On August 2, 2022 Ablaze Pharma and Wenjiang District Government of Chengdu reported that jointly signed the strategic agreement during the Conference of Major Advanced Manufacturing Projects by Foreign Direct Investment (Press release, Ablaze Pharmaceuticals, AUG 2, 2022, View Source [SID1234617367]). About 26,000㎡ of industrial land is selected in the Chengdu Medical City, with an initial investment of 100 million USD to build-up an innovative R&D and manufacturing center for targeted radiation therapies, where five anti-tumor varieties are under research at present, varying from Ac-225 to Lu-177. Ablaze Pharma intends to introduce the world-class innovative targeted radiopharmaceutical therapies (TRT) product designs and clinical experiences into Wenjiang District and jointly building-up the industrial chains of innovative radioactive targeted drug together with the industrial advantages of Wenjiang District.

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"We are deeply impressed by the strong support and recognition to the newly emerging targeted radiopharmaceutical enterprises from the Wenjiang District Government in the city of Chengdu," said Dr. Alex Qiao, President and CEO of Ablaze Pharmaceuticals, "Ablaze hopes to work with other companies in the park to build an ecosystem of targeted radiopharmaceuticals from early discovery to commercialization with the help of the resource advantages in nuclear science and technologies in Sichuan Province, and to promote the future development and progress of radiopharmaceutical drugs in China."

"Welcome and congratulations to Ablaze Pharma for the deployment of the R&D and manufacturing center in Chengdu Medical City. In next step, Chengdu Medical City will strengthen the investments and talent attractions to optimize the business environment for synergies to Ablaze Pharma and more industrials so as to build-up the leading highland of the domestic radiopharmaceutical industry." Li Zhang, Deputy Head Of The Management Committee Of Chengdu Medical City, Head Of The Investment Promotion Bureau said.

News Link by Chengdu Medical City： View Source

About Chengdu Medical City

Sichuan Province is an important base of nuclear industries of China, with national and provincial radioisotope and drug industry-academia platforms such as the National Engineering Research Center for isotopes and drugs, the Radioisotope And Drug R&D Center, and the Provincial Radioisotope Engineering Technology Research Center. These platforms form a collaborative and shared development with the layout of the pharmaceutical track in Chengdu Medical City, which can also enhance the synergies and collaborations of the academic and industrial chains between upstream and downstream. Chengdu Medical City has proactively made precise efforts to its radiopharmaceutical layouts, integrating the advantages of nuclide supplies, drug deliveries and R&D services, so as to accelerate the development of radiopharmaceutical industry in high efficiency and to gradually develop into the upland for radiopharmaceutical industrial hubs of integrated R&Ds, productions and applications.

On August 2, 2022 Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), reported financial results for the three months ended June 30, 2022 and provided an update on key milestones (Press release, Lexicon Pharmaceuticals, AUG 2, 2022, View Source [SID1234617327]).

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"We received acceptance last week of our New Drug Application (NDA) for sotagliflozin for the treatment of heart failure with a standard review assigned by the FDA and a PDUFA action date anticipated in May 2023," said Lonnel Coats, Lexicon’s chief executive officer. "As we mentioned in the announcement of the acceptance, we are seeking a broad heart failure label in the NDA, informed by our regulatory discussions, that encompasses heart failure patients with and without diabetes. We believe that the results of SOLOIST-WHF in patients admitted for recent worsening heart failure will be an important element distinguishing our proposed label."

"In another major accomplishment this quarter, we announced positive top-line results from our Phase 2 RELIEF-DPN-1 study of LX9211 in painful diabetic neuropathy at the end of June, achieving proof-of-concept for LX9211 with its novel mechanism of action in a historically difficult to treat indication," Mr. Coats continued. "We expect to report top-line results in the fourth quarter of this year from a second proof-of-concept study of LX9211 in post-herpetic neuralgia. We believe that our recent achievements for both sotagliflozin and LX9211 have the potential to be transformative for our organization, our stakeholders, and most importantly, patients."

Second Quarter Highlights

Sotagliflozin

A poster was presented at the 6th Annual HEART IN DIABETES Conference evaluating the effect of sotagliflozin on major adverse cardiovascular events (MACE: cardiovascular [CV] death, non-fatal myocardial infarction [MI] and non-fatal stroke) across the sotagliflozin clinical program of over 20,000 patients with type 1 or type 2 diabetes. The results showed that treatment with sotagliflozin was associated with a statistically significant and clinically meaningful reduction in MACE in patients with T1D and T2D.
A new analysis of data from the SCORED Phase 3 clinical trial of sotagliflozin was presented at the 82nd Scientific Sessions of the American Diabetes Association. The analysis showed that treatment with sotagliflozin significantly reduced HbA1c overall and across prespecified subgroups, including those with stage 4 chronic kidney disease with a severe decrease in glomerular filtration rate (eGFR <30mL/min/1.73m2), possibly reflecting the dual SGLT-1/2 mechanism of action of sotagliflozin.
LX9211

Positive top-line results for the Phase 2 proof-of-concept study of LX9211 for the treatment of painful diabetic neuropathy (RELIEF-DPN-1) were achieved at the end of the second quarter of 2022. Full results from the complete RELIEF-DPN-1 study are expected to be presented at a medical meeting in the fourth quarter of 2022.
Patient enrollment continued in the Phase 2 proof-of-concept study of LX9211 for the treatment of post-herpetic neuralgia (RELIEF-PHN-1), from which top-line results are expected in the fourth quarter of 2022.
Second Quarter 2022 Financial Highlights

Research and Development (R&D) Expenses: Research and development expenses for the second quarter of 2022 increased to $13.4 million from $10.3 million for the corresponding period in 2021, primarily due to increases in salaries and benefits and higher professional and consulting costs related to the resubmission of our NDA for sotagliflozin.

Selling, General and Administrative (SG&A) Expenses: Selling, general and administrative expenses for the second quarter of 2022 increased to $10.7 million from $7.9 million for the corresponding period in 2021, primarily due to increases in salaries and benefits, professional and consulting costs and marketing costs relating to preparations for the commercial launch of sotagliflozin.

Net Loss: Net loss for the second quarter of 2022 was $24.6 million, or $0.16 per share, as compared to a net loss of $18.1 million, or $0.13 per share, in the corresponding period in 2021. For the second quarters of 2022 and 2021, net loss included non-cash, stock-based compensation expense of $2.8 million for both quarters.

Cash and Investments: As of June 30, 2022, Lexicon had $62.0 million in cash and investments, as compared to $86.7 million as of December 31, 2021. This amount does not include $82.2 million in approximate net proceeds received from the company’s July 27, 2022 public offering and concurrent private placement of its common stock.

Conference Call and Webcast Information

Lexicon management will hold a live conference call and webcast today at 5:00 pm ET / 4:00 pm CT to review its financial and operating results and to provide a general business update. The dial-in number for the conference call is 888-886-7786 and the conference ID for all callers is 78319165. The live webcast and replay may be accessed by visiting Lexicon’s website at www.lexpharma.com/events. An archived version of the webcast will be available on the website for 14 days.

On August 2, 2022 Phanes Therapeutics, Inc. (Phanes), an emerging leader in innovative discovery research and clinical development in oncology, reported that the U.S. Patent and Trademark Office (USPTO) has granted the patent (Patent No. US 11,401,329) of its anti-CD47 antibodies (Press release, Phanes Therapeutics, AUG 2, 2022, View Source [SID1234617318]). The patent relates to the invention of anti-CD47 monoclonal antibodies and bispecific antibodies comprising an anti-CD47 arm, including PT886, an anti-claudin18.2/anti-CD47 bispecific antibody being developed for gastric and pancreatic cancers, and PT217, an anti-DLL3/anti-CD47 bispecific antibody being developed for the treatment of small cell lung cancer.

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Phanes has received clearance from the US FDA to commence Phase I studies with PT886 in June 2022 and expect to file IND with PT217 this year. Both PT886 and PT217 have been granted orphan drug designation from the FDA in June this year.

"This is the sixth Phanes patent granted this year." said Dr. Ming Wang, PhD, MBA, Founder and CEO of Phanes Therapeutics. "As Phanes expands from a research to a clinical development stage organization, we expect to have additional patent applications issued, further strengthening the intellectual property portfolio and competitiveness of our pipeline."

On August 2, 2022 Evogene Ltd. (NASDAQ: EVGN) (TASE: EVGN), a leading computational biology company aiming to revolutionize life-science product development across several market segments, reported that it will release its financial results for the second quarter of 2022 on Wednesday, August 31, 2022 (Press release, Evogene, AUG 2, 2022, View Source [SID1234617317]).

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On the day of the announcement, Company management will host a conference call to discuss the results at 9:00 AM Eastern time, 4:00 PM Israel time.

To access the conference call, please dial +1-888-281-1167 toll free from the United States, or +972-3-918-0609 internationally. Access to the call will also be available via live webcast through the Company’s website at www.evogene.com.

A replay of the conference call will be available approximately two hours following the completion of the call. To access the replay, please dial +1-888-326-9310 toll free from the United States, or +972-3-925-5901 internationally. The replay will be accessible through September 2, 2022, and an archive of the webcast will be available on the webcast link for the following twelve months.

On August 2, 2022 Envisagenics, Inc., a New York-based biotechnology company leveraging artificial intelligence (AI) and RNA-splicing analytics for discovery and development of disease specific therapeutics, reported that it was awarded a Small Business Innovation Research (SBIR) Direct to Phase II grant from the National Cancer Institute (NCI), part of the National Institutes of Health (NIH) (Press release, Envisagenics, AUG 2, 2022, View Source [SID1234617315]). This grant will provide $2 million over 2 years to commercialize Envisagenics’ proprietary drug discovery platform, SpliceIOTM, for the discovery of novel targets for immuno-oncology (IO) therapeutic development. SpliceIO is one of the latest AI drug discovery platforms developed by Envisagenics, which complements the SpliceCore platform for the discovery of splicing drug targets using RNA-seq data.

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"What the SpliceCore platform does for antisense drugs, SpliceIO is doing for IO drugs. SpliceIO discovers splicing-derived neoantigens for immunotherapies using RNA-seq data as a sole input," said Martin Akerman, Ph.D., Chief Technology Officer and Co-founder of Envisagenics. "This funding will help scale Envisagenics’ target pipeline by enabling validation of IO targets at the protein level, a critical step for advancing candidate targets to the next stage of development."

Envisagenics will apply its platform to identify splicing-derived neoantigens in BRCA1/2 carriers at-risk for developing breast cancer and develop a high-throughput approach to validate its findings using proteomic data. Within the scope of this grant, Envisagenics will collaborate with researchers at Northwestern University Feinberg School of Medicine: Dr. Seema Khan (Co-Leader of the Cancer Prevention Program of the Lurie Comprehensive Cancer Center and Bluhm Family Professor of Cancer Research) and Dr. Susan Clare (Research Associate Professor of Surgery). "We are excited to collaborate with Envisagenics to apply its innovative technology leveraging splicing analytics for neoantigen discovery in BRCA1/2 carriers, an exemplar population for prophylactic intervention, given their high risk of developing breast or ovarian cancers, and the increasing recognition that immune interventions are particularly appropriate in the cancer prevention arena," said Dr. Khan.

Envisagenics was previously awarded Phase I and Phase II grants from the National Institute of General Medical Sciences (NIGMS, NIH) to develop the SpliceCore software platform. A Phase I SBIR grant was also awarded by the NCI to expand SpliceCore’s capabilities for discovery of splicing-derived neoantigens. "We are grateful for the NIH’s continued support of innovative technologies and enabling AI-driven biotechnology companies like Envisagenics to continue to develop next generation technologies to accelerate the discovery and development of therapies for patients in need," said Maria Luisa Pineda, Ph.D., Chief Executive Officer and Co-founder of Envisagenics.