BPC August 27 update

ESMO presentations to watch; Biotech week in review

Weekly watchlist

This last week had increased developments for COVID-19 vaccines with the full approval of Pfizer and BioNTech’s vaccine in individuals 16 years of age and older, while a small-cap acquisition sparked a much-awaited rally and signs of sector rotation in biotech stocks.

This week’s watch list focuses on companies presenting at the European Society for Medical Oncology (ESMO) conference to be held September 16-21, 2021. Abstracts for the conference are scheduled to be released on Monday September 13 at 00:05 CEST (Sunday September 12 at 6:30pm EST).

First, let’s review the week that was with notable news makers.

REGULATORY:

Pfizer (NYSE: PFE) and BioNTech (NASDAQ: BNTX) celebrated the approval of COMIRNATY, the COVID-19 vaccine for use in adults aged 16 and older. They also initiated a supplemental Biologics License Application (sBLA) to the FDA for the approval of a booster (third) dose. The companies intend to complete submission of the sBLA by the end of this week.

Cassava Sciences (NASDAQ:SAVA) shares tanked following allegations of false or misleading data in its Alzheimer’s trials to close the week down 44% to $58.34. Labaton Sucharow LLP.’s citizen petition calls for the ongoing Phase 2 and pending Phase 3 trials to be halted until a complete data audit is completed by the FDA. The FDA has only commented that it has received the petition. In Cassava’s press release responding to the civil petition for the FDA to audit its data, Cassava named Quanterix as the company that generated the results in question. Quanterix refuted claims that they interpreted test results for the Alzheimer’s Association International Conference (AAIC) in July 2021, stating they only collected the data but did not conduct the analysis. Cassava confirmed this relationship in a press release Friday.

Cara Therapeutics (NASDAQ:CARA) announced that the FDA approved KORSUVA (difelikefalin) for injection for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis. Shares closed the week up 6% to $14.58.

Axsome Therapeutics, Inc. (NASDAQ: AXSM) shares closed the week up 11% to $24.00 following news the FDA has delayed its decision regarding its review of the New Drug Application (NDA) for AXS-05 for the treatment of major depressive disorder. The initial PDUFA date was scheduled for August 22, 2021. The FDA has not requested additional information from the company.

Ascendis Pharma A/S (NASDAQ: ASND) obtained FDA approval for its drug SKYTROFA (lonapegsomatropin-tcgd), the first once-weekly treatment for pediatric growth hormone deficiency. Shares closed the week up 28% to 154.76

CLINICAL UPDATES:

Theravance Biopharma, Inc. (NASDAQ: TBPH) shares plunged 41% to $8.23 for the week, on news top-line data from its Phase 2b trial of izencitinib, for the treatment of ulcerative colitis, did not meet its primary endpoint.

OTHER:

Pfizer Inc. (NYSE: PFE) announced Monday that it will acquire Trillium Therapeutics Inc. (NASDAQ: TRIL) and its CD47 assets for $2.26 billion, or $18.50 per share, representing a 118% premium to the 60-day weighted average price. Shares surged to close the week up 184% to $17.32.

Drug Price Stage Catalyst Market Cap

ADAP – Adaptimmune Therapeutics plc
ADP-A2M4CD8 (SURPASS)
Solid tumors

$5.40
+0.11  +2%
Phase 1 Phase 1 data released September 13, 2021 - 4% of patients received CR, 28% received PR, 44% received SD, 12% received PD, 3% not evaluable. Additional data due at ESMO September 16-21, 2021.
$842.9 million

AGEN – Agenus Inc.
Balstilimab (anti-PD-1) and Zalifrelimab - AGEN1884 (anti-CTLA-4)
Cervical cancer

$5.83
+0.26  +5%
Phase 2 Phase 2 data showed in 125 patients, the objective response rate (ORR) was 26%, with 9% of patients achieving a complete response (CR), and 17% of patients achieving a partial response (PR), noted September 17, 2021.
$1.4 billion

AYLA – Ayala Pharmaceuticals Inc.
AL101 (ACCURACY)
Adenoid cystic carcinoma

$12.02
-0.13  -1%
Phase 2 Preliminary Phase 2 data had a disease control rate (DCR) of 70% (23/33 patients), partial responses (PR) in 3 patients (9%), stable disease (SD) in 20 patients (61%). Progressive disease (PD) was observed in 8 patients (24%), noted September 16, 2021. Additional Phase 2 data due in 2022.
$159.2 million

AZN – AstraZeneca PLC
ENHERTU (trastuzumab deruxtecan) - DESTINY-Breast03
Second line HER2+ breast cancer

$55.56
-1.04  -2%
Phase 3 Phase 3 data trial met primary endpoint - August 9, 2021. Late breaker at ESMO September 18, 2021.
$172.1 billion

BGNE – BeiGene Ltd.
DKN-01 and Tislelizumab ( DisTinGuish)
Gastric / Gastroesophageal Junction Cancer

$403.14
+17.90  +5%
Phase 2a Phase 2a data showed of the 25 patients, 15 patients had experienced a partial response (PR), 6 patients had stable disease (SD), 1 patient was non-evaluable for response (NE), and 3 patients were unable to complete a full cycle of DKN-01 therapy. The ORR was 68.2%, with 90% ORR in DKK1-high patients and 56% in DKK1-low patients noted September 16, 2021.
$37.5 billion

BYSI – BeyondSpring Inc.
Plinabulin (Trial 103) - DUBLIN-3
Non small cell lung cancer - refractory

$22.91
+0.40  +2%
Phase 3 Phase 3 top-line data met primary endpoint of overall survival (p = 0.03) - August 4, 2021. Late breaker at ESMO September 20, 2021. NDA Submission for plinabulin in NSCLC 1H 2022.
$698.6 million

FSTX – F-star Therapeutics Inc.
FS120
Advanced Cancer

$7.59
+0.62  +9%
Phase 1 Phase 1 trial in progress update at ESMO September 16, 2021. Further update trial progress later this year.
$156.5 million

MRK – Merck & Company Inc.
KEYTRUDA (pembrolizumab) + chemo (KEYNOTE-826)
Cervical Cancer

$71.68
-0.29  -0%
Phase 3 Phase 3 trial met dual primary endpoints of overall survival (OS) and progression-free survival (PFS) - June 22, 2021. Late breaker data to be presented at ESMO September 18, 2021.
$181.4 billion

MRTX – Mirati Therapeutics Inc.
Adagrasib (MRTX-849), Erbitux (cetuximab) and KEYTRUDA (pembrolizumab) - KRYSTAL-01
Solid Tumors

$174.05
+5.03  +3%
Phase 1/2 Phase 1/2 cetuximab data to be orally released at ESMO September 19, 2021.
$9 billion

SBTX – Silverback Therapeutics Inc.
SBT6050 (monotherapy and pembrolizumab)
HER2 Positive Solid Tumors

$12.55
+0.05  +0%
Phase 1 Phase 1/1b presented at ESMO September 16, 2021. Among 18 evaluable patients for tumor types of interest, 1 patient had a confirmed partial response (5%). In addition, stable disease was reported in 7 patients (38%).
$439.7 million

SYRS – Syros Pharmaceuticals Inc.
SY-5609
Solid tumors

$5.08
-0.37  -7%
Phase 1 Phase 1 abstract to be released late September 16, 2021. Phase 1 dose-escalation data to be presented at ESMO September 20, 2021.
$314.6 million

TCRR – TCR2 Therapeutics Inc.
Gavo-cel (TC-210)
Mesothelin-positive solid tumors

$9.99
-5.73  -36%
Phase 1/2 Phase 1/2 data showed 1 Grade 3 and 1 Grade 5 [patient death] reported. 6 patients achieved partial response (PR), and 1 complete response (CR). Overall response rate (ORR) of 31%. By independent review assessment, the ORR was 25% with a DCR Rate of 81%. The median overall survival for patients with mesothelioma is 11.2 months, whereas the median progression free survival (PFS) is 5.9 months, September 17, 2021.
$381.6 million

VSTM – Verastem Inc.
VS-6766 and Defactinib - FRAME
KRAS mutant advanced solid tumors

$2.76
+0.06  +2%
Phase 1/2 Phase 1/2 updated data due at ESMO September 19, 2021.
$498.9 million