Today’s Daily Dose brings you news about Pandion’s phase Ia trial of autoimmune disease drug PT101 in healthy volunteers; Matinas BioPharma’s anticipated milestone for this quarter; Calithera’s disappointing results from phase II study of Telaglenastat in patients with renal cell carcinoma, Provention Bio’s near-term regulatory catalyst; and disbanding of Haven Healthcare joint venture.
1. Calithera Falls to New Low As Renal Cell Carcinoma Trial Fails
Shares of Calithera Biosciences Inc. (CALA) plunged over 40% to touch a new low on Monday, following disappointing topline results from a phase II study of Telaglenastat in patients with advanced or metastatic renal cell carcinoma, dubbed CANTATA.
In the phase II trial, the combination of Telaglenastat and Cabozantinib did not meet the primary endpoint of improving progression free survival when compared to approved drug Cabozantinib alone.
As a result of the disappointing trial results and in order to allow it to focus on ongoing programs, Calithera will trim its workforce by roughly 35 percent.
The company will continue to focus on its phase II trial of Telaglenastat in non-small cell lung cancer, dubbed KEAPSAKE, phase I study of CB-280 in patients with cystic fibrosis and emerging pipeline.
CALA closed Monday’s trading at $2.72, down 44.60%.
2. Haven Healthcare to End Operations in February
Haven Healthcare, a joint venture formed by Berkshire Hathaway’s Warren Buffett, Amazon’s Jeff Bezos and JP Morgan Chase’s Jamie Dimon in 2018, is all set to end its operations at the end of February 2021.
The joint venture was formed to make primary care easier to access, insurance benefits simpler to understand and easier to use, and prescription drugs more affordable.
In a statement issued yesterday, Haven noted that “moving forward, Amazon, Berkshire Hathaway, and JPMorgan Chase & Co. will leverage these insights and continue to collaborate informally to design programs tailored to address the specific needs of their own employee populations”.
3. Matinas BioPharma to Report ENHANCE-IT Trial Data This Quarter
The FDA has conditionally accepted Lypdiso as the proposed brand name for Matinas BioPharma Holdings Inc.’s (MTNB) drug candidate MAT9001.
MAT9001 is being developed for the treatment of cardiovascular and metabolic conditions.
An open-label, randomized, 28-day crossover study assessing the pharmacodynamic effects of MAT9001 against Amarin Corp.’s (AMRN) approved drug Vascepa, dubbed ENHANCE-IT, is underway, with topline data expected this quarter (Q1, 2021).
MTNB closed Monday’s trading at $1.74, up 27.94%. In after-hours, the stock was up another 10.92% at $1.93.
4. Ocugen On a Roll as Partner’s COVID-19 Vaccine Gets Regulatory Nod in India
Shares of Ocugen Inc. (OCGN) hit a new 52-week high on Monday, thanks to the emergency use approval of its partner Bharat Biotech’s COVID-19 vaccine, Covaxin, in India.
Covaxin, which is currently in phase III trials in India, is said to have a potentially broader coverage against multiple protein antigens of the coronavirus. Being a whole-viron inactivated vaccine, Covaxin could be effective against mutated coronavirus strains including the UK variant, according to Indian Council of Medical Research (ICMR) Director General Balram Bhargava.
Last month, Ocugen appointed a vaccine scientific advisory board comprised of leading academic and industry experts in the vaccine field to evaluate the clinical and regulatory path to approval of Covaxin in the U.S.
OCGN closed Monday’s trading at $3.07, up 67.76%. In after-hours, the stock gained another 5% and was at $3.22.
5. Pandion Soars on Safety Trial Data of Autoimmune Disease Drug PT101
Shares of Pandion Therapeutics (PAND) jumped more than 47% on Monday, following positive top-line data from its phase Ia trial of PT101 in healthy volunteers, achieving the primary objective of safety and tolerability.
PT101 is an engineered IL-2 mutein fused to a protein backbone, in development for ulcerative colitis, systemic lupus erythematosus, and other autoimmune diseases.
The company plans to initiate a phase 1a/2b clinical trial of PT101 in ulcerative colitis in mid-2021 and phase II clinical trial in systemic lupus erythematosus in the second half 2021.
Pandion made its debut on the Nasdaq Global Market on July 17, 2020, offering its shares at a price of $18 each.
PAND has thus far hit a low of $10.28 and a high of $27.75. The stock closed Monday’s trading at $21.94, up 47.74%.
6. Provention Bio to Face FDA in July
Provention Bio Inc.’s (PRVB) immunotherapy drug Teplizumab, proposed for the delay or prevention of clinical type 1 diabetes (T1D) in at-risk individuals, has been accepted for priority review by the FDA, with a decision expected on July 2, 2021.
Type 1 diabetes, previously known as juvenile diabetes, is an autoimmune disease in which the body’s immune system attacks and destroys the insulin-producing beta cells of the pancreas.
According to an article, published in the Lancet journal last August, in a phase II study, at-risk individuals, i.e., relatives of patients with type 1 diabetes who did not have diabetes but were at high risk for developing it, when treated with single 14-day course of Teplizumab were diagnosed with type 1 diabetes 48.4 months after treatment while the participants on placebo were diagnosed with the disease 24.4 months after the start of the study.
Provention acquired all rights to Teplizumab from MacroGenics Inc. in 2018. MacroGenics had licensed Teplizumab to Eli Lilly and Company (LLY) in 2007. After Teplizumab failed in a phase III trial, Lilly had pulled the plug on the drug candidate in October 2010.
PRVB closed Monday’s trading at $18.26, up 7.79%.
7. Stocks That Hit New Highs/Lows
Bionano Genomics Inc. (BNGO) closed Monday’s trading at a 52-week high of $7.20, up 33.77%.
Jaguar Health Inc. (JAGX) closed at a 52-week high of $1.78, up 118.40%.
ViewRay Inc. (VRAY) closed at a 52-week high of $6.41, up 67.80%.
Calithera Biosciences Inc. (CALA) closed at an all-time low of $2.72, down 44.60%.
Clever Leaves Holdings Inc. (CLVR) closed at an all-time low of $8.89, down 0.11%.
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