CCXI To Face FDA In April, CRDF Soars On Colorectal Cancer Trial Data, VCNX In Deal With MRK

investing biotech 042420 18sep20

Today's Daily Dose brings you news about ChemoCentryx's regulatory catalyst in July, Checkpoint's $20 million bought deal offering, CytRx's potential milestone payment, Cardiff Oncology's encouraging colorectal cancer trial results, and Vaccinex's near-term catalyst.

Read on…

1. ChemoCentryx to Face FDA in April

ChemoCentryx Inc.'s (CCXI) New Drug Application for Avacopan, proposed for the treatment of ANCA-Associated Vasculitis, has been accepted for FDA review, with a decision expected on July 7, 2021.

ANCA-associated vasculitis is a systemic disease in which over-activation of the complement pathway further activates neutrophils, leading to inflammation and destruction of small blood vessels. This disease mostly affects the kidneys and lungs.

The current standard of care for ANCA-associated vasculitis consists of courses of Cyclophosphamide or Rituximab, which are non-specific immuno-suppressants, combined with glucocorticoids (steroids) and this treatment regimen is found to be associated with a number of side effects.

If approved, analysts expect Avacopan to achieve blockbuster sales.

CCXI closed Thursday's trading at $52.57, down 2.07%.

2. Checkpoint Announces Bought Deal Offering

Checkpoint Therapeutics INC. (CKPT) has entered into an underwriting agreement with H.C. Wainwright & Co., LLC under which the underwriter has agreed to purchase 7.14 million shares of common stock of the company at a price of $2.80 per share, less underwriting discounts, and commissions.

The underwriter also has a 30-day option to purchase up to an additional 1.07 million shares of common stock. The gross proceeds from the offering are expected to be about $20 million.

The offering is expected to occur on or about September 22, 2020, subject to certain conditions.

Earlier in the day, the company announced promising updated interim results from the ongoing global, open-label, multicohort, phase I trial of Cosibelimab, in patients with advanced cancers, including the registration-enabling cohort of patients with metastatic cutaneous squamous cell carcinoma.

Cosibelimab demonstrated a 51.4% objective response rate ("ORR") and 5 patients achieved a complete response rate in half the planned pivotal cohort, according to updated results. As per the interim results presented last year, Cosibelimab demonstrated a 50% ORR and 1 patient in the metastatic cutaneous squamous cell carcinoma cohort achieved a complete response.

CKPT closed Thursday's trading at $3.51, down 17.22%.

3. CytRx to Get Milestone Payment, If Arimoclomol Gets Approved

CytRx Corp.'s (CYTR.OB) investigational drug Arimoclomol, which was sold to Orphayzme A/S, has been accepted for priority review by the FDA - with a decision expected on March 17, 2021.

Arimoclomol is proposed for the treatment of Niemann-Pick Disease Type-C, a rare progressive genetic disorder characterized by the accumulation of cholesterol and other fatty substances (lipids) in tissues and organs.

CytRx would receive milestone payments of $6 million in the U.S., $4 million in Europe, and $2 million in Japan upon approval of Arimoclomol, plus royalties.

CYTR.OB closed Thursday's trading at $0.66, unchanged from the previous day's close.

4. Cardiff Oncology Hits a High

Shares of Cardiff Oncology Inc. (CRDF) hit a new high, following encouraging efficacy signal from the ongoing phase Ib/II study evaluating its investigational drug Onvansertib in combination with FOLFIRI and Avastin for second-line treatment of patients with KRAS-mutated metastatic colorectal cancer.

According to the trial results, 10 of 11 (91%) patients achieved disease control, with only 1 patient progressing in less than 6 months while on treatment. Onvansertib in dose levels of 12 and 15 mg/m2 have been cleared for safety and four patients have been treated at the third dose level of 18 mg/m2 and two more will be enrolled, noted the company.

Commenting on the findings, Daniel Ahn, D.O., lead investigator, and medical oncologist, Mayo Clinic Cancer Center, Arizona, said, "The addition of Onvansertib to standard-of-care shows promise as a novel second-line option for patients with difficult-to-treat KRAS-mutated mCRC. A critical unmet need exists for these patients, as second-line treatment has a relatively low response rate and generally confers a poor prognosis."

CRDF closed Thursday's trading at $8.11, up 39.59%.

5. Sonoma's Partner Gets Canadian Approval for Nanocyn Disinfectant & Sanitizer

Sonoma Pharmaceuticals Inc.'s (SNOA) partner, MicroSafe Group, Dubai, has received approval from Health Canada for their patented and trademarked Nanocyn Disinfectant & Sanitizer.

Nanocyn is manufactured by Sonoma using its patented Microcyn Technology.

The Nanocyn Disinfectant & Sanitizer was approved in Australia in May this year for use against SARS-CoV2 (COVID-19).

SNOA closed Thursday's trading at $7.57, down 2.20%.

6. Vaccinex To Report Huntington's disease Trial Data In Sep/October

Vaccinex Inc. (VCNX) has entered into collaboration with Merck (MRK) to evaluate its investigational drug Pepinemab in combination with KEYTRUDA in the treatment of patients with advanced, recurrent, or metastatic head and neck squamous cell carcinoma.

In the clinical trial that will evaluate the combination of Pepinemab and KEYTRUDA, 65 patients with head and neck squamous cell carcinoma will be enrolled, with key endpoints of the study being objective response, progression-free survival, and overall survival.

Pepinemab, the lead drug candidate of Vaccinex, is under a phase II study in Huntington's disease, dubbed SIGNAL, with topline data expected late September or early October.

VCNX closed Thursday's trading at $5.93, up 12.10%.

7. Stocks That Moved On No News

Entera Bio Ltd. (ENTX) closed Thursday's trading at $1.33, up 25.47%.

Capricor Therapeutics Inc. (CAPR) closed Thursday's trading at $5.89, up 22.71%.

Alterity Therapeutics Limited (ATHE) closed Thursday's trading at $2.40, up 18.23%.

Inovio Pharmaceuticals Inc. (INO) closed Thursday's trading at $15.67, down 15.39%.

SunLink Health Systems, Inc. (SSY) closed Thursday's trading at $1.01, down 10.69%.

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