argenx to Present at Upcoming Investor Conferences

On November 10, 2021 argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer, reported that members of management will participate in several upcoming conferences (Press release, argenx, NOV 10, 2021, View Source [SID1234595128]):

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Guggenheim Healthcare Talks | Idea Forum | 3rd Annual Neuro/Immunology Day. Fireside chat on Monday, November 15, 2021 at 9:40 a.m. ET.
Evercore ISI 4th Annual HealthCONx Conference. Fireside chat on Tuesday, November 30, 2021 at 12:35 p.m. ET.
Piper Sandler 33rd Annual Healthcare Conference. Pre-recorded fireside chat will be made available on November 22, 2021 at 10:00 a.m. ET.

Additional information regarding these events will be available on the Investors section of the argenx website at argenx.com/investors.

Lennham Pharmaceuticals Announces Discovery of Next Generation Testosterone Candidate

On November 10, 2021 Lennham Pharmaceuticals, a privately-held company focused on the creative use of deuterium chemistry to improve the metabolic and pharmacological profile of existing compounds, reported the discovery and patenting of its next generation testosterone candidate, d3-testosterone (Press release, Lennham Pharmaceuticals, NOV 10, 2021, View Source [SID1234595144]).

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The U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allowance for broad patent claims covering the use of d3-testosterone. Once issued, the patent will expire in 2041.

The allowed claims cover a method of treating male hypogonadism with d3-testosterone. Lennham’s patent disclosure covers numerous additional applications for d3-testosterone, including as a treatment for breast cancer, female sexual disorders, and as a gender affirming hormone therapy.

In non-clinical studies, d3-testosterone strongly resisted metabolism to the estrogen estradiol when compared to testosterone. Lennham’s non-clinical studies also demonstrated that d3-testosterone has similar androgen receptor agonist activity as testosterone. Lennham intends to present or publish data concerning d3-testosterone at upcoming scientific forums.

"Testosterone has demonstrated significant clinical benefit in treating a variety of conditions including breast cancer, female sexual dysfunction, male hypogonadism, and as gender affirming hormone therapy, but its therapeutic use has been limited in part because of estrogen-related side effects," said Bradford C. Sippy, Founder and CEO of Lennham. "Based on our preclinical studies and the scientific literature, we believe that d3-testosterone, by addressing estrogen-related limitations, has the potential to unlock the full therapeutic utility of testosterone therapy and become a best-in-class hormone treatment."

About Testosterone

Testosterone is a naturally occurring hormone that is found in both men and women. Products containing testosterone and prodrugs of testosterone, such as testosterone undecanoate, have been approved for use by FDA to treat certain conditions such as male hypogonadism and delayed puberty.

Testosterone is metabolized in humans to estradiol, 5α-dihydrotestosterone (DHT), and other hormones. The conversion of testosterone to estradiol, the primary estrogen metabolized from testosterone and the most prevalent estrogen in humans, is linked to several side effects of testosterone therapies, such as gynecomastia. It is reported that 30% of men using a testosterone therapy also use an aromatase inhibitor or and selective estrogen receptor modulator, products indicated to treat breast cancer, to reduce or treat symptoms of hyperestrogenism.1

Testosterone has been identified as a potentially useful treatment in other diseases and conditions, such as breast cancer2 and female sexual disorders3, but concerns about estradiol-related side effects such as breast cancer have limited its therapeutic potential4,5,6.

About Deuterated Testosterone

Deuterium is a naturally occurring, stable isotope of hydrogen, with an additional neutron in its nucleus. Selectively substituting hydrogen with deuterium, or deuteration, is a way to alter a molecule’s metabolic profile while maintaining its core pharmacodynamic characteristics.

Deuteration strengthens the chemical bond between two elements. Depending on where deuterium is placed, it has the potential to alter the overall metabolism of a molecule, or to reduce conversion to specific, unwanted metabolites.

Deuteration has been successfully leveraged in several approved and/or late-stage pharmaceutical products.

In non-clinical studies, d3-testosterone was shown to be highly resistant to metabolism to estradiol, potentially resulting in improved safety and tolerability profile versus testosterone.

Lennham’s allowed patent claims cover a method of treating hypogonadism in a male subject by orally, parenterally, or transdermally administering to the subject a pharmaceutical composition comprising between 1 mg and 1,000 mg of d3-testosterone, or a related prodrug.

Supernus to Participate in Upcoming November Investor Conferences

On November 10, 2021 Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, reported that the Company’s management will participate and host investor meetings at the following upcoming November 2021 investor conferences (Press release, Supernus, NOV 10, 2021, View Source [SID1234595185]).

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Stifel 2021 Virtual Healthcare Conference
Date: November 15, 2021
Participation Type: Fireside Chat
Presentation Time: 2:00 p.m. EST

Jefferies London Healthcare Conference
Date: November 18, 2021
Participation Type: Fireside Chat
Presentation Time: Pre-recorded, available beginning November 18 at 3:00 a.m. EST / 8:00 a.m. GMT

A live webcast of the Stifel fireside chat, as well as replays of both fireside chats will be accessible by visiting Events & Presentations in the Investor section on the Company’s website at www.supernus.com. An archived replay of each webcast will be available for 60 days on the Company’s website after the respective conference.

Summary of Consolidated Financial Results for the First Six Months of the Fiscal Year Ending March 31, 2022(PDF?441KB)

On November 10, 2021 Sysmex reported that (Press release, Sysmex, NOV 10, 2021, View Source [SID1234595214])

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1. Results for the First Six Months of the Fiscal Year Ending March 31, 2022
(1) Operating results
(2) Financial condition

2. Dividend
3. Financial Forecast for the Year Ending March 31, 20224.

Other Information
(1) Changes in significant consolidated subsidiaries (which resulted in changes in scope of consolidation):
No (2) Changes in accounting policies and accounting estimates
1) Changes in accounting policies required by IFRS:
No 2) Other changes in accounting policies:
No 3) Changes in accounting estimates:
No (3) Number of outstanding stock (common stock)

1) Number of outstanding stock at the end of each fiscal period (including treasury stock): 209,485,632 shares as of Sep. 30, 2021; 209,443,232 shares as of Mar. 31, 2021
2) Number of treasury stock at the end of each fiscal period: 447,055 shares as of Sep. 30, 2021; 446,876 shares as of Mar. 31, 2021
3) Average number of outstanding stock for each period (cumulative): 209,014,581 shares for the six months ended Sep. 30, 2021 208,859,643 shares for the six months ended Sep. 30, 20201.

Qualitative information on quarterly financial results
1) Operating performance analysis Future-related information contained in the text below is based on the judgement as of the end of the fiscal period under review. During the first six months of the fiscal year ending March 31, 2022, the Japanese economy was affected by the COVID-19 pandemic. Despite progress with rolling out vaccines, social activity and personal consumption remained sluggish, due to reissuing the state of emergency and the priority preventative measures. Overseas, economic deregulation led to a gradual economic recovery, albeit with variations among countries and regions. Even so, the outlook remains uncertain due to the gradual shrinking of fiscal and monetary policies and the impact of the global shortage of semiconductors. On the healthcare front, we are seeing major changes in the healthcare environment due to the COVID-19 pandemic, as well as an aging society and increasingly diverse health and medical needs.

In Japan, expectations are mounting for new medical services to address the "new normal," such as resolving the pressure on medical systems due to a rise in the number of infections, stable supplies of necessary supplies and a response to digitalization in the medical field. Looking overseas, aging populations in developed countries are driving demand for the moderation of medical systems. In emerging markets, healthcare demand is increasing, and demand is rising for higher levels of healthcare quality, service enhancements and preventive medicine. As a result, we are seeing rapid advances in the application of artificial intelligence, big data analysis and other leading-edge technologies, which are expected to provide further opportunities for growth. Against this backdrop, Sysmex continued to expand its product portfolio in the hematology field. We launched a next-generation flagship model, XR-Series Automated Hematology Analyzer, and a compact three-part differential model, the XQ-Series Automated Hematology Analyzer in Japan. We will continue with a global sales rollout after receiving regulatory approval in individual countries.

We aim to contribute optimization of laboratory operations according to regional characteristics and facilities’ needs. In the life science field, we formed a strategic alliance related to joint development and global business with QIAGEN N.V., which has extensive experience in the development of companion diagnostics*1 in the field of oncology. By leveraging QIAGEN’s experience in developing companion diagnostics, Sysmex expects to strengthen its global relationships with pharmaceutical companies. We will work toward the early development and clinical implementation of companion diagnostics. "Genetic diagnosis and counseling for inherited retinal dystrophy (IRD)*

2 using a genetic testing system (tentatively named the IRD Panel Testing System), which Sysmex and the Kobe City Eye Hospital have been developing jointly, has received Advanced Medical Care B*3 approval. Going forward, we will commence this testing at the Kobe City Eye Hospital. In addition, we will increase the number of cooperating facilities for advance medical care that can perform this test, in the aim of increasing opportunities for patients to receive medical care. As the global general distributor, Sysmex continued to market hinotori to medical institutions in Japan. (The hinotori Surgical Robot System is the first made-in-Japan robotic-assisted surgery system.) We are working with Medicaroid Corporation, a joint venture between Sysmex and Kawasaki Heavy Industry, Ltd., to obtain regulatory approval overseas, and we will begin introducing the system in overseas markets, as well.

*1 Companion diagnostics: Testing to predict the efficacy or risk of side effects of specific drugs before prescription. *2 Inherited retinal dystrophy (IRD): IRD is an inherited progressive disease thought to be caused by genetic mutations. The main symptoms are night blindness, narrowing of the visual field, and loss of vision, which can lead to blindness in some cases. Several diseases with similar symptoms are collectively referred to as inherited retinal dystrophy.
*3 Advanced medical care B: Advanced medical care is new experimental medical technology whose effectiveness and safety have not yet been evaluated, and which has been designated by the Ministry of Health, Labor and Welfare as a medical technology to be evaluated for effectiveness and safety in order to determine whether it should be covered by insurance in the future. Within this category, Advanced medical care B may be conducted only at medical institutions that meet the facility criteria set for each medical technology.

Kinnate Biopharma Inc. Reports Third Quarter 2021 Financial Results

On November 10, 2021 Kinnate Biopharma Inc. (Nasdaq: KNTE) ("Kinnate"), a biopharmaceutical company focused on the discovery and development of small molecule kinase inhibitors for difficult-to-treat, genomically defined cancers, reported financial results for the quarter ended September 30, 2021 (Press release, Kinnate Biopharma, NOV 10, 2021, View Source [SID1234595231]).

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"With the active recruitment of additional patients at multiple centers in the United States ongoing in the KN-8701 clinical trial, we are pleased with the continued advancement of the KIN-2787 program," said Nima Farzan, Chief Executive Officer of Kinnate. "We believe our recent collaboration with Guardant Health also presents a unique opportunity to assess real-world outcomes and further supports our work to improve the lives of cancer patients with limited treatment options. Unlike currently available treatments that target only Class I BRAF kinase alterations, KIN-2787 targets Class II and Class III BRAF alterations, where it has the potential to be a first-line targeted therapy, in addition to covering Class I BRAF alterations."

Other Recent Business Highlights and Corporate Update:

Announced a collaboration with Guardant Health, a leading precision oncology company, focused on characterizing the prevalence of patients with advanced solid tumors bearing BRAF Class I, II and III alterations. The study will also assess real-world clinical outcomes stratified by BRAF alteration class and by treatment line and type. Preliminary analyses conducted utilizing the GuardantINFORM platform suggest that the prevalence of Class II and III alterations across patients with advanced and metastatic solid tumors screened via liquid biopsy-based comprehensive genomic profiling (CGP) is higher than previously understood. Among the nearly 6,000 patients who were identified as having BRAF alteration-positive cancers, approximately 55% were found to be harboring Class II and III alterations across all tumor types. When looking across common tumor types – Non-Small Cell Lung Cancer (NSCLC), Melanoma and Colorectal Cancer (CRC) – approximately 65%, 20% and 30% of oncogenic BRAF alterations, respectively, are BRAF Class II and III. In addition to NSCLC, Melanoma, and CRC, BRAF Class II and III alterations are also detected at substantial rates in other common and rare tumor types such as prostate, breast, duodenal adenocarcinoma, renal pelvis urothelial carcinoma, and cholangiocarcinoma. These findings, as well as other studies that will assess real-world clinical outcomes stratified by BRAF Class and by treatment, are planned for presentation at a future date.
Presented design and rationale details of a Phase 1 clinical trial (KN-8701: NCT04913285) evaluating KIN-2787 during the AACR (Free AACR Whitepaper)-NCI-EORTC Virtual AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper). KN-8701 is a first-in-human, multicenter, non-randomized, open-label, Phase 1 clinical trial of KIN-2787 in adult patients with BRAF mutant advanced and metastatic solid tumors (AMST). KIN-2787 is given orally BID continuously in 28-day cycles until drug intolerance or disease progression. Planned sample size is approximately 115 patients in two parts: Part A is a trial of dose-escalation to maximum tolerated dose open to patients with AMST driven by BRAF Class I, Class II or Class III genomic alterations. Part B will evaluate a selected dose of KIN-2787 in three cohorts of patients with melanoma, NSCLC, or other AMST, each driven by BRAF Class II or Class III alterations. Standard Phase 1 enrollment criteria are required, and key exclusion criteria include known clinically active brain metastases from non-brain tumors, and prior receipt of BRAF-, MEK-, or MAPK-directed inhibitor therapy (except for cases in which these inhibitors were used in indications approved by the U.S. Food and Drug Administration (FDA)).
Announced results from preclinical studies evaluating Kinnate’s lead Fibroblast Growth Factor Receptor (FGFR) inhibitor candidate, KIN-3248 during a virtual poster session at the joint JCA-AACR Precision Cancer Medicine International Conference. The poster presentation highlighted data which show that in biochemical and cellular assays, KIN-3248 exhibited nanomolar potency against all four wild-type FGFR family members but not against other non-FGFR kinases. Importantly, KIN-3248 was active against mutations associated with resistance to FGFR inhibitors both in the clinic and in experimental models, including the FGFR2 and FGFR3 gatekeeper (V565X and V555M, respectively), molecular brake (N550X and N540X, respectively), and activation loop (L618V and K650M, respectively) mutations with less than a five-fold difference in IC50 values relative to corresponding wild-type receptors. In addition, dose-dependent inhibition of FGFR2- and FGFR3-driven human in vivo xenografts, including one with an acquired gatekeeper mutation, was attained with once-daily KIN-3248 treatment and was well tolerated. This efficacy was accompanied by both pharmacodynamic biomarker modulation and downstream pathway inhibition. Kinnate anticipates filling an Investigational New Drug application for KIN-3248 with the FDA in the first half of 2022.
Announced that on December 3, 2021 Eric Murphy, Ph.D. will transition from the company’s Chief Scientific Officer to a member of its Scientific Advisory Board.
Third Quarter 2021 Financial Results

Third quarter net loss for 2021 was $24.7 million, compared to $10.5 million for the same period in 2020.
Third quarter research and development expenses for 2021 were $18.7 million, compared to $8.5 million for the same period in 2020.
Third quarter general and administrative expenses for 2021 were $6.1 million, compared to $2.0 million for the same period in 2020.
As of September 30, 2021, the total of cash and cash equivalents and investments was $347.9 million, exclusive of the China joint venture’s cash.