Affimed Says FDA Grants Fast Track Designation For AFM13 With AlloNK To Treat R/r Hodgkin Lymphoma

Immuno-oncology company Affimed N.V. (AFMD) announced that the FDA has granted fast track designation to the combination of its innate cell engager (ICE) AFM13 with AlloNK for the potential treatment of relapsed/refractory (r/r) Hodgkin lymphoma (HL).

The combination treatment is entering Phase 2 development and will be investigated in Affimed’s LuminICE-203 study (NCT05883449), which received IND-clearance earlier this year. The study also includes an exploratory cohort of CD30-positive peripheral T-cell lymphoma patients.

The FDA’s decision is based on available data showing the potential of the AFM13 and AlloNK combination therapy to overcome current limitations in the treatment of r/r HL.

LuminICE-203 builds on the clinical findings from the phase 1/2 AFM13-104 trial (NCT04074746), in which investigators assessed AFM13 in combination with cord blood-derived natural killer cells in heavily pretreated patients with CD30-positive Hodgkin lymphoma and non-Hodgkin lymphoma.

Data presented to date from this trial have shown outstanding clinical results in late-stage, multi-refractory, patients with a 94% overall response rate (ORR), a 71% complete response (CR) rate and a well-managed safety profile at the recommended phase 2 dose (RP2D).

Oil Prices Edge Higher Ahead Of IEA And OPEC Reports

Oil prices edged higher on Tuesday amid supply worries stemming from fresh disruption from powerful storms and floods in eastern Libya.

Benchmark Brent crude futures climbed 0.7 percent to $91.30 a barrel, while WTI crude futures were up 0.8 percent at $88.03.

Four major oil ports in Libya – Ras Lanuf, Zueitina, Brega and Es Sidra – were closed from Saturday evening for three days, due to flooding and a storm, which killed about 2,000 people.

Investors also await the release of OPEC’s closely watched monthly report as well as the International Energy Agency monthly report for clues of how demand is likely to hold up this year.

Most importantly, traders await forecasts of Chinese demand amid dwindling bets that the country will drive oil demand to record highs this year.

Industry data on U.S. crude stocks from the American Petroleum Institute will be published later in the day.

Pre-market Movers: HSDT, UPTD, ADTX, RENB, MLGO…

The following are some of the stocks making big moves in Tuesday’s pre-market trading (as of 07.45 A.M. ET).

In the Green

Helius Medical Technologies, Inc. (HSDT) is up over 62% at $12.02.
Renovaro Biosciences Inc. (RENB) is up over 20% at $3.92.
MicroAlgo Inc. (MLGO) is up over 14% at $3.40.
Zai Lab Limited (ZLAB) is up over 12% at $29.28.
NextGen Healthcare, Inc. (NXGN) is up over 10% at $21.43.
Eve Holding, Inc. (EVEX) is up over 9% at $8.00.
Crixus BH3 Acquisition Company (BHAC) is up over 8% at $11.38.

In the Red

TradeUP Acquisition Corp. (UPTD) is down over 30% at $15.23.
Aditxt, Inc. (ADTX) is down over 20% at $32.81.
Reliance Global Group, Inc. (RELI) is down over 14% at $2.58.
VinFast Auto Ltd. (VFS) is down over 13% at $25.61.
SeqLL Inc. (SQL) is down over 13% at $15.45.
TRxADE HEALTH, Inc. (MEDS) is down over 13% at $10.09.
Manchester United plc (MANU) is down over 9% at $21.39.
Heliogen, Inc. (HLGN) is down over 7% at $6.88.
Hanryu Holdings, Inc. (HRYU) is down over 7% at $4.40.
Wheeler Real Estate Investment Trust, Inc. (WHLR) is down over 7% at $3.90.
Sibanye Stillwater Limited (SBSW) is down over 6% at $5.62.

Intel To Divest About 10% Stake In IMS Nanofabrication Business To TSMC

Intel Corp. (INTC) announced Tuesday that it has agreed to sell an approximately 10% stake in the IMS Nanofabrication business to Taiwan Semiconductor Manufacturing Co. Ltd. or TSMC (TSM).

TSMC’s investment values IMS at approximately $4.3 billion, consistent with the valuation of the recent stake sale to Bain Capital Special Situations.

Intel will retain majority ownership of IMS, which will continue to operate as a standalone subsidiary under the leadership of CEO Dr. Elmar Platzgummer. The transaction is expected to close in the fourth quarter of 2023.

IMS is the established industry leader in multi-beam mask writing tools required to develop advanced extreme ultraviolet lithography (EUV).

Together, Bain Capital and TSMC’s investments provide IMS with increased independence and reinforce confidence in the significant opportunity ahead of IMS.

Intel initially invested in IMS in 2009 and ultimately acquired the remaining stakes in 2015. In June 2023, Intel announced an agreement to sell an approximately 20% stake in IMS to Bain Capital.

AbbVie Reports Top-line Results From Phase 3 SEQUENCE Clinical Trial Of Risankizumab

Biopharmaceutical company AbbVie, Inc. (ABBV) announced Tuesday top-line results from the Phase 3 SEQUENCE clinical trial evaluating risankizumab (SKYRIZI, 600 mg intravenous [IV] induction at week 0, 4 and 8 and 360 mg subcutaneous injection [SC] starting at week 12 and every 8 weeks thereafter) versus ustekinumab (STELARA, IV dose at week 0 and 90 mg SC every 8 weeks thereafter) through week 48 in patients with moderately to severely active Crohn’s disease who have failed one or more anti-TNFs.

The results of the first primary endpoint, clinical remission (per Crohn’s Disease Activity Index [CDAI], defined as CDAI <150) at week 24, met non-inferiority of risankizumab versus ustekinumab, with remission rates of 59% in risankizumab group and 40% in ustekinumab group.

The results of the second primary endpoint, endoscopic remission at week 48 met superiority of risankizumab versus ustekinumab, with remission rates of 32% in risankizumab group and 16% in ustekinumab group.

The safety profile of risankizumab in the SEQUENCE study was consistent with the known safety profile of risankizumab.

Risankizumab (SKYRIZI) is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.