On December 16, 2021 Cullinan Oncology, Inc. (Nasdaq: CGEM) ("Cullinan"), a biopharmaceutical company focused on developing a diversified pipeline of targeted therapies for cancer patients, reported updated data from the Company’s ongoing Phase 1/2a trial of CLN-081 in non-small cell lung cancer (NSCLC) patients whose tumors harbor epidermal growth factor receptor (EGFR) exon 20 insertion mutations that have progressed on or after prior therapy (Press release, Cullinan Oncology, DEC 16, 2021, View Source [SID1234597297]).

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"The updated data from our ongoing Phase 1/2a study in a larger number of patients further reinforce CLN-081’s differentiated clinical profile. CLN-081 has demonstrated both a high response rate and durable responses in heavily pre-treated patients," said Nadim Ahmed, Chief Executive Officer of Cullinan Oncology. "For many lung cancer patients currently receiving EGFR inhibitors, treatment related side effects can significantly impact their daily lives. In this regard, we are encouraged by CLN-081’s favorable safety profile at the 100mg BID dose."

The current analysis of the ongoing trial included a total of 73 NSCLC patients with EGFR exon 20 insertion mutations who received at least one dose of CLN-081 and were evaluable for safety as of the data cutoff. CLN-081 was administered orally, at dose levels including 30, 45, 65, 100 and 150 mg twice daily (BID). Based on prespecified safety and efficacy criteria, enrollment at the Phase 2a cohort for 100mg BID was expanded up to the planned maximum of 36 patients. Additional patients were also enrolled at the 150mg BID dose level, although enrollment was subsequently discontinued after a total of 11 patients based on overall assessment of the clinical profile at this dose level. Guided by these data,100mg BID was nominated as the Recommended Phase 2 Dose (RP2D) for CLN-081.

Efficacy Highlights:

Efficacy data from patients enrolled in the 100mg BID cohort:

Of 36 response evaluable patients, 14 achieved a confirmed PR for a 39% confirmed response rate and one additional patient had a PR that was pending confirmation at the time of the data cut-off.
The median duration of response was >15 months and the median progression free survival was 12 months in the initial cohort of phase 1 patients (N=13).
Safety and Tolerability Highlights:

Treatment related EGFR associated adverse event (AE) data for patients enrolled in the 100mg BID cohort:

Rash has been limited to Grade 1 and 2 events (54% and 18% of patients, respectively). Events were manageable with conventional supportive care and no patients have experienced Grade 3 or greater treatment-related rash.
Diarrhea has been limited to Grade 1 and 2 events (26% and 8% of patients, respectively). No prophylactic regimen has been required to ameliorate the incidence or severity of diarrhea to date, and no patients have experienced Grade 3 or greater treatment-related diarrhea.
"We are pleased with CLN-081’s safety and efficacy to date. CLN-081 has demonstrated antitumor activity among heavily pre-treated patients, including patients treated previously with other EGFR inhibitors or immunotherapy, and across a spectrum of exon 20 mutational sub-types," said Jon Wigginton, M.D., Chairman of the Cullinan Oncology Scientific Advisory Board and Senior Advisor. "We are similarly encouraged by the emerging durability data shown in this update, which we believe could also reflect the benefit of the drug’s favorable safety and tolerability profile. Our goal now is to review these results and potential future clinical development with the FDA and to move CLN-081 as expeditiously as possible into late-stage development."

Additional data are available in a presentation accompanying this press release on the Events section of our website.

About CLN-081

CLN-081 is an orally available, irreversible EGFR inhibitor that selectively targets cells expressing EGFR exon 20 insertion mutations while sparing cells expressing wild type EGFR. Cullinan is evaluating various doses of CLN-081 in a Phase 1/2a trial in patients with NSCLC harboring exon 20 mutations whose disease has progressed on or after prior therapy.

On December 16, 2021 Cellestia Biotech AG reported that the European Commission (EC) has granted CB-103 an orphan designation for the treatment of Acute Lymphoblastic Leukaemia (ALL) (Press release, Cellestia Biotech, DEC 16, 2021, View Source [SID1234597294]).

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This is the first Orphan Designation granted to CB-103. It is an important milestone in the development of CB-103, as it represents an official recognition from EMA that CB-103 looks promising in bringing significant benefit to those affected by ALL.

On December 16, 2021 BioCanRx’s network community, stakeholders and sponsors met virtually for the fifth Summit for Cancer Immunotherapy (Summit4CI) – BioCanRx’s annual scientific conference. Summit4CI brought together close to 400 attendees including leading scientists, clinicians, trainees, economists and representatives from industry, patient groups, charities and government (Press release, BioCanRx, DEC 16, 2021, View Source;utm_medium=rss&utm_campaign=successful-virtual-summit-cancer-immunotherapy [SID1234597291]).

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The Scientific Programming Committee organized a great agenda including plenaries on Advances in Cellular Immunotherapy, Approaches to Making Cold Tumors Hot and Advances in Pediatric Immunotherapy. The Oxford-style Debate focused on "Who is driving the CAR: NK cells vs T Cells." It was Dr. Jean-Sébastien "T cells rule" Delisle VS Dr. Michele "NK cells rock" Ardolino. After a lively debate, with strong arguments presented on both sides, the audience voted and declared Dr. Ardolino the winner.

Our network trainees took part in an HQP Development Day including a Meet the Experts lunch and more. Again this year, the scientific posters by our trainees were of a high calibre. Learn more about the HQP activities at the 2021 Summit4CI.

The BioCanRx-Cancer Stakeholder Alliance Learning Institute was back for its fourth edition at Summit4CI. It brought together four patient/caregiver leaders (Patient Scholars) and four Highly Qualified Personnel (Academic Scholars) in a series of virtual interactive Knowledge Exchange Sessions with the purpose of teaching patients/caregivers about the emerging and innovative concepts in immune-oncology and providing HQP an opportunity to learn from patients and get feedback about their research. Each Patient Scholar was paired with an Academic Scholar and the pairs presented key takeaways in plain language of the scientific Summit talks during the Knowledge Exchange Sessions.

The Learning Institute participants also took part in the Patient-Researcher Roundtable – a workshop-style event where Patient Scholars and funded BioCanRx Investigators discussed actionable ways to involve patient partners in their research programs. The event was facilitated by Drs. Manoj Lalu and Justin Presseau, of the Ottawa Hospital Research Institute, and included engagement by BioCanRx’s Cancer Stakeholder Alliance working group members. "With great discussions and conversation, the Learning Institute brings to light the importance of patient collaboration in research, as well as the translation of scientific information into plain language that is easily understood by all," said Dr. Stéphanie Michaud, President and CEO of BioCanRx.

BioCanRx also held a Public Forum titled ‘Understanding Cancer Immunotherapy Clinical Trials in Canada: Are they Needed Now More than Ever?’ Speakers included a clinical trial doctor, a patient partner who has participated in a clinical trial and a scientist who spoke about the latest developments in immunotherapy cancer research and treatments. You can watch the forum here.

Many thanks to our Scientific Programming Committee and all our Summit4CI speakers, the HQP Working Group and our Learning Institute organizers. A big thank you to our 2021 sponsors and exhibitors – we could not hold the Summit without your strong support!

BioCanRx’s Summit4CI Speaker Series will be resuming in the new year! Stay tuned to the Summit4CI website cancersummit.ca or biocanrx.com for announcements.

We hope you’ll save the date for next year’s Summit4CI! We’ll be meeting ‘in-person’ in Montreal at the Fairmont The Queen Elizabeth Hotel – November 19 – 21, 2022!

On December 16, 2021 invIOs (innovative Immuno-Oncology) GmbH, a privately held biotechnology company developing novel therapies for cancer, reported it will commence operations on 1 January 2022 (Press release, Apeiron Biologics, DEC 16, 2021, View Source [SID1234597288]).

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invIOs, a fully owned subsidiary of APEIRON Biologics AG has been assigned APEIRON’s innovative cancer immunotherapy activities and all related clinical and preclinical R&D projects.

invIOs’ CEO Peter Llewellyn-Davies and his management team have taken this step to realize the full potential of its cutting-edge development projects and to create an early clinical-stage focused entity to allow investors to benefit from significant upside potential, especially specialized international biotech investors.

The proprietary cell therapy technology platform for the modulation of intracellular Immuno-Oncology targets enables rapid treatment of patients using their own cells with short out-of-body time in an out-patient setting. The groundbreaking concept allows access to indications that have previously not been addressable by earlier cell therapy approaches.

The first clinically validated target is the immune master-checkpoint Cbl-b; the clinicalstage lead candidate APN401 will show results in the near term on safety with data from an ongoing Phase 1b trial to be finalized in Q2 2022. A discovery pipeline with two additional promising candidates could give rise to new effective therapies for cancer patients, namely INV441 aiming to activate TILs (tumor-infiltrating lymphocytes) in solid tumors and INV501, an oral small molecule for tumor specific immune activation.

Peter Llewellyn-Davies, CEO of invIOs, comments: "Our passion is to develop life-saving therapies for patients suffering from cancer where there currently exist only limited treatment options. invIOs’ highly experienced team has a proven track-record of taking drugs to market with a core competency in immuno-oncology. The new company is geared towards enabling innovation and growth and will facilitate access to funding from specialized investors and partners. invIOs’ novel approach represents an investment opportunity with significant upside potential and important benefits for healthcare professionals and patients."

invIOs is headquartered in Vienna, Austria and will streamline the development of novel therapies in immuno-oncology backed by the acumen of the existing team. Accordingly, all current APEIRON employees are assigned to invIOs.

On December 16, 2021 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, reported that the Company is participating in the LifeSci Partners 11th Annual Corporate Access Event, which will be held virtually from January 5-7, 2022, and the H.C. Wainwright BioConnect Conference, which will be held January 10-13, 2022 (Press release, Anixa Biosciences, DEC 16, 2021, https://ir.anixa.com/news/detail/989/anixa-biosciences-to-participate-in-upcoming-january-investor-conferences-lifesci-partners-annual-corporate-access-event-and-h-c-wainwright-bioconnect-conference [SID1234597287]).

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Participation and presentation details are below:

LifeSci Partners Corporate Access Event:
Dr. Amit Kumar, Chairman, President and Chief Executive Officer of Anixa Biosciences will present on a panel entitled, "Cancer Vaccines: Promises, Promises…Has Their Day Come?" on Friday, January 7th, 2:00 pm ET.
During the duration of the LifeSci Corporate Access Event, the Anixa Biosciences management team will be available for 1×1 meetings with interested investors. Register here to submit a meeting request or to hear the panel discussion.
H.C. Wainwright BioConnect Conference:
Anixa Biosciences will present at the H.C. Wainwright BioConnect Conference and a recording of the presentation will be accessible beginning January 10th at 7:00 am ET. To listen to the presentation, visit the Investor Relations/Events & Presentations portion of Anixa’s company website.
The Anixa Biosciences management team will be available for 1×1 meetings with interested investors. Register here for the conference.