On March 29, 2021 Hutchison China MediTech Limited ("HUTCHMED") (Nasdaq/AIM: HCM) reported that on March 26, 2021, it granted conditional awards ("LTIP Awards") under the Long Term Incentive Plan adopted by HUTCHMED in 2015 ("LTIP") and share options under the Share Option Scheme adopted by HUTCHMED in 2015 as refreshed in April 2020 (the "Share Option Scheme") (Press release, Hutchison China MediTech, MAR 29, 2021, View Source [SID1234577245]).

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1. Performance-related LTIP Award for the HUTCHMED Financial Year 2021 ("Performance LTIP") – award based on a maximum cash amount, which amount is determined by the achievement of performance targets for the financial year ending 31 December 2021. The performance targets will be determined by the Remuneration Committee of HUTCHMED based on the strategic objectives of HUTCHMED.

The Shares, to be purchased by the Trustee following determination of the cash amount based on actual achievement of performance targets, will then be held by the Trustee until the underlying LTIP Awards are vested. Vesting will occur two business days after the date of announcement of the annual results of HUTCHMED for the financial year ending December 31, 2023. Vesting will also depend upon the continued employment of the award holder with the HUTCHMED group and will otherwise be at the discretion of the Board of Directors of HUTCHMED.

HUTCHMED has granted the following LTIP Awards for the Performance LTIP to the following PDMRs:

Award Holder Maximum amount for the Performance LTIP
Mr Christian Hogg (Executive Director and Chief Executive Officer) US$1,616,538
Mr Johnny Cheng (Executive Director and Chief Financial Officer) US$657,211
Dr Weiguo Su (Executive Director and Chief Scientific Officer) US$1,622,123
An additional 585 employees of HUTCHMED and its subsidiaries have simultaneously been granted LTIP Awards under the Performance LTIP.

2. Share Option Scheme

HUTCHMED granted share options under its Share Option Scheme to 147 employees to subscribe for a total of 8,279,900 Ordinary Shares represented by 1,655,980 American Depositary Shares ("ADSs") (each equating to five Ordinary Shares) subject to the acceptance of the grantee. Details of such share options granted prescribed are as follows:

Date of grant : March 26, 2021
Exercise price of share options granted : US$27.94 per ADS
Number of share options granted : 8,279,900 represented by 1,655,980 ADSs (five share options shall entitle the holder thereof to subscribe for one ADS)
Closing market price of ADSs on the date of grant : US$27.66 per ADS
Validity period of the share options : From March 26, 2021 to March 25, 2031
Among the share options granted, a total of 1,391,800 share options represented by 278,360 ADSs were granted to Mr Christian Hogg, Dr Weiguo Su and Mr Johnny Cheng (Executive Directors of the Company), being persons discharging managerial responsibility under the EU Market Abuse Regulation as follows:-

Grantee Number of share options granted
Mr Christian Hogg (Executive Director and Chief Executive Officer) 868,900 Ordinary Shares represented by 173,780 ADSs
Mr Johnny Cheng (Executive Director and Chief Financial Officer) 240,500 Ordinary Shares represented by 48,100 ADSs
Dr Weiguo Su (Executive Director and Chief Scientific Officer) 282,400 Ordinary Shares represented by 56,480 ADSs

(a) Mr Christian Hogg
1 Details of the person discharging managerial responsibilities/person closely associated
a) Name Mr Christian Hogg
2 Reason for the notification
a) Position/status Executive Director and Chief Executive Officer
b) Initial notification/Amendment Initial notification
3 Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitor
a) Name Hutchison China MediTech Limited
b) LEI 2138006X34YDQ6OBYE79
4 Details of the transaction(s): section to be repeated for (i) each type of instrument; (ii) each type of transaction; (iii) each date; and (iv) each place where transactions have been conducted
a) Description of the financial instrument, type of instrument
Identification code
Option over American Depositary Share (each equating to five Ordinary Shares of US$0.10)

Option over American Depositary Share with ADS ISIN: US44842L1035

b) Nature of the transaction
Grant of options in respect of 868,900 Ordinary Shares represented by 173,780 ADSs under the Share Option Scheme.

The share options granted are exercisable subject to a vesting schedule of 25% on each of the first, second, third and fourth anniversaries of the effective date of grant.

c) Price(s) and volume(s)
Price(s) Volume(s)
Nil 173,780
d) Aggregated information
— Aggregated volume
— Price N/A
e) Date of the transaction 2021-03-26
f) Place of the transaction Outside a trading venue

(b) Mr Johnny Cheng
1 Details of the person discharging managerial responsibilities/person closely associated
a) Name Mr Johnny Cheng
2 Reason for the notification
a) Position/status Executive Director and Chief Financial Officer
b) Initial notification/Amendment Initial notification
3 Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitor
a) Name Hutchison China MediTech Limited
b) LEI 2138006X34YDQ6OBYE79
4 Details of the transaction(s): section to be repeated for (i) each type of instrument; (ii) each type of transaction; (iii) each date; and (iv) each place where transactions have been conducted
a)
Description of the financial instrument, type of instrument

Identification code

Option over American Depositary Share (each equating to five Ordinary Shares of US$0.10)

Option over American Depositary Share with ADS ISIN: US44842L1035

b) Nature of the transaction
Grant of options in respect of 240,500 Ordinary Shares represented by 48,100 ADSs under the Share Option Scheme.

The share options granted are exercisable subject to a vesting schedule of 25% on each of the first, second, third and fourth anniversaries of the effective date of grant.

c) Price(s) and volume(s)
Price(s) Volume(s)
Nil 48,100
d) Aggregated information
— Aggregated volume
— Price N/A
e) Date of the transaction 2021-03-26
f) Place of the transaction Outside a trading venue

(c) Dr Weiguo Su
1 Details of the person discharging managerial responsibilities/person closely associated
a) Name Dr Weiguo Su
2 Reason for the notification
a) Position/status Executive Director and Chief Scientific Officer
b) Initial notification/Amendment Initial notification
3 Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitor
a) Name Hutchison China MediTech Limited
b) LEI 2138006X34YDQ6OBYE79
4 Details of the transaction(s): section to be repeated for (i) each type of instrument; (ii) each type of transaction; (iii) each date; and (iv) each place where transactions have been conducted
a)
Description of the financial instrument, type of instrument

Identification code

Option over American Depositary Share (each equating to five Ordinary Shares of US$0.10)

Option over American Depositary Share with ADS ISIN: US44842L1035

b) Nature of the transaction
Grant of options in respect of 282,400 Ordinary Shares represented by 56,480 ADSs under the Share Option Scheme.

The share options granted are exercisable subject to a vesting schedule of 25% on each of the first, second, third and fourth anniversaries of the effective date of grant

c) Price(s) and volume(s)
Price(s) Volume(s)
Nil 56,480
d) Aggregated information
— Aggregated volume
— Price N/A
e) Date of the transaction 2021-03-26
f) Place of the transaction Outside a trading venue

On March 29, 2021 Checkmate Pharmaceuticals, Inc. (NASDAQ: CMPI) ("Checkmate"), a clinical stage biopharmaceutical company focused on developing its proprietary technology to harness the power of the immune system to combat cancer, reported full year 2020 financial results and provided an update on recent progress (Press release, Checkmate Pharmaceuticals, MAR 29, 2021, View Source [SID1234577267]).

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"We made strong progress in 2020, laying the groundwork to broaden and accelerate our CMP-001 clinical program in melanoma and other solid tumor indications," said Barry Labinger, President and Chief Executive Officer of Checkmate.

Recent Progress

In December 2020, Checkmate announced a clinical collaboration with Bristol Myers Squibb to evaluate vidutolimod (formerly CMP-001) in combination with nivolumab. The companies will collaborate on two melanoma clinical trials.
In January 2021, Checkmate appointed Robert F. Dolski as Chief Financial Officer. Mr. Dolski brings more than 20 years of diversified management experience as a life sciences financial executive.
Vidutolimod (formerly CMP-001) Anticipated 2021 Milestones

Advance lead melanoma indication toward potential registration, supported by two Phase 2 trials. These trials will study vidutolimod in combination with nivolumab for the treatment of anti-PD-1 refractory melanoma and first-line metastatic or unresectable melanoma. We initiated patient dosing in the first-line melanoma trial in March 2021. Trial sites have been activated and patient screening is underway in the refractory melanoma study.
Expand into new indications, such as head and neck cancer, which is expected to be supported by a Phase 2 proof-of-concept trial. This trial will study vidutolimod in combination with pembrolizumab for the treatment of first-line head and neck cancer. Trial sites have been activated and patient screening is underway. Initial data from this trial are expected before the end of 2021.
Full Year 2020 Financial Results

Cash, cash equivalents and investments: Cash, cash equivalents and investments were $125.9 million as of December 31, 2020.
Research and development expenses (R&D): R&D Expenses for the full year 2020 were $26.7 million, compared to $24.3M for the prior year. The increase was primarily attributable to increased headcount and consulting costs in connection with preparing for the initiation of planned additional clinical trials of CMP-001. These increases were partially offset by a decrease in contract manufacturing costs.
General and administration expenses (G&A): G&A expenses for the full year 2020 were $10.2 million, compared to $4.6 million for the prior year. The increase was primarily attributable to increases in personnel and other operating expenses incurred in connection with Checkmate beginning to operate as a publicly traded company.
Net loss: Net loss for the full year 2020 was $36.9 million, compared to $28.3 million for the prior year.

On March 29, 2021 Onconova Therapeutics, Inc. (NASDAQ: ONTX) ("Onconova"), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, reported that Steven Fruchtman, M.D., President and Chief Executive Officer, will present a Company overview and hold one-on-one meetings during the Spring 2021 Oncology Investor Conference, sponsored by the National Foundation for Cancer Research (Press release, Onconova, MAR 29, 2021, View Source [SID1234577283]).

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Event: Spring 2021 Oncology Investor Conference
Date: The virtual conference will take place March 29 to April 2, 2021
Onconova Presentation: Thursday, April 1, 2021 at 11:50 a.m. Eastern time
Conference Registration Link: View Source

A webcast of Dr. Fruchtman’s presentation will be available on the Company’s website at View Source beginning Friday, April 2nd.

On March 29, 2021 Therapeutic Solutions International, Inc., (OTC Markets: TSOI), reported new data and a new patent filing demonstrating this new immunotherapy derived from inducible pluripotent stem cells (iPSC) induces potent and selective killing of cancer associated blood vessels (Press release, Therapeutics Solutions International, MAR 29, 2021, View Source [SID1234577300]).

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In contrast to other approaches, the current immunotherapy involves transfection of the enzyme alpha1,3-galactosyltransferase into the iPSC, following that iPSC cells are transformed into tumor endothelial-like cells and used for immunization. The introduction of the alpha1,3-galactosyltransferase gene causes the cells to express to Gal alpha 1-3Gal beta-4-GlcNAc (alpha Gal). Alpha Gal is one of the most potent immune stimulating molecules in nature, evoking one of the most potent immune responses known to man.

"Previous immunotherapies activate and recruit approximately 1 out of 1,000,000 immune cells to attack cancer whereas the current approach activates as much as 1 out of 100 immune cells," said Dr. James Veltmeyer, Chief Medical Officer of the Company. "It is well known in the field of xenotransplantation that humans possess 1 to 5% of their antibodies directed towards the alpha Gal epitope which is found in all animals with the exception of monkeys and humans. This is God’s way of stopping inter-species transplantation. By directing this potent antibody response against tumor blood vessels our preliminary data supports feasibility of this novel approach in attacking the Achilles heel of cancer, which is angiogenesis."

Side by side comparison between the currently described approach and approaches, such as placental derived cancer endothelial vaccines like ValloVax by Batu Biologics, suggest significantly higher level of immunity towards cancer angiogenesis can be obtained with the currently described approach.

"The advantage of using iPSC technology is that we are generating consistent and reproducible cell therapy products, which are two features essential for partnership with Big Pharma as well as progression through the regulatory process," said Famela Ramos, Vice President of Business Development. "What we are talking about here is the production of a Third Generation Cellular Immunotherapy for cancer."

"Our Company’s philosophy has always been to leverage existing propensities of the body as opposed to fighting the body," stated Timothy Dixon, President and CEO of the Company and co-inventor. "I commend our collaborating scientists for the completely novel concept of leveraging existing premade antibodies as a new way of shutting down the formation of new blood vessels by the cancer."

On March 29, 2021 ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, reported the publication of Phase I data in The Journal of ImmunoTherapy of Cancer (JITC) (Press release, ImmunityBio, MAR 29, 2021, View Source [SID1234577246]). The publication, titled "Phase I study of a multitargeted recombinant Ad5 PSA/MUC-1/ brachyury-based immunotherapy vaccine in patients with metastatic castration-resistant prostate cancer (mCRPC)" highlighted the safety, T-cell immunogenicity, and clinical activity of ImmunityBio’s second-generation human adenovirus (hAd5) in patients with incurable mCRPC. ImmunityBio’s hAd5 is designed to deliver tumor-associated antigens, or TAAs, and neoepitopes (expressed only by cancer cells) and has the capability to induce T-cell memory due to the activation of both CD4+ and CD8+ T cells along with antibody (or humoral) responses.

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"The finding of T-cell-mediated immunity induced in 100% of 17 prostate cancer patients whose white blood cells were evaluated in the study validates the ability of our hAd5 vaccine platform to generate a potent response to antigens delivered," said Patrick Soon-Shiong, M.D., Founder and Executive Chairman of ImmunityBio. "Furthermore, the demonstration that the vaccine can be administered repeatedly, without adverse effects at the dose of 5x 1011 viral particles, supports the application of this hAd5 platform in both cancer and infectious diseases such as COVID-19. These early results, which include signals of clinical activity and durable stable disease, are encouraging for patients with highly resistant advanced metastatic prostate cancer and warrants further study."

Study Highlights:

Eligible patients had to have incurable metastatic castration-resistant metastatic prostate cancer with radiologic evidence of progression or PSA progression
The vaccine was safe and well tolerated with no grade >3 treatment-related adverse events or dose-limiting toxicities (DLTs) observed
The recommended Phase II dose was 5×1011viral particles (VPs) administered three times repeatedly every 3 weeks
One patient achieved a partial response (PR), 5 patients had confirmed stable disease (SD) for greater than 6 months, with confirmed PSA decline
Median progression-free survival (PFS) was 22 weeks (95% confidence interval: 19.1 to 34)
Median overall survival (OS) was not reached, and the 12-month OS probability for all patients was 83.3% (95% confidence interval: 56.8% to 94.3%)
100% (17 out of 17) of patients mounted T-cell responses to at least one tumor-associated antigen and 16 of 17 (94%) patients developed T-cell responses to >1 antigen encoded by the vaccine
In the Phase 1 study undertaken in collaboration with Investigators at the Genitourinary Malignancy Branch of the National Cancer Institute, 18 patients with mCRPC who had advanced, incurable disease were given concurrently three hAd5 vaccines targeting PSA, brachyury, and MUC-1 at 5×1011 (VPs) each, subcutaneously every 3 weeks for a maximum of three doses (dose de-escalation cohort), followed by a booster vaccine every 8 weeks for 1 year (dose-expansion cohort only). Additional trial details can be found at clinicaltrials.gov-NCT03481816.

ImmunityBio has developed multiple product candidates that use this hAd5 viral vector to deliver tumor-associated antigens, which are being studied in multiple Phase I and Phase II clinical trials as potential vaccines for the treatment of solid tumors including breast, pancreatic, lung, head and neck, and prostate cancers. Importantly, these hAd5-based vaccines have shown an ability to overcome previous adenovirus immunity in cancer patients and in preclinical models. This same hAd5 viral vector has been applied for the treatment of infectious diseases and is in clinical trials for SARS-CoV-2 using hAd5 S+N as antigen constructs.