receive $10 million in an upfront payment and near-term milestone payment. Additionally, RAPT will receive up to $48 million in success-based development milestones and up to $60 million in potential sales milestones, as well as double-digit royalties on any future sales of FLX475 in the specified territories. In return, Hanmi will receive an exclusive license to develop, in parallel with RAPT, and commercialize FLX475 for the treatment of cancer in South Korea and China, including Taiwan and Hong Kong. In addition to leveraging its clinical trial infrastructure in Korea and China to augment RAPT’s ongoing Phase 1/2 clinical study of FLX475, Hanmi will also conduct a Phase 2 clinical trial in Korea and China to evaluate FLX475 in patients with gastric cancer.

"FLX475 targets "charged" tumors including virally-associated cancers, gastric cancer, non-small cell lung cancer, triple negative breast cancer and head and neck cancers, which are predicted to have high levels of CCR4 ligands, regulatory T cells and CD8+ effector T cells," said Yung-Jue Bang, M.D., Ph.D., professor of Medical Oncology at Seoul National University Hospital. "I believe FLX475 has the potential to offer patients a new therapeutic option that is desperately needed, particularly in Korea, which has the highest rate of gastric cancer in the world."

"This collaboration with Hanmi can provide us an entry point into the Asian market, allowing us to potentially expand our geographic footprint in a region with high prevalence of patients with "charged" tumors who we believe are most likely to respond to FLX475," said Brian Wong, M.D., Ph.D., president and CEO of RAPT Therapeutics. "Hanmi, with its fully integrated R&D infrastructure and nimble execution efficiency, has accumulated clinical development experiences and an extensive network of key opinion leaders. We believe Hanmi is a perfect partner for the development of FLX475."

FLX475 is a small molecule CCR4 antagonist designed to block the migration of regulatory T cells (Treg) specifically into tumors, but not healthy tissues. Treg represent a dominant pathway for downregulating the immune response, and may limit the effectiveness of currently available therapies such as checkpoint inhibitors. RAPT is developing FLX475 for the treatment of a broad range of "charged" tumors, which represent cancer types the company believes are most likely to respond to FLX475, where a large quantity of Treg cells are likely to be the cause of immune suppression within the tumor. FLX475 blocks the migration of Treg to the tumor, which may restore naturally occurring antitumor immunity and synergizing with a variety of both conventional and immune-based therapies, such as radiation, chemotherapy, checkpoint inhibitors, immune stimulators and adoptive T cell therapy.

RAPT is currently enrolling patients in a Phase 1/2 study of FLX475 as a monotherapy, and in combination with pembrolizumab, in patients with "charged" tumors and expect results from the Phase 2 portion of the trial in the first half of 2020.

On December 3, 2019 DelMar Pharmaceuticals, Inc. (Nasdaq: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported that Mr. Saiid Zarrabian, Chief Executive Officer of DelMar, will be a featured presenter at the LD Micro Invitational Conference on December 10, 2019 at 2:40 pm PST, at the Luxe Sunset Boulevard Hotel in Los Angeles, CA (Press release, DelMar Pharmaceuticals, DEC 3, 2019, View Source [SID1234551871]).

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Management will also be available for one-on-one meetings.

For those interested in attending or for registered attendees who wish to request meetings, please contact David Scher at [email protected] or visit www.ldmicro.com for more information.

On December 3, 2019 Kyn Therapeutics, a clinical-stage biotechnology company, reported it is rebranding to Ikena Oncology (Press release, KYN Therapeutics, DEC 3, 2019, View Source [SID1234551888]). The rebranding reflects the evolution of the Company beyond its continued achievements in immuno-metabolism, as well as its renewed commitment to biomarker-driven oncology drug development. The rebranding is accompanied by announcement of the clearance by the U.S. Food and Drug Administration (FDA) of the Company’s investigational new drug (IND) application for IK-175, a small molecule antagonist of AHR. In addition, Ikena unveiled a new discovery program aimed at modulating the Hippo signaling pathway for treatment of cancer. Ikena has five development and discovery programs with multiple clinical and regulatory milestones expected in 2020, including report of preliminary clinical data on its lead program IK-007, an EP4 antagonist.

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Mark Manfredi, Ph.D., President and Chief Executive Officer of Ikena Oncology, commented, "Ikena Oncology represents the growth and evolution of our vision, strategy, capabilities and values. We look forward to leveraging these drivers to build on our efforts to become an industry leader in novel therapeutics for patients battling cancer."

The new name "Ikena" is derived from the combination of "i" which refers to the individual patient and "ken" which means knowledge, thereby illustrating the Company’s focus on using its insights to identify patients most likely to benefit from its therapies.

Advancement and Expansion of Development Pipeline

The expanded Ikena Oncology development pipeline is composed of patient-directed programs addressing distinct molecular targets and biologic pathways within and outside of immuno-metabolism, including immunotherapies and tumor cell intrinsic product candidates:

IK-007: A highly selective, first-in-class, oral EP4 receptor antagonist targeting the prostaglandin E2 (PGE2) immunosuppressive signaling pathway. IK-007 (formerly ARY-007) is being investigated in two ongoing Phase 1b/2 studies in combination with Merck’s anti-PD-1 therapy Keytruda (pembrolizumab) in patients with advanced or progressive microsatellite stable colorectal cancer (MSS CRC) and in patients with advanced or metastatic PD-1/L-1 refractory non-small cell lung cancer (NSCLC). Ikena is employing a robust, biomarker strategy by analyzing blood, tumor and urine biomarkers relevant to T cell checkpoint inhibitors and EP4 signaling. Ikena expects to report preliminary data in 2020.
IK-175: A selective oral AHR antagonist which prevents AHR-modulated tumor promotion through its influence on both the tumor and the immune system. The Company’s recently FDA-cleared IND enables the commencement of a first-in-human clinical study in which the anti-tumor activity of IK-175 (formerly KYN-175) will be evaluated as a single agent, and in combination with other therapies, in cancers with activated AHR. Ikena expects to initiate a clinical study evaluating IK-175 in early 2020. Ikena is employing a multi-assay AHR activation biomarker strategy to select lead cancer indications and enable prospective selection of patients believed most likely to benefit from IK-175. A patent application with claims directed to IK-175 has been deemed allowed by the United States Patent and Trademark Office. The AHR antagonist program is the subject of a global strategic collaboration with Celgene, now Bristol-Myers Squibb.
IK-412: A highly potent and stable kynurenine-degrading enzyme (or "Kynase") that may be able to overcome resistance to immune modulating agents. Ikena expects to file an IND for IK-412 (formerly KYN-412) in the second half of 2020. The first-in-human clinical study will be focused on patients with cancers that express high IDO1/TDO2. IK-412 is the subject of a global strategic collaboration with Bristol-Myers Squibb.
Hippo Program: The Hippo signaling pathway is a key tumor suppressor axis with tumor cell intrinsic dependence and immune system mechanisms of action. It is highly mutated in several cancer types, providing a streamlined path to clinical proof-of-concept. For example, there is a high prevalence of NF2 loss of function mutations in mesothelioma and LATS1/2 in bladder and renal cancers. Currently in the lead optimization stage, Ikena expects to identify a development candidate during the second half of 2020.
"As we launch our new corporate identity, we anticipate an exciting 2020 that includes multiple clinical and regulatory milestones. We are encouraged by the ongoing studies investigating IK-007 in combination with Keytruda in patients with MSS CRC and PD-1/L-1 refractory NSCLC, and look forward to continuing enrollment. Moreover, we aim to advance IK-175 into the clinic, file an IND for IK-412, and identify a development candidate for the Hippo program," concluded Dr. Manfredi.

The Company’s website is now available at IkenaOncology.com.

On December 3, 2019 QBiotics Group Limited (QGL), a life sciences company developing novel anticancer and wound healing pharmaceuticals, reported that it has dosed its first patient in a Phase I/II clinical trial evaluating the optimal dosing and safety of its lead product, tigilanol tiglate, in patients with head and neck squamous cell carcinoma (HNSCC) (Press release, QBiotics, DEC 3, 2019, View Source [SID1234551905]).

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Dr Victoria Gordon, Managing Director and CEO of QBiotics, said, "We are delighted to announce the treatment of our first patient in our multi-site clinical study, which includes trial sites in Australia and India. Cancers of the head and neck rank as the sixth most common cancer diagnosed worldwide[1] with more than 2 million[2] new cases each year. The high rate of HNSCC is largely driven by tobacco use, and increased infection with human papillomavirus (HPV)."

Dr Gordon continued, "This study marks an important advancement for QBiotics’ oncology pharmaceutical. It follows our successful first-in-man QBC46-H01 study[3] in a range of solid tumours, which demonstrated patients with squamous cell carcinoma, the most common type of head and neck cancer, had encouraging tumour responses when treated with tigilanol tiglate."

Surgery and radiotherapy are currently the primary local treatments for HNSCC. However, these treatments can come with challenges such as damage to healthy tissue and impacting a person’s ability to breathe, hear, see, smell, swallow or taste as well as adversely affecting appearance. Better local therapies are therefore needed. Direct intratumoural injection with tigilanol tiglate may offer advantages as it directly targets tumour cells and reaches infiltrating cancer cells that can be missed by surgery. This approach limits exposure and damage to surrounding healthy tissues, reducing the risk of functional or cosmetic impairment. Intratumoural injection also offers the potential for reduced toxicity due to localised (target site) treatment, compared to systemic toxicity induced by chemotherapeutic agents.

The Phase I/II open label "QBC46-H03" study, is a dose escalation study in patients with HNSCC aimed at determining the maximum tolerated dose (MTD) and recommended dose level for further studies. The study will also investigate safety, tolerability and tumour response following a single or multiple (two to three) doses of tigilanol tiglate. It will enrol up to 40 patients from the Tata Medical Centre in Kolkata, the Tata Memorial Hospital in Mumbai, the Princess Alexandra Hospital in Brisbane, and other clinical sites in Australia.