On May 11, 2021 Anticancer Bioscience (ACB), pioneers in synthetic lethal approaches to precision oncology, reported that progress in its MYC-synthetic lethal (MYC-SL) program (Press release, Anticancer Bioscience, MAY 11, 2021, View Source [SID1234579676]). The Company has identified three classes of novel small molecule compounds that demonstrate robust anti-cancer activity in preclinical studies, acting through interfering with mitosis and blocking cytokinesis. ACB is progressing through optimization and final candidate selection with the goal of progressing at least one of these MYC-SL compounds into clinical trials by 2022.

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The MYC family oncogene, encoding a transcription factor Myc, is deregulated in over 50% of human cancers, and this deregulation is frequently associated with poor prognosis and unfavorable patient survival. Myc has a central role in almost every aspect of the oncogenic process, orchestrating proliferation, apoptosis, differentiation, and metabolism. Direct targeting of Myc has been a challenge for decades owing to its "undruggable" protein structure, with a lack of a drug binding pocket. The synthetic lethality associated with Myc overexpression is being explored for its potential in the development of novel anti-cancer therapies.

Commenting on the progress and pre-clinical data, Dun Yang PhD, Founder, President, and CEO of ACB said:

"We are excited by our early in vitro and in vivo pre-clinical studies and in our molecular biology work to identify the target that our novel compounds hit. In animal models, data consistent with the in vitro studies has confirmed that the MYC-SL compounds act through interfering mitosis and blocking cytokinesis. We have filed patents on our compounds and are progressing rapidly through optimization to candidate selection and IND enabling studies."

The novel target for ACB’s MYC-SL compounds has been identified and will be subject to peer review publication in due course.

ACB has developed an innovative and proprietary general utility new scaffold-drug fragment (GUNS-DF) library approach to small molecule drug discovery. It is constructing 10 types of pilot GUNS-DF libraries, each of which contains a distinct core scaffold. Twenty compounds with excellent drug-like properties have been identified from three types of GUNS-DF libraries with a potency of less than 20 nM in a cell-based assay for MYC-SL agents. This potency was achieved after synthesizing and screening approximately 350 analogs during lead optimization.

At low nM concentrations, these compounds elicited potent cytotoxicity in a panel of 50 cell lines representing a variety of human malignancies. With adequate bioavailability, many of these compounds also suppressed the growth of various cancer cell lines that grew as xenografts in immunocompromised mice.

Having raised CNY131m (~USD21m) in seed finance to fund its discovery research, ACB is currently pursuing a Series A financing to progress at least one of its MYC-SL compounds into clinical trials.

ACB will be showcasing its innovative drug discovery platforms and pipeline at ChinaBio and BioEquity in May, and at BIO in June.

On May 11, 2021 ASLAN Pharmaceuticals (Nasdaq:ASLN), a clinical-stage immunology focused biopharmaceutical company developing innovative treatments to transform the lives of patients, reported financial results for the first quarter ended March 31, 2021 and provided an update on its clinical development activities (Press release, ASLAN Pharmaceuticals, MAY 11, 2021, View Source [SID1234579692]).

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Dr Carl Firth, Chief Executive Officer, ASLAN Pharmaceuticals, said: "We have continued to make solid progress in 2021 and we are on track to complete the expansion cohort in our multiple ascending dose trial for ASLAN004 with an additional 27 patients expected to be enrolled by mid-2021 followed by the announcement of topline data expected in the third quarter of 2021. We are excited to expand our senior management team with two highly experienced executives, Dr Karen Veverka, who will be leading our clinical development program, and Joseph Suttner to lead clinical operations. In addition, we are preparing for our Phase 2b trial for ASLAN004, which we expect to initiate in the second half of 2021. Our robust financial position provides the resources to fund development activities and achieve additional value creating milestones for shareholders."

First quarter 2021 and recent business highlights

Clinical development

ASLAN004

Positive interim data from the three dose cohorts of the ongoing Phase 1 randomised, double-blind placebo controlled multiple ascending dose (MAD) study of ASLAN004 for the treatment of moderate to severe atopic dermatitis (AD) were announced in March. ASLAN004, a novel, first-in-class antibody, was well tolerated across all doses and showed improvements compared to placebo in all efficacy endpoints, supporting its potential as a differentiated treatment for AD. Additional data from the expansion cohort is planned for the third quarter of 2021.
New data from the Single Ascending Dose study that demonstrate ASLAN004’s favourable tolerability profile as an IL-13Rα1 inhibitor and as a differentiated treatment method for atopic dermatitis patients were accepted for poster presentation at the 2021 Society for Investigative Dermatology virtual meeting on 6 May. The data will also be published in the fall edition of the Journal of Investigative Dermatology.
Corporate updates

Appointed Dr Karen Veverka as Vice President, Medical to lead ASLAN’s clinical medical development program for new products, including Phase 2 and 3 trials. Dr Veverka brings more than 20 years of experience in the pharmaceutical industry, as well as significant preclinical and clinical research and development (R&D) experience in immunology and dermatology. Prior to joining ASLAN, Dr Veverka was Senior Medical Director and Medical Head for the Innovative Portfolio at LEO Pharma, a leader in global dermatology. At LEO she led the development of brand medical strategy and execution of medical affairs activities for products in the AD and psoriasis therapeutic areas, including tralokinumab. Dr Veverka has also held leadership roles at Novartis and GTx. Dr Veverka earned her PhD in Pharmacology at The Mayo Clinic Graduate School of Biomedical Sciences and completed a postdoctoral research fellowship at St Jude Children’s Research Hospital.
Appointed Joseph Suttner as Vice President, Clinical Operations. Mr Suttner brings more than 20 years in clinical operations and R&D, including more than 8 years in dermatology. Mr Suttner has successfully led clinical operations teams at Dermira, PellePharm and several other biotechnology companies through Phase 2b trials in AD, Gorlin syndrome, and actinic keratosis, among other conditions.
Anticipated upcoming milestones

Completion of MAD clinical study of ASLAN004 in moderate-to-severe AD patients with clinical results expected in third quarter of 2021.
Initiation of Phase 2b study of ASLAN004 for AD expected in the second half of 2021.
First quarter 2021 financial highlights

Cash used in operations for the first quarter of 2021 was US$7.6 million compared to US$5.2 million in the same period in 2020.
Research and development expenses were US$3.8 million in the first quarter of 2021 compared to US$2.4 million in the first quarter of 2020. The increase was driven by manufacturing expenses incurred in preparation for the Phase 2b trial of ASLAN004.
General and administrative expenses were US$3.1 million in the first quarter of 2021 compared to US$1.0 million in the first quarter of 2020. The increase was due to the increase in headcount and staffing costs in preparation for the Phase 2b trial of ASLAN004 and additional corporate costs incurred to support the fundraising activities that were concluded in the first quarter of 2021.
Net loss for the first quarter of 2021 was US$6.7 million compared to a net loss of US$3.0 million for the first quarter of 2020.
Cash, cash equivalents and short-term investments totalled US$100.8 million as of 31 March 2021 compared to US$14.3 million as of 31 December 2020. Following the financing activities in the first quarter of 2021, which raised combined gross proceeds of approximately US$101 million, management believes that its cash and cash equivalents will be sufficient to fund operations into 2023.
The weighted-average number of American Depository Shares (ADSs) outstanding in the computation of basic loss per share for the first quarter of 2021 was 51.4 million (representing 257.2 million ordinary shares) compared to 38.0 million (representing 190.0 million ordinary shares) for the first quarter of 2020. Following the financing activities in the first quarter of 2021, the number of ADSs outstanding on 31 March 2021 was 69.5 million (representing 347.6 million ordinary shares). One ADS is the equivalent of five ordinary shares.

On May 11, 2021 Ashvattha Therapeutics, a clinical stage biotech company focused on novel hydroxyl dendrimer therapeutics (HDTs) targeting unmet medical needs in neuro-oncology, neurology and ophthalmology, reported that it will present at the Sachs 7th Annual Immuno-Oncology Innovation Forum, held virtually, May 18-20, 2021 (Press release, Ashvattha Therapeutics, MAY 11, 2021, View Source [SID1234579708]).

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Jeffrey Cleland, Ph.D., Chairman, CEO and President of Ashvattha Therapeutics will provide an overview of the company, and its pipeline enabled by a proprietary hydroxyl dendrimer (HD) technology platform – a differentiated, superior approach to targeted intracellular therapy.

"We are excited to present our strategy in neuro-oncology therapeutics for the first time at the Sachs Immuno-Oncology Forum," said Jeffrey Cleland, Ph.D., Chairman, CEO & President at Ashvattha Therapeutics. "There remains a significant unmet need in treating primary and metastatic brain cancers with therapeutic agents that can cross the blood brain barrier and precisely target tumor associated macrophages. We are developing an HD imaging agent, D6-B483, to demonstrate uptake of HDs in gliomas and brain metastases. This agent will also be used as a radiotherapeutic. HDTs currently in preclinical studies are designed to manipulate the tumor microenvironment toward a pro-inflammatory state increasing innate immune responses to the tumor."

Ashvattha’s technology platform consists of HDs that selectively target regions of inflammation within the body. Current cancer treatments have dose-limiting toxicity reducing efficacy, and even precision medicine and targeted therapies lack sufficient specificity to tumors. Most cancer drugs do not cross the blood-brain barrier (BBB) to treat brain cancer. In addition, current immune therapies do not target tumor-associated macrophages (TAMs). Ashvattha’s HDTs widen the therapeutic window and increase the maximum tolerated dose, for better patient outcomes. Its proprietary compounds also target and treat brain tumors with durable effects inside TAMs for up to 30 days. Ashvattha is currently on track to initiate a D6-B483 Phase 1 study in patients with glioblastoma multiforme or brain metastases by end of 2021.

The 7th Annual Immuno-Oncology Innovation Forum is designed to bring together thought leaders from cancer research institutes, patient advocacy groups, pharma and biotech to facilitate partnering, funding and investment. Members of the management team will be available for virtual meetings at the conference. For more information, visit the conference website: View Source

On May 11, 2021 Imvax, a clinical stage immuno-oncology company driven to transform patient treatment and outcomes with its novel technology platform, reported that John Furey, chief executive officer, will present at the UBS Global Healthcare Virtual Conference at 1 p.m. EDT Wednesday, May 26, 2021 (Press release, Imvax, MAY 11, 2021, View Source [SID1234579725]).

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Mr. Furey, Dr. David Andrews, chief medical officer, and Dr. Mark Exley, chief scientific officer, will also participate in one-on-one investor meetings during the conference.

The presentation will be webcast live and will be available for replay for 30 days following the event at https://bit.ly/3gPPF8U.

On May 11, 2021 Eli Lilly and Company (NYSE: LLY) and MiNA Therapeutics Limited, a pioneer in RNA activation therapeutics, reported a global research collaboration to develop novel drug candidates using MiNA’s proprietary small activating RNA (saRNA) technology platform (Press release, Eli Lilly, MAY 11, 2021, View Source [SID1234579662]).

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Under the terms of the agreement, MiNA will utilize its saRNA platform to research up to five targets selected by Lilly that aim to address diseases across Lilly’s key therapeutic focus areas. Lilly will be responsible for preclinical and clinical development of candidates and will retain exclusive commercialization rights for any products resulting from the collaboration. MiNA will receive a $25 million upfront payment and is eligible to receive potential development and commercialization milestones up to a total of $245 million per target, as well as tiered royalties from the low-single to low-double digits on product sales resulting from the collaboration.

"Small activating RNAs are a promising new technology, which will expand the breadth of Lilly’s RNA therapeutics platform and the targets we can pursue," said Andrew C. Adams, Ph.D., vice president for new therapeutic modalities at Lilly. "We are excited about the potential of combining MiNA’s leading saRNA platform and our expertise in new modalities to accelerate development of RNA-based medicines in areas of high unmet medical need."

"This collaboration with Lilly is an important validation of our saRNA platform," said Robert Habib, CEO of MiNA Therapeutics. "Lilly’s expertise in the field of RNA therapeutics and clinical development will greatly enhance our efforts to realize the technology’s full potential. Together, we aim to unlock new targets in multiple therapeutic areas and to ultimately move them towards clinical development and commercialization."

This transaction will be reflected in Lilly’s reported results and financial guidance according to Generally Accepted Accounting Principles (GAAP). There will be no change to Lilly’s 2021 non-GAAP earnings per share guidance as a result of this transaction.