On August 5, 2020 Genor Biopharma Co. Inc reported that National Medical Products Administration (NMPA) has granted priority review status to its new drug application (NDA) for Geptanolimab, a PD-1 mAb, on July 28, 7 days after the NDA acceptance (Press release, Genor Biopharma, AUG 5, 2020, View Source [SID1234594762]).

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Relapsed/refractory Peripheral T cell Lymphoma (PTCL) is the first indication that Genor targeted for its Geptanolimab. It is currently the first PD-1 mAb in China and globally being applied for this disease setting.

On August 5, 2020 Tiziana Life Sciences plc (Nasdaq: TLSA / AIM: TILS) (the "Company" or "Tiziana"), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, reported the closing of its registered direct offering (the "Offering") of American Depositary Shares ("ADSs") on the NASDAQ Global Market (Press release, Tiziana Life Sciences, AUG 5, 2020, View Source [SID1234568593]). As announced on 3 August 2020, Tiziana issued 11,009,615 ADSs (representing 22,019,230 new ordinary shares of nominal value £0.03 each in the capital of the Company ("Ordinary Shares")) at a price of $5.20 per ADS raising gross proceeds of approximately $57.25 million (before deducting placement agent fees and offering expenses). Each ADS offered represents two (2) Ordinary Shares. All ADSs sold in the Offering were offered by the Company. The number of Ordinary Shares represented by ADSs comprised in the Offering were within existing shareholder authorities.

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ThinkEquity, a division of Fordham Financial Management, Inc., acted as the sole placement agent manager for the Offering.

Tiziana intends to use the net proceeds received from this Offering (i) to advance the clinical development of Foralumab, (ii) to initiate a trial in HCC patients with Milciclib, (iii) to expedite clinical development of TZLS-501 for coronavirus COVID-19, and for working capital and other general corporate purposes. Tiziana’s Ordinary Shares are admitted to trading on AIM, a market of the London Stock Exchange plc ("AIM"), under the symbol "TILS". The ADSs are listed for trading on the Nasdaq Global Market under the symbol "TLSA".

This Offering was being made pursuant to a registration statement on Form F-3, as amended (File No. 333-236013), previously filed with the U.S. Securities and Exchange Commission (the "SEC"), which became effective on February 6, 2020.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. A final prospectus supplement and accompanying base prospectus relating to this offering have been filed with the SEC and are available at the SEC’s website at View Source

Copies of the final prospectus supplement and accompanying prospectus relating to the offering may be obtained from ThinkEquity, a division of Fordham Financial Management, Inc., 17 State Street, 22nd Floor, New York, New York 10004, by telephone at (877) 436-3673, by email at [email protected]. Electronic copies of the final prospectus supplement and accompanying prospectus will also be available on the SEC’s website at View Source

Total Voting Rights

In conformity with DTR 5.6.1, the Company notifies that as at the date of this announcement, it has a single class of shares in issue being Ordinary Shares and that following the issue of the Ordinary Shares to be issued in the Offering, the total number of Ordinary Shares in issue is 190,559,823 There are no Ordinary Shares held in treasury. Each Ordinary Share entitles the holder to a single vote at general meetings of the Company.

The figure of 190,559,823 Ordinary Shares may be used by shareholders (and others with notification obligations) as the denominator for the calculations by which they will determine whether they are required to notify their interest in, or a change to their interest in, the Company under the Financial Conduct Authority’s Disclosure Guidance and Transparency Rules.

The person who arranged for the release of this announcement on behalf of the Company was Keeren Shah, Chief Financial Officer of Tiziana

On August 5, 2020 Sysmex Inostics, Inc., a global leader and pioneer in blood-based circulating tumor DNA (ctDNA) analysis for oncology, reported the publication of a clinical study evaluating the performance of plasma RAS mutation testing with OncoBEAM RAS CRC as compared to standard of care tissue-based RAS testing in the United Kingdom (UK) (Press release, Sysmex Inostics, AUG 5, 2020, View Source [SID1234568250]).

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OncoBEAM RAS CRC is a CE-IVD test that uses BEAMing technology, an enhanced digital PCR method optimized for high sensitivity blood-based mutation detection for metastatic colorectal cancer (mCRC) patients. This is the first study of its kind in the UK with confirmatory testing performed across laboratories certified to run the OnocBEAM RAS CRC test. Investigators also utilized the highly sensitive nature of OncoBEAM testing to also explore the clinical value of detecting changes in plasma RAS mutation status in patients treated with anti-EGFR antibody therapy.

The overall percent agreement between the OncoBEAM assay and tissue-based testing for RAS mutations was 86.0% (86/100), with a 100% reproducibility of test results between three labs located in the UK, Germany, and Japan. This demonstrates that blood-based testing with an appropriate and well validated assay can serve as an alternative to tissue-based testing and can improve access to precision medicine globally.

Colorectal cancer (CRC) continues to be one of the leading causes of cancer-related deaths globally. Anti-EGFR monoclonal antibodies have demonstrated significant improvements in survival of patients with wild-type RAS tumors mCRC. However, tissue-based biomarker testing has been shown to present several challenges, such as tumor molecular heterogeneity, poor tissue quality, and logistical issues, which can contribute to delays in treatment initiation. Importantly, as patients undergo treatment with targeted therapies, insight into changing tumor molecular dynamics would require repeat tissue biopsies, which is not practical in routine clinical management. Since mCRC patients already undergo regular blood draws throughout treatment; testing with the OncoBEAM RAS assay can deliver valuable insights into tumor response.

The ability to draw serial blood samples and perform OncoBEAM ctDNA longitudinal analyses of RAS mutant allelic fraction (MAF) variation before and during anti-EGFR therapy provides opportunities to identify emerging RAS mutant clones early during treatment. This minimally invasive approach provides better visualization of treatment responses and failures, enabling personalized therapy approaches for mCRC patients, with the goal of improving outcomes. The lead and senior authors of the study, Dr. Theodora Germetaki and Dr. Mark Saunders, Department of Medical/Clinical Oncology, The Christie Hospital, Manchester, UK conclude: "We showed that 20% of patients showed a change in their RAS mutational status during treatment. These results demonstrate there is an opportunity to more precisely understand an individual patient’s tumor response using longitudinal plasma testing in order to establish new clinical decision points for the management of patients receiving EGFR inhibitor therapy." Ongoing studies are exploring the outcomes and cost-effectiveness of OncoBEAM RAS testing to guide the management of anti-EGFR treatment in mCRC patients.

Overall, this study shows the value of an ultrasensitive OncoBEAM liquid biopsy RAS test in overcoming sampling bias associated with tissue biopsy to enable rapid turn-around time of molecular test results for more timely initiation of first-line treatment and early detection of RAS mediated resistance in patients receiving anti-EGFR therapy.

The publication, titled "Blood-based RAS mutation testing: concordance with tissue-based RAS testing and mutational changes on progression," was published in Future Oncology July 27, 2020, by Theodora Germetaki, et al. View Source

On August 5, 2020 Aileron Therapeutics (NASDAQ:ALRN) reported business highlights and financial results for the second quarter ended June 30, 2020 (Press release, Aileron Therapeutics, AUG 5, 2020, View Source [SID1234565069]).

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"We continue to make important progress advancing our goal to deliver a novel chemoprotective medicine that can protect cancer patients against multiple serious, often life-threatening chemotherapy-induced side effects," said Manuel Aivado, M.D., Ph.D., President and Chief Executive Officer of Aileron. "We’re pleased with the preliminary data we reported in June from the dose optimization part of our ongoing Phase 1b proof-of-concept clinical trial of ALRN-6924 to protect against chemotherapy-induced bone marrow toxicities in small cell lung cancer patients undergoing treatment with topotecan. These data showed clinically meaningful protection against severe chemotherapy-induced anemia and thrombocytopenia. In addition, a signal of protection against Grade 4 neutropenia in the first treatment cycle was observed at the 0.3 mg/kg dose level."

Dr. Aivado further commented, "Key inflection points for Aileron in the coming months include final Phase 1b dose optimization data in addition to preliminary data from the recently initiated schedule optimization part of the trial, both in the fourth quarter, as well as the initiation of our healthy volunteer study of ALRN-6924 in the third quarter. These milestones will further support and de-risk our plans to expand development of ALRN-6924 for multiple cancer types and various chemotherapies, to ultimately deliver this unique chemoprotective medicine to as many patients with p53-mutated cancers as possible, which could translate to approximately half of all cancer patients."

Key Second Quarter and Recent Highlights

Ongoing ALRN-6924 Proof-of-Concept Phase 1b Study

Part one of study: dose optimization

Announced positive interim dose optimization results. In June 2020, Aileron announced positive interim data from the open-label dose optimization part of its ongoing Phase 1b clinical study of ALRN-6924. The study is evaluating ALRN-6924 as a therapeutic agent administered ahead of chemotherapy to protect against chemotherapy-induced bone marrow toxicities in patients with p53-mutated small cell lung cancer (SCLC) who are being treated with topotecan.
In the dose optimization part of the study, ALRN-6924 was administered at three dose levels (0.3, 0.6, and 1.2 mg/kg) 24 hours before each dose of topotecan. Topotecan was administered days 1 through 5 every 21 days.

As reported in June, treatment with ALRN-6924 resulted in a protective effect against severe chemotherapy-induced anemia and thrombocytopenia compared to historical controls. In addition, patients treated with 0.3 mg/kg ALRN-6924 met the protocol-defined criterion for reduction of NCI CTC Grade 3/4 neutropenia to ≤50% in the first treatment cycle, triggering a cohort expansion at this dose level, from six to 14 patients.

Completed enrollment in dose optimization expansion cohort. Aileron recently announced completion of enrollment into the 0.3 mg/kg dose level cohort expansion, to reach a total of 14 patients treated at this dose and the 24-hour before topotecan schedule
Part 2 of study: schedule optimization

Initiated enrollment in schedule optimization part of study. In June 2020, Aileron announced that it began enrollment in the schedule optimization part of its ongoing Phase 1b clinical study. This part of the study is intended to determine whether ALRN-6924 given six hours before topotecan further enhances the protective effects observed when ALRN-6924 was given 24 hours before topotecan in the dose optimization part of the trial, as described above. Aileron plans to report final dose optimization data, including data from the dose optimization expansion cohort, in the fourth quarter of 2020. In addition, Aileron also plans to report preliminary schedule optimization data in the fourth quarter of 2020. Aileron will continue to carefully monitor the effect of the coronavirus pandemic on its clinical trial sites and the healthcare system, which may impact its planned data announcements.

Planned Healthy Volunteer Study

In the third quarter of 2020, Aileron plans to initiate enrollment in a healthy volunteer study to determine dosing schedules for ALRN-6924 that will support and further de-risk the company’s long-term vision to provide a chemoprotective medicine for patients with p53-mutated cancer regardless of cancer type or chemotherapeutic drug.

Corporate

Completed public offering of common stock. In June 2020, Aileron completed a public offering of common stock, priced at a public offering price of $1.10 per share, raising $10.3 million in aggregate net proceeds, including shares sold to the underwriter pursuant to its exercise of its option to purchase additional shares and after deducting underwriting discounts and commissions and offering expenses.
Second Quarter 2020 Financial Results

Cash Position: Cash, cash equivalents and investments as of June 30, 2020 were $18.9 million, compared to $18.3 million as of December 31, 2019.
Research and Development Expenses: Research and development expenses for the quarter ended June 30, 2020 were $2.5 million, compared to $4.3 million for the quarter ended June 30, 2019. The decrease is primarily a result of a $1.2 million decrease in clinical development expenses attributed to the completion of patient dosing in our Phase 2a expansion cohort of the combination of ALRN-6924 and IBRANCE (palbociclib) for the treatment of MDM2-amplified advanced solid tumors during the first quarter of 2020 and the effect of cost-saving measures implemented in 2019 and 2020.

General and Administrative Expenses: General and administrative expenses were $1.9 million for the quarter ended June 30, 2020, compared to $3.1 million for quarter ended June 30, 2019. The decreased expense in 2020 primarily reflects cost-saving initiatives that were implemented in March 2020 and lower administrative support-related costs in 2020 as compared to 2019.

Net Loss: Net loss was $4.4 million for the quarter ended June 30, 2020, compared to $7.2 million for the corresponding period in 2019.
How ALRN-6924 Works to Protect Healthy Cells from Chemotherapy-Induced Damage

ALRN-6924 is being developed by Aileron as a novel chemoprotective medicine to treat and protect healthy cells in patients with cancer that harbors p53-mutations to reduce or eliminate chemotherapy-induced side effects.

Chemotherapy targets cells that are cycling, or undergoing the process of cell division. In cancer cells, the cell cycle is unchecked, which leads to uncontrolled cell proliferation, a hallmark of cancer. Certain types of healthy cells also naturally need to cycle, such as bone marrow cells (which give rise to red blood cells, white blood cells, and platelets), hair follicle cells, skin cells, and cells lining the oral cavity and the gastrointestinal tract. As a result, chemotherapy targets and kills both cycling healthy cells and cycling cancer cells. This, in turn, leads to a spectrum of chemotherapy-induced side effects, from unpleasant to life-threatening.

ALRN-6924, an investigational first-in-class MDM2/MDMX dual inhibitor, is administered to cancer patients shortly before chemotherapy. ALRN-6924 is designed to selectively activate normal p53 protein in patients’ healthy cells, temporarily and reversibly pausing cell cycling to shield healthy cells from chemotherapy. The protection is limited to healthy cells, as ALRN-6924 cannot work in p53-mutated cancer cells given that p53 has lost function in those cells. Therefore, cancer cells continue to cycle uninterrupted, remaining fully susceptible to destruction by chemotherapy.

On August 5, 2020 GeneCentric Therapeutics, Inc. and Erasmus University Medical Center (EUMC) reported that they have entered into a research collaboration to identify RNA-based drug response markers and novel, targeted therapies in the setting of non-muscle invasive bladder cancer (NMIBC) (Press release, GeneCentric Therapeutics, AUG 5, 2020, View Source [SID1234564815]). The research will comprehensively characterize the tumor and immune biology, as well as the tumor microenviroment related to NMIBC, and will apply GeneCentric’s Bladder Cancer Subtype Profiler (BSP), among other novel assays, to predict disease progression and drug response in these patients.

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The collaboration, led at EUMC by Tahlita Zuiverloon, MD, PhD, Principal Investigator at the Erasmus MC Urothelial Cancer Research Group (EUCRG), will involve the retrospective longitudinal, genomic analysis of samples from a sizeable cohort of NMIBC patients who received surgery and adjuvant treatment. "This collaboration will provide a more complete and fundamental understanding of NMIBC drivers of disease progression, innate and active immune system involvement, and factors related to treatment response and failure or drug resistance," said Dr Zuiverloon. "We look forward to the new insights that the application of GeneCentric’s comprehensive molecular profiling platform can provide as we eagerly pursue new therapeutic options for NMIBC patients."

"To date, genomic subtypes for disease progression risk and drug response to NMIBC have not been well characterized," said Dr. Mike Milburn, President and CEO of GeneCentric Therapeutics. "This exciting research collaboration has potential to augment our molecular gene signatures to help define these subtypes and inform clinical decision making and drug development. There is a significant clinical need and opportunity to improve outcomes, as treatment of NMIBC is evolving with the emergence of novel targeted therapies, potentially including FGFR inhibitors, in addition to the current standard of care."