On May 17, 2021 Vincerx Pharma, Inc. (Nasdaq: VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, reported financial results for the first quarter ended March 31, 2021 and provided a corporate update (Press release, Vincerx Pharma, MAY 17, 2021, View Source [SID1234580154]).

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"The clearance of Vincerx’s first company-sponsored IND is an important milestone that paves the way for the initiation of our planned Phase 1b dose escalation study of VIP152 in patients with relapsed/refractory chronic lymphocytic leukemia and Richter syndrome in the second half of the year," said Ahmed Hamdy M.D., Chief Executive Officer of Vincerx. "This rapid execution is a testament to our team’s capabilities, and builds upon our Phase 1b expansion study in patients with MYC-driven hematologic malignancies and solid tumors, expected to begin patient dosing in the second quarter. Both studies are part of our comprehensive clinical program, which leverages early signals of Phase 1 clinical activity to evaluate the potential of VIP152 in challenging oncology populations. We look forward to continued progress across these important milestones in the clinic, which will also include the presentation of Phase 1 data in patients with double-hit lymphoma at ASCO (Free ASCO Whitepaper)."

Dr. Hamdy continued, "For our preclinical assets, we were pleased to present compelling preclinical data on VIP236 at the AACR (Free AACR Whitepaper) Annual Meeting, highlighting that VIP236 has the potential to provide potent, highly targeted antitumor activity to address the needs of patients with advanced and aggressive cancers. We remain focused on rapidly advancing our pipeline from a clinical and regulatory standpoint and look forward to providing further updates."

Recent Highlights

Announced U.S. Food and Drug Administration (FDA) clearance of Investigational New Drug (IND) Application to initiate a Phase 1b dose escalation study evaluating VIP152, a highly selective PTEFb/CDK9 inhibitor, in patients with relapsed/refractory chronic lymphocytic leukemia (CLL) and Richter syndrome (RS)

Presented preclinical data on VIP236, a novel small molecule drug conjugate (SMDC), at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021

Hosted Key Opinion Leader (KOL) event on bioconjugation and CDK9 inhibitors, featuring presentations by Brian Druker, M.D., Knight Cancer Institute, and Anthony W. Tolcher, M.D., NEXT Oncology

Announced that Phase 1 safety and efficacy dose escalation data from patients with double-hit lymphoma will be presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting
Announced formation of Scientific Advisory Board (SAB) composed of world leading academics and industry leaders in cancer research and therapeutics

Announced completion of public warrant redemption and receipt of cash proceeds of approximately $37.3 million.
First Quarter 2021 Financial Results

Vincerx Pharma ended the first quarter with $53.4 million in cash and cash equivalents, which does not include the proceeds from the public warrant redemption noted above, compared to $61.8 million at December 31, 2020.

Net loss for the first quarter ended March 31, 2021 was $6.3 million, or $0.46 per share, basic and diluted.

Research and development (R&D) expenses were $4.8 million for the quarter ended March 31, 2021, consisting primarily of $2.7 million in stock-based compensation expense, $1.3 million in new employee salaries and $0.8 million of outside services in preparation for our anticipated clinical trials.

General and administrative (G&A) expenses were $4.8 million for the quarter ended March 31, 2021, consisting primarily of $2.0 million in stock-based compensation expense, $0.9 million related to new employee salaries and $1.5 million of legal, accounting and other professional services in support of our intellectual property protection and operations as a newly formed public company.

On May 17, 2021 AffyImmune Therapeutics, Inc., a clinical stage biotechnology company finding safe, effective ways to use CAR T cells against solid cancers, reported that the US Food and Drug Administration (FDA) granted Fast Track designation to its lead compound, AIC100, for the treatment of anaplastic thyroid cancer and refractory poorly differentiated thyroid cancer (Press release, AffyImmune Therapeutics, MAY 17, 2021, View Source [SID1234580172]). The company previously received Orphan Drug designation for AIC100.

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The FDA’s Fast Track designation is designed to facilitate development and expedite review of drug candidates to treat serious conditions and address an unmet medical need. Receipt of Fast Track designation provides grounds for more frequent interaction with the FDA throughout the drug development process for more rapid advancement, earlier approval and access for patients.

"We are pleased to have received Fast Track designation for our first-in-human CAR T cell product currently being tested in patients with refractory thyroid cancer," remarked Eric von Hofe, President and COO of AffyImmune. "It highlights the unmet need in treating refractory solid tumors and points to the potential of AIC100 to address that need. We look forward to a close relationship with the FDA to expedite development and future approvals."

In connection with the approval, AffyImmune has made available its expanded access policy for AIC100 at View Source

On May 17, 2021 Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) ("Sonnet" or the "Company"), a biopharmaceutical company developing innovative targeted biologic drugs, reported its financial results for the three months ended March 31, 2021 and provided a business update (Press release, Sonnet BioTherapeutics, MAY 17, 2021, View Source [SID1234580194]).

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"Over the course of the quarter, we have made several advancements across our pipeline products, most notably of which are the completion of non-human primate (NHP) toxicology study of SON-080 and the completion of a repeat dose study of SON-1010 in NHPs," commented Pankaj Mohan, Ph.D., Founder and CEO. "Additionally, we were thrilled to have our abstract detailing data from our NHP study of SON-1010 accepted for presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting."

FY 2021 Second Quarter and Recent Corporate Updates

Sonnet provided the following updates on its lead pipeline assets:

The Company successfully completed multiple NHP GLP toxicology studies with SON-1010 (FHAB-IL12) and is generating data to prepare an IND submission to initiate clinical studies in the second half of 2021.

Regarding SON-080, the Company intends to file a US IND to initiate a Phase 1b/2a pilot-scale efficacy study in the Chemotherapy-Induced Peripheral Neuropathy (CIPN) indication during the second half of 2021. Additionally, as part of the recently announced partnership with New Life Therapeutics, the companies intend to file an ex-US IND equivalent for a Phase 1b/2a pilot-scale efficacy study in Diabetic Peripheral Neuropathy (DPN) during the second half of 2021. Going forward, Sonnet will exclusively refer to the low-dose IL-6 programs, namely CIPN and DPN, using the SON-080 designation, the latter of which had previously been known as the SON-081 program.

The Company’s first bispecific candidate, SON-1210 (IL-FHAB-IL15), is undergoing cell line and process development activities. Sonnet expects completion of NHP studies in the second half of this year with an IND submission during the first half of 2022.

Sonnet has manufactured bi-specific preclinical constructs of SON-2014 (GMcSF-FHAB-IL18), as well as IL18-FHAB-IL12 and IL12-FHAB-GMcSF that are being evaluated for in vivo efficacy, biomarker profiles and fluorescence-activated cell sorting (FACS) assessment in single dose and multi-dose preclinical studies. The Company intends to initiate commercial cell line development necessary for future clinical studies, with an IND submission for SON-2014 targeted for the second half of 2022.

Sonnet has added key senior management hires of Richard Kenney, M.D. as Chief Medical Officer and Manuel Dafonseca as Head of Clinical Operations, as the Company prepares to advance its FHAB platform into its first clinical study.

"During the quarter, we were able to successfully draw from our at-the-market sales agreement with BTIG and bring in over $10 million of capital to the Company", commented Jay Cross, CFO. "This additional funding will enable us to continue driving our R&D activities forward and furthers our goal of bringing much need therapeutic advancements to patients."

FY 2021 Second Quarter Ended March 31, 2021 Financial Results

●As of March 31, 2021, Sonnet had $6.7 million cash on hand.
●As previously announced, on February 5, 2021, Sonnet entered into an at-the-market sales agreement with BTIG, LLC, for an aggregate offering of up to $15.9 million. Through March 31, 2021, the Company sold an aggregate of 4,021,561 shares for net proceeds of $10.2 million to Sonnet. The company has not sold shares though this facility since March 12, 2021.
●Research and development expenses were $3.8 million for the three months ended March 31, 2021, compared to $1.3 million for the three months ended March 31, 2020. The increase of $2.5 million was primarily due to increased expenditures for the development of the cell line for IL12-FHAB and IL12-FHAB-IL15

General and administrative expenses were $2.2 million for the three months ended March 31, 2021, compared to $1.3 million for the three months ended March 31, 2020. The increase of $1.0 million was primarily due to an increase in insurance expense of related to directors and officer’s insurance, and in increase in payroll and share-based compensation expense to support our expanded operations.

On May 17, 2021 Wugen reported that it is adding a new subset of NK cells to the cell therapy toolkit with its memory NK cell approach, which may lead to high antitumor efficacy without requiring a CAR or other modifications (Press release, Wugen, MAY 17, 2021, View Source [SID1234580426]).

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The company was formed in 2018 to develop off-the-shelf CAR T cell therapies, but broadened its scope to include memory NK cells after in-licensing the technology from Washington University in St. Louis last year.

Now, it has programs for both cell types running in parallel, with each expected to start clinical development next half.

Unmodified NK cells have historically fallen short on efficacy, and companies have increasingly turned to the addition of a tumor antigen-specific CAR to harness and concentrate activity against the tumor. CAR NK cells are attracting broad industry attention as clinical validation builds.

"NK cell platforms are now really coming to the fore in industry in terms of the realization that off-the-shelf, allogeneic NK cells will be competitive against CAR T cells," said Daniel Kemp, who joined Wugen as CEO this month after serving as VP and head of cell therapies BD & operations at Takeda Pharmaceutical Co. Ltd. (Tokyo:4502; NYSE:TAK).

Wugen thinks its memory NK cells may attain high levels of efficacy without a CAR.

CMO Jan Davidson told BioCentury memory NK cells are a subset with an enhanced effector function. Specifically, they express more activating receptors and have fewer inhibitory signals. They also produce more cytotoxic effector molecules and cytokines to activate downstream components of the immune system, and they persist longer.

He added that most NK cell therapies aren’t enriched for the memory NK subpopulation because the subtype is formed through a process that naturally occurs in the tumor, but NK cell therapies are usually sourced from cord blood or induced pluripotent stem cells.

The company has an in vitro process for converting NK cells harvested from healthy donors into the memory phenotype using cytokines to drive them into a highly activated functional state.

The memory NK cells have been tested in investigator-initiated studies at Washington University in St. Louis in several acute myelogenous leukemia (AML) settings. Next, Wugen plans to begin a study in the relapsed/refractory population.

"We’re building on the existing data in AML, where there’s a high unmet need and the cells can be potentially curative. This is a quick path to develop this strategy and be able to help patients in short order, but after that, there are a lot of different opportunities," said Ryan Sullivan, VP and head of NK research at Wugen.

Davidson noted that the company has strong preclinical evidence of efficacy in solid tumors.

Kemp added that the company will explore engineered versions of the cells as well, "whether through CAR mechanisms or other types of modifications."

In solid tumors, Sullivan told BioCentury there’s an opportunity to combine the NK cells with mAbs that act via antibody-dependent cellular toxicity (ADCC) — a process that recruits NK cells to kill the antibody-bound tumor cells. Many cancer therapies including anti-CTLA-4 mAb Yervoy ipilimumab heavily rely on ADCC for therapeutic efficacy, and are less effective in patients with compromised innate immune systems.

"A lot of the patients who these mAbs are administered to have some level of immunosuppression, so there’s a poor response, but we’re providing the engine to potentiate the ADCC capability," said Sullivan.

Kemp noted Wugen is interested in building strategic relationships around the ADCC mechanism.

With its allogeneic CAR T cell platform, Wugen is first tackling T cell malignancies. The indication has proven challenging because when designed to hit a T cell target on malignant cells, the CAR Ts can destroy themselves through fratricide. Wugen is sidestepping fratricide by deleting CD7.

At least four companies have CAR T cell therapies in development to treat T cell cancers. Davidson and Sullivan aren’t aware of other companies developing memory NK cell therapy products.

In March, Wugen granted development, manufacturing and commercialization rights to Alpha Biopharma Inc. for its universal memory NK and CAR T cells for certain cancers in mainland China, Hong Kong, Macao, Taiwan and Singapore. The same month, it signed a deal with HCW Biologics Inc. to use its fusion molecules in the manufacturing of Wugen’s cell therapies.

The company raised $36 million in a series A round, and is currently raising a series B round.

On May 17, 2021 Cerecor Inc. (NASDAQ: CERC), a biopharmaceutical company focused on becoming a leader in the development and commercialization of treatments for rare and orphan diseases, reported that members of its senior management team will participate in three upcoming virtual investor conferences (Press release, Cerecor, MAY 17, 2021, View Source [SID1234580115]).

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2021 RBC Capital Markets Global Healthcare Virtual Conference
Date: Tuesday, May 18, 2021
Time: 8:35 AM ET

Oppenheimer Rare & Orphan Disease Summit
Date: Friday, May 21, 2021
1×1 meetings only

Jefferies Virtual Healthcare Conference
Date: Wednesday, June 2, 2021
Time: 1:00 PM ET

A live webcast of the presentation at the 2021 RBC Capital Markets Global Healthcare Virtual Conference and the Jefferies Virtual Healthcare Conference can be accessed under the "News/Events" page in the Investors section of the Company’s website at www.cerecor.com.