PTX Media related, page-17

The below is from the last 4C.

"The Phase 1b basket study of PTX-100 in several solid and haematological cancers has recruited
patients for the highest dose level of 2,000 mg/m2. As detailed in previous updates, a number of
patients remained on the therapy longer than anticipated which has required additional
manufacturing. Manufacturing is currently underway and is on schedule. Headline safety results
are expected to be reported in the coming quarter."

From the AGM presentation Nov 2020:

"PTX-100 ADDRESSES MANY TYPES OF RAS MUTATIONS
80% of cancer Ras cancer patients harbour
more than one Ras mutation!

Competitor drugs are targeting one very
specific type of Ras mutation
• KRAS G12C
• This approach can lead to underwhelming
responses and/or relapse

PTX-100 has a unique mechanism that can
potentially address all K-Ras and N-Ras
mutant cancers"

From endpoints news today:

"Mirati steps on the gas with KRAS inhibitor, looking to claim second approval behind Amgen's Lumakras

Nicole DeFeudisEditor

Amgen beat Mirati to the finish line with the first-ever approved KRAS inhibitor back in May. But Mirati’s picking up the pace and says it could be looking to carve out a space on the market by the end of the year with what it thinks is the better of the two data sets as monotherapy.
The FDA has granted breakthrough designation to Mirati’s adagrasib in non-small cell lung cancer patients with the KRAS-G12C mutation following prior therapy, the company said on Thursday.
The decision was based on preliminary results from the Phase I/II KRYSTAL-01 trial, in which 45% of patients saw an objective response, according to data presented in October. Those numbers come from a pooled data set of 51 patients who received 600 mg doses in Mirati’s Phase I/Ib and II. Forty-five percent achieved a partial response, and 51% saw stable disease as of the August cut-off. Five patients had unconfirmed partial responses, which were later confirmed, according to Mirati.
In a pooled set of 110 patients (also including those with colorectal cancer and other tumors), 30% suffered Grade 3 or 4 treatment-related side effects, the most frequent being increased ALT and AST. Two patients died due to treatment-related events, including one with pneumonitis and one with cardiac failure.
“We look forward to submitting a New Drug Application for adagrasib in the second half of this year and further advancing adagrasib across a broad development plan with the goal of improving clinical outcomes in patients with KRASG12C mutated cancers,” CEO Charles Baum said in a statement.
For decades KRAS was seen as an “undruggable” target. There had been a variety of attempts to break down those hurdles, but Amgen’s Lumakras came out on top in May when it scored an approval in non-small cell lung cancer patients with the KRAS-G12C mutation. The drug — also known as sotorasib — posted a 37.1% overall response rate among 126 patients with advanced NSCLC. There were three complete responses and 43 partials, with a median duration of response of 10 months.
But Amgen’s data in other tumor types are less impressive. In a Phase I trial in colorectal, sotorasib posted just a 7.1% response rate, with the majority of the 42 patients in the trial receiving at least three prior lines of therapy. In other tumors outside of NSCLC and colorectal, just three of 22 patients showed partial responses seven weeks after treatment.
Back in October, Evan Seigerman at Credit Suisse wrote:This highly anticipated data suggests continued strong efficacy that could be seen as superior to Amgen’s Sotorasib. While the presenter was hesitant to make a direct cross trial comparison, we think this data is incrementally very positive for Mirati and could allow for Adagrasib to emerge as the “winner” in the monotherapy setting.
Earlier this month, China’s Zai Lab shelled out $65 million in cash (with up to $273 million more on the line) for an exclusive license to adagrasib in the Greater China region. The deal also comes with royalties in the “high-teens to low-twenties-percent.” Mirati will hold an option to co-commercialize adagrasib in China if it so chooses, and retains full commercial rights elsewhere.
“Their capabilities position Mirati to further develop adagrasib for patients with cancer who harbor the KRASG12C mutation around the world,” Baum said at the time."

PTX's PTX 100 phase 1 trial is as a monotherapy in a basket of different cancers. There have been no adverse events reported to date.

This is an exciting time for both patients and shareholders.